chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Acute lymphocytic leukaemia, Areflexia, Aspiration bone marrow, Chemotherapy, Chest X-ray abnormal
Clinical narrative: Information has been received regarding a case in litigation concerning a male with areflexic bladder, and a history of sinus congestion, cough and respiratory distress who on 24-NOV-1994 was vaccinated with a second dose of Recombivax HB. On 04-DEC. the patient experienced Acute Lymphoblastic Leukemia and was hospitalized. Reported from Litigation Report. "The office of Special Master's has ordered a petitioner to show cause why a claim that the hepatitis B vaccine caused a child's health problems should not be dismissed." The Special Master on 16-Oct, held that the patient's health problems were the result of acute lymphoblastic leukemia unrelated to the vaccine. The special master issued the following findings which the petitioners will have to answer to avoid dismissal: Hepatitis B vaccine does not cause acute lymphoblastic leukemia (ALL). The interval between the patient's second vaccination and the onset of his neurologic difficulties was three months beyond the period appropriate for linking vaccination to an autoimmune disease. The patient's onset of neurologic difficulties occurred while his brother had chickenpox. The patient's immune system was already compromised by his ALL and viruses, such as chickenpox, can lead to neurologic problems. Even if the vaccine caused a significant aggravation of the patient's pre-existing areflexic bladder, the sequelae of that significant aggravation did not last for more than 6 months as the Vaccine Act requires for compensation. According to the Special Master, the patient now 17, received his second hepatitis b vaccination on 24-Nov-1994. On 04-Dec, he was admitted to the hospital with a history of congestion, cough, and respiratory distress. Emergency room staff noted a "very abnormal" chest x-ray with an enlarged pleural effusion on the right side and a small one on the left. He also had a mediastinal mass. He underwent bone marrow aspiration and chemotherapy. Upon internal review, neurologic difficulties and worsening of significant aggravation of areflexic bladder were considered other important medical events. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Mediastinal mass, Nasal congestion, Neurological symptom, Pleural effusion
Clinical narrative: Information has been received regarding a case in litigation concerning a male with areflexic bladder, and a history of sinus congestion, cough and respiratory distress who on 24-NOV-1994 was vaccinated with a second dose of Recombivax HB. On 04-DEC. the patient experienced Acute Lymphoblastic Leukemia and was hospitalized. Reported from Litigation Report. "The office of Special Master's has ordered a petitioner to show cause why a claim that the hepatitis B vaccine caused a child's health problems should not be dismissed." The Special Master on 16-Oct, held that the patient's health problems were the result of acute lymphoblastic leukemia unrelated to the vaccine. The special master issued the following findings which the petitioners will have to answer to avoid dismissal: Hepatitis B vaccine does not cause acute lymphoblastic leukemia (ALL). The interval between the patient's second vaccination and the onset of his neurologic difficulties was three months beyond the period appropriate for linking vaccination to an autoimmune disease. The patient's onset of neurologic difficulties occurred while his brother had chickenpox. The patient's immune system was already compromised by his ALL and viruses, such as chickenpox, can lead to neurologic problems. Even if the vaccine caused a significant aggravation of the patient's pre-existing areflexic bladder, the sequelae of that significant aggravation did not last for more than 6 months as the Vaccine Act requires for compensation. According to the Special Master, the patient now 17, received his second hepatitis b vaccination on 24-Nov-1994. On 04-Dec, he was admitted to the hospital with a history of congestion, cough, and respiratory distress. Emergency room staff noted a "very abnormal" chest x-ray with an enlarged pleural effusion on the right side and a small one on the left. He also had a mediastinal mass. He underwent bone marrow aspiration and chemotherapy. Upon internal review, neurologic difficulties and worsening of significant aggravation of areflexic bladder were considered other important medical events. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Caesarean section, Drug exposure during pregnancy, Foetal disorder, HELLP syndrome
Clinical narrative: Information has been received from a certified medical assistant and a physician via the Merck Pregnancy registry concerning a 16 year old white female with adjustment disorder with depressed mood and a history of atypical squamous cell of undetermined significance, HPV infection, cervical intraepithelial neoplasia I and herpes simplex type 1 who on 23-OCT-2006, was vaccinated with a first dose of Gardasil (lot 653736/0868F). On 27-DEC-2006, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot 653736/0868F). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 27-DEC-2006, after administration of Gardasil, the patient stated "I may be pregnant". A urine HCG test was positive. The patient was sent for quantitative HCG levels and an abdominal ultrasound. On 27-DEC-2006, the patient started therapy with prenatal vitamins. The date of her last menstrual period was 22-NOV-2006. The patient's estimated date of delivery was 29-AUG-2007. On 09-FEB-2007, an ultrasound was normal, intrauterine pregnancy at 10 +2. On 16-APR-2007, a diagnostic laboratory test, maternal serum alpha-fetoprotein (MSAFP) was performed for screening purposes. The results were reported as negative. On 20-APR-2007 an ultrasound was performed for dating purposes and the confirmed estimated delivery date was 03-SEP-2007. On 01-JUN-2007 to 08-JUN-2007, the patient was prescribed clindamycin, 150mg 4 times per day for the treatment of paronychia. On 05-JUN-2007 to 10-JUN-2007, the patient was put on acyclovir, 200 mg 5 times per day for the treatment of a fever blister. On 09-JUL-2007 to 16-JUL-2007, the patient was placed on metronidazole, 500 mg two time per day for the treatment of bacterial vaginosis. Pregnancy outcome information stated that on 20-JUL-2007, the patient delivered a male liveborn infant weighing 4 pounds 5 ounces. She was 34 weeks and 2 days from her last menstrual period (LMP). The infant was reported as normal. There were no congenital anomalies. However, there were other complications such as respiratory distress syndrome and hyperbilirubinemia. The mother of the infant also had complications during the pregnancy reported as Hellp syndrome and she needed to have an emergency caesarean section for unknown reasons. On 02-AUG-2007, the infants length measured 17.5 inches and his head circumference measure 36.5 cm. At the time of this report, the patient's outcome was unknown. Upon internal review, unexpected emergency c-section was considered to an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Paronychia, Ultrasound scan normal, Urine human chorionic gonadotropin positive, Vaginitis bacterial
Clinical narrative: Information has been received from a certified medical assistant and a physician via the Merck Pregnancy registry concerning a 16 year old white female with adjustment disorder with depressed mood and a history of atypical squamous cell of undetermined significance, HPV infection, cervical intraepithelial neoplasia I and herpes simplex type 1 who on 23-OCT-2006, was vaccinated with a first dose of Gardasil (lot 653736/0868F). On 27-DEC-2006, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot 653736/0868F). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 27-DEC-2006, after administration of Gardasil, the patient stated "I may be pregnant". A urine HCG test was positive. The patient was sent for quantitative HCG levels and an abdominal ultrasound. On 27-DEC-2006, the patient started therapy with prenatal vitamins. The date of her last menstrual period was 22-NOV-2006. The patient's estimated date of delivery was 29-AUG-2007. On 09-FEB-2007, an ultrasound was normal, intrauterine pregnancy at 10 +2. On 16-APR-2007, a diagnostic laboratory test, maternal serum alpha-fetoprotein (MSAFP) was performed for screening purposes. The results were reported as negative. On 20-APR-2007 an ultrasound was performed for dating purposes and the confirmed estimated delivery date was 03-SEP-2007. On 01-JUN-2007 to 08-JUN-2007, the patient was prescribed clindamycin, 150mg 4 times per day for the treatment of paronychia. On 05-JUN-2007 to 10-JUN-2007, the patient was put on acyclovir, 200 mg 5 times per day for the treatment of a fever blister. On 09-JUL-2007 to 16-JUL-2007, the patient was placed on metronidazole, 500 mg two time per day for the treatment of bacterial vaginosis. Pregnancy outcome information stated that on 20-JUL-2007, the patient delivered a male liveborn infant weighing 4 pounds 5 ounces. She was 34 weeks and 2 days from her last menstrual period (LMP). The infant was reported as normal. There were no congenital anomalies. However, there were other complications such as respiratory distress syndrome and hyperbilirubinemia. The mother of the infant also had complications during the pregnancy reported as Hellp syndrome and she needed to have an emergency caesarean section for unknown reasons. On 02-AUG-2007, the infants length measured 17.5 inches and his head circumference measure 36.5 cm. At the time of this report, the patient's outcome was unknown. Upon internal review, unexpected emergency c-section was considered to an other important medical event. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a licensed practical nurse concerning a 14 year old female with no pertinent medical history who on 20-SEP-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot #657617/0384U). There was no concomitant medication. On 25-SEP-2007, the patient was found to be pregnant with a positive Pregnancy test at the office. Follow-up information received from the licensed practical nurse reported that the patient had an abortion at approximately 5 weeks gestation. The licensed practical nurse reported that the abortion was for reasons other than therapy with Gardasil, including that the patient was only 14 years old. Upon internal review, abortion was considered to be an other important medical event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Diaphragmalgia, Gallbladder disorder, Gastric disorder, Ileus paralytic
