chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Mobility decreased, Tenderness
Clinical narrative: 10July08-First Anthrax  vaccination was issued in my left arm.  Two days later my arm started to swell and became red at the injection site.  This adverse reaction lasted approximately one week after getting the vaccine.  I was bed ridden for three days; however, I decided not to go to the hospital because I was already off duty for the days I was ill. 04May09- Second Anthrax vaccination was issued in my right arm.  My right arm was very sore and became red and very swollen for approximately a week and a half after the vaccine was issued.  I was unable to move it without being in extreme pain. I had to prop it up while sitting or laying down. I was unable to sleep on it or move it while walking.  I took over the counter medication to relieve some pain, but it didn't help much so I decided not to take it again.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Three days after experienced fever of 103, chills, body aches, chest pain and shortness of breath.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Headache, Pyrexia
Clinical narrative: Three days after experienced fever of 103, chills, body aches, chest pain and shortness of breath.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix normal, Urine analysis normal, Viral infection, White blood cell count normal
Clinical narrative: Three days after experienced fever of 103, chills, body aches, chest pain and shortness of breath.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Fatigue, Muscle fatigue
Clinical narrative: tightness in chest, shortness of breath, EXTREME fatigue, chronic joint pain, muscle fatigue.
Age: 35.0
Sex: F
Vaccine: HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: HAS HX OF GRAVES DISEASE SINCE 2006. UNDER TREATMENT AND MEDICATION. NEEDED IMMUNIZATIONS TO OBTAIN JOB TO DO SONOGRAMS IN HOSPITAL. GIVEN IMMUNIZATIONS AT 0900 C/O OF FEELING NUMB AND TINGLING TO LT HAND GOING UP TO LT SHOULDER WITH SLIGHT BURNING SENSATION IN BACK OF HEAD WITH NUMBNESS AND TINGLING TO BACK OF HEAD AT 09:15. PULSE TAKEN AT 64BPM. AT 9:45 C/O OF NUMBNESS TO FACE. AT 9:50 C/O NUMBNESS AND TINGLING TO BOTH ARMS AND LT LEG. AT 9:50 BOTH ARMS AND LT LEG AND BACK OF HEAD WITH NUMBNESS AND TINGLING. AT 10:05 NUMBNESS AND TINGLING STARTING TO GO AWAY. AT 10:05 SYMPTOMS GOING AWAY. AT 10:10 LEFT AS SYMPTOMS RESOLVED AND ALMOST GONE. ADVISED TO SEE DOCTOR IF SYMPTOMS WORSEN OR RETURN.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received ZOSTAVAX 4/16/09. Developed herpes zoster 4/26/09 over T9 on right.
Age: 5.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ZOSTAVAX given to 5 year old without complications. Called patients mom on 5/23/09 & 5/26/09
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Computerised tomogram normal, Grand mal convulsion, White blood cell count normal
Clinical narrative: Fever, Tmax 103.8.  Multiple tonic / clonic seizures in 1st 24hrs after vaccine admin. (currently 5). ER: CT+LP.  Still febrile lasts  seizure 1030 am 5/27/09.
Age: 24.0
Sex: M
Vaccine: HEPAB, MNQ
Symptoms: Body temperature increased, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Throat irritation
Clinical narrative: Client seen at ED on 5/11/09 for c/o scratchy throat feeling as if was swollen.Had received vaccinations that am for HepA/B and meningococcal. Was seen at Urgent Care and given EpiPen. Diagnosis at ED:Allergic reaction/dyspnea. Rx-Prednisone and Sudafed plus.Patient was discharged from ED.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Arthralgia, Asthenia, Basophil count decreased, Blood culture negative, Chills
Clinical narrative: Info reported to our clinic by patient's PCP. 4 hours after receiving vaccines pt reports fever of 102 with rigors and sweats. Later that evening, she developed black papular lesions near vaginal introitus. 3 days later, she continued to report fever of 102F, and arthralgia. Had a localized red area on the arm where vaccines given. Gyn MD unroofed lesion which had a black necrotic center and sent specimen to  pathology. May 26th, pt reported to this RN that she still felt generally weak, but was without fever and lesions were healing.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Eosinophil count, Herpes simplex serology negative, Hyperhidrosis, Injection site erythema, Lymphocyte count decreased
Clinical narrative: Info reported to our clinic by patient's PCP. 4 hours after receiving vaccines pt reports fever of 102 with rigors and sweats. Later that evening, she developed black papular lesions near vaginal introitus. 3 days later, she continued to report fever of 102F, and arthralgia. Had a localized red area on the arm where vaccines given. Gyn MD unroofed lesion which had a black necrotic center and sent specimen to  pathology. May 26th, pt reported to this RN that she still felt generally weak, but was without fever and lesions were healing.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Monocyte count increased, Necrosis, Neutrophil count increased, Platelet count normal, Pyrexia
Clinical narrative: Info reported to our clinic by patient's PCP. 4 hours after receiving vaccines pt reports fever of 102 with rigors and sweats. Later that evening, she developed black papular lesions near vaginal introitus. 3 days later, she continued to report fever of 102F, and arthralgia. Had a localized red area on the arm where vaccines given. Gyn MD unroofed lesion which had a black necrotic center and sent specimen to  pathology. May 26th, pt reported to this RN that she still felt generally weak, but was without fever and lesions were healing.
