chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 7 1/4 x 6 3/4 cm area of redness & warmth (L) upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt noticed red swollen bump (about 2.5 inches wide) at injection site on 6/25/121 that felt warm. Site started itching evening of 6/26/12.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt was injected 6/17/12 noticed redness in area on 6/18/12 hurt when touched only does not bother her otherwise approximately 5 in long.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Erythema, Poor quality sleep, Pruritus generalised
Clinical narrative: 5:25 pm - Patient pays for ZOSTAVAX prescription and soon receives ZOSTAVAX injection. Patient mentions feeling a little "lightheaded" while conversing with the pharmacist. Pharmacist asks if patient is feeling OK and if still a little lightheaded. Patient says "no". 6:00 pm - Patient says she's feeling OK and leaves pharmacy area / store to go to a store next door. 6:15 pm - Patients returns to pharmacy with visible rash, erythema, generalized itching, very uncomfortable and asks pharmacist for help. 6:20 pm - Patient given 50mg oral diphenhydramine liquid. 6:24 pm - 911 called and one EPIPEN injection administered to right thigh. Patient improving as rash and itch lessen in intensity; patient more at ease. 6:30 pm - EMS arrives and evaluates patient. Patient blood pressure measures 73/51. Patient is not transported to pharmacy; EMS states patient is OK. 6:50 pm - Patient waits for family member to arrive to drive her home. Patient states she's feeling much better. Patient hands are shaking somewhat but patient is not complaining. Pharmacist takes patient's blood pressure - 190/95. 7 pm - Patient's son arrives to drive patient home. Next day 9 AM - Pharmacist calls patient. Patient states she's doing fine/feels fine though she didn't sleep well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 5:25 pm - Patient pays for ZOSTAVAX prescription and soon receives ZOSTAVAX injection. Patient mentions feeling a little "lightheaded" while conversing with the pharmacist. Pharmacist asks if patient is feeling OK and if still a little lightheaded. Patient says "no". 6:00 pm - Patient says she's feeling OK and leaves pharmacy area / store to go to a store next door. 6:15 pm - Patients returns to pharmacy with visible rash, erythema, generalized itching, very uncomfortable and asks pharmacist for help. 6:20 pm - Patient given 50mg oral diphenhydramine liquid. 6:24 pm - 911 called and one EPIPEN injection administered to right thigh. Patient improving as rash and itch lessen in intensity; patient more at ease. 6:30 pm - EMS arrives and evaluates patient. Patient blood pressure measures 73/51. Patient is not transported to pharmacy; EMS states patient is OK. 6:50 pm - Patient waits for family member to arrive to drive her home. Patient states she's feeling much better. Patient hands are shaking somewhat but patient is not complaining. Pharmacist takes patient's blood pressure - 190/95. 7 pm - Patient's son arrives to drive patient home. Next day 9 AM - Pharmacist calls patient. Patient states she's doing fine/feels fine though she didn't sleep well.
Age: 9.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Approximately 15 minutes after vaccines administered, client got up from chair where he was sitting and said 'could you tell me where I can find a bathroom and started to walk toward mother, he fell and hurt his chin on the floor. Apparent fainting. He was lifted to a chair and soon revived up with whiffs of alcohol & name calling to which he responded.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Tenderness
Clinical narrative: All over red itch rash - that is. Painful to the touch.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Received vaccine 6-15-12. For 3 days the left upper arm was painful. When the pain resolved he noticed weakness in his LUE which is still present.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site discharge, Injection site induration, Injection site pruritus, Vaccination complication
Clinical narrative: Pt recv'd varicella vaccine 6/26/12, mother presented to clinic the following day, 6/27/11 to report concern about adverse reaction to vaccine. Left arm shows 5.5 cm induration with an open sore central to induration. Clear discharge noted and cellulitis. No fever, no pain. Some itching. Cleaned wound & placed antibiotic ointment and covered infection precautions given. Pt to return if needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Wound treatment
Clinical narrative: Pt recv'd varicella vaccine 6/26/12, mother presented to clinic the following day, 6/27/11 to report concern about adverse reaction to vaccine. Left arm shows 5.5 cm induration with an open sore central to induration. Clear discharge noted and cellulitis. No fever, no pain. Some itching. Cleaned wound & placed antibiotic ointment and covered infection precautions given. Pt to return if needed.
