chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: I played gold two (2) hours after getting my flu vaccine injection.  Injection given at 10AM, 10/07/2008.  About eight (8) hours after the vaccination I started to get a headace, felt very cold (like I was coming down with a cold), even to the point I was shivering and my teeth were chatering.  I took two Aleve and went to bed with an extra blanket on at about 9:00PM.  At about 3:30AM my fever broke (woke up sweating profusely).  At 6:00AM day after injection I felt fine.  I have felt OK since.    I know this vaccine is a dead virus and will not give you the flu.  But when talking with the Nurse Practionner, she felt we should report this, as it may be a side effect not listed.
Age: 31.0
Sex: M
Vaccine: FLU3, HEP, MNQ, YF
Symptoms: Blood product transfusion, CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Demyelination
Clinical narrative: Ascending weakness in legs and arms - diagnosed as GBS. Treated with IVIG 2 gm/kg (175 gm) given over 3 days (9/30 to 10/2) and IVIG 1 gm/kg (90 gm) given over 2 days (10/4 to 10/5). 10/27/08-records received for DOS 9/29-10/8/08-DC DX: GBS. Presented to ED with 2 day history of worsening ascending lower and upper extremity weakness with abnormal sensation. Tightness and tingling of fingertip, elbow and knee. Unable to rise from squat. Episode of a fall. PE: ascending stocking glove neuropathy with weakness and decreased vibratory sensation in hands and feet. Swallowing difficulties. Treated with IVIG. 1/28/2010 Last seen in clinc 3/5/09. At that time continued to report fatigue, fine moto deficits, numbness in feet.  On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.
Age: 31.0
Sex: M
Vaccine: FLU3, HEP, MNQ, YF
Symptoms: Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Hypokinesia
Clinical narrative: Ascending weakness in legs and arms - diagnosed as GBS. Treated with IVIG 2 gm/kg (175 gm) given over 3 days (9/30 to 10/2) and IVIG 1 gm/kg (90 gm) given over 2 days (10/4 to 10/5). 10/27/08-records received for DOS 9/29-10/8/08-DC DX: GBS. Presented to ED with 2 day history of worsening ascending lower and upper extremity weakness with abnormal sensation. Tightness and tingling of fingertip, elbow and knee. Unable to rise from squat. Episode of a fall. PE: ascending stocking glove neuropathy with weakness and decreased vibratory sensation in hands and feet. Swallowing difficulties. Treated with IVIG. 1/28/2010 Last seen in clinc 3/5/09. At that time continued to report fatigue, fine moto deficits, numbness in feet.  On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.
Age: 31.0
Sex: M
Vaccine: FLU3, HEP, MNQ, YF
Symptoms: Muscular weakness, Red blood cells CSF positive
Clinical narrative: Ascending weakness in legs and arms - diagnosed as GBS. Treated with IVIG 2 gm/kg (175 gm) given over 3 days (9/30 to 10/2) and IVIG 1 gm/kg (90 gm) given over 2 days (10/4 to 10/5). 10/27/08-records received for DOS 9/29-10/8/08-DC DX: GBS. Presented to ED with 2 day history of worsening ascending lower and upper extremity weakness with abnormal sensation. Tightness and tingling of fingertip, elbow and knee. Unable to rise from squat. Episode of a fall. PE: ascending stocking glove neuropathy with weakness and decreased vibratory sensation in hands and feet. Swallowing difficulties. Treated with IVIG. 1/28/2010 Last seen in clinc 3/5/09. At that time continued to report fatigue, fine moto deficits, numbness in feet.  On exam found to have reduced reflexes and sensations. Expected to continue improvement over the next 12 months with likely no residual deficits.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: patient called day of administration (10/7/08 about 11:30 AM)reporting some itching on injection site, resolved with hydrocortisone cream application.  Came in for evaluation 10/9/08.  Site slightly bruised (on aspirin therapy)slightly raised and red about 2 cm x 4cm oval, warm to touch.  Patient has been icing area and applying hydrocortisone to site.  I advised a check by her doctor to r/o possible reaction to bandage, but area looks like possible injection site reaction to vaccine with secondary infection.  Patient is also diabetic and higher risk for secondary infections.  Pending patient follow up after MD appointment.  Patient reports never having a reaction with influenza vaccine in past history, but un-reported number if times received injection in past.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: patient called day of administration (10/7/08 about 11:30 AM)reporting some itching on injection site, resolved with hydrocortisone cream application.  Came in for evaluation 10/9/08.  Site slightly bruised (on aspirin therapy)slightly raised and red about 2 cm x 4cm oval, warm to touch.  Patient has been icing area and applying hydrocortisone to site.  I advised a check by her doctor to r/o possible reaction to bandage, but area looks like possible injection site reaction to vaccine with secondary infection.  Patient is also diabetic and higher risk for secondary infections.  Pending patient follow up after MD appointment.  Patient reports never having a reaction with influenza vaccine in past history, but un-reported number if times received injection in past.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: FLU SHOT GIVEN ON 10072008. RED, SLIGHTLY RAISED,HOT 7.5X6CM
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site streaking, Injection site warmth
