chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Influenza like illness, Rash
Clinical narrative: Report 2001003520-1 describes joint pain in a 76 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health care professional. On 05/27/99, the vaccinee received her first dose of Lymerix. "shortly therafter" she developed a "large rash on her stomach, joint pain, fatigue, and general flu-like symptoms". She was placed on unspecified oral antibiotic therapy starting on 06/10/99 and ultimately was administered intravenous antibiotics from 10/29/99 through 11/26/99. The intravenous antibiotics reportedly relieved "many" of her symptoms. As of 02/01/02, the vaccinee continued to experience joint pain and fatigue. The adverse event of "arthralgia" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Oedema
Clinical narrative: Report 2001003631-1 describes pain in a female vaccinee of unspecified age who received LYMERIX. The information in this report is received via a journal article and has not been verified by a physician or other health care professional. In may 1999, the vaccinee received her second dose of LYMERIX. "Shortly after vaccination", the vaccinee began experiencing burning pain in her back, numbness in her arms, and aches and swelling in an ankle. "Just the thought of walking across the yard hurt me", said the vaccinee. By December, 1999, the pain was so intense, the vaccinee was considering reconstructive surgery for her ankle. As of 02/01/01, the outcome of the events in unknown. The adverse events of "numbness", "ankle pain", and "ankle swelling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Rash maculo-papular
Clinical narrative: This infant had swelling, pain, redness with fluctuance and warmth at the injection site on the right upper thigh with splotching..
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fibromyalgia, Insomnia, Pain, Red blood cell sedimentation rate increased
Clinical narrative: This patient had a gradual onset of pain in both knees, left ankle and heel. General feeling of aching, trouble sleeping. Feeling as though hit by a truck. Climbing stairs became a problem. After 3-4 months she began to seek treatment, which lead to a rheumatologist diagnosis of fibromyalgia syndrome.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Pyrexia
Clinical narrative: This infant had a fever of 100.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Gout, Oedema
Clinical narrative: After receiving my first series of Lymerix injections, I started to have gout like symptoms alternating between both of my ankles along with my knees. During this period a couple of uric acid test showed normal levels. My doctor has sent me to a podiatrist, who took x-rays, and extensive blood work, and he could not find anything wrong with my ankles. He then referred me to a rheumatologist, his diagnosis was I do not have arthritis, he thinks it is the gout. For the past 8 years I have a history of getting the gout once or twice a year without taking any preventative medication, only watching my diet. Since May 2000, I started with 100 mg of Alapurinol, then was increased to 300 mg, along with watching my diet without any help with the pain. When I do get the gout after taking my medication, colchicine 0.6 mg the swelling starts to subside within a few hours. This other swelling takes a few days to subside. None of the three doctors will admit to me my problems were from the Lymerix injections.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Lymphadenopathy, Oedema, Pain
Clinical narrative: A 34 year old health care worker presented 12/19/00to request the Hep B vaccination, PPD placement, and the flu shot. On 12/21/00 the patient presented complaining of swelling and tenderness in the right supraclavicular area, no previous episode. No other area of tenderness, PPD negative. The area was examined by the RN and the MD. The right supraclavicular lymph node tender, moveable, 1 cm palpable. Injection site normal. The patient was told to take Tylenol or Motrin when necessary and return if not resolved in one week. Numerous follow up phone calls made unable to reach the patient. The patient presented to the MD today for unrelated problem. Reports that right supraclavicular pain and swelling completely resolved in 1-2 weeks after the injection. Area was examined no swelling, no tenderness, no cervical lad injection site WNL.
Sex: F
Vaccine: FLU3
Symptoms: Cardiovascular disorder, Dysgeusia, Paraesthesia
Clinical narrative: The pt complained of funny taste in mouth, palate, tingling in back of head. Went to ER on 1/3/01 and 1/10/01. Complained of decreased circulation in LUE and LLE.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Pain
Clinical narrative: This patient's left arm had weakness and pain.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Coma, Hypoventilation, Lethargy, Rash, Urticaria
Clinical narrative: Within 5 minutes after receiving his vaccinations the infant began having hives, got lethargic, not responding to normal stimuli, respirations shallow at 26, rash on face and body. The doctor was notified. Benadryl IM was administered. The infant was monitored for 5 minutes the injection rash disappeared. The baby then became responsive, respirations increased to 42, HR at 128. The baby was released home after monitoring for 30 minutes.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Myalgia, Paraesthesia, Rash
Clinical narrative: This patient had a rash, myalgias, fatigue, and paresthesia of the hands.
