chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Neck pain, Thyroid disorder, Urinary tract infection, Visual disturbance, Vomiting
Clinical narrative: The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: White blood cell count increased
Clinical narrative: The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Egg size red edematous area at injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash
Clinical narrative: Rash L thigh X 2 days, post varicella/DTaP immunizations.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Vesicular lesions over entire trunk, body, all, anal area 7 days post vaccine. No treatment given.
Age: 9.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Eye inflammation
Clinical narrative: Inflammation both eyes 20-30 minutes after injection. No resp. distress. Sent to ER, Benadryl po.
Age: 1.7
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: TC received from grandmother of child vaccinated on 8/21/02  reporting that pt had a fever of approx. 101-102 degrees on night of vaccination 8/16/02. She reports that pt has a fever only at night, and is fine during the day. Grandmother was advised to call private provider for follow-up to be sure sx were not from other illness rather than immunization.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pain
Clinical narrative: Severe and acute pain in joints, hands, knees and feet. But now has chronic pain all other the body except face and top of head.
Age: 4.5
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Had DTaP, Hep A, MMR. L deltoid area swollen and red-had DTaP (Daptacel) #5 and hep A #1 on this side. R deltoid area received MMR #2 dose.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site pain, Pruritus, Rash maculo-papular
Clinical narrative: Site soreness with induration for 1 week. 5cm maculopapular rash. Site pruritis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt presented with redness and swelling at injection site of the left thigh. No fever/chills.
Age: 1.49
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: L leg swollen with redness. No fever/chills. It occur 1 day after receiving the vaccine (DTaP). Tx-cool compreses/warm compress made appt with Dr.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt had swelling and redness in the L thigh.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy, Oedema
Clinical narrative: Received rabies vaccines 8/15 and had arm/shoulder and arm lymphadenopathy starting 8/16/02 in the evening. Maximum edema, lymphadenopathy at 48 hours.
Age: 1.6
Sex: M
Vaccine: UNK
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Diarrhea, fever, fussiness, decreased appetite, redness at inj site.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema
Clinical narrative: R upper inner leg red.
Age: 14.0
Sex: F
Vaccine: HEP, TD
Symptoms: Eyelid oedema, Face oedema, Swelling face
Clinical narrative: Swelling of face, upper and lower eyelids, upper and lower lips-unable to open mouth. Recovering.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Pain in jaw, Parotitis
Clinical narrative: Patient has had a painful left jaw for several days, with no other symptoms.  On physical exam today, he has a mild parotitis.  Patient was advised to avoid spicy or sour foods, to eat foods that don't require a lot of chewing, and to take Ibuprofen as needed for pain.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection, Pain, Rash
Clinical narrative: Adverse event actually happened nearly 5 years later. Near the end of June 2002, my son developed a painful rash on both sides of his neck. After realizing this was no ordinary rash (about a week after its appearance), I took him to the doctor. They took a culture, and called me several days later to tell me it was positive for shingles. This, they said, was most likely from the vaccine. We are no longer with the practice where the vaccine was administered. If you need the address of the practice where herpes was diagosed, email me, or contact me at the above address or phone number.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Difficulty in walking, Joint stiffness, Malaise
Clinical narrative: Information has been received from a 53 year old male consumer with no remarkable past medical history and no known allergies who in April 2002 and on 5/12/02 was vaccinated with doses of hepatitis B vaccine recombinant. There was no concomitant medication. After each injection, he developed low grade fever and pain in the back of his neck. He reported that the pain was moving to different parts of his body. The pain continued through the end of May 2002, and started getting worse. He reported this to a physician who told him he was probably having a reaction to hepatitis B vaccine recombinant. It was reported that laboratory studies were done. The pt stated that he has so much pain at the present time (August 2002) that he cannot walk or drive and that he has a constant feeling of malaise with pain. He inquired "when will all this cease" and that "no one has been able to tell him." The consumer mentioned possible legal action. The pt's pain persisted. Follow up info received from the pt's physician indicated that the pt developed muscle aches, an elevated rheumatoid factor and an elevated sedimentation rate. The physician reported that the pt received hepatitis B vaccine recombiant once in May 2002 (reported as 5/12/02 by the pt) and once in June 2002 (reported as April 2002 by the pt). It was reported that after the first shot in the series, the pt reported muscle aches and pains. Upon receipt of the second shot in the series, the pt reported more severe aches and pains. The physician noted that he inherited the pt on 8/1/02. On 8/1/02 the physician took bloodwork. The results of laboratory tests showed an elevated rheumatoid factor and an elevated sedimentation rate. The pt reported to the physician that he was unable to work. No further information was provided. Follow-up info received from the consumer indicated a concern about the treatment of his muscle weakness and arthritic pain. Additional conflicting follow-up info received from the consumer indicated that he received the first dose of hepatitis B vaccine recombinant  back in April of 2002. He reported that "since he got the dose, he has been experiencing some problems with his back and knees." He reported once again that he received the second dose in May 2002. He said that the problems got worse and that the pain in his back and knees increased and that it had gotten to a point where he could hardly walk anymore. He feels that his "bones have tightened up," and has been told that the symptoms resemble arthritic problems. He has also recently been diagnosed with polymyalgia and reported that he was currently receiving prednisone. Upon internal review, polymyalgia was determined to be an other important medical event. Additional info has been requested.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Muscular weakness, Myalgia, Neck pain, Pain, Polymyalgia rheumatica
