chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Intense itching/redness at injection site - started approx. 10 min after injection. No progression of sx. Did take BENADRYL dose x 1 after multiple hours (72) which helped to resolve sx.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Choking, Dyspnoea, Erythema, Urticaria, Vomiting
Clinical narrative: Mother describes hearing baby having breathing problems. She found baby was vomiting profusely & choking. Then noticed baby had red hives on face & chest; abdomen. By the time infant returned to office at 12:55 symptoms not present. Temp 97.3.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Diffuse urticarial rash - 10 days post vaccination.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Diffuse macular papular rash (urticarial) about 10 days post vaccination.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever after 1 hour of receiving shots of 102.8. Fever went to 103.1 degrees with TYLENOL. Slept after leaving office for about 1 hr, but did not sleep after that for about 8 hrs. Fever & irritability for about 3 days following shots. MOTRIN did help. No rashes or redness at injection site.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Cyanosis, Erythema, Immediate post-injection reaction, Retching
Clinical narrative: Immediately after injection pt became red in face, started coughing, trying to vomit, lips turned blue, wheezing. Oxygen sat 89-91%. Pt. given Epi, breathing tx with XOPENEX and another inj.of Epi. Pt states improved, but was transferred via EMS to local hospital.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Immediately after injection pt became red in face, started coughing, trying to vomit, lips turned blue, wheezing. Oxygen sat 89-91%. Pt. given Epi, breathing tx with XOPENEX and another inj.of Epi. Pt states improved, but was transferred via EMS to local hospital.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Malaise
Clinical narrative: 5/13/11 2AM States noted onset of hives & RUQ stomach pains & not feeling well. Temp 102.2 at 5AM. 10:45AM c/o Rt upper quadrant pain, chills, joint pain.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: 5/13/11 2AM States noted onset of hives & RUQ stomach pains & not feeling well. Temp 102.2 at 5AM. 10:45AM c/o Rt upper quadrant pain, chills, joint pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 8 cm of redness, induration, and calor
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Abasia, Ataxia, CSF test normal, Cataplexy, Fatigue
Clinical narrative: A serious spontaneous report of narcolepsy and non-serious event of weight gain has been received from a physician concerning a four-year-old female, subsequent to FLUMIST. The patient's medical history was not reported. The patient had no concomitant medications. The patient received FLUMIST on 01-Oct-2010. The first symptoms to start were tiredness, hyporeflexic and ataxia to a point of inability to walk. The child was normal and was not on concomitant medications prior to onset of symptoms. The child became symptomatic in Nov-2010 and was hospitalized in Dec-2010 for several days. MRI and CSF tests were normal. Weight gain was also reported. The child was symptomatic at the time of reporting and prescribed modafinil as diagnosed with narcolepsy and cataplexia. The outcome of all the events was not recovered.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Hyporeflexia, Narcolepsy, Nuclear magnetic resonance imaging normal, Weight increased
Clinical narrative: A serious spontaneous report of narcolepsy and non-serious event of weight gain has been received from a physician concerning a four-year-old female, subsequent to FLUMIST. The patient's medical history was not reported. The patient had no concomitant medications. The patient received FLUMIST on 01-Oct-2010. The first symptoms to start were tiredness, hyporeflexic and ataxia to a point of inability to walk. The child was normal and was not on concomitant medications prior to onset of symptoms. The child became symptomatic in Nov-2010 and was hospitalized in Dec-2010 for several days. MRI and CSF tests were normal. Weight gain was also reported. The child was symptomatic at the time of reporting and prescribed modafinil as diagnosed with narcolepsy and cataplexia. The outcome of all the events was not recovered.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Culture, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt recd Pneumovax at appt 5/11/2011. On 5/12/2011 in am called w/ redness sl pain and swelling 50 cent size area on posterior left arm at injection site I told her to apply cold compress and take antihistamine c/b if worse.  5/13 ealy afternoon called c/o more redness swelling and now febrile- I called in Keflex for presumed cellulitis.  I sent a sample of the vaccine to the local lab for culture. Notified pt., our clinic director and the VAERS.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt recd Pneumovax at appt 5/11/2011. On 5/12/2011 in am called w/ redness sl pain and swelling 50 cent size area on posterior left arm at injection site I told her to apply cold compress and take antihistamine c/b if worse.  5/13 ealy afternoon called c/o more redness swelling and now febrile- I called in Keflex for presumed cellulitis.  I sent a sample of the vaccine to the local lab for culture. Notified pt., our clinic director and the VAERS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt noticed a "bump" and redness around site in shape of a rectangle also painful "size of a box of cigarettes" pt will put hot compresses on.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose, Borrelia test, Injection site erythema, Local reaction, Red blood cell sedimentation rate
Clinical narrative: Local reaction of redness and warmth surrounding vacination site approximatly size of a small orange.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site warmth, White blood cell count
Clinical narrative: Local reaction of redness and warmth surrounding vacination site approximatly size of a small orange.