Clinical narrative: PATIENT WAS PRESENTED WITH A RED, HOT RASH ON HIS ARM AT INJECTION SITE WITH A WHITE STREAK RUNNING TOWARD THE ARM PIT.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Childhood disintegrative disorder, Regressive behaviour, Speech disorder developmental
Clinical narrative: Parents begin to slowly notice that child began to not make milestones appropriate for his age. He slowly stopped doing appropriate behaviors for his age and began to regress. Child continued to lose language he had previously had and could not work simple puzzles that had been easily mastered.  1/23/09 Received Neuro medical records of  12/20/2005-2/23/2006. FINAL DX: Autism, static encephalopathy, speech deficits Records reveal patient was in early intervention program when evaluated.  Socialization skills were delayed, speech mostly jargon, poor eye contact, unable to follow simple commands, stereotypical repetitive behavior.  10/28/08 Reviewed PCP office records of 10/31/05. FINAL DX: delayed expressive speech, allergy.   On day of Hep A vax (no record of flu vax), pt w/recent ear infection & cough.  PCP noted delayed speech & referred to early childhood intervention.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES ON SHOULDER AND BACK
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Accidental needle stick
Clinical narrative: PT RECEIVED INFLUENZA VACCINE, AND AS ADMINISTRATOR WAS ATTEMPTING TO ACTIVATE THE SAFETY GLIDE FEATURE OF THE SYRINGE, THE ADMINISTRATOR WAS STUCK BY THE NEEDLE IN THE RIGHT FIRST FINGER.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Borrelia burgdorferi serology negative, CSF culture positive, CSF oligoclonal band absent, Cranial nerve disorder, Cytomegalovirus test positive
Clinical narrative: Developed left eye ptosis and lateral deviation on 9/28/08.  This progressed somewhat until he was brought to medical attention the next day.  MRI of brain showed enhancing left third cranial nerve lesion.  Infectious and autoimmune workup negative except for CSF CMV PCR which was positive with negative serum serologies and PCR.  He was started on a short course of steriods and has been improving. 10/20/08-records received-Presented to ED 9/29/08- with C/O left eyelid drooping pupil dilation and eye deviated to left since day prior. Hit left eyebrow 2 weeks ago. Impression left 3rd nerve palsy.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Enterovirus serology test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Eye movement disorder, HIV antibody negative
Clinical narrative: Developed left eye ptosis and lateral deviation on 9/28/08.  This progressed somewhat until he was brought to medical attention the next day.  MRI of brain showed enhancing left third cranial nerve lesion.  Infectious and autoimmune workup negative except for CSF CMV PCR which was positive with negative serum serologies and PCR.  He was started on a short course of steriods and has been improving. 10/20/08-records received-Presented to ED 9/29/08- with C/O left eyelid drooping pupil dilation and eye deviated to left since day prior. Hit left eyebrow 2 weeks ago. Impression left 3rd nerve palsy.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Human herpes virus 6 serology negative, Immunology test, Polymerase chain reaction, Syphilis test negative, Varicella zoster serology negative
Clinical narrative: Developed left eye ptosis and lateral deviation on 9/28/08.  This progressed somewhat until he was brought to medical attention the next day.  MRI of brain showed enhancing left third cranial nerve lesion.  Infectious and autoimmune workup negative except for CSF CMV PCR which was positive with negative serum serologies and PCR.  He was started on a short course of steriods and has been improving. 10/20/08-records received-Presented to ED 9/29/08- with C/O left eyelid drooping pupil dilation and eye deviated to left since day prior. Hit left eyebrow 2 weeks ago. Impression left 3rd nerve palsy.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Hypoaesthesia, Oxygen saturation normal, Paraesthesia
Clinical narrative: This was the patient's first flu shot.  Within 2 minutes of receiving the vaccine she started to complain of loss of vision, feeling very hot and had labored breathing.  911 was immediately contacted.  The patient remained responsive and started to complain of numbness and tingling in extremities.  I gave the patient 50mg diphenhydramine by mouth.  When the paramedics arrived they took her vitals and determined she was having a vagal response.  At this point the patient was feeling better and breathing and eye sight were back to normal.  She refused additional medical treatment from the paramedics and after 30 minutes returned to work by escort.  She remained under close supervision of a co-worker for the rest of the work day.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope vasovagal, Visual disturbance