Clinical narrative: Information has been received from a mother concerning her 21 year old daughter with no known drug allergies who on 17-MAY-2007 was vaccinated with her first dose of Gardasil, injection. Concomitant therapy included hormonal contraceptives (unspecified). In the "middle of July" estimated to be approximately 15-JUL-2007, "about two months" after the first dose of Gardasil, the patient experienced paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm. The chest pain extended to her diaphragm area. At first, the physician thought the patient had acid reflux. Further testing showed that she had paralysis of the stomach and a slow down of the gallbladder. The patient started to "get better" about 4 weeks before the third dose, estimated to be 21-OCT-2007. On 21-NOV-2007 the patient received her third dose of Gardasil. The patient's symptoms came back. The patient underwent the following tests: diabetes (results not provided), scleroderma (results not provided), gallbladder (no stones) and liver scan (results not provided). The patient's paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm persisted. Unspecified medical attention was sought. OME statement: Upon internal review, paralysis of the stomach was determined to be an other important medical event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Liver scan
Clinical narrative: Information has been received from a mother concerning her 21 year old daughter with no known drug allergies who on 17-MAY-2007 was vaccinated with her first dose of Gardasil, injection. Concomitant therapy included hormonal contraceptives (unspecified). In the "middle of July" estimated to be approximately 15-JUL-2007, "about two months" after the first dose of Gardasil, the patient experienced paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm. The chest pain extended to her diaphragm area. At first, the physician thought the patient had acid reflux. Further testing showed that she had paralysis of the stomach and a slow down of the gallbladder. The patient started to "get better" about 4 weeks before the third dose, estimated to be 21-OCT-2007. On 21-NOV-2007 the patient received her third dose of Gardasil. The patient's symptoms came back. The patient underwent the following tests: diabetes (results not provided), scleroderma (results not provided), gallbladder (no stones) and liver scan (results not provided). The patient's paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm persisted. Unspecified medical attention was sought. OME statement: Upon internal review, paralysis of the stomach was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Muscle twitching
Clinical narrative: Information has been received from a nurse in a physician's office concerning her teenage daughter who on approximately 05-NOV-2007 "three weeks ago", was vaccinated with her first dose of Gardasil 0.5mL intramuscularly. Concomitant therapy included MENACTRA and influenza virus vaccine (unspecified). In approximately November 2007, the patient experienced paralysis to one side of her upper lip and twitching to one side of her upper lip. The patient recovered. The product quality complaint unit was not involved. Upon internal review, paralysis of one side of the upper lip was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received as part of a pregnancy registry from a physician concerning a female who was vaccinated with Gardasil. As of 26-NOV-2007, the patient "recently" miscarried. Upon interval review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Respiratory arrest, Vomiting
Clinical narrative: Information has been received from a registered nurse, concerning a 16 year old female patient, who on 15-SEP-2007 was vaccinated IM with the first dose of Gardasil (lot # not reported). After the vaccination, the patient passed out and stopped breathing. The patient remained at the physician's office and recovered (time duration not reported). On approximately 15-NOV-2007 ("two months later"), the patient was vaccinated IM with the second dose of Gardasil (lot # not reported). Following the second vaccination, she vomited. She again remained at the physician's office for observation, and recovered (duration of time not specified). Upon internal review the event of stopped breathing was considered serious, as an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received through the pregnancy registry through a 22 year old female who on 20-OCT-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT) and zolpidem tartrate (AMBIEN). On approximately 27-OCT-2007 the patient found out she was pregnant (not further specified). On approximately 24-NOV-2007 the patient experienced a miscarriage. The patient sought unspecified medical attention with a physician. Upon internal review, miscarriage was determined to be an other important medical event. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional via a Pharmacist concerning a patient who on an unspecified date was vaccinated with Pneumovax 23 (lot# unknown). Subsequently the patient experienced an unspecified reaction and was hospitalized. Medical attention was sought. No other information was available. At the time of reporting it was unknown if the patient had recovered. The unspecified reaction required hospitalization. This is one of two reports from the same source. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Barium enema, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on approximately 06-NOV-2007 was vaccinated PO with the second 2.0 ml dose of Rotateq (no lot number provided). Concomitant drug therapy included "antimicrobial (unspecified)." On 20-NOV-2007 two and a half weeks after being vaccinated, the patient experienced intussusception characterized by an abnormal stool and was hospitalized for a total of 3 days. A barium enema test was performed and the patient underwent surgery to repair the intussusception." On 23-NOV-2007 the patient was released from the hospital. Subsequently, the patient recovered. There was no product quality complaint. The physician also considered intussusception to be an other important medical event (surgery). Additional information has been requested.  