chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Caesarean section, Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included abnormal pap smear, asthma, autoimmune deficiency syndrome and hepatitis B. On 03 August 2009, at 16 weeks gestation, at 14:58 the subject received the 1st dose of HAVRIX (unknown, unknown arm). Her last menstrual period was on an unspecified date and estimated date of delivery was on 20 January 2010. The patient was exposed to HAVRIX during the 2nd trimester. Follow-up information was received on 13 April 2010 via healthcare professional. Additional medical conditions included bacterial vaginosis, candidiasis, herpes simplex virus and human immunodeficiency virus. Concurrent medications included KALETRA, TRUVADA, Azithromycin, Valaciclovir hydrochloride, Metronidazole, VENTOLIN HFA, MEPRON, Albuterol, Ferrous sulfate, Prenatal vitamins and TERAZOL. The subject was diagnosed with chronic hepatitis B prior to pregnancy; perinatal exposure to HIV with lifelong infection and AIDS diagnosis. Inconsistent adherence to antiretroviral treatment for hepatitis B and HIV during pregnancy. On 29 September 2009, at approximately 24 weeks gestation, the subject experienced an additional events of immune reconstitution syndrome and on 28 December 2009, at approximately 36 weeks and five days, oral herpes simplex virus 1 lesion. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the immune reconstitution syndrome and oral herpes simplex 1 lesion were improved. On 29 December 2009, after 36 weeks and six days gestation, the subject gave birth to a female live infant. The infant was delivered by cesarean section; weight, Apgar score and length were not provided. The neonate experienced weight loss and respiratory syncytial virus. Please see report A0801954B for details regarding the 'baby' case.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Angina pectoris
Clinical narrative: This report was received from the investigator on 12 April 2010. A 35 year-old male subject received the following vaccines on 15 March 2009:  ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Nine days after vaccination, the subject reportedly experienced angina pectoris. The subject had a history of high blood pressure, elevated cholesterol, abnormal electrocardiogram, dizziness/fainting spells, shortness of breath, asthma and numbness or paralysis. The outcome was not reported.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Encephalitis, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: This report was received from the investigator of a trial on 12 April 2010. A 29 year-old male subject with medical history significant for headaches and numbness or paralysis received ACAM2000 (lot number not reported) on 05 December 2008. The subject also received anthrax vaccine (manufacturer and lot number were not reported) that same day. Sixteen days prior, the subject received TYPHIM VI (lot # not reported) and anthrax vaccine (manufacturer and lot # not reported). Thirteen days after receipt of ACAM2000, the subject was reportedly diagnosed with encephalitis of unspecified cause. The medical record review found one code of "other causes of encephalitis" with a diagnosis date of 18 December 2008 and one code of "unspecified cause of encephalitis" on 24 December 2008. An MRI of the spinal cord on 18 December 2008 was abnormal, no other details were provided. No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 12 April 2010. A 27 year-old male subject received the following vaccine on 15 January 2009: ACAM2000 (lot number not reported). Twenty days after vaccination, the subject was diagnosed with unspecified acute pericarditis and unspecified disease of the pericardium. The subject had no reported medical history. The subject had an abnormal troponin I on 28 January 2009 (results 00.71). No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease
Clinical narrative: This report was received from the investigator of a trial on 12 April 2010. A 57 year-old male subject received ACAM2000 vaccine, lot number not reported on 24 February 2009, and anthrax vaccine (other manufacturer and lot number not reported) on 17 February 2009. On 09 March 2009 (13 days after vaccination with ACAM2000 the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of abnormal electrocardiogram (date not provided). On 25 February 2009, the subject had an electrocardiogram which was abnormal. On 11 March 2009, the subject had an echocardiogram which was normal. The outcome was not reported. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Pain, Pain in extremity
