chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Patient received pneumococcal vaccine, lot# 0877R, right deltoid in clinic 12/20/05. Called office 12/22/05 to report right deltoid pain, itching, redness, swelling at injection site, et syncope on 12/20/05. Advised to go to ER. 12/23/05 notified patient at ER with fever 103, severe body myalgias, HA, suspects meningitis. Work up for meningitis was negative. WBC 20,000. Patient was discharged 12/27/05.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pruritus, Pyrexia, Syncope, White blood cell count increased
Clinical narrative: Patient received pneumococcal vaccine, lot# 0877R, right deltoid in clinic 12/20/05. Called office 12/22/05 to report right deltoid pain, itching, redness, swelling at injection site, et syncope on 12/20/05. Advised to go to ER. 12/23/05 notified patient at ER with fever 103, severe body myalgias, HA, suspects meningitis. Work up for meningitis was negative. WBC 20,000. Patient was discharged 12/27/05.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Patient received Pneumococcal Pneumovax vaccine IM right deltoid lot #0605R. Called 12/22/05 to report right arm swelling, heat, itching, underarm pain. Advised patient to take allegra and ibuprofen. 12/23/05 called patient. Patient doing better, pain gone, swelling improved.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient went to ER with local reaction to left arm from pneumovax 23 lot #0740R. Swelling, pain at site.
Age: 0.15
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Nasal congestion, Otitis media, Tracheobronchitis
Clinical narrative: Child seen 11/14/05 at health department and 2 month shots given. 9 days later (11/23/05) child found dead in his crib by his mother. Child had some congestion prior to death. 8/4/06 Received autopsy report which revealed COD as acute tracheobronchitis with otitis media/ss
Sex: M
Vaccine: FLUN3
Symptoms: Upper respiratory tract infection
Clinical narrative: A patient experienced upper respiratory infection after receiving FluMist in 17 Nov 2005.  The upper respiratory infection has persisted for about six days at the time of report.  Further information has been requested.  The clinical outcome is unknown.  The reporter causality is not provided.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Lacrimation increased, Nasal congestion, Vomiting
Clinical narrative: A consumer reported that her child experienced vomiting, severe headache, stuffy nose and watering eyes 2 days after receiving FluMist vaccine on 25 Oct 2005.  In school, vomited four times.  Motrin and Dimetapp were given orally.  By 29 Oct 2005, the patient had recovered from all symptoms except for the stuffy nose.  The reporter added that the other child received FluMist but did not have any adverse reaction.  The reporter assessed the events as possibly related to FluMist.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: A nurse from a doctor's office reported that patient with no past medical history experienced fever of 103 degrees Fahrenheit, coughing and body aches 3 days after receiving FluMist vaccine on 04 Nov 2005.  The patient was seen at doctor's office and was given Tylenol and albuterol. On 08 Nov 05, the patient's mother called the doctor's office to report that the patient was still coughing, had body aches and low grade fever of 100 degrees Fahrenheit. The reporter causality is not provided. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Headache
Clinical narrative: A patient received FluMist vaccination on 28 Nov 2005 for influenza immunization.  Within 1-2 hours of receiving FluMist patient experienced dizziness and headache.  When the symptoms occurred patient called facility where they received the vaccination however was not given any specific instructions. No additional information was available at the time of this report.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise, Unintended pregnancy
Clinical narrative: Felt ill (malaise).  Vaccine exposure during pregnancy.  Non serious spontaneous case from a Pharmacist involving a woman who felt ill.  The reporter causality is possible to FluMist. A woman received FluMist vaccination intra-nasally for influenza immunization on 12 Nov 2005.  The woman was 31 weeks pregnant at time of vaccination. On an unspecified date she felt ill. It was not reported whether or not the symptoms continued.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Generalized rash-fine, small reddened papules with itching.  Child awoke this AM with the rash and complained of itching. Gave Benadryl phone order 2 tsp. Had vaccine 13 hrs prior; had also just completed a second course of Zithromax on the same day.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain, Pyrexia
Clinical narrative: Immediate pain after injection , fever that night.  Pain in left shoulder still decreased range of motion, severe pain in the front of shoulder.  Seen in ER the by an ortho specialist. Given two cortisone injections (October and December) and still unable to bring arm across chest and nonstop pain.  Had an MRI in Dec 2005, showed
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site and arm pain - redness, swelling, red pin point at site.
Age: 1.22
Sex: M
Vaccine: DTAPH, MMR, PNC, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Child developed fine red rash on right thigh which progressed to right side of body and right arm, lasted 6 weeks.  Didn't seem to bother child.  Pediatrician didn't think it was vaccine related.