1/11/08 Reviewed hospital medical records which reveal patient experienced irritability, black stools & bilious emesis x 12 hours which progressed to bloody stools.  Went to outlying ER where gastrograffin enema reveals IS that could not be reduced despite 3 attemps.  Transferred to higher level of care for surgical management.  Admitted 11/20-11/23/2007.  On admit, lethargic, distended abdomen w/epigastric mass palpablel.  To OR for exp lap, no bowel resection needed.  Did well post op & d/c to home. Final DX: intussusception, surgically reduced. 1/22/08 Reviewed vax record.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Facial pain, Lip swelling, Oedema peripheral, Oral pain
Clinical narrative: Information has been received from a 72-year-old male consumer with allergies to glycerol, ORGANIDIN, etodolac, and MYLICON and a history of "hernia surgery a couple of years ago" who had a physical about 04-Oct-2007. On 11-OCT-2007 he was vaccinated intramuscularly with a first dose of Zostavax. There was no concomitant medication. On approximately 14-OCT-2007 "about 3 days post vaccination) the patient experienced "swollen feet, hand, tongue, lips, and finger tips". The consumer also reported that he experienced "swelling of his throat which has closed his airway flow" and that he has developed "pimples on his upper body and hairline". The consumer also experienced "cheek soreness causing them to be raw inside". He has been to the emergency room about three times and has been hospitalized for an overnight stay. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Stomatitis, Swollen tongue
Clinical narrative: Information has been received from a 72-year-old male consumer with allergies to glycerol, ORGANIDIN, etodolac, and MYLICON and a history of "hernia surgery a couple of years ago" who had a physical about 04-Oct-2007. On 11-OCT-2007 he was vaccinated intramuscularly with a first dose of Zostavax. There was no concomitant medication. On approximately 14-OCT-2007 "about 3 days post vaccination) the patient experienced "swollen feet, hand, tongue, lips, and finger tips". The consumer also reported that he experienced "swelling of his throat which has closed his airway flow" and that he has developed "pimples on his upper body and hairline". The consumer also experienced "cheek soreness causing them to be raw inside". He has been to the emergency room about three times and has been hospitalized for an overnight stay. The outcome was reported as not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Benign intracranial hypertension, Computerised tomogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a health care provider on 21 November 2007. A 3-year-old female patient with medical history of cataracts, had received an intramuscular left deltoid injection of Menactra, lot number U2419AA and an intramuscular left deltoid injection of Adacel, lot number C2775AA on 29 October 2007 and four days later complained of headaches leading to hospitalization on 14 November 2007. The patient was admitted to the hospital for two to three days (discharge date not provided), and was diagnosed with Pseudotumor "cereberi". Corrective treatments were not reported. Diagnostic testing included an MRI and CT of the head and a spinal tap (results not provided). The patient had not received any vaccines during the four weeks prior to receipt of Menactra and Adacel. The patient had not been ill and had not been taking any concomitant medications at the time of vaccination. According to the reporter, the patient had recovered completely from the event. No further information was provided. 1/22/08-records received for DOS 11/15-11/17/07 DC DX: Pseudotumor cerebri. Presented with 2 week history of headache which has not gone away with 1-2 seconds blurring or blackouts of vision. Papilledema on exam. and 11/21-11/22/07-DC DX: Headache improved status post lumbar puncture. Pseudotumor cerebri. HX of recently diagnosed pseudotumor with chronic recurrent headaches.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of an unspecified adverse event in a 68-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline). The subject's medical history, concurrent conditions, and concurrent medications were not reported. No other vaccines were reported to be administered on the date of receipt of Fluarix. On 16 November 2007 the subject received unspecified dose of Fluarix (unknown). The dose was recorded as the 1st dose of Fluarix, however, information regarding previous immunization with influenza virus vaccine was not provided. On 27 November 2007, 11 days after vaccination with Fluarix, the subject experienced an unspecified adverse event which required hospitalization, and product complaint. The reported adverse event was that a male subject was hospitalized and placed in an intensive care unit 11 days after vaccination with Fluarix. No specific adverse events were reported. The reporting physician is seeking a possible quality assurance issue with the vaccine as to the cause of the subject's hospitalization. The physician considered the events were disabling and life threatening as well as requiring hospitalization. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with Fluarix.
