chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Diarrhoea, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Initial report received from a consumer's parent on 10 December 2010. A 5-month-old female infant received on 10 November 2010 at 11:00 AM an intramuscular right thigh injection of INFLUENZA VACCINE, manufacturer provided as sanofi pasteur (lot number not reported) and died eight days later. The patient had no medical history, took no concomitant medications, no previous illness and had no illness at the time of vaccination. On 10 November 2010 in the evening, the patient developed a fever which was as high as 102 (units not provided). Over the next few days, the patient developed irritability, lethargy, diarrhea and loss of appetite. The patient was seen by a physician four days after the vaccination. The patient died on 18 November 2010. The outcome was reported as fatal. Documents held by sender: None.
Age: 0.43
Sex: F
Vaccine: FLU3, PNC13, FLU3, FLU3
Symptoms: Death, Decreased appetite, Diarrhoea, Irritability, Lethargy
Clinical narrative: Initial report received from a consumer's parent on 10 December 2010. A 5-month-old female infant received on 10 November 2010 at 11:00 AM an intramuscular right thigh injection of INFLUENZA VACCINE, manufacturer provided as sanofi pasteur (lot number not reported) and died eight days later. The patient had no medical history, took no concomitant medications, no previous illness and had no illness at the time of vaccination. On 10 November 2010 in the evening, the patient developed a fever which was as high as 102 (units not provided). Over the next few days, the patient developed irritability, lethargy, diarrhea and loss of appetite. The patient was seen by a physician four days after the vaccination. The patient died on 18 November 2010. The outcome was reported as fatal. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Areflexia, Asthenia, CSF test, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial report received from a health care professional on 13 December 2010. A 30-year-old female patient received on 23 July 2010 in the PM a right arm intramuscular injection of ADACEL, manufacturer sanofi pasteur lot number C346840 (invalid lot number). The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. The patient had no adverse events following prior vaccination however; she had a hypertrophic scare from smallpox vaccine that she received in 2004. On 04 August 2010 at 6:00 AM, the patient developed symptoms of Guillain-Barre Syndrome which started with bilateral paresthesia. The symptoms progressed over the next five days to ascending paresthesia, weakness, difficulty walking, headache and nausea. The patient was seen in the Emergency Room where it was noticed that she had absent reflexes. The patient was admitted to the hospital on 08 August 2010. The patient had cerebral spinal fluid studies, a magnetic resonance imaging with and without contrast and "NCS" (results not reported). The patient was hospitalized from 08 August 2010 until 11 August 2010. The outcome was reported as recovered. The event of hypertrophic scare was captured in case 2010-06975. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Nausea, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 13 December 2010. A 30-year-old female patient received on 23 July 2010 in the PM a right arm intramuscular injection of ADACEL, manufacturer sanofi pasteur lot number C346840 (invalid lot number). The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. The patient had no adverse events following prior vaccination however; she had a hypertrophic scare from smallpox vaccine that she received in 2004. On 04 August 2010 at 6:00 AM, the patient developed symptoms of Guillain-Barre Syndrome which started with bilateral paresthesia. The symptoms progressed over the next five days to ascending paresthesia, weakness, difficulty walking, headache and nausea. The patient was seen in the Emergency Room where it was noticed that she had absent reflexes. The patient was admitted to the hospital on 08 August 2010. The patient had cerebral spinal fluid studies, a magnetic resonance imaging with and without contrast and "NCS" (results not reported). The patient was hospitalized from 08 August 2010 until 11 August 2010. The outcome was reported as recovered. The event of hypertrophic scare was captured in case 2010-06975. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Scan with contrast
Clinical narrative: Initial report received from a health care professional on 13 December 2010. A 30-year-old female patient received on 23 July 2010 in the PM a right arm intramuscular injection of ADACEL, manufacturer sanofi pasteur lot number C346840 (invalid lot number). The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. The patient had no adverse events following prior vaccination however; she had a hypertrophic scare from smallpox vaccine that she received in 2004. On 04 August 2010 at 6:00 AM, the patient developed symptoms of Guillain-Barre Syndrome which started with bilateral paresthesia. The symptoms progressed over the next five days to ascending paresthesia, weakness, difficulty walking, headache and nausea. The patient was seen in the Emergency Room where it was noticed that she had absent reflexes. The patient was admitted to the hospital on 08 August 2010. The patient had cerebral spinal fluid studies, a magnetic resonance imaging with and without contrast and "NCS" (results not reported). The patient was hospitalized from 08 August 2010 until 11 August 2010. The outcome was reported as recovered. The event of hypertrophic scare was captured in case 2010-06975. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on back of neck.