Age: 5.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema 4 inches and swelling about 4 inches wide over anterior aspect of right thigh with itching.  Benadryl and Keflex given.
Age: 0.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia
Clinical narrative: The muscle strength in my left arm is declining.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Flushing, Pruritus
Clinical narrative: Patient Recieved Pneumovax for pneumonia vaccine and was a little nervous because of her severe allergy to different types of nuts. 5 - 10 minutes after her vaccination she felt fine. About 20 - 25 minutes later, the patient felt a bit warm and felt like she was itching all over. She described it as wearing wool. She was a little red and felt like she had a couple of red marks on her. She otherwise felt fine. She was administerd 50 mg of oral Benadryl and rested in a chair for 30- 40 minutes. The patient felt better with the wool type itching having subsided.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Immunizations provided 1/11/06 Mother called 1/13/06 stating that child had a red, swollen area on his left arm.  She felt that it was larger today than when she first noted it 1/12/06. Encouraged mom to have child seen. Could also apply some topical benadryl and cool compresses for comfort.   Mom did have child seen at the office, red area 95x80mm non-tender.  Reinforced comfort measures, and to call if any further concerns.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: High fever of 105.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: PT REPORTED RASH FROM SHOULDER TO ELBOW, SLIGHTLY ITCHY, TX'D WITH BENADRYL 25MG, RASH GONE IN 4 DAYS.
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Exactly one week after the MMR was administered, she experienced fever and vomiting for 3 days. In total she was ill for 5 days before she began to hold liquids/soft foods and reduced to mild to no fever.   She had a mild rash on neck and upper body after the MMR, but more than 2 weeks after it was administered.
Age: 1.95
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Coma, Crying, Listless, Opisthotonus, Pallor
Clinical narrative: 18hrs after DTaP #4 and Hib #3 given, pt woke up from sleep in am crying.  W/in minutes, began retching and subsequently became listless and unresponsive, while maintaining spontaneous breathing. Duration was 15min, no seizure activity, + back arching, and + generalized pallor/grey appearance.  Self-resolved, w/ slow return to baseline activity level over several hours.
Age: 1.95
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Retching
Clinical narrative: 18hrs after DTaP #4 and Hib #3 given, pt woke up from sleep in am crying.  W/in minutes, began retching and subsequently became listless and unresponsive, while maintaining spontaneous breathing. Duration was 15min, no seizure activity, + back arching, and + generalized pallor/grey appearance.  Self-resolved, w/ slow return to baseline activity level over several hours.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Rash maculo-papular, Vasculitis
Clinical narrative: Red, splotchy rash appeared on legs and progressed to forearms. Itchy at first then it subsided. Led to full body coverage of red rash. Spots and rash was not inflammed only erythematous. Patient saw primary care provider 6-7 days after rash appeared and was given a Medrol dose pack. Blood work was obtained and all came back within normal limits. Another round of prednisone was given as well as Kenalog. Improvement has been slow. Recovery is still in process.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Arteriosclerosis, Atherosclerosis, Cardiac arrest, Cardio-respiratory arrest, Cardiovascular disorder
Clinical narrative: Employee arrived for routine Hep B inj #2. Denies previous reaction to inj #1. Inj give without incident, no signs or symptoms of reaction. Patient had fallen on knee prior to injection. Medical Records received from Alegent ER stated patient experienced cardiopulmonary arrest. Final autopsy report received on 1/24/06 revealed COD severe arteriosclerosis, hypertensive cardiovascular disease and coronary artery disease.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Coronary artery disease, Hypertension
Clinical narrative: Employee arrived for routine Hep B inj #2. Denies previous reaction to inj #1. Inj give without incident, no signs or symptoms of reaction. Patient had fallen on knee prior to injection. Medical Records received from Alegent ER stated patient experienced cardiopulmonary arrest. Final autopsy report received on 1/24/06 revealed COD severe arteriosclerosis, hypertensive cardiovascular disease and coronary artery disease.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Right thigh red, swollen, 20cm x 12cm induration - minimally tender.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Pt got varicella disease after vaccine.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Rash maculo-papular
Clinical narrative: Rash maculopapular on 01/05/2006, no fever, mild fussiness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Pain
Clinical narrative: Right arm swollen, hard, hot, red and painful to touch.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS per autopsy 1/3/06.  No added information from autopsy report rec'd 01/18/2006/sr
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrointestinal haemorrhage, Guillain-Barre syndrome, Laboratory test abnormal, Paralysis