Age: 10.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: 17CM X 17CM CELLULITIS TO RIGHT ARM. RIGHT ARM REDNESS AND WARM TO THE TOUCH.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Menstruation delayed
Clinical narrative: My period is always regular. My period was 6 days late, however, and I was extremely nervous about being pregnant. Luckily, I found this website (listed below) that has A LOT of posts about women's periods being SUPER late after getting the HPV Vaccine. You should really list this as a side effect, so women don't panic!!!!  http://www.steadyhealth.com/Gardarsil_shot__Late_period__Negative_Pregnancy_test__t108560.html
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Red welp around the injection site about 3-4" x 1.5" in diameter that was itchy. One week later the welp is now about 2" x 1" in diameter and less itchy.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Pyrexia
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Electromyogram abnormal, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Injection site urticaria, Injection site warmth, Intervertebral disc degeneration, Intervertebral disc protrusion, Joint sprain
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Neck pain, Nerve compression, Nerve conduction studies normal, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Rash, Swelling, Urticaria
Clinical narrative: Symptoms: Fever, Sweating, Nauseas, Swelling/redness at vaccination site in as large as a pancake. Severe pain left arm at vaccination site, severe pain entire arm including left hand, left side of neck and left shoulder blade. Stiffness, limited movement. Symptoms continue all week and remain unchanged on 5/13/2011 at 7:18 pm. Went back to Doctor on Wed, 5/11. He prescribed Amoxicillin 500 MG 3 times a day. Oxycodone-Acetaminophen 5-325 - 1 to tablets every six hours as needed for pain. Advil caps as needed. Allergy tablets as needed. Ice packs on left arm/shoulder area. Have not yet recovered from adverse reaction. Took time off from Work on Wed, Thurs and Fri (May 11-13) for excessive pain, limited movement left arm.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Joint range of motion decreased, Limb discomfort, Loss of consciousness
Clinical narrative: Patient email: "After I got the injection.. My left arm was very sore and swollen as you said it would be. The next day the soreness and aches travelled from just my arm to my entire body (specifically my neck and back). I have been unable to lift my arm to 90 degrees without discomfort. I then passed out in the shower, was nauseous with GI upset, chills and low grade fever all day yesterday. Today I am starting to feel better and am back at work. My left arm soreness is improving and I am able to lift it better with less discomfort. My body aches continue, but no fever. Just achy lungs."
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Lung disorder, Nausea, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient email: "After I got the injection.. My left arm was very sore and swollen as you said it would be. The next day the soreness and aches travelled from just my arm to my entire body (specifically my neck and back). I have been unable to lift my arm to 90 degrees without discomfort. I then passed out in the shower, was nauseous with GI upset, chills and low grade fever all day yesterday. Today I am starting to feel better and am back at work. My left arm soreness is improving and I am able to lift it better with less discomfort. My body aches continue, but no fever. Just achy lungs."