Age: 42.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Rash papular, Red blood cell count normal, Skin discolouration, Urine analysis normal, White blood cell count increased
Clinical narrative: Info reported to our clinic by patient's PCP. 4 hours after receiving vaccines pt reports fever of 102 with rigors and sweats. Later that evening, she developed black papular lesions near vaginal introitus. 3 days later, she continued to report fever of 102F, and arthralgia. Had a localized red area on the arm where vaccines given. Gyn MD unroofed lesion which had a black necrotic center and sent specimen to  pathology. May 26th, pt reported to this RN that she still felt generally weak, but was without fever and lesions were healing.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: 48 hours after vaccine administration the patient reported experiencing some fever, chills, and muscle pain at site of injection.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Called on 5/25 to report severe muscle pain in left arm with limited ROM. Pain started after 2nd dose of Twinrix 5/4/09 but became worse after 3rd dose and was still severe one week after receving er doses. States pain and movemnet improved after OTC Motrin and Benadryl
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Generalized varicella-like rash, greater than 50 lesions on face, neck, trunk, arms, buttocks, and legs
Age: 68.0
Sex: U
Vaccine: PPV, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Unintentionally gave expired Pneumovax dated 04/02/2009 Lot#0963U on 5/26/09
Age: 52.0
Sex: M
Vaccine: JEV
Symptoms: Oedema peripheral
Clinical narrative: pt left hand and forearm had slight swelling
Age: 28.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Joint range of motion decreased
Clinical narrative: paresthesias of bilateral feet and lower legs, bilat forearms, R hand and inability to fully extend R index finger; started the morning after the vaccine; states she also feels weak; advised observation. 5/29/09 Medical records received DOS 5/27/09. PRIMARY DIAGNOSIS: Vaccines Allergic Reaction Post Vaccination - Woke up next morning with tingling in right hand, bilateral legs from knees down, and bilateral forearms. Arms and legs weak, difficult to walk. Finger nails are tender. Pain in index finger - cannot straighten. Substernal chest soreness.
Age: 3.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Anorexia, Body temperature increased, Cough, Immune system disorder, Listless
Clinical narrative: Fever over 103 F 12 hours later lasting for 4 days with no appetite, listless and not very responsive, would only take some water. Followed by 2 days of l01 F eating 1/4 of her normal intake but taking lots of liquids.The child is still ill, with temp of 100, caughing and runny nose.  She appears to have caught a cold/flu on the 25th possibly due to lowered immune system. Child was given regular doses of Motrin to help lower her temperatureand liquids whenever she would consume them.
Age: 3.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pyrexia, Rhinorrhoea, Unresponsive to stimuli
Clinical narrative: Fever over 103 F 12 hours later lasting for 4 days with no appetite, listless and not very responsive, would only take some water. Followed by 2 days of l01 F eating 1/4 of her normal intake but taking lots of liquids.The child is still ill, with temp of 100, caughing and runny nose.  She appears to have caught a cold/flu on the 25th possibly due to lowered immune system. Child was given regular doses of Motrin to help lower her temperatureand liquids whenever she would consume them.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea
Clinical narrative: Temperature 101-103 approximately 24 hrs. post vaccination and loose stools - presented in clinic - no other symptoms.
