chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Tachypnoea, Urticaria, Use of accessory respiratory muscles
Clinical narrative: - approx 5 minutes after administration of the vaccines, patient had abrupt onset of facial and lip swelling, lethargy, paleness with perioral cyanosis, and tachypnea - epinephrine was administered SQ immediately and she was placed on 100% O2 by facemask and EMS was called - EMS arrived within 7 minutes and transported her to hospital; prior to arrival to EMS, patient was pale, and lethargic with occasional outbursts of agitation - she had impressive lip swelling, pale appearance and hives noted on upper thighs; she was drooling but there was no stridor - she had clear breath sounds - tachypnea and mild retractions were also noted; she was also tachycardic but this was noted approx 3 min after the administration of SQ epinephrine. - contact by ER - patient received another dose of epi in ER along with Benadryl and steroids - stable and doing well - BP a little low - considering PICU vs IMC admission.  10/1/09 ED records received DOS 9/24/09 to 9/25/09. Assessment: Acute Anaphylaxis. Patient developed immediate oral swelling, lip edema, and emesis. Presents with general weakness, decreased level of consciousness, lightheadedness, rapid respirations, coughing, wheezing. Pale, tired. Erythematous splotches legs. Observe overnight.
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Blood glucose increased, Dyspnoea, Heart rate increased, Infection
Clinical narrative: double respitory and heart rate.  Breathing difficulty.  bone marrow produced 24,000 extra white blood cells signifying an infection. high blood sugar levels.  Vaccine accidently overdosed 2x. 10/8/09 Hospital medical records received for 6/24/2009-7/2/2009. FINAL DX: r/o suspected sepsis; hypoglycemia; tachypnea; hyperbilirubinemia; feeding/growth & nutrition issues. Records reveal patient 38-wk preemie born via spontaneous vaginal delivery following good prenatal care.  Pregancy complicated w/H1N1 infection tx w/tamiflu 5 wks prior to delivery & asymptomatic for 1 wk prior to delivery.  Apgars 8/9 at 1/5 min.  Temp instability then increased respiratory rate from 78 to 88, glucose 92 & transferred to NICU.  Tx w/IVF & IV antibiotics x 7 days.  O2 sats 96% on RA.  Improved & d/c to home.
Sex: F
Vaccine: HEP
Symptoms: Respiratory rate increased, White blood cell count increased
Clinical narrative: double respitory and heart rate.  Breathing difficulty.  bone marrow produced 24,000 extra white blood cells signifying an infection. high blood sugar levels.  Vaccine accidently overdosed 2x. 10/8/09 Hospital medical records received for 6/24/2009-7/2/2009. FINAL DX: r/o suspected sepsis; hypoglycemia; tachypnea; hyperbilirubinemia; feeding/growth & nutrition issues. Records reveal patient 38-wk preemie born via spontaneous vaginal delivery following good prenatal care.  Pregancy complicated w/H1N1 infection tx w/tamiflu 5 wks prior to delivery & asymptomatic for 1 wk prior to delivery.  Apgars 8/9 at 1/5 min.  Temp instability then increased respiratory rate from 78 to 88, glucose 92 & transferred to NICU.  Tx w/IVF & IV antibiotics x 7 days.  O2 sats 96% on RA.  Improved & d/c to home.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia facial, Palpitations
Clinical narrative: Patient has a hypertensive reaction with a BP of 160/100 compared with her normal readings of 104/80. She experienced facial numbness and heart palpitations.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hyperhidrosis, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: pt. stated she had history of fainting with shots but had not occurred in over 10 years. After injection was complete pt. immediately stated she did not feel well and fainted in her chair. I was able to hold her for a few minutes and she never appeared to lose consciousness. She was sweaty, nausea, and cold. We moved her to the floor and elevated her feet with a cold towel on her face/head. Pt requested paramedics and they checked her out and said she was stable. Pt stayed in pharmacy for about 30 minutes until she went home. She was feeling better when she left.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: pt. stated she had history of fainting with shots but had not occurred in over 10 years. After injection was complete pt. immediately stated she did not feel well and fainted in her chair. I was able to hold her for a few minutes and she never appeared to lose consciousness. She was sweaty, nausea, and cold. We moved her to the floor and elevated her feet with a cold towel on her face/head. Pt requested paramedics and they checked her out and said she was stable. Pt stayed in pharmacy for about 30 minutes until she went home. She was feeling better when she left.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site mass, Injection site scab, Pain in extremity
Clinical narrative: Pt is complaining that the injection site is "oozing" and then forming a scab and that her arm is hurting from the shoulder down towards her hand. She has a lump at the injection site
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Ear discomfort, Headache, Metabolic function test, Nuclear magnetic resonance imaging abnormal
Clinical narrative: headache day of injection 8/18, ear discomfort and sudden hearing loss 8/19 to R ear. appointment with PCP 8/20. appt with ENT specialist 8/24, prescribed prednisone. appointment with audiologist 8/24. apointment with ENT specialist and Audiologist 9/8. MRI ordered and done 9/10. appt 9/11 with ENT specialist for steroid injection to R ear. Appt 9/22 with ENT specialist and audiologist. labs ordered.  9/28/09 ENT Consultant records DOS 8/24/09 DOS 8/24/09 to 9/27/09. Assessment: Sensorineural Hearing Loss. Patient c/o decreased hearing (R) ear, dizziness. Profound sensorineural hearing loss (R) ear, normal hearing (L) ear. Tinnitus. Nausea. Left maxillary sinus bone mucous retention cyst  12/30/09 Pediatric Medical records received for DOS 08/24/09, 09/15/09.  Telephone request for referral to ENT specialist. On prednisone and will f/u with ENT Impression : viral hearing loss, probably not vaccine related..
