chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB
Symptoms: Injection site haematoma
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bruise at the injection site in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Co-suspect vaccinations included unspecified vaccine(s); manufacture(s) unspecified; unknown on an unspecified date. On an unspecified date, the subject received an unspecified dose TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced a bruise at the injection site. The reporting nurse inquired if TWINRIX could be administered in the gluteal area, since the subject experienced a bruise after her last TWINRIX vaccine. In addition, the nurse stated that the patient received other unspecified vaccines on the TWINRIX vaccination, so she was unspecified. No further information was provided. Follow-up information was received on 26 August via a nurse, who stated that she did consider this to be an adverse event. It was unclear if the subject received the TWINRIX vaccine in her thigh or deltoid.
Age: 41.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 41-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), and Yellow fever vaccine (Sanofi). Concurrent medical conditions included hypothyroidism. Concurrent medications included LEVOXYL. On 21 August 2008 the subject received the 1st dose TWINRIX (1 ml, unknown, left arm), and the 1st dose of Yellow fever vaccine (unknown, left arm). Four hours after vaccination with TWINRIX and Yellow fever vaccine, on 21 August 2008, the subject experienced fever, chills and body pain. The subject was treated with TYLENOL and bedrest. As of August 2008, the events were resolved. The reporting nurse stated that the vaccination subject attributed the events to vaccination with TWINRIX, and does not want to continue the vaccination series. The healthcare professional considered the events were possibly related to vaccination with TWINRIX, but stated that the likely cause of the events was the Yellow fever vaccine instead of TWINRIX.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis A virus A virus igm antibody positive in a 20-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On unspecified dates in June and July 2008, the subject received the 1st dose and 2nd dose of TWINRIX (unknown). On an unspecified date after vaccination with TWINRIX, the subject had a hepatitis panel to test for chlamydia. On 22 August 2008, at an unspecified time after having the hepatitis panel taken, the subject's test results came back hepatitis A virus IGM antibody positive. At the time of reporting the outcome of the event was unspecified.
Age: 48.0
Sex: F
Vaccine: HEPAB, MEN, TD
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of antigenemia in a 48-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccinations given on an unspecified date in August 2008, included diphtheria and tetanus toxoids adsorbed; manufacturer unspecified; unknown; and a meningitis vaccine, strain not specified; manufacturer unspecified; unknown. On an unspecified date in August 2008, the subject received the 1st dose of TWINRIX (.5 unknown, unknown). Approximately one week after (7 to 8 days) receiving the TWINRIX vaccine, the subject gave blood to the American Red Cross and was informed that she had hepatitis B surface antigen in her blood. The subject subsequently received her 2nd dose of TWINRIX on 10 September 2008. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 06 October 2008 indicated that the event of antigenemia began on 11 August 2008. The outcome of the event was not known at the time of reporting, but the reporter felt that the event was possibly related to treatment with TWINRIX. It was documented that the subject would be tested 3 to 4 months after immunization.
Sex: U
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with TWINRIX (GlaxoSmithKline). In  2006 the subject completed the TWINRIX series. It was reported that the subject was not showing protection against antibodies. The subject had not responded to therapy. The reporter had limited information. No adverse events were reported.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Burning sensation, Joint swelling
Clinical narrative: Information has been received from a physician concerning a female adult with a history of pneumococcal infection who on 19-MAY-2008 was vaccinated with MERUVAX II (lot # 654402/0035U). Concomitant therapy included penicillin (unspecified). Subsequently, on 02-JUN-2008 the patient developed muscle pain. The patient started with pain in her neck which then traveled to her ankles and hands. It was not noted if medical attention was sought or if lab studies were performed. At the time of the reporter the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a physician concerning this 51 year old white female with increased cholesterol, hypertension, and two other health conditions (illegible) and thyroid cyst who on 19-May-2008 was vaccinated S.Q. in the left arm with MERUVAX II (Wister RA 27/3) (lot # 654402/0035U). There was no illness at the time of vaccination. Subsequently, on 03-JUN-2008 the patient started with progressive multi joint swelling and pain. The patient also had burning on the left side of her throat and pain in the left clavicular area. At the time of the report, the patient's symptoms totally resolved as per the patient's email correspondence on 07-JUL-2008.Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Information has been received from a physician concerning a female adult with a history of pneumococcal infection who on 19-MAY-2008 was vaccinated with MERUVAX II (lot # 654402/0035U). Concomitant therapy included penicillin (unspecified). Subsequently, on 02-JUN-2008 the patient developed muscle pain. The patient started with pain in her neck which then traveled to her ankles and hands. It was not noted if medical attention was sought or if lab studies were performed. At the time of the reporter the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a physician concerning this 51 year old white female with increased cholesterol, hypertension, and two other health conditions (illegible) and thyroid cyst who on 19-May-2008 was vaccinated S.Q. in the left arm with MERUVAX II (Wister RA 27/3) (lot # 654402/0035U). There was no illness at the time of vaccination. Subsequently, on 03-JUN-2008 the patient started with progressive multi joint swelling and pain. The patient also had burning on the left side of her throat and pain in the left clavicular area. At the time of the report, the patient's symptoms totally resolved as per the patient's email correspondence on 07-JUL-2008.Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Pain in extremity, Throat irritation
Clinical narrative: Information has been received from a physician concerning a female adult with a history of pneumococcal infection who on 19-MAY-2008 was vaccinated with MERUVAX II (lot # 654402/0035U). Concomitant therapy included penicillin (unspecified). Subsequently, on 02-JUN-2008 the patient developed muscle pain. The patient started with pain in her neck which then traveled to her ankles and hands. It was not noted if medical attention was sought or if lab studies were performed. At the time of the reporter the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a physician concerning this 51 year old white female with increased cholesterol, hypertension, and two other health conditions (illegible) and thyroid cyst who on 19-May-2008 was vaccinated S.Q. in the left arm with MERUVAX II (Wister RA 27/3) (lot # 654402/0035U). There was no illness at the time of vaccination. Subsequently, on 03-JUN-2008 the patient started with progressive multi joint swelling and pain. The patient also had burning on the left side of her throat and pain in the left clavicular area. At the time of the report, the patient's symptoms totally resolved as per the patient's email correspondence on 07-JUL-2008.Additional information is not expected.
Age: 0.6
Sex: F
Vaccine: RV5, RV5
Symptoms: Diarrhoea, Pneumonia, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 7 month old female patient with severe combined immune deficiency disorder, who in 2008 was vaccinated with an unspecified number of doses of ROTATEQ.  In approximately October 2008, "about 1 month ago", the patient developed rotavirus gastroenteritis and was hospitalized since the onset of the symptoms.  The patient had received supportive care for intermittent diarrhea and dehydration.  At the time of reporting, the patient had not recovered.  Gastroenteritis rotavirus was considered to be a disabling event.  Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a 7 month old female patient with severe combined immune deficiency disorder, who in 2008 was vaccinated with an unspecified number of doses of ROTATEQ.  In approximately October 2008, "about 1 month ago", the patient developed rotavirus gastroenteritis and was hospitalized since the onset of the symptoms.  The patient had received supportive care for intermittent diarrhea and dehydration.  At the time of reporting, the patient had not recovered.  Gastroenteritis rotavirus was considered to be a disabling event.  Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site atrophy
Clinical narrative: Initial report received on 18 November 2008 from a health care professional, the consumer, and a company representative for Sanofi Aventis. A 54-year-old female patient, who had no concurrent illnesses, and past medical history of depression and allergic rhinitis, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2789CA) on 13 October 2008 at 12:15 pm with a pre-filled syringe. Ten days post-vaccination, the patient was evaluated by her physician and diagnosed with progressive atrophy at the injection site. A copy of a picture of the left deltoid area was provided. No relevant diagnostic tests or laboratory data were performed. At the time of this report, the patient had not recovered. Documents held by sender: Photo of left deltoid area.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who in approximately May 2008, also reported as six months ago, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). On approximately 27-OCT-2008, the patient was vaccinated with a third 0.5 ml dose of GARDASIL (lot number, injection site and route not reported). Concomitant therapy included pain medication. 24 hours after receiving the third dose, on approximately 28-OCT-2008, also reported as about three weeks ago, the patient experienced chest pain, nausea and pain in her stomach. However there was no vomiting. Unspecified medical attention was sought. The patient's events persisted. The patient's events were considered to be disabling. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Chest pain, Nausea