Age: 8.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abscess, Cellulitis, Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Prevnar ordered, Pneumovax administered instead, with the flu shot - (R) deltoid 11/27/07.  12/7/07 Reviewed hospital medical records which reveal patient experienced significant swelling, pain, induration & redness of right arm w/fever x 2 days.  Initially had nausea & only injection site was involved but then spread to involve entire right arm.  Seen at urgent care & dx w/allergic reaction to vax.  Condition worsened & seen by PCP, started on antibiotics & instructed to go to hospital if worsened.  Continued to worsen & admitted 11/29-12/4/2007.  Surgery consult done.  To OR on 12/1/07 for abscess I/D & biopsy of deltoid fascia.  No d/c summary available, obtained admit/dc dates from ROI. FINAL DX: right arm cellulitis & abscess s/p immunization; I/D of abscess.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: None stated  12/28/07 Hospital medical records reviewed which reveal patient experienced irritability, intermittent bouts of inconsolable crying, spitting up, diet refusal, abdominal pain, reduced oral intake & suspected UTI.  Admitted 11/18-11/19/2007.  Peds GI consult done. FINAL DX: none provided, peds GI dx of acute episode of decreased oral intake possibly related to vaccinations & subsequent air travel.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Gaze palsy, Tremor
Clinical narrative: Approximately 15 minutes after patient received 4 vaccines, patient had a 5 second "seizure-like" episode, eyes rolling back, head extremities shaking.  Patient observed in office for 3 hours - recovered well at intervention.  On 12/3/07, mom reported patient did well over the weekend at home.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: See chart note Hives-dw. <30" after F/U #2.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, FLUN3, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Flu Mist given nasally to 8 mo old child
Age: 0.5
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Flu mist given nasally to 10 month old child
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hive like rash 3 days after influenza shot given.
Age: 15.0
Sex: F
Vaccine: HPV4
Clinical narrative: Numbness L /arm/elbow traveled to (L) side of leg/thigh ->knee 12/17/07-office note received for DOS 11/21/07-numbness down to left elbow/arm nubness down left side of leg from thigh to knee. DTRs intact. Gait normal. Strength equal. Face movements normal.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: 25 min after injection client complains of feeling throat swelling (on inspection throat was swollen) - difficulty swallowing.  Lungs clear by auscultation - no respiratory distress at that time.  Benadryl 50mg PO given - monitored - pt. recovered.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, itching, general malaise, shakiness.  Given Benadryl & ice packs to area. Red area 20cm x 16cm, warm to touch.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Redness, swelling, itching, general malaise, shakiness.  Given Benadryl & ice packs to area. Red area 20cm x 16cm, warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid ptosis, Myasthenia gravis
Clinical narrative: Patient received vaccine at a public clinic.  After 3 days, developed complete ptosis right eyelid and moderate to severe ptosis left upper lid.  Referred to neurolgy for treatment of M.G. 1/14/08-records received 10/25/07-C/O right eye swelling questionable reaction from flu shot. PE: droopy right upper eyelid.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Vaccine for virus vaccine.  Bottom of vial was cracked and no liquid in vial.  Noticed when attempted to withdraw diluent.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomited x12 11/13/07-11/14/07.  Diarrhea & low grade fever 11/15/07.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomited x12 11/13/07-11/14/07.  Diarrhea & low grade fever 11/15/07.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Headache, Pain, Rash erythematous, Rash macular
Clinical narrative: 2 days after receiving Flu Mist, pt began to have itchy, red rash on lower legs and lower back.  Since then, rash is lighter, but still with itching.  On exam today, faint macular, papular, & in some places vesicular rash on lower legs, lower back, abd, chest, neck & head.  Also had HA chills & body aches which lasted 2 days.
Age: 36.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: 2 days after receiving Flu Mist, pt began to have itchy, red rash on lower legs and lower back.  Since then, rash is lighter, but still with itching.  On exam today, faint macular, papular, & in some places vesicular rash on lower legs, lower back, abd, chest, neck & head.  Also had HA chills & body aches which lasted 2 days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Mobility decreased, Muscle rigidity, Muscle swelling, Myalgia
Clinical narrative: Swollen, hard, painful bicep muscle extending 4 inches x 6 inches, painful with any arm motion.  Headache for 3 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Feeling drunk
Clinical narrative: Woozy, disoriented about 15 minutes after receiving flu vaccine Thermisol free 2mg 0.25 LD.  Felt "drunk" for 4 plus hours during ER visit.
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Nasal oedema, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Nasal congestion, nasal swelling, fever, sore throat, coughing.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reported by mother 11-29-07 - raised swollen reddened, warm area left arm around injection site (viper V2 of arm)
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient got Menactra, Tdap, influenza around 3:30 pm 11-15-07, 12 hours later 11-16-07 3am had high fever 102, nausea,and vomiting, unable to hold Tylenol down. To Emergency that am, got IV's, nausea medication.