Age: 1.0
Sex: M
Vaccine: IPV
Symptoms: Fall, Head injury, Irritability
Clinical narrative: Received vaccine at 10:30am 12/17/10. At 4:00pm mom called reporting child did not nap. Was extra fussy, concerned about vaccine reaction. At 6:26pm spoke to on call MD. Reporting fussy, s/p fall w/head trauma. Went to ER at 10pm.
Age: 0.78
Sex: M
Vaccine: FLU3
Symptoms: Moaning, Pyrexia, Somnolence
Clinical narrative: 9 month H/M. Received Flu shot on 12/2/10 in AM had fever 104.9 within 24 hours of vaccination; sleepy, moaning lasted 24-48 hrs - recovered.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Nerve injury, Pain in extremity
Clinical narrative: Injection site (left deltoid) became sore the day of the injection and then painful. Pain worsened, and pain extended to entire left arm. Also had some numbness to hand & fingers within days of the injection. Pain/numbness persisted >2 months, but is somewhat better now. Physician anticipated recovery will take 6 months and believed it to be nerve-related damage.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Lg, red, firm, hot to touch.
Age: 38.0
Sex: M
Vaccine: DT
Symptoms: Rash
Clinical narrative: Rash
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Described that an itchy rash which started after dinner, in the evening,  in the bicep and waistband area.  The rash continued to spread to most of the rest of his body by the next day (Tuesday, 11/02/10).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUN3, HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash macular
Clinical narrative: Had red blotchy, itchy skin across chest on face from shoulder to wrist.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Rash
Clinical narrative: Rash with redness, swelling, warmth L deltoid (site of injection). Low grade temp.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Initial case was received on 06 October 2010 from a healthcare professional. A 15 year old female received on 04 October 2010 a left deltoid intramuscular injection of FLUZONE (lot number UT3580CA). Within 24 hours on 05 October 2010, the patient experienced redness and swelling from the top of the shoulder down to the elbow and around the left arm. The arm was warm to touch. The patient had no illness at the time of the vaccination, received no other vaccinations within 4 weeks and had no reactions following prior vaccinations. She had no pre-existing medical conditions, no allergies and no concomitant medications. The patient was seen at an urgent care facility. There was "no respiratory involvement." The treatment included steroids NOS. As of this report the patient had not recovered. Follow-up information received from a health care professional on 17 December 2010. From the following new information received, this case was upgraded to serious. Per the reporter, the patient was seen in their office on 06 October 2010 and diagnosed with cellulitis involving the left arm that spread from the injection site. The patient was treated with a 3 days course of ROCEPHIN injections and then a 10 day course of oral Cephalexin. Recovery status was not updated by the reported. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Initial case was received on 06 October 2010 from a healthcare professional. A 15 year old female received on 04 October 2010 a left deltoid intramuscular injection of FLUZONE (lot number UT3580CA). Within 24 hours on 05 October 2010, the patient experienced redness and swelling from the top of the shoulder down to the elbow and around the left arm. The arm was warm to touch. The patient had no illness at the time of the vaccination, received no other vaccinations within 4 weeks and had no reactions following prior vaccinations. She had no pre-existing medical conditions, no allergies and no concomitant medications. The patient was seen at an urgent care facility. There was "no respiratory involvement." The treatment included steroids NOS. As of this report the patient had not recovered. Follow-up information received from a health care professional on 17 December 2010. From the following new information received, this case was upgraded to serious. Per the reporter, the patient was seen in their office on 06 October 2010 and diagnosed with cellulitis involving the left arm that spread from the injection site. The patient was treated with a 3 days course of ROCEPHIN injections and then a 10 day course of oral Cephalexin. Recovery status was not updated by the reported. Documents held by sender: None.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient developed Guillain Barre Syndrome 7 weeks following influenza vaccine, 3.5 weeks following DTP vaccine.
