chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, UNK
Symptoms: Vomiting
Clinical narrative: Reactions after receiving Vaccine A (Anthrax Shot) in the middle of the desert.  nausea  diarrhea  double vision  dizziness  shortness of breath  Reactions after receiving Pyridostigmine Bromide Pills.  Severe Chest Pain and tightness of chest Trouble Breathing and shortness of breath Gastrointestinal upset, nausea, vomiting  Abdominal cramps and diarrhea  Increased salivation and tearing  Increased sweating  Muscle cramps  Muscle twitching  Muscle weakness  Migraine Headaches  Hallucinations Cough Blurry Vision Problems with swallowing food and water Problems with Balance  Botulinum Toxoid Vaccine received in arm.  Was still experienceing same signs associated with Anthrax vaccine.  Botulinum Toxoid Vaccine seemed to intensify these symptoms.  Received and took 1991 pink Malaria Pill/vaccine for several weeks.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm - redness, swelling, hot to touch at injection site, size of a half dollar x3-4 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Erythema, Swelling
Clinical narrative: Right arm - red, swollen.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Face oedema, Hypoaesthesia
Clinical narrative: About three hours after receiving the vaccine, the person had some lower lip and chin numbness. Patient had flu shots in the past with no problems. Recommend she go to the E.R. She went to an emergency clinic and the physician said she had a mild anaphylactic reaction. At this point did have facial swelling. She was treated. Follow-up call to this person the next day found her to be fine. Follow up report received on 04/28/2005:  Allergic reaction related to Motrin allergy.
Age: 11.0
Sex: F
Vaccine: FLU3, HIBV, PPV, TD
Symptoms: Cellulitis, Pain, Pyrexia, Swelling
Clinical narrative: Vaccines given 12/6/04. On 12/7/04, Mom reported fever of 101.0 F and right arm was swollen. Seen in ER, no tx, ER MD told Mom normal reaction to pneumococcal vaccine. 12/10/04-- nurse contacted and advised area of swelling "size of softball" and arm hurting.  Referred to PMD that day & prescribed Keflex for cellulitis secondary to pneumococcal vaccine, improvement noted within 24 hours of starting antibiotic, with continued improvement noted on 12/13/04.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Rash erythematous
Clinical narrative: 5 inch diameter slightly raised, reddened area, non-fluctuant, non tender right anterior thigh.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: CHICKENPOX LESIONS APPEARED A FEW DAYS AFTER VARICELLA VACCINE WAS GIVEN.  PT DID NOT PRESENT TO MEDICAL UNTIL LESIONS HAD RESOLVED.
Age: 18.0
Sex: M
Vaccine: MEN, TD
Symptoms: Cyanosis, Myasthenic syndrome, Pallor, Tinnitus, Visual disturbance
Clinical narrative: Patient complained of vision darkening, ears buzzing within 5 minutes of injections. Legs collapsed; became cyanotic. Remained conscious and responsive. Denied breathing problems, numbness or tingling. Cyanosis substantially resolved within 1 minute; remained pale. Vitals taken within 3 minutes of collapse; normal BP. Pulse 60. No intervention; given Gatorade. Observed 20 minutes and released. Time course of events approximately 15 minutes to apparent full recovery, although still pale one hour later.100% O2 saturation at time of vitals.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Within a day of the flu shot, I began experiencing and continue to experience constant pain and tingling in my left hand ring finger. Patient reported to RN on 02/02/05, states he has intermittent pain and tingling in left ring finger, started in left middle ring and pinky fingers. Now it is just in the ring finger and severity is decreased. However, is noticeable most of the time per patient. Patient was advised to contact PMD for neurological exam.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Two weeks after flu vaccine given, complained of left side facial droop. Diagnosed as Bell's Palsy by ER physician. Prednisone 60mg po q d for 5 days ordered, then 40mg for 2days, then 30mg for 2 days, then 20mg for 2 days, then 10mg for 2 days and then 5mg for 2 days. Referred to a neurologist. Also given Acyclovir 400mg po bid for 7days and Ibuprofen. 12/06/04, somewhat improved.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: Presented to PER, 1 day after discharged from hospital for asthma exacerbation and receiving a flu shot for the first time. Mom noticed rash to both arms and stomach at home on 02/02/05. Came to pediatric emergency room with rash and hives to body. Given Benadryl, no fever reported.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Screaming
Clinical narrative: Screaming and jerking episodes about 1 to hours after administration of vaccine. (Second vaccine given about 2 weeks after 1st flu vaccine) Follow up 02/07/05: Child did not die, Clinic will fax EEG report.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Crying, Flushing, Restlessness, Swelling face
Clinical narrative: Less than 5 minutes after immunization, while grandmother was changing child, child began screeching, not crying. Face became flushed and unconsolable screech continued. Restless with intermittent screeching. R36 AP 86-90. Grandmother reported facial swelling and swallowing between screeching. 10 minutes later still. Awaiting ambulance  given Epinephrine 1:1000, 0.15ml IM left thigh, other physician consulted. Grandmother holding over shoulder, responds when spoken to and intermittenly restless. Ambulance carried to emergency room.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Pt was inadvertently given 0.5ml of purified protein derivative IM in Left deltoid at the same time received Dtap injection 0.5ml in right deltoid. Pt waited 10-15min post vaccination for monitoring. No adverse effect were reported at that time. IPV on a pt. When I went to go draw the vaccine I noticed the difference of size and shape of the vials. I automatically advised the pediatrician about the incident.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Herpes zoster
Clinical narrative: Shingles (Herpes Zoster)
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Blister, Capillary disorder, Contusion, Dermatitis bullous, Pain
Clinical narrative: 2/2/05 PC from mother states 1/23/05 noted blisters on arms similar to chicken pox. Dr stated appeared to be broken capillaries on 1/30 and 2/1 mother noted bruising on legs. Child very restless night of 2/1/05 possibly due to leg pain. Mother awaiting lab results done by family doctor
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness at vaccination site, right deltoid.