Age: 7.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Convulsion, Injection site inflammation, Pyrexia, Vomiting
Clinical narrative: The patient's mother referred that after vaccination her daughter had fever for 3 days, inflammation in the injection site (left arm), seizures and vomiting.
Age: 2.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Pyrexia, Vomiting
Clinical narrative: Patient's mother referred that her son  presented fever, vomiting and inflammation in the injection-site. He received Tylenol and Pedialyte for 24 hours. He was seen by the pediatrician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Nine days after recieving Zostavax, patient developed herpes zoster involving right facial, shoulder, and Upper extremity regions.  Patient seen in local clinic for urgent care and was treated with valcyclovir
Age: 27.0
Sex: F
Vaccine: FLUN3, PPV
Symptoms: Drug exposure during pregnancy
Clinical narrative: Received Flumist, was unaware that she was 2 weeks pregnant at the time of administration.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Abdominal pain, Intussusception, Vomiting
Clinical narrative: 11/19/07 began with abd. pain and vomiting. taken to ER in Findlay in evening, discharged to home when vomiting ceased.  symptoms continued that week and febrile suppositories given. on 11/24/07 taken to PCACC and xray, CT scan done. transferred to Hospital and had surgery for intusseption. 1/9/08-records received for DOS 11/24-11/28/07. DC DX: Intussusception. Laproscopic reduction of ileocolonic intussusception. Five days prior to admission developed abdominal pain and emesis. Bowel movement present with bloody mucus 2-3 days prior to admission.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Fifteen minutes after injection client complained of generalized itching at injection site.  Denied respiratory distress of SOB.  Took benadryl.  Primary physician notified and client driven by co-worker to physician office.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: soreness at site of injection, headache,occasional shooting pains down right arm
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: 3 INCH DIAM REDDENED RAISED AREA, SENSITIVE TO TOUCH   OTHERWISE "FEELS FINE"
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Hospital RN administered influenza vaccination Fluvirin o.5ml - states that she almost immediately developed hives which progressed, with pruritis - reported to Employee Health approx 1 hour later - escorted to Emergency Dept, received epinephrine, steroids, and pepcid - responded well, discharged several hours later to home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed rash on left armpit and back first noticed on Saturday December 1st.  Emergency Room visit was made and shingles was diagnosed by visual assessment.  Prednisone and another medication was prescribed.  Child also having recurring ear infections, bronchitis, and possible MRSA infection for 1 month or so before shingles diagnosis.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDDENED SWOLLEN AREA ON RIGHT ARM AT SITE OF PNEUMO SHOT
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Loss of consciousness
Clinical narrative: Within 5 minutes my son couldn't hear or see.  He thought he was going to black out.  He doesn't remember me taking him from hallway back to exam table.  It has been 5 hours since he was at doctors office and he is still suffering with a headache and dizziness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: Within 5 minutes my son couldn't hear or see.  He thought he was going to black out.  He doesn't remember me taking him from hallway back to exam table.  It has been 5 hours since he was at doctors office and he is still suffering with a headache and dizziness.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Chills, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: VERY SORE RIGHT ARM, SWOLLEN LYMPH NODES UNDER RIGHT AXILLA, FEVER, CHILLS
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site rash
Clinical narrative: Parents report that shortly after leaving the Health Department where injection was given, a red ring formed around the injection site, the next day the child's whole leg turned red and child had red rash and temperature of 101.  Parents stated that they medicated child with Zyrtec (5 mg./5 ml) dose 1.5 ml, prescribed for them by the allergist to treat allergic reactions.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Facial pain, Headache, Pharyngolaryngeal pain, Sinus headache
Clinical narrative: 11/28/07[11:30AM] Sinus pressure/headache/aching throat within 1-hour of vaccine. Following morning 11/29/07 [6:30AM] severe sinus pressure, swollen face, throat pressure. [2:30PM] significant facial pain, symptoms of throat closing. [3:15PM] Dr. Visit to MD primary care physician - confirmed sinus infection and breathing difficulty; prescribed Arithromycin and Benedryl. Took 2 benedryl every 4 hours for remainder of day; took 2 Arithromycin. 11/30/07 [6:30AM] continued taking Benedryl every 4 hours for throat pressure; taking one Arithromycin for add'l 4 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Swelling face, Throat tightness
Clinical narrative: 11/28/07[11:30AM] Sinus pressure/headache/aching throat within 1-hour of vaccine. Following morning 11/29/07 [6:30AM] severe sinus pressure, swollen face, throat pressure. [2:30PM] significant facial pain, symptoms of throat closing. [3:15PM] Dr. Visit to MD primary care physician - confirmed sinus infection and breathing difficulty; prescribed Arithromycin and Benedryl. Took 2 benedryl every 4 hours for remainder of day; took 2 Arithromycin. 11/30/07 [6:30AM] continued taking Benedryl every 4 hours for throat pressure; taking one Arithromycin for add'l 4 days.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Surrounding erythema (about 5 cm in diameter) appreared very shortly after administration of either HiB or IPV in right thight.  Knot develop at site.  Pt had fever to 101 for 2 days.  Antibiotics were prescribed (Bactrim, then Clindamycin), but pt did not tolerate any doses of either.  The erythema resolved in 3 days, but the small knot, and tenderness at the site, remain.