Age: 19.0
Sex: M
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Hep A given- immediately after patient received vaccine he fainted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Patient developed hives about 22 hours after receiving 4yr boosters- DTap, IPV, MMR and VZV. No previous reaction, no respiratory or GI symptoms. Hives were treated with BENADRYL in the beginning. Hives started to subside 5/25, but are still present today.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received DTAP, HIB + HEP A ~ 5-11-09. Patient noticed redness + swelling at injection site ~ 24 hours after vaccination (5-12-09). Left thigh ~ 7 1/2 X 3 1/2 in. Patient here in office for eval of reaction.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient came to office 5-26-09 + reported she had warmth + redness to injection site 5-20-2009 which resolved; then on 5-22-2009 she began to have shoulder pain radiating down arm to elbow; she has also been picking strawberries + cherries.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 1st Hep A vaccination 2/20/09 - only 2 mo - Between 1st and 2nd dose -should be 6 mo.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Cough, Injection site pruritus
Clinical narrative: Patient c/o itching at the site, 5min later started coughing. Mom stated he was having an asthma attack, but did not have inhaler. Dr. notified and nebulizer treatment started with pulse ox.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash at injection site right deltoid (1) day after injection was given.  Seen by Dr. 2 day after c/o rash and itching BENADRYL was prescribed by Dr.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event.  Mis administration of TDAP.  Pt is 9 yrs old - should of been TD.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of joint pain in an adult female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  On an unspecified date the subject received unspecified dose of BOOSTRIX (details unknown).  At an unspecified time after vaccination with BOOSTRIX, the subject experienced joint pain.  The subject was seen by her primary care physician.  At the time of reporting the outcome of the event was unspecified.  Follow-up received from reporting healthcare professional on 22 May 2009: The subject was 28-years-old.  The subject's alcohol use was social and she was a non-smoker.  Past medical history included migraines.  Concurrent medications included Yaz, Fioricet and Prenatal vitamins (for lactation).  On 29 April 2009, the subject received a dose of BOOSTRIX (0.5 mL, intramuscular, left deltoid).  Two days after vaccination with BOOSTRIX, the subject experienced joint pain and redness at injection site.  It was reported that blood tests may have been performed for possible rheumatoid arthritis.  This case was assessed as medically serious by GSK.  The outcome of the events was unknown.  The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.  The healthcare professional considered that the events could also have been associated with medical history or a concurrent condition, and the subject's physician was performing tests for rheumatoid arthritis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: KINRIX & VARICELLA vaccine given into (R) arm 4x4 cm area of erythema and 9x7 cm area of erythema surrounding injection site to: Septra
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: DAPTACEL and VARIVAX vaccines given into (L) leg. 8 x 11 cm area of erythema and warmth on anterior (L) thigh. Septra.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac flutter, Oedema peripheral, Rash
Clinical narrative: Rash on arm next day, took BENADRYL heart flutter was noticed on Thursday (2 days later). By Friday arm was swelled went down by Sunday.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for VARIVAX, a pregnancy registry product, concerning a 15 year old female patient who on 15-JUL-2008 was vaccinated with a dose of VARIVAX (lot #659844/0085X) when she was pregnant. That same day, she was vaccinated with hepatitis A virus vaccine (unspecified) and MENACTRA. On 26-AUG-2008, the patient had a urine pregnancy test done confirming the pregnancy. No adverse event was reported. The patient sought medical attention informing staff she missed her period after she was vaccinated. Follow up information received on 20-MAY-2009 from the physician stated that the patient received a dose of VARIVAX, GARDASIL, and MENACTRA at the same medical center. Two weeks after the pregnancy was confirmed the patient had an elective termination of pregnancy. At the time of reporting the patient's outcome was unknown. Upon internal review elective termination was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female with seasonal allergy and no know drug allergies who on 11-MAY-2009 was vaccinated intramuscularly in the left arm with first dose of GARDASIL (lot number 662229/1497X). Concomitant therapy included ALLEGRA and NASONEX. Within one or two days after vaccination, on approximately 12-MAY-2009, the patient experienced rash and hives on the left arm that was also pruritic. The physician believed that the patient using BENADRYL was an intervention to prevent serious criteria. As of 20-MAY-2009, the patient was recovering. The patient sought medical attention by making a phone call. The reporting physician considered the pruritic rash and hives