Age: 0.7
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Diffuse red papular rash on face, upper extremities and trunk which appeared 3 days, post vax of Hep-B #2. Denies exposure to new foods or products. Treated with Prelone X 3 days and Atarax.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: Erythematous rash started in left arm the next morning and spread to other arm, legs and trunk but not face. No fever or other symptoms. Rash still apparent at 13:30 on 12/26/00. Referred to Pediatric Clinic for evaluation and follow-up or ER prn.
Age: 1.8
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: On 1/10/00, left deltoid swollen, red, hard to touch and hot. Mom says symptoms started right after IZ's and symptoms have gotten worse. Redness, tenderness had grown to under the arm this AM. Advised mom to call child's doctor. On 1/11/01, the doctor says that the child has cellulitis but he is feeling better. Treated with pain medicines and taking antibiotics.
Age: 1.8
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site warmth
Clinical narrative: On 1/10/00, left deltoid swollen, red, hard to touch and hot. Mom says symptoms started right after IZ's and symptoms have gotten worse. Redness, tenderness had grown to under the arm this AM. Advised mom to call child's doctor. On 1/11/01, the doctor says that the child has cellulitis but he is feeling better. Treated with pain medicines and taking antibiotics.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mother states that her daughter received the varicella vaccine in 1995 and came down with this disease on 1/1/01.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mother states that her son received the varicella vaccine in 1995 and came down with the chickenpox on 1/17/01. Mother states that her son had over 120 pox.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever for 3 days after receiving shots, 1 week earlier. Seen in ER X 1 and then by pediatrician.
Age: 38.0
Sex: F
Vaccine: HEP, TD
Symptoms: Eye swelling
Clinical narrative: Called on 1/24/01, eyes swollen, took Sudafed and are still puffy. Called client on 1/25/01 and left eyelid better, right eyelid worse. On 1/30/01, some puffiness on eyelids but much better. Plans to get #2 Hep-B shot.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Two hours, post vax, pt felt light-headed which lasted about 1/2 hour. At the same time, pt's right arm and leg felt tingly, lasting about 3 hours. In the AM of 12/28/00, woke up with right arm and leg feeling tingly, progressing to numbness in the right hand and foot. Numbness persisted until around 12/31/00. Pt still has periodic numbness on top of right foot.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Irritability, Pruritus, Pyrexia, Urticaria
Clinical narrative: Mother reported "hive" on left cheek 1/2 hour, post vax. Hive on left leg and smaller hives later. Fever to 100.5F, fussy and "itchy". Fever up to 101.8F, the following day. No further problem.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Anorexia, Dyspnoea, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Mother reported left thigh was red and swollen at site of injection; he had trouble breathing on the 4th day, post vax, though the 6th day; hives starting on 5th day, post vax and continuing through to the 6th day; vomiting and loss of appetite from the 4th to 6th day, post vax. Took to health center on day 6, 1/11/01.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Vomiting
Clinical narrative: Mother reported left thigh was red and swollen at site of injection; he had trouble breathing on the 4th day, post vax, though the 6th day; hives starting on 5th day, post vax and continuing through to the 6th day; vomiting and loss of appetite from the 4th to 6th day, post vax. Took to health center on day 6, 1/11/01.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt came down with chickenpox after receiving varicella vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Upper respiratory tract infection
Clinical narrative: Arm from just above the elbow to the top of her shoulder, became red, swollen, indurated but not tender within 24 hours, post vax. Had a fever, 3 days, post vax, and an URI.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Injection site inflammation, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Arm from just above the elbow to the top of her shoulder, became red, swollen, indurated but not tender within 24 hours, post vax. Had a fever, 3 days, post vax, and an URI.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: No reaction at the time of immunizations. Went to doctor the next day with his right leg swollen, red and with increased warmth. This is contained above the knee. The leg does not appear tender. He has been running a low-grade fever. He has had a clear runny nose. Appetite is good, but fussier than usual. Dx'd with a reaction to shots. If the child worsens or develops fever, mother is to call. Mother called on Saturday morning and said child's fever spiked to 102F. She was going to bring him over so I could recheck him, but when I called back in the afternoon, father said the fever had resolved. It was down below 100F, he was much better, leg was less swollen and they felt he would do well.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rhinorrhoea
Clinical narrative: No reaction at the time of immunizations. Went to doctor the next day with his right leg swollen, red and with increased warmth. This is contained above the knee. The leg does not appear tender. He has been running a low-grade fever. He has had a clear runny nose. Appetite is good, but fussier than usual. Dx'd with a reaction to shots. If the child worsens or develops fever, mother is to call. Mother called on Saturday morning and said child's fever spiked to 102F. She was going to bring him over so I could recheck him, but when I called back in the afternoon, father said the fever had resolved. It was down below 100F, he was much better, leg was less swollen and they felt he would do well.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Pt had red spots on left thigh but decreasing. Induration over 24 hours. Mom noted "red bump" 2/6/01 on left upper thigh. Increased in size during next 12 hours. Hot, firm to touch. No elevation in temperature. Full range of motion of both legs. Area showed improvement as of 2/11/01 with no residual sequellae.