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: Patient called 2 days post-immunization to report warmth, redness, swelling and a mild rash.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased eye contact, Disturbance in attention, Emotional disorder, Unresponsive to stimuli
Clinical narrative: I noticed my son was non responsive to me a few hours after the shot was administered. He would not look at me or respond to any verbal or physical communication. He played with his toys like a robot and had no sign of emotion or awareness of anything around him. I called his pediatrician right away and she told me to go to the hospital if he didn't improve. He remained like this for two days and the entire time I kept trying to communicate to him and there was no response. It was very scary!!!! On the third day he slowly made eye contact with me and by day five he started responding to me more. I did take him in to be checked out and there was nothing they could do for him. He now has attention problems and I believe it has something to do with what happened. I am currently having him evaluated.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS within 24 hours.
Age: 0.7
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.27
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The site of injection with induration, swelling, redness, warmth & tenderness. Healing gradually with BENADRYL & cold compresses.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Vascular test normal
Clinical narrative: Information has been received from a physician (neurologist) concerning a 15 year old female patient with no drug reactions or allergies and no pertinent medical history who in December 2011, was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular in the left deltoid (lot number not reported). There was no concomitant medication. The physician was reporting the patient was referred to her by primary care physician for evaluation on 20-JUN-2012 of persistent left arm paresthesia and muscle weakness following the first dose of GARDASIL in December 2011. The left arm pain diminished after 1 week, but muscle weakness, especially involving the pronator and supinator muscles and paresthesia had persisted. Therapy with GARDASIL was discontinued. There was no treatment given for persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and the left arm pain. At the time of the report the patient's outcome was recovering. Vascular studies were performed on an unknown date, with a result of negative for thrombus. The patient sought medical attention via office visit. Therapy with GARDASIL was not reintroduced. Persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and left arm pain were considered to be disabling by the reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.26
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.4
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.69
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: 6/7/12 Day of injection - none. 6/8/12 Arm/shoulder sore & tender. No fever, no redness, no swelling, x 4 days. 6/11/12 Evening - two fingers of hand of arm of injection, stiffness, curled up, very hard to open them back - worse 1st couple days - 6/12/12 Experienced stiffness in jaw x 2 days. Other hand experiencing stiffness in ring and pinkie fingers- not as severe. 6/28/12 As of today still experiencing (R) hand stiffness in a.m. after night.
Age: 1.31
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.28
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old male patient with hydrocephalus and neurogenic bladder who in 2010 was vaccinated with a dose of MMR II (dose route not reported), (Lot#664660/1016Y). Subsequently on an unknown date, the patient experienced anaphylactic reaction from MMR II. The patient was given BENADRYL and "epinephrine shot" and sent to ER. It was unknown if the patient was hospitalized from the emergency room. The patient was recovered (recovery date was not reported). Anaphylactic reaction was considered to be immediately life-threatening. Additional information has been requested. A lot check has been initiated.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Increasing erythema/warmth x 2 days with max size 8 cm diameter stable the 3rd day with decreased erythema. (+) fevers the first 2 days.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 79 year old male patient, who in May 2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route not reported). It was reported that on unknown date the patient got Zoster. On unknown date the patient was admitted to hospital. It was not reported the length of the stay of patient in the hospital. At the time of report the patient status was not recovered. Additional information has been requested.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Hib vaccine was given in addition to PENTACEL.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza, Multi-organ failure
Clinical narrative: Case number PHHY2012US054996 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a patient (age and sex not specified). The patient's medical history included severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On an unspecified date after vaccination, the patient developed influenza. On an unknown date the patient died due to multiple organ failure. No other information pertaining to this patient was available. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Death