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who in approximately May 2008, also reported as six months ago, was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). On approximately 27-OCT-2008, the patient was vaccinated with a third 0.5 ml dose of GARDASIL (lot number, injection site and route not reported). Concomitant therapy included pain medication. 24 hours after receiving the third dose, on approximately 28-OCT-2008, also reported as about three weeks ago, the patient experienced chest pain, nausea and pain in her stomach. However there was no vomiting. Unspecified medical attention was sought. The patient's events persisted. The patient's events were considered to be disabling. No further information is available.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Disorientation, Encephalitis, Intensive care
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of encephalitis in a 78-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (.5 unknown, unknown, left arm). On 9 November 2008, 3 days after vaccination with FLULAVAL, the subject experienced encephalitis, acute delirium and dementia. The healthcare professional was notified by a physician of an adverse event that occurred after a subject received a FLULAVAL vaccination. The subject is the physician's father. The subject was vaccination on 06 November 2008 and about three of four days later, the subject developed extreme dementia and was hospitalized. The subject was diagnosed with encephalitis and is still in the intensive care unit (ICU) at the time of the report. The reported healthcare professional did not know the facility were the subject was vaccinated at the time of the report. The physician has also completed a VAERS form and submitted to the FDA. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Delirium, Dementia, Encephalitis, Intensive care
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of encephalitis in a 78-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (.5 unknown, unknown, left arm). On 9 November 2008, 3 days after vaccination with FLULAVAL, the subject experienced encephalitis, acute delirium and dementia. The healthcare professional was notified by a physician of an adverse event that occurred after a subject received a FLULAVAL vaccination. The subject is the physician's father. The subject was vaccination on 06 November 2008 and about three of four days later, the subject developed extreme dementia and was hospitalized. The subject was diagnosed with encephalitis and is still in the intensive care unit (ICU) at the time of the report. The reported healthcare professional did not know the facility were the subject was vaccinated at the time of the report. The physician has also completed a VAERS form and submitted to the FDA. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Malaise, Tachycardia
Clinical narrative: Felt malaise and sick starting 15 min post vaccination.  Later afternoon went to ER & was admitted for tachycardia.  11/26/2008 MR received for DOS 11/12-13/2008 with D/C DX: Paroxysmal Atrial Fibrillation, now in sinus.  Mild hypertension. Ptpresented to ER with tachycardia, palpitations, and SOB which began after receiving flu shot. Found to be in A-fib upon arrival with ventricular rate 130-190s. Tx with diltiazem with improvement to the 110s. No cardiac hx. Self converted to SR during stress echo. D/C on ASA.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Had Polysaccharide vaccine on 11/5/08 during office physical before a surgery (left hand ring trigger finger) on 11/11/08. Got 102 temp on 11/5/08. To ER hospital on 11/6/08 and temperature was 103 degrees. I still had a 99.2 temperature on the day of my surgery 11/11/08 and surgery was done.  1/19/09 Reviewed ER medical records of 11/06/2008 FINAL DX: febrile reacton s/p pneumovax vaccination Records reveal patient experienced fever, dizziness, fatigue, dry cough, right lower chest pain w/cough.  Temp in Er 103.3. Tx w/antipyretics & d/c to home.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Large area of redness "3x3" soreness & warm to touch fever 101 degrees, 97.8 degrees at time of visit on 11/9/08
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pain since injection. Swelling and large red area around injection site. Reddened area 70mm, swollen area 30mm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Activities of daily living impaired, Computerised tomogram normal, Diarrhoea, Fatigue
Clinical narrative: Client stated that s/s began 5/15/08 with swelling of R arm x 2 wks with soreness; nausea; tiredness; legs very heavy and unable to walk.  Diarrhea x 7 wks beginning 5/15/08 (on antibiotics x2).  Absent from work x 3 d in may after injection; was seen in a local ED for inability to ambulate in June 08
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Parasite stool test negative, Sensation of heaviness