Age: 1.01
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Yellow skin
Clinical narrative: turning yellow
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Antepartum haemorrhage
Clinical narrative: Vaginal bleeding
Age: 19.0
Sex: F
Vaccine: HEP, IPV, TYP, YF
Symptoms: Injection site papule, Urticaria
Clinical narrative: 4 x 1 1/2 cm, wheal, posterior, left arm and small papules, left shoulder. NO SOB or choking.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: muscle aches, headache, nausea, poor appetite, weakness
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING, DIZZINESS, LIGHTHEADEDNESS, SYMPTOMS LASTED APPROX 30 MINS, TREATED WITH COLD COMPRESSES AND REST
Age: 1.71
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: VOMIT, WATERY / LOOSE MOTION, FEVER
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial case was retrieved from the scientific literature on 16 December 2010. "In 2008, potential temperature compromise of one lot of trivalent inactivated influenza vaccine (TIV) led to the revaccination of 13,210 patients within 28 days of receipt of their initial TIV dose. We conducted a retrospective cohort study to determine if these individuals experienced a higher rate of medically attended events (MAE) than those receiving only one TIV dose. We found no increase in MAE among those rapidly revaccinated (odds ration 1.08; 95% confidence intervals 0.80, 1.45), which may reassure individuals of the safety of revaccination with TIV should it be necessary, thereby leading to increased compliance with influenza vaccination recommendations." Between 14 and 21 October 2008, 19,351 patients were vaccinated with trivalent inactivated influenza vaccine which had been affected by a possible temperature compromise during shipment. Of those patients, 13,210 were subsequently revaccinated with a second dose of trivalent influenza vaccine (TIV) (influenza vaccine manufacturer and lot number not reported) within 28 days of the first vaccination. O those patients, 52 patients experienced a total of 54 adverse events, including adverse event of medication (9), allergy (unspecified (3), cellulitis (7), fever (5), headache (14), infection following vaccination (1), limb swelling/pain (12), lymphadenitis (2), and urticaria (1). In 23 patient records, a specific medication other than TIV was listed as the cause of the adverse effect. Among all patients vaccinated only female sex was significantly associated with any adverse events, and incidence was highest among those revaccinated 1 to 3 days after receiving the initial dose. In addition to the events previously described, the unexposed cohort group also had reports of anaphylaxis and complication of care following one dose of TIV. Outcome was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Bradyphrenia, Feeling abnormal, Gait disturbance, Irritability
Clinical narrative: This case was initially reported by a consumer, who is also the patient, on 15 December 2010. A 79-year-old female patient received an INFLUENZA VACCINE (manufacturer reported as "possibly Sanofi Pasteur", lot not reported) in the left arm on 22 November 2010. The patient had a history of increased blood pressure and temporal arteritis (for past 3 years); she had previously experienced swelling and a hard knot at the site of a pneumococcal vaccine, and had received numerous influenza vaccines in the past. Concomitant medications included prednisone, a blood pressure pill, and Vitamin B12 1000mg. According to the patient, approximately 6 hours post-vaccination she began experiencing fever, nausea, vomiting, and difficulty in moving. Approximately 12 hours post-vaccination, she had a fever of 103 degrees and was unable to get out of bed. She was seen by a physician the day after vaccination, at which time she complained of difficulty walking and "brain function problem", described as fuzziness, slow thinking process, and balance problems when walking. The patient noted that she had been seen by a "brain doctor". Outcome was not reported.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was initially reported by a consumer, who is also the patient, on 15 December 2010. A 79-year-old female patient received an INFLUENZA VACCINE (manufacturer reported as "possibly Sanofi Pasteur", lot not reported) in the left arm on 22 November 2010. The patient had a history of increased blood pressure and temporal arteritis (for past 3 years); she had previously experienced swelling and a hard knot at the site of a pneumococcal vaccine, and had received numerous influenza vaccines in the past. Concomitant medications included prednisone, a blood pressure pill, and Vitamin B12 1000mg. According to the patient, approximately 6 hours post-vaccination she began experiencing fever, nausea, vomiting, and difficulty in moving. Approximately 12 hours post-vaccination, she had a fever of 103 degrees and was unable to get out of bed. She was seen by a physician the day after vaccination, at which time she complained of difficulty walking and "brain function problem", described as fuzziness, slow thinking process, and balance problems when walking. The patient noted that she had been seen by a "brain doctor". Outcome was not reported.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Joint swelling, Pain