Clinical narrative: Information has been received from a 53 year old male consumer with no remarkable past medical history and no known allergies who in April 2002 and on 5/12/02 was vaccinated with doses of hepatitis B vaccine recombinant. There was no concomitant medication. After each injection, he developed low grade fever and pain in the back of his neck. He reported that the pain was moving to different parts of his body. The pain continued through the end of May 2002, and started getting worse. He reported this to a physician who told him he was probably having a reaction to hepatitis B vaccine recombinant. It was reported that laboratory studies were done. The pt stated that he has so much pain at the present time (August 2002) that he cannot walk or drive and that he has a constant feeling of malaise with pain. He inquired "when will all this cease" and that "no one has been able to tell him." The consumer mentioned possible legal action. The pt's pain persisted. Follow up info received from the pt's physician indicated that the pt developed muscle aches, an elevated rheumatoid factor and an elevated sedimentation rate. The physician reported that the pt received hepatitis B vaccine recombiant once in May 2002 (reported as 5/12/02 by the pt) and once in June 2002 (reported as April 2002 by the pt). It was reported that after the first shot in the series, the pt reported muscle aches and pains. Upon receipt of the second shot in the series, the pt reported more severe aches and pains. The physician noted that he inherited the pt on 8/1/02. On 8/1/02 the physician took bloodwork. The results of laboratory tests showed an elevated rheumatoid factor and an elevated sedimentation rate. The pt reported to the physician that he was unable to work. No further information was provided. Follow-up info received from the consumer indicated a concern about the treatment of his muscle weakness and arthritic pain. Additional conflicting follow-up info received from the consumer indicated that he received the first dose of hepatitis B vaccine recombinant  back in April of 2002. He reported that "since he got the dose, he has been experiencing some problems with his back and knees." He reported once again that he received the second dose in May 2002. He said that the problems got worse and that the pain in his back and knees increased and that it had gotten to a point where he could hardly walk anymore. He feels that his "bones have tightened up," and has been told that the symptoms resemble arthritic problems. He has also recently been diagnosed with polymyalgia and reported that he was currently receiving prednisone. Upon internal review, polymyalgia was determined to be an other important medical event. Additional info has been requested.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Information has been received from a 53 year old male consumer with no remarkable past medical history and no known allergies who in April 2002 and on 5/12/02 was vaccinated with doses of hepatitis B vaccine recombinant. There was no concomitant medication. After each injection, he developed low grade fever and pain in the back of his neck. He reported that the pain was moving to different parts of his body. The pain continued through the end of May 2002, and started getting worse. He reported this to a physician who told him he was probably having a reaction to hepatitis B vaccine recombinant. It was reported that laboratory studies were done. The pt stated that he has so much pain at the present time (August 2002) that he cannot walk or drive and that he has a constant feeling of malaise with pain. He inquired "when will all this cease" and that "no one has been able to tell him." The consumer mentioned possible legal action. The pt's pain persisted. Follow up info received from the pt's physician indicated that the pt developed muscle aches, an elevated rheumatoid factor and an elevated sedimentation rate. The physician reported that the pt received hepatitis B vaccine recombiant once in May 2002 (reported as 5/12/02 by the pt) and once in June 2002 (reported as April 2002 by the pt). It was reported that after the first shot in the series, the pt reported muscle aches and pains. Upon receipt of the second shot in the series, the pt reported more severe aches and pains. The physician noted that he inherited the pt on 8/1/02. On 8/1/02 the physician took bloodwork. The results of laboratory tests showed an elevated rheumatoid factor and an elevated sedimentation rate. The pt reported to the physician that he was unable to work. No further information was provided. Follow-up info received from the consumer indicated a concern about the treatment of his muscle weakness and arthritic pain. Additional conflicting follow-up info received from the consumer indicated that he received the first dose of hepatitis B vaccine recombinant  back in April of 2002. He reported that "since he got the dose, he has been experiencing some problems with his back and knees." He reported once again that he received the second dose in May 2002. He said that the problems got worse and that the pain in his back and knees increased and that it had gotten to a point where he could hardly walk anymore. He feels that his "bones have tightened up," and has been told that the symptoms resemble arthritic problems. He has also recently been diagnosed with polymyalgia and reported that he was currently receiving prednisone. Upon internal review, polymyalgia was determined to be an other important medical event. Additional info has been requested.