Clinical narrative: Client stated that s/s began 5/15/08 with swelling of R arm x 2 wks with soreness; nausea; tiredness; legs very heavy and unable to walk.  Diarrhea x 7 wks beginning 5/15/08 (on antibiotics x2).  Absent from work x 3 d in may after injection; was seen in a local ED for inability to ambulate in June 08
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Incorrect drug dosage form administered
Clinical narrative: None. Pt. was given HIB component of PENTACEL mixed w/ sterile water and no DTaP/IPV component. No adverse effects. Will require repeat vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction (B) legs. Tx cool compresses & Benadryl (L) 8cm x 6cm (R) 6cm x 3.5cm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Developed chicken pox. Injection 10/3/08.  Lesions started 10/6/08
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Papular, erythemic cluster (some with whiteheads, not vesicular, developed 4 days after VARIVAX at site of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Post herpetic neuralgia, Rash erythematous
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 63 year old female with high blood pressure and high cholesterol and no allergies, who on 15-JUN-2007 was vaccinated with ZOSTAVAX (Merck). Lot # 657676/0619U, intramuscularly into her left deltoid. Concomitant therapy possibly included Simvastatin (MSD) and Lisinopril (manufacturer unknown). It was reported that the patient on 30-JAN-2008 developed shingles. It began as pain only, in back and to right side at about T6-T8 level dermatome. Pain increased and red, vesicular rash appeared in dermatomal band on 06-FEB-2008 (previously reported as shortly before 07-FEB-2008). Patient was given ZOVIRAX, prednisone, and LYRICA. But she still developed postherpetic neuralgia. The symptoms persisted for approximately two months. On approximately 18-MAR-2008 (previously reported as by April 2008), the patient has completely recovered. There were no laboratory test performed, in follow-up information the physician also reported "unfortunately, no testing of vesicles was done (because the rash and pain were pathognomonic for herpes zoster)". In follow-up information shingles and post-herpetic neuralgia were considered to be and other important medical events. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 63 year old female with high blood pressure and high cholesterol and no allergies, who on 15-JUN-2007 was vaccinated with ZOSTAVAX (Merck). Lot # 657676/0619U, intramuscularly into her left deltoid. Concomitant therapy possibly included Simvastatin (MSD) and Lisinopril (manufacturer unknown). It was reported that the patient on 30-JAN-2008 developed shingles. It began as pain only, in back and to right side at about T6-T8 level dermatome. Pain increased and red, vesicular rash appeared in dermatomal band on 06-FEB-2008 (previously reported as shortly before 07-FEB-2008). Patient was given ZOVIRAX, prednisone, and LYRICA. But she still developed postherpetic neuralgia. The symptoms persisted for approximately two months. On approximately 18-MAR-2008 (previously reported as by April 2008), the patient has completely recovered. There were no laboratory test performed, in follow-up information the physician also reported "unfortunately, no testing of vesicles was done (because the rash and pain were pathognomonic for herpes zoster)". In follow-up information shingles and post-herpetic neuralgia were considered to be and other important medical events. No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 63 year old female with penicillin allergy, cholesterol high and hyperthyroidism who on 21-OCT-2008 was vaccinated with PNEUMOVAX 23 0.5 mL, intramuscularly (lot number was unspecified by reporter). Concomitant therapy included SYNTHROID, simvastatin (MSD) and LOVAZA. It was reported that the patient who received the PNEUMOVAX 23 was seen on 24-OCT-2008 for fever of 103F. The nurse stated that the patient went to the ER and was hospitalized, and was diagnosed with pneumonia at the hospital. Patient recovered on an unspecified date. This is one of three cases reported by the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 31-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 658560/1062U). There were no concomitant medications. Subsequently, the patient was pregnant. The patient had an office visit. An ultrasound was performed. The patient's last menstrual period was 30-NOV-2007 and her estimated delivery date was 11-AUG-2008. No product quality complaint was involved. In January 2008 the patient had an elective termination. It was unknown if the fetus was normal and if the products of conception were examined. The patient had no previous pregnancies. Upon internal review the elective termination was considered to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myoclonic epilepsy