Age: 8.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Urticaria
Clinical narrative: Mother states client broke out into hives on 1/22/05. She still had hives on 01/31/05 so she took her to the doctor and he said it was from the FluMist. Client seen by Dr.
Age: 8.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: Mother states client broke out into hives on 1/22/05. She still had hives on 01/31/05 so she took her to the doctor and he said it was from the FluMist. Client seen by Dr.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Pt developed fever 103.1 R 24 hours post immunizations. Physical exam normal.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Hypertension, Myocarditis, Pericarditis, Renal disorder, Weight decreased
Clinical narrative: Information regarding Dryvax (smallpox vaccine dried calf lymph type injection) was received from the mother in law of a 26 year old male pt who received a dose in 2003, and developed myocarditis, pericarditis, increased blood pressure, kidney problems and lost 35 pounds over one year. No medical history per reporter. Indication for Dryvax was immunization. Product was administered in 2003. Dose regimen was 1 dose. Pt was not taking concomitant therapy. In 2003, while in Iraq for active military duty, the pt received a dose of Dryvax and 3 days post vaccination, had severe chest pain and was admitted to the intensive care unit for approx 5 days. The pt was diagnosed with myocarditis and pericarditis in 2003, and was transferred. The reporter also stated that pt developed increased blood pressure, kidney problems (renal disorder) and lost 35 pounds over one year indicating his current weight to be 175 pounds. The reporter also stated the pt was treated and prescribed multiple medications, which were unk. The pt's recovery status is UNK. No additional information was available at the time of this report.
Age: 0.46
Sex: F
Vaccine: PNC
Symptoms: Erythema, Face oedema, Pruritus
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a physician regarding a 5 year old female patient who received a second dose on 1/24/05 and experienced redness and itching over her whole body, and swelling of the face. The patient's concurrent illnesses include eczema and lactose intolerance. Indication for Prevnar was immunization. Product was administered on 1/24/05. Dose regimen was 0.5ml 1 time per day (IM). Patient was not taking concomitant therapy. The patient received a second dose of Prevnar on 1/24/05, and one hour later, developed redness and itching over her whole body and swelling of the face. Epinephrine and steroids were administered in the emergency room, on 1/24/05, but the patient was not admitted to the hospital. The reporter stated that the child is lactose intolerant, and at 0800 AM on 1/24/05, ate cereal which may have contained dried milk. The patient recovered. No additional information was available at the time of this report.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blister, Cellulitis, Hypersensitivity, Oedema peripheral, Pain
Clinical narrative: Right arm swelling, felt warm, took Naprosyn with relief of pain. Two days later very swollen, went to ER. The ER physician diagnosed as cellulitis and treated with IV Leviquin for 3 days then po for 7 days. Also had blisters. Saw dermatologist 5 days after the incident for routine check up, he felt that patient had had an allergic reaction to the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vasodilation procedure
Clinical narrative: Right arm swelling, felt warm, took Naprosyn with relief of pain. Two days later very swollen, went to ER. The ER physician diagnosed as cellulitis and treated with IV Leviquin for 3 days then po for 7 days. Also had blisters. Saw dermatologist 5 days after the incident for routine check up, he felt that patient had had an allergic reaction to the vaccine.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain, Back pain, Diarrhoea, Fatigue, Muscle spasms
Clinical narrative: Continuous nausea after AVA #1. Nausea, chronic diarrhea (2 months) with mild abdominal pain and severe fatigue after AVA #2. Also severe generalized myalgia. Swelling of the hands and finger joints. Severe back pain and spasm lasting several weeks.  Still has chronic fatigue, trembling of hands.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nausea, Oedema peripheral, Osteoarthritis, Tremor
Clinical narrative: Continuous nausea after AVA #1. Nausea, chronic diarrhea (2 months) with mild abdominal pain and severe fatigue after AVA #2. Also severe generalized myalgia. Swelling of the hands and finger joints. Severe back pain and spasm lasting several weeks.  Still has chronic fatigue, trembling of hands.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Vaccine positive rechallenge
Clinical narrative: Continuous nausea after AVA #1. Nausea, chronic diarrhea (2 months) with mild abdominal pain and severe fatigue after AVA #2. Also severe generalized myalgia. Swelling of the hands and finger joints. Severe back pain and spasm lasting several weeks.  Still has chronic fatigue, trembling of hands.