to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female with seasonal allergy and no know drug allergies who on 11-MAY-2009 was vaccinated intramuscularly in the left arm with first dose of GARDASIL (lot number 662229/1497X). Concomitant therapy included ALLEGRA and NASONEX. Within one or two days after vaccination, on approximately 12-MAY-2009, the patient experienced rash and hives on the left arm that was also pruritic. The physician believed that the patient using BENADRYL was an intervention to prevent serious criteria. As of 20-MAY-2009, the patient was recovering. The patient sought medical attention by making a phone call. The reporting physician considered the pruritic rash and hives to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain in extremity, Paralysis, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient who received two doses of GARDASIL. The patient had no difficulties after the first dose. After the second dose the patient experienced a high fever, soreness in her arm and temporary paralysis. The patient sought medical attention through an office visit. Upon internal review, temporary paralysis was determined to be an other important medical event. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who on 17-MAR-2009 was intramuscular vaccinated with the first 0.5ml GARDASIL vaccine (Lot # 661846/1312X). The patient has no medical history. There was no concomitant medication. Approximately 6 weeks after administration, the patient developed a "seizure-like activity" and "dizziness" when she was getting out of the bathtub. She saw a neurologist and had an MRI which was negative. The patient now has occasional vertigo. The patient was considered to be recovering at the time of the report. The patient has not received any additional doses yet. Follow up information has been received from this certified medical assistant. She reported that no other vaccines were administered at the time of GARDASIL dose. She could not confirm that the patient actually had a seizure (stating that "seizure-like activity" was what was reported by the patient's mother), and could not give a more definitive AE onset date. Upon internal review, "seizure-like activity" was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Carcinoma in situ, Cervical dysplasia, Loop electrosurgical excision procedure, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female with no medical history who was vaccinated with her first (lot# 658222/0927U), second (lot# 658222/0927U) and third (lot# 659964/1978U) dose of GARDASIL on 22-AUG-2007, 08-SEP-2007 and 19-MAR-2008, respectively. On 04-MAY-2009 the patient was diagnosed with high grade squamous intraepithelial lesion carcinoma in situ after a PAP test. The patient had a LEEP Procedure done on 15-MAY-2009. The patient sought unspecified medical attention. Additional information received via telephone from a medical assistant on 19-MAY-2009. Medical assistant reported that the patient's second dose of GARDASIL was administered on 08-NOV-2007 (not 08-SEP-2007 as previous reported). There were no concomitant vaccines administered with GARDASIL vaccinations. The medical assistant confirmed that the patient had a PAP smear test on 04-MAY-2009 and had a LEEP on 15-MAY-2009. The reporter did not know the patient's recovery status. The patient did not have a scheduled follow up visit with physician at the time. The reporter considered high grade squamous intraepithelial lesion carcinoma in situ to be an other important event and disabling. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pyrexia, Throat tightness
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who experienced fever a few hours after receiving the first dose of GARDASIL. The patient received the second dose of GARDASIL on 13-MAY-2009 and after a few hours, the patient's mother called in stating that the patient felt like her throat was closing that she couldn't breathe. Lot #'s were not available. Patient was brought to the emergency room but she was not admitted in the hospital. At the time of the report the patient's AE improved. Follow-up information has been received from a nurse practitioner who stated that the patient was treated in the emergency room. The patient was treated with BENADRYL IV and fluids. The patient was not admitted to the hospital. The patient had recovered. Follow-up information received from a medical assistant at the nurse practitioner's office stated that the patient's mother called the office and reported that her daughter felt as if her throat was closing. The physician then advised that the patient be taken to the hospital. Upon internal review, felt like throat was closing and couldn't breath, requiring treatment with IV antihistamine, were considered to be other important medical events. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy breast abnormal, Breast cancer in situ, Breast mass, Breast tenderness, Mammogram abnormal