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on unspecified date was vaccinated with a dose of GARDASIL. After three hours of GARDASIL vaccination, the patient developed myoclonic seizures. The patient sought medical attention at the office and emergency room. Upon internal review, myoclonic seizures were determined to be an other important medical event. At the time of reporting, 20-NOV-2008, the outcome of the patient was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse who reported that a patient reported that her "16 or 17 year old" female friend was vaccinated with a second dose of GARDASIL (Lot # not provided). Subsequently, she developed seizures and had to be taken to the hospital. Nurse reported that her patient reported that her friend also claimed that tests were performed in the hospital and the hospital physician felt her seizures were a result of GARDASIL and treated her with unspecified medications. The patient outcome was not provided. Upon internal review seizure was determined to be another important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who 2 weeks ago, on approximately 06-NOV-2008, was vaccinated with a dose of GARDASIL.  The patient experienced syncope and seizure-like symptoms after receiving the vaccine.  The patient experienced the symptoms while she was still at the physician's office.  The patient sought medical attention through an office visit.  Subsequently, the patient recovered.  Upon internal review seizure-like symptoms was determined to be another important medical event.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Irritability
Clinical narrative: Information has been received from a physician concerning a 16 week old female patient, who this summer of 2008 was vaccinated orally with the second dose of ROTATEQ, and within a week experienced irritability and had a blood on the stool. The patient was brought in the emergency room and was hospitalized. Patient was diagnosed of intussusception. The patient possibly underwent an ultrasound. Subsequently, the patient recovered. No further information is available.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Blood product transfusion, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Information has been received from a physician concerning an approximately 3 months old female patient with no concomitant medications, no pertinent medical history and no drug reactions/allergy reactions, who was vaccinated with the first dose of ROTATEQ (lot# not provided) one pouch orally. 2 weeks later the patient was admitted to the hospital for idiopathic thrombocytopenic purpura (ITP). It was reported that on admission the patient's platelet count was 3000. She was hospitalized for 2 days and was treated with intravenous immunoglobulin (IVIG). On 18-NOV-2008 the patient's platelet count was 128000. Physician recommended that the patient not receive any additional doses of ROTATEQ. At the time of this report the patient was recovering. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Angiogram abnormal, Dyspnoea, Inflammation
Clinical narrative: Labored Breathing --> CTA in ER demonstrated bilateral ground glass consistent with inflammatory process-possible "viral pneumonia".
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Akinesia, Crying, Hyperaesthesia
Clinical narrative: Skin sensitivity, crying excessively, could not move. 12/30/2008 MR received for DOS 11/20/08. Pt in for 12 yr WCC and vax. Dx with B OM. Returned to office that pm with c/o irritability, body pain and crying. Referred to ER. 1/5/09 ER records received for 11/20/08 visit with dx:  Immunization reaction. Pt presented with lightheadedness, body aches, sensitive skin, malaise and chills. Tx with Solumedrol and Benadryl.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, induration of 4.3cm x 5cm. Warm to touch, tenderness, itching.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Redness, swelling, induration of 4.3cm x 5cm. Warm to touch, tenderness, itching.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: redness, swelling- induration of 5 cm x 6 cm.  Warm to touch, severe itching tenderness
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: redness, swelling- induration of 5 cm x 6 cm.  Warm to touch, severe itching tenderness
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Initial report received on 19 November 2008 from a health care professional. A male patient had received a dose of FLUZONE SV 2008-2009 on 05 November 2008. The lot number, route and site of administration was not provided. Approximately 12 days post-vaccination, the patient began to experienced symptoms that were later confirmed by his family physician to be Bell's Palsy. It was not reported whether any diagnostic test's or laboratory data were completed. It was also not reported whether any treatment was received for the event. The recovery status of the patient was not provided. The reporter is not convinced the event is related to the vaccine. Documents held by sender: None. The reporter for this case is the same as for case 2008-03427.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pain in (L) deltoid started the day received the vaccine; only 20% better after 5 weeks of pain with shoulder ROM mildly tender to palp.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pustule, Injection site ulcer
Clinical narrative: The patient developed a pus filled area at the site of injection. The area then proceeded to ulcerate into 0.5x 1.5 cm area.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm pain that radiated to elbow requiring treatment with Ibuprofen and moist heat frequently x 4 mo.- ongoing. Occurred with admin. of GARDASIL #1 (06/19/2008) and #2(10/27/2008). Onset immediately post injection both dates.