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient email: "After I got the injection.. My left arm was very sore and swollen as you said it would be. The next day the soreness and aches travelled from just my arm to my entire body (specifically my neck and back). I have been unable to lift my arm to 90 degrees without discomfort. I then passed out in the shower, was nauseous with GI upset, chills and low grade fever all day yesterday. Today I am starting to feel better and am back at work. My left arm soreness is improving and I am able to lift it better with less discomfort. My body aches continue, but no fever. Just achy lungs."
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pustule, Injection site swelling
Clinical narrative: Significant swelling/pus in left thigh 2 days post MMR/V & KINRIX. Concern for possible cellulitis vs vaccine reaction. Started on KEFLEX.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 12 days after SC VZV vaccine injection into (R) triceps patient developed low grade fever which then resolved, then redness, swelling, tenderness (5 cm) over injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site oedema, Injection site pain, Joint swelling
Clinical narrative: Pt presented to office for PPD reading and parents noted a "swollen knee". Pt had non-erythematous edema at (L) thigh from injection site upper/lateral thigh down to knee with mild tenderness without warmth. Advised to give ibuprofen & apply ice.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site swelling
Clinical narrative: P.C. from pt's. mother stating that child noticed bruising, tenderness & fist-sized swelling to vaccination site about 2 days after injection. Cautioned to seek medical attention if sx not resolving or worsening. Try cold compress & BENADRYL.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Pt had Tdap 5/6/2011. Developed severe dizziness 48 hrs later. Went to ED. Stated ED physician thought it could've been related.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Pt had immediate emesis when given vaccine orally.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus generalised
Clinical narrative: Broke out in severe itching from head to toe varies places lasting 7-8 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Red swollen lump at injection site - very hard - within 3 hrs. of injection. Proceeded by red swelling of entire upper arm. Pain & itching - severe. Hot to touch. Symptoms continued from 5/6/11 to 5/9/11 - as I decided to make an appt. with my doctor. He recognized and treated as an allergic reaction to ZOSTAVAX vaccine. Instructed: 3x daily 2.5% Hydrocortisone ointment 3 x daily - ice 3x daily & BENADRYL 2x daily painful from base of neck to forearm. Consulted with doctor on 5/13/11. Follow-up symptoms are getting better. Still itching - redness is now pink & lump shrinking. Ongoing symptoms to date.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Red swollen lump at injection site - very hard - within 3 hrs. of injection. Proceeded by red swelling of entire upper arm. Pain & itching - severe. Hot to touch. Symptoms continued from 5/6/11 to 5/9/11 - as I decided to make an appt. with my doctor. He recognized and treated as an allergic reaction to ZOSTAVAX vaccine. Instructed: 3x daily 2.5% Hydrocortisone ointment 3 x daily - ice 3x daily & BENADRYL 2x daily painful from base of neck to forearm. Consulted with doctor on 5/13/11. Follow-up symptoms are getting better. Still itching - redness is now pink & lump shrinking. Ongoing symptoms to date.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Hypoaesthesia, Injection site anaesthesia, Musculoskeletal chest pain, Nodule
Clinical narrative: Pt c/o uncomfortable, numbing/tingling pain, 5/10 scale, to the anterior chest wall, (L) mid-clavicular line, 2-3 intercostal space. Pea-sized, soft, moveable nodule, noted, tender to touch. Also c/o numbness to the injection site, (L) deltoid.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Pt c/o uncomfortable, numbing/tingling pain, 5/10 scale, to the anterior chest wall, (L) mid-clavicular line, 2-3 intercostal space. Pea-sized, soft, moveable nodule, noted, tender to touch. Also c/o numbness to the injection site, (L) deltoid.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Upper arm/deltoid 6 x 4 cm area of redness, warm to touch, swelling & painful.