Clinical narrative: Family noticed baby was blue and called 911.  Baby was coded and pronounced at approx 1755.  At this time I do not have exact times.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Infantile spitting up, Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: 02/9/2012 Patient began spitting up alot.  February 21, 2012 pt. presented to office with increased vomiting and signs of dehydration. Pt. sent to Hospital and diagnosed with intussusception.  Surgical intervention incurred.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 02/9/2012 Patient began spitting up alot.  February 21, 2012 pt. presented to office with increased vomiting and signs of dehydration. Pt. sent to Hospital and diagnosed with intussusception.  Surgical intervention incurred.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: 02/9/2012 Patient began spitting up alot.  February 21, 2012 pt. presented to office with increased vomiting and signs of dehydration. Pt. sent to Hospital and diagnosed with intussusception.  Surgical intervention incurred.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient complained of pain in back of legs and back of neck wanting something to remove it from her system. Does not plan to repeat vacc to complete series. Dose #1 only. Called 8 AM next day. Too "herbals" Relieved pain.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chest pain, Dehydration, Hypersensitivity, Muscle spasms
Clinical narrative: Patient called the clinic this morning to report an allergic reaction to the Tdap that she received in clinic on Friday around 11:30 am. Around 7:30 pm on Friday evening-started having chest pain, tachycardia, pail nail beds, low grade temperature (not measured), muscle spasms and dehydration. Denies rash on swelling, no swelling or pain at injection site. Had friend give IV fluids at home. Later to ER-given IV steroids, BENADRYL and famotidine. Rx'd oral steroids-on day 3 of steroid's reports that she is doing OK. Will f/u at clinic-if any other problems occur. Discussed with patient that we will feel out VAER's and send to CDC.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Tachycardia
Clinical narrative: Patient called the clinic this morning to report an allergic reaction to the Tdap that she received in clinic on Friday around 11:30 am. Around 7:30 pm on Friday evening-started having chest pain, tachycardia, pail nail beds, low grade temperature (not measured), muscle spasms and dehydration. Denies rash on swelling, no swelling or pain at injection site. Had friend give IV fluids at home. Later to ER-given IV steroids, BENADRYL and famotidine. Rx'd oral steroids-on day 3 of steroid's reports that she is doing OK. Will f/u at clinic-if any other problems occur. Discussed with patient that we will feel out VAER's and send to CDC.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Headache, Injection site erythema, Puncture site swelling
Clinical narrative: Approximately 10-15 minutes post vaccine -> 3 cm in diameter area of redness and mild swelling around puncture site. No wheezing or dyspnea. Dexamethasone given IM in rt deltoid. Approximately 30 minutes later, returned to office with redness around injection site for Dexamethasone = 5 cm in diameter. Complained also of headache and coughing. Vital signs were stable except for respiratory rate (30-40 per minute range). Treated with Albuterol via nebulization and counting slowly (to relieve anxiety and hyperventilatory symptoms) EMS arrived approximately 20-30 minutes into treatment. Most of symptoms had subsided. Redness of the injection sites was less. She was taken to the ER for observation and discharged after several hours.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Pyrexia, Vomiting
Clinical narrative: Fever; tmax 103 F (~24 hrs); vomiting; induration at injection site.
Age: 20.0
Sex: F
Vaccine: HEPA, TD, YF
Symptoms: Throat tightness
Clinical narrative: C/o throat tightening.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Waiting to pay bill my daughter passes out on floor. Passed out she did not hit her head. Had some shots.  V/S at 10:00 AM 94/53 - pulse 51 - pt denies any pain or hitting herself when passes out, states "feels fine>" 10:10 V/S 94/60 - pulse 51 - pt discharged home with mom with no distress noted.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Pt had Pentacel injection R upper thigh, PCV13 injection L upper thigh and Rotateq (oral) vaccinations done/given @ 3 pm 1-31-12. 40 mg Tylenol given PO prior to shots. 0 Problems 15 min p injections. Later that evening (8 pm) mother said child's legs were both red, with bright red spots and hard lumps under injection sites - warm to touch. Next day 2-1-12 - temp elevations up to 99.8, increased restlessness. Legs still red, painful to touch. Next day 2-2-12 - fever of 101.5 - brought down by Tylenol. Red bumps L thigh from hip to knee, sm. amt R thigh. 0 fevers. 0 painful to palpation per mom 2-3-12.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site warmth, Pyrexia, Restlessness