Clinical narrative: Initial case received from a healthcare professional on 16 December 2010. A 79-year-old male patient received FLUZONE HIGH-DOSE (lot number U3612AA) on 01 October 2010. On 11 October 2010, 10 days post-vaccination, the patient notified his physician that he was experiencing pain all over his body, swollen ankles, and high blood pressure. He was seen by his physician, who confirmed that the symptoms had not been present prior to vaccination. No additional information was reported. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dyspnoea, Erythema, Heart rate increased, Nausea
Clinical narrative: Entire was itching, redness on face, chest, arms - in the evening had extremely fast heartbeat last for 2-3 hours - unable to breathe - rapid heartbeat - temp was 101, nausea.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Entire was itching, redness on face, chest, arms - in the evening had extremely fast heartbeat last for 2-3 hours - unable to breathe - rapid heartbeat - temp was 101, nausea.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test, Full blood count, Hypoaesthesia oral, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Paresthesias of hands and feet w/numbness of the tip of tongue after having a flu shot one week prior at which time he states he also had some viral symptoms.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Vitamin B12
Clinical narrative: Paresthesias of hands and feet w/numbness of the tip of tongue after having a flu shot one week prior at which time he states he also had some viral symptoms.
Age: 46.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Ear discomfort, Musculoskeletal pain, Neck pain, Pruritus
Clinical narrative: Called clinic about 2.5 hours after vaccine administered.  Stated ears burning and face itching. No other symptoms.  Advised to take 25 mg Benadryl and return to clinic/EC if symptoms did not resolve or got worse.  Patient contacted by clinic next day and pt complained of neck and shoulder pain, no other symptoms
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Headache
Clinical narrative: Headache lasting 36 hours Fatigue lasting 3 days
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm, swollen measurment of 2" X 2" inches. Total measurement of 3 1/2 " X 3 1/2 ".
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient came to clinic for 2 year wcc.  Dr checked his vaccination records on his ECW visit screen, and it appeared that patient recieved only 1 dose of Hepatitis A vaccine.  Dr ordered another dose of the vaccine, which was given. When the Medical Assistant printed the "immunization record" page to give to facility, she noticed that this was the patient's third dose of Hepatitis A.  She informed Dr who was able to explain the situation to the patient's parents before they left the clinic.  This RN informed the manufacturer, who did not have any information regarding 2 doses of Havrix.  Was referred to the Centers for Disease Control and Prevention.  This RN wrote the following email:   To Whom it May Concern,  I was given this email address by a GlaxoSmithKline representative in order to investigate adverse effects related to a third dose of Havrix Hepatitis A vaccine (720EL.U./0.5ml).  I am an RN at a public health clinic, and a 2 year old patient of ours was given 3 doses of Havrix - at ages 1 year, 18 months, and 2 years.  The patient was given the third dose yesterday and did not have any medical issues immediately after the third dose was given.  I spoke with the GSK representative in order to determine if there are any known adverse events associated with a third dose.  I was told that they had no studies regarding 3 doses for children, and that you may have more information.  If you can provide me with any information regarding 3 doses for pediatric patients, it would be helpful.    Please let me know if you need any more information from my end.  Thank you,  and recieved the following response:  We don't have any data on this issue. But hepatitis A vaccine is an extremely safe vaccine and this sort of thing happens all the time without incident. Also keep in mind that we routinely give 3 doses of hepatitis A vaccine as Twinrix (although to an older age group).   Centers for Disease Control and Prevention  Supervisor and Dr were made aware.  In order to attempt to prevent the same issue in the future, we have asked that MAs print out the vaccination records of patients so that the providers are able to see more clearly which vaccines have been given.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Infant developed bloody stools the night after vaccines given. Breastfed no history of blood in stool.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Employee was given vaccine in right deltoid approximately 6 finger widths down from the shoulder. Approximately 3 wks after injection arm still sore. Saw MD no signs of any complications at site, just pain reported by employee. No fever, no redness, but employee reports pain with lifting arm above shoulder more in AM.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Dyspnoea, Pyrexia, Respiratory tract congestion
