chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate, Staring, Stool analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Streptococcal identification test, Urine analysis, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient complaint: 64 yr old male presents with c/o having a flu and  pneumonia injections 2 weeks ago and now has soreness, redness, and skin peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin exfoliation
Clinical narrative: Patient complaint: 64 yr old male presents with c/o having a flu and  pneumonia injections 2 weeks ago and now has soreness, redness, and skin peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Erythema, Induration, Inflammation, Pain
Clinical narrative: Patient complaint: 64 yr old male presents with c/o having a flu and  pneumonia injections 2 weeks ago and now has soreness, redness, and skin peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin discolouration, Skin exfoliation, Tenderness
Clinical narrative: Patient complaint: 64 yr old male presents with c/o having a flu and  pneumonia injections 2 weeks ago and now has soreness, redness, and skin peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.
Age: 28.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Activities of daily living impaired, Arthralgia, Electromyogram, Facial palsy, Feeling cold
Clinical narrative: Administered first of six-series Anthrax immunization course on 10 DEC 2003.  Also given #1 Hep A, #1 Hep B, Typhoid and Smallpox (smallpox not documented, but Patient describes process and procedures accurately).  Approx. 4 weeks later, had sx of coldness, numbness, twitching L side of face.  Lost expression on L side of face.  Within six months, dx w/Bell's Palsy at local facility and hospitalized.  Given 2 gm Rocephin IV x approx. 6 weeks, during and post hospitalization. Sx gradually subsided, but still has occasional coldness, twitching of L side of face.  Despite dx of Bell's Palsy w/possible relationship to vaccines, was given second Anthrax immunization on 15 Sep 2004, along with #2 Hep B and #2 Hep A.  Deployed in Oct. 2004.  Beginning Oct/Nov 2004, began to experience stiffness, pain and swelling of ankles, feet, knees, hands, shoulders, elbows, lower back (sacrum).  Symptoms ebb and flow but pain and swelling in knees, wrist, hands has gradually increased in intensity to average 7/10 pain level.  Able to function fairly well with pain at 5-6/10 level, but not higher.
Age: 28.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Full blood count normal, Hypoaesthesia, Joint stiffness, Joint swelling, Laboratory test
Clinical narrative: Administered first of six-series Anthrax immunization course on 10 DEC 2003.  Also given #1 Hep A, #1 Hep B, Typhoid and Smallpox (smallpox not documented, but Patient describes process and procedures accurately).  Approx. 4 weeks later, had sx of coldness, numbness, twitching L side of face.  Lost expression on L side of face.  Within six months, dx w/Bell's Palsy at local facility and hospitalized.  Given 2 gm Rocephin IV x approx. 6 weeks, during and post hospitalization. Sx gradually subsided, but still has occasional coldness, twitching of L side of face.  Despite dx of Bell's Palsy w/possible relationship to vaccines, was given second Anthrax immunization on 15 Sep 2004, along with #2 Hep B and #2 Hep A.  Deployed in Oct. 2004.  Beginning Oct/Nov 2004, began to experience stiffness, pain and swelling of ankles, feet, knees, hands, shoulders, elbows, lower back (sacrum).  Symptoms ebb and flow but pain and swelling in knees, wrist, hands has gradually increased in intensity to average 7/10 pain level.  Able to function fairly well with pain at 5-6/10 level, but not higher.