Sex: M
Vaccine: ANTH
Symptoms: Blister, Blood thyroid stimulating hormone increased, Headache, Hypoaesthesia, Hypothyroidism
Clinical narrative: I was enlisted in the military where in1999 involuntarily I received a series of six anthrax vaccine shots. With recent online research I have learned of others having adverse reactions similar to mine, severe hypothyroidism. I was not diagnosed until 2002, when, I experienced total numbness from my shoulders to my fingertips. I thought I was suffering cardiac arrest at that time. I was sent off to a local hospital. They were not able to diagnose me with anything, so I was sent home to my primary care physician who was able to diagnose me. His presentation of my diagnosis was more than startling. He told me that I have the worst case of this autoimmune disorder he had ever known of and that medically I shouldn't be alive. My tsh was 370 more than seventy times the normal high. He explained that it was not a chemical imbalance. I lost my job almost immediately after notifying them with no reason or notification of termination. At the time I was up for a considerable promotion. I now struggle everyday. It takes more than half the day for my mind and body to wake up. I am lethargic in all that I do. My memory retention is nonexistent. I forget things in mere minutes. I now face lifetime medication for a disease that I should not have. I am seeking compensation for, what was supposed to be protective, but now is punitive. If this is not the appropriate agency please forward to that agency with all attached information. If not possible to do so please direct me to the appropriate agency. Follow up 02/07/05: He reports initial additional symptoms of daily headaches & blistering rash on his abdomen at onset of AE. He currently takes 150 mg Levothyroxine, but his TSH remains elevated. Rash and headache have abated. He has no immuization records, but left the sevice in Aug.1999. He denies receiving other vaccines at the time of the anthrax vaccinations. Follow up 03/07/05: Immunization records indicates 5 doses of anthrax vaccine was administered. These were as follows: Dose #5 07/28/99-Lot #FAV044, Dose #4 03/12/1999-Lot #FAV036, Dose #3 03/04/1999-Lot #FAV038, Dose #2 02/18/1999-Lot#FAV34,  Dose #1 12/15/1998-Lot #FAV36.
Sex: M
Vaccine: ANTH
Symptoms: Immune system disorder, Lethargy, Memory impairment
Clinical narrative: I was enlisted in the military where in1999 involuntarily I received a series of six anthrax vaccine shots. With recent online research I have learned of others having adverse reactions similar to mine, severe hypothyroidism. I was not diagnosed until 2002, when, I experienced total numbness from my shoulders to my fingertips. I thought I was suffering cardiac arrest at that time. I was sent off to a local hospital. They were not able to diagnose me with anything, so I was sent home to my primary care physician who was able to diagnose me. His presentation of my diagnosis was more than startling. He told me that I have the worst case of this autoimmune disorder he had ever known of and that medically I shouldn't be alive. My tsh was 370 more than seventy times the normal high. He explained that it was not a chemical imbalance. I lost my job almost immediately after notifying them with no reason or notification of termination. At the time I was up for a considerable promotion. I now struggle everyday. It takes more than half the day for my mind and body to wake up. I am lethargic in all that I do. My memory retention is nonexistent. I forget things in mere minutes. I now face lifetime medication for a disease that I should not have. I am seeking compensation for, what was supposed to be protective, but now is punitive. If this is not the appropriate agency please forward to that agency with all attached information. If not possible to do so please direct me to the appropriate agency. Follow up 02/07/05: He reports initial additional symptoms of daily headaches & blistering rash on his abdomen at onset of AE. He currently takes 150 mg Levothyroxine, but his TSH remains elevated. Rash and headache have abated. He has no immuization records, but left the sevice in Aug.1999. He denies receiving other vaccines at the time of the anthrax vaccinations. Follow up 03/07/05: Immunization records indicates 5 doses of anthrax vaccine was administered. These were as follows: Dose #5 07/28/99-Lot #FAV044, Dose #4 03/12/1999-Lot #FAV036, Dose #3 03/04/1999-Lot #FAV038, Dose #2 02/18/1999-Lot#FAV34,  Dose #1 12/15/1998-Lot #FAV36.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Dyskinesia
Clinical narrative: Mom reported 24 hours post immunization patient had " involuntary head jerking." Took child to doctor, nothing found as to cause the "head jerking." Mom states it is starting to subside.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oedema peripheral, Pain