Clinical narrative: This was the patient's first flu shot.  Within 2 minutes of receiving the vaccine she started to complain of loss of vision, feeling very hot and had labored breathing.  911 was immediately contacted.  The patient remained responsive and started to complain of numbness and tingling in extremities.  I gave the patient 50mg diphenhydramine by mouth.  When the paramedics arrived they took her vitals and determined she was having a vagal response.  At this point the patient was feeling better and breathing and eye sight were back to normal.  She refused additional medical treatment from the paramedics and after 30 minutes returned to work by escort.  She remained under close supervision of a co-worker for the rest of the work day.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of itching in an adult subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2008 the subject received unspecified dose of FLUARIX (unknown). In 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced itching, increased heart rate, rash and trouble breathing. The pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated in the emergency room. Treatment was not specified. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with FLUARIX. A product complaint was reported. The pharmacist reported that 5 to 7 adults (exact number unknown) who are employees of the hospital experienced reactions to FLUARIX. The events known to the reporter were documented above. It was noted that there could be additional events. All of the subjects had to be treated in the emergency room. Details of the treatment were not specified. Limited subject information was known at the time of reporting. The pharmacist only knew one lot number, but there may have been others (unknown at the time of reporting). These 5 to 7 subjects are out of a total of 22 doses of FLUARIX given. Due to the high rate of reactions, the hospital stopped using the FLUARIX because they feel the reactions are due to a quality issue with the product.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoglycaemia, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included diabetes controlled by diet and heart disease. There were no concurrent medications. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject experienced hypoglycemia and sleepiness. This case was assessed as medically serious by GSK. Product complaint was reported. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave 20 doses of FLULAVAL in the morning and three subjects reported hypoglycemia.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypoglycaemia, Malaise, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 77-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject is not a diabetic and has a history of chronic kidney disease, stage 4 and on on dialysis. Also has a medical history of anemia and currently has hypertension. There were no concurrent medications. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject experienced hypoglycemia, sleepiness, lack of energy and feeling unwell. This case was assessed as medically serious by GSK. Product complaint was reported. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave three doses of FLULAVAL in the morning and three subjects reported hypoglycemia.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Fatigue, Feeling abnormal, Hypoglycaemia, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hypoglycemia in a 43-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject is not a diabetic and receives unspecified thyroid medication concurrently. On the morning of 7 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 7 October 2008, about 1 hour after vaccination with FLULAVAL, the subject started to feel bad and experienced hypoglycemia (drop in blood sugar to 17 per serum test) and sleepiness. Fatigue was also documented. This case was assessed as medically serious by GSK. Product complaint was reported. The subject was given orange juice and peanut butter crackers and about 30 minutes later, her blood sugar was 49. At the time of reporting the outcome of the events was unspecified. The reporter stated that they gave 20 doses of FLULAVAL in the morning and three subjects reported hypoglycemia.
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Influenza like illness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Flu like symptoms. Fever, hot/cold intervals Red and painful sit.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Daughter called 10-4-08 reporting her mother's right arm was very red clear down past the elbow, hot to the touch and painful.  Daughter is an RPh and had instructed mom to ice it and take Tylenol for the pain - will keep an eye on it and see MD on Monday if needed.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Palpitations, Paraesthesia, Pyrexia
Clinical narrative: 8hrs after receiving shot pt complained of dizzyness sweating fever heart palpitations legs tingling
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: 3cc dose adm. drug error 6 dose injection arm red, painful @ site.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: 3 cc dose administered. Drug error 6 dose injection. Arm red painful @ injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: 3 cc dose administered. Arm red, painful @ injection site.
Age: 1.12
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Received immuns 9/29/08 (VZV right thigh).  On 10/7 developed 9 pruritis papules right lateral thigh, no fever.
Age: 8.0
Sex: F
Vaccine: FLU3, MMR, TD, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Rt. deltoid presents with redness & edema 2" x 3"; pt reports "much better" at 5pm next day.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Migraine, Nausea
Clinical narrative: She got pain and muscle cramps at site of injection w/in 5 minutes. After 2 hrs, she felt nauseated and severe migraine headache that lasts until the next day.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site mass, Injection site warmth, Oedema peripheral
Clinical narrative: (L) arm red, swollen, knotted area @ injection site - warm to touch.