Clinical narrative: Information has been received from a health care worker concerning a 23 year old female patient with anxiety disorder and penicillin allergy who on 29-JAN-2009, 27-JUL-2009 and 24-MAR-2010 received the first (intramuscularly), second and third dose of GARDASIL respectively (Lot # 662300/0100Y for third dose). Concomitant therapy included clonazepam, CYMBALTA and ORTHO TRI-CYCLEN. On 31-MAR-2010 the patient called the physician's office with arm pain. The physician recommended warm compression alternating with ice, and ibuprofen. The patient's pain did not improve, so she came to the office later that day. While in the office, the physician found "no redness and nothing visible". She complained of pain in the left arm radiating into the elbow, shoulder, and chest wall. The physician continued to recommend ice and heat along with naproxen and hydrocodone with acetaminophen. On 05-APR-2010, she was again seen in the office. The patient still had arm pain. She complained that she needed to sit with the arm supported. She stated that the pain was sharp with motion and radiated to the elbow and upper back. It caused her to miss a few days of work. The physician gave her prednisone and oxycodone with acetaminophen. At the time of this report, the patient was not recovered. The patient sought unspecified medical attention. The reporter considered the adverse events to be disabling and other important medical events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with papanicolaou smear abnormal and papilloma viral infection positive (possibly for 16 and 18) and drug reactions or allergies reported as none who on 27-JAN-2010 was vaccinated with a first dose of GARDASIL (lot # 662299/1099Y) intramuscularly. There was no concomitant medication. It was reported that after first dose of vaccine she had no adverse effects. On 29-MAR-2010 she received second dose of GARDASIL (lot # not reported). On the same night as the second dose of vaccine on 29-MAR-2010, she developed a fever, itching and a generalized rash on the abdomen, arms and neck. The rash spread, so she reported to the office on 06-APR-2010. There was no fever when she reported to the office. The physician gave her a prescription for BENADRYL 50mg three times daily for 5 days. At the time of the report on 08-APR-2010 she was recovering. There were no laboratories diagnostics studies performed. Fever, itching and generalized rash on the abdomen, arms and neck were considered to be an other important medical event by the primary reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Epilepsy
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with epilepsy who on unspecified dates was vaccinated with two doses of GARDASIL, 0.5 ml, IM. Concomitant therapy included hormonal contraceptives (unspecified), started "about the same time as the first dose of GARDASIL". The dosage of the birth control pill was increased due to the patient also taking LAMICTAL. The physician reported that the patient had experienced an increase in frequency of seizures since her first dose of GARDASIL. The physician reported that the patient was under the care of an unspecified neurologist due to her known history of epilepsy. At the time of the report the patient's outcome was not specified. The patient sought medical attention by an office visit. No diagnostic tests were performed. Upon internal review increase in frequency of seizures was determined to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: HBHEPB
Symptoms: Autism, Incorrect dose administered
Clinical narrative: Information has been received from a consumer concerning his son who on unspecified dates was vaccinated with three 0.5 mL doses of COMVAX right after he was born while still in the hospital and "3 more doses later on". The lot numbers was provided as lot# 653272/0011F, 655548/1243F, and 655551/1244F. The consumer did not specified if these were the ones given to his son when he was in the hospital or if they were the ones given after he got out. The consumer did not specify what hospital his son was in and did not say how long he was there after having been born. Since then, his son had developed autism. It was unknown if medical attention was sought. At the time of the report, the patient's status was unknown. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Large local reaction, localized pain increasing in severity over the day, and developed a warm red rash.  Pt. will continue Ibuprofen and given ORAPRED 30 mg X 3 days.
Age: 9.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Local reaction, Pain, Rash erythematous, Skin warm
Clinical narrative: Large local reaction, localized pain increasing in severity over the day, and developed a warm red rash.  Pt. will continue Ibuprofen and given ORAPRED 30 mg X 3 days.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: Erythema, pain, body ache, fever for the first, second and third days. Pt. took Aleve during these days which helped with swelling of injection site and body aches. Pt. seen in office on 3/24/2010 at which time, no fever, no redness.  She does have large subcutaneous nodule at the site of injection which is painful to touch.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Erythema, pain, body ache, fever for the first, second and third days. Pt. took Aleve during these days which helped with swelling of injection site and body aches. Pt. seen in office on 3/24/2010 at which time, no fever, no redness.  She does have large subcutaneous nodule at the site of injection which is painful to touch.