Age: 28.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP
Symptoms: Muscle twitching, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Administered first of six-series Anthrax immunization course on 10 DEC 2003.  Also given #1 Hep A, #1 Hep B, Typhoid and Smallpox (smallpox not documented, but Patient describes process and procedures accurately).  Approx. 4 weeks later, had sx of coldness, numbness, twitching L side of face.  Lost expression on L side of face.  Within six months, dx w/Bell's Palsy at local facility and hospitalized.  Given 2 gm Rocephin IV x approx. 6 weeks, during and post hospitalization. Sx gradually subsided, but still has occasional coldness, twitching of L side of face.  Despite dx of Bell's Palsy w/possible relationship to vaccines, was given second Anthrax immunization on 15 Sep 2004, along with #2 Hep B and #2 Hep A.  Deployed in Oct. 2004.  Beginning Oct/Nov 2004, began to experience stiffness, pain and swelling of ankles, feet, knees, hands, shoulders, elbows, lower back (sacrum).  Symptoms ebb and flow but pain and swelling in knees, wrist, hands has gradually increased in intensity to average 7/10 pain level.  Able to function fairly well with pain at 5-6/10 level, but not higher.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test abnormal, Rhesus antibodies negative, Ultrasound scan
Clinical narrative: Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who became pregnant during the series of vaccinations. The patient was being seen at a different clinic for the series. The patient received her first dose "a few months ago" (date unspecified). The patient's LMP was 10-Jan-2008. The patient returned to the clinic two weeks ago for a pregnancy test and was inadvertently administered a second dose of GARDASIL. On approximately 20-MAR-2008, the patient was vaccinated with her second dose of GARDASIL (lot number unspecified). Concomitant therapy included PEDIARIX and a third vaccine (name not known at the time of report). The patient has had a urine pregnancy test that was positive and blood work completed. She also had an ultrasound performed on 26-Mar-2008 and the results are pending. The patient has not reported any difficulties thus far. Follow up information was received from a Licensed Practical Nurse who reported that the patient had not returned to her clinic, the patient received her prenatal care at another clinic. The L.P.N had gotten in contact with the patient's mother. It was reported that the pregnancy ended in spontaneous abortion at five months (approximately on 10-JUN-2008). The patient was RH negative and had not received any Rhogam in preparation for the pregnancy. The patient's doctor stated that this was the reason for the miscarriage and that it was not related to the vaccination with GARDASIL. The L.P.N indicated that the patient is pregnant again and "everything was going well with the pregnancy". No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive, Wrong drug administered
Clinical narrative: Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who became pregnant during the series of vaccinations. The patient was being seen at a different clinic for the series. The patient received her first dose "a few months ago" (date unspecified). The patient's LMP was 10-Jan-2008. The patient returned to the clinic two weeks ago for a pregnancy test and was inadvertently administered a second dose of GARDASIL. On approximately 20-MAR-2008, the patient was vaccinated with her second dose of GARDASIL (lot number unspecified). Concomitant therapy included PEDIARIX and a third vaccine (name not known at the time of report). The patient has had a urine pregnancy test that was positive and blood work completed. She also had an ultrasound performed on 26-Mar-2008 and the results are pending. The patient has not reported any difficulties thus far. Follow up information was received from a Licensed Practical Nurse who reported that the patient had not returned to her clinic, the patient received her prenatal care at another clinic. The L.P.N had gotten in contact with the patient's mother. It was reported that the pregnancy ended in spontaneous abortion at five months (approximately on 10-JUN-2008). The patient was RH negative and had not received any Rhogam in preparation for the pregnancy. The patient's doctor stated that this was the reason for the miscarriage and that it was not related to the vaccination with GARDASIL. The L.P.N indicated that the patient is pregnant again and "everything was going well with the pregnancy". No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Complication of delivery, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 17 years old female patient with no pertinent medical history and no known drug allergies/drug reactions who in June 2008 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. It was reported that the patient had not received the third dose and it has been determined to be pregnant. it was reported that on 02-FEB-2009 a prenatal ultrasound was performed and it revealed a normal pregnancy. Last menstrual period was approximately 16-JUN-2008 and the estimated delivery date was on 25-MAR-2009. The patient sought medical attention with a office visit. Follow up information from a registered nurse concerning the patient with a history of Chlamydia and no concurrent medical conditions who in June 2008 was vaccinated with the second dose of GARDASIL (lot # unknown). Date of last menstrual period was 18-JUN-2008 and estimated conception date unknown. The estimated delivery date was 25-MAR-2009. Follow up information from a registered nurse concerning the female patient who on 16-MAR-2009 delivered a normal male baby without congenital anomalies weighting 2945 gm, apgar score 6/7 (38 6/7 weeks from LMP). Complications during delivery included nuchal cord x1 (tight), and resuscitation was performed at delivery and the baby was admitted to the special care nursery for grunting. During pregnancy there were no complications, infections or illnesses, and no diagnostic tests were performed. Upon internal review, nuchal cord x1 (tight) requiring resuscitation was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Aplastic anaemia, Haematology test