Clinical narrative: Patient reports adverse event as therapist told her to do so.  She reports a severe headache on the evening of 12/03/2004 and by 12/04/2004 she went to the ER. By this time was experiencing pain and swelling in left arm that required to be ice packed for 1.5 days. She is currently in therapy for her left arm. Reports no more headaches and improving left arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Neuropathy, Paraesthesia, Thermal burn
Clinical narrative: Parasthesias, radiculoneuropathy, burning sensation in back.  All symptoms began the day after vaccine administration. ? Guillain Barre Syndrome.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Coma, Pyrexia, Tremor
Clinical narrative: Patient with episodes described by parent as shaking ("startling") of body lasting up to 30 seconds during which the patient was not responsive to name being called. Mother of child reports that during each episode patient was noted to have fever. The fever and shaking episodes started 6 days after MMR and varivax given.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site pain, Myalgia, Pain in extremity, Prostatic disorder
Clinical narrative: Pain in arm at injection site began on 1/18/05. Spread to thigh muscles, feet, hands. Pain keeps moving, but is not improving.  Has prostate inflammation so went to urologist on 2/3/05, but urologist said pain is not related to prostate. Will see primary MD on 2/5/05. Is taking Ibuprofen for pain. Also has fatigue.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Hypersensitivity, Nausea
Clinical narrative: 911 was called, patient symptoms were pale, weak, dizzy, nausea, headache and blurred vision. ER notes stated normal EKG, released with diagnosis of "possible reaction to flu shot."
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Vision blurred
Clinical narrative: 911 was called, patient symptoms were pale, weak, dizzy, nausea, headache and blurred vision. ER notes stated normal EKG, released with diagnosis of "possible reaction to flu shot."
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Dizziness, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Patient appeared at health department on 10/29/04, complaining of sore right arm at injection site, fever, loss of appetite, lightheadness and complete exhaustion.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Day after Td vaccine, left arm very sore. By the second day could not raise that arm and also had redness and warmth on arm size of a thumb, 2 days after vaccine. On 01/16/05, started itching and had whelps develop, along with some shortness of breath during the next night. On 01/17/2005, face started swelling on right side & spread to entire face including lips, eyes and nose. Seen by PMD on 01/19/05, treated with Prednisone dose pack.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Swelling face, Urticaria
Clinical narrative: Day after Td vaccine, left arm very sore. By the second day could not raise that arm and also had redness and warmth on arm size of a thumb, 2 days after vaccine. On 01/16/05, started itching and had whelps develop, along with some shortness of breath during the next night. On 01/17/2005, face started swelling on right side & spread to entire face including lips, eyes and nose. Seen by PMD on 01/19/05, treated with Prednisone dose pack.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Right thigh swollen, erythematous, and tender this am when child awoke. Shortly after, the left thigh looked the same with swelling and redness. Mother applied hot pack. At 1400 today, the left thigh appeared normal, the right is still swollen with overlying erythema, measuring 1/2 in larger in circumference than the left.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Received call from mother on 12/7/04 stating patient had a fever (100.2 oral pacifier thermometer) and child's fontanelle was bulging and he was irritable. At doctor's request, mom took patient to E.D. for evaluation.  At ED, the MRI report was normal.  Lumbar puncture was 21 WBC and TNTC RBC's with normal protein and sugar and the CBC showed a WBC of 28,000 with 70% PMN and one band. Because of his improved appearance and softening fontanelle, he was sent home after receiving Ceftriaxone. He had follow up appointments on 12/8/04 and 12/9/04. He received Ceftriaxone 12/8/04.  His bld, csf, urine cultures were negative on 12/7/04.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP
Symptoms: Fontanelle bulging, Pyrexia
Clinical narrative: Received call from mother on 12/7/04 stating patient had a fever (100.2 oral pacifier thermometer) and child's fontanelle was bulging and he was irritable. At doctor's request, mom took patient to E.D. for evaluation.  At ED, the MRI report was normal.  Lumbar puncture was 21 WBC and TNTC RBC's with normal protein and sugar and the CBC showed a WBC of 28,000 with 70% PMN and one band. Because of his improved appearance and softening fontanelle, he was sent home after receiving Ceftriaxone. He had follow up appointments on 12/8/04 and 12/9/04. He received Ceftriaxone 12/8/04.  His bld, csf, urine cultures were negative on 12/7/04.