Age: 43.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Arthralgia, Erythema, Fatigue, Joint swelling, Myalgia
Clinical narrative: Fatigue, severe migrating arthralgias and myalgias (sometimes with swelling and erythema) for the past 9 months. Have tried NSAIDS and steroid injections.  Follow up 06/04/2001: "Patient has not recovered from adverse event.  Fatigue, migrating joing, muscle pain, confusion, digestive problems, light-headed, ears ringing... 35-40 days plus several days left work early or come in late."
Age: 43.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: Fatigue, severe migrating arthralgias and myalgias (sometimes with swelling and erythema) for the past 9 months. Have tried NSAIDS and steroid injections.  Follow up 06/04/2001: "Patient has not recovered from adverse event.  Fatigue, migrating joing, muscle pain, confusion, digestive problems, light-headed, ears ringing... 35-40 days plus several days left work early or come in late."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a 2 month old Caucasian female who on 11/9/99 was vaccinated with haemophilus b conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot P0474 reported-invalid lot #). Concomitant therapy included diphtheria toxoid/pertussis vaccine/tetanus vaccine (Infanrix). On approx. 11/9/99, the pt experienced a red and irritated injection site. The pt was administered diphtheria toxoid (+) tetanus toxoid vaccine at 4 months of age with no response. The pt had a similar reaction following vaccination with haemophilus B conjugate vaccine (WAES00011060). No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Unevaluable event
Clinical narrative: The pt died one week after receiving immunizations.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Aneurysm, Cardiac disorder
Clinical narrative: Received phone from from daughter of pt requesting manufacturer and lot number. Stated that her father died at 8:30 PM the day he received the flu vaccine from a heart aneurysm.
Age: 39.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Chest pain, Fatigue, Neuropathy peripheral, Pain, Tremor
Clinical narrative: It was reported that a 39 year old male pt received IPOL and HEP-B (2nd dose) on 6/11/99 for travel. The pt started with "severe pain and burning in all four limbs and trunk, tremors, fatigue" on 6/17/99. Dx'd as small fiber neuropathy. Pt was treated with Prednisone. The pt had received other travel vaccines on 5/5/99. Pt was evaluated at hospital. New being followed at another hospital. Reportedly, modified work schedule. Pt under care of a Neurologist. Further information is requested.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Encephalitis, Immune system disorder
Clinical narrative: Information has been received from a physician concerning a 14 month old female with failure to thrive and possible immunodeficiency who on approx. 1/16/01, was vaccinated with MMR II. On approx. 1/23/01, the pt experienced encephalitis, seizures and immune deficiency (that could have possibly been present prior to vaccination). The encephalitis, seizures and immune deficiency required hospitalization. At the time of the report (2/6/01), a spinal tap was pending. The pt's hospitalization continued and the pt was noted to be in poor condition. Additional information has been requested. Follow-up states the pt has died.
Age: 70.0
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Difficulty in walking, Guillain-Barre syndrome, Hypoaesthesia, Pain
Clinical narrative: On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Difficulty in walking, Guillain-Barre syndrome
Clinical narrative: On 01/19, this patient had weakness in all extremities and inability to walk. Diagnosis - Acute Guillain Barre' Syndrome.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: On 12/08/00, this patient had a sudden onset of numbness and weakness. Diagnosed with Guillain Barre' Syndrome. The follow-up reports state hypertension, arthritis, leg cramps cataract surgery benign breast tumor, appendectomy before the onset of GBS symptoms as ongoing medical conditions. And prior to the onset of GBS symptoms, the pt also experienced headache.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Confusional state, Mental impairment, Neoplasm
Clinical narrative: Following vaccination the pt's family noticed a sudden onset of confusion and mental deterioration in 1/99. A rapid progression from short-term memory loss to death in March 2000. A diagnosis of paraneoplastic disorder was given. Further information is requested.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Pyrexia, Rash erythematous, Viral infection
Clinical narrative: On 1/31/01, parents reported fever and rash and temperature of 106.1F with red/pink, slightly raised rash on neck, head, abdomen and back. Seen by provider on 2/3/01 and child had extensive maculopapular rash on abdomen, chest and back. Physician's impression is viremia per blood culture done. Given Rocephin but results were no growth after 5 days.