Clinical narrative: Pt had Pentacel injection R upper thigh, PCV13 injection L upper thigh and Rotateq (oral) vaccinations done/given @ 3 pm 1-31-12. 40 mg Tylenol given PO prior to shots. 0 Problems 15 min p injections. Later that evening (8 pm) mother said child's legs were both red, with bright red spots and hard lumps under injection sites - warm to touch. Next day 2-1-12 - temp elevations up to 99.8, increased restlessness. Legs still red, painful to touch. Next day 2-2-12 - fever of 101.5 - brought down by Tylenol. Red bumps L thigh from hip to knee, sm. amt R thigh. 0 fevers. 0 painful to palpation per mom 2-3-12.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 12 m.o Female received varicella vaccine 2-3-12. Full blown chicken pox today 2-9-12. Dx: made by clinical indicators. In Box 9, wrote: will run its course.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal cramping and diarrhea for 24 hours. Not reported to clinic for two months.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Crying, Decreased appetite, Irritability, Screaming
Clinical narrative: Patient was noticeably more fussy the afternoon of his appointment.  That day he slept longer intervals than ever before but was extremely fussy when awake.  This continued until 5:30 on 6/27 when he had an approximately 3.5hr stretch of inconsolable crying and screaming and poor appetite.  That night he slept through the night (12:00AM to 9:00AM) despite being breastfed and usually waking up twice in that time span.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Client stated her R arm became very swollen and throbbing with pain a short time after receiving her shot. She came back here later to find us closed. She went to ER to have it checked. They advised applying an ice pack. Today she said it is much better. I looked at it. It's approx the size of a quarter. Slightly red. I advised she alternate ice/warm packs. Also to watch for sign of more redness or throbbing. If so to see a M.D.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Varicella post vaccine
Clinical narrative: 3-12-12 dx with chickenpox. Vesicle lesion w/ crust and mostly already drying out.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Allergy test negative, Crying, Decreased appetite, Eye pruritus, Pruritus
Clinical narrative: June 18, 2012 To VAERS My son was given his one year old shots on his birthday on Thursday, May 31, 2012 at his regular Clinic. Two days after his shot, my baby started crying and his body was full of rashes. He has been itching his eyes and head continually. He has lost his appetite dramatically, but would still drink his milk. We took him to Clinic and the Doctor ordered that blood sample should be taken for allergic reactions. That was done at hospital. The result was negative. The Shots that were allegedly administered by Clinic on May 31st, 2012 were, DTaP, 4th shot, Haemophilus Influenzae type b (hib), Hepatitis A, Pneumoccocal vaccines. My child still has the side effects 18 days later, Sunday, June 17th, 2012. We are worried and do not know what to do. No treatment has followed this reaction. Only 0.2% hydrocortisone was prescribed by the nurse at clinic and by Hospital emergency Doctor to help him with the itching. Though it has, the adverse symptoms are still there. Please contact us at your earliest convenience by phone or the email provided below. Your cooperation means a lot to us. Last time we wanted to visit all the medical providers the doctor referred us to before we reported the adverse symptom to VAERS. Today, it is June 28, 2012. Almost a month from the date his shots were administered. At this point, we decided to report to VAERS, because none of the medical providers have found out what the problem is, we are reaching to a point where we have no medical provider to go to. We have also visited a dermatologist who verbally told us that it is probably a virus or of that sort, may or may not be the shots, but skin needed treatment. He later found out patient's insurance was not active that day, and sent us home without legally diagnosing patient's problems, or without prescribing medicine. The rashes on my son's body have decreased, however his face is still full of it and he still has decreased appetite. Patient rarely cried the first year of his life. He now cries daily, hourly, and by the minute. He rolls over his bed again and again. We don't know what he is trying to tell us. Getting worried is a daily hobby for us now. After visiting hospital emergency twice, his regular Clinic three times, a dermatologist, and not to forget, an allergy doctor, we are finally giving up. We don't know what to do.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Rash generalised, Restlessness
Clinical narrative: June 18, 2012 To VAERS My son was given his one year old shots on his birthday on Thursday, May 31, 2012 at his regular Clinic. Two days after his shot, my baby started crying and his body was full of rashes. He has been itching his eyes and head continually. He has lost his appetite dramatically, but would still drink his milk. We took him to Clinic and the Doctor ordered that blood sample should be taken for allergic reactions. That was done at hospital. The result was negative. The Shots that were allegedly administered by Clinic on May 31st, 2012 were, DTaP, 4th shot, Haemophilus Influenzae type b (hib), Hepatitis A, Pneumoccocal vaccines. My child still has the side effects 18 days later, Sunday, June 17th, 2012. We are worried and do not know what to do. No treatment has followed this reaction. Only 0.2% hydrocortisone was prescribed by the nurse at clinic and by Hospital emergency Doctor to help him with the itching. Though it has, the adverse symptoms are still there. Please contact us at your earliest convenience by phone or the email provided below. Your cooperation means a lot to us. Last time we wanted to visit all the medical providers