Clinical narrative: The first week of April 2005, she was diagnosed with Guillain Barre Syndrome. She was totally paralyzed and on respiratory assistance. She is now in a rehab hospital. She is much better now 1/06, but still in rehab and speech therapy.  Discharge summary of 4/9-5/23/05. FINAL DX: Guillain-Barre syndrome; respiratory failure; GI bleed. Records reveal patient experienced weakness of left eye & left extremities which rapidly progressed to include all extremities.  Neuro consult done.  Tx w/IVIG.  Developed respiratory failure due to progressive muscular weakness & intubated; SVT resolved; hypotension, resolved w/fluids & blood transfusion; emergent laparoscopy for GI bleeding secondary to gastric artery lacerations; DVT in RUE s/p PICC line insertion; constipation; hypomagnesium; Trached w/collar O2, tube feeding & nonambulatory upon d/c to inpatient rehab facility.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Feeling cold, Hyperhidrosis, Nausea
Clinical narrative: Anaphylaxis to flu shot. Dyspnea, audible crackles, diaphoretic, nausea, skin cool to touch, nausea, accessory muscles to breath.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Dyskinesia
Clinical narrative: Two days after vaccination patient has a 30-40 min episode of upper and lower extremities rhythmic jerking movements without LOC; No fever;recovered with IV valium.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Anaphylactic reaction, Apnoea, Cleft lip and palate, Cyanosis, Face oedema
Clinical narrative: 5-10 minutes status post vaccines, developed respiratory distress, apnea; given O2. Saturation initially 70% increasing to high 80s with O2. EMS activated. Taken via EMS to ER. Received 5Q Epi and corticosteroids. Observed as inpatient. Discharged next morning.  2/7/06 Discharge Summary reviewed stated patient experienced premature birth w/cleft lip & palate (s/p repair), glaucoma, developmental delay (decreased speech), cyanosis, apnea, urticaria, wheezing, uvular & facial swelling, hypoxia.  Final dx: acute anaphylactic reaction, life threatening event, possible egg allergy.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Glaucoma, Hypersensitivity, Hypoxia, Laryngeal oedema, Premature baby
Clinical narrative: 5-10 minutes status post vaccines, developed respiratory distress, apnea; given O2. Saturation initially 70% increasing to high 80s with O2. EMS activated. Taken via EMS to ER. Received 5Q Epi and corticosteroids. Observed as inpatient. Discharged next morning.  2/7/06 Discharge Summary reviewed stated patient experienced premature birth w/cleft lip & palate (s/p repair), glaucoma, developmental delay (decreased speech), cyanosis, apnea, urticaria, wheezing, uvular & facial swelling, hypoxia.  Final dx: acute anaphylactic reaction, life threatening event, possible egg allergy.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Respiratory distress, Speech disorder, Urticaria, Wheezing
Clinical narrative: 5-10 minutes status post vaccines, developed respiratory distress, apnea; given O2. Saturation initially 70% increasing to high 80s with O2. EMS activated. Taken via EMS to ER. Received 5Q Epi and corticosteroids. Observed as inpatient. Discharged next morning.  2/7/06 Discharge Summary reviewed stated patient experienced premature birth w/cleft lip & palate (s/p repair), glaucoma, developmental delay (decreased speech), cyanosis, apnea, urticaria, wheezing, uvular & facial swelling, hypoxia.  Final dx: acute anaphylactic reaction, life threatening event, possible egg allergy.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal
Clinical narrative: Received fluzone vaccine in AM and had 4 hour episode of internal chills and feeling incapacitated.  Denies diaphoresis during episode.  Felt "chilled to my core."
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain
Clinical narrative: Patient reported had flu shot 1 month ago December 7th.  Since that date has experienced pain, arm and finger, numbness, and lost range of motion in right arm.  X-rays done by doctor - no arthritis, no bone or shoulder injury.  Currently using heat, Tylenol and Advil.  To start physical therapy on Thursday, 01/12/2006.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Injection site warmth, Oedema
Clinical narrative: Erythema, edema, heat at site of immunization.  Edema has increased since date of injection, right arm deltoid.  Approximately 50mm diameter of circular swelling around injection site.
Age: 0.56
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, PNC
Symptoms: Dyskinesia, Erythema, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Onset 4am, 12/13/2005 - Generalized erythema, jerking head back and forth, shaking arms/legs, increased heart rate, fever 104.3-102.6  Possible febrile seizure.  Prescribed Tylenol, Motrin, Oral fluids.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Treatment: Ice alternating with heat, Motrin/Tylenol PRN; 10.5cm diameter erythematous area of R deltoid warm to touch and tender to palpation.  Central firm area of 5 cm diameter.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Multiple papules, vesicles
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face, Urticaria
Clinical narrative: About 1hr after administration of vaccination patient had onset of urticaria 1 degree on arm (upper) and upper legs-led to hives-same area-symptoms lessened by evening.  Awoke next morning with facial swelling.  No dyspnea or difficulty swallowing  Treatment with Medrol dose pack, Zyrtec.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Swelling
Clinical narrative: Small amount of redness and swelling to area 48 hours.