Clinical narrative: I get a congestion in chest like (mucus) and cough, dizziness and fever. I am taking medication over the counter (Nyquil) but I am getting worse and I do not have way to be attended by doctor at this time because the holidays.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgias, chills, fever to 101+.  Do not remember exact level, but close to 102.  No other symptoms; no URI, cough or other sources of fever.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: 1)Blisters on the face, arms, chest and legs 2)Irritation
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain, Blood immunoglobulin M increased, Diarrhoea, Foreign travel, Hepatitis A antibody positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date in 2010 the subject received 1st dose of TWINRIX (unknown). On an unknown date, approximately two weeks after vaccination with TWINRIX, the subject experienced nausea and vomiting. Approximately one month after vaccination with TWINRIX, the subject experienced hepatitis A virus IgM antibody positive, possible hepatitis A IgM increased. The subject went abroad two days after TWINRIX was administered and approximately two weeks later developed nausea and vomiting. After the subject returned from abroad, approximately one month after TWINRIX was administered, Hepatitis A titer was drawn and the subject was positive for Hepatitis A IgM. The reporter was concerned about Hepatitis A disease versus IgM elevations from vaccine itself. The reporter did not have additional information. At the time of reporting the outcome of the possible hepatitis A, IgM increased, hepatitis A virus IgM antibody positive, nausea and vomiting were unspecified. Follow-up information was received on 21 December 2010 from healthcare professional via Merck. The healthcare professional notified Merck on 07 December 2010 that the subject received TWINRIX on 29 October 2010 and then traveled to a foreign country. While overseas the subject became extremely ill [unwell], and had to return early from the trip. The onset date was reported as 29 November 2010. The subject experienced diarrhea, fevers, abdominal pain, increased liver function tests and weight loss. Antibody titers to Hepatitis A and Hepatitis B were taken, which showed an antibody titers to hepatitis B and increased reactive antibodies to Hepatitis A (IgM reactive). The subject sought medical attention. At the time of the report no further information was available. The outcome of the events were unspecified.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody positive, Liver function test abnormal, Malaise, Nausea, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date in 2010 the subject received 1st dose of TWINRIX (unknown). On an unknown date, approximately two weeks after vaccination with TWINRIX, the subject experienced nausea and vomiting. Approximately one month after vaccination with TWINRIX, the subject experienced hepatitis A virus IgM antibody positive, possible hepatitis A IgM increased. The subject went abroad two days after TWINRIX was administered and approximately two weeks later developed nausea and vomiting. After the subject returned from abroad, approximately one month after TWINRIX was administered, Hepatitis A titer was drawn and the subject was positive for Hepatitis A IgM. The reporter was concerned about Hepatitis A disease versus IgM elevations from vaccine itself. The reporter did not have additional information. At the time of reporting the outcome of the possible hepatitis A, IgM increased, hepatitis A virus IgM antibody positive, nausea and vomiting were unspecified. Follow-up information was received on 21 December 2010 from healthcare professional via Merck. The healthcare professional notified Merck on 07 December 2010 that the subject received TWINRIX on 29 October 2010 and then traveled to a foreign country. While overseas the subject became extremely ill [unwell], and had to return early from the trip. The onset date was reported as 29 November 2010. The subject experienced diarrhea, fevers, abdominal pain, increased liver function tests and weight loss. Antibody titers to Hepatitis A and Hepatitis B were taken, which showed an antibody titers to hepatitis B and increased reactive antibodies to Hepatitis A (IgM reactive). The subject sought medical attention. At the time of the report no further information was available. The outcome of the events were unspecified.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Vomiting, Weight decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date in 2010 the subject received 1st dose of TWINRIX (unknown). On an unknown date, approximately two weeks after vaccination with TWINRIX, the subject experienced nausea and vomiting. Approximately one month after vaccination with TWINRIX, the subject experienced hepatitis A virus IgM antibody positive, possible hepatitis A IgM increased. The subject went abroad two days after TWINRIX was administered and approximately two weeks later developed nausea and vomiting. After the subject returned from abroad, approximately one month after TWINRIX was administered, Hepatitis A titer was drawn and the subject was positive for Hepatitis A IgM. The reporter was concerned about Hepatitis A disease versus IgM elevations from vaccine itself. The reporter did not have additional information. At the time of reporting the outcome of the possible hepatitis A, IgM increased, hepatitis A virus IgM antibody positive, nausea and vomiting were unspecified. Follow-up