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate
Clinical narrative: headache day of injection 8/18, ear discomfort and sudden hearing loss 8/19 to R ear. appointment with PCP 8/20. appt with ENT specialist 8/24, prescribed prednisone. appointment with audiologist 8/24. apointment with ENT specialist and Audiologist 9/8. MRI ordered and done 9/10. appt 9/11 with ENT specialist for steroid injection to R ear. Appt 9/22 with ENT specialist and audiologist. labs ordered.  9/28/09 ENT Consultant records DOS 8/24/09 DOS 8/24/09 to 9/27/09. Assessment: Sensorineural Hearing Loss. Patient c/o decreased hearing (R) ear, dizziness. Profound sensorineural hearing loss (R) ear, normal hearing (L) ear. Tinnitus. Nausea. Left maxillary sinus bone mucous retention cyst  12/30/09 Pediatric Medical records received for DOS 08/24/09, 09/15/09.  Telephone request for referral to ENT specialist. On prednisone and will f/u with ENT Impression : viral hearing loss, probably not vaccine related..
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Oropharyngeal pain, Sputum purulent
Clinical narrative: Severe hoarseness; sore throat, treated with Sudafed, Aleve, and Vitamin C 500mg, plenty of fluids. I still have symptoms present after one week, expectorating yellow secretions.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dysarthria, Headache, Hypoaesthesia, Hypoaesthesia facial, Nuclear magnetic resonance imaging
Clinical narrative: Headache, then blurry vision, numbness in right hand the right side of the face, numbness on right side of the body. Slurred speech. No treatment. Blurred vision lasted 5 minutes,numbness went away in about 1 hour. 10/6/09 PCP medical records neuro and ophth consults DOS 2/17/09 to 9/22/09. Assessment: Transient visual loss, headache, migraine, hyperopia. Patient presents with blurred vision, floaters. Tingling in hand, shoulder, facial area, down leg, felt that she would pass out. Lightheaded, nauseous. Numbness right side. Oral contraceptives.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Vision blurred
Clinical narrative: Headache, then blurry vision, numbness in right hand the right side of the face, numbness on right side of the body. Slurred speech. No treatment. Blurred vision lasted 5 minutes,numbness went away in about 1 hour. 10/6/09 PCP medical records neuro and ophth consults DOS 2/17/09 to 9/22/09. Assessment: Transient visual loss, headache, migraine, hyperopia. Patient presents with blurred vision, floaters. Tingling in hand, shoulder, facial area, down leg, felt that she would pass out. Lightheaded, nauseous. Numbness right side. Oral contraceptives.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Confusional state, Eye disorder, Headache, Hypoaesthesia
Clinical narrative: since 8/6/09 pt has had headaches, eye problems, confusion, numbeness in hands and feet.  Had MRI that was negative, bones are achey.  Pt had Strep at the end of July, vomiting with amoxicillin then inner ear infection in august.10/19/09.     10/05/09 Neurology consult received DOS 9/22/09. Assessment: Panic attacks. Patient was first noted to have red itchy bumps on arms and abdomen. The bumps eventually went away. Throat was red, placed on amoxicillin and started to vomit. Found to have urinary tract infection, placed on antibiotic and vomited again. Inner ear infection, placed on antibiotics, vomited, could not eat. Became confused and was seen at an ER where she had a panic attack followed by perioral numbness along with numbness and tingling of hands and feet. Fecal retention, ER visit, panic attacks. Patient now to be evaluated for c/o paresthesias over hands / feet , malaise, arthralgia. Neurological exam normal.Primary care and emergency department records received for dates of service 8/7/09 to 9/22/09.  Dx:  Streptococcal pharyngitis on 8/7/09. Vomiting, diarrhea, dehydration, tonsillitis 8/11/09.  Acute sinusitus 9/4/09.  Abdominal pain, vomiting in ED 9/6/09.  Weakness, constipation, chills, numbness 9/8/09. Weakness, depression with anxiety, numbness and abdominal pain 9/9/09.  Anxiety, vomiting in ED 9/10/09.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Labyrinthitis, Streptococcal infection, Vomiting
Clinical narrative: since 8/6/09 pt has had headaches, eye problems, confusion, numbeness in hands and feet.  Had MRI that was negative, bones are achey.  Pt had Strep at the end of July, vomiting with amoxicillin then inner ear infection in august.10/19/09.     10/05/09 Neurology consult received DOS 9/22/09. Assessment: Panic attacks. Patient was first noted to have red itchy bumps on arms and abdomen. The bumps eventually went away. Throat was red, placed on amoxicillin and started to vomit. Found to have urinary tract infection, placed on antibiotic and vomited again. Inner ear infection, placed on antibiotics, vomited, could not eat. Became confused and was seen at an ER where she had a panic attack followed by perioral numbness along with numbness and tingling of hands and feet. Fecal retention, ER visit, panic attacks. Patient now to be evaluated for c/o paresthesias over hands / feet , malaise, arthralgia. Neurological exam normal.Primary care and emergency department records received for dates of service 8/7/09 to 9/22/09.  Dx:  Streptococcal pharyngitis on 8/7/09. Vomiting, diarrhea, dehydration, tonsillitis 8/11/09.  Acute sinusitus 9/4/09.  Abdominal pain, vomiting in ED 9/6/09.  Weakness, constipation, chills, numbness 9/8/09. Weakness, depression with anxiety, numbness and abdominal pain 9/9/09.  Anxiety, vomiting in ED 9/10/09.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Eye discharge, Headache, Ocular hyperaemia
