chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications or vaccinations. The subject had not experienced drug reactions in the past. The subject's medical history included febrile seizure and reactive airway disease. on 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm). On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injections site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch. The subject had no range of motion problems and was playing and acting fine with no fever. The subject had not received treatment, but was seen at the doctor's office. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications or vaccinations. The subject had not experienced drug reactions in the past. The subject's medical history included febrile seizure and reactive airway disease. on 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm). On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injections site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch. The subject had no range of motion problems and was playing and acting fine with no fever. The subject had not received treatment, but was seen at the doctor's office. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications or vaccinations. The subject had not experienced drug reactions in the past. The subject's medical history included febrile seizure and reactive airway disease. on 12 May 2009 at 10:00 the subject received unspecified dose of KINRIX (0.5 ml, unknown route, left arm). On 12 May 2009, less than one day after vaccination with KINRIX, the subject experienced arm discomfort at injection site; he complained of his arm bothering him at the injections site. On 14 May 2009, approximately 48 hours after vaccination with KINRIX, the subject experienced injection site reaction with swelling of arm to twice the size of his other arm from his elbow to shoulder, and redness, which was described as "more pink than red" and warm to touch. The subject had no range of motion problems and was playing and acting fine with no fever. The subject had not received treatment, but was seen at the doctor's office. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Nausea, Wheezing
Clinical narrative: Patient developed myalgias in the neck and back within 24 hours of administration of Td booster.  Also had some nausea and some wheezing starting approx 36 hours after the Td booster. Treated with Xopenex inhaler, benadryl, and ibuprofen at home; given a prednisone oral burst 20mg/day x 5 days 2 days after Td was administered.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with unspecified drug reactions/allergies and medical history who on 13-FEB-2009 was vaccinated IM with 0.5ml first dose of GARDASIL (lot number:661531/1311X) and second dose on 6-APR-2009 (Lot number 661952/1129X). Concomitant therapy included hormonal contraceptives (unspecified) and Adderall. Laboratory test were not performed. The nurse practitioner stated the patient received the second dose of the vaccine and experienced swollen glands on the left side of the neck. On 30-APR-2009, the patient went to see her primary care physician with neck pain and then a chiropractor. Subsequently on 6-MAY-2009, the patient came to see the nurse practitioner and she felt that intervention to prevent serious criteria was referring the patient to an ENT physician (Ears, nose, throat physician) to determine if a biopsy was needed. The outcome of the patient was not recovered and she sought medical attention by nurse and physician's office. Additional Information has been requested.  6/2/09 Medical records received DOS 2/13/09 to 5/27/09. FINAL DIAGNOSIS: Lymphadenopathy. Post vaccination reports feeling tired, sits with head turned to left, neck pain. Took several doses of Advil followed by nausea and vomiting. Headaches. Tenderness left lateral neck, palpable lymph node. Later several swollen glands. Chiropractic adjustments. Vaginal discharge. Vaginitis. Vaginal dryness.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Myocardial infarction, Pneumonia
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old male with hypertension, cancer, diabetes and a history of heart attack who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 657525/0554U) IM, 0.5ml. Concomitant therapy included fentanyl, COMBIVENT, PLAVIX, insulin, LASIX, PRILOSEC, FLOMAX, IMDUR, antineoplastic (unspecified), RANEXA, metoprolol, OS-CAL and vitamin D (unspecified). On 05-MAY-2009 the patient experienced heart attack and was hospitalized. While at the hospital he was found to have pneumonia. The pneumonia was not diagnosed immediately so the patient now has difficulty breathing. The patient's wife reported that the patient did many tests at the hospital but the pharmacist did not know which ones. The patient had just been released from the hospital by the report time. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Haematochezia, Mucous stools, Nasopharyngitis