Clinical narrative: Information has been received from a consumer concerning his 18 year old daughter with no pertinent medical history or no known drug allergies, who on approximately 29-AUG-2008 (reported as last week of August 2008) was vaccinated with the first dose of GARDASIL (Lot not reported). In December 2008 she received the second dose of GARDASIL (Lot not reported). There was no concomitant medication. On approximately 08-SEP-2008 (reported as the second week of September), the patient was diagnosed with aplastic anemia. She was having blood work every week and several other tests were performed. On an unspecified date, the patient stayed in the hospital for 10 days. As of 03-MAR-2009, the patient had not recovered from aplastic anemia. Additional information has been requested.  4/14/09 Received hospital medical records of 2/24-3/5/2009. FINAL DX: very severe aplastic anemia; profound pancytopenia Records reveal patient experienced progressive anemia & fever, HA, blurred vision, sore throat, epistaxis, gum bleeding, nausea, 1 episode of emesis x 1 mo.  Developed petechiae & wet purpura, tachycardia, HA.  Tx w/IV antibiotics, multiple blood & plt transfusion & immunosuppressive therapy.  Gradually improved & d/c to home on oral antibiotics, continued immunosuppresants to be f/u in clinic  4/14/09 Received PCP medical records of 2/21-2/24/2009. FINAL DX: none provided Records reveal pt had been seen in urgent care 2/21 for sore throat, fever, nausea, vomiting, fatigue, malaise.  Had been exposed to sick contacts at school.  Dx w/pharyngitis & URI.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) who was told by a patient's mother that she heard from a school staff member concerning a female child who was vaccinated with doses of GARDASIL on an unspecified date. Subsequently the patient experienced a seizure. At the time of reporting, the outcome was unknown. Upon internal review, seizures was considered to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of two reports from the same source. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her now 11 year old nephew who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed autism "from MMR II". It was reported that he was fine before the vaccine was given. Upon internal review, autism was determined to be an other important medical event. It was also reported that the patient's brother developed autism after vaccination (WAES # 0904USA00813). No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her now 12 year old nephew who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed autism "from MMR II." It was reported that he was fine before the vaccine was given. Upon internal review, autism was determined to be an other important medical event. It was also reported that the patient's brother developed autism after vaccination (WAES # 0904USA00236). No further information is available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cranial nerve disorder, Ear pain, Headache, Herpes zoster, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a male who on 04-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In March 2009 while the patient was on vacations he developed shingles. The patient had pain that was diagnosed as "ophthalmic division of the 5th cranial nerve". He had pain from his left ear to his temple and scalp with numbness of his left eyebrow. The physician said he had severe postherpetic neuralgia. The patient was hospitalized twice and treated with VALTREX and VICODIN. The patient sought unspecified medical attention. The patient had not recovered. Additional information has been requested.  Follow up information was received from a physician who reported the 76 year old patient was vaccinated on the left side with a 0.5 cc dose of ZOSTAVAX (Merck) (lot # 659267/1836U). The patient has a history of chicken pox. It was unknown if the patient had recently been exposed to chicken pox or herpes zoster. The patient went to the emergency room at a hospital on 08-MAR-2009 and 09-MAR-2009 but was not admitted. The patient was seen by an ophthalmologist at an eye center on 10-MAR-2009. The physician saw the patient in the office on 26-MAR-2009. The physician stated that the left 5th cranial nerve-ocular branch was healed when he saw the patient. The lesions had healed but the neuralgia still persisted. He indicated that the patient experienced pain reaching from the left ear to the temple to the scalp. The physician stated that he kept the patient on VALTREX and instructed the patient to come back in 1 month. The physician indicated that his concern involved the potentially lifelong pain that the patient could experience as a result of the postherpetic neuralgia. Follow up information was received from the physician concerning the 77 year old (previously reported as 76 year old, also reported as 78 year old) retired patient with atrial fibrillation (A. FIB), prostate cancer, coronary atherosclerosis, hypertension, and diabetes type II who was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) on 04-APR-2009. In AM on 08-MAR-2009, the patient developed clinical shingles involving left 5th cranial nerve distribution and was evaluated in the Emergency room at a hospital. He had persistent post herpetic neuralgia. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning a male who on 04-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In March 2009 while the patient was on vacations he developed shingles. The patient had pain that was diagnosed as "ophthalmic division of the 5th cranial nerve". He had pain from his left ear to his temple and scalp with numbness of his left eyebrow. The physician said he had severe postherpetic neuralgia. The patient was hospitalized twice and treated with VALTREX and VICODIN. The patient sought unspecified medical attention. The patient had not recovered. Additional information has been requested.  Follow up information was received from a physician who reported the 76 year old patient was vaccinated on the left side with a 0.5 cc dose of ZOSTAVAX (Merck) (lot # 659267/1836U). The patient has a history of chicken pox. It was unknown if the patient had recently been exposed to chicken pox or herpes zoster. The patient went to the emergency room at a hospital on 08-MAR-2009 and 09-MAR-2009 but was not admitted. The patient was seen by an ophthalmologist at an eye center on 10-MAR-2009. The physician saw the patient in the office on 26-MAR-2009. The physician stated that the left 5th cranial nerve-ocular branch was healed when he saw the patient. The lesions had healed but the neuralgia still persisted. He indicated that the patient experienced pain reaching from the left ear to the temple to the scalp. The physician stated that he kept the patient on VALTREX and instructed the patient to come back in 1 month. The physician indicated that his concern involved the potentially lifelong pain that the patient could experience as a result of the postherpetic neuralgia. Follow up information was received from the physician concerning the 77 year old (previously reported as 76 year old, also reported as 78 year old) retired patient with atrial fibrillation (A. FIB), prostate cancer, coronary atherosclerosis, hypertension, and diabetes type II who was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) on 04-APR-2009. In AM on 08-MAR-2009, the patient developed clinical shingles involving left 5th cranial nerve distribution and was evaluated in the Emergency room at a hospital. He had persistent post herpetic neuralgia. Additional information is not expected.
Sex: F
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial report was received from another manufacturer (document number 45216582), who received the report from a health care professional, who is also the patient. An adult female patient (date of birth reported as 1961) had received Pertussis vaccination (manufacturer, lot number not reported) as a child, and two years ago while in nursing school, she contracted pertussis from a patient. The patient sought medical attention which as specified as "office" and subsequently recovered from the event. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an 82 year old female patient with no drug reaction/allergies, who on 23-JAN-2009 at about 12:00, was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  Concomitant therapy included BUSPIRONE HC1, LEVOTHROID, NIASPAN, MSD, TOPROL XL TABLETS and low dose aspirin.  On the morning of 24-JAN-2009, within 24 hours after she received her injection of ZOSTER vaccine live (Oka/Merck), the patient noticed that she was red at the injection site, sore at the injection site, hot to touch at the injection site, tight feeling at the injection site and swelling at the injection site about the size of a softball.  She did not have any difficult breathing. On 25-JAN-2009, she treated the injection site with LANACANE, but she did not notice any improvement in the symptoms.  There was no relevant laboratory data.  As of 25-JAN-2009, the redness at the injection site, soreness at the injection site, feeling hot to touch at the injection site, tight feeling at the injection site and swelling at the injection site felt as though they were worsening.  The patient planned to contact her physician for additional instruction on treatment of the reactions.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Sleep disorder
Clinical narrative: Employee reporting disturbed sleep at night secondary to pain at injection site.  She is reporting that she experiences some numbness from shoulder to elbow at night.  States upon questioning that she has full range of motion to left arm during daily activities.  Primary concern voiced by employee is numbness and disturbed sleep.  States she takes Ibuprofen on a regular basis, and this has not had any effect on the nightime discomfort.  Advised to follow-up with her primary care physician.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddness about 4-6 cm left deltoid. warm to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pyrexia, Rash