Age: 1.75
Sex: M
Vaccine: PNC
Symptoms: Insomnia, Irritability
Clinical narrative: Irritable, crying and won't sleep. This is out of character, per mom. None or questionable fever. Recheck with child's parent on 2/15/01; child is getting back to normal and is playful.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: Referred to Rheumatologist on 4/26/00 for 1st appt. Has been seen by them on 6/5/00, 9/11/00 and 12/11/00. Pt taking Prednisone, currently. Next scheduled appt. is 3/5/01.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Oedema peripheral
Clinical narrative: Swelling of hands and feet which occurred the same day the pt received Prevnar vaccine; resolved without treatment in 24-48 hours.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Anxiety, Depression, Fatigue, Headache, Infection
Clinical narrative: Vaccine is believed to have triggered my severe and chronic case of Lyme disease. I've been sick for 1 1/2 years. Symptoms include; sleep disorder, headaches, fatigue, nausea, neck and shoulder pain, depression and anxiety.
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Nausea, Neck pain, Pain, Sleep disorder
Clinical narrative: Vaccine is believed to have triggered my severe and chronic case of Lyme disease. I've been sick for 1 1/2 years. Symptoms include; sleep disorder, headaches, fatigue, nausea, neck and shoulder pain, depression and anxiety.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth, Irritability, Pyrexia
Clinical narrative: Woke up next morning with a temperature of 103F, fussy, clingy and acting spacy. 2 days later, had red and warm spot on right thigh and continued temperature. Seen in office on 2/12/00. No temperature; no rash and is better.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Bursitis, Fatigue, Pain, Sleep disorder
Clinical narrative: General feeling of aching all over, tiredness, trouble sleeping and problem with bursitis in left foot (hardly ever stops hurting). Hands aching and an all over feeling of lousiness. Treated with cortisone shots and is seeing doctor for further testing.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 104F and fussiness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Puffy arm and red from elbow to shoulder.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Thursday and Friday had a sore arm. Saturday, muscles ached and arm was red and hot from shoulder to elbow. States allergic to eggs, but eats baked products with eggs and eats 1 egg a week.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Feeling hot, Hypokinesia, Swelling
Clinical narrative: Pt stated his left arm felt "tight" about 21:00 on 1/11/01. No complaint of pain or fever but did have some difficulty raising left arm to face. Left elbow area was red, ward to touch and swollen approx. 3/4 larger than the right elbow. Checked by doctor, who recommended Benadryl. Also advised to take Tylenol if needed. Keep left arm elevated when in bed and use warm compresses.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Nausea, Neck pain, Pain in jaw
Clinical narrative: Pt complaining of "burning pain" around neck, jaw and both collar bones. Upset stomach with nausea and vomiting, "heart pounding" and shortness of breath. Pt instructed not to take flu shots in the future.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Stomach discomfort, Vomiting
Clinical narrative: Pt complaining of "burning pain" around neck, jaw and both collar bones. Upset stomach with nausea and vomiting, "heart pounding" and shortness of breath. Pt instructed not to take flu shots in the future.
Age: 59.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Pt noticed, 3 days ago, that right arm deltoid muscle area began itching. Has 2 areas approx. 2 1/2" below site of Tetanus that is red and slightly warm feeling and "looks better than they did; were almost red". Possible allergic reaction to TD vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 2/5/01 at 11:35, mom called stating he had leg pain and pt was walking on leg. No fever , redness or swelling but was warm consistently. Gave him Motrin. On 2/7/01 at 16:05, mom removed bandaid from injection site on left leg and under bandaid it looks red and with pus; no redness around bandaid site. Advised to go to urgent care facility. Urgent care doctor told to apply Bactroban ointment and use warm compresses to site.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Arm from just above elbow to shoulder became red, swollen, warm and indurated but not painful.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Arm from just above elbow to shoulder became red, swollen, warm and indurated but not painful.
Age: 1.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Rash erythematous, Swelling, Swelling face, Urticaria
Clinical narrative: On 2/10/01, rash started on trunk (red and raised) and progressed to entire body. On 2/11/01, facial swelling and knees swelling. Took to ER and was dx'd with urticaria. Placed on Prelone and Atarax.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Rash macular, Vomiting
Clinical narrative: Vomiting and blotching of palms. Redness noted on feet and in face. At 15:00, doing well. At 17:00, resting.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash
Clinical narrative: Pt had generalized rash involving shoulder and upper arm of injection arm. Rx'd OTC Caladryl lotion.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Vaccine positive rechallenge
Clinical narrative: Developed chickenpox on 4/6/98, unknown length of illness. Developed chickenpox again on 1/22/01. Supportive care.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt developed chickenpox with a duration of about 7 days. Treated with Famvir 500mg X 10 days; Benadryl and Calamine.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Dyskinesia, Tremor
Clinical narrative: Involuntary body jerking, episodic, with onset approx. 14 hours, post vax. Duration of shaking symptoms, 1 second. Occurrence was 1-4 times a minute. Duration of total episodes about 1 1/2-2 hours.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis acneiform, Paraesthesia, Pruritus
Clinical narrative: Vaccine given 2/2/01. Pt developed acne-like rash on face and generalized itchy, tingly skin on 2/9/01. Pt was instructed to use Benadryl and call office if not improved.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia
Clinical narrative: Weakness, fatigue, mono-like symptoms X 7 days, following each vaccine. Pt recovered.