Clinical narrative: Information has been received from an investigator concerning a 35 year old female with no known drug allergies, with HIV and alcohol use who entered a study. On 16-JUL-2008 the patient was vaccinated with the first dose of GARDASIL 0.5 mL via injection. On 11-SEP-2008, she was vaccinated with the second dose of GARDASIL 0.5 mL via injection and the third dose of GARDASIL was administered on 12-JAN-2009. Concomitant therapy included Kaletra, Truvada and Loestrin. Approximate duration of use of concomitant medications was reported as 2 months. On 09-APR-2009, the patient presented to the clinic for a non-study visit with complaints of feeling a lump on her right breast for three weeks. Upon evaluation by provider, the subject was referred for a mammogram for diagnosis. The mammogram was performed on 16-APR-2009 and revealed an abnormality in the right breast that was highly suspicious for ductal carcinoma in situ. On 20-APR-2009 the patient was seen for the right breast lump and right breast tenderness. There was no nipple discharge, no axillary nodes of skin changes were noted. There was no family history of breast cancer. A biopsy was recommended by clinic provider. The biopsy was performed on 04-MAY-2009. On 07-MAY-2009 the patient received pathology results from the breast biopsy that confirmed the lump was ductal carcinoma in situ (grade 4). The patient was scheduled to visit with specialist to explore treatment options on 12-MAY-2009. Follow-up information was received in a pathology report. The patient had 1x1 cm palpable mass. On 04-MAY-2009, a right breast core needle biopsy was performed and ductal carcinoma in situ, high grade) was diagnosed. The patient's ductal carcinoma in situ (grade 4) persisted. The reporting investigator classified the event of ductal carcinoma in situ (grade 4) as possibly related to study therapy with GARDASIL. The patient's ductal carcinoma in situ (grade 4) was considered to be an other important medical event. Additional information is expected.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male family member, now 8 years old, who experienced autism after receiving vaccines at age 2. The reporter could not specify which vaccines the child received and who manufactured them. It was unknown if the patients sought medical attention. Follow-up information has been received from a registered nurse who reported that the patient was vaccinated with MMR II before developing autism. Upon internal review, autism was determined to be an other important medical event. No further information is available. This is one of several reports received from the same source.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male family member, now 10 years old, who experienced autism after receiving vaccines at age 2. The reporter could not specify which vaccines the child received and who manufactured them. It was unknown if the patients sought medical attention. Follow-up information has been received from a registered nurse who reported that the patient was vaccinated with MMR II before developing autism. Upon internal review, autism was determined to be an other important medical event. No further information is available. This is one of several reports received from the same source.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood human chorionic gonadotropin positive, Caesarean section, Drug exposure during pregnancy, Failed induction of labour, Foetal disorder
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for VARIVAX (Oka/Merck) concerning a 26 year old female with asthma who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. On 26-SEP-2008, the patient was vaccinated with a second dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. Concomitant therapy included albuterol as needed. Subsequently, on 27-OCT-2008 a serum pregnancy test was performed and the patient was determined to be pregnant (LMP was in July 2008 and estimated date of delivery is 08-MAR-2009). No problems reported. The patient went to the office. Follow up information was received from the nurse practitioner. It was reported the baby was born on 11-MAR-2009. The patient was induced for pre-eclampsia at term. The patient told the reporter she eventually had a ceasarean. The patient thought it might have been a "failed induction", but the reporter did not have specific. The reporter saw and evaluated the baby for normal newborn jaundice on day 4 (approximately 14-MAR-2009). The baby was otherwise normal and healthy, and had a normal birth weight, though the reporter couldn't recall the exact weight. Upon internal review, "failed induction" for ceasarean was determined to be an other important medical event. No further information was available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Pre-eclampsia
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for VARIVAX (Oka/Merck) concerning a 26 year old female with asthma who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. On 26-SEP-2008, the patient was vaccinated with a second dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. Concomitant therapy included albuterol as needed. Subsequently, on 27-OCT-2008 a serum pregnancy test was performed and the patient was determined to be pregnant (LMP was in July 2008 and estimated date of delivery is 08-MAR-2009). No problems reported. The patient went to the office. Follow up information was received from the nurse practitioner. It was reported the baby was born on 11-MAR-2009. The patient was induced for pre-eclampsia at term. The patient told the reporter she eventually had a ceasarean. The patient thought it might have been a "failed induction", but the reporter did not have specific. The reporter saw and evaluated the baby for normal newborn jaundice on day 4 (approximately 14-MAR-2009). The baby was otherwise normal and healthy, and had a normal birth weight, though the reporter couldn't recall the exact weight. Upon internal review, "failed induction" for ceasarean was determined to be an other important medical event. No further information was available.