Clinical narrative: Patient had rash.  She went to the doctor and it was diagnosed as shingles.  She had a fever and flu like symptoms preceding the rash.  The rash was on her right breast, arm and back.  She is taking antiviral therapy.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had rash.  She went to the doctor and it was diagnosed as shingles.  She had a fever and flu like symptoms preceding the rash.  The rash was on her right breast, arm and back.  She is taking antiviral therapy.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: I had rash on all my neck for two days, I had fever yesterday, it last only one day and I still have the swelling of glands starting yesterday. I haven't visit the doctor yet, but I am eating a lot of vitimine C and for my rashes, I bought the Gynecort for anti-itch.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Herpes zoster, Influenza like illness
Clinical narrative: Two days after receiving the shingles vaccine on April 3, 2009  I had flu like smyptoms.  Headache, sleepless nights, chills, achy all over,very weak, for three days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain
Clinical narrative: Two days after receiving the shingles vaccine on April 3, 2009  I had flu like smyptoms.  Headache, sleepless nights, chills, achy all over,very weak, for three days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: 03/31/09 Dtap given, 04/01/09 Pt. had axillary temp of 103, 04/02/09 Pt. had 2-3cm redness at injection site
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction to Dtap (given on 03/30/09), right arm swollen and red (4cm). Pt. came back to office on 04/01/09.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Arthralgia, Blood iron decreased, Blood test normal, Blood thyroid stimulating hormone normal, Fatigue
Clinical narrative: within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds.  4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra.  RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat.  Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Haemoglobin normal, Insomnia, Joint lock, Joint stiffness, Joint swelling
Clinical narrative: within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds.  4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra.  RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat.  Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Lethargy, Metabolic function test, Papilloma viral infection, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds.  4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra.  RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat.  Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Thyroxine normal
Clinical narrative: within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds.  4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra.  RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat.  Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood gases, Convulsion, Full blood count, Metabolic function test
Clinical narrative: seizures X2  4/29/09 Received Hospital medical records for 2/8-2/9/2009 & 4/5-4/7/2009. FINAL DX: new onset seizures Records reveal patient experienced choking, shaking, back arched, color red, breathless, jaws clenched, eyes rolled back in head.  Afterward appeared lost & confused.  Had similar episode in ER on 2/4 while fever of 101.  Loaded w/antiseizure meds.  Neuro consult done.  Remained stable & d/c home w/PCP & neuro f/u.  Returned 4/5-4/7/09 w/recurrent seizure-like activity.  24-hour EEG abnormal & patient tx w/Keppra.  D/C to home w/PCP & Neuro f/u.
Age: 51.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Injection site erythema, Swelling
Clinical narrative: Reddened area, size of half-dollar, left arm.Swelling arm/neck/shoulder. MD diagnosed cellulitis.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. had painful red swollen 4 X 3 1/2" area on left arm after vaccination
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 40mmx28mm red raised area at site of injection  generic benadryl given
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, PNC
Symptoms: Anorexia, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: low appetite, fever, seizure
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: urticaria- abdomen/chest/lumbar
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Intermittent shooting pains in right arm, soreness at injection site, no redness or swelling at site
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Convulsion, Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Administered Tdap and Gardisil, pt.'s head dropped, was unresponsive, arms and legs drew up in seizure-like activity, pt. was incontinent of urine, pt. regained consciousness after several seconds.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: left arm 2" redness, warm to touch, itches
Age: 2.0
Sex: M
Vaccine: HEP, HIBV, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: high fever and high pitched screaming two hours after vaccines given, lasted for 2 hours
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Incoherent, Loss of consciousness, Nausea, Pallor
Clinical narrative: After administration of all 4 vaccines, upon departure and standing, client reported feeling dizzy.  Assisted client back to chair.  Client fainted.  Incoherent or unconscious for approximately 30 seconds.  Client then nauseated and vomited clear fluid (mucus); pale.  BP assessed and cool rag applied to forehead.  Given water to drink.  Remained in clinic 20-25 minutes. BP assessed and monitored.  Stable at departure.  Voiced no complaints at departure.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope, Vomiting
Clinical narrative: After administration of all 4 vaccines, upon departure and standing, client reported feeling dizzy.  Assisted client back to chair.  Client fainted.  Incoherent or unconscious for approximately 30 seconds.  Client then nauseated and vomited clear fluid (mucus); pale.  BP assessed and cool rag applied to forehead.  Given water to drink.  Remained in clinic 20-25 minutes. BP assessed and monitored.  Stable at departure.  Voiced no complaints at departure.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia, Rash macular, Vaccination complication