Age: 64.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Laboratory test abnormal, Oedema peripheral, Paraesthesia
Clinical narrative: A 64 year old female patient reported that she received an injection of Tetanus Toxoid on 04/03/00. The next day, she developed swelling of her hands. Her hands are reportedly numb during the day, except when she tries to pick up a pen or a tool; the hands and fingers then tingle. Her hands throb when she is in bed. The patient stated that the physician prescribed Celecoxib, which did not provide relief. Follow up information was received from the physician on 08/06/00. The patient recovered.
Age: 33.0
Sex: M
Vaccine: TTOX
Symptoms: Influenza like illness, Muscle spasms, Neck pain, Pain, Pyrexia
Clinical narrative: A 33 year old male reported that he had received an injection of Tetanus Toxoid on 08/03/00. The next day he experienced flu-like symptoms. On 08/14/00, he developed "severe" neck pain, body aches, decreased sensation of his extremities, and muscle spasms in his back and right forearm. On 09/02/00, he developed a "mild" fever. Follow-up info reeived from the physician on 02/26/2001, indicated that the physician did not confirm the pt's reaction. The physician stated that the pt "did not have a reaction to Tetanus toxoid."
Age: 33.0
Sex: M
Vaccine: TTOX
Symptoms: Sensory disturbance
Clinical narrative: A 33 year old male reported that he had received an injection of Tetanus Toxoid on 08/03/00. The next day he experienced flu-like symptoms. On 08/14/00, he developed "severe" neck pain, body aches, decreased sensation of his extremities, and muscle spasms in his back and right forearm. On 09/02/00, he developed a "mild" fever. Follow-up info reeived from the physician on 02/26/2001, indicated that the physician did not confirm the pt's reaction. The physician stated that the pt "did not have a reaction to Tetanus toxoid."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cellulitis, Hypokinesia, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: 7 days, post vax, child brought in by mom, secondary to being irritable and swelling in left thigh and pain upon movement and cellulitis; started on IV antibiotics and Benadryl in hospital for 2 days. Had a fever of 101.8F; indurated area of cellulitis in thigh 1cm X 1 1/2cm; responded to antibiotics. Discharged home.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: 7 days, post vax, child brought in by mom, secondary to being irritable and swelling in left thigh and pain upon movement and cellulitis; started on IV antibiotics and Benadryl in hospital for 2 days. Had a fever of 101.8F; indurated area of cellulitis in thigh 1cm X 1 1/2cm; responded to antibiotics. Discharged home.
Age: 2.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Infection, Injection site abscess, Injection site mass, Meningitis, Mental retardation severity unspecified
Clinical narrative: A father reported that his 24 month old son received an injection of Tri-Immunol in 1988 and subsequently, developed a fever and a knot at the injection site. One week, post vax, he was admitted to the hospital; he received a spinal tap and was dx'd with viral meningitis. The child was later dx'd as having mild mental retardation. Follow-up information received from a healthcare provider on 3/8/01, idicated that the child received Tri-Immunol and Orimune on 8/20/87. On 8/23/87, he developed an abscess at the injection site. He was admitted to the hospital and the abscess drained. A culture was positive for Haemophilus influenzae B. He was discharged after 7 days. The abscess resolved by 9/7/87. A psychological report also received on 3/8/01, indicated that the child was tested to be within the mentally deficient range with associated impairment in adaptive behavior.
Age: 2.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Pyrexia
Clinical narrative: A father reported that his 24 month old son received an injection of Tri-Immunol in 1988 and subsequently, developed a fever and a knot at the injection site. One week, post vax, he was admitted to the hospital; he received a spinal tap and was dx'd with viral meningitis. The child was later dx'd as having mild mental retardation. Follow-up information received from a healthcare provider on 3/8/01, idicated that the child received Tri-Immunol and Orimune on 8/20/87. On 8/23/87, he developed an abscess at the injection site. He was admitted to the hospital and the abscess drained. A culture was positive for Haemophilus influenzae B. He was discharged after 7 days. The abscess resolved by 9/7/87. A psychological report also received on 3/8/01, indicated that the child was tested to be within the mentally deficient range with associated impairment in adaptive behavior.