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Diabetes mellitus, Hypersensitivity, Laboratory test abnormal, Memory impairment
Clinical narrative: Report A0323046A (formerly 2000007830-1) describes vasculitis in a 64 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was initially received from the subject and has not been verified by a physician or other healthcare professional. Follow-up information was received from a lawyer. The subject had no relevant medical history. Concurrent medications included vitamins. On 3/15/00, the subject received his third injection of LYMErix. The reporting lawyer stated that the subject had received an injection of LYMErix during the  summer of 2001. Two hours post-immunization, the subject experienced uncontrollable trembling and his body ached. He called the emergency room and was told he was having an allergic reaction. In addition, the pt reported that "strange results were found on blood work." "HLA-DR4" was positive. He stated that he had the "beginnings of arthritis." The subject was treated with Benadryl. Information received on 6/23/00 reported the arthritis as ongoing but the other events as resolved. On 8/16/02, the lawyer alleged that the subject he experienced "vasculitis, diabetes, short-term memory loss, and a whole list of other conditions" following immunization with LYMErix. As of 8/16/02, the outcomes of the events were unknown. The adverse event "vasculitis" is considered medically serious.
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Tremor, Vasculitis
Clinical narrative: Report A0323046A (formerly 2000007830-1) describes vasculitis in a 64 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was initially received from the subject and has not been verified by a physician or other healthcare professional. Follow-up information was received from a lawyer. The subject had no relevant medical history. Concurrent medications included vitamins. On 3/15/00, the subject received his third injection of LYMErix. The reporting lawyer stated that the subject had received an injection of LYMErix during the  summer of 2001. Two hours post-immunization, the subject experienced uncontrollable trembling and his body ached. He called the emergency room and was told he was having an allergic reaction. In addition, the pt reported that "strange results were found on blood work." "HLA-DR4" was positive. He stated that he had the "beginnings of arthritis." The subject was treated with Benadryl. Information received on 6/23/00 reported the arthritis as ongoing but the other events as resolved. On 8/16/02, the lawyer alleged that the subject he experienced "vasculitis, diabetes, short-term memory loss, and a whole list of other conditions" following immunization with LYMErix. As of 8/16/02, the outcomes of the events were unknown. The adverse event "vasculitis" is considered medically serious.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Dizziness postural, Dyspnoea, Throat tightness
Clinical narrative: 14 year old male who developed acute onset shortness of breath, chest tightness, throat cloasing and dizziness upon standing within several hours of receiving Hep A vaccine #2 and T dose of Keflex for infected cyst.
Age: 0.8
Sex: F
Vaccine: DTAP, PNC
Symptoms: Anorexia, Cough, Feeling hot, Flushing, Pyrexia
Clinical narrative: Pt's mother reports that she noticed pt was warm around 1pm and checked her temp. which was 104 degrees F. Stated pt very pale, crying, dry cough, was vomiting, and refusing to eat Given Motrin(infant) 1/2 tsp after taking with infant Tylenol 1/4 tsp. 08/23/2002 temp down to 101 degrees. Follow up T/C to parent on 08/26/2002 per mom-infant well today. 8/26/2002 In talking to parent today she stated that infant crying Sat. and half Sun. and vomiting consisted through Sat.
Age: 0.8
Sex: F
Vaccine: DTAP, PNC
Symptoms: Screaming, Vomiting
Clinical narrative: Pt's mother reports that she noticed pt was warm around 1pm and checked her temp. which was 104 degrees F. Stated pt very pale, crying, dry cough, was vomiting, and refusing to eat Given Motrin(infant) 1/2 tsp after taking with infant Tylenol 1/4 tsp. 08/23/2002 temp down to 101 degrees. Follow up T/C to parent on 08/26/2002 per mom-infant well today. 8/26/2002 In talking to parent today she stated that infant crying Sat. and half Sun. and vomiting consisted through Sat.