Clinical narrative: Eyes bloodshot within 1 hour after vaccinatio, loose stools, headache, temp 98, green drainage from both eyes
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Induration, Injection site reaction, Rash pruritic
Clinical narrative: local reaction at injection site.  Red, indurated, pruritic area left arm 4cm diameter in size. Developed a very small pruritic area the day after injection, which worsened in size by the following morning.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC
Symptoms: Erythema, Induration
Clinical narrative: PT WAS NOTED TO HAVE A RED RAISED AREA APPROXIMATLEY 10/5MM INDURATION AFTER VACCINE WAS GIVEN. PT WAS ASKED TO STAY IN CLINIC FOR OBSERVATION, 1 TEASPOON OF BENADRYL WAS GIVEN PO. MOTHER WAS INSTRUCTED TO MONITOR FOR OTHER SIGNS AND SYMPTOMS OF ALLERGIC REACTION INCLUDING HIGH FEVER OVER 102 AFTER ADMIN. CHILDREN TYLENOL/MOTRIN, RASH THAT CONTINUES TO INCREASE IN SIZE OR THAT GOES ALL OVER BODY, SOB,LETHERGY NEDDS TO BE REPORTED TO EMERGENCY ROOM AND/PRIVATE PHYSICIAN ASAP.MOTHER STATES THAT SEE UNDERSTANDS. PT ALSO INSTRUCED TO INFORM PRIVATE DR. OF REACTION ASAP.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I received the TDAP shot Monday 09-21-09 at the time I had no problems three days later my right under arm (lymphnoid) swelled up and was very painful I took a 800 mg ibuprofen and it did help a little but the site stayed swollen for several days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Erythema, Oedema peripheral
Clinical narrative: Arm showed redness and swelling approximately 4 inches below the injection site.  Patient was seen by physician and diagnosed with an allergy to a component of the flu vaccine
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Eye swelling, Flushing, Neck pain, Pain in extremity
Clinical narrative: approximately 30 minutes after adminstration of seasonal flu vaccine increasingly severe radiating pain in deltoid to neck and ear began, facial flushing, swelling of both orbits.Went to onsite emergency dept. and was treated with IV benadryl, solumedrol, and tagament.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: approximately 30 minutes after adminstration of seasonal flu vaccine increasingly severe radiating pain in deltoid to neck and ear began, facial flushing, swelling of both orbits.Went to onsite emergency dept. and was treated with IV benadryl, solumedrol, and tagament.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy, Headache
Clinical narrative: 9/15/09 - Received flu vaccine   9/18/09 - Began with a severe headache.   9/19/09 - Woke up with Left sided facial drooping. Went to the ER
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash macular
Clinical narrative: Rednees on skin started Tuesday 09-22-09.  Pt was given the vaccine on 09-21-09.  Red splotchy area approximately 4 inches in diameter around injection site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Flu vaccine given on 09-22-2009 at 2 p.m., hives and swelling on hands started at 9 pm on 9-22-09 until 7 p.m. on 09-23-09. Benadryl was taken orally three times. No trouble after last dose.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Within a few minutes after administration,there was profound swelling  left deltoid.  Ice pack applied Benadryl 50mg po given at 10:30am. She returned to work.  I called her at 2:15pm she felt well though deltoid was still swollen. Her plan is to call her MD which she had done that day.  She has a allergy to mangoes.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, No reaction on previous exposure to drug, Pain in extremity, Sleep disorder
Clinical narrative: Had flu vaccine administered at pharmacy and have had trouble with my arm ever since. For the first week it was painful to sleep, my arm was extremely sore. As of date I can not fully extend my arm. Went back to the clinic today and was told to go to my primary doctor. He started me on anti-inflammatory medicine. The person given the shot could have administered it in a weird place in the arm. I noticed that it was given at a higher spot than normal. My arm when I move it certain ways almost feels like a pinched nerve. I went in before the shot fine and did nothing to cause pain in the arm. I also have gotten a flu shot every year with no adverse effects. This is day 13. Will see if the anti-inflammatory helps. This is most unusal for me and like I stated...I have never had anything like this happen after a seasonal flu shot. Thanks for your time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Condition aggravated, Crying, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: After receiving first set of immunizations patient had an episode of body stiffning with arms flexed. Patient did not have loss of consiousness or syncope. Patient started crying again and having normal infant activity after placed on exam table. VS after episode: P 112, R 40, T 99.0 axillary. Mother states this has happened in the past when patient is crying, angry, or hungry. Mother was told to take patient to ER for further evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Irritability, Pruritus, Rash morbilliform
Clinical narrative: Broke out in a measles type rash within 24 hours of receiving vaccines and became irritable with itching, but no fever.Mother called to report symptoms the next day, and took the patient to the pediatrician 09/24/09 who said it looked like a measles reaction, but stated they don't usually occur for a week after the shot. Said if pt. developes a fever over the next few days, she would consider it a viral infection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Irritability, Rash morbilliform