Age: 1.45
Sex: M
Vaccine: DTAP, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 103-104 x 2 1/2 days. Max temp 104.4 by pacifier thermometer. Fussy with fever.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection transmission via personal contact, Skin ulcer, Viral infection
Clinical narrative: Possible vaccine failure. Varicella lesions erupted 1/22/05. Exposed to sister with varicella eruption 1/3/05. 50 plus lesions.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Apnoea, Hypothermia, Sudden infant death syndrome
Clinical narrative: Patient was found this afternoon cold and not breathing.  His resuscitation was not successful.  Autopsy report received stated COD was SIDS.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: EPSDT visit age 7 wks, immunizations given 1-19-05.  Parent notified clinic via telephone, child L thigh red, swollen 1-25-05.  Advised to bring child to clinic immediately.  Mom had no transportation.  Advised to go to nearest ER.  Parent presents c child 1-26-05 - sent to ER - cellulitis post vaccine.  Admitted to hospital 1/26/05.
Age: 1.03
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Temperature of 103 degrees, 5 1/2 hours after vaccine. Follow up report received 02/09/2005: states child's fever resolved in a few hours, and fine since.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Regional lymphadenopathy, left supraclavicular adenopathy on lateral side of vaccination.
Age: 1.68
Sex: M
Vaccine: DTAP, FLU3, PNC, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis right anterior thigh verses Varivax reaction. PCV7 and Varivax given in right lower extremity, with initial local erythema and swelling, which significiantly increased. Seen 01/07/05, given a prescription for Keflex 50 mg po, condition improved.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: Patient complaining of having a bump on the left arm yesterday, 02/02/05. This morning, she found the whole arm red and swollen with blisters formed on the lower portion of the upper arm. Patient was seen by  a physician who prescribed Prednisone 40mg for 2 days with Benadryl po. Will follow up with patient tomorrow at the office.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: From initial information received on 10/11/04 from a physician regarding an adverse event occurring in the USA, it was reported that a four month old female patient received her second dose of ACTHIB, lot number UE229AA, administered IM in the right thigh; a second dose of DAPTACEL, lot number C1699AA, administered IM in the left thigh; a second dose of IPOL, lot number X1040, administered SC in the right thigh; and a second dose of PREVNAR, lot number A74398D, administered IM in the left thigh on 10/7/04 at 2:15 PM. 18 hours later, on 10/8/04 at 9:00 AM, the patient experienced three episodes of four minute seizures, which consisted of stiffness and lateral nystagmus. All of the seizures were followed by a post-ictal period. There was no documented fever. The patient was seen in the emergency room and, following the third seizures, she was treated with phenobarbital and admitted to the hospital. A CBC, chemistry profile, and cerebrospinal fluid were all normal. A CT scan of the head was also normal. The results of urine and serum amino acids and cyanoacids, as well as an electroencephalogram are still pending. It was reported that the patient had no further seizures since receiving phenobarbital. From additional information received on 11/8/04 from a physician, it was reported that the patient did not have any illnesses at the time of vaccination. The patient was hospitalized for four days starting 10/8/04 and treated with phenobarbital. She was discharged from the hospital on 10/11/04. Diagnostic tests and laboratory data obtained included a normal EEG, normal head CT as well as normal blood work up. No bacterial infection was found. Reportedly, the patient experienced another seizure on 11/3/04 but no changes were made. From additional information received on 1/28/05 from a physician, it was reported that the patient was diagnosed with epileptic disease, Per the reporter, the patient is doing well with no seizures since November of 2004 when she was started on phenobarbital. It was also reported that there is history of seizure or other neurological disorders in either the patient's aunt or uncle. No further information is anticipated. This case is considered closed.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Epilepsy, Musculoskeletal stiffness, Nystagmus
Clinical narrative: From initial information received on 10/11/04 from a physician regarding an adverse event occurring in the USA, it was reported that a four month old female patient received her second dose of ACTHIB, lot number UE229AA, administered IM in the right thigh; a second dose of DAPTACEL, lot number C1699AA, administered IM in the left thigh; a second dose of IPOL, lot number X1040, administered SC in the right thigh; and a second dose of PREVNAR, lot number A74398D, administered IM in the left thigh on 10/7/04 at 2:15 PM. 18 hours later, on 10/8/04 at 9:00 AM, the patient experienced three episodes of four minute seizures, which consisted of stiffness and lateral nystagmus. All of the seizures were followed by a post-ictal period. There was no documented fever. The patient was seen in the emergency room and, following the third seizures, she was treated with phenobarbital and admitted to the hospital. A CBC, chemistry profile, and cerebrospinal fluid were all normal. A CT scan of the head was also normal. The results of urine and serum amino acids and cyanoacids, as well as an electroencephalogram are still pending. It was reported that the patient had no further seizures since receiving phenobarbital. From additional information received on 11/8/04 from a physician, it was reported that the patient did not have any illnesses at the time of vaccination. The patient was hospitalized for four days starting 10/8/04 and treated with phenobarbital. She was discharged from the hospital on 10/11/04. Diagnostic tests and laboratory data obtained included a normal EEG, normal head CT as well as normal blood work up. No bacterial infection was found. Reportedly, the patient experienced another seizure on 11/3/04 but no changes were made. From additional information received on 1/28/05 from a physician, it was reported that the patient was diagnosed with epileptic disease, Per the reporter, the patient is doing well with no seizures since November of 2004 when she was started on phenobarbital. It was also reported that there is history of seizure or other neurological disorders in either the patient's aunt or uncle. No further information is anticipated. This case is considered closed.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Chest pain, Chills, Headache, Hypokinesia
Clinical narrative: By phone, patient reported erythema and pain at the injection site, fever, myalgia, headache.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: By phone, patient reported erythema and pain at the injection site, fever, myalgia, headache.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: By phone, patient reported erythema and pain at the injection site, fever, myalgia, headache.