information was received on 21 December 2010 from healthcare professional via Merck. The healthcare professional notified Merck on 07 December 2010 that the subject received TWINRIX on 29 October 2010 and then traveled to a foreign country. While overseas the subject became extremely ill [unwell], and had to return early from the trip. The onset date was reported as 29 November 2010. The subject experienced diarrhea, fevers, abdominal pain, increased liver function tests and weight loss. Antibody titers to Hepatitis A and Hepatitis B were taken, which showed an antibody titers to hepatitis B and increased reactive antibodies to Hepatitis A (IgM reactive). The subject sought medical attention. At the time of the report no further information was available. The outcome of the events were unspecified.
Sex: F
Vaccine: DTAP
Symptoms: Cough, Fatigue, Pertussis, Post-tussive vomiting, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a female subject of unspecified age who was vaccinated with DTPA (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date in 2008 the subject received unspecified dose of DTPA (with small D + P) (unknown). At an unspecified time after vaccination with DTPA (with small D + P), the subject experienced vaccination failure, pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting. The subject stated that "there should be some mention of the rare possibility of the vaccine being ineffective. I had my TDAP two years ago. I understand there is another strain of Pertussis that is not affected by the vaccine". The subject's physician originally diagnosed her with bronchitis but the cough continued and worsened after about two weeks. The physician "recognized my symptoms of cough, fatigue, post-tussive vomiting, clear nasal discharge". The subject stated she currently has Pertussis (Paroxysmal stage). This case was assessed as medically serious by GSK. At the time of reporting the pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting were unresolved.
Sex: F
Vaccine: DTAP
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a female subject of unspecified age who was vaccinated with DTPA (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date in 2008 the subject received unspecified dose of DTPA (with small D + P) (unknown). At an unspecified time after vaccination with DTPA (with small D + P), the subject experienced vaccination failure, pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting. The subject stated that "there should be some mention of the rare possibility of the vaccine being ineffective. I had my TDAP two years ago. I understand there is another strain of Pertussis that is not affected by the vaccine". The subject's physician originally diagnosed her with bronchitis but the cough continued and worsened after about two weeks. The physician "recognized my symptoms of cough, fatigue, post-tussive vomiting, clear nasal discharge". The subject stated she currently has Pertussis (Paroxysmal stage). This case was assessed as medically serious by GSK. At the time of reporting the pertussis, clear nasal discharge, cough, fatigue and post-tussive vomiting were unresolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest X-ray, Lobar pneumonia, Pyrexia
Clinical narrative: She developed URI sx, fever and pneumonia LLL diagnosed 6 days later.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity
Clinical narrative: 1) Soreness on (L) arm 5/10 2) Red, swollen & firm area (27cm around the upper arm x 17cm from upper arm to elbow) noted on (L) arm 3) Treatment was for cellulitis (prophylacticly) - KEFLEX 250mg QID 5 days.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 3 in. diameter swelling and redness, tenderness to touch.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Swelling at injection site, stiffness got better but now 6 week later patient thinks nerve may have been hit with injection, trouble lifting arm above shoulder, bruising.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Malaise, Skin discolouration
Clinical narrative: 2 hrs following flu iz, felt flush, turned white, took a bath & needed assistance out of bathtub - then started "feeling sick". Is fine now 12/16/10.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Fatigue, Immediate post-injection reaction, Skin tightness
Clinical narrative: Immediately after injection felt fatigue, dry throat, tightness in face. Sx. persisted x 2 days. Called PCP, no response. Needed no treatment. No fever, chills, HA, myalgias.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Pt did not know she was pregnant. Received FLUMIST at school where she works. Pt was 3 weeks pregnant. No adverse reaction. Was told to report. Was reported to CDNS/FDA and MedImmune.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, pain & erythema & induration at injection site.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a registered nurse concerning a "toddler" female patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot# not reported) 2 ml. orally. The nurse stated that the patient had received the ROTATEQ (doses given and incident occurrence after which dose unspecified) and on unspecified date the patient developed the rotavirus and was hospitalized. The patient recovered and was discharged. No further information is available.