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Day of injection: 5/5. Just below deltoid on left arm, skin is swollen and red, wrapping around his deltoid muscles. Pt stated he has had PNEUMOVAX do that before. (Last PNEUMOVAX 6/6/2006). Advised cold packs, BENADRYL and TYLENOL. Next day: 5/6 checked left bicep area, continues to have generalized redness that appears slightly raised, and very tender to touch. The area has spread more since yesterday. I told him his pulse was probably raised (at 90) due to his fever (99.5); 5/9 checked with pt about his left upper arm reaction. Stated he took BENADRYL all weekend and the redness was completely gone. He stated good appetite and he had went on his routine am walk this morning. Denied fever or pain. Diphenhydramine, acetaminophen.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Vaccine positive rechallenge
Clinical narrative: Day of injection: 5/5. Just below deltoid on left arm, skin is swollen and red, wrapping around his deltoid muscles. Pt stated he has had PNEUMOVAX do that before. (Last PNEUMOVAX 6/6/2006). Advised cold packs, BENADRYL and TYLENOL. Next day: 5/6 checked left bicep area, continues to have generalized redness that appears slightly raised, and very tender to touch. The area has spread more since yesterday. I told him his pulse was probably raised (at 90) due to his fever (99.5); 5/9 checked with pt about his left upper arm reaction. Stated he took BENADRYL all weekend and the redness was completely gone. He stated good appetite and he had went on his routine am walk this morning. Denied fever or pain. Diphenhydramine, acetaminophen.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Found genital wart
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Laboratory test, Pruritus, Respiratory disorder, Urticaria
Clinical narrative: 25 X 19 flare hive Wheezing, itching, respiratory reaction problem breathing, delayed respiratory reaction. Given Hydroxyzine and 2 weeks later prednisone.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: 25 X 19 flare hive Wheezing, itching, respiratory reaction problem breathing, delayed respiratory reaction. Given Hydroxyzine and 2 weeks later prednisone.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Fatigue, Headache, Laboratory test, Pain
Clinical narrative: A few hours after receiving the vaccine, I became very achy all over my body, suddenly tired, and sweating even though I was cold. It felt as though I had a bad case of the flu, though my only symptoms were achy bones and muscles, fever, and headache. I had a fever ranging from 99 to 101 for a solid 24 hours and could barely move.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: A few hours after receiving the vaccine, I became very achy all over my body, suddenly tired, and sweating even though I was cold. It felt as though I had a bad case of the flu, though my only symptoms were achy bones and muscles, fever, and headache. I had a fever ranging from 99 to 101 for a solid 24 hours and could barely move.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Pt presented to Health Center on 12/23/10 and was diagnosed with new Bell's Palsy.  Pt was treated with valacyclovir and artificial tears.
Age: 66.0
Sex: M
Vaccine: PPV, TD, VARZOS
Symptoms: Epistaxis, Ophthalmological examination abnormal, Vitreous floaters
Clinical narrative: On 22 March, at the recommendation of Dr., I received three simultaneous inoculations at the Clinic:  Tetanus, Zostavax and Pneumovax (23).  Within a week I experienced minor nose-bleeds with strange dark-red blood.  Within a day after the nose-bleeds, about Friday, I noticed a sharp increase in the number of "floaters" in the intraocular fluid of both eyes, but particularly in the left eye.  These floaters continue to interfere with my vision. I then scheduled an examination with my ophthalmologist who confirmed that I did have a large number of floaters, but there was no reasonable treatment at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Injection site swelling, Weight bearing difficulty
Clinical narrative: Swelling of (L) leg & knee. Unable to bear weight.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: (L) arm swelling & red. Cellulitis - KEFLEX 500 mg 2 PO BID x 10D.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: Patient developed a Zoster rash in 2 dermatomes- L4 and L5 on his r. lower leg.  Had a 99.5 fever as well, following sl diarrhea illness.