Clinical narrative: Broke out in a measles type rash within 24 hours of receiving vaccines and became irritable with itching, but no fever.Mother called to report symptoms the next day, and took the patient to the pediatrician 09/24/09 who said it looked like a measles reaction, but stated they don't usually occur for a week after the shot. Said if pt. developes a fever over the next few days, she would consider it a viral infection.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Paraesthesia, Tremor
Clinical narrative: Patient received flu vaccine around 11:30 am.  Patient left clinic and "went to the store" with his wife where he began to feel light headed and "trembly".  He reported slight parasthesia in left leg.  Patient and wife left store and immediately came back to our clinic.  Arrived here again at approximately 12:00 noon.  At this time symptoms still existed, but were milder.  Pt stated "I just don't feel right".  Pt advised to return home and rest, take Benadryl for reaction treatment and Aleve for the aches.  Wife will monitor.  We followed up with a phone call at 4:00 pm and pt states he is doing much better.  He had taken Aleve and Benadryl and symptoms are beginning to resolve.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: Employee states a raised itching rash on forehead with slight brown coloration along hairline and eyebrows .  Employee unsure of when itching started pre or post vaccine immunization
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Culture throat, Enlarged uvula, Pharyngeal erythema, Streptococcal identification test
Clinical narrative: Red throat, swollen uvula
Age: 18.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Dyskinesia, Immediate post-injection reaction, Nausea, Oxygen saturation normal, Pallor
Clinical narrative: 9/17/09 approx 15:00 Pt presents with her mother to facility today for mmr and meningococcal vaccines. Immediately after the vaccines had been administered, pt became pale and fainted while sitting in the chair.  She came to quickly and then almost immediately fainted again. Again, she came to very quickly. After coming to each time, she immediately asked "what happened?".  Both times she fainted, her body "jerked momentarily" as she was passing out.  LPN was present the 2nd time the pt fainted. A wet, cool cloth was placed on her forehead and she c/o nausea though she never did vomit.  Vs were taken immediately: 1500: BP: 96/35, P: 54, O2Sats: 99%. She remained in the chair until I took her to a gurney to lie down via wheelchair at approx 1505. 1510: BP: 104/63, P: 55.  Explained to pt and her mother what causes fainting and reassured them that it is not uncommon to faint after getting injections or having blood draws.  They say this has never happened to her before. 1515: Pt lying down and states she's feeling better, but still with nausea. Color is much better. 1520: BP: 106/65, P: 57.  Pt is sitting up and drinking orange juice.  No c/o nausea at this time. 1525: BP: 117/74, P: 63. 1530: BP: 107/73, P: 50. 1535:  Pt feeling better and ready to leave.  No complaints at this time.  All questions answered.  Advised pt to tell medical personnel that she has a hx of fainting next time she needs shots or blood draw.  Pt agreed and verbalized understanding.  Pt left walking independently and with a steady gait. 1725:  I received a message to call patient's father.  When I called him back, he asked, "What caused my daughter to have a seizure today".  I explained she didn't have a seizure and he interrupted me with a raised voice and said "even a rocket scientist can tell someone's having a seizure if their arms are flailing, let alone a nurse".  (Father was not in the clinic today when the pt fainted).  I started to respond to father and he immediately asked to speak to my manager.  My manager is not in clinic today, so I transferred him to RN team lead.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Syncope
Clinical narrative: 9/17/09 approx 15:00 Pt presents with her mother to facility today for mmr and meningococcal vaccines. Immediately after the vaccines had been administered, pt became pale and fainted while sitting in the chair.  She came to quickly and then almost immediately fainted again. Again, she came to very quickly. After coming to each time, she immediately asked "what happened?".  Both times she fainted, her body "jerked momentarily" as she was passing out.  LPN was present the 2nd time the pt fainted. A wet, cool cloth was placed on her forehead and she c/o nausea though she never did vomit.  Vs were taken immediately: 1500: BP: 96/35, P: 54, O2Sats: 99%. She remained in the chair until I took her to a gurney to lie down via wheelchair at approx 1505. 1510: BP: 104/63, P: 55.  Explained to pt and her mother what causes fainting and reassured them that it is not uncommon to faint after getting injections or having blood draws.  They say this has never happened to her before. 1515: Pt lying down and states she's feeling better, but still with nausea. Color is much better. 1520: BP: 106/65, P: 57.  Pt is sitting up and drinking orange juice.  No c/o nausea at this time. 1525: BP: 117/74, P: 63. 1530: BP: 107/73, P: 50. 1535:  Pt feeling better and ready to leave.  No complaints at this time.  All questions answered.  Advised pt to tell medical personnel that she has a hx of fainting next time she needs shots or blood draw.  Pt agreed and verbalized understanding.  Pt left walking independently and with a steady gait. 1725:  I received a message to call patient's father.  