Clinical narrative: 5 days after MMR vaccination our daughter developed a 101 degree fever. The the 6th day our daughter had a febrile seizure due to a 104 fever.  She has recovered from seizure, however 4 days later she developed a blotchy rash over her entire torso, neck , legs and vaginal area.  Rash has since receded, however she is still suffering from a low grade fever of 100-101. It has since been 7 days from the intital onset of fever symptoms.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal X-ray, Abdominal pain, Computerised tomogram normal, Dehydration, Full blood count normal
Clinical narrative: Protracted vomiting, dehydration and abdominal pains.  4/14/09 Received hospital medical records of 4/9-4/12/2009. FINAL DX: cyclic vomiting; abdominal migraine Records reveal patient experienced abdominal pain, nausea & vomiting.  Exam revealed constipation, tx w/enema & antinausea meds w/o improvement.  Neuro consult done & med changed to IV valproic acid which provided relief.  D/C to home w/neuro & GI f/u on new meds.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Metabolic function test normal, Urine analysis normal, Vomiting, X-ray normal
Clinical narrative: Protracted vomiting, dehydration and abdominal pains.  4/14/09 Received hospital medical records of 4/9-4/12/2009. FINAL DX: cyclic vomiting; abdominal migraine Records reveal patient experienced abdominal pain, nausea & vomiting.  Exam revealed constipation, tx w/enema & antinausea meds w/o improvement.  Neuro consult done & med changed to IV valproic acid which provided relief.  D/C to home w/neuro & GI f/u on new meds.
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Haemorrhage, Injection site erythema, Injection site pruritus, Pain, Pruritus
Clinical narrative: Pt. came in 02-25-09. States she had pain, swelling and itching lasted 2 weeks after injection (given 11/3/08). She didn't do anything then and about a week ago on the injection site was red and itching, she scratched, and bleed and she is worried. The doctor hold her to put on Vaseline. It healed after a week. I called MERCK and relate info and follow up with Pt. She is fine now 4/11/09
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Scratch, Swelling
Clinical narrative: Pt. came in 02-25-09. States she had pain, swelling and itching lasted 2 weeks after injection (given 11/3/08). She didn't do anything then and about a week ago on the injection site was red and itching, she scratched, and bleed and she is worried. The doctor hold her to put on Vaseline. It healed after a week. I called MERCK and relate info and follow up with Pt. She is fine now 4/11/09
Age: 69.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt. came in 02-25-09. States she had pain, swelling and itching lasted 2 weeks after injection (given 11/3/08). She didn't do anything then and about a week ago on the injection site was red and itching, she scratched, and bleed and she is worried. The doctor hold her to put on Vaseline. It healed after a week. I called MERCK and relate info and follow up with Pt. She is fine now 4/11/09
Age: 1.01
Sex: M
Vaccine: MMR, PNC
Symptoms: Rash
Clinical narrative: Pt developed a rash on right arm shortly after vaccine administration
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Screaming
Clinical narrative: Swelling, redness, very hot, doubled in size on the evening of 04/06/09. Mother gave Benadryl and the next morning pt. woke up screaming of pain. Mother took Pt to the ER on the morning of 04/07/09.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 8X6 cm area of induration over R deltoid with 13x10 cm of erythema, non-tender, no expressible d/c. Received DAPTACEL 4/9/09 R deltoid
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Skin lesion
Clinical narrative: On March 20, 2009 - developed severe headache. Seen by PMD on March 23, who diagnosed shingles. 3 lesions on scalp - (L) side of head - cultured by MD. pain from top of head down to nape of neck - midline. Still taking TYLENOL for headaches. Treated with Valacyclovir for 10 days and Prednisone which she stopped after 9 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: L thigh with large erythematous edematous puritic patch around site of DTaP & varicella injections -> 5" wide x 4" long; To ER + office.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Blepharospasm, Excessive eye blinking, Grimacing
Clinical narrative: Eye twitching, blinking, facial grimace beginning on day of administration of vaccine and has been ongoing. Frequency about 4x/10 minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Parotitis
Clinical narrative: Bilat parotitis day 13 after MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Erythematous discoloration with slight induration approximately 9-10 cm, no c/o pain.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Positive erythema 15x16cm left thigh, not tender, + warmth and itch. Continue TYLENOL and IBUPROFEN; BENADRYL for itching.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: pass out after the shots, became pale around 5 sec no treatment needed.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Amnesia, Arthralgia, Blood testosterone decreased, Laboratory test abnormal, Urinary incontinence
Clinical narrative: Joints ache and pain in all of them, incontinence urinary, memory loss.