Age: 64.0
Sex: F
Vaccine: DPP
Symptoms: Chills, Pyrexia
Clinical narrative: I got severe chills with fever. It continued throughout the night until the next day morning.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Croup infectious, Dyspnoea
Clinical narrative: Hours after receiving nasal Flumist, the patient experienced a croup-like illness--barky cough, shortness of breath.  No fever and no preceding URI symptoms.  Mom said it was severe enough that she would have come into the ED, had her husband been home. The illness was much improved the next day.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Fever (ave about 102), body aches, chills, head ache, extreme pain and redness at injection site. Treated with 4x200mg ibuprofen every 4 hours. Symptoms tapered off about 72 hours later. As of 3:30 PM 05/15/2011, still have head ache, low fever, and some body aches. Some discomfort at injection site.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (ave about 102), body aches, chills, head ache, extreme pain and redness at injection site. Treated with 4x200mg ibuprofen every 4 hours. Symptoms tapered off about 72 hours later. As of 3:30 PM 05/15/2011, still have head ache, low fever, and some body aches. Some discomfort at injection site.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted for about 10 seconds and recovered right away.
Age: 1.51
Sex: F
Vaccine: HEP
Symptoms: Differential white blood cell count normal, Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Pt experienced a single febrile seizure 3 hours after receiving the Hepatitis B vaccine. Pt was transported via ambulance to ER. Evaluation by ER doctor proved WNL. Pt seen in office next day - eval was normal. PMHx is neg for previous vaccine reactions and febrile seizures.
Age: 1.51
Sex: F
Vaccine: HEP
Symptoms: Differential white blood cell count normal, Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Pt experienced a febrile seizure 9 hours after receiving the Hepatitis B vaccine. Pt was monitored at home. Evaluation at MD office 24 hrs later proved WNL. Neg PMHx re: vaccine reactions or febrile seizures. Pt experienced a single event.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient developed mild fever, chills, shakes about 27 hrs after vaccine. Symptoms began 5/14/11 8 pm and were gone upon awakening the next morning. No treatment given.
Age: 31.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Pain in extremity
Clinical narrative: Patient came back to clinic after lunch complaining of Difficulty breathing and severe pain in left arm and chest. Patient said it felt like he was having a stroke.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: ACUTE PERICARDITIS
Age: 72.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Mechanical ventilation, Respiratory failure
Clinical narrative: Patient was admitted to Regional Medical Center with ascending paralysis. She now is in respiratory failure and currently on a ventilator.
Age: 72.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Patient was admitted to Regional Medical Center with ascending paralysis. She now is in respiratory failure and currently on a ventilator.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hyperacusis
Clinical narrative: Headache lasting longer then a week. With sensitivity to loud sounds.
Age: 73.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Skin warm, Ultrasound scan normal
Clinical narrative: Mild swelling 3" below (LA) medially & slightly warm to touch. Seen in f/u on 5-9-11 & redness spread from elbow, distally to wrist of left arm. Rx'd with KEFLEX & had extremity US done r/o clot. US normal, no DVT.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pain
Clinical narrative: Headaches, nausea, side pain and body aches - symptoms started the day after receiving vaccine.
Sex: M
Vaccine: RAB, TYP, YF
Symptoms: Dysarthria, Nausea, Vertigo
Clinical narrative: Initial report was received from a health care professional on 04 May 2011. A male patient (age not reported) with no reported past medical history had received on 22 March 2011, a second dose intramuscular injection of IMOVAX Rabies (lot number and site of administration not reported) and two hours later experienced vertigo, nausea and slurred speech that lasted for "about" one hour. On 15 March, the patient had also received the following vaccines: dose one intramuscular injection of IMOVAX Rabies (lot number and site of administration not reported), YF VAX (lot number, route and site of administration not reported) and oral TYPHOID Vaccine (manufacturer and lot number not reported). The patient was evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was reported as fully recovered. Documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, MNQ, RAB, TYP, YF, HEPA, IPV, MNQ, RAB, TYP, YF