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old hospitalized female with pneumonia, urinary tract infection, diabetes, hypertension, coronary artery disease, dehydration and protein-C deficiency as well as no drug allergies who on 18-MAY-2009 was admitted to the hospitalization for pneumonia, urinary tract infection and dehydration. It was reported that on 19-MAY-2009 she was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (662687/0983X). Concomitant therapy included LEVAQUIN and vancomycin. She developed redness, pain, and skin blistering at the injection site on left deltoid region around 20-MAY-2009. Recurrent temperatures of 101 Fahrenheit had been recorded for this patient. The patient sought medical attention and was at the hospital. The patient was recently put on vancomycin for cellulitis prophylaxis and was recently given SOLUMEDROL. The patient had recovered. The reporter considered the adverse experiences to be other important medical events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL and MMR II, Pregnancy Registry products, concerning a female patient with no known drug allergies who on 11-FEB-2009 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X), 0.5 mL, intramuscular administration. Concomitant therapy administered on 11-FEB-2009 included MMR II (lot # 662817/1366X) albumin status rHA, and Tdap (unspecified). It was reported that the patient was pregnant. LMP was in January 2009, EDD was 08-OCT-2009. No adverse effect was reported. The patient sought medical attention at the physician's office. Follow up information was received from a licensed practical nurse. She reported that the patient received the GARDASIL, MMR II and Tdap (manufacturer unknown) early in her pregnancy. The licensed practical nurse stated that this patient had her pregnancy confirmed at the health department (urine hCG test) and after a few weeks, she called to report that she had a miscarriage (specific date not provided). The licensed practical nurse reported she requested that the patient come in for follow up, but she had not seen or heard from her since the phone call. Upon internal review miscarriage was determined to be an other important medical event. No further information is available. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria/Hives neck back, abdomen arms and leg started 5/21/09 in the evening.  Treated with Zyrtec X 7 days.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: L. arm "PPD" testing using ANTHRAX Vaccine - 5m experienced area of erythema 3' X 2 1/2: with 1 cm central induration. Tender, not hot - Resolved.  ANTHRAX Vaccine inadvertently given subdermal as PPD test. Incident reported immediately.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. HPV vaccine ordered by physician and nurse administered it. The child was 5 yrs old and the vaccine should not have been given, as it is indicated for females 9 and over
Age: 1.5
Sex: F
Vaccine: FLUX, PNC
Symptoms: Injection site rash, Rash papular
Clinical narrative: Papular (raised) rash in crops over the antero-medical aspect of left thigh no erythema.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Reaction at  Inj site.  Red itchy rash.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: erythematous patch over the vaccine site left upper arm - lateral posterior aspect no warmth; no tenderness; full range of motion
Sex: M
Vaccine: DTAP, DTAP, DTAPH
Symptoms: Vaccination failure
Clinical narrative: Would consider this a vaccine failure for him to be fully immunized and get pertussis at age 7
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccine was administered to left deltoid on Tuesday May 26, 2009.  Came to office today to show me his left arm which was reddened around the entire arm at the deltoid area and warm to touch. Arm was not hard.  No other symptoms. Suggested physician visit however patient is unsure as to whether he will seek.
Age: 19.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Quarter-sized area of enduration 2-4 inches above right elbow.  Nickel-sized area of enduration 2-4 inches above left elbow.  Slight erythema to both arms.  Patient states slight tenderness to left arm.      5/26/2009--telephone call to patient.  Patient not at home.  Dad states patient has recovered.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Lymphadenopathy, Pain, Rash
Clinical narrative: Member had  small pox vaccine on the 17th of May. He returned for follow up on the 26th. His skin reaction showed local redness and white blister. He also had body aches and lymphadenopathy. On the 27th he returned complaining of a rash on the upper trunk. He stated it did not itch. He also stated his systemic symptoms had resolved.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Skin reaction
Clinical narrative: Member had  small pox vaccine on the 17th of May. He returned for follow up on the 26th. His skin reaction showed local redness and white blister. He also had body aches and lymphadenopathy. On the 27th he returned complaining of a rash on the upper trunk. He stated it did not itch. He also stated his systemic symptoms had resolved.