Age: 1.07
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Approximately 12 min after vaccination were given, the child experienced red blotches on face the redness then became raised welts on forehead, cheeks, chin and child began scratching face.  The child continued to cry- no wheezing or shortness of breath experienced.  Sent patient with mother to ER (2 blocks away from health dept.).  Was examined by nurse at hospital.  Welts began to subside.  Child not crying-playing.  No shortness of breath, wheezing, lungs clean, no laryngeodema.  Benadryl liquid given at 6:30 pm due to red, macular rash on back-persisting.  Orders were Benadryl .25mg every 4-6 hrs for rash.  Patient discharged home with mother.  Ordered by Dr no further doses of MMR.  Needs to be evaluated by an allergist before next set of DTaP vaccinations. Phoned patient mother and patient doing well.  Slept last night.  Did not repeat Benadryl during night.  Patient fine this AM and has recovered.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying a lot since vaccination.  Diagnosis from ER vaccination reaction.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Erythema, Feeling hot, Injection site mass, Nasal congestion
Clinical narrative: Patient's mom called to report child had #2 Varicella vaccine and started to hurt right away, site become swollen with "deformed lump" on 12/22/05.  Red in color, warm to touch, low grade fever and chills.  Patient became congested with sore throat while arm better 12/23.  Patient used ice and Advil reported to family doctor.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Swelling
Clinical narrative: Patient's mom called to report child had #2 Varicella vaccine and started to hurt right away, site become swollen with "deformed lump" on 12/22/05.  Red in color, warm to touch, low grade fever and chills.  Patient became congested with sore throat while arm better 12/23.  Patient used ice and Advil reported to family doctor.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Reddened warm area to right upper arm with slight tenderness and previous increased swelling.  Prescribed Omnicef 250/=1 tsp for 10 days and Benadryl PRN.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site swelling
Clinical narrative: Received immunization on 1/9/06.  Mom noticed red raised area in the spot where shots were given.  L thigh was a baseball size, R thigh was a nickel size.  Raised areas still present.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dermatitis contact, Hypersensitivity, Rash
Clinical narrative: rash-contact dermatitis versus allergic reaction vaccine
Age: 16.0
Sex: M
Vaccine: DT
Symptoms: Hallucination, Pruritus, Restlessness
Clinical narrative: Hallucinating, restless, itching all over with no visible rash.  No swelling or redness at injection site.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Visual disturbance
Clinical narrative: Client developed exaggeration of her symptoms of benign tumor at base of brain, i.e.-dizziness and problem with depth perception for 48 hrs after receiving Hep B vaccine.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Viral infection
Clinical narrative: Never had chicken pox or vaccine.  Dr. office 10-15-05 1st Varicella vaccine and 4 days later a few spots arms, neck, face.  7 days later chicken pox rash over all body.  To Dr.'s office diagnosed with chickenpox.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Arm swollen and tender to touch.
Age: 1.05
Sex: M
Vaccine: HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Rash, Rash morbilliform
Clinical narrative: Rash developed on 1/10/06 worse on 1/11/06.  Diffuse morbilliform rash-some areas coalesced into one large papule.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Vaccine administered in left deltoid 11am 12/22/05.  Patient states arm swelled, red, painful to touch by 8pm on 12/22/05.  Reported to Dr. on 12/23/05.  States arm is improving and will use Benadryl for reaction.