Age: 1.6
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Wrong technique in drug usage process, X-ray
Clinical narrative: Doctor believes injection was in bursa causing bursitis-severe pain in left shoulder
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Patient was asleep and became chilled and began shivering for about an hour.   Finally shaking stopped.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Dysphagia, Dysphoria, Gaze palsy, Tremor
Clinical narrative: See attached history/ M Record
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: See attached history/ M Record
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: Pt describes fever, achiness, redness @ injection site lasting for 3 days. Has had influenza vaccine previously w/o any problems. She describes these s.e's as being severe.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, TTOX, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: TD given instead of DTAP.  Child shoud have received DTAP because of age.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient telephoned the 1-866 number and requested a call back. She called on 11-25-08 and I called her that day.  She stated that since she had the flu vaccination she has had arm pain.  At first she said she thought it would go away and did not call us.  Yesterday, 11-25-08 was the first day she called to notify us.  She states she has gone to an orthopedic surgeon for an evaluation of the pain.  She states the physician found no broken bones and prescribed some Diclofenac for the pain.  She states that she has the pain and wants to know what to do.  She called our clinic to see what she should now do.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Within less then 10 hours patient was nausea, hot and sweaty
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Drug level increased, Drug toxicity
Clinical narrative: Phenytoin toxicity, also reported in VA ADERS. 12/29/2008 MR received for DOS 11/25-28/2008 with D/C DX:  Dilantin Toxicity.  Hx of seizure d/o. Pt presented to ER with c/o feeling unwell and tired x 1 wk as well as episodes of SOB.  Seen twice in ER previously. This am pt  was feeling hot/cold, dizzy, shakey and feeling as though would fall. Admitted for observation. On 11/26/08 pt developed substernal chest pain/pressure which resolved on it's own. EKG was WNL. On 11/27 pt developed twitching  of jaw. No new seizure activity.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Feeling cold, Hyperhidrosis, Tremor
Clinical narrative: Five hours after vaccination, I began to have trouble breathing.  My voice got really horse and I felt that I was only able to take in about 60-70% of my normal air.  Then, I got extremely cold and couldn't get warm.  I got under covers and began shaking fiercly.  This went on for several hours and finally stopped after several sweats.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Pt woke with faint red raised rash over her arms face and back which developed and included strong itching as the day progressed. Went to MD 11/25/2008 and received a prescription which relieved her symptoms.No reaction to previous  flu vaccine in 2006.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received Menactra on 10/12/05.  pt given second dose of Menactra on 02/20/07.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HEPA, PPV
Symptoms: Abnormal behaviour, Anorexia, Crying, Fluid intake reduced, Injection site induration
Clinical narrative: fever, constant crying (unconsolable), knot at injection site, injection site hot, not eating, not sleeping, drinking very little, and not wanting to walk or be picked up.  So far we are treating with an ice pack, ibuprofen, and TLC.  His symptoms normally last a month or longer before he returns to normal.  If symptoms persist he will be taken to the ER.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HEPA, PPV
Symptoms: Injection site warmth, Pyrexia, Sleep disorder
Clinical narrative: fever, constant crying (unconsolable), knot at injection site, injection site hot, not eating, not sleeping, drinking very little, and not wanting to walk or be picked up.  So far we are treating with an ice pack, ibuprofen, and TLC.  His symptoms normally last a month or longer before he returns to normal.  If symptoms persist he will be taken to the ER.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: LIGHT HEADEDNESS, DIZZINESS, DIAPHORERIC
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Feeling hot, Flushing, Swollen tongue, Urticaria
Clinical narrative: within minutes of receiving vaccines became hot/flushed and developed hives over body and experienced swelling of tongue. Has history of severe allergic reactions ands carries treatment medications with her. She took benadryl, doxepin, and chlortrimeton. Symptoms resolved without taking epinephrine as well.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Hypersensitivity, Myalgia