Age: 0.9
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia, Respiratory rate increased, Restlessness, Tremor
Clinical narrative: Fever of 104 (digital tympanic) 10pm night of shots, vomited X 1, shaky but no seizure, rapid breathing. Mom started giving Tylenol 0.8ml every 4 hours. Fever ran 101 the next day. Child was irritable, restless x 1.5 days after onset of fever, then was back to normal behavior. Prevnar withheld per MD on 9/29/08, requested report to VAERS.
Age: 0.9
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Fever of 104 (digital tympanic) 10pm night of shots, vomited X 1, shaky but no seizure, rapid breathing. Mom started giving Tylenol 0.8ml every 4 hours. Fever ran 101 the next day. Child was irritable, restless x 1.5 days after onset of fever, then was back to normal behavior. Prevnar withheld per MD on 9/29/08, requested report to VAERS.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pt. got pneumonia vaccine RA, IM, lot #15414 on 10-6-08. Pt stated and showed nurse on 10-8-08 where shot was given. Pt. stated it was given too high. Went to private Dr, 10-7-08. Dr. gave him Hydrocodone for pain. Nurse gave him DEPO-MEDROL, 40 mg, LD, IM. Advise to use heat packs, rest x 2 days, then start gradual ROM exercises.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Migraine, Nausea, Paraesthesia
Clinical narrative: She got a tingling and numbness sensation in her left arm within half an hour. Then she felt nauseated. She then threw up twice. She felt dizzy and had a severe migraine headache. I asked her to go to the ER but she didn't go. She went to her doctor's office the next day.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: She got a tingling and numbness sensation in her left arm within half an hour. Then she felt nauseated. She then threw up twice. She felt dizzy and had a severe migraine headache. I asked her to go to the ER but she didn't go. She went to her doctor's office the next day.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: As soon as patient received VARIVAX she fainted. I (the physician) came in the room right away; she was alert & oriented O2 sat 96% on R.A. Her lip is pale & hands are sweaty; The rest of physical exam is within normal limit. I think pt has vaso-vagal episode secondary to fear of vaccination
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Erythemia, induration, fever
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient received Tdap on 9/29/08.  Called on 10/2/08 reporting over past few days arm very sore, painful at night, "swollen area on neck above clavicle" - declined to be evaluated.  Called patient on 10/8/08 and left message to see how she is feeling - have not received call back from patient.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: red area on L DLT with 24 hours of vaccination given in LDT that day went to pediatrician given Benadryl cream area is resolving.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: At inj. site 4 x 4 cm area of erythema, induration, heat; pain. Area increasing x 2 days Tx Ceclor 250, 1 TSP BID x 7d Moist, heat to area; Tylenol for pain.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth, Pyrexia
Clinical narrative: 7 cm erythematous, hot, painful streak from injection site ant thigh -> behind L knee -> just below L knee. Febrile Rx Amox 125/5 TID X 7d.  Motrin\Tylenol
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: R upper arm very red from shoulder to elbow & swollen low grade fever/treated with Medrol Dose Pak
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: 4cm erythematous area along the left upper extremity at where immunization given
Age: 8.9
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. received Tdap. Outside of age prescribed. Last DTaP given 8/25/05.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Amenorrhoea, Pregnancy test, Urine analysis abnormal
Clinical narrative: Symptoms: Amenorrhea.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rash, Throat tightness
Clinical narrative: Facial, ear, chest rash. Flushed. Throat felt "clogged".
Age: 1.3
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Lethargy, Vaccine positive rechallenge
Clinical narrative: Lethargic (pt demonstrated this same side effect when he received his previous vaccinations). O.5 ml given instead of 0.25 ml.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: 11/9/2007 - FluMist given.  She received vaccine about 12 noon, then returned to wk.  Approximately 8 pm she began to sneeze.  The next day she had sniffles, sneezing worse and diffuse aches (like a cold).  The next day, Sunday, she had a cough.  She went to Urgent Care on Monday c/o temp 101, stuffy head, congestion, cough and treated for URI w/meds and given NFW for 2-3 days.  Symptoms lasted 2 weeks.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing, Upper respiratory tract infection
Clinical narrative: 11/9/2007 - FluMist given.  She received vaccine about 12 noon, then returned to wk.  Approximately 8 pm she began to sneeze.  The next day she had sniffles, sneezing worse and diffuse aches (like a cold).  The next day, Sunday, she had a cough.  She went to Urgent Care on Monday c/o temp 101, stuffy head, congestion, cough and treated for URI w/meds and given NFW for 2-3 days.  Symptoms lasted 2 weeks.