Sex: F
Vaccine: DTAP, DTAPH
Symptoms: Pertussis, Polymerase chain reaction, Vaccination failure
Clinical narrative: This should probably be considered a vaccine failure since the child was fully immunized and was diagnosed with pertussis at age 6.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Low grade fever (not even 100) 5/26 in the evening followed by redness and swelling at the site on 5/27. Fever gone 5/28 although redness & swelling still present.  Will be followed.  IPV also given on upper outer aspect of left arm.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom noticed swelling and redness at injection site 5/27/2009. Prescribed keflex and benadryl.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash generalised
Clinical narrative: TELEPHONE CALL FROM MOTHER STATING CHILD HAD RASH ON BODY WHICH APPEAR 45 MINS POST IMMUNIZATION. CLIENT RETURNED TO CLINIC A FINE PIN POINTED RASH NOTED ON BOTH FEET UP TO ANKLES AND AROUND NECK. BABY REPONSIVE, PLAYFUL AND EXHIBITED NO OTHER SYMTOMS. BABY WAS EXAMINED BY MD. WILL RETURN TO CLINIC IN ONE WEEK FOR FOLLOW UP
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Ophthalmological examination, Visual impairment
Clinical narrative: 2nd day after receiving TdaP imm., pt. was sitting sewing at approx. 10:30am and had magnified circles in front of both eyes.  Vision was not affected.  Then the pattern went to a rainbow, zig zag pattern travelling across the line of vision.  Lasted about 15 minutes.  Pt. went to ER to be evaluated, with neg. findings.  Called her optometrist and he said it sounded like occular migraines.  It was the first and only time the pt. has had these symptoms.  Has had no further symptoms.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Rash, Sensory loss
Clinical narrative: Rash, decreased sensation and decreased strength in the left arm.  7/7/09 Hospital records received DOS 5/11/09 to 5/15/09. Assessment: Disturbed sensory perception, mononeuropathy. Patient presented with blotchy streaked erythematous left upper arm rash, raised nodule. Left arm numbness C5-T1 dermatomes. Complaints of tingling and pain. Swelling. No sensation to sharp or dull touch. Episode of chest pain and shortness of breath.  7/20/09 ICD-9 Codes: 354.9, 782.1, 346.90, 781.3, 781.2, 787.91, 723.1, 789.00, 782.0
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: patient had rash c/ second injection, but thought it was due to starting a new OTC product.  3rd immunization given, and rash reappeared.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Bursitis, Hypoaesthesia, Inflammation, Joint range of motion decreased
Clinical narrative: Tingling, numbness, pain, limited ROM and inability to perform many normal activities of daily living. Diagnosed with axillary nerve dysfunction... put on medrol dose pack... after 1 week symptoms were not improved ... placed on another medrol dose pack ... two weeks later symptoms still not improved. MRI done and then began cortisone injections related to bursitis secondary to nerve and muscle inflammation.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Tingling, numbness, pain, limited ROM and inability to perform many normal activities of daily living. Diagnosed with axillary nerve dysfunction... put on medrol dose pack... after 1 week symptoms were not improved ... placed on another medrol dose pack ... two weeks later symptoms still not improved. MRI done and then began cortisone injections related to bursitis secondary to nerve and muscle inflammation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Three vaccines given to pt, Lt leg Varicella was administered, Rt leg MMR and Kinrix administered.  Lt leg area 35cm/25cm red and swelling.  Rt leg bruising, swelling 5inx4.5in, tender to touch and painful weight bearing.  Fever with tylenol given by MOC.  MOC advised to apply cool compresses, benadryl for the reaction to go to ED if worsening condition.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Three vaccines given to pt, Lt leg Varicella was administered, Rt leg MMR and Kinrix administered.  Lt leg area 35cm/25cm red and swelling.  Rt leg bruising, swelling 5inx4.5in, tender to touch and painful weight bearing.  Fever with tylenol given by MOC.  MOC advised to apply cool compresses, benadryl for the reaction to go to ED if worsening condition.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Body temperature increased, Rash, Streptococcal identification test
Clinical narrative: Rash developed 48 hours after immunization. Low grade temp.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthma, Chills, Dyspnoea, Feeling cold