the doctor referred us to before we reported the adverse symptom to VAERS. Today, it is June 28, 2012. Almost a month from the date his shots were administered. At this point, we decided to report to VAERS, because none of the medical providers have found out what the problem is, we are reaching to a point where we have no medical provider to go to. We have also visited a dermatologist who verbally told us that it is probably a virus or of that sort, may or may not be the shots, but skin needed treatment. He later found out patient's insurance was not active that day, and sent us home without legally diagnosing patient's problems, or without prescribing medicine. The rashes on my son's body have decreased, however his face is still full of it and he still has decreased appetite. Patient rarely cried the first year of his life. He now cries daily, hourly, and by the minute. He rolls over his bed again and again. We don't know what he is trying to tell us. Getting worried is a daily hobby for us now. After visiting hospital emergency twice, his regular Clinic three times, a dermatologist, and not to forget, an allergy doctor, we are finally giving up. We don't know what to do.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: Injection site became red and swollen with a white ring around the area.  This would "calm down" and then flare up again in a couple of hours.  Now 2 weeks later the patient reports that there is some skin sloughing of the area.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient reports that she received MMR on 06/21/2012 and on 06/25/2012 developed a rash on her abdomen. Denies fever or other symptoms.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: Patient describing dry cough.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Feeling hot, Syncope
Clinical narrative: Patient started feeling hot which was followed by syncope.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Angiogram abnormal, Arterial disorder, Cardiac function test normal, Cerebrovascular accident, Haematology test normal
Clinical narrative: Had L MCA stroke. Full Heme, Neuro, Rheum, Vascular, Cardio, ID work-ups all negative. Final diagnosis was Cerebral Arteriopathy. This is reported to be a post-viral phenomenon, often Varicella, so Neurologist questions if could be similar issue from Varivax as well.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test normal, Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Rheumatoid factor negative
Clinical narrative: Had L MCA stroke. Full Heme, Neuro, Rheum, Vascular, Cardio, ID work-ups all negative. Final diagnosis was Cerebral Arteriopathy. This is reported to be a post-viral phenomenon, often Varicella, so Neurologist questions if could be similar issue from Varivax as well.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING OF THE RIGHT THIGH AND AN ERYTHEMATOUS, WARM TO TOUCH RASH, WHICH BLANCHES. Treated with Benadryl and Tylenol began to resolve 1 1/2 hrs later.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Pallor
Clinical narrative: SWELLING OF THE RIGHT THIGH AND AN ERYTHEMATOUS, WARM TO TOUCH RASH, WHICH BLANCHES. Treated with Benadryl and Tylenol began to resolve 1 1/2 hrs later.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother of pt states day after vaccination redness, swelling and warmth to deltoid muscle where vaccines administered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Patient experienced a red wheal around site of injection; localized reaction with swelling & mild heat produced. Patient did not experience any breathing difficulties.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain at site, red - itchy - hot to touch area 7" long & 3" wide started 6-13-12 - Lasted until 6-19-12 - Client used BENADRYL ice pack and a little cortisone cream.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Dyspnoea
Clinical narrative: As per mom patient started with shortness of breath in the evening of day vaccines administer.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Irritability, Mucous stools
Clinical narrative: Diarrhea, mucousy stools and fussiness for three days after vaccine.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Irritability, Mucous stools
Clinical narrative: Mucousy stools, Diarrhea, and fussiness worse than first set of vaccines at 2 months. Administered all vaccines except Rotavirus at 6 month visit and he had no adverse reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hyporesponsive to stimuli, Hypotension
Clinical narrative: Hypotensive - hyporesponsive reaction approximately 10 minutes after injection. Resolved in 20 minutes. O2 administered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Mild case of shingles, tiny vesicles on flank area, rash & itching at site of reaction. Showed up the following 2 weeks, received triamcinolone 0.5% cr. on 6/5/12.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Mild case of shingles, tiny vesicles on flank area, rash & itching at site of reaction. Showed up the following 2 weeks, received triamcinolone 0.5% cr. on 6/5/12.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction
Clinical narrative: Developed some blue and red discoloration of deltoid area of both arms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Asthma, Condition aggravated, Erythema, Urticaria
Clinical narrative: Erythema [illegible word] face and body with hives; spontaneously resolved in less than 1 hour. [illegible word] of asthma. Prescribing antihistamines for allergies.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema
Clinical narrative: Redness on left leg, Child crying.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Open wound, Skin lesion
Clinical narrative: Vesicle-like rash @ injection site (L arm) with redness and a single lesion that had been scratched and is now open.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Injection site erythema, induration, pain with hive like rash running to inside arm and down arm; fever, chills, headache.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Injection site erythema, induration, pain with hive like rash running to inside arm and down arm; fever, chills, headache.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haematoma, Skin warm, Urticaria
Clinical narrative: Pt reported hives developing around right arm. Hives not itchy, warm to the touch, no open areas noted, bruise at injection site.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dizziness, Dyskinesia, Excoriation, Fall, Headache
Clinical narrative: Fainted in waiting office, found exhibing slight jerking movements on floor.  Sustained visable abrasion to cheek where impact was made with floor.  Needed 1 and 1/2 hour to recover from dizziness and lightheadedness.  Had vision changes and ringing in the ears prior to fainting.  Headache lasted until 7:00 PM on 6/27/12.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: Fainted in waiting office, found exhibing slight jerking movements on floor.  Sustained visable abrasion to cheek where impact was made with floor.  Needed 1 and 1/2 hour to recover from dizziness and lightheadedness.  Had vision changes and ringing in the ears prior to fainting.  Headache lasted until 7:00 PM on 6/27/12.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Headache, Nausea, Nervousness, Syncope
Clinical narrative: Fainted in waiting office, found exhibing slight jerking movements on floor.  Sustained visable abrasion to cheek where impact was made with floor.  Needed 1 and 1/2 hour to recover from dizziness and lightheadedness.  Had vision changes and ringing in the ears prior to fainting.  Headache lasted until 7:00 PM on 6/27/12.
Age: 0.51
Sex: M
Vaccine: DPP, HEP, HIBV, IPV, PPV
Symptoms: Head banging
Clinical narrative: Head banging.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Fibromyalgia, Influenza like illness, Injected limb mobility decreased, Myalgia
Clinical narrative: Low grade fever - transient. Flu like symptoms - transient. Myalgia (R) arm - severe. Myalgia (R) leg - mild. Restricted movement (R) arm - severe. Restricted weight bearing (R) arm - severe. Fatigue. Fibromyalgia.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: Low grade fever - transient. Flu like symptoms - transient. Myalgia (R) arm - severe. Myalgia (R) leg - mild. Restricted movement (R) arm - severe. Restricted weight bearing (R) arm - severe. Fatigue. Fibromyalgia.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell abnormality, Swelling
Clinical narrative: Large red circular, raised area. No itching or pain, developed over 2 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Large red circular, raised area. No itching or pain, developed 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Pt received ZOSTAVAX at local pharmacy & developed red, swollen & hot area at injection site with 3 blisters.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt received ZOSTAVAX at local pharmacy & developed red, swollen & hot area at injection site with 3 blisters.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Restlessness
Clinical narrative: 5 days after vaccines pt had diarrhea and restlessness.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling on the arm (left) where immunizations were administered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site, pt said she is going to see her doctor today 6/28/12.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian torsion
Clinical narrative: Ovarian torsion after receiving HPV.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient called immunizing pharmacist on 6/28/12 to report red, swollen reaction at injection site (left arm/deltoid). Area hard and approximately 2-3 inches in diameter.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: PNEUMOVAX administered 6/26 at 2:45 pm. Pt presented at 8:15 am on 6/28 with pain, swelling, redness of the arm. Pt used BENADRYL, helped with pain - no affect w/ swelling & redness. Pt to f/u w/ physician on 6/29 if still having problems.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: ZOSTAVAX was given into the deltoid muscle and resulted in a raised area where the injection was given. Vaccine was given by a nurse at a clinic and not known if IM or SQ.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ZOSTAVAX was given into the deltoid muscle and resulted in a raised area where the injection was given. Vaccine was given by a nurse at a clinic and not known if IM or SQ.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt developed itchy rash on arms approx. a week after getting vaccine rash lasted for > 3 wks pt saw Dr got Rx for prednisone, hydroxyzine, TOPICORT on 6/28.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Agitation, Anxiety, Erythema, Injection site swelling
Clinical narrative: DTaP given in (L) arm, pt very anxious & agitated - 6-27-12. Raised red 2 1/2" x 3" to (L) - arm swollen site. Seen in office 6-28-12 with above noted.