Age: 2.0
Sex: U
Vaccine: PNC
Symptoms: Balance disorder, Difficulty in walking, Vertigo
Clinical narrative: True vertigo. Pt states "I'm falling" and grabs onto something for stability. States "the trees are falling on me". Pt trips "as if drunk"; onset 24 hours after Prevnar. Symptoms lasted until 1/17/01.
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Arthropathy, Autoantibody positive, Fatigue, Hypoaesthesia
Clinical narrative: Within a week of the 2nd vaccine, the pt started to "feel less well." She was aching, tired, "gloomy of outlook" and "too exhausted to go to the gym". Her arthritic symptoms became worse. In late May, the symptoms of numbness, and wide-spread tingling returned. She was seen by a neurologist. The neurologist reportedly said that he thinks she has and antibody reaction to the vaccine. Apparently he feels that the antibodies in the vaccine have triggered her body to be overactive in its production of antibodies and so they are not content with attacking the bad guys, but are also attacking the nerves and joints. She self-medicated with round the clock ibuprofen for two weeks. The ibuprofen partially alleviated the arthritic symptoms but did not relieve the numbness and tingling. As of 2/1/01, the outcome of these events is unknown.
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Malaise, Nervous system disorder, Pain, Thinking abnormal
Clinical narrative: Within a week of the 2nd vaccine, the pt started to "feel less well." She was aching, tired, "gloomy of outlook" and "too exhausted to go to the gym". Her arthritic symptoms became worse. In late May, the symptoms of numbness, and wide-spread tingling returned. She was seen by a neurologist. The neurologist reportedly said that he thinks she has and antibody reaction to the vaccine. Apparently he feels that the antibodies in the vaccine have triggered her body to be overactive in its production of antibodies and so they are not content with attacking the bad guys, but are also attacking the nerves and joints. She self-medicated with round the clock ibuprofen for two weeks. The ibuprofen partially alleviated the arthritic symptoms but did not relieve the numbness and tingling. As of 2/1/01, the outcome of these events is unknown.
Age: 68.0
Sex: M
Vaccine: LYME
Symptoms: Laboratory test abnormal, Oedema peripheral, Pain, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Report 2001003926-1 describes rheumatoid arthritis in a 68 year old male who received Lyme disease vaccine. This report was received from the patient and has not been verified by a physician or other health care professional. This patient is a avis hunter and fisher. He received his first injection of Lymerix on 04/14/99, no adverse experience was reported following the receipt of this injection. He received his second injection of Lymerix on 05/19/99. By 08/99, approximately three months following the second injection, the joints in the patient's fingers and wrists became "extremely" swollen. In 10/99, the patient was seen by a neurologist, who performed unspecified test and x-rays to rule out carpal tunnel syndrome; the results of these procedures were not provided. The neurologist referred the patient to an orthopedic physician. The patient was seen by the orthopedist in 11/99, at which time Lidocaine was injected into the patient's hand. This provided no relief. The orthopedist referred the patient to a physiatrist, who conducted motor nerve conduction tests and unspecified muscle tests. The physiatrist made a cast and brace for the patient's right hand and prescribed physical therapy. The patient received physical therapy twice weekly from 12/99 through 04/00. The patient stated, "My hands were still swollen so much I could not tie my shoestrings of brush my teeth and were extremely painful". The patient received his third injection of Lymerix in 07/00. The patient's hands and wrists became "worse than ever". He was seen by his internist. A diagnosis of rheumatoid arthritis was reportedly made and the patient was referred to a rheumatologist, who prescribed  Medrol. As of 02/01/01, the patient stated, "I never had RA before. However, due to the Lyme vaccine, my blood work showed a RA factor of 95, which should have been 20." The adverse event of rheumatoid arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: This patient had a Influenza vaccine 01/26/01 (Friday), woke up (Sunday) 01/28/01, with numbness and cold sensation in feet and legs. Progressively increased upward to the waist over a weeks time. Describes current numbness as "80%" numb from waist down. Is seeking medical care from 2 physicians. MRI is scheduled.
Sex: U
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: A pharmacist reported that a patient received an injection on 08/18/00 and subsequently developed a "mild" anaphylactic reaction. The reporter also indicated that the patient has an allergy to horses. This report is considered medically important. No further information was available at the date of this report.
Age: 7.0
Sex: M
Vaccine: TTOX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: A sister reported that her 7 year old brother received an injection of tetanus toxoid for a head wound in 1959 and reportedly developed complete paralysis from head to toes. He was hospitalized where a diagnosis of Guillain Barre Syndrome was made. The pt was intermittently hospitalized over 3 years. As of 1/5/00, no further information was available.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: nurse reported that a 60 year old female received an injection  approximately 20 years ago and subsequently experienced an anaphylactic reaction. The reporter stated that the patient was told that the reaction was "related to an allergy to horse serum". She recovered. This event is considered medically important.