When I called him back, he asked, "What caused my daughter to have a seizure today".  I explained she didn't have a seizure and he interrupted me with a raised voice and said "even a rocket scientist can tell someone's having a seizure if their arms are flailing, let alone a nurse".  (Father was not in the clinic today when the pt fainted).  I started to respond to father and he immediately asked to speak to my manager.  My manager is not in clinic today, so I transferred him to RN team lead.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt. came in for 4 month vaccinations and received Pediarix (DTap, Hep B, IPV) in Right Thigh.  Pt. had fever of 102.5 which started about 4-5 hours post injection and continued with fever for 4 days.  On the 3rd day post-injection (20 Sep 09) mom noticed rash starting on trunk of body.  The following day 21 Sep 09 Noah's body was covered with a fine rash from head to toe with continued spikes of fevers as well.  Mom stated she has not changed laundry detergents, soaps or clothing.  Pt. instructed to follow-up with pediatrician ASAP.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Abdominal discomfort, Cold sweat, Dyskinesia, Gaze palsy, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccinations, patient arched back, neck extended back and to the right, eyes fluttered and rolled back.  Patient not responsive; not answering questions or talking.  She was eased from the chair to the floor.  Her body was stiff and jerking and had to be fully supported by 2 individuals.  The jerking stopped within 2 minutes.  Patient remained lethargic, eyes opened and then slowly closed repeatedly for the next ~15 minutes.  Patient complained of upset stomach immediately following seizure-like activity, but denied needing to vomit.  Skin was pale and moist. 10/7/09 ER records received for date 9/21/09. DC DX: seizure vs. syncope. Presenting sx: As pt was receiving vaccine, she arched her back, may have had loss of consciousness and/or seizure. Pt states in ER feeling fine. Assessment: PE WNL. ICD9 codes: 781.0, 780.39.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Laboratory test normal, Lethargy, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Immediately after receiving vaccinations, patient arched back, neck extended back and to the right, eyes fluttered and rolled back.  Patient not responsive; not answering questions or talking.  She was eased from the chair to the floor.  Her body was stiff and jerking and had to be fully supported by 2 individuals.  The jerking stopped within 2 minutes.  Patient remained lethargic, eyes opened and then slowly closed repeatedly for the next ~15 minutes.  Patient complained of upset stomach immediately following seizure-like activity, but denied needing to vomit.  Skin was pale and moist. 10/7/09 ER records received for date 9/21/09. DC DX: seizure vs. syncope. Presenting sx: As pt was receiving vaccine, she arched her back, may have had loss of consciousness and/or seizure. Pt states in ER feeling fine. Assessment: PE WNL. ICD9 codes: 781.0, 780.39.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Posturing, Pregnancy test negative, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Immediately after receiving vaccinations, patient arched back, neck extended back and to the right, eyes fluttered and rolled back.  Patient not responsive; not answering questions or talking.  She was eased from the chair to the floor.  Her body was stiff and jerking and had to be fully supported by 2 individuals.  The jerking stopped within 2 minutes.  Patient remained lethargic, eyes opened and then slowly closed repeatedly for the next ~15 minutes.  Patient complained of upset stomach immediately following seizure-like activity, but denied needing to vomit.  Skin was pale and moist. 10/7/09 ER records received for date 9/21/09. DC DX: seizure vs. syncope. Presenting sx: As pt was receiving vaccine, she arched her back, may have had loss of consciousness and/or seizure. Pt states in ER feeling fine. Assessment: PE WNL. ICD9 codes: 781.0, 780.39.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Headache, Malaise, Nausea, Syncope
Clinical narrative: Syncopal episode approximately 5 minutes after administration of vaccine. No injury sustained. No sustained loc. Vital signs stable. Lied down for a bit, drank some juice and regained strength and left office after 20 mins. Did have breakfast this morning. Phone f/u in the evening--child still not feeling completely well--h/a, nausea. No fever. No vomiting. Recommended Tylenol dose.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Patient described arm feeling "tingling" and not able to grip items with right hand. As time progressed, patient stated forearm felt "cold" and fingers were "numb"
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Loss of consciousness, Nonspecific reaction, Respiratory arrest
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stopped breathing in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 September 2009 between 08:15 and 08:30, the subject received a dose of FLULAVAL (unknown). On 21 September 2009, within 15 to 30 minutes of vaccination with FLULAVAL, the subject experienced stopped breathing, passed out, seizure and nonspecific reaction. The healthcare professional reported a subject experienced a "reaction" in the office after receiving FLULAVAL. The subject passed out, had a seizure and stopped breathing. The rescue squad was called and he was taken to the emergency room. It is unknown what type of treatment he received, although all events resolved that day. The healthcare professional considered the events were life threatening. On 21 September 2009, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Skin warm