Clinical narrative: Information has been received from a physician concerning a 9 week old male with no pertinent medical history reported who on 13-MAY-2009 was vaccinated orally with first dose of ROTATEQ (dose and lot number not provided). Secondary suspect therapy included RECOMBIVAX (manufacturer unknown), PENTACEL and PREVENAR. The physician reported that the patient's mother brought the patient to the office because he had been having "stool with blood and stringy mucous in it for the past three weeks" (also reported as 22-MAY-2009). The mother also reported that the patient was recovering from a cold. The patient sought unspecified medical attention. Upon internal review stool with blood was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Grand mal convulsion, Rash generalised
Clinical narrative: We received from a consumer the following information on 14 May 2009: A female patient was vaccinated with Influenza virus vaccine (batch no. or manufacturer unknown) in Nov 2007. In November 2007 she experienced two grand mal seizures. On 07 Nov 2007 she was placed on Tegretol to treat the seizures. In 2007 the patient also experienced a rash all over her body. In Jan 2009 she was switched to Tegretol XR and the event continued (unclear which of both events continued). No further information had been provided. Company assessment : Serious criterion: medically significant. Causality: Insufficient data. The amount of data is not sufficient to finally assess causality. Expectedness assessment according to product information: Grand mal seizure is unexpected, rash all over the body is expected after vaccination with Fluvirin, Begrivac, Agrippal, or Fluad. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. Ref no:NA09-001601. On 01 JUN 2009 we received the following information: Made several unsuccessful attempts to contact the reporter to obtain additional information. On 02 JUN 2009 we received the following information: Due to an internal mistake we have to correct the initial receive date from 14 MAY 2009 to 13 MAY 2009. We received the following information from a physician on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). A 19-year-old woman was vaccinated with influenza virus vaccine (batch no. and manufacturer unknown) in NOV 2007. On 02 JUN 2009 we received the same information as on 13 MAY 2009 (due to an internal oversight identified only on 17 JUN 2009). Other no.: PHEH2009US. Other no.: S2009US.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Administered ZOSTAVAX vaccine 5/20/09 at 9:30am. Reported she awoke next am with generalized hives over body including buttocks and scalp. No swelling or difficulty breathing. Took BENADRYL. Hives faded, nearly resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/9/09 went to ED with swelling to right leg. Red and warm to touch.
Age: 0.2
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hot, firm area on Rt deltoid approx 2min wide running 1/2 to elbow. Parent reports started 1 after administration vaccine. Mother plans PMD visit.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: Rash on back, abdomen, arms, face after vaccine (24 hours) no high fever. Mother plans PMD visit due to current ear infection also.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash generalised, Urticaria
Clinical narrative: Chief Complaint (1/1): This 12 month old female presents today for evaluation of a rash. Rash-Associated Signs and Symptoms: The following characteristics of the rash are noted. Location first noted: shot site, spread to right foot then right hand and then right eye and started 1 days. Sx associated signs and symptoms: Associated signs and symptoms include Received Hep A and PREVNAR on 5-22-09 in right thigh. Woke morning of 5-23-09 with swelling and redness at shot site. On the afternoon of 5-23-09 she had swelling and hives of right foot followed by hives and swelling of right hand. Shortly after had swelling of right eye. Gave BENADRYL after our pc yesterday. Last dose before bed. Rash gone this morning. No changes or new foods. Pt was accompanied by her mother and father. Seen after posted regular office hours at 9:24 AM.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Head injury, Heart rate normal, Syncope
Clinical narrative: 2:10 fainted after vaccination and bumped head on floor. Monitored for 50 minutes. Sent home with mom to monitor s/s concussion. BP 94/60, P 72
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Chest pain, Folliculitis, Herpes zoster, Rash
Clinical narrative: Right thorax- rash and pain. Treated with BACRIM DS initially and changed to Acyclovir treated x 1 week. Treatment started 4/09- 4/24/09. Folliculitus / Herpes zoster.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on right thorax returned after 2nd Hep. B vaccine - came to clinic on 5/7/09 - 'Shingles'. Treated with ACYCLOVIR X 3 weeks- 5/22/09 still symptomatic - Also given BACTRIM DS to follow up next week.