Clinical narrative: Patient states he had muscle aches, fever, weakness and difficulty breathing 3-4 hours after the shot. Did not seek medical attention. States he went to bed and woke up during the night with vomiting and diarrhea which lasted 7 days.  Finally saw family doctor who told him he had allergic reaction to flu shot
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient states he had muscle aches, fever, weakness and difficulty breathing 3-4 hours after the shot. Did not seek medical attention. States he went to bed and woke up during the night with vomiting and diarrhea which lasted 7 days.  Finally saw family doctor who told him he had allergic reaction to flu shot
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Influenza, Pyrexia, Vomiting projectile
Clinical narrative: Experienced an intense flu cycle, 4.5 hours after vaccination. Onset of bone-racking chills at 8:00 PM, 11/25/08, lasting for 2 hours, then uncontrollable projectile vomiting, then fever (slight at first) which built up until it broke at 3:15AM, 11/26/08.  Bundled in blankets for chills, took Tylenol Rapid Action liquid for fever, and applied ice packs to forehead, back of neck and chest.  Took ice chips by mouth from 11PM, 11/25/08 until 3AM, 11/26/08.  Slept from 3:15 - 6:20 and woke up feeling weak, but certainly better.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Small intestinal obstruction
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 9/28/08 for small intestine obstruction. Vaccination took place on 10/31/07. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE REporting Form upon request.  12/31/08 Reviewed hospital medical records of 9/28-10/07/2008. FINAL DX: small bowel obstruction w/ischemic bowel;exp lap; small bowel resection w/primary anastamosis; lysis of adhesions; wound erythema Records reveal patient experienced intermittent burning severe chest & epigastric pain, nausea, vomiting, abdominal distention.  Failed conservative treatment & taken to OR on 10/1.  Improved & d/c to home on oral antibiotics w/clinic f/u.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Fall, Pyrexia
Clinical narrative: Child got slight fever on 11/21/08. Then on 11/23/08, got dizzy & fell down on the kitchen floor,no LOC. Is ok now.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: LEFT ARM SWOLLEN FROM SHOULDER TO ELBOW, WARM TO TOUCH
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Cough, Dyspnoea, Fatigue
Clinical narrative: shoulder begin to ache, by evening site was swollen to size of grapefruit and hard and hot to the touch.  At 6:00p.m, got very congested and started coughing alot,hard to breathe,(the hard to breathe part subsided after a few seconds) felt weak, tired, and could feel pain all the way to my fingertips.  felt mild nausea and headache that lasted for three and a half days.  Took nyquil two nights in a row and by Friday morning felt better but only worked half day. Did not feel completely back to normal until Sunday afternoon except for the soreness still around the site of the shot.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: shoulder begin to ache, by evening site was swollen to size of grapefruit and hard and hot to the touch.  At 6:00p.m, got very congested and started coughing alot,hard to breathe,(the hard to breathe part subsided after a few seconds) felt weak, tired, and could feel pain all the way to my fingertips.  felt mild nausea and headache that lasted for three and a half days.  Took nyquil two nights in a row and by Friday morning felt better but only worked half day. Did not feel completely back to normal until Sunday afternoon except for the soreness still around the site of the shot.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Respiratory tract congestion
Clinical narrative: shoulder begin to ache, by evening site was swollen to size of grapefruit and hard and hot to the touch.  At 6:00p.m, got very congested and started coughing alot,hard to breathe,(the hard to breathe part subsided after a few seconds) felt weak, tired, and could feel pain all the way to my fingertips.  felt mild nausea and headache that lasted for three and a half days.  Took nyquil two nights in a row and by Friday morning felt better but only worked half day. Did not feel completely back to normal until Sunday afternoon except for the soreness still around the site of the shot.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Hypersensitivity
Clinical narrative: Pt presented to HD in no acute distress 11/13. Shots given 11/10/08. Mother states child was taken to ER 11/12. Received steroid shot for allergic reaction, erythematous area 9-10 cm in child's  Dr. prescribed amoxcillin.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope after injection approx 1 min.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Atrioventricular block
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a complete heard block. Vaccination took place on 10/1/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  12/31/08 Reviewed study SAE report. Hospitalized 10/8-10/11/2008. FINAL DX: complete heart block Records reveal patient experienced dizziness, diaphoresis, weakness & pain in left arm.  Intensive care.  Pacemaker inserted.