Age: 23.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site swelling
Clinical narrative: Today on 4/15/10 patient reports that day after Hepatitis B vaccine given on 1/5/10 (left Deltoid IM) he had swelling in upper arm that involved the shoulder down to his elbow.  Denies pain with swelling and states that he did not inform anyone of the swelling because it was not painful.  Patient states that the swelling lasted approximately 1 month.  He reports this to me today when he presents for his second Hep B vaccine.  Denies any other problems specifically SOB, hives, itching, etc.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count normal, Injection site pain, Injection site swelling
Clinical narrative: Progressive pain and swelling below injection site
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Asthma, Condition aggravated, Epstein-Barr virus test positive, Headache
Clinical narrative: Lethargy, not feeling well, headache, pain in abdomen on 12/18. Since then, repeated colds and continuing lethargy, as well as an asthma attack.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Lethargy, Malaise, Nasopharyngitis
Clinical narrative: Lethargy, not feeling well, headache, pain in abdomen on 12/18. Since then, repeated colds and continuing lethargy, as well as an asthma attack.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Urticaria
Clinical narrative: Lesions on bilateral hands and elbows. Patient had c/o urticaria. Treated with Benadryl for urticaria.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Ataxia, Blood culture negative, C-reactive protein decreased, CSF glucose normal
Clinical narrative: Initially fussy, fever to 102 F, NBNB emesis. Developed waxing and waning mental status, ataxic gait. Admitted after 8 days of symptoms. Eventually diagnosed with ADEM and started on Solumedrol with improvement but not complete resolution of symptoms after 3 days of steroid. Plan to continue for 2 more days and discharge on 3 week prednisone taper.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: CSF protein normal, CSF white blood cell count increased, Enterovirus test negative, Epstein-Barr virus test negative, Herpes simplex serology negative
Clinical narrative: Initially fussy, fever to 102 F, NBNB emesis. Developed waxing and waning mental status, ataxic gait. Admitted after 8 days of symptoms. Eventually diagnosed with ADEM and started on Solumedrol with improvement but not complete resolution of symptoms after 3 days of steroid. Plan to continue for 2 more days and discharge on 3 week prednisone taper.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Irritability, Mental status changes, Nuclear magnetic resonance imaging abnormal, Polymerase chain reaction, Pyrexia
Clinical narrative: Initially fussy, fever to 102 F, NBNB emesis. Developed waxing and waning mental status, ataxic gait. Admitted after 8 days of symptoms. Eventually diagnosed with ADEM and started on Solumedrol with improvement but not complete resolution of symptoms after 3 days of steroid. Plan to continue for 2 more days and discharge on 3 week prednisone taper.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Vomiting, White blood cell count increased
Clinical narrative: Initially fussy, fever to 102 F, NBNB emesis. Developed waxing and waning mental status, ataxic gait. Admitted after 8 days of symptoms. Eventually diagnosed with ADEM and started on Solumedrol with improvement but not complete resolution of symptoms after 3 days of steroid. Plan to continue for 2 more days and discharge on 3 week prednisone taper.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling, Urticaria
Clinical narrative: Pain in arm-first day; swelling and hives, noticed morning of 4/13/2010; called advice nurse morning of 4/14/2010; took ibuprofen and Benadryl - symptoms lessened.
Age: 1.99
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching left thigh.  Treated with amoxicillin and Benadryl ~ 4/12, improving today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling left deltoid
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 2-3cm erythematous area, warm to touch, given Bbactroban ointment.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm became increasingly sore and stiff by the time I was going to bed (about 11 PM) I was unable to move my arm in any direction more the 3 or 4 inches and was in a lot of pain.  I was unable to move my arm for the next 3 days.  My arm began to ease up a little but as of today (April 15, 2010) I am still unable to lift more than a couple of pounds with that arm or I will have a great deal of pain and I am unable to reach behind my back or raise my arm above my head.  I am in frequent pain even when I don't move my arm.  I am unable to sleep on my left side.  I am unable to hold my arm up (as if holding a book) more than a couple of minutes without being very painful.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Borrelia test negative, Computerised tomogram normal, Cytomegalovirus test negative, Injection site pain, Lymphadenopathy
Clinical narrative: injection site still tender.developed a rash/hives on arms & legs in february lasting 6wks.then fever(103-104) accompanied by lymphadenopathy on april 4.fever lasted 1 wk.viral work-up negative
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rash, Urticaria, Viral test negative
Clinical narrative: injection site still tender.developed a rash/hives on arms & legs in february lasting 6wks.then fever(103-104) accompanied by lymphadenopathy on april 4.fever lasted 1 wk.viral work-up negative