Age: 60.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: By phone, patient reported erythema and pain at the injection site, fever, myalgia, headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Anaphylactic reaction, Asthma, Condition aggravated, Hypersensitivity
Clinical narrative: Since 2 weeks after the vaccine- I have increased asthma problems, severe reactions to anything with any corn or corn derivitives- to the point of anaphaxis- and needing epinephrine almost daily. I have now been referred due to the severity of the reactions and the numbers of them. 60 Day Follow up: Con't to have problems with anything made from any type of corn or derivatives-thermisel, cornstarch, dextrose. Information from medical records state sneezing, itching as symptoms. msv Per follow up report-Continue to go into anaphelaxis with any exposure to corn products-especially popcorn or any derivative of corn including gellatin.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rhinitis
Clinical narrative: Since 2 weeks after the vaccine- I have increased asthma problems, severe reactions to anything with any corn or corn derivitives- to the point of anaphaxis- and needing epinephrine almost daily. I have now been referred due to the severity of the reactions and the numbers of them. 60 Day Follow up: Con't to have problems with anything made from any type of corn or derivatives-thermisel, cornstarch, dextrose. Information from medical records state sneezing, itching as symptoms. msv Per follow up report-Continue to go into anaphelaxis with any exposure to corn products-especially popcorn or any derivative of corn including gellatin.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash erythematous, Skin ulcer
Clinical narrative: Pt s/p smallpox vaccination on 13 Jan 05. One week later patient developed red raised rash to surrounding area but denied itching or scratching. Pt presented to me on 04 Feb 05 with continued raised red rash, 4 inches in diameter, with erythematous base. Mild excoriation, no vesicles or pustules. Pt with other skin lesions, consistent with psoriasis.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Fall, Hypoaesthesia, Malaise, Myalgia
Clinical narrative: Received vaccine (mist) at 4pm on 2/2.  On 2/3 at 10:40 am, began to feel light-headed and queasy while sitting in class.  5 minutes later, fainted and fell to floor.  Dazed upon being revived.  Felt very ill for next hour (shaky, nauseaous, "numb" legs and arms [tingly, unsteady], dizzy).  At 24 hours since first reaction, continues to have sore muscles throughout body especially legs & arms, and runny nose, unsteady physically, "balloon head."
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Paraesthesia, Rhinorrhoea, Syncope, Tremor
Clinical narrative: Received vaccine (mist) at 4pm on 2/2.  On 2/3 at 10:40 am, began to feel light-headed and queasy while sitting in class.  5 minutes later, fainted and fell to floor.  Dazed upon being revived.  Felt very ill for next hour (shaky, nauseaous, "numb" legs and arms [tingly, unsteady], dizzy).  At 24 hours since first reaction, continues to have sore muscles throughout body especially legs & arms, and runny nose, unsteady physically, "balloon head."
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 2 month old male participant in a study who experienced SIDS. The participant received the first dose on 5/29/01. The participant also received the first dose of Infanrix, the first dose of Engerix B and the first dose of IPOL on 5/29/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 5/29/01. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, and IPOL. On 5/31/01, 2 days post vaccination, the patient expired as a result of SIDS per the county coroner's office. The investigator considered the relationship between sudden infant death syndrome and Prevnar to be remote. The medical monitor considered the event to be not related to the study product. This report of a serious, labeled event is being submitted in an expedited time frame as requested by the FDA. No additional information reported on autopsy report rec'd 03/02/2005. Autopsy Report received which states COD is SIDS.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar was received from an investigator regarding a 3month old male participant in a study who experienced SIDS. The participant received the first dose on 4/12/02. The participant also received the first dose of Infanrix, the first dose of Engerix B, the first dose of Act-HIB, and the first dose of IPOL on 4/12/02. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/12/02. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, Act-HIB, and IPOL. On 5/15/02, the patient expired as a result of SIDS per the county coroner's office. The investigator and medical monitor considered sudden infant death syndrome to be not related to the study product. The report of a serious labeled event is being submitted in an expedited time frame as requested by the FDA.