Symptoms: Feeling abnormal, Headache, Neurological examination normal, Tremor
Clinical narrative: Initial report received from a health care professional on 04 May 2011. A 20-year-old female patient received on 01 March 2011 the following vaccines (manufacturers and lot numbers not reported): YF VAX (first dose), POLIOMYELITIS Vaccine Inactivated (adult dose), oral TYPHOID vaccine, HEPATITIS A vaccine (first dose), MENVEO vaccine, and RABAVERT (first dose). On 09 March 2011, the patient received a second dose of RABAVERT. On 10 March 2011, the patient developed "tremors, diffuse headache and feeling dazed". On 11 March 2011, the patient had a physical exam of a neuro exam, gait, strength, vital signs all within normal limits, yet she did demonstrated mild tremors to her hands, arms and feet. Her symptoms began after the second dose of the rabies vaccine. It was determined by the CDC that it may or may not have been the RABAVERT vaccine that was the cause and encouraged the patient to complete the series but instead switch to IMOVAX for the last dose. When the patient returned for her follow-up appointment on 14 March 2011, her symptoms were resolved. The patient, on schedule, was switched to IMOVAX (lot number not reported) for the last dose which was given on 06 April 2011. The outcome was reported as resolved. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, MNQ, RAB, TYP, YF, HEPA, IPV, MNQ, RAB, TYP, YF
Symptoms: Condition aggravated, Feeling abnormal, Headache, Neurological examination normal, Poor quality sleep
Clinical narrative: Initial report received from a health care professional on 04 May 2011. A 20-year-old female patient received on 01 March 2011 the following vaccines (manufacturers and lot numbers not reported): YF VAX (first dose), POLIOMYELITIS Vaccine Inactivated (adult dose), oral TYPHOID vaccine, HEPATITIS A vaccine (first dose), MENVEO vaccine, and RABAVERT (first dose). On 09 March 2011, the patient received a second dose of RABAVERT. On 10 March 2011, the patient developed "tremors, diffuse headache and feeling dazed". On 11 March 2011, the patient had a physical exam of a neuro exam, gait, strength, vital signs all within normal limits, yet she did demonstrated mild tremors to her hands, arms and feet. Her symptoms began after the second dose of the rabies vaccine. It was determined by the CDC that it may or may not have been the RABAVERT vaccine that was the cause and encouraged the patient to complete the series but instead switch to IMOVAX for the last dose. When the patient returned for her follow-up appointment on 14 March 2011, her symptoms were resolved. The patient, on schedule, was switched to IMOVAX (lot number not reported) for the last dose which was given on 06 April 2011. The outcome was reported as resolved. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, MNQ, RAB, TYP, YF, HEPA, IPV, MNQ, RAB, TYP, YF
Symptoms: Tremor
Clinical narrative: Initial report received from a health care professional on 04 May 2011. A 20-year-old female patient received on 01 March 2011 the following vaccines (manufacturers and lot numbers not reported): YF VAX (first dose), POLIOMYELITIS Vaccine Inactivated (adult dose), oral TYPHOID vaccine, HEPATITIS A vaccine (first dose), MENVEO vaccine, and RABAVERT (first dose). On 09 March 2011, the patient received a second dose of RABAVERT. On 10 March 2011, the patient developed "tremors, diffuse headache and feeling dazed". On 11 March 2011, the patient had a physical exam of a neuro exam, gait, strength, vital signs all within normal limits, yet she did demonstrated mild tremors to her hands, arms and feet. Her symptoms began after the second dose of the rabies vaccine. It was determined by the CDC that it may or may not have been the RABAVERT vaccine that was the cause and encouraged the patient to complete the series but instead switch to IMOVAX for the last dose. When the patient returned for her follow-up appointment on 14 March 2011, her symptoms were resolved. The patient, on schedule, was switched to IMOVAX (lot number not reported) for the last dose which was given on 06 April 2011. The outcome was reported as resolved. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Onset of hives within couple hours of having second HPV vaccine, first on abdomen, then spreading throughout, somewhat itchy, but no resp symptoms. Developed additional and different hives the next day and some finger swelling, again no resp or GI symptoms. Able to drink and eat normally. On 14 Apr seen in primary care and in ER on 15 Apr when sxs did not resolve with BENADRYL. Given DECADRON IM in ER. No other exposures identified such as foods, chemicals, inhalations, or illness that might have caused the hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left deltoid red warm to touch and pt. states itches x 3days now 5/5/11.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Diarrhoea, Rash