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Borrelia test negative, Burning sensation, Chest pain, Computerised tomogram normal
Clinical narrative: Got the new H1N1 vaccine and Started with weird cool sensations in head neck back arms and legs. Has since then turned into burning contant pain in head neck back arms and legs. Started so bad that I couldn't hold head up was in bed for the first 2 months. Was weak, had rapid heart beat chest pain. Started having zapping burning pains in head that is constant and never goes away. Has been constant for the past 4 months, getting worse not getting better. Even started with burning gums and tongue. Feeling of cool air going through left eye. Have had chronic nausea but the worst is the burning pain in my head. Left toes started mildy tingling on occasion. So far have been in and out of emergency room since shot, have had to be admitted to hospital for testing and evaluation. Have seen neurologist, rheumatologist, infectious disease doctor, primary physician, and the list goes on and on. All say since all testing is showing negative it points to vaccine.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gingival pain, Glossodynia, Heart rate increased, Immunology test normal, Laboratory test normal
Clinical narrative: Got the new H1N1 vaccine and Started with weird cool sensations in head neck back arms and legs. Has since then turned into burning contant pain in head neck back arms and legs. Started so bad that I couldn't hold head up was in bed for the first 2 months. Was weak, had rapid heart beat chest pain. Started having zapping burning pains in head that is constant and never goes away. Has been constant for the past 4 months, getting worse not getting better. Even started with burning gums and tongue. Feeling of cool air going through left eye. Have had chronic nausea but the worst is the burning pain in my head. Left toes started mildy tingling on occasion. So far have been in and out of emergency room since shot, have had to be admitted to hospital for testing and evaluation. Have seen neurologist, rheumatologist, infectious disease doctor, primary physician, and the list goes on and on. All say since all testing is showing negative it points to vaccine.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia, Peripheral coldness
Clinical narrative: Got the new H1N1 vaccine and Started with weird cool sensations in head neck back arms and legs. Has since then turned into burning contant pain in head neck back arms and legs. Started so bad that I couldn't hold head up was in bed for the first 2 months. Was weak, had rapid heart beat chest pain. Started having zapping burning pains in head that is constant and never goes away. Has been constant for the past 4 months, getting worse not getting better. Even started with burning gums and tongue. Feeling of cool air going through left eye. Have had chronic nausea but the worst is the burning pain in my head. Left toes started mildy tingling on occasion. So far have been in and out of emergency room since shot, have had to be admitted to hospital for testing and evaluation. Have seen neurologist, rheumatologist, infectious disease doctor, primary physician, and the list goes on and on. All say since all testing is showing negative it points to vaccine.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Posture abnormal, Thyroid function test normal, Vitamin B12 normal, White blood cell count normal
Clinical narrative: Got the new H1N1 vaccine and Started with weird cool sensations in head neck back arms and legs. Has since then turned into burning contant pain in head neck back arms and legs. Started so bad that I couldn't hold head up was in bed for the first 2 months. Was weak, had rapid heart beat chest pain. Started having zapping burning pains in head that is constant and never goes away. Has been constant for the past 4 months, getting worse not getting better. Even started with burning gums and tongue. Feeling of cool air going through left eye. Have had chronic nausea but the worst is the burning pain in my head. Left toes started mildy tingling on occasion. So far have been in and out of emergency room since shot, have had to be admitted to hospital for testing and evaluation. Have seen neurologist, rheumatologist, infectious disease doctor, primary physician, and the list goes on and on. All say since all testing is showing negative it points to vaccine.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Inflammation, Influenza like illness, Myalgia, Oedema peripheral
Clinical narrative: Fever- 38.3 C Flu like symptoms, muscle ache, inflammation of the deltoid- red and swollen
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Fever- 38.3 C Flu like symptoms, muscle ache, inflammation of the deltoid- red and swollen
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pain, Pyrexia, Swelling