Age: 1.27
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Child developed urticaria within 24 hours of vaccine administration.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old white female with an aspirin allergy and a penicillin allergy, hypertension (stable), hyperlipidemia (stable), and osteoarthritis (stable) who on 11/24/04 was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant medications included levothyroxine sodium, simvastatin, valdecoxib, and a multivitamin. Subsequently, the patient developed a mild local reaction. The patient was seen in the office on 11/26/04 and treated with moxifloxacin hydrochloride as a prophylaxis. The reporter indicated that on 11/24/04 the patient's husband also received pneumococcal 23v polysaccharide vaccine from the same vial, and developed cellulitis (WAES0412USA00518). The reporter stated that other patient's also received pneumococcal 23v polysaccharide vaccine from the same vial, and did not experience adverse symptoms. The patient's outcome was unknown. Follow up information indicated that the patient returned to the office on 11/26/04 with a localized area of redness, swelling, and discomfort over the injection site in the left deltoid. Diagnosis was cellulitis versus local reaction to pneumococcal 23v polysaccharide vaccine. The patient was treated with warm compresses, ibuprofen PRN and moxifloxacin hydrochloride. The patient recovered. The redness, swelling and discomfort at the injection site were considered other important medical event (OMIC). Additional information is not expected.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: 4 month old boy seen on 12/23/04 for routine well child visit. Patient well; no history of illnesses. Received Pediarix, Prevnar, HIB #2 that morning. Later in evening, seized and hospitalized for 1 week. 60 Day follow up: Pt has a mixture of seizure types including myoclonic and absence. Is currently being followed by a pediatric neurologist and on antiseizure medications.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Dizziness, Hypertension, Pain
Clinical narrative: Patient received flu and pneumonia vaccines on 01/21/05. On 01/25/05 her blood pressure was high and today it is 200/100 and she has dizziness. She called her doctor that manages her HTN,  who instructed her to take additional medication. I explained to the patient that my knowledge the flu and pneumonia vaccines should not cause your blood pressure to elevate, but that she could have soreness and tenderness of the area, which she indicated she did. I advised client to recall her BP doctor, if unable to reach them go to ER, as she attempted to recheck her BP during our conversation and her machine stated twice that it was unable to read. I notified my supervisor.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Drug ineffective, Infection, Influenza, Viral infection
Clinical narrative: 1. Got the Flu 1 day after vaccination. Treated with Augmentin and Ampicillin. 2. Got the mumps 7 days after vaccination, treated with IV steroids in emergency room, followed by 6 days of oral methylprednisolone. 3. As of 01/29/05 still not fully recovered. Follow up 02/15/05: Vaccination given at another facility, manufacturer and lot number for vaccine not available.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza
Clinical narrative: Had the flu that was treated with Zithromax. Follow up 02/15/05: Information on manufacturer and lot number of vaccine not available, vaccinated at another facility.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Patient broke out in chicken pox 15 days after vaccination.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information received from school, unable to complete from in it's entirety.
Age: 1.09
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Irritability, Rash
Clinical narrative: Rash - noticed 1/26, mild redness, mildly fussy.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Rash noted on back and around waist.  Patient reports rash and itching started the day after injection.  Also had fever for 3 days after injection.  Patient treated with Kenalog 40mg Intramuscular, right glut.max; patient treated with OTC hydrocortizone cream.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Itching, swelling and increased warmth day after vaccine given.
Age: 1.28
Sex: M
Vaccine: DTAPH, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site swelling, Pyrexia
Clinical narrative: Warmth, discharge, fever, red streak from left side, redness, swollen area around site on left thigh - cellulitis. Treated with Augmentin 2 times a day for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 7cm on left later thigh at site of DTAP and IPV redness, induration, with slight inepular borders, and tenderness.
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Infection
Clinical narrative: 1/21/2005 Patient had history of Crohn's Disease.  In remission for 1 year.  On no steroids.  Dr. felt patient should receive vaccine.  Patient works as an aid at hospital.  Frequently exposed to shingles.  Complaint of abdominal pain and possibly chicken pox.  No lesions.