Clinical narrative: Pt was in clinic in AM for vaccine. No problems at time of administration. Several his after left clinic mom called & reported rash & diarrhea. Instructed to take to ER. Pt was in no. Rx ZOFRAN, PRELONE, & BENADRYL. Follow up with PMD 2-3 days.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram head, Computerised tomogram normal, Febrile convulsion
Clinical narrative: Viral URI sx's with clear rhinorrhea and fever. Developed hyperpyrexia with resultant complex febrile seizure. PICU admit x 2 days. Developed viral rash on 5/2/2011.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13
Symptoms: Hyperpyrexia, Intensive care, Pyrexia, Rhinorrhoea, Viral rash
Clinical narrative: Viral URI sx's with clear rhinorrhea and fever. Developed hyperpyrexia with resultant complex febrile seizure. PICU admit x 2 days. Developed viral rash on 5/2/2011.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Viral URI sx's with clear rhinorrhea and fever. Developed hyperpyrexia with resultant complex febrile seizure. PICU admit x 2 days. Developed viral rash on 5/2/2011.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Fatigue, Injection site swelling, Pain
Clinical narrative: Pt had TDAP 5/6/11 felt she had not had tetanus for many years - had fever, body aches, joint pains, fatigue, redness, swelling at site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt had TDAP 5/6/11 felt she had not had tetanus for many years - had fever, body aches, joint pains, fatigue, redness, swelling at site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Within 3 days of receiving vaccine, patient complaint of nerve. Within 5 days she got the shingles. Was in hospital for few days (not sure for how long) and is still being treated for shingles.
Age: 1.19
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Erythema, Vomiting
Clinical narrative: 12-1pm - 5/6/11 - Temp 101 degrees A. Redness - size of pea. Gave TYLENOL - 2:30 - Temp 102.3 R. warm bath - 3:00pm -T - 102.3 - more TYLENOL- diarrhea - 7-8pm - ER = vomiting - 102.5 degrees. Sat. am 8:30 fine 5/7/11.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site pruritus, Papule
Clinical narrative: Child complained of pain at injection site and itching. Parent reported 3-inch diameter redness with white papula in the center. By day 5 post- injection, redness and itching had diminished.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: My daughter had a high fever for 2 to 3 days following the shot (E.R.) said not to worry and I gave her ADVIL and TYLENOL 3 or 4 days later she had a violent seizure. Stopped in - no appointment. (Now has seizures without meds. she is on.)
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) upper arm induration and erythema 11 x 10 cm x 24hrs. Started 24hrs after getting shot. (-) fever or other sx.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: GARDASIL injection was administered in left arm. No immediate reaction. The following morning a severe rash the size of a baseball was apparent. The rash lasted approximately one -1- week. This was the first injection of the series. Informed by pediatrician NOT to continue with the series.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Enterococcal bacteraemia, Injection site vesicles, Oropharyngeal blistering
Clinical narrative: During the patient's admission to the hospital on 04/15/2011 she received PNEUMOVAX, 0.5 mL in left deltoid, and was discharged without complications. On 05/01/2011 she was admitted to the hospital and began intravenous vancomycin hydrochloride to treat the presence of enterococcal bacteremia. She was then discharged on 05/06/2011 with a PICC line. On 05/11/2011, she woke up with blisters present on her left arm at the PNEUMOVAX site and in her mouth.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Two patients who received PNEUMOVAX 23 injections prior to hospital discharge reported red welts and pain at the injection site. This lot of Merck product was quarantined from hospital inventory and Merck was notified. Lot: 1295Z Exp: 20APR12 NDC: 0006-4943-00.
Age: 44.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling, fever in area of shot.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Polymerase chain reaction, Rash maculo-papular, Rash pruritic, Skin lesion, Varicella virus test positive
Clinical narrative: Approximately 16 days after VARIVAX given, baby developed pruritic maculopapular rash - first on arm, then face and over next 2 days spread to both arms & back. On 5/7/11 there were less than 20 lesions. No fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HIBV, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There is no adverse events. Pt received vaccine out of licensure. Pt had Hib #1 after the age of 1 and didn't need a fourth one.