Clinical narrative: Pain at site of vaccination without hives at shot - fever, swelling, body aches within 24 hours  - without rash left deltoid.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot raised are at site. Given MPTRIN PRN.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in a trial on 13 April 2010. A 37 year-old male subject received ACAM2000 (lot number not reported) on 12 March 2009. The subject previously received TYPHIM VI (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported) on 21 February 2009. On 24 March 2009 (twelve days after vaccination with ACAM2000, live the subject was diagnosed with non-specific myocarditis. On 23 March 2009, the subject had an electrocardiogram which was abnormal. On 24 March 2010, the subject had a Troponin I which was 1.79 (abnormal) and an echocardiogram which was also abnormal. The subject had no significant medical history. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 13 April 2010. A 19 year-old male subject received the following vaccines on 11 January 2009: ACAM2000 (lot number not reported); and Anthrax vaccine (other manufacturer and lot number not reported). Eleven days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On 22 January 2009, the subject had a Troponin I and electrocardiogram which were reported as abnormal. On 03 February 2009, the subject had an echocardiogram which was also abnormal. The subject had no significant medical history. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This report was received from the investigator in the above mentioned trial on 13 April 2010. A 19 year-old male subject received the following vaccines on 11 January 2009: ACAM2000 (lot number not reported); and Anthrax vaccine (other manufacturer and lot number not reported). Eleven days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On 22 January 2009, the subject had a Troponin I and electrocardiogram which were reported as abnormal. On 03 February 2009, the subject had an echocardiogram which was also abnormal. The subject had no significant medical history. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Initial report received on 06 November 2009 from a health care professional. A male patient (demographics not provided) had received a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number not reported) two weeks prior to 06 November 2009. At an unspecified amount of time later, the patient complained of numbness in his thumb (site not reported); this required a doctor visit. At the time of the report, no further information was available. Follow-up information was received from the pharmacist on 08 April 2010. Based upon this new information, the case has been upgraded to serious. The patient was a 59-year-old male, with no relevant medical history. He was not ill at the time of vaccination, and was not taking any other medications. On 21 October 2009 he received a left upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP005AA), near the shoulder joint. The day of vaccination he complained of pain in the shoulder area, and later developed numbness in the left thumb. He was treated with a steroid injection, hot packs, and massage, and had seen "great improvement". The numbness resolved after a "few weeks", and the event was considered to be recovered. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Allergy test, Dry mouth, Dyspnoea, Injection site erythema, Injection site pruritus
Clinical narrative: Initial report was received 16 March 2010 from a health care professional who provided a copy of a VAERS report (VAERS ID 373035). A 34-year-old female patient had received a first dose intramuscular left arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP053AA on 11 December 2009 at 12:45 PM, and 10 minutes later, she developed shortness of breath, vertigo, dry mouth and swelling at the site. According to the reporter, the adverse event category was "Allergic". The event required evaluation by a health care professional, but did not require hospitalization. An unspecified amount of time later, the patient recovered. The patient had not been taking any concomitant medications and she had no concurrent illnesses or pre-existing medical conditions. Laboratory and diagnostic testing was reported as "none". On 16 March 2010, 95 days after receiving the vaccine, the patient had eaten yogurt which contained gelatin and the site of Influenza A H1N1 2009 Monovalent Vaccine - Preservative injection received on 11 December 2009 (year reported as 2010) became red, itchy and swollen. A recovery status was not reported for these symptoms. The patient had a past history of an unspecified adverse event which occurred at nine years of age after she had received a first dose of injectable Influenza vaccine (manufacturer, lot number and date of administration not reported). No additional information was provided at the time of the report. Follow-up information was received on 09 April 2010 from a healthcare professional. On 11 December 2009, the patient's shortness of breath, vertigo, dry mouth and swelling at site persisted for 4-6 hours, with unspecified treatment given in the hospital. Unspecified allergy testing was performed on an unspecified date. The patient received no vaccinations within 4 weeks prior to 11 December 2009. She had no illness at the time of the vaccination. There were no known allergies. On an unspecified date, the patient was "normal" except for redness at the site. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site swelling, Reaction to previous exposure to any vaccine, Vaccination complication, Vertigo