Age: 10.0
Sex: F
Vaccine: VARCEL
Clinical narrative: Received VARIVAX 5-21-09, seen in office 5/23/09 arm, red, warm to touch for 2 days. 15 x 14 cm erythemas with 4 x 6 cm central induration and 5-6 2 mm papula.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: On 5/18/09 given VARIVAX, developed erythema with 3 mm central papule vesicle seen on 5/21/09.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Rash at injection site
Age: 56.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Burning sensation, Cold sweat, Dizziness, Dysstasia, Headache
Clinical narrative: Approximate 4 minutes after receiving vaccines; I started getting dizzy, nauseated, cold sweat, and a headache.  There was a burning in my arm going up to my head right after the vaccine was giving for the HEP A  While at counter at the pharmacies, I had to support myself on the counter as I was having a hard time standing up.  I then left the pharmacies, and ended up on a bench outside with my head between my legs on a bench until security asked if I was OK.  Do not know how long that was.  Believe it was the HEP A (HAV) the caused the problem as a co-worker had similar but worst problem and was treated at hospital. I then tried to drive home, but was unable to drive and pull over for 15 more minutes. I then ate some food and made it home.
Age: 56.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Nausea
Clinical narrative: Approximate 4 minutes after receiving vaccines; I started getting dizzy, nauseated, cold sweat, and a headache.  There was a burning in my arm going up to my head right after the vaccine was giving for the HEP A  While at counter at the pharmacies, I had to support myself on the counter as I was having a hard time standing up.  I then left the pharmacies, and ended up on a bench outside with my head between my legs on a bench until security asked if I was OK.  Do not know how long that was.  Believe it was the HEP A (HAV) the caused the problem as a co-worker had similar but worst problem and was treated at hospital. I then tried to drive home, but was unable to drive and pull over for 15 more minutes. I then ate some food and made it home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4 inch circular redness with warmth. no s/s infection. supportive care : compresses and motrin prn.
Age: 23.0
Sex: M
Vaccine: HEP, MMR, MNQ, PPV, TDAP, UNK, VARCEL
Symptoms: Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Patient states that he had vaccinations administered on Tuesday and wednesday afternoon around 1:30 p.m. he began having fever and chills. He also had body aches on Thursday, with some residual body aches today. Patient was febrile on Wednesday and Thursday, with fever resolving itself on Friday morning. Patient also has erythemia to posterior side of left upper arm. According to consent, the vaccinations administered in this region were MMR and PPV23. Patient has no swelling to any other areas of arms. Patient has had no anti-biotics therapy, but has been taking Alieve for fever and body aches.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Approximate 2 minutes after receiving vaccines:  I passed out. Right after I woke up I started throwing up and the Rn clinic was unable to stop it and they transfer me the emergency Room.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Eye movement disorder, Feeling hot, Paraesthesia
Clinical narrative: A few minutes after I got the 1st shot, body felt warm and tingly. Then I had a small seizure according to the tech, but did not lose consciousness. The whole incident was less than 10 secs. He said my eye movement rapid. 9 days later, felt the same previous symptoms, but did not have a seizure.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: tdap booster given approx 10 am on 5/27/09 r del im. spoke with pt on 5/29 and she reports on 5/28/09 she awoke with headache and chills took temp was 99.9 then later in day temp 100.3. pt reports on 5/29/09 sx resolved but was adamant shot was culprit since she hadn't beensick in years,informed her vaers would be filled out.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Full blood count, Streptococcal identification test, Upper respiratory tract infection, Vomiting
Clinical narrative: TEMP103LN,VOMITING,URI.sYMPTOMS STARTED IN THE PM AFTER SHOTS.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Woke early AM 5/19/09 with frequent vomiting and fever.  Frequent vomiting lasted until 0700, then final, isolated emesis at 1700.  Temp max 103.  Fever and fatigue continued 5/20.  Did not go to school 5/19-5/20.  Felt better 5/21- no fever, returned to school.  Only symptomatic care given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Malaise, Nausea, Vomiting