Age: 0.52
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema
Clinical narrative: 1 inch-circular area redness- R thigh
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Swelling
Clinical narrative: Swollen, red, hot L arm
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Feeling cold, Flushing, Hot flush
Clinical narrative: Approx 15 mins afer injection, patient reported feeling hot, then cold, alternatley had facial flushing c/o dizziness.  Assisted into relining position.  Vital signs WNL.  Observed for 1 hour.  Pt recovered.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Crying, Pyrexia, Tremor
Clinical narrative: FEVER OF 104.2, SHAKING, CRYING FOR 2 HOURS & 10 MINUTES, SEIZURES.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypokinesia, Pain
Clinical narrative: Started with mild pain at 5pm on 11-29-05, achy joint of shoulder.  At 2-3 am 11/30 severe pain, horrible, could not lie on lt side, could not elevate arm, now 12/12 remains tender, unable to raise arm easily to reach into cupboard, cannot sleep on lt side deltoid arm very tender.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This patient who was hospitalized for endometrial cancer was administered a pneumococcal vaccine on 08/29/2005. On 08/30/2005 she noticed increased pain and swelling at the pneumococcal injection site. The inflamed area around the injection site was 2 inches. The affected area was warm to the touch and was treated with ice packs. The patient was prescribed Benadryl orally 25-50 mg as needed.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Pt received Varivax vaccine, pt came into office with chicken pox disease.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Myalgia, Pain
Clinical narrative: Developed severe myalgias in right deltoid, right shoulder, right thoracic back, and radiated to left thoracic back.  Painful to do tasks at work like typing and note taking.  (Pt is right handed.)  No paresthesias.  History of similar myalgias occurring after administration of flu shot,  lasting for 3 months.  No erthyema or swellling of site.  No relief of symptoms with pain medication (tylenol).  Very sensitive to medications, did not want to take muscle relaxers or ibuprofen.  Recommended to pt to try moist heat and biofreeze topical lotion.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Developed systemic rash 2 hours after vaccinations.
Age: 0.51
Sex: M
Vaccine: HIBV
Symptoms: Crying, Feeling hot, Malaise, Tremor
Clinical narrative: He fell asleep at 7pm very quickly, 5 minutes. It usually takes 30.  He seemed fine though.  He woke up a 8:30 pm, which is unusual and did not fall back asleep until 9:30.  While awake and in my arms he cried softly and wimpered for about 30 minutes.  Normally, he cries hard and loud.  He seemed week and my wife thought he looked pale. I kept him on my shoulder and he would fall asleep wimpering and wake up 4 or 5 minutes later.  He eventually fell asleep at 9:30.  While sleeping on my shoulder he would quiver has hands and feet slightly, not usual either.  We did not take his temperature, but my wife thought his temperature seemed normal to touch.  I thought he seemed a little warm.  We checked in on him until 11:15 and then went to bed.  We checked him at 1 AM and he was OK.  At 3 he woke up crying and nursed, then fell back asleep.  In the morning he seemed fine. Basically, it seemed as if he was not feeling well.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Back pain, Balance disorder, Blood creatinine increased, Blood test
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein abnormal, CSF test abnormal, Chest X-ray, Coordination abnormal, Electromyogram abnormal
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Faecal incontinence, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Laboratory test abnormal, Lumbar puncture, Muscular weakness, Muscular weakness
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Scan brain, Sensory loss
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Skull X-ray, Spinal X-ray, Transaminases increased, Urinary incontinence, X-ray
Clinical narrative: Tingling and numbness in both hands and both feet, weak muscles in upper back, lower back, legs and arms poor bladder and bowel control, limited numbness in legs and lower torso up to but not including the chest  TREATMENT 5 days of IV of immunogobulins each day 30ml except for days 4 which was 24ml and day 5 which was 26ml because enough was not found. Information from Medical records includes back pain as symptoms. msv  Discharge summary states reflexes decreased, ataxia, GBS, weak. msv 3/31/2010 Follow up: Sensory loss in legs and feet along with recurrent pain in hand and forearms developing arthritis in joints.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient started with an outbreak of zoster on 1/12/06 in the dermatonal distribution where the vaccine was originally given (S2 on the right).
Age: 1.59
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: 1-14-06 Had 20 second seizure @ 3am, Temp 102.
Age: 36.0
Sex: F
Vaccine: ANTH, FLUX
Symptoms: Arthralgia, Erythema, Fatigue, Joint stiffness, Muscle atrophy
Clinical narrative: Patient received AVA #1 on 17 Dec 03 noticed an intense burn for 5 min that radiated down hand immediately following the vaccination.  Noticed slight redness and swelling at the injection site.  Mid Jan 04 noticed stiffness and soreness of hips, knees and shoulders that would require taking 10 steps just to straighten up from a sitting position.  Initially thought it was due to deployment and poor quality beds.  Patient reported problems keeping up with people walking at a normal gain, nothing drastic, just trailing 10-15 steps behind others in her unit.  Noticed that stiffness was worse in the morning and after periods of inactivity.  Stated began feeling like the day after completing a road march and whole body was fatigued.  Noted some days were better than others, muscles felt sore, but joints bothered more.  Initially hips were most bothersome.  Pain described as a deep pain, #4 scale 1-10 with 10 being worse, with varying degrees of intensity but always present.  Tylenol and physical therapy would help a little but noticed no relief with ibuprofen.  Did initially have problems with foot pain but that is not as bothersome now, however no longer walking as did in the past.  Reports occasional stiffness of hands and mild muscle discomfort.  Describes this discomfort as a fatigue more so than a ache.  Notices that always tired, and unable to attribute this fatigue with activity.  Noticed that there is an increase in the aching when it is cold.  Has had rheumatologic evaluation and to date no diagnosis has been determined.