Clinical narrative: Initial report was received 16 March 2010 from a health care professional who provided a copy of a VAERS report (VAERS ID 373035). A 34-year-old female patient had received a first dose intramuscular left arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP053AA on 11 December 2009 at 12:45 PM, and 10 minutes later, she developed shortness of breath, vertigo, dry mouth and swelling at the site. According to the reporter, the adverse event category was "Allergic". The event required evaluation by a health care professional, but did not require hospitalization. An unspecified amount of time later, the patient recovered. The patient had not been taking any concomitant medications and she had no concurrent illnesses or pre-existing medical conditions. Laboratory and diagnostic testing was reported as "none". On 16 March 2010, 95 days after receiving the vaccine, the patient had eaten yogurt which contained gelatin and the site of Influenza A H1N1 2009 Monovalent Vaccine - Preservative injection received on 11 December 2009 (year reported as 2010) became red, itchy and swollen. A recovery status was not reported for these symptoms. The patient had a past history of an unspecified adverse event which occurred at nine years of age after she had received a first dose of injectable Influenza vaccine (manufacturer, lot number and date of administration not reported). No additional information was provided at the time of the report. Follow-up information was received on 09 April 2010 from a healthcare professional. On 11 December 2009, the patient's shortness of breath, vertigo, dry mouth and swelling at site persisted for 4-6 hours, with unspecified treatment given in the hospital. Unspecified allergy testing was performed on an unspecified date. The patient received no vaccinations within 4 weeks prior to 11 December 2009. She had no illness at the time of the vaccination. There were no known allergies. On an unspecified date, the patient was "normal" except for redness at the site. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Axonal neuropathy, Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Initial case received on 09 April 2010 from a consumer, who is also the patient's wife. A 68-year-old male patient received an injection of Influenza A (H1N1) 2009 Monovalent - Preservative (lot not reported) in January 2010. The patient had a history of diabetes, and was taking LANTUS and APIDRA concomitantly. On an unreported date after vaccination, the patient began experiencing falls, could not stand up, and could barely move. On 05 February 2010 he was hospitalized and diagnosed with GUILLAIN-BARRE. He remained hospitalized for 18 days, and was treated with intravenous immunoglobulin G. He was discharged to rehab, and was scheduled to be discharged home on 10 April 2010. According to the patient's wife, he was "doing better". While in rehab, he was switched from LANTUS to LEVEMIR. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dysstasia, Fall, Guillain-Barre syndrome, Hypokinesia, Immunoglobulin therapy
Clinical narrative: Initial case received on 09 April 2010 from a consumer, who is also the patient's wife. A 68-year-old male patient received an injection of Influenza A (H1N1) 2009 Monovalent - Preservative (lot not reported) in January 2010. The patient had a history of diabetes, and was taking LANTUS and APIDRA concomitantly. On an unreported date after vaccination, the patient began experiencing falls, could not stand up, and could barely move. On 05 February 2010 he was hospitalized and diagnosed with GUILLAIN-BARRE. He remained hospitalized for 18 days, and was treated with intravenous immunoglobulin G. He was discharged to rehab, and was scheduled to be discharged home on 10 April 2010. According to the patient's wife, he was "doing better". While in rehab, he was switched from LANTUS to LEVEMIR. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood gases normal, Chest X-ray normal, Computerised tomogram normal, Influenza serology negative, Lumbar puncture normal
Clinical narrative: Information has been received from a registered nurse, concerning an 8 week male patient, with no pertinent medical history and not known drug allergies who on 29-OCT-2009, received orally the first dose of ROTATEQ (lot number 664398/0573Y) (also reported as Lot # 0753Y). Other vaccines administered the same day included PENTACEL (lot number C3297AA), PREVNAR (lot number D65510) and ENGERIX-B (lot number AHBVB761CA). The nurse reported that on 28-OCT-2009, "the night before the patient was vaccinated", the patient's father "possibly saw twitching of shoulders and face" (baby's mother did not see it). On the evening of 29-OCT-2009, the patient's mother witnessed seizure like activity, described as jerking episodes while patient was feeding. Next day, on 30-OCT-2009, the episodes continued when the patient was not feeding, so patient was taken to the emergency room. The patient was admitted overnight and underwent a full work up. Computed axial tomography (CT) and spinal tap were normal. Electroencephalography (EEG) ordered by the neurologist was normal. It was reported that baby was afebrile but congested, and there was no seizure activity noted by the neurologist or staff. It was reported that the patient recovered from seizure like activity. The discharge summary mentioned myoclonus and bocavirus. The events were not disabling or life threatening per the nurse. It was also reported that the patient was recently (date unspecified) administered his 2nd dose of ROTATEQ and had no adverse reactions and that the first dose of ROTATEQ was not administered at that office. No further information is available. On 30-Oct-2009, the patient was admitted overnight to the emergency room.