Clinical narrative: 5/28, mother called and reported that Kahlyndra c/o not feeling well approximately 2 hours after vaccine administration. Following am c/o nausea, and vomited x4 hrs, temp 101. Advised to see a physician if no improvement after 12 hrs. 5/29, mother states she took her to the dr, and he could not find any reason for symptoms, possible virus, no evidence vaccine related. Child is recovered.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: Pt went to a pharmacy clinic to receive Zostavax. Pt is s/p renal transplant and on chronic immunosuppression.  Screening questionnaire used was downloaded from your (CDC) site per pharmacist on later inquiry by me. Immunosuppression is addressed but transplant is not specifically mentioned.  THE PATIENT DOES NOT READ OR WRITE (unknown by pharmacist). The patient was immunized. Fortunately, there was no adverse reaction. (Specific date and time of vaccination are not known by me; did try to obtain from pharmacist. Pt unsure and family was not aware.)I am basically reporting in hopes of getting you to change your screening form to specifically mention transplant as a contraindication. Many health care providers and patients call us to ask if transplant patients can be vaccinated. This gentleman could have had a much worse outcome. Not all patients make the connection between immunosuppression and transplant.  Pharmacist was not particularly concerned; I called him at the request of the patient's primary care provider who I had alerted to the situation.  He also thought the pharmacy might change the form.  After alerting our pharmacies of the situation, we have changed our screening form to specifically mention transplant.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site induration, Injection site pain
Clinical narrative: 1-2-09 Tdap administered R deltoid.  1-9-09 Soreness reported to Employee Health Nurse. 2-27-09 - Appointment scheduled due to report of persistent pain at injection site.  MD evaluation describes induration that is palpable.  Dx of chronic inflammation - advised to take Ibuprofen consistently. 3-20-09 Reports that the soreness persists.  No further phone contact from Employee Health - no further contact from the employee to today's date.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, White blood cell count increased
Clinical narrative: within 24 hrs after vaccination, arm became red, swollen, and painful. admitted to hospital 48 hrs after vaccine receive, and treated for cellulitis of arm. 6/8/09 MR received for DOS 5/13-15/2009 with D/C DX;  Cellulitis; right upper arm.. HTN-good control.  S/P small intestine resection due to ruptured diverticulum with peritonitis-improved. Diverticulosis. Pt presented back to hospital after recent surgery with c/o sore and inflamed R upper arm.  T=100.6'F. Dx with cellulitis and admitted for IV abx which improved.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Increased upper airway secretion, Lethargy, Malaise
Clinical narrative: Hep B #1 adm. 2:30pm,Fri.22 May 2009.  3 days later 2am woke up with difficulty breathing, productive cough with green phlegm, no fever.  All day (3rd day-Monday) felt lethargic, decreased energy and sick.  Used albuterol inhaler of mother's at 1pm on 3rd day(Monday).Had shortness of breath all day through Wednesday.Today, Friday, has productive cough.Came in today for TB test and MMR (both given)
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Tuberculin test
Clinical narrative: Hep B #1 adm. 2:30pm,Fri.22 May 2009.  3 days later 2am woke up with difficulty breathing, productive cough with green phlegm, no fever.  All day (3rd day-Monday) felt lethargic, decreased energy and sick.  Used albuterol inhaler of mother's at 1pm on 3rd day(Monday).Had shortness of breath all day through Wednesday.Today, Friday, has productive cough.Came in today for TB test and MMR (both given)
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Induration, Local reaction, Skin warm, Urticaria
Clinical narrative: localized reaction distal to injection site(whihc was on right deltoid) extending about 6 cm with induration to inner bicep.  Has minimal warmth, not too suspicious for cellulitis, looked to be hypersensitivity reaction with localized wheal/hive formation.  Covering for infection due to appearance though.  Xyzal 5 mg daily also.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Has fever, generalized body aches and chills. Reports that they do not have a thermometer so have not been able to take a temperature. Some localized redness at site of vaccine without swelling or significant pain. "She has not been able to get out of bed".