Age: 36.0
Sex: F
Vaccine: ANTH, FLUX
Symptoms: Musculoskeletal discomfort, Myalgia, Pain, Swelling
Clinical narrative: Patient received AVA #1 on 17 Dec 03 noticed an intense burn for 5 min that radiated down hand immediately following the vaccination.  Noticed slight redness and swelling at the injection site.  Mid Jan 04 noticed stiffness and soreness of hips, knees and shoulders that would require taking 10 steps just to straighten up from a sitting position.  Initially thought it was due to deployment and poor quality beds.  Patient reported problems keeping up with people walking at a normal gain, nothing drastic, just trailing 10-15 steps behind others in her unit.  Noticed that stiffness was worse in the morning and after periods of inactivity.  Stated began feeling like the day after completing a road march and whole body was fatigued.  Noted some days were better than others, muscles felt sore, but joints bothered more.  Initially hips were most bothersome.  Pain described as a deep pain, #4 scale 1-10 with 10 being worse, with varying degrees of intensity but always present.  Tylenol and physical therapy would help a little but noticed no relief with ibuprofen.  Did initially have problems with foot pain but that is not as bothersome now, however no longer walking as did in the past.  Reports occasional stiffness of hands and mild muscle discomfort.  Describes this discomfort as a fatigue more so than a ache.  Notices that always tired, and unable to attribute this fatigue with activity.  Noticed that there is an increase in the aching when it is cold.  Has had rheumatologic evaluation and to date no diagnosis has been determined.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Injection site atrophy
Clinical narrative: 5-1cm subcutaneous atrophy at injection site.  No obvious muscular antibody.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Application site reaction, Pyrexia, Rash vesicular
Clinical narrative: Patient called office, exposure to chicken pox, varicella like rash, itchy, vesicular.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Dermatitis bullous, Pruritus, Rash vesicular
Clinical narrative: Patient called office, exposure to chicken pox, varicella like rash, itchy, vesicular.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Dizziness, Dyspnoea, Heart rate irregular, Injection site oedema
Clinical narrative: Initial report received on 01/10/2006 from a health care professional. A 44 year old male with no significant medical history had received his first administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1866AA, in the right deltoid, on the afternoon of 12/02/2005. At an unspecified time later, he developed swelling to both of his hands and at the injection site. On 12/07/2005 the patient was seen in the physicians office with local swelling to the right deltoid and he was diagnosed with mild myalgia. On 12/09/2005 he returned to the physicians office and all of his symptoms had improved to where he only had aching in his left hand. The patient stated that he was much better and the physicians exam that day was negative. On 01/09/2006 the patient returned to the physicians office with a complaint of cough, shortness of breath and swelling of the lower extremities. He was referred to the ER and left AMA. On 01/10/2006 the patient was again seen in the physicians office with increased SOB, dizziness, 3+ tibial edema, increased jugular vein distention, irregular heart beat and weight increase to 238 lbs. The patient was sent to the hospital via ambulance. Per the reporter, it is unknown if the patient recovered from these events at the time of this report.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Oedema, Oedema peripheral, Pain, Vasodilatation
Clinical narrative: Initial report received on 01/10/2006 from a health care professional. A 44 year old male with no significant medical history had received his first administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1866AA, in the right deltoid, on the afternoon of 12/02/2005. At an unspecified time later, he developed swelling to both of his hands and at the injection site. On 12/07/2005 the patient was seen in the physicians office with local swelling to the right deltoid and he was diagnosed with mild myalgia. On 12/09/2005 he returned to the physicians office and all of his symptoms had improved to where he only had aching in his left hand. The patient stated that he was much better and the physicians exam that day was negative. On 01/09/2006 the patient returned to the physicians office with a complaint of cough, shortness of breath and swelling of the lower extremities. He was referred to the ER and left AMA. On 01/10/2006 the patient was again seen in the physicians office with increased SOB, dizziness, 3+ tibial edema, increased jugular vein distention, irregular heart beat and weight increase to 238 lbs. The patient was sent to the hospital via ambulance. Per the reporter, it is unknown if the patient recovered from these events at the time of this report.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Weight increased
Clinical narrative: Initial report received on 01/10/2006 from a health care professional. A 44 year old male with no significant medical history had received his first administration (route not reported) of Fluzone SV 2005 2006 USP, lot number U1866AA, in the right deltoid, on the afternoon of 12/02/2005. At an unspecified time later, he developed swelling to both of his hands and at the injection site. On 12/07/2005 the patient was seen in the physicians office with local swelling to the right deltoid and he was diagnosed with mild myalgia. On 12/09/2005 he returned to the physicians office and all of his symptoms had improved to where he only had aching in his left hand. The patient stated that he was much better and the physicians exam that day was negative. On 01/09/2006 the patient returned to the physicians office with a complaint of cough, shortness of breath and swelling of the lower extremities. He was referred to the ER and left AMA. On 01/10/2006 the patient was again seen in the physicians office with increased SOB, dizziness, 3+ tibial edema, increased jugular vein distention, irregular heart beat and weight increase to 238 lbs. The patient was sent to the hospital via ambulance. Per the reporter, it is unknown if the patient recovered from these events at the time of this report.