Age: 17.0
Sex: F
Vaccine: HEP, TD
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever - feeling of Malaise - began 24 hours after administration of vaccine.  Responded to Tylenol.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site pain, Pyrexia
Clinical narrative: 01/26/2005 12:30OPM - patient felt warm, fever at 6:00PM T 100.3, gave Tylenol at 10:00PM temp noted 01/27/2005 T 100.8, legs tender sore all day, screamed in pain when touched.  Tylenol given during day.  Site of injection no redness - 11/28/2005 tem 102.1, no tenderness with either leg.  Seen at Clinic.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: After being immunized, developed wheezing.  Returned to clinic to be evaluated, bilateral respiratory wheezing with coarse bronchi.  Several small urticarial lesions.  Received Benadryl 25MG by mouth and Albuterol via nebulizer.  Wheezing cleared.
Age: 35.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Erythema, Haematochezia
Clinical narrative: Received vaccinations 01/20/2005. Symptoms started 05:30 AM 01/21/2005 with abdominal pain , dizziness and sweats without fever , nausea and vomiting : has diarrhea. Sole of feet itchy : the skin red from head to toes. Most symptoms gone in approx 3 hours, though abdominal pain persisted for several days. Also , bloody stools for 3 - 4 days.
Age: 35.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Hyperhidrosis, Pruritus
Clinical narrative: Received vaccinations 01/20/2005. Symptoms started 05:30 AM 01/21/2005 with abdominal pain , dizziness and sweats without fever , nausea and vomiting : has diarrhea. Sole of feet itchy : the skin red from head to toes. Most symptoms gone in approx 3 hours, though abdominal pain persisted for several days. Also , bloody stools for 3 - 4 days.
Age: 33.0
Sex: F
Vaccine: YF, YF
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Developed pruritic rash at injection site about 8 hours after vaccination ; subsequent spread to trunk. No other symptoms.
Age: 33.0
Sex: F
Vaccine: YF, YF
Symptoms: Injection site reaction, Pruritus, Rash maculo-papular
Clinical narrative: Developed pruritic rash at injection site about 8 hours after vaccination ; subsequent spread to trunk. No other symptoms.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Varicella illness (about 2 dozen lesions) approximately 3 years after vaccine.
Age: 1.26
Sex: M
Vaccine: FLU3, PNC, VARCEL
Symptoms: Nausea, Rash erythematous, Skin ulcer, Vomiting
Clinical narrative: Reports child had 2 lesions approx 1/25/05 - one on leg, 1 on trunk.  Now has 4 lesions in different areas.  First one is "scabbed over."  Red, raised, w white center.  Started nausea & "uncontrollable" vomiting last night & has vomited today also but not uncontrollably, denies fever.  Advised to contact PCP, encouraged fluids & no ASA
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Left arm swelling, redness, pain, and itching.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash
Clinical narrative: RASH OF LEFT DELTOID/ALLERGIC REACTION TO FLU SHOT PER DR. HYDROCORTIZE 0.5% BID X 7 DAYS PER DR. NO FLU SHOTS.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling, Tenderness, Tension
Clinical narrative: Patient returned to office aprox 24 hours after vaccine administration. He presented with tense, pink, puffy left arm from shoulder to right above elbow, He was able to move arm and fingers. Mild tenderness noted with touch. He was afebrile and had no other symptoms. Treated with ibuprofen 200 mg and Benadryl 25 mg every 6 hours or when needed.
Age: 3.0
Sex: M
Vaccine: DTAPH, HEPA
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: Right thigh with leg warm , red cellulitis. Amoxil , Zyrtec , Benadryl
Age: 1.61
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Redness , local reaction / Hot pack
Age: 4.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Had DTP 2 days ago complained of redness and swelling at the site of the vaccine injection.
Age: 11.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pt had tetanus toxoid shot on the right buttock 10 days ago he noticed swelling and pain at site of injection, no fever.
Age: 47.0
Sex: F
Vaccine: HEPAB, IPV, TD, TYP
Symptoms: Headache, Iritis, Ocular hyperaemia, Photophobia, Pruritus
Clinical narrative: 12/20/04 left eye red, itching, headache; 12/26/04 eye sensitive light; 12/30/04 diagnosed iritis vision reduced to shadows; 1/13/05 eye improving not resolved.
Age: 47.0
Sex: F
Vaccine: HEPAB, IPV, TD, TYP
Symptoms: Visual disturbance
Clinical narrative: 12/20/04 left eye red, itching, headache; 12/26/04 eye sensitive light; 12/30/04 diagnosed iritis vision reduced to shadows; 1/13/05 eye improving not resolved.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hypokinesia, Muscular weakness, Myalgia, Shoulder pain
Clinical narrative: Severe, Sharp pains in upper musle and shoulder area.  About one weeks after the second shot. Later part of Jan and First part of Feb.  Pain  constant and lower musle weekness and sharp pain in elbow area, loss of strength, trouble climbing ladders.
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, Pain, Shoulder pain
Clinical narrative: Uncomfortable and sometimes nearly severe pain in shoulder/arm (area of vaccination), since second vaccination.