Age: 1.8
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 22 month old who got shots on 08/20/2002. Mom called 8/22/2002 to report redness on left thigh and swollen. Started 8/21/2002. Says baby not crying in pain or having other problems. Disc.  continuing to use Tylenol and let child play in warm bath water or use warm compresses to leg. Call back if not improved.
Age: 65.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Depression, Enzyme abnormality, Erythema
Clinical narrative: Since 4/12/00 muscle pains, joint pains, weakness, fever, lip pains. Disability now being evaluated for oculopharyngeal muscular dystrophy and mitrochondrial myopathy.  60 Day follow up states still has mypathy, general redness. **Follow-up report on 2/19/03: Per phone call from PT's husband on 2/13/03, add lethargy and depression as updates.
Age: 65.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: Since 4/12/00 muscle pains, joint pains, weakness, fever, lip pains. Disability now being evaluated for oculopharyngeal muscular dystrophy and mitrochondrial myopathy.  60 Day follow up states still has mypathy, general redness. **Follow-up report on 2/19/03: Per phone call from PT's husband on 2/13/03, add lethargy and depression as updates.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Lymphadenopathy, Parotitis, Tenderness
Clinical narrative: Client received 1st MMR on 8/8/02. Symptoms started on 8/15/02 with c/o jaw stiffness, tenderness, (B) ear. Client noticed swollen lymph gland one day later under (R) ear. Symptoms persist today. Has dr's appoint. today. 8/22/02 saw PMD toda. PMD diagnosed parotitis, severe infection and ordered client not to receive 2nd MMR.
Age: 4.7
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Aunt reports child received shots on 8/16/02 (Friday). On next day, upper left arm was red and swollen approx. size of 50 cent piece. Redness and swelling gone by 8/19/02.
Age: 4.3
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site oedema
Clinical narrative: Mom reports child received shots 8/16/02. On 8/17/02 child's arm was red and swollen from approx. 1" above elbow to top of left arm. Top of arm was oozing and crusty. Checked by MD, who told mom to call HD and report. Swelling gone by 8/20/02.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: C/O pain Wed pm, Thurs. (8/15/02) pain  was worse, temp 99.8-taken Alieve-8/16/02-temp 100.8, red, painful. Used hot compresses and Alieve, 8/17/01 area warm to touch, red, fever. Seen 8/18/02-pain better, no fever itching. Mon. 8/9/02 arm red, warm and swollen, unable to take Benadryl. Benadryl cream and Alieve.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Pyrexia
Clinical narrative: C/O pain Wed pm, Thurs. (8/15/02) pain  was worse, temp 99.8-taken Alieve-8/16/02-temp 100.8, red, painful. Used hot compresses and Alieve, 8/17/01 area warm to touch, red, fever. Seen 8/18/02-pain better, no fever itching. Mon. 8/9/02 arm red, warm and swollen, unable to take Benadryl. Benadryl cream and Alieve.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying
Clinical narrative: Inconsolable crying follwing 1-1 1/2 hours after shots. Brought back to office on same day-afternoon-physical exam, esseentially normal except "crying." No treatment. Stable.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Injection site erythema, Injection site rash
Clinical narrative: Inconsolable crying following vaccines (3) 1-1 1/2 hours. The pt was reexamined (within 2 hrs) physical exam was essentially unremarkable except crying and large erythematous macular rashes at inj sites. Somewhat better after Motrin. 8/21 follow up call, he was fine.
Age: 12.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, warmth and swelling at injection site. 2 1/2 inches in diameter on L arm (Td site).
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: Reddened area > 2 inches in size. Child seen at hospital.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and swelling at site of DTaP injection.
Age: 1.2
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Seen for local reaction to DTaP, red and swollen and warm to touch.