Age: 76.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: Adult patient inadvertently received incorrect vaccine on 10/1/08. Patient received pediatric Dtap. Patient stated he had no adverse effects from the vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Asthenia, Chest pain, Dizziness, Dysphagia, Oropharyngeal pain
Clinical narrative: Immediately after receiving vaccines, c/o generalized weakness, color pale, ringing in ear.  Child did not lose consciousness, vital signs remained stable; monitored, left office without further concerns.  Child returned to office 9/23/08 with c/o chest pain, sore throat, slight dizziness, difficulty swallowing - Evaluated by physician again on 9/29/08, all symptoms resolved.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Pallor, Tinnitus
Clinical narrative: Immediately after receiving vaccines, c/o generalized weakness, color pale, ringing in ear.  Child did not lose consciousness, vital signs remained stable; monitored, left office without further concerns.  Child returned to office 9/23/08 with c/o chest pain, sore throat, slight dizziness, difficulty swallowing - Evaluated by physician again on 9/29/08, all symptoms resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: C/O pain in left upper arm since flu shot, and lateral aspect of left shoulder. Pain with ROM in left shoulder. NO redness, no swelling, no effusion of (L) shoulder and no ecchymosis noted. Tx: Alternate hot and cold compress, soak in warm tub. Tylenol #3 for pain. Follow-up as needed.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Swelling, Urticaria
Clinical narrative: Erythema, swelling @ site with swelling, hives, anterior, lateral to injection site. Obvious swelling pain @ supraclavicular infraclavicular area.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Medication error, Pain in extremity
Clinical narrative: 3cc administration. Drug error arm painful, red at injection site.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc administered - drug error. Arm painful red @ injection site.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc administered - drug error - 6 dose injection. Arm painful, red @ injection site.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc administered (drug error), 6 dose inj. Arm painful and red @ injection site.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc administered (drug error). 6 dose injection. Arm painful, red @ injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3cc admin. Drug error 6 dose injection. Arm painful red at site.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc dose administered - drug error. 6 dose injection. Arm red, painful @ inj. site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: 3 cc dose administered - drug error. 6 dose injection. Arm red, painful @ injection site.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: 3 cc dose adm. Drug error. 6 dose injection. Arm red, painful @ site.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Initial report received from a patient's parent, who is a nurse practitioner, on 12 September 2008. A 14-year-old male patient developed lethargy, fatigue, chills, loose stools and nausea 10 days after he had received an intramuscular left deltoid injection of Menactra (lot number not known). The patient also experienced dizziness approximately one week after the vaccination. Lethargy, chills and loose stools resolved in 72 hours. The dizziness also resolved at an unspecified time. At the time of the report, nausea and fatigue continued. Follow-up informaton was received 08 october 2008 from a health care professonial who reviewed the casre information and stated that the patient had a concomitant diagnosis of mononucleosis and had recovered from the event. No further information was provided at the time of the report.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Infectious mononucleosis, Lethargy, Nausea
Clinical narrative: Initial report received from a patient's parent, who is a nurse practitioner, on 12 September 2008. A 14-year-old male patient developed lethargy, fatigue, chills, loose stools and nausea 10 days after he had received an intramuscular left deltoid injection of Menactra (lot number not known). The patient also experienced dizziness approximately one week after the vaccination. Lethargy, chills and loose stools resolved in 72 hours. The dizziness also resolved at an unspecified time. At the time of the report, nausea and fatigue continued. Follow-up informaton was received 08 october 2008 from a health care professonial who reviewed the casre information and stated that the patient had a concomitant diagnosis of mononucleosis and had recovered from the event. No further information was provided at the time of the report.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Erythema, Feeling of body temperature change, Headache, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Initial report was received 18 September 2008 from a health care professional.  A 12-year-old female patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2636AA and a first dose right deltoid intramuscular injection of GARDASIL, lot number 0843X (manufacturer Merck) on 11 September 2008, and on the evening of vaccination, she developed numbness in her face.  By the following morning, the numbness had worsened and she complained of a prickly feeling in her cheeks and around her lips, and her face felt hot and cold.  The patient's face also appeared pink and puffy.  By the afternoon, her lips became tingly.  The patient's mother called their health care provided to report the symptoms and stated the patient complained that her head was hurting (onset time and date not reported).  The patient had not experienced any fever and no other symptoms occurred.  The patient received corrective treatment with BENADRYL.  By the following morning (date not reported), all symptoms had resolved.  