Clinical narrative: Achy body, tingling sensation from armpit to forearm. Forearm warm to the touch.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pruritus, Somnolence, Urticaria
Clinical narrative: Within 12 hours of shot, experienced uncommon fatigue, drowsiness. Within 24 hours of shot, began to itch and had a few whelps on my arms. Initially assumed it was a reaction to a mosquito or spider bite. A few hrs. later entire body covered in whelps with tremendous itching till I applied hydrocortisone cream and took BENADRYL. 48 hrs. after shot, whelps still severe.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had PNEUMOVAX and FLUZONE admin. on 9/22/09 and developed redness and swelling to entire left upper arm 9/24/09. Seen by his physician and placed on antibiotic.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: - Hard to walk -  Pain on right side thigh/hip.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Ear pain, Injection site erythema, Injection site swelling, Joint swelling, Local reaction
Clinical narrative: 9/9/09 - large local reaction - 29 inch area swelling, erythema at site of injection  -  Also ear pain on left - 9/10/09 - Swelling left face, arm, hand, leg, ankle treated with BENADRYL and Prednisone 50 mg for 3 days then tapered - 9/11/09 - Swelling improved - Urticaria began  - 9/12/09 Symptoms improved by 9/17/09 - Symptoms resolved.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Swelling face, Urticaria
Clinical narrative: 9/9/09 - large local reaction - 29 inch area swelling, erythema at site of injection  -  Also ear pain on left - 9/10/09 - Swelling left face, arm, hand, leg, ankle treated with BENADRYL and Prednisone 50 mg for 3 days then tapered - 9/11/09 - Swelling improved - Urticaria began  - 9/12/09 Symptoms improved by 9/17/09 - Symptoms resolved.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness on L thigh measures 10 x 12 mm, tender to touch.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Skin plaque, Skin swelling, Skin warm
Clinical narrative: Developed annular plaque - hot red + raised.  8 cm x 10 cm.  Reaction occurred within 3 hours.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site. Prescribed CIPRO, ANAPROXIN
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Flushing, Heart rate increased, Pruritus, Urticaria
Clinical narrative: Skin itching, reddened skin whelps, increased pulse, skin flushing, treatment BENEDRYL 2.5 mg by mouth.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Swelling
Clinical narrative: Lt arm cellulitis - severity 7/10 edema + pain from shoulder to elbow.  Immunizations given 9/23 5:45 PM.  Swelling noted 9 PM - increasing in severity until seen by PCP 9/24 9 AM.  Treated with AUGMENTIN 8.75-12.5 x 7 days.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen cellulitis upper arm RA.
Age: 51.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: I advised nurse to administer FLUMIST to this patient, after admin. she noted she is 51; and thus >49yoa.
Age: 0.52
Sex: F
Vaccine: DTAP, FLU3, HEP, IPV, PNC, RV1
Symptoms: No adverse event
Clinical narrative: None stated
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Discomfort, Fatigue, Herpes zoster
Clinical narrative: My wife had a serious-severe-case of shingles in Oct. 07. Nothing could be done to alievate the pain and discomfort because of the lateness of getting it diagnosed. In december we both got the shot to prevent myself from getting shingles and she to prevent shingles from reacuring. Over a month ago or a Sunday I developed sever stomach pains ,no vomiting or gastro problems. Getting ready for bed we observed a slight rash on my left side. Within hours it flaired up and by Monday when I went to the doctors I had a full blown case. I was given an anti viral med. Wether this eased my discomfort or what my condition was nothing compared to that of my wife-still has the discomfort in her right side. As I write this report, after a month, I am tried, lack energy and have been taking Hydrocodone to relieve the pain at night, and during the day when needed. I have just started my refill and have been told that if the pain persists I will have to put on something other a narcotic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: My wife had a serious-severe-case of shingles in Oct. 07. Nothing could be done to alievate the pain and discomfort because of the lateness of getting it diagnosed. In december we both got the shot to prevent myself from getting shingles and she to prevent shingles from reacuring. Over a month ago or a Sunday I developed sever stomach pains ,no vomiting or gastro problems. Getting ready for bed we observed a slight rash on my left side. Within hours it flaired up and by Monday when I went to the doctors I had a full blown case. I was given an anti viral med. Wether this eased my discomfort or what my condition was nothing compared to that of my wife-still has the discomfort in her right side. As I write this report, after a month, I am tried, lack energy and have been taking Hydrocodone to relieve the pain at night, and during the day when needed. I have just started my refill and have been told that if the pain persists I will have to put on something other a narcotic.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash papular, Rash pustular
Clinical narrative: Small red papulo pustules on both legs.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Haematoma, Nerve injury, Pain, Paraesthesia
Clinical narrative: Pain, paresthesias, hemaroma and superficial nerve irritation.