Age: 4.0
Sex: M
Vaccine: DPP, HBHEPB, MMR, OPV
Symptoms: Abnormal behaviour, Autism, Condition aggravated, Disturbance in attention, Excessive masturbation
Clinical narrative: August 18, 1991. "Hold up four fingers. That's right, you're four years old!" On patient's birthday he was coming down with a cold. August 19, 1991. On his day-after-birthday, patient received his four-year immunizations. He was sick. The doctor noted that patient had "no eye contact," was "known to have autism," and was "screaming all the time." Patient received three vaccines: for oral polio; diphtheria, tetanus, and pertussis; and measles, mumps, and rubella. One month later, at the request of the school, patient received his Haemophilus b conjugate vaccine. August 25, 1991. Patient began the regular fall semester of his Early Childhood Intervention program. "He reentered the Early Learning Program," I wrote in a letter to a friend, "and met all of his first year developmental goals within a month. His teachers are astounded. So are we." September 6, 1991. Which therapy was helping patient? I said vitamins; another said light. Careful to keep our disagreement from spilling over to patient, I wrote to Dr. for advice. He suggested that we try one therapy at a time and observe the results. We took patient off B6 and DMG. "By the third week in September," I wrote in my diary, "Patient was 100% un-potty trained and was using no language except 'eee-Up!' He was masturbating like mad." All systems were failing: potty training, language, attention span. November 5, 1991. I wrote, "Attempts to replicate last summer's light therapy results have not been successful We charted patient's behavior in potty training, masturbation, commands, eye contact, socialization, and use of language. After more than two weeks, there was no clear improvement in his behavior on the light therapy compared to baseline behavior in the categories we charted." Patient had cratered. We put him back on vitamin B6 and DMG. From a twenty-first century perspective, it's tempting to conclude that patient's four-year vaccinations were at least partially responsible for his regression. But in 1991, vaccines were not suspected as a trigger for autism. Because patient's regression didn't occur immediately after the shots, we didn't suspect a link. All we knew was that we were at the bottom of the crater, and patient wasn't responding to the B6 and DMG either. We were stuck.  6/4/09 Received medical records from parent reporter for 12/18/90-8/19/1991. FINAL DX: autism, mental retardation & Soto's syndrome Records reveal patient had delayed speech & language development & fine motor skills w/intermittent periods of regression.  Exam revealed only fleeting eye contact, no speech, repetitive play & self stimulation 6/17/10 Follow up: Inflammatory Goual disease, possible autistic enterocolitis and autism.
Age: 4.0
Sex: M
Vaccine: DPP, HBHEPB, MMR, OPV
Symptoms: Screaming, Social avoidant behaviour, Speech disorder developmental
Clinical narrative: August 18, 1991. "Hold up four fingers. That's right, you're four years old!" On patient's birthday he was coming down with a cold. August 19, 1991. On his day-after-birthday, patient received his four-year immunizations. He was sick. The doctor noted that patient had "no eye contact," was "known to have autism," and was "screaming all the time." Patient received three vaccines: for oral polio; diphtheria, tetanus, and pertussis; and measles, mumps, and rubella. One month later, at the request of the school, patient received his Haemophilus b conjugate vaccine. August 25, 1991. Patient began the regular fall semester of his Early Childhood Intervention program. "He reentered the Early Learning Program," I wrote in a letter to a friend, "and met all of his first year developmental goals within a month. His teachers are astounded. So are we." September 6, 1991. Which therapy was helping patient? I said vitamins; another said light. Careful to keep our disagreement from spilling over to patient, I wrote to Dr. for advice. He suggested