The patient had also received an injection of ADACEL (lot number not reported) within four weeks prior to receipt of MENACTRA and GARDASIL.  No further information was provided.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: Initial report was received 18 September 2008 from a health care professional.  A 12-year-old female patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2636AA and a first dose right deltoid intramuscular injection of GARDASIL, lot number 0843X (manufacturer Merck) on 11 September 2008, and on the evening of vaccination, she developed numbness in her face.  By the following morning, the numbness had worsened and she complained of a prickly feeling in her cheeks and around her lips, and her face felt hot and cold.  The patient's face also appeared pink and puffy.  By the afternoon, her lips became tingly.  The patient's mother called their health care provided to report the symptoms and stated the patient complained that her head was hurting (onset time and date not reported).  The patient had not experienced any fever and no other symptoms occurred.  The patient received corrective treatment with BENADRYL.  By the following morning (date not reported), all symptoms had resolved.  The patient had also received an injection of ADACEL (lot number not reported) within four weeks prior to receipt of MENACTRA and GARDASIL.  No further information was provided.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Feeling of body temperature change, Flushing, Headache, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Initial report was received 18 September 2008 from a health care professional.  A 12-year-old female patient had received a left deltoid intramuscular injection of MENACTRA, lot number U2636AA and a first dose right deltoid intramuscular injection of GARDASIL, lot number 0843X (manufacturer Merck) on 11 September 2008, and on the evening of vaccination, she developed numbness in her face.  By the following morning, the numbness had worsened and she complained of a prickly feeling in her cheeks and around her lips, and her face felt hot and cold.  The patient's face also appeared pink and puffy.  By the afternoon, her lips became tingly.  The patient's mother called their health care provided to report the symptoms and stated the patient complained that her head was hurting (onset time and date not reported).  The patient had not experienced any fever and no other symptoms occurred.  The patient received corrective treatment with BENADRYL.  By the following morning (date not reported), all symptoms had resolved.  The patient had also received an injection of ADACEL (lot number not reported) within four weeks prior to receipt of MENACTRA and GARDASIL.  No further information was provided.
Sex: F
Vaccine: RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a female with no allergies or pertinent medical history who was vaccinated po with a third dose of ROTATEQ.  There was no concomitant medication.  The physician reported that the patient was given all three doses of ROTATEQ and had a suspected case of intussusception and was hospitalized.  The patient was given a barium enema.  The patient was not given the vaccine at the reporting physician's office and was not the reporting physician's patient.  Subsequently, on 04-OCT-2008 the patient recovered from suspected case of intussusception.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: RV5, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning a female with no allergies or pertinent medical history who was vaccinated po with a third dose of ROTATEQ.  There was no concomitant medication.  The physician reported that the patient was given all three doses of ROTATEQ and had a suspected case of intussusception and was hospitalized.  The patient was given a barium enema.  The patient was not given the vaccine at the reporting physician's office and was not the reporting physician's patient.  Subsequently, on 04-OCT-2008 the patient recovered from suspected case of intussusception.  A product quality complaint was not involved.  Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Hypersensitivity
Clinical narrative: Pt presents with allergic reaction to Anthrax.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, tenderness at vaccination site
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Nausea, Oedema peripheral, Pain, Pruritus
Clinical narrative: (L) arm swelling, itching, soreness, nausea, temp. Hospitalized 3 days. Ice pack and Benadryl. Did EKG and ECHO. 10/15/08 Reviewed hospital medical records of 10/2-10/04/2008. FINAL DX: local vaccine reaction Records reveal patient experienced weakness, nausea, itching, injection site swelling, induration & erythema left deltoid.  Cardiology consult done.
Age: 69.0
Sex: M
Vaccine: FLU3
Clinical narrative: Chronic inflammatory demyelinating neuropathy attack.  1/19/09 Reviewed hospital d/c summary for 1/8-1/12/2008. FINAL DX: chronic inflammatory demyelinating polyradiculopathy. Records reveal patient experienced recurrence of pain, weakness of right leg, low back pain, difficulty sleeping.  Tx w/IVIG x 5 days w/improvement.  D/c to home with on continued pain management w/neuro outpatient f/u.  1/8/09 Reviewed PCP medical records for 7/22/08-10/24/08 FINAL DX: recurrent chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced right hip pain, arthritis, constipation, insomnia, hyperesthesia of skin & dx w/herpes zoster, tx w/antiviral meds. 7/22/08 record indicates pt recently released from hosp s/p chronic demyelinating polyradiculopathy.  Continued to have pain, difficulty walking, gait disturbance, depression & falling down at that time.    12/2/08 Reviewed hospital medical records of 10/16-10/19/2006. FINAL DX: chronic inflammatory demyelinating polyradiculopathy Records reveal patient experienced recurrent pain & weakness left leg beginning 9/2006.  Admitted for IVIG x 4 days.  Improved & d/c to home.  10/27/06 GI consult done for normocytic normochromic anemia & colonoscopy.