Clinical narrative: I received this second HB shot during a 9:30 am appointment on 5-20-09.  The first HB shot I received was from the same physician a month earlier on 4-20-09. I did not have an adverse reaction to this first HB shot.  I did have a reaction to the second HB shot. I began to have severe chills with body aches, aches in joints and headache at 10:30 pm on 5-22-09.  My teeth were chattering very badly, I could not get warm, my pulse felt fast and my breathing felt faster and with some difficulty.  These symptoms occurred over the Memorial Day weekend on a Friday night.  I did not want to go to the ER. I thought I might be having a bad reaction to the shot.  I took an over the counter Benedryl tablet (25 mg) and used my nebulizer with abluterol sulfate.  I have severe asthma and this seemed to help my breathing get a little easier.  The chills subsided by morning, but the body aches, headache and feeling of malaise persisted for the next two days. I do not want to get the third series in this set because I am afraid of the bad reaction.  I have to get updated immunizations for a medical training program that I am attending.  I expect that my immune system has had enough of HB.  I will ask my doctor to to a titer test if possible so I can skip the third shot of HB. In retrospect, I probably should have gone to the ER.  I was very sick and very frightened by this reaction.  The respiratory symptoms in conjunction with my asthma was not good.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Heart rate increased, Malaise, Pain, Respiratory rate increased
Clinical narrative: I received this second HB shot during a 9:30 am appointment on 5-20-09.  The first HB shot I received was from the same physician a month earlier on 4-20-09. I did not have an adverse reaction to this first HB shot.  I did have a reaction to the second HB shot. I began to have severe chills with body aches, aches in joints and headache at 10:30 pm on 5-22-09.  My teeth were chattering very badly, I could not get warm, my pulse felt fast and my breathing felt faster and with some difficulty.  These symptoms occurred over the Memorial Day weekend on a Friday night.  I did not want to go to the ER. I thought I might be having a bad reaction to the shot.  I took an over the counter Benedryl tablet (25 mg) and used my nebulizer with abluterol sulfate.  I have severe asthma and this seemed to help my breathing get a little easier.  The chills subsided by morning, but the body aches, headache and feeling of malaise persisted for the next two days. I do not want to get the third series in this set because I am afraid of the bad reaction.  I have to get updated immunizations for a medical training program that I am attending.  I expect that my immune system has had enough of HB.  I will ask my doctor to to a titer test if possible so I can skip the third shot of HB. In retrospect, I probably should have gone to the ER.  I was very sick and very frightened by this reaction.  The respiratory symptoms in conjunction with my asthma was not good.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site rash, Swelling face
Clinical narrative: Mom called stated Pt had started getting a rash to both legs, mom informed to bring back to clinic, then mom called and stated he was getting swollen to face and went to ER. Tried calling Mom no answer
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient with reddened raised area at site of VARIVAX injection. Approximately 1/2 hour after injection- seen by MD recommended ice and BENADRYL.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying, Muscle twitching, Pyrexia
Clinical narrative: Inconsolable crying with head twitching - lasted for about 30 minutes - low grade fever 1st 24 after shots.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on arm, legs + face.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: - Fever body aches, arm pain. Approx 1 in redness @ injection site. - Recommended IBUPROFEN 600 mg q 6 hrs prn. - Went to ER - 5-27-09
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypoaesthesia, Insomnia, Paraesthesia, Pyrexia
Clinical narrative: Patient complained of "high" fever several hours after injection (although did not have a thermometer). Sweating, could not sleep, numbness and tingling in both legs. Symptoms resolved in approximately 24 hours. Was patient's 2nd injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Heart rate normal, Lip swelling, Vomiting
Clinical narrative: Vomited x 1; eyes and lips became swollen and puffy after leaving office. Returned 30 minutes later; pulse 98%, BP 112/68. BENADRYL 1tsp po given in office.
Sex: U
Vaccine: PNC, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Redness- painful -  swelling (L) thigh - 3cm X 4 cm 1day post vaccination
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Eye pain, Fatigue, Optic neuritis, Visual acuity reduced
Clinical narrative: 2 days post 1st dose pt noted flashes in visual field and fatigue.  Inc in flashes after 2nd dose.  Reported dec in visual field 2-3 days post 3rd dose, Inc in flashes and severe eye pains.  Symptoms:  Pain.  Dx Optic Neuritis in 06.  7/31/09 Medical records received DOS 6/13/06 to 2/27/09. Assessment: Optic Neuritis. Quadrantanopsia, myopia, astigmatism. Ischemic optic neuropathy: optic neuropathy of unknown origin. Eye flashes, sharp pain, dull ache. Visual field loss. Visual impairment. Difficulty breathing. Upper respiratory infection. Closed fracture of talus. Viral syndrome. Patellorfemoral syndrome.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC
Symptoms: Blister
Clinical narrative: Multiple Vesicles
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Fatigue, Rash generalised
Clinical narrative: Generalized rash developed within past 3 days 5/25/09. Blisters - vesicles with fluid - fatigue.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: Deltoid muscle pain and swelling. Supra clavicular adenopathy
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pain, 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.