that we try one therapy at a time and observe the results. We took patient off B6 and DMG. "By the third week in September," I wrote in my diary, "Patient was 100% un-potty trained and was using no language except 'eee-Up!' He was masturbating like mad." All systems were failing: potty training, language, attention span. November 5, 1991. I wrote, "Attempts to replicate last summer's light therapy results have not been successful We charted patient's behavior in potty training, masturbation, commands, eye contact, socialization, and use of language. After more than two weeks, there was no clear improvement in his behavior on the light therapy compared to baseline behavior in the categories we charted." Patient had cratered. We put him back on vitamin B6 and DMG. From a twenty-first century perspective, it's tempting to conclude that patient's four-year vaccinations were at least partially responsible for his regression. But in 1991, vaccines were not suspected as a trigger for autism. Because patient's regression didn't occur immediately after the shots, we didn't suspect a link. All we knew was that we were at the bottom of the crater, and patient wasn't responding to the B6 and DMG either. We were stuck.  6/4/09 Received medical records from parent reporter for 12/18/90-8/19/1991. FINAL DX: autism, mental retardation & Soto's syndrome Records reveal patient had delayed speech & language development & fine motor skills w/intermittent periods of regression.  Exam revealed only fleeting eye contact, no speech, repetitive play & self stimulation 6/17/10 Follow up: Inflammatory Goual disease, possible autistic enterocolitis and autism.
Age: 50.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash macular, Rash papular, Rash rubelliform
Clinical narrative: Pt presented 13 days s/p vaccination of MMR, TDaP & Varicella w/ rubella type rash; pink macular papular rash involving face, UE's & torso; Pt also w/ low grade fever (subjective).  Symptoms started last PM.  Tx'd w/ benadryl, zyrtec & tylenol only at this point.  Expect resolution in the next 3-4 days.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash on trunk 26 days after Immunization administration, rash non tender, pre eval.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cough, Dysphonia, Dyspnoea, Heart rate normal, Oxygen saturation normal
Clinical narrative: Patient received vaccines at 12:00 at 14:45 became hoarse and felt like he was having difficulty breathing, also mild cough. Developed flat, red rash on cheeks, arms and legs. Received BENADRYL (375mg) and 15 mg PREDNISONE in office with improvement in symptoms. No wheezing on exam, no facial swelling sent home with BENADRYL q 4-6 x 24 hours and PREDNISONE 15mg 131b x 3 days. 02 sat= 96%  BP= 112/65; HR- 60.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash erythematous
Clinical narrative: Patient received vaccines at 12:00 at 14:45 became hoarse and felt like he was having difficulty breathing, also mild cough. Developed flat, red rash on cheeks, arms and legs. Received BENADRYL (375mg) and 15 mg PREDNISONE in office with improvement in symptoms. No wheezing on exam, no facial swelling sent home with BENADRYL q 4-6 x 24 hours and PREDNISONE 15mg 131b x 3 days. 02 sat= 96%  BP= 112/65; HR- 60.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Condition aggravated, Decreased appetite, Erythema, Lethargy, Rash
Clinical narrative: Pt had been lethargic, decreased appetite. Bright red rash on cheeks and face. Rash on legs, had slight rash prior to administration on legs now more red and spreading.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Received MMR and VARIVAX vaccine 4/3/09. Missed period 4/17/09, did not know was pregnant at time.
Age: 36.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Large, red area on arm;  Warm to touch.  Swollen (1.5X10 cms).  Placed on MEDROL DOS-PAK.  Dx: Localized allergic reaction.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: 2 days after, redness 2-3 " down arm, warm to touch. Ached. 0 Fever. 3rd day stinging, less redness.