Sex: U
Vaccine: TTOX
Symptoms: Anaphylactic reaction
Clinical narrative: A pharmacist reported that a patient received  a tetanus injection 44 years ago and experienced an anaphylactic reaction. The patient recovered. As of May 24, 2000, no further information was available. This event is considered medically important.
Sex: F
Vaccine: TTOX
Symptoms: Eye swelling, Rash
Clinical narrative: A physician reported that a female, now 42 years of age, received an injection of Tetanus Toxoid approximately 20 years ago and subsequently developed a rash and puffy eyes. She recovered.
Age: 46.0
Sex: M
Vaccine: TTOX
Symptoms: Balance disorder, Coordination abnormal, Dyspnoea, Fall, Hypoaesthesia
Clinical narrative: A sister reported that her 46 year old brother received an injection of Tetanus Toxoid absorbed in 04/99 for a head wound. He subsequently experienced numbness of his elbows and legs, shortness of breath, falling, loss of balance an incoordination. As of 01/05/00, no further info was available.
Age: 46.0
Sex: M
Vaccine: TTOX
Symptoms: Injury
Clinical narrative: A sister reported that her 46 year old brother received an injection of Tetanus Toxoid absorbed in 04/99 for a head wound. He subsequently experienced numbness of his elbows and legs, shortness of breath, falling, loss of balance an incoordination. As of 01/05/00, no further info was available.
Age: 71.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Rash erythematous
Clinical narrative: A 71 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, on 09/15/98 and a few days later, reportedly developed a red, itchy rash "all over" her back and arms. The patient reportedly recovered within 10 days. Additional information received from the physician on 05/24/00 indicated that the date of vaccine administration was 09/15/98, and the onset of the erythematous rash was 09/23/00. The patient remained recovered. Manufacturer's Comment: The lot # was reported as 0918970; however, this is not a valid Lederle lot number.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A53 year old female inadvertently received an injection of Tetanus Toxoid Adsorbed, on 01/31/00, instead of PPD. That same day, she developed an injection site reaction characterized by redness and swelling. She was treated with Benadryl.
Sex: F
Vaccine: TTOX
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia, Serum sickness
Clinical narrative: A female reported that she received an injection of Tetanus Toxoid Adsorbed, and subsequently developed a fever, sore throat, and swollen lymph nodes. The patient considered this to be a serum sickness like reaction. The reporter declined to provide additional information and declined to grant permission for the follow up investigation.
Sex: M
Vaccine: TTOX
Symptoms: Unevaluable event
Clinical narrative: A pharmacist reported that a male received an injection of Tetanus Toxoid 25 to 30 years ago and developed an unspecified reaction. He recovered. No further info was available at the date of this report.
Sex: F
Vaccine: TTOX
Symptoms: Unevaluable event
Clinical narrative: A pharmacist reported that a female received Tetanus Toxoid adsorbed, 25 years ago and subsequently, developed and unspecific reaction. The patient recovered. As of 03/09/00, no further information was available.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Anorexia, Anxiety, Asthenia, Cough, Ear disorder
Clinical narrative: A patient, now 50 years of age, reported that she received an injection of Tetanus Toxoid 10 years ago and subsequently developed shaking and tremors. She also developed a runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, "extreme" anxiety, headache, "cracking and popping" in her head and ears, palpitations, and her right ear had "sensitive hearing". She recovered.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Insomnia, Palpitations, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: A patient, now 50 years of age, reported that she received an injection of Tetanus Toxoid 10 years ago and subsequently developed shaking and tremors. She also developed a runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, "extreme" anxiety, headache, "cracking and popping" in her head and ears, palpitations, and her right ear had "sensitive hearing". She recovered.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Tongue discolouration, Tremor
Clinical narrative: A patient, now 50 years of age, reported that she received an injection of Tetanus Toxoid 10 years ago and subsequently developed shaking and tremors. She also developed a runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, "extreme" anxiety, headache, "cracking and popping" in her head and ears, palpitations, and her right ear had "sensitive hearing". She recovered.
Sex: F
Vaccine: TTOX
Symptoms: Injection site abscess, Injection site induration, Injection site rash
Clinical narrative: A nurse reported that a female inadvertently received Tetanus Toxoid Adsorbed, or Tetanus and Diphtheria Toxoids Adsorbed, intradermally, instead of PPD. The patient experienced a sterile abscess at the injection site and a rash surrounding the area of induration. The patient was seen by a physician and the sterile abscess was excised. A topical steroid was prescribed for the rash.