Age: 1.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Diarrhoea, Injection site erythema, Pyrexia, Urticaria
Clinical narrative: Giant red welt at injection site, inconsolable crying from the time we left the doctors office until hours later (late in the afternoon), high fever that I was unable to get down using Motrin, cold bath, etc.  Finally called the doctor on call when her fever reached 104.7 degrees and was told that it was a "normal" reaction.  She had diarrhea for several days afterwards.
Age: 42.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Dizziness, Nausea, Pyrexia, Vertigo
Clinical narrative: On 12/17/05, I developed severe constant dizziness, nausea, fever of 102 and diarrhea.  I went home from work half way through my 1st shift and took 25mg of Meclizine thinking it was vertigo, which I have on rare occasions.  After 4 days in bed the all symptoms were resolved but I noticed that I was hard of hearing in my left ear.  This has not improved and has worsened.  I am being treated by a family doctor since 01/15/06 for possible fluid behind the inner ear and I am taking 250mg of Azithromycin tablets and Profen Forte DM Tab.
Age: 18.0
Sex: M
Vaccine: TYP, YF
Symptoms: Asthenia, Headache, Vomiting
Clinical narrative: Pt received vaccinations at 5:45pm on 01-17-06. Returned home with mother and around 6:30pm c/o H/A, vomitted X 1, weak. Had not eaten before vaccinations. Ate supper around 9:30, H/A improved. Went to school 01-18-06 with no c/o this am.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a physician concerning an 83 year old female patient with an iodine allergy who in 21-Dec-2005 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. At the time of vaccination the patient had "PMR", low back pain, atrial arrhythmias, and hypertension. On the same day, 21-Dec-2005, following vaccination, the patient experienced a systemic reaction "following revaccination" and became completely white and stiffened up. Unspecified medical attention was sought. Subsequently, the physician's office called the pt on 28-DEC-2005 to check her status and the pt noted that she had recovered completely, as of 21-DEC-2005. No product quality complaint was involved. The reporter considered the adverse experiences to be other important medical events (OMIC). Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Oedema, Pain, Rash erythematous
Clinical narrative: Information has been received from a Registered Nurse concerning a 74 year old male consultant with an allergy to penicillin who on 26-Oct-2005 at 11:00 a.m. was vaccinated IM in left deltoid with his first dose of pneumococcal 23v polysaccharide vaccine (lot #651539/6607R). The patient was ill with chronic sinusitis at the time of vaccination. There was no concomitant medication. On the same day, the patient's left arm became sore. On 27-Oct-2005 the patient felt fatigued and developed redness over left arm for 24 hours. On 28-Oct-2005 there was a 22 cm area of redness, warmth, and slight edema which extended medically overlying medial distal arm. Over 50% over anterior lateral aspect of arm. Overlying bilateral anterior flanks there was a confluent erythematous eruption with satellite macules - symmetrical. There was also an associated abdominal rash. The patient required unspecified medical intervention. On 31-Oct-2005, the patient recovered. The reporter felt that the fatigue, warm skin, edema, erythema, pain in extremity and erythematous rash were other important medical events (OMIC). No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a Registered Nurse concerning a 74 year old male consultant with an allergy to penicillin who on 26-Oct-2005 at 11:00 a.m. was vaccinated IM in left deltoid with his first dose of pneumococcal 23v polysaccharide vaccine (lot #651539/6607R). The patient was ill with chronic sinusitis at the time of vaccination. There was no concomitant medication. On the same day, the patient's left arm became sore. On 27-Oct-2005 the patient felt fatigued and developed redness over left arm for 24 hours. On 28-Oct-2005 there was a 22 cm area of redness, warmth, and slight edema which extended medically overlying medial distal arm. Over 50% over anterior lateral aspect of arm. Overlying bilateral anterior flanks there was a confluent erythematous eruption with satellite macules - symmetrical. There was also an associated abdominal rash. The patient required unspecified medical intervention. On 31-Oct-2005, the patient recovered. The reporter felt that the fatigue, warm skin, edema, erythema, pain in extremity and erythematous rash were other important medical events (OMIC). No further information is available.