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, VARCEL
Symptoms: Rash macular, Rash vesicular, Scab, Varicella, Varicella post vaccine
Clinical narrative: Upon interview, patient denies history of varicella illness and could not recall vaccination prior to in processing. Multiple, different size maculo-vesicular rash over the face, chest, abdomen, upper and lower extremities skin. Patient has been afebrile and pain free. Patient was serologically tested and found varicella non-immune upon entry (7/2/2008). Patient received varicella vaccination on 7/9/2008. Patient received second dose of varicella vaccination on 8/8/2008. While admitted to hospital, diagnosis: chicken pox. Patient remained on droplet isolation precautions and received Acyclovir and Moxifloxacin. Hospital Principal Diagnosis: Varicella vaccine induced chickenpox. Discharge: Patient lesions crusted and the lesions are no longer contagious, returned to military.  10/23/2008 MR received for DOS 8/30-9/2/2008 with D/C DX:  Varicella Vaccine Induced Chicken Pox.  Pt presented with vesicular/pustular rash all over x 2 days.  Pt has inguinal and submandibular lymphadenopathy. Worsening productive cough with yellow/green sputum x 3 weeks. Pt placed on contact and airborn isolation and tx with Acyclovir and Moxifloxin. D/C when lesions crusted over.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Oedema peripheral, Pain, Stomach discomfort
Clinical narrative: Arm swollen for 4 days after shot; also body aches, chills, and stomach upset. Lost 2 days of work due to adverse reaction. 1st time ever.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: 5,OCT,2008 reports to clinic with malaise/fatigue and chills. Pt states symptoms developed 4,OCT,2008 afternoon. Experienced N/V/Chills. Woke up vomiting 3 to 4 times last noc. Cannot keep food or liquids down today. Reported to clinic 09:15 5,OCT,2008.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Retching, Vomiting
Clinical narrative: Following day, patient reported vomiting w/o fever, nausea or any other symptom.  Vomiting was accompanied by a constant "gagging" feeling.  Only lasted one day.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Left and right arms, warm, swollen.  Increased pain started to hurt at 8 PM 10/01/08.  Took Tylenol with no relief.  10/03/08 no improvement.  10/6/08 Improved.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt. started with urticarial rash approx. 24 hours after administration of 6 mos. immunizations. Treated with BENADRYL, then po steroids (also fever to 101 degrees).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: 3 pm (L) side neck stiff. 5 pm (L) side neck pain. 7 pm (L) shoulder pain, radiating down to elbow with muscle spasm from shoulder to elbow. Could not sleep due to pain, 9/6/08. 9/30/08, increase pain (L) neck to elbow, per MD, use ice/heat/ADVIL 400 mg, every 4 hours. 10/1/08, in MD office, Cortisone injection to (R) arm. TENS unit applied x 30 mins. Amp 1x 15 mg, Hydrocodone 10 mg. Rx given 10/2/08. Back to MD for TENS unit therapy - off work 3 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: 3 pm (L) side neck stiff. 5 pm (L) side neck pain. 7 pm (L) shoulder pain, radiating down to elbow with muscle spasm from shoulder to elbow. Could not sleep due to pain, 9/6/08. 9/30/08, increase pain (L) neck to elbow, per MD, use ice/heat/ADVIL 400 mg, every 4 hours. 10/1/08, in MD office, Cortisone injection to (R) arm. TENS unit applied x 30 mins. Amp 1x 15 mg, Hydrocodone 10 mg. Rx given 10/2/08. Back to MD for TENS unit therapy - off work 3 days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Myalgia, Pain
Clinical narrative: About 15 minutes after receiving flu shot.  I began to feel tightness of my throat and chest and head and difficulty breathing. About 2 hours later I began to feel urgency to cough and my throat more tight about 6 hours after the shot I began having body aches, muscle pain and fever of 100. Resolving throat and head tightness and congestion.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tension headache, Throat tightness, Upper respiratory tract congestion
Clinical narrative: About 15 minutes after receiving flu shot.  I began to feel tightness of my throat and chest and head and difficulty breathing. About 2 hours later I began to feel urgency to cough and my throat more tight about 6 hours after the shot I began having body aches, muscle pain and fever of 100. Resolving throat and head tightness and congestion.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Balance disorder, Injection site erythema, Injection site rash, Muscular weakness
Clinical narrative: FLU AND PNEUMO in (R) arm, Wed NOC, redness, rash at injection site, weakness of legs, unsteady - Improved by Mon 10/6/08
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Hives within 2 hours of administration