Age: 31.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pt with swelling and pain at site (R deltoid) of injection. -SOB, -LDC, -fever, -lip swelling. Reaction occurred on day of injection (8/15/02) and pt presented on 8/20/02 with resolving symptoms.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: 8/5/02 Rec'd varicella vaccine 8/9/02. Returned to clinic with left arm red and swollen. Dr Rx Rocephin IM, Augmentin PO, Motrin and Benadryl. 8/12/02 returned to clinic doing better. No more varicella vaccine. Allegic to varicella Dr stated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mom noticed large red area on R upper arm the day post immunizations given when she started to bathe him that night. Says it swelled a lot but child did not say it hurt. Mom called today abt area and HV made to see reaction. 5" x 5" red area with large swelling on R upper outer arm and rounding arm. Warm to touch. Inst. to use warm compresses and continue Tylenol. See PMD if worsens. Child alert and cooperative. Playing today at babysitter's.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient received DTaP left arm 08/19/2002. On 08/20/2002 pt seen in office with erythema, swelling of arm. Treated with Keflox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: L thigh 9cm x 12cm mild erythema no induration. + warmth and slight tender.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema
Clinical narrative: 8/23/02 3.8 x 3cm redness at injection site (applied 8/22/02. No warmth or tenderness.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: 08/23/2002 5x4 cm (widest length & width); plus redness; plus warmth; plus pain to touch.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Fever of 103 approx 48 hours post vaccination and scattered patches of erythroderma (legs, buttocks, cheeks). Treated with Tylenol, Motrin and Benadryl.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Face oedema, Glomerulonephritis, Headache, Laboratory test abnormal
Clinical narrative: Pt received TD 8/12. Started w/ sore throat and fever 8/14. Treated with Rocephin, cot'd w/ fever. Developed myalgias/arthralgias, neck stiffness, headache, rash. Subsequently, admitted 8/17 to hospital. Had (-) spinal tap, (-) CT of head, (-) CXR. urine showed glomerulonephritis. Rash on palms, (-) soles of feet, swollen face and extremities. ? (-). Pt treated with Prednisone 8/18, Benadryl and ??. ?? cont'd with ?? and ??? D/C'd 8/21/02. Nurse follow up on 06/16/04 states: "ADD: Serum Sickness (SERUM SICK) Secondary to Td vax ADD: Pyelonephritis (PYELONEPHRITIS) ADD: (+) ASO Titer (LAB TEST ABNORM)" Nurse follow up on 06/16/04 states: "none."
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Myalgia, Oedema peripheral, Pharyngolaryngeal pain, Pyelonephritis
Clinical narrative: Pt received TD 8/12. Started w/ sore throat and fever 8/14. Treated with Rocephin, cot'd w/ fever. Developed myalgias/arthralgias, neck stiffness, headache, rash. Subsequently, admitted 8/17 to hospital. Had (-) spinal tap, (-) CT of head, (-) CXR. urine showed glomerulonephritis. Rash on palms, (-) soles of feet, swollen face and extremities. ? (-). Pt treated with Prednisone 8/18, Benadryl and ??. ?? cont'd with ?? and ??? D/C'd 8/21/02. Nurse follow up on 06/16/04 states: "ADD: Serum Sickness (SERUM SICK) Secondary to Td vax ADD: Pyelonephritis (PYELONEPHRITIS) ADD: (+) ASO Titer (LAB TEST ABNORM)" Nurse follow up on 06/16/04 states: "none."
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Rash, Serum sickness
Clinical narrative: Pt received TD 8/12. Started w/ sore throat and fever 8/14. Treated with Rocephin, cot'd w/ fever. Developed myalgias/arthralgias, neck stiffness, headache, rash. Subsequently, admitted 8/17 to hospital. Had (-) spinal tap, (-) CT of head, (-) CXR. urine showed glomerulonephritis. Rash on palms, (-) soles of feet, swollen face and extremities. ? (-). Pt treated with Prednisone 8/18, Benadryl and ??. ?? cont'd with ?? and ??? D/C'd 8/21/02. Nurse follow up on 06/16/04 states: "ADD: Serum Sickness (SERUM SICK) Secondary to Td vax ADD: Pyelonephritis (PYELONEPHRITIS) ADD: (+) ASO Titer (LAB TEST ABNORM)" Nurse follow up on 06/16/04 states: "none."
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Approximately 3" area of erythma  distal to injection site warm to touch no puritis. Likely local response. Rx x 5-10 days to cover unlikely 2" cellulitis.