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Oxygen saturation decreased, Respiratory syncytial virus test negative, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse, concerning an 8 week male patient, with no pertinent medical history and not known drug allergies who on 29-OCT-2009, received orally the first dose of ROTATEQ (lot number 664398/0573Y) (also reported as Lot # 0753Y). Other vaccines administered the same day included PENTACEL (lot number C3297AA), PREVNAR (lot number D65510) and ENGERIX-B (lot number AHBVB761CA). The nurse reported that on 28-OCT-2009, "the night before the patient was vaccinated", the patient's father "possibly saw twitching of shoulders and face" (baby's mother did not see it). On the evening of 29-OCT-2009, the patient's mother witnessed seizure like activity, described as jerking episodes while patient was feeding. Next day, on 30-OCT-2009, the episodes continued when the patient was not feeding, so patient was taken to the emergency room. The patient was admitted overnight and underwent a full work up. Computed axial tomography (CT) and spinal tap were normal. Electroencephalography (EEG) ordered by the neurologist was normal. It was reported that baby was afebrile but congested, and there was no seizure activity noted by the neurologist or staff. It was reported that the patient recovered from seizure like activity. The discharge summary mentioned myoclonus and bocavirus. The events were not disabling or life threatening per the nurse. It was also reported that the patient was recently (date unspecified) administered his 2nd dose of ROTATEQ and had no adverse reactions and that the first dose of ROTATEQ was not administered at that office. No further information is available. On 30-Oct-2009, the patient was admitted overnight to the emergency room.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Computerised tomogram normal, Convulsion, Dyskinesia, Electroencephalogram normal, Lumbar puncture normal
Clinical narrative: Information has been received from a registered nurse, concerning an 8 week male patient, with no pertinent medical history and not known drug allergies who on 29-OCT-2009, received orally the first dose of ROTATEQ (lot number 664398/0573Y) (also reported as Lot # 0753Y). Other vaccines administered the same day included PENTACEL (lot number C3297AA), PREVNAR (lot number D65510) and ENGERIX-B (lot number AHBVB761CA). The nurse reported that on 28-OCT-2009, "the night before the patient was vaccinated", the patient's father "possibly saw twitching of shoulders and face" (baby's mother did not see it). On the evening of 29-OCT-2009, the patient's mother witnessed seizure like activity, described as jerking episodes while patient was feeding. Next day, on 30-OCT-2009, the episodes continued when the patient was not feeding, so patient was taken to the emergency room. The patient was admitted overnight and underwent a full work up. Computed axial tomography (CT) and spinal tap were normal. Electroencephalography (EEG) ordered by the neurologist was normal. It was reported that baby was afebrile but congested, and there was no seizure activity noted by the neurologist or staff. It was reported that the patient recovered from seizure like activity. The discharge summary mentioned myoclonus and bocavirus. The events were not disabling or life threatening per the nurse. It was also reported that the patient was recently (date unspecified) administered his 2nd dose of ROTATEQ and had no adverse reactions and that the first dose of ROTATEQ was not administered at that office. No further information is available. On 30-Oct-2009, the patient was admitted overnight to the emergency room.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Myoclonus, Respiratory tract congestion, Viral infection
Clinical narrative: Information has been received from a registered nurse, concerning an 8 week male patient, with no pertinent medical history and not known drug allergies who on 29-OCT-2009, received orally the first dose of ROTATEQ (lot number 664398/0573Y) (also reported as Lot # 0753Y). Other vaccines administered the same day included PENTACEL (lot number C3297AA), PREVNAR (lot number D65510) and ENGERIX-B (lot number AHBVB761CA). The nurse reported that on 28-OCT-2009, "the night before the patient was vaccinated", the patient's father "possibly saw twitching of shoulders and face" (baby's mother did not see it). On the evening of 29-OCT-2009, the patient's mother witnessed seizure like activity, described as jerking episodes while patient was feeding. Next day, on 30-OCT-2009, the episodes continued when the patient was not feeding, so patient was taken to the emergency room. The patient was admitted overnight and underwent a full work up. Computed axial tomography (CT) and spinal tap were normal. Electroencephalography (EEG) ordered by the neurologist was normal. It was reported that baby was afebrile but congested, and there was no seizure activity noted by the neurologist or staff. It was reported that the patient recovered from seizure like activity. The discharge summary mentioned myoclonus and bocavirus. The events were not disabling or life threatening per the nurse. It was also reported that the patient was recently (date unspecified) administered his 2nd dose of ROTATEQ and had no adverse reactions and that the first dose of ROTATEQ was not administered at that office. No further information is available. On 30-Oct-2009, the patient was admitted overnight to the emergency room.