Age: 1.54
Sex: F
Vaccine: PNC13
Symptoms: Electroencephalogram abnormal, Hypopnoea, Loss of consciousness, Pallor
Clinical narrative: Around 3am on 6/22/12 patient woke up acting normally. About 10 minutes later she had sudden loss of consciousness with pallor and shallow respirations. This lasted approximately 20min. She slowly became more alert and returned to baseline within 2 hours. Parents called 911 and she was evaluated in the ER.
Age: 1.46
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: More than (30) vesicular lesions on erythematous base scattered over trunk, face, (R) auricle & diaper area.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Feeling cold, Headache, Nausea
Clinical narrative: Patient went home after immunization in afternoon developed headache, nausea, felt cold. Woke up next morning, fever 100.2 degrees, felt very cold, had difficulty breathing. Seen in office, received albuterol aerosol treatment. Felt better. Had chest discomfort, used albuterol x 2 same day. Improved next day.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Patient went home after immunization in afternoon developed headache, nausea, felt cold. Woke up next morning, fever 100.2 degrees, felt very cold, had difficulty breathing. Seen in office, received albuterol aerosol treatment. Felt better. Had chest discomfort, used albuterol x 2 same day. Improved next day.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Headache, Oropharyngeal pain, Pyrexia, Sneezing
Clinical narrative: Felt feverish, headache, sore throat, difficulty swallowing sneezing. All symptoms began after receiving Tdap on 6/27/12. Seen by PA-C, Rapid strep neg. Will treat symptoms only. No medications prescribed.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Felt feverish, headache, sore throat, difficulty swallowing sneezing. All symptoms began after receiving Tdap on 6/27/12. Seen by PA-C, Rapid strep neg. Will treat symptoms only. No medications prescribed.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: 4-5 pustules on (L) thigh 9 days s/p VARIVAX, also quarter size red area at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Paraesthesia oral, Pruritus
Clinical narrative: Increased 50 cent size redness and larger area of swelling tingling tongue & lips local itching.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pruritus, Swelling
Clinical narrative: 50 cent size redness and larger area of swelling, headache, local area itchy.
Age: 20.0
Sex: U
Vaccine: MNQ
Symptoms: Electrocardiogram normal, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: 2 hr after MENACTRA vaccine RA pt c/o HA, N/V, arm & leg muscle aches.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Culture urine negative, Irritability, Rash, Urine analysis normal, Vomiting
Clinical narrative: Day after immunizations developed vomiting, facial rash, and increased fussiness.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Fontanelle bulging, Lumbar puncture normal, Pyrexia
Clinical narrative: Brought to office 1 day after receiving PEDIARIX with bulging fontanel & low grade fever 99.7 (ax) sent to ER for spinal tap, which was negative.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness (5cm). Only reacted to Varicella injection site.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Confusional state, Loss of consciousness, Pallor
Clinical narrative: After receiving GARDASIL 0.5ml, pt. stated, "I feel confused." She lost consciousness for a few seconds and became pale. She recovered quickly. Her mom was present.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: On 6-26-12 Pneu vaccine admin RA SQ 0.5 cc. 6-27-12 Patient called pain, swelling, antibiotic refused.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Erythema, Local swelling, Ultrasound scan
Clinical narrative: 6-22-12 Admin Pneumo vaccine LA SQ. 6-23-12 Area red, swelling gave antibiotic. 6-24-12 ER temp. IV.