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: immediate reaction dizzy, flushed, nausea, headache (sharp) photophobia Resolved after 10 minutes
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia
Clinical narrative: immediate reaction dizzy, flushed, nausea, headache (sharp) photophobia Resolved after 10 minutes
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Rash started one day later (red with small bumps)
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Broke out into rashes
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: red spot - sore to touch - hot to touch - antibiotic & benedryl treatment
Sex: U
Vaccine: FLU3
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Generalized maculopapular erythema drug reaction rash
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dyskinesia, Syncope
Clinical narrative: Within 1 minute of receiving GARDASIL (last of 4 vaccines given) pts eyes fluttered & she had syncopal episode for a few seconds with several jerks of lower legs concurrent with syncope. Recovered from that in several seconds. No change with pulse, BP or O2 sat throughout
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: after administration VARIVAX SQ in R arm pt immediately had redness & swelling @ site of injection. There was approximately 3x5 cm redness and 1x1 cm induration. Gave 2 tsp of Zyrtec here in office
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Pt came to clinic to receive his 1st Anthrax vaccination. Pt was also to receive Typhoid and Flu Mist. Anthrax was given in L arm subQ. Approx. 1 minute later pt stated he felt like he was going to pass out. He then passed out. I took him to the floor, treated for syncope along with physician. Pt evaluated in clinic and return to duty.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis - warm, painful induration of deltoid area on left
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain in extremity
Clinical narrative: 2 days after injection patient complained of severe diffuse myalgias and (L) arm pain - no rash, no shortness of breath refused to take symptomatic treatment. Now (4 days after injection) arm sore, 2cm erythema myalgia resolved. improving
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Vaccines received Monday, 9/23/08. On 10/1/08 mother noticed swelling at injection site on R leg. Pt. c/o itching but denies pain
Age: 1.6
Sex: M
Vaccine: HEP, HEPA, PNC
Symptoms: Abnormal behaviour, Balance disorder, Bruxism, Crying, Dyskinesia
Clinical narrative: 1) L ant thigh redness swelling 2) unusual behaviors - "Frankenstein-like" walk, walking into walls, grinding teeth, thrusting tongue, crying, sucking on Mom's shoulder
Age: 1.6
Sex: M
Vaccine: HEP, HEPA, PNC
Symptoms: Erythema, Gait disturbance, Swelling
Clinical narrative: 1) L ant thigh redness swelling 2) unusual behaviors - "Frankenstein-like" walk, walking into walls, grinding teeth, thrusting tongue, crying, sucking on Mom's shoulder
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Diet refusal, Hypophagia, Mouth ulceration, Pyrexia, Throat irritation
Clinical narrative: Patient developed sores on the outside and inside of mouth and throat. She was refusing to eat or drink. Patient also had fevers 102-103 x 2 days. PCP x 2 visits, both visits PCP diagnosed chicken pox from vaccine. Now has pox on both legs. still has sores.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Patient developed sores on the outside and inside of mouth and throat. She was refusing to eat or drink. Patient also had fevers 102-103 x 2 days. PCP x 2 visits, both visits PCP diagnosed chicken pox from vaccine. Now has pox on both legs. still has sores.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Cried for 4 hours. Left leg redness and swelling.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion, Pyrexia, Roseola
Clinical narrative: Patient had a febrile seizure 2 days after immunization fever lasted total 4 days then patient broke out in what looks like a roseola rash when fever broke
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash in a 60-year-old male subject who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). Concurrent medical conditions included allergy to cephalexin and sulfa allergy. Concurrent medications included Lisinopril, FLOMAX and Aspirin. on 23 September 2008, at 10:00, the subject received 1st dose of Hepatitis B vaccine (potentially ENGERIX B, but not known for sure) in the left arm. On 26 September 2008, 3 days after vaccination with Hepatitis B vaccine, the subject developed a rash on both upper arms, buttocks, tops of his feet and upper thigh. It was not going away, so the subject sought medical attention and was prescribed and treated with MEDROL DOSE PAK. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. The pharmacist considered the event was possibly related to vaccination with Hepatitis B vaccine.