Age: 3.8
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: child awaken with swollen, hot to the touch upper Lt arm. Swelling in circum. around upper arm with skin swelling; elbow to shoulder swelling. Rx. Zyrtec syrup 1/2 tsp q day x 3-4 days.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Pain
Clinical narrative: Delayed reporting of arm complaint in arm rec'd Hep b vaccination. R delt 2/7/02 Recombivax dose rec'd. Did not report this post vaccination. Stated arm was sore and had some hand and digit aching for three days. Stated complaints onset 2 days after he had the injection. States it completely resolved. Pt stated to nurse it was the left arm that was sore. He did not call back to verify as requested.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea and high fever off and on.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Influenza like illness, Pyrexia
Clinical narrative: Fever of 104 degrees. Joint pains. Flu like symptoms.
Age: 0.75
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Generalized tonic-clonic. Seizure activity- brief less than 2 mins.
Age: 18.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Asthenia, Chest pain, Discomfort, Flushing, Hyperhidrosis
Clinical narrative: Heaviness in chest, weakness, pale and sweaty. Discomfort in arm.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Arthropathy, Furuncle, Joint swelling, Medication error
Clinical narrative: This report describes joint pain in a 40 year old female who received Lyme disease vaccine recombinant OspA. This report was received  from the vaccinee and her friend  and has not been verified by a physician or other health care profesional.  The subject's medical history and concurrent conditions were not specified. Concurrent medications included unspecified thyroid medication, daily multivitamin, vitamin b and vitamin E.. Reportedly, in 2000, the vaccinee received three subcutaneous injections of Lymerix. The patient reported that in May 2002, she experienced "joint pain starting in (her) neck", a "bent" right thumb, and swollen wrist. Additionally, it was reported that she experienced a low-grade fever and boils. The subject sought medical attention. As of 08/13/02, joint pain, "bent " thumb, and swollen wrist were reported as "unresolved". The low grade fever and boiler were reported as "worse". The adverse events "joint pain" and swollen wrist" do not meet serious criteria, but are being submitted as an expedited report by special FDA request the 06/28/00 letter.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: This report describes joint pain in a 40 year old female who received Lyme disease vaccine recombinant OspA. This report was received  from the vaccinee and her friend  and has not been verified by a physician or other health care profesional.  The subject's medical history and concurrent conditions were not specified. Concurrent medications included unspecified thyroid medication, daily multivitamin, vitamin b and vitamin E.. Reportedly, in 2000, the vaccinee received three subcutaneous injections of Lymerix. The patient reported that in May 2002, she experienced "joint pain starting in (her) neck", a "bent" right thumb, and swollen wrist. Additionally, it was reported that she experienced a low-grade fever and boils. The subject sought medical attention. As of 08/13/02, joint pain, "bent " thumb, and swollen wrist were reported as "unresolved". The low grade fever and boiler were reported as "worse". The adverse events "joint pain" and swollen wrist" do not meet serious criteria, but are being submitted as an expedited report by special FDA request the 06/28/00 letter.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Myalgia
Clinical narrative: This report describes fainting in a 40 year old female vaccinee who received Lyme disease vaccine recombinant OspA (Lymerix) the report was received from the vaccinee and has not been verified by a physician or other health care professional. the medical history included skin problems due to well water being contaminated with fecal matter, arm soreness following receipt of tetanus toxoid, and knees and ankle pain following receipt of rabies vaccine. There were no concurrent medications
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Pyrexia
Clinical narrative: This report describes joint soreness and aching in a 50 year old female who received Lyme disease vaccine recombinant OspA (lymerix). This report was resolved from the vaccine and has not been verified by a physician or other healthcare professional. The medical history and concurrent conditions were not very specified. Concurrent medications included unspecified headache medications. "Approximately four years ago ", the vaccinee reportedly received the three-injection series of Lymerix On 06/07/02, she reportedly developed a fever of 102 degree F and her joints were achy and sore. Her fever reportedly increased when she lay down to go to sleep. The vaccinee stated that she went to her physician who tested her for Lyme disease and "other conditions caused by ticks.". She reported that her physician prescribed doxycycline in case she did have Lyme disease. The adverse event "joint pain' dose not meet serious criteria, but is being submitted as an expedited report by special FDA report per the 06/28/00 letter.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Atypical Measles-- MMR given 8/19/2002                    Measles diagnosed 8/30/2002
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Nausea, Syncope, Tremor
Clinical narrative: After receiving Menomune SQ, patient became faint, shaky, c/o headache and nausea.  BP  115/73  P  78.  Routed to physician immediately.  Lungs clear. Vital signs 97.1-77-16  BP  121/75.  Dx:  mild adverse side effect Meningococcal vaccine.  Observed and released.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: From faxed correspondence received at manufacturer on 8/23/02, it was reported that a 2 month old female received first dose of DTaP (tripedia), IPV (IPOL), Comvax, and PCVJ vaccines on 7/29/02. Patient developed seizure on 7/30/02. Patient recovered from event.  Follow up on 01/21/04: "The pt's full name and contact information was provided. Information was confirmed, no additional information was received. CAse closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Found unresponsive by father, prone position on pillow.