Age: 55.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Site reaction. mild edema, tenderness, slight erythema.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: 2-2 1/2 inch area around injection site is warm, swollen and red with nodule. Painful. Difficulty raising arm and lifting arm. Recommended medical evaluation due to limited use of arm. Has used TYLENOL.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: 2-2 1/2 inch area around injection site is warm, swollen and red with nodule. Painful. Difficulty raising arm and lifting arm. Recommended medical evaluation due to limited use of arm. Has used TYLENOL.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Patient was given initial dose of Gardasil vaccine in (R) deltoid.  Almost immediately after vaccine was given she c/o dizziness & then lost consciousness.  Was sitting in a chair and was able to elevate her legs on another chair.  Regained consciousness after about 10 secs.  Transferred her to a table where she laid with legs elevated 10 min.  Provided juice to client.  Cont'd to feel shaky after 25 min. Phoned he mom who picked her up & drove her home.  B/P 110/70 HR50.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, bruising with a few hours of administration. Patient + presented with above symptoms in office 72 hours later. Temp 96.9 F.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Autoimmune disorder, Cognitive disorder
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain and joint swelling, weakness, fatigue, rashes, decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Initial medical records received on 30 April 2009 indicated that three doses of LYMERIX were administered to the subject with dates August 1999, September 1999 and August 2000.  A form completed on 23 November 2005 and signed by a podiatrist indicated that the subject had polyneuropathy secondary to LYMERIX vaccine.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Joint swelling, Nerve conduction studies abnormal, Neurological symptom, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain and joint swelling, weakness, fatigue, rashes, decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Initial medical records received on 30 April 2009 indicated that three doses of LYMERIX were administered to the subject with dates August 1999, September 1999 and August 2000.  A form completed on 23 November 2005 and signed by a podiatrist indicated that the subject had polyneuropathy secondary to LYMERIX vaccine.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Polyneuropathy, Rash, Sensory level abnormal
Clinical narrative: This case was reported via a statement of injuries received via a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain and joint swelling, weakness, fatigue, rashes, decreased activities of daily life, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX".  At the time of reporting the outcome of the events was unspecified.  Initial medical records received on 30 April 2009 indicated that three doses of LYMERIX were administered to the subject with dates August 1999, September 1999 and August 2000.  A form completed on 23 November 2005 and signed by a podiatrist indicated that the subject had polyneuropathy secondary to LYMERIX vaccine.
Age: 54.0
Sex: F
Vaccine: MMR, TD
Symptoms: Atrophy, Injected limb mobility decreased, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Patient came in clinic stating that she could no longer move her left arm. Patient had had some swelling in left arm after a Td vaccine on 12/04/07. It later progressed to left shoulder pain and now has advanced to atrophy in the left arm/shoulder.  6/8/09 Medical records received 3/27/08 to 5/7/09. Assessment: Rotator cuff tendonitis.  Cervical radiculopathy. Post vaccination patient states that there was swelling and pain at injection site in 2007. Now complains of shoulder pain, neck pain. Tenderness on palpation in cervical region, shoulder, trapezius spasm, shoulder rotation / abduction decreased, tenderness on palpation of biceps/triceps, weakness. Patient unable to afford diagnostic testing to confirm rotator cuff disorder, cervical radiculopathy.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Nervousness
Clinical narrative: Pt called on 5/26/09 c/o feeling nervousness. States that it started ~ 3 days after receiving Adacel inj. which he is still having the SX. as of appt on 5/28/09
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Feeling hot, Injection site rash, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Blotchy, red-macular rash to left thigh. Warm to touch, swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Blotchy, red-macular rash to left thigh. Warm to touch, swollen.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Vomiting
Clinical narrative: Tdap vaccine given, Patient with h/o fainting with shots, became weak, laid down, had episode of emesis, VSS, patient treated and recovered, mother was present, recovered in stable conditions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient received Subcutaneous dose of ZOSTAVAX 5/26/09. Patient returned to pharmacy 5/29/09 with questions about localized reaction to injection. Site was red, slightly raised, about 2" diameter. No pain, no itching.