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Exposure to chemical pollution, Rash generalised
Clinical narrative: 9 month 22D old female presents with c/o Rash for yest woke with rash all over yest AM, spread since.        Flu shot given Friday (11/30), AGE noted 1 wk ago(11/22), Due to have PE Tubes tomorrow. Also, poss. chemical exposure as former trailer had been "bombed" for insects months ago; family went in over this weekend and child was playing on floor.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: 11/29/07-noticed red area size of a quarter, area was warm,firm,and started to itch. 12/30-red area was larger, itching more.  Benadryl cream and ice packs helped very little.  By 12/1 the red area was about 2 in. by 3 in.  On 12/2 the redness had begun to go away, but still itching some.  Today (12/3) it has continued to lessen, the itching is less, it is no longer warm, and the firm area has just about gone away.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Laboratory test normal, Secondary transmission, Sick relative, Vomiting
Clinical narrative: My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.  Interrogative; my stepson later received the Flu-Mist on 29 Nov. On 2 Dec, He became ill with the identical symptoms that my 3 year old displayed. They both vomited several times over a period of 4-5 hours.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Secondary transmission, Sick relative, Vomiting
Clinical narrative: My Stepson, who is in very good health, received the Flu Mist inhaler on 29 Nov. He became Violently ill with-in 24-30 hours of administration. I would not had given it a second thought except for what  had happen earlier in the week. That narrative follows.                                                 My Daughter received the shot on Tuesday 20 Nov. By Thursday 22 Nov late morning, she was throwing-up. Her symptoms lasted for approximately 5 hours. On 23 Nov, 24 hours after the onset of symptoms in my almost 3 year old daughter, my 45 year old sister, whom lives in my house-hold as well, became violently ill with vomiting, diarrhea chills, etc. On 24 Nov, 20 hours later, I became ill with the same symptoms and 2 hours after me, my wife became ill. My mother came into town that Thursday, 20 Nov, but never became ill. My stepson returned from his fathers on the Sunday, 25 Nov, and did not contract the illness. My 1 year old son was in the same room at the doctor's office when my 3 year old daughter received the Flu Mist inhaler. He threw-up on Thursday and acted ill as well as ran a temperature the same time my daughter did. But, he did not become more seriously ill until the evening of the 24th-25 of Nov. He threw-up several times during the same period that my wife and I became ill. He did not get diarrhea though. I am in the service and in very good health. I receive the flu shot every year and had had one 3-4 weeks prior to these illnesses. My wife is in good health and has not had the flu shot this year.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Injection site haemorrhage, Pyrexia
Clinical narrative: VACCINE REACTION BOTH LEGS
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Contusion
Clinical narrative: Patient had bruising on arm between shoulder and elbow.  Patient is taking coumadin.