Sex: M
Vaccine: DTAP, DTPHIB, HIBV
Symptoms: Antisocial behaviour, Anxiety, Depression, Drug toxicity, Faecal incontinence
Clinical narrative: An attorney reported that a male patient received injections of Hib-Titer (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate)), Acel-Immune (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) and Tetramune (diphtheria and tetanus toxoids and pertussis vaccine absorbed and haemphilus b conjugate vaccine (diphtheria crm197 protein conjugate)) vaccines as part of his childhood immunizations. It is alleged that, as a result of the toxicity from the thimerosal and the mercury and/or other heavy metal in the vaccines, he had the following symptoms:  severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that the patient was exposed to heavy metals from emissions from a chemical plant. These events were considered medically important. No further information was available as of the date of this report.
Sex: M
Vaccine: DTAP, DTPHIB, HIBV
Symptoms: Hearing impaired, Movement disorder, Speech disorder
Clinical narrative: An attorney reported that a male patient received injections of Hib-Titer (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate)), Acel-Immune (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) and Tetramune (diphtheria and tetanus toxoids and pertussis vaccine absorbed and haemphilus b conjugate vaccine (diphtheria crm197 protein conjugate)) vaccines as part of his childhood immunizations. It is alleged that, as a result of the toxicity from the thimerosal and the mercury and/or other heavy metal in the vaccines, he had the following symptoms:  severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that the patient was exposed to heavy metals from emissions from a chemical plant. These events were considered medically important. No further information was available as of the date of this report.
Age: 1.5
Sex: M
Vaccine: IPV
Symptoms: Nerve injury
Clinical narrative: From mailed correspondence received at manufacturer on 8/21/02 from a manufacturer, it was reported that an 18 month old male received a dose of Polio vaccine. No date of vaccination provided. Patient developed a damaged nerve in his leg. The doctor's first thought it was drop foot but later determined that it was related to the polio shot. The patient was hospitalized. Physician contact permission was denied by the reporter. No further details were provided.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning his sister's child who was vaccinated with a dose of MMR (second generation)(lot number not reported). The reporter stated that the child had been diagnosed as being autistic shortly after receiving MMR (second generation). Upon internal review, the patient's autism was considered an other medical event. The reporter also stated that his sister had an adverse experience post vaccination with MMR (second generation). Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Hepatitis C virus
Clinical narrative: Report A0372185A describes hepatitis C infection in a 39 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The medical hisotry, concurrent conditions, and concurrent medications were not specified. The vaccinee didn't think she had any problems following receipt of the first two LYMErix injections. The vaccinee reported that she received injections of LYMErix in 1999 2000 and 2001. It was reported that six months after receiving her third LYMErix injection, possibly in 2001, she experienced liver problems. She was seen by her physician, who recently made a diagnosis of hepatitis C. According to the vaccinee, she also had other problems but said that there were too many things to explain. The vaccinee stated that the events persisted as of 6/19/02 and were probably related to LYMErix administration. Hepatitis C is considered manufacturer medically serious.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Dehydration, Diarrhoea, Febrile convulsion, Haematochezia
Clinical narrative: Apprx. 2-3 hrs after immunizations, fever increased 103.80 (rectal). Mother reported infant had convulsions was taken to ER and admitted to hospital for dehydration. Had bloody stools. Diagnosed with Roto Virus. Dr. stated maybe vaccines could have triggered episode.  Nurse follow up on 07/22/04 states: "febrile seizure, diarrhea, vomiting, sinusitis ,  otitis media."
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Otitis media, Pyrexia, Sinusitis, Viral infection, Vomiting
Clinical narrative: Apprx. 2-3 hrs after immunizations, fever increased 103.80 (rectal). Mother reported infant had convulsions was taken to ER and admitted to hospital for dehydration. Had bloody stools. Diagnosed with Roto Virus. Dr. stated maybe vaccines could have triggered episode.  Nurse follow up on 07/22/04 states: "febrile seizure, diarrhea, vomiting, sinusitis ,  otitis media."