Age: 61.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthritis, Computerised tomogram normal, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 18 June 2012. A 61-year-old male patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4068, (corresponding sanofi pasteur Inc. lot number U4304AA) on 21 March 2012. On the same day, the patient experienced pain down his left arm, decreased grip strength and arm weakness which persisted since the vaccination. The patient's CAT scan was negative. The patient had no illness at the time of vaccination. The patient had allergies to "Welcal", sulfa and "Avalox" and a medical history of hypertension, hypercholesterolemia, latent diabetes mellitus (DM), kidney stones and phlebitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: X-ray abnormal
Clinical narrative: Initial report was received from a health care professional on 18 June 2012. A 61-year-old male patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4068, (corresponding sanofi pasteur Inc. lot number U4304AA) on 21 March 2012. On the same day, the patient experienced pain down his left arm, decreased grip strength and arm weakness which persisted since the vaccination. The patient's CAT scan was negative. The patient had no illness at the time of vaccination. The patient had allergies to "Welcal", sulfa and "Avalox" and a medical history of hypertension, hypercholesterolemia, latent diabetes mellitus (DM), kidney stones and phlebitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Computerised tomogram normal, Grip strength decreased, Muscular weakness, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 18 June 2012. A 61-year-old male patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4068, (corresponding sanofi pasteur Inc. lot number U4304AA) on 21 March 2012. On the same day, the patient experienced pain down his left arm, decreased grip strength and arm weakness which persisted since the vaccination. The patient's CAT scan was negative. The patient had no illness at the time of vaccination. The patient had allergies to "Welcal", sulfa and "Avalox" and a medical history of hypertension, hypercholesterolemia, latent diabetes mellitus (DM), kidney stones and phlebitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pruritus, Skin warm
Clinical narrative: Severe edema, erythema, itching, hot to touch from base of neck down to shoulder blade to below the elbow of left arm. Symptoms slowly faded over 5-6 days.
Age: 19.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Blood test normal, Dizziness, Photophobia, Swelling
Clinical narrative: Swelling all over body. Low grade temp 99 degrees. Dizziness. Sensitivity to light. Treatment of steroids times 4 days.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Nausea, Neck pain
Clinical narrative: Pt's arm was immediately sore she reported. She had fatigue and chills nausea pain in the neck and arm. Fever 101-102. Arm was edematous. Heart rate was tachycardic in the Emergency Room up to 153.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: Pt's arm was immediately sore she reported. She had fatigue and chills nausea pain in the neck and arm. Fever 101-102. Arm was edematous. Heart rate was tachycardic in the Emergency Room up to 153.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Blood culture negative, Blood test abnormal, Body temperature increased, CSF test normal
Clinical narrative: Information has been received from a physician concerning a 13 week old (reported as 3 month) female patient with a history of vomiting, diarrhoea, dehydration and hospitalization (the patient was hospitalized from 11-MAY-2012 to 14-MAY-2012 due to vomiting, diarrhoea, dehydration) with a negative results of medical test including stool cultures, "rotavirus", fecal blood cell, urine, blood, cerebral spinal fluid and respiratory cultures (the patient was administered unspecified antibiotics and was rehydrated) who on 15-MAY-2012 was vaccinated with a 2.0 ml first dose of ROTATEQ, (Lot # not reported). There was no concomitant medication. On 18-MAY-2012 the patient was found unresponsive at home after a nap. The patient was admitted to the hospital. Her rectal temperature was 100.01 and blood tests reflected dehydration. The patient was given IV fluids and supportive measures. The patient was pronounced dead on 18-MAY-2012. The physician reported, at autopsy, negative stool culture and positive rotavirus antigen ID. The caused of death has not yet been determined. Additional information has been requested. All adverse events were determined as significant disability, life threatening and other important medical events.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture negative, Culture stool negative, Culture urine negative, Death, Dehydration
Clinical narrative: Information has been received from a physician concerning a 13 week old (reported as 3 month) female patient with a history of vomiting, diarrhoea, dehydration and hospitalization (the patient was hospitalized from 11-MAY-2012 to 14-MAY-2012 due to vomiting, diarrhoea, dehydration) with a negative results of medical test including stool cultures, "rotavirus", fecal blood cell, urine, blood, cerebral spinal fluid and respiratory cultures (the patient was administered unspecified antibiotics and was rehydrated) who on 15-MAY-2012 was vaccinated with a 2.0 ml first dose of ROTATEQ, (Lot # not reported). There was no concomitant medication. On 18-MAY-2012 the patient was found unresponsive at home after a nap. The patient was admitted to the hospital. Her rectal temperature was 100.01 and blood tests reflected dehydration. The patient was given IV fluids and supportive measures. The patient was pronounced dead on 18-MAY-2012. The physician reported, at autopsy, negative stool culture and positive rotavirus antigen ID. The caused of death has not yet been determined. Additional information has been requested. All adverse events were determined as significant disability, life threatening and other important medical events.