Age: 17.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Rash, Swelling face
Clinical narrative: Facial and neck swelling. No laryngeal involvement
Age: 17.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Local swelling, Swelling face
Clinical narrative: Facial and neck swelling. No laryngeal involvement
Age: 1.88
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Crying, Gait disturbance, Injection site induration, Injection site swelling, Poor quality sleep
Clinical narrative: Several hours after vaccination with PCV13 in the right thigh (IM injection), thigh swelled and became hard.   Did not want to walk.  Slept poorly overnight, with crying.  Following morning walked with limp.  NOTE: THIS IS NOT UNUSUAL IN ITSELF.  HOWEVER, WE STARTED VACCINATING CHILDREN WITH PCV13 LAST WEEK, AND I HAVE RECEIVED 3 PHONE CALLS IN 5 DAYS REGARDING PAINFUL LEGS IN 15-24 MONTH OLDS, ACCOMPANIED BY RELUCTANCE OR REFUSAL TO WALK FOR MANY HOURS.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Autoimmune disorder, Madarosis
Clinical narrative: A spontaneous report of serious event of autoimmune reaction manifested by hair loss from eyelashes and eyebrow and non-serious event of "received H1N1 LAIV on Oct 2009 and Jan 2010" has been received from a mother/consumer concerning a nine-year-old female, subsequent to H1N1 2009 Monovalent Vaccine Live, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in Oct -2009, the patient received first dose and on an unknown date in Jan-2010, received second dose of H1N1 2009 Monovalent Vaccine Live, Intranasal, for an unknown indication. Two weeks after the dose in January, the child started loosing her eyelashes and part of eyebrow. The child was seen by a doctor, who diagnosed it as an autoimmune reaction. As per reporter the event was due to the vaccine. The outcome for the reported adverse event received H1N1 LAIV on Oct 2009 and Jan 2010 was considered  resolved and outcome of the event autoimmune reaction was unknown at the time of reporting. Additional information was received on 20-Apr-2010 and incorporated into the narrative: reporter type, medical history and concomitant medication, vaccination dates, route of vaccination. Other information received on 20-Apr-2010 are: county name, vaccinated at, DOB of patient, lot number of both H1N1 vaccines. Additional information received on 18-May-2010 and incorporated into the narrative: information on medical test and outcome of event. Other information received was: reporter name.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Nervousness
Clinical narrative: Pt. reported feelings of shaking and shivering to whole body, mostly upper body, unsure if related to vaccines.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Surgery, X-ray
Clinical narrative: Pt. seen in ER and orthopedic surgeon for arm pain following influenza vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed a shingles like rash on neck, ear & head on left side.  Rash started approximately 4/9/10.  ER Dr. prescribed VALTREX one gram three times a day X 7 days & LYRICA 75 mg three times a day X 7 day.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Patient had a fever of 100.8, vomited three times had a heart rate of 160. was given ibuprofen which brought his temp down for 4 hours. Patient had a temp of 100.6 later in the evening moderately controlled by ibuprofen.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Swelling and induration at site starting day after injection (4/13/10). Pt came in on 4/15/10 for check and at that time induration was 30 mm round and redness was 70x50 mm round.  Minimal pain.  Pt cites had occurred before when she received a SQ injctn from pediatrician many years ago and forgot to mention it before this injection was given.
Age: 42.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swelling and bright redness to injection site, nausea, fever.
Age: 1.11
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Right leg slightly swollen, red, and warm to touch. No fever today - had  low grade temp on evening of vaccination but fever went down after mother administered MOTRIN. Pt was given Rx for ZYRTEC. Area was marked and instructions given for mother to bring pt in for follow up on 4/09/10.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Aphasia, Autism spectrum disorder, Deafness, Decreased appetite, Dizziness
Clinical narrative: Fever, dizzy; would fall down without warning and not put hands out. Stopped eating, projectile vomiting, stopped talking, glazed over look in eyes, screamed non stop, acted as if could not hear anymore. Complete different child. These symptoms never went away.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Fall, Pyrexia, Screaming, Staring, Vomiting projectile
Clinical narrative: Fever, dizzy; would fall down without warning and not put hands out. Stopped eating, projectile vomiting, stopped talking, glazed over look in eyes, screamed non stop, acted as if could not hear anymore. Complete different child. These symptoms never went away.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Metal poisoning, Muscular weakness, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: I was an athletic hiker and jogger. Suddenly, over a period of a few days, I had pain and weakness in both legs. Nerve pain. Had bloodwork for MS, which came back negative. Had MRI of lumbar spine which was negative. People with spina bifida occulta and other neural tube defects can't convert folic acid to its active form, methyl folate. This keeps their bodies from detoxing normally. This made me more prone to not being able to detox the mercury.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: I was an athletic hiker and jogger. Suddenly, over a period of a few days, I had pain and weakness in both legs. Nerve pain. Had bloodwork for MS, which came back negative. Had MRI of lumbar spine which was negative. People with spina bifida occulta and other neural tube defects can't convert folic acid to its active form, methyl folate. This keeps their bodies from detoxing normally. This made me more prone to not being able to detox the mercury.
Age: 76.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal stiffness
Clinical narrative: Extreme muscular stiffness in the mornings. Improves with activity, then returns upon prolonged sitting or reclining.