Sex: U
Vaccine: VARCEL
Symptoms: Eye swelling, Rash, Urticaria
Clinical narrative: Rash broke out on chest, stomach, back of neck and under arms, swollen eyes with welt under right eye.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Awoke 9/24/2009 w/scattered red 2-3 mm papules on face, trunk, extremities some. Vesicular-none crusted. New ones coming out rapidly.
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Crying, Injection site pruritus, Rash, Wheezing
Clinical narrative: Less than 10 mins after vaccines given pt developed rash on face and arms and began crying. Pruritic at site of INFANRIX. Began crying and wheezing, required Epinephrine, DECADRON, and BENADRYL in office, paramedics took him to ED.
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Cough, Crying, Emergency care, Medical observation, Rash
Clinical narrative: Less than 10 mins after vaccines given pt developed rash on face and arms and began crying. Pruritic at site of INFANRIX. Began crying and wheezing, required Epinephrine, DECADRON, and BENADRYL in office, paramedics took him to ED.
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Urticaria, Wheezing
Clinical narrative: Less than 10 mins after vaccines given pt developed rash on face and arms and began crying. Pruritic at site of INFANRIX. Began crying and wheezing, required Epinephrine, DECADRON, and BENADRYL in office, paramedics took him to ED.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Vomiting, fever, rash all over body with in 30 minutes to 1 hour.  BENADRYL 12.5mg children's meltaway given and ambulance called to monitor.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Decreased appetite, Dyspnoea, Feeling cold, Headache
Clinical narrative: Had abdominal pain, headache, loss of appetite, still feels like upper respiratory illness, difficulty breathing; feel cold.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Had abdominal pain, headache, loss of appetite, still feels like upper respiratory illness, difficulty breathing; feel cold.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Decreased appetite, Headache, Injection site pain
Clinical narrative: Pt had abdominal pain, headache, loss of appetite. Awful pain where shot was given.
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 2 days post vaccination, pt c/o redness, itching, rash.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site induration
Clinical narrative: Hard area around injection site - Uncomfortable - Went to ER.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Marked erythema surrounding injection site, fever, chills, nausea, vomiting on day 7-8 after vaccine. Also areas of possible dissemination on upper and lower extremities. LEVAQUIN 750 mg daily X 5 days given empirically.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Abdominal pain, Anorexia, Barium double contrast, Enema administration, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 31-JUL-2009 a 5 month old female was vaccinated with the first dose of ROTATEQ (Lot No. 663716/0287Y) by mouth. The patient received pneumococcal vaccine and DTaP + Hib + Poliovirus vaccine as concomitant vaccination. Patient had a history of nasopharyngeal reflux and upper respiratory tract infection (AM of vaccination). On 06-AUG-2009 patient experienced symptoms of abdominal pain, anorexia and vomiting that was bile stained and presented to the emergency room (ER). The patient underwent and air contrast enema, abdominal Xray and abdominal ultrasound. A urine culture revealed no growth, KUB Xray revealed abnormal results, dilated central bowel loops. Blood gases PH 7.34 (L) pco2 33. Medical records were received on 24-AUG-2009 for the date of service of 06-AUG-2009 to 07-AUG-2009 and reported that the patient presented with two days of emesis. Assessment was intussusception. It was reported that the barium air contrast was successful. The listing indicated with one or more of the events required hospitalization, and were considered to be immediately life-threatening. A Lot Check has been initiated. The original reporting source was not provided. The VAERS ID No. is 353801. A preliminary lot check investigation was performed. To date our investigation had found that this lot conformed lot quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Blood gases, Blood pH
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 31-JUL-2009 a 5 month old female was vaccinated with the first dose of ROTATEQ (Lot No. 663716/0287Y) by mouth. The patient received pneumococcal vaccine and DTaP + Hib + Poliovirus vaccine as concomitant vaccination. Patient had a history of nasopharyngeal reflux and upper respiratory tract infection (AM of vaccination). On 06-AUG-2009 patient experienced symptoms of abdominal pain, anorexia and vomiting that was bile stained and presented to the emergency room (ER). The patient underwent and air contrast enema, abdominal Xray and abdominal ultrasound. A urine culture revealed no growth, KUB Xray revealed abnormal results, dilated central bowel loops. Blood gases PH 7.34 (L) pco2 33. Medical records were received on 24-AUG-2009 for the date of service of 06-AUG-2009 to 07-AUG-2009 and reported that the patient presented with two days of emesis. Assessment was intussusception. It was reported that the barium air contrast was successful. The listing indicated with one or more