Age: 44.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Asthenia, Blood glucose increased, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Weakness and dizziness especially upon standing. Hot feeling in face and head - sweating on face and head.  Fasting blood sugar 131 (diabetic). Occurred upon waking the day following vaccination (approx. 16 hours).  Symptoms continue but seem less severe 26 hours after vaccination.  Symptoms come and go every 30 to 45 minutes.  Feel better lying down.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Chest X-ray normal, Incorrect route of drug administration, Respiratory disorder
Clinical narrative: Patient given vaccine IV push instead of subcutaneously pt HR 130's but anxious and getting respiratory treatment. HR in 70's in 15 min.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bradycardia, Hypoaesthesia, Incorrect route of drug administration, Muscle spasms, Tachycardia
Clinical narrative: Patient given vaccine IV push instead of subcutaneously pt HR 130's but anxious and getting respiratory treatment. HR in 70's in 15 min.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Injection site pain
Clinical narrative: Patient only complained of pain at the injection sight, died three days after vaccinated.
Age: 7.0
Sex: M
Vaccine: DPP
Symptoms: Abnormal behaviour
Clinical narrative: Patient was extremely exciteable when his cousin that he hadn't seen in over a year came to visit us, his grandparents.  The boys love each other, but they are extremely competitive - they are both 8 years old.  Patient's mother arrived for our Easter Egg hunt and later the boys all went to fish on the lake (we live on the lake).  Within a few minutes, patient was arguing with his brother about who gets which fishing rod - and his mother was taking him up to the shed to find another one.  Patient drew back and hit his mother on the hand.  It was not broken, but they went to the Emergency Room anyway for xrays.  Patient received a whipping from his Dad for this action.  I don't feel it was right, he was competing with his cousin and had been all day.  His cousin was also fishing.  Patient was really upset, more than usual and took it out on his Mom.  He is the sweetest and most thoughtful boy I know of (course I'm Nana) but I think the medicine played a part.  He started it 2 weeks ago.  Please help me.  I've got to try to explain this to my son and his wife.  Patient is taking pills for the ADD - not vaccinations. Thank you.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm is red, no swelling noted, arm is warm, but so is other, painful to touch.  Patient was advised to put ice on arm and alternate with warm compresses.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Skin ulcer
Clinical narrative: ulcerated left upper arm
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bronchoscopy, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Feaver, caugh,weak, breathing problems
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test, Pyrexia, X-ray
Clinical narrative: Feaver, caugh,weak, breathing problems
Sex: U
Vaccine: FLU3
Symptoms: Maternal drugs affecting foetus, Pneumonia, Pyloric stenosis, Surgery
Clinical narrative: This serious case was received on 01 April 2009 from a health care professional. An approximately 3 week old patient (gender not specified) received FLUZONE SV 2007-2008 (lot number not reported) transplacentally on 15 November 2007. The patient was born on 14 May 2008 at a gestational age of 39.7 weeks. Apgar score at one minute and five minutes were both 9. On 07 June 2008 the patient had pyloroplasty for pyloric stenosis. The child recovered from the surgery. On 13 November 2008 the patient was diagnosed with pneumonia. No further information was reported. This case has the same reporter as case number 2009-01354.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial report received 01 April 2009 from a health care professional, who is also the patient. According to the reporter, they developed the "flu" an unspecified amount of time after they had received an influenza vaccination (manufacturer and lot number not reported) during the same influenza season. No laboratory or diagnostic testing had been performed. Information pertaining to the event symptoms, dates of onset, duration and severity were not reported and the patient declined to provide additional information. The patient's recovery status was not reported. Documents held by sender: None.