Age: 4.9
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Erythema, swelling, and pain occurring immediately after vaccine given. Pt experienced rapid increase in swelling and erythema 48 hours after vaccine given. Pt admitted and treated for cellulitis-swelling so intense that compaitment syndrome was considered. MRI performed. Clinical improvement within 48 hours of hospitalization. Symptoms essentially resolved. 10/09/02 Per review of medical records injection site reaction was diagnosis. Told to avoid Hep A vaccine in future.  The folow-up states "9/3/02 symptoms reported were in the L arm, site of Hep A vaccination."
Age: 45.0
Sex: F
Vaccine: HEPA, TD, YF
Symptoms: Chills, Dizziness, Injection site erythema, Pain, Paraesthesia
Clinical narrative: Spinning, dizziness, blurred vision, with tingling sensation L side of face 24 hours post injections. T elevation that evening 103.5 along with chills/aches. Erythema around Td site approx. 7" yellow fever site erythema 50 cent size.
Age: 45.0
Sex: F
Vaccine: HEPA, TD, YF
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Spinning, dizziness, blurred vision, with tingling sensation L side of face 24 hours post injections. T elevation that evening 103.5 along with chills/aches. Erythema around Td site approx. 7" yellow fever site erythema 50 cent size.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Varicella rash- onset 08/23/2002 am. Pt did have fever x T day on 08/15/2002. Vaccine was given 08/09/2002
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: Fever 102 degrees. "Jerky" no seizure
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: 3 1/2 in x 1 1/2in slightly erythemic, fading, non-tender area to L thigh at injection site.
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Dyskinesia, Tremor
Clinical narrative: Mother reported on 02/22/2002 involuntary movement while nursing. EEG abd CT scheduled. Both neg/ nl. Child also had visit with child neurologist on 03/15/2002 and 04/14/2002. Mother states these shaking spells happened while nursing on occasions from 01/15/2002 until 03/09/2002. He received 2nd Prevnar on 04/29/2002.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Tremor
Clinical narrative: Mother states child had shaking spells following the injection. (See previous report filed by our office.) Mother did not notify us of this until recently. Mother thought he was having a seizure.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2 x2 cm of erythema and edema developed over the following 24 hrs post injection of Prevnar into light thigh.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: 7cm x 7cm erythmic, nontender area around injection site. Left thigh.
Age: 10.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Rash, Swelling
Clinical narrative: 08/18/02 @ 7:00 am awoke with rash all over and  swelling noted all over body. Went to ER @ 11:15 & received injection. He went again ER at night.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local reaction- warmth/erythema induration (mild cellulitis) @ site of injection on left thigh , no systematic sxs, no lymphadenenetes
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Rash erythematous
Clinical narrative: Telephone call from pt's mom; states that left thigh is red slightly swollen. Denies fever. State that child has been fussy.
Age: 4.6
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 12 hours after receiving the MMR vaccine she developed a large red hard knot on R leg. Had previous type of reaction at 18 mos. of age when 1st MMR was given. The reaction with 1st MMR was more severe in the fact that she had some necrosis in injection site that had ruptured a few days before a surgeon was to cut out the dead tissue. Right now is stable.
Age: 4.8
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: L arm-swelling, red, hot, tender 1/3 length of arm upper.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Face oedema, Pruritus
Clinical narrative: On 8/26/02, pt reported adverse  rxn following 7/23/02 HBV #1 injection. Was seen at hospital ER for "anaphylactic reaction: lips were swollen, turned almost inside out; throat itching and felt like it was closing; given 2 shots."  "No food eaten that night cause a problem."
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Pt notified provider that she was in the ER experiencing shortness of breath, lightheadedness and rapid pulse. Friend in the ER found BP to be elevated. Symptoms began roughly 3-4 hours post immunization. Pt was seen in the ER and reportedly received a steroid injection, Benadryl and was sent home.
Age: 2.8
Sex: M
Vaccine: VARCEL
Symptoms: Muscle twitching, Pyrexia, Tremor
Clinical narrative: Temperature of 102.3. Head started shaking jerking his arms (twitch for about an hour). Acted 'dopey and out of it' for an hour or so. Mother states child has made a complete recovery.
Age: 2.3
Sex: M
Vaccine: VARCEL
Symptoms: Facial palsy
Clinical narrative: Mother reports the morning after receiving varicella vaccine her child could not move the right side of his face. Seen by MD who diagnosed with Bell's palsy. Put on Pediatred et (x5 days) and Ceftin (x10 days). NO improvement by 8/12/02. To get MRI of head 8/14/02.