of the events required hospitalization, and were considered to be immediately life-threatening. A Lot Check has been initiated. The original reporting source was not provided. The VAERS ID No. is 353801. A preliminary lot check investigation was performed. To date our investigation had found that this lot conformed lot quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Culture urine negative, Decreased appetite, Enema administration, Intussusception, Laboratory test abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 31-JUL-2009 a 5 month old female was vaccinated with the first dose of ROTATEQ (Lot No. 663716/0287Y) by mouth. The patient received pneumococcal vaccine and DTaP + Hib + Poliovirus vaccine as concomitant vaccination. Patient had a history of nasopharyngeal reflux and upper respiratory tract infection (AM of vaccination). On 06-AUG-2009 patient experienced symptoms of abdominal pain, anorexia and vomiting that was bile stained and presented to the emergency room (ER). The patient underwent and air contrast enema, abdominal Xray and abdominal ultrasound. A urine culture revealed no growth, KUB Xray revealed abnormal results, dilated central bowel loops. Blood gases PH 7.34 (L) pco2 33. Medical records were received on 24-AUG-2009 for the date of service of 06-AUG-2009 to 07-AUG-2009 and reported that the patient presented with two days of emesis. Assessment was intussusception. It was reported that the barium air contrast was successful. The listing indicated with one or more of the events required hospitalization, and were considered to be immediately life-threatening. A Lot Check has been initiated. The original reporting source was not provided. The VAERS ID No. is 353801. A preliminary lot check investigation was performed. To date our investigation had found that this lot conformed lot quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Ultrasound abdomen, Urinary system X-ray, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 31-JUL-2009 a 5 month old female was vaccinated with the first dose of ROTATEQ (Lot No. 663716/0287Y) by mouth. The patient received pneumococcal vaccine and DTaP + Hib + Poliovirus vaccine as concomitant vaccination. Patient had a history of nasopharyngeal reflux and upper respiratory tract infection (AM of vaccination). On 06-AUG-2009 patient experienced symptoms of abdominal pain, anorexia and vomiting that was bile stained and presented to the emergency room (ER). The patient underwent and air contrast enema, abdominal Xray and abdominal ultrasound. A urine culture revealed no growth, KUB Xray revealed abnormal results, dilated central bowel loops. Blood gases PH 7.34 (L) pco2 33. Medical records were received on 24-AUG-2009 for the date of service of 06-AUG-2009 to 07-AUG-2009 and reported that the patient presented with two days of emesis. Assessment was intussusception. It was reported that the barium air contrast was successful. The listing indicated with one or more of the events required hospitalization, and were considered to be immediately life-threatening. A Lot Check has been initiated. The original reporting source was not provided. The VAERS ID No. is 353801. A preliminary lot check investigation was performed. To date our investigation had found that this lot conformed lot quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Dyspnoea, Dyspnoea exertional, Electrocardiogram abnormal, Heart rate normal
Clinical narrative: Patient reported chest pain that started 19 Sep 09 while assigned to foreign country.  After receiving small pox vaccination patient developed flu like symptoms with chest pain.  Flu symptoms stopped, but chest pain continued, described as unrelated to activity, retrosternal, radiating to the back, exacerbated by supine position.  Patient using Naprosyn 500mg PO BID x 7 days then PRN.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Oxygen saturation, Pericarditis, Troponin
Clinical narrative: Patient reported chest pain that started 19 Sep 09 while assigned to foreign country.  After receiving small pox vaccination patient developed flu like symptoms with chest pain.  Flu symptoms stopped, but chest pain continued, described as unrelated to activity, retrosternal, radiating to the back, exacerbated by supine position.  Patient using Naprosyn 500mg PO BID x 7 days then PRN.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase normal, Cardiac enzymes normal, Cardiovascular evaluation
Clinical narrative: Patient reported chest pain that started 19 Sep 09 while assigned to foreign country.  After receiving small pox vaccination patient developed flu like symptoms with chest pain.  Flu symptoms stopped, but chest pain continued, described as unrelated to activity, retrosternal, radiating to the back, exacerbated by supine position.  Patient using Naprosyn 500mg PO BID x 7 days then PRN.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Influenza like illness, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient reported chest pain that started 19 Sep 09 while assigned to foreign country.  After receiving small pox vaccination patient developed flu like symptoms with chest pain.  Flu symptoms stopped, but chest pain continued, described as unrelated to activity, retrosternal, radiating to the back, exacerbated by supine position.  Patient using Naprosyn 500mg PO BID x 7 days then PRN.