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema, Malaise
Clinical narrative: A female, now 64 years of age, reported that she received an injection of Tetanus Toxoid Adsorbed, more than 20 years ago. Subsequently, she became "very ill" and was "in bed for a week". She also developed swelling at the injection site. The reporter indicated that her arm swelled "3 times the size". She recovered.
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema
Clinical narrative: A nurse reported that a patient inadvertently received an intradermal injection of Tetanus Toxoid Adsorbed and subsequently developed redness at the site of the injection. No further info was available at the date of this report. This is 1 of 2 patients from this facility who experienced this event following receipt of an intradermal injection of Tetanus Toxoid.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: A pharmacist reported that a female, now 66 years of age, received an injection site reaction of Tetanus Toxoid in 1983. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days.
Age: 43.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Injury, Skin nodule
Clinical narrative: A nurse reported that a 43 year old female received an injection of Tetanus Toxoid Adsorbed, on 10/23/00 for a puncture wound. On 10/25/00, she developed an injection site reaction characterized by pain, swelling and "knots" under her arm. As of 10/27/00 , the pain and swelling had resolved.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported that a 40 year old male inadvertently received an injection of Tetanus Toxoid Adsorbed, on 11/06/00, instead of an IM injection and that day, he developed an injection site reaction characterized by pain and swelling of his forearm. As of 11/07/00, his symptoms persisted.
Sex: U
Vaccine: TTOX
Symptoms: Lymphadenopathy
Clinical narrative: A physician reported that a patient received an injection of Tetanus Toxoid Adsorbed, more than 10 years ago. One week post-immunization, the patient developed progressive axillary and cervical lymphadenopathy which continued for 3 to 5 days. No further info was available at the date of this report.
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: A physician reported that he treated several patients who inadvertently received Tetanus Toxoid subcutaneously at an unknown facility. The patients experienced injection site reactions characterized by redness, swelling and induration. As of 11/16/00, no further information was available. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 19.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: A pharmacist reported that a female, now 66 years of age, received an injection of Tetanus toxoid in 1953. Immediately post-immunization, she developed a fever and an injection site reaction characterized by swelling and pain that extended from her fingertips up through her arm. She recovered after 5 to 6 days.
Sex: F
Vaccine: TTOX
Symptoms: Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported that a female patient received an injection of Tetanus Toxoid Adsorbed, in 1990 and, "a couple of days after injection", developed an injection site reaction characterized by mild to moderate redness and swelling. The patient was subsequently seen by a physician; she required no medical treatment.
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema
Clinical narrative: A pharmacist reported that a patient received an injection of Tetanus Toxoid. Subsequently, the patient developed erythema at the injection site. No further info was available at the date of this report.
Age: 66.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site abscess
Clinical narrative: A medical assistant reported that a 66 year old male patient received an injection of Tetanus Toxoid in June 1999. In January, 2000, the patient developed an abscess at the injection site which was treated with antibiotics and Bactroban.
Sex: F
Vaccine: TTOX
Symptoms: Chest discomfort, Hypertension
Clinical narrative: A female patient reported she received an injection of Tetanus Toxoid in 1986, and subsequently developed hypertension and chest tightness. The patient recovered.
Sex: M
Vaccine: TTOX
Symptoms: Movement disorder, Stupor
Clinical narrative: A nurse reported that an adult male, now 67 years of age, received an injection of Tetanus Toxoid in 1971. He subsequently became "bedridden for 4 days and almost comatose". He recovered.
Age: 20.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported that a 20 year old male inadvertently received an injection of Tetanus Toxoid on 11/14/00 and immediately, developed an injection site reaction characterized by redness, swelling, pain and induration. On 05/16/00, he returned to the clinic and was instructed to apply cold packs to the site and self-administer extra strength acetaminophen for pain. The patient was again seen at the clinic on 05/21/00 and had recovered. This is 1 of 5 patients from this facility who was administered Tetanus Toxoid intradermally.
Age: 46.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: A 46 year old male inadvertently received an injection of Tetanus Toxoid on 11/14/00 and immediately, developed an injection site reaction characterized by redness, swelling, pain and induration. On 11/16/00, he returned to the clinic and was instructed to apply cold packs and to self-administer extra strength acetaminophen for the pain. The patient was seen again on 11/20/00 and he recovered. This is 1 of 5 patients from this facility who was administered Tetanus Toxoid intradermally.
Sex: M
Vaccine: TTOX
Symptoms: Malaise
Clinical narrative: The wife of a male, who had been in his 20's reported that her husband received an injection of Tetanus Toxoid 8 to 10 years ago and experienced "general malaise"  which lasted approximately 10 months.