Age: 7.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events occurs. This is vaccine given out of licensure. Pt received DTaP instead of Td due to age.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizziness 4/30 0400 -> resolved "late afternoon". Increased BP.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dyspnoea, Pallor, Wheezing
Clinical narrative: Child was very apprehensive. After injection was pale & weak; did not pass out. Smelling salt used. Began to c/o trouble breathing 10-15" after. Wheezing in chest detected, mother & 911 called. Oral BENADRYL 25mg given by school nurse. O2 & Epinephrine administered by paramedics. Taken to ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Localized redness, itching. PO BENADRYL PRN.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Mother reports 10-15 red flat spots on child's neck and chest. States child feels fine. No fever. Did not seek medical care.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: herpes zoster in a child who received 2 doses of varicella vaccine
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Woke with pink nonraised itchy rash on front of neck 3 consecutive mornings after receiving vaccinations. Tx with Benadryl q 6hours. No rash on day 4. No addtional s/s of reaction. No previous hx or similar event.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis (R) thigh. Tx: AUGMENTIN ES 600 - 42.9/5ml sig: 2 tsp BID x 10 days.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Severe swelling covering large area. Pt claims covered all of upper arm.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Erythema, Fatigue, Oropharyngeal pain, Pyrexia, Rash maculo-papular
Clinical narrative: Developed extensive erythematous maculopapular lesions to abdomen, thighs & legs 10 days after Smallpox, Tetanus, & Anthrax vaccination, 9 days afer oral surgery; 4 wisdom teeth extracted. Seen in ER & Dermatology. Next day developed faint erythematous lesions on neck, arms, & hands. Seen in clinic with c/o sore throat, light fever, feeling tired. Prescribed CLARITIN; ZYRTEC; ATARAX & BENADRYL.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Skin lesion, Streptococcus test, Streptococcus test negative
Clinical narrative: Developed extensive erythematous maculopapular lesions to abdomen, thighs & legs 10 days after Smallpox, Tetanus, & Anthrax vaccination, 9 days afer oral surgery; 4 wisdom teeth extracted. Seen in ER & Dermatology. Next day developed faint erythematous lesions on neck, arms, & hands. Seen in clinic with c/o sore throat, light fever, feeling tired. Prescribed CLARITIN; ZYRTEC; ATARAX & BENADRYL.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Developed extensive erythematous maculopapular lesions to abdomen, thighs & legs 10 days after Smallpox, Tetanus, & Anthrax vaccination, 9 days afer oral surgery; 4 wisdom teeth extracted. Seen in ER & Dermatology. Next day developed faint erythematous lesions on neck, arms, & hands. Seen in clinic with c/o sore throat, light fever, feeling tired. Prescribed CLARITIN; ZYRTEC; ATARAX & BENADRYL.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Streptococcus test negative
Clinical narrative: Developed extensive erythematous maculopapular lesions to abdomen, thighs & legs 10 days after Smallpox, Tetanus, & Anthrax vaccination, 9 days afer oral surgery; 4 wisdom teeth extracted. Seen in ER & Dermatology. Next day developed faint erythematous lesions on neck, arms, & hands. Seen in clinic with c/o sore throat, light fever, feeling tired. Prescribed CLARITIN; ZYRTEC; ATARAX & BENADRYL.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Appx 50mm circular reddened, itchy area at injection site on right arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: PT WAS GIVEN VACCINE IN LEFT ARM. A FEW HOURS LATER THE PT CALL AND HER ARM WAS SWOLLEN THE SIZE OF A GOLF BALL. THERE ARE NO OTHER SYMPTOMS AT THIS TIME. MD WAS CALLED.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Alanine aminotransferase increased, Amino acid level, Ammonia normal, Anion gap normal, Anticonvulsant drug level therapeutic
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.