Age: 62.0
Sex: U
Vaccine: PNC
Symptoms: Lymphoma, Tongue neoplasm malignant stage unspecified
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with cancer of the tongue and nodes in neck. Vaccination took place on 9/25/2007. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.  12/31/08 Reviewed study SAE. FINAL DX: cancer of tongue & nodes in neck Records reveal patient experienced pain with swallowing.  Scheduled to have surgery & begin chemo.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Influenza like illness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: PATIENT AND HER MOTHER COMPLAINED OF PATIENT EITH LOW GRADE FEVERS AND FLU LIKE SYMPTOMS AFTER GETTING THE FIRST TWO INJECTIONS. ALSO COMPLAINED OF NUMBNESS IN HER ARM
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Blood glucose increased, Dysphagia, Face oedema, Fatigue
Clinical narrative: Headaches, weakness, sore arm, generalized hives, severe urticaria and fatigue, difficulty swallowing, marked facial edema. 12/17/2008 MR received for ER 10/26/08 and admit 10/27-11/1/2008 with D/C DX: Acute Allergic Reaction with diffuse, severe urticaria and angioedema-felt to be 2' to recent vaccination.  Minimal liver enzyme elevation-felt to be 2' to allergic rxn. Pt initially presented to ER 10/26/08 with urticaria and lip swelling. Tx with steroid and antihistimines with 80% improvement. Returned the next day with worsening urticaria, generalized erythema/rash, and swollen lips, face and eyelids. Readmitted for more IV steroids with 90% improvement.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain in extremity, Swelling face, Urticaria, White blood cell count increased
Clinical narrative: Headaches, weakness, sore arm, generalized hives, severe urticaria and fatigue, difficulty swallowing, marked facial edema. 12/17/2008 MR received for ER 10/26/08 and admit 10/27-11/1/2008 with D/C DX: Acute Allergic Reaction with diffuse, severe urticaria and angioedema-felt to be 2' to recent vaccination.  Minimal liver enzyme elevation-felt to be 2' to allergic rxn. Pt initially presented to ER 10/26/08 with urticaria and lip swelling. Tx with steroid and antihistimines with 80% improvement. Returned the next day with worsening urticaria, generalized erythema/rash, and swollen lips, face and eyelids. Readmitted for more IV steroids with 90% improvement.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: 1) Arm muscle soreness at injection site & generalized fatigue for 2-3 days after vaccine; 2) REASON FOR THIS REPORT: then onset 1 week after vaccine of severe spinal pain radiating down both legs, severe headache, low grade fever, night sweat X 1 night, chills & fatigue progressively worsening over 3 days with no known exposure to meningitis or any other viral illness. Symptoms peaked in severity from 11/13pm-11/14pm and relieved after acupuncture and several days of ibuprofen and rest.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Night sweats, Pyrexia
Clinical narrative: 1) Arm muscle soreness at injection site & generalized fatigue for 2-3 days after vaccine; 2) REASON FOR THIS REPORT: then onset 1 week after vaccine of severe spinal pain radiating down both legs, severe headache, low grade fever, night sweat X 1 night, chills & fatigue progressively worsening over 3 days with no known exposure to meningitis or any other viral illness. Symptoms peaked in severity from 11/13pm-11/14pm and relieved after acupuncture and several days of ibuprofen and rest.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Pentacel was given but only the Dtap/IPV portion, it was not mixed with the Hib portion.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Child had cough, fever, runny nose and rash 7-10 days after vaccination. No treatment given.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Intussusception. 01/06/2009 MR received for DOS 11/20-23/2008 with D/C DX:  Intussusception. Pt initially presented to PCP with c/o bilious emesis x3, refusing po, irritability and crying. Pale, mottled and lethargic. Sent to ER for transport to higher level of care. PE (+) for decreased activity, back arching, abdominal tenderness, single macule on suprapubic skin. IS (+) on BE but unable to reduce.  Taken to OR for Irreducible Ileocolic IS-laparoscopy.  Reduction of IS. Appendectomy. Post-op uneventful and d/c home.
Age: 1.29
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 104. ER trip.
Age: 52.0
Sex: M
Vaccine: TD, DT
Symptoms: Hypotension, No reaction on previous exposure to drug, Rash, Rash pruritic, Tachycardia
Clinical narrative: Pt received TD toxoid 0.5 ml im at medical center on 11/10/08 at 4:30 pm. He was transferred here for ETOH detox. At ER here he developed pruritic skin rash noted at 11-23pm, initial VS were OK. He was treated with DECADRON 4 mg im and BENADRYL 50 mg im. Within one hour, he developed hypotension, tachycardia, worsening skin rash. He was given another 4 mg im of DECADRON, IV NSS, EPIPEN 0.3 mg/0.3 ml im with improvement. Comment - On 7/22/08, Pt had TD toxoid without reaction.  12/16/08 Reviewed ER medical records of 11/10/2008. FINAL DX:alleged assault, ETOH intoxication, fall, contusion of forehead & nasal avulsion. Tx w/wound care & Td.  Transferred to higher level of care.  2/18/09 Received Hospital d/c summary of 11/21/-11/24/08. FINAL DX: acute alcohol intoxication; alcohol dependent; personality disorder; DTs; alcoholic liver disease Records reveal patient w/multiple hospitalizations for same.  Improved & d/c to rehab program.