Age: 37.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Vaccinated in morning with Hepatitis A and given oral Typhoid which patient started taking at 12PM that day.  Vaccinated with Yellow Fever in afternoon of same day.  Began mild itching next day, gone 01/12/2006 but Yellow Fever site is a raised red welt, hot and sore to touch.  Denies fever, chills, achy.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: CSF lymphocyte count increased, CSF protein increased, CSF white blood cell count increased, Erythema, Induration
Clinical narrative: On 12/23 patient developed fever up to 104 at home. Presents to hosp ER and noted document that left arm demonstrates an area of erythema about the size of a silver dollar, tender to touch and indurated. Fever continued per patients about 12 days. Admitted on 12/31 for evaluation meningitis. Follow-up: Red swollen.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Liver function test abnormal, Pyrexia, Swelling, Tenderness
Clinical narrative: On 12/23 patient developed fever up to 104 at home. Presents to hosp ER and noted document that left arm demonstrates an area of erythema about the size of a silver dollar, tender to touch and indurated. Fever continued per patients about 12 days. Admitted on 12/31 for evaluation meningitis. Follow-up: Red swollen.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC
Symptoms: Cough, Croup infectious, Diarrhoea, Dyspnoea, Ear infection
Clinical narrative: The day of the shots he got a fever of 101.5 within an hour. A few days later he could not breath so the doctors gave him steroids orally and through shots also through breathing treatments. The treatments were not helping for very long. He was admitted into the hospital. He seemed a little better, then before we left the hospital he got a weird rash and a fever. I continued medicine at home. A few weeks later he got diarrhea and was vomiting for weeks. Before this he had a check up and was perfect. He never even had a runny nose. This has been going on for over a month. He is still vomiting. 3/21/06-Reviewed 11-page d/c summary. Final diagnosis was croup (LARYNGITIS). Symptoms were noted as purulent drainage from nares, cough with stridor, and runny nose. No respiratory distress was noted.  Chronic cough, runny nose, rashes, sore throats, ear infection, hyper.  All these things started the day he got the shots.  I am taking him to a specialist in June.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC
Symptoms: Laryngitis, Oropharyngeal pain, Psychomotor hyperactivity, Pyrexia, Rash
Clinical narrative: The day of the shots he got a fever of 101.5 within an hour. A few days later he could not breath so the doctors gave him steroids orally and through shots also through breathing treatments. The treatments were not helping for very long. He was admitted into the hospital. He seemed a little better, then before we left the hospital he got a weird rash and a fever. I continued medicine at home. A few weeks later he got diarrhea and was vomiting for weeks. Before this he had a check up and was perfect. He never even had a runny nose. This has been going on for over a month. He is still vomiting. 3/21/06-Reviewed 11-page d/c summary. Final diagnosis was croup (LARYNGITIS). Symptoms were noted as purulent drainage from nares, cough with stridor, and runny nose. No respiratory distress was noted.  Chronic cough, runny nose, rashes, sore throats, ear infection, hyper.  All these things started the day he got the shots.  I am taking him to a specialist in June.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC
Symptoms: Rhinitis, Rhinorrhoea, Stridor, Vomiting
Clinical narrative: The day of the shots he got a fever of 101.5 within an hour. A few days later he could not breath so the doctors gave him steroids orally and through shots also through breathing treatments. The treatments were not helping for very long. He was admitted into the hospital. He seemed a little better, then before we left the hospital he got a weird rash and a fever. I continued medicine at home. A few weeks later he got diarrhea and was vomiting for weeks. Before this he had a check up and was perfect. He never even had a runny nose. This has been going on for over a month. He is still vomiting. 3/21/06-Reviewed 11-page d/c summary. Final diagnosis was croup (LARYNGITIS). Symptoms were noted as purulent drainage from nares, cough with stridor, and runny nose. No respiratory distress was noted.  Chronic cough, runny nose, rashes, sore throats, ear infection, hyper.  All these things started the day he got the shots.  I am taking him to a specialist in June.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Throwing up all night.  Temperature of 99.0, rash all over body.  Treatment Benadryl.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient got fever of 103.7 degrees after vaccinated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: Swelling left deltoid.
Age: 1.03
Sex: M
Vaccine: MMR
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Patient presented with Varicella like rash
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Left leg red, hot, tender