Age: 0.58
Sex: F
Vaccine: DTPIHI
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Approximately 5 days after receiving her scheduled 6 month vaccinatins including the DTP she had a seizure. After an MRI and two EEG's the docter's never determined the cause. She had a total of 8 seizures during an eight month period of time. She has not had any vaccines since that time and has now been seizure free for a year.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash papular
Clinical narrative: 5:00 PM C/O ITCHING TO  LEFT UPPER EXTREMITY AND TORSO,  SCANT RAISED PAPULES TO LEFT FOREARM AND WRIST 5:15 VS B/P 132/76,P 93,RR 20 BENEDRYL 25MG PO GIVEN FOR ITCHING. MONITORED IN MEDICAL OFFICE.5:45 PM CONTINUE TO C/O ITCHING WITH INCREASED IRRITATION SPREADING T/O TORSO, DR NOTIFIED, RECEIVED ORDERS TO REPEAT BENEDRYL AND GIVE UP 100MG PO PRN, GAVE 25MG MORE AT THIS TIME, CONTINUE TO MONITOR IN MEDICAL OFFICE. 6:20PM VS B/P 108/82, P 82, RR20  PATIENT STATES TO HAVE DECREASED IRRITATION AND LESS ITCHING AT THIS TIME, NOTABLE FOR DECREASED RAISED RASH TO LEFT FOREARM AND WRIST AREAS.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Malaise, Pharyngeal oedema, Swelling face, Swollen tongue
Clinical narrative: Woke up Feeling Bad - (But felt bad going to bed - took Benadryl for Throat swelling 50 mg Dose) AM Tongue/Face Swollen Badly and Neck Swollen Took Benadryl; Took more Benadryl; Wheezing Symptoms Duration 2 hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Woke up Feeling Bad - (But felt bad going to bed - took Benadryl for Throat swelling 50 mg Dose) AM Tongue/Face Swollen Badly and Neck Swollen Took Benadryl; Took more Benadryl; Wheezing Symptoms Duration 2 hours.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration
Clinical narrative: Redness, induration at injection site of (R) deltoid from pneumococcal vaccine. Redness around upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLUX
Symptoms: Body temperature increased, Febrile convulsion, Vomiting
Clinical narrative: Temperature over 105F (even with having taken Tylenol to reduce any fever) - led to vomiting and a febrile seizure (which lasted no more than 10 minutes).  This all happened about 11 hours after the DTaP immunization.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Induration, Oedema peripheral, Pruritus
Clinical narrative: L arm swelling and itching since he got his Menactra vaccine 2 days ago.  Was bigger yesterday.  Smaller, but still firm and swollen today.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: On 11-16-07, noted rash above injection sites right leg covering upper thigh and lower abdomen, but not diaper rash. Rash hive-like. No fever no unusual crying. Went to regular doctors check up appointment on 11-21-07 Rash resolving. No treatment needed.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Nasal congestion, Nasopharyngitis, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: 24 to 48 hrs after vaccine sore throat, then felt like a cold (runny nose, congestion)
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rec'd Menactra 10/10/07 starting 3 days later pt developed intermittent hive-like rash/itchy lasting until at least 11/16/07 No other symptoms
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Tongue disorder
Clinical narrative: 11am-screened for flu shot-stated she was immune-compromised and on a lot of med. for rheumatoid arhtirits. Metronidazole, Prednisone-denies egg allergy. Flu shot given. 11:05-negative for problems 11:10 c/o tongue feeling weird and difficulty breathing BP 160/90 P-112 called fire depart-911.  11:05 Epinephrine 0.3 mg sc (R) deltoid adm. by nurse EMT's on site. Family notified. Pt responding and Transported to hospital
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection sites = cellulitis.  Treated with Omnicef.
Age: 0.1
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic-hyporesponsive reaction shortly after 2 mos vaccines lasting few days.  ? "Still not same" per parents.  ?Ne exam.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Erythema, Induration, Oedema
Clinical narrative: Local edema, erythema, and induration with bruising.  Had mild systemic symptoms that resolved in 2-3 days.  Onset of reaction within 6 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Skin test, Urticaria
Clinical narrative: Developed hives after receiving the flu vaccine.  Has hx of allergy to thimerosal, no allergy to egg/egg products.
Age: 6.0
Sex: F
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Culture, Injection site abscess, Injection site discharge
Clinical narrative: Abscess at site of vaccines. Pustular drainage 6 days after vaccine administration. Treated with drainage and Septra.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Fx F.S com area of redness, induration upper left arm
Age: 0.22
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Rhinorrhoea, Wrong drug administered
Clinical narrative: Flu mist given (not 24 mos old yet).  Instructions were to watch for any respiratory distress as well as flu symptoms.  On 11-8-07 (day after) mother stated child had runny nose and 2 diarrhea diapers.  No ther symptoms or fever.  11-9-07 doing fine.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Reddened rash like area to (L) deltoid states "a little itchy" at site. Benadryl taken by pt 11/15/07. Spoke to pt 11-16-07 1430 and rash beginning to fade. 11-28-07 Resolved.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Arthralgia, Hypersensitivity, Rash pruritic
Clinical narrative: Seen in ED 2 days after vaccines.  Received w/ pruritic rash & joint achiness.  Dx'd with "allergic reaction" and given diphenhydramine & prednisone.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling hot, Flushing, Wheezing
Clinical narrative: Chest tightness and wheezing. Spouse informed writer this lasted approx 5-10 min and that sx slowly resolved over evening. At onset felt hot, flushed followed by chest tightness and wheezing per pt.