Age: 19.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cyanosis, Dizziness, Hypotension, Paraesthesia, Presyncope
Clinical narrative: About 5-10 mm after immunizations were given (Hep A - Varicella - Meningococcal). Pt developed throat tingling sensation and dizziness, then collapsed. Mom note his face color was green > L. blue. Pt without AMS. Vital signs initially with low BP but with observation his BP recovered. BS was in the 70's. No systemic allergy reaction noted belief secondary to vasovagal response.
Age: 19.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Syncope, Throat irritation
Clinical narrative: About 5-10 mm after immunizations were given (Hep A - Varicella - Meningococcal). Pt developed throat tingling sensation and dizziness, then collapsed. Mom note his face color was green > L. blue. Pt without AMS. Vital signs initially with low BP but with observation his BP recovered. BS was in the 70's. No systemic allergy reaction noted belief secondary to vasovagal response.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site urticaria, Respiratory tract congestion, Urticaria
Clinical narrative: Approx 15 min after 1 mms given, child dev. hives near injection site, L leg. variable hives on trunk back & face.  Pt given diphenhydramine 10 mg in clinic.  Mother cont med after 4-6 h at home over 48 hrs, as Sx resolved.  Pt also initially had some airway congestion but no wheezing, cyonisis or other changes.  Resolved with benadryl
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hypophagia, Irritability, Pallor, Pyrexia, Rotavirus test positive
Clinical narrative: Fever 101.7 degrees F, vomiting, irritability, pallor, poor feeding, sleepy presented to ED approximately 7:30pm on 5/25/2009.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: Fever 101.7 degrees F, vomiting, irritability, pallor, poor feeding, sleepy presented to ED approximately 7:30pm on 5/25/2009.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On Tues 05/18/2009 pt told mom left upper arm hurts.  Mom noticed left arm red, swollen warm to touch.  Mom called Dr, she told mom to put heat on arm.  Mom called Wed, saw child in office gave her 1000 mg ot RECEPHIN IM (500 in each thigh).
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX;  measles and varicella virus vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX.  On an unspecified date the subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling.  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children on their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm.  Please see A0780875A, A0780876A, A0780877A, A0780878A,  A0780879A for the six additional cases reported by the nurse.  At the time of reporting the event was resolved.  The healthcare professional considered the event was probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with combined KINRIX. Previous and/or concurrent vaccination included live MMR II (strain not specified), manufacturer unspecified given on the same unspecified date as KINRIX, MMR and VARIVAX; manufacturer unspecified given on the same unspecified date as KINRIX. On an unspecified date the subject received 1st dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site). A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected. All of the children were within the four to six years age range. She stated that she gave KINRIX on one arm and MMR vaccine and VARIVAX on the other arm. Please see A0780868A, A0780876A, A0780877A, A0780878A, A0780879A and A0780880A for the six additional cases reported by the nurse. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX;  measles and varicella virus vaccine;  manufacturer unspecified given on the same unspecified dated as KINRIX.  On an unspecified date subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling and arm redness.  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she had gone to one of the children's school and was able to see a large are of swelling in the upper arm with redness.  The child denied any pain.  Please see A0780868A,  A0780875A, A0780877A, A0780878A, A0780879A, and A0780880A for the six  additional cases reported by the nurse.  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR (strain not specified); manufacturer unspecified given on the same unspecified date as KINRIX; measles and varicella virus vaccine; manufacturer unspecified given on the same unspecified date as KINRIX. On an unspecified date the subject received 1st dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site). A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected. All of the children were within the four to six years age range. She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm. Please see A0780868A, A0780875A, A0780876A, A0780878A, A0780879A and A0780880A for the six additional cases reported by the nurse. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swelling (injection site) in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR; manufacturer unspecified given on the same unspecified date as KINRIX; measles and varicella virus vaccine; manufacturer unspecified given on the same unspecified date as KINRIX. On an unspecified date the subject received 1st dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling (injection site). A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected. All of the children were within the four to six years age range. She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm. Please see A0780868A, A0780875A, A0780876A, A0780877A, A0780879A and A0780880A for the six additional cases reported by the nurse. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.