Age: 2.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at site of injection ice packs to injection site and take TYLENOL prn. Pain follow up on 12/23/10.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Bone scan abnormal, Complex regional pain syndrome, Computerised tomogram abnormal, Dysphagia
Clinical narrative: Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Joint effusion, Muscle atrophy, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal infection, Streptococcus test positive, Walking aid user, White blood cell count increased
Clinical narrative: Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Arm swelling: at shot large local reaction, hot, red, swollen, tender.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Arm swelling: at shot large local reaction, hot, red, swollen, tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt. received flu vaccine #2 on 12-20-10 in (L) leg, came back to office 12-21-10 with large approximately 3cm irregularly shaped raised area of erythema sl. firm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, FLU3
Symptoms: Injection site erythema
Clinical narrative: Pt. received flu vaccine #2 on 12-20-10 in (L) leg, came back to office 12-21-10 with large approximately 3cm irregularly shaped raised area of erythema sl. firm.
Age: 10.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Death, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 year old male with no medical history and no prex illness who on 07-SEP-2010, received a dose of GARDASIL (lot number: 666121/1778Y) in right arm. Secondary suspect included VAQTA (lot number: 667932/0568Z) in right arm. Concomitant therapy included MENACTRA (lot number: UA3058AA) in left arm and TRIPEDIA (lot number: C3476AA) in left arm. On 17-SEP-2010 afternoon, the patient's mother called to state that her son was sick and feeling very weak. The mother was recommended to take the patient to nearest emergency room as the patient was about 50 miles away and his mother took him to emergency room where he was transferred to another hospital. The listing indicated that one or more of the events resulted in death, required hospitalization, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 666121/1778Y) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (lot # 667932/0568Z) were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Reported that started with eye scleritis bilateral shortly after 1st HPV vaccine and on 11/2/10 had #2 HPV. Almost given 9/2/2010. Immediately had lightheaded dizziness and numbness in (L) UE radiating down arm. Patient seen in ER as numbness radiated to trunk and LE. Has been seen by neurology and persists with symptoms. Scleritis treated by Dr., patient was placed on Indomethacin prior to #2 HPV and symptoms had improved. On 11/2/2010 patient had #2 HPV vaccine and developed symptoms as reported above within minutes. On 12/9/10 patient developed loss of peripheral vision and was seen at clinic diagnosis of optic neuritis/neuropathy. MRI was done and patient also had reaction to "Gad" (vomiting/warmth and itching). Mother reported above events to PCP. Specialist consultation notes pending.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Hypoaesthesia, Immediate post-injection reaction, Neuropathy peripheral, Nuclear magnetic resonance imaging
Clinical narrative: Reported that started with eye scleritis bilateral shortly after 1st HPV vaccine and on 11/2/10 had #2 HPV. Almost given 9/2/2010. Immediately had lightheaded dizziness and numbness in (L) UE radiating down arm. Patient seen in ER as numbness radiated to trunk and LE. Has been seen by neurology and persists with symptoms. Scleritis treated by Dr., patient was placed on Indomethacin prior to #2 HPV and symptoms had improved. On 11/2/2010 patient had #2 HPV vaccine and developed symptoms as reported above within minutes. On 12/9/10 patient developed loss of peripheral vision and was seen at clinic diagnosis of optic neuritis/neuropathy. MRI was done and patient also had reaction to "Gad" (vomiting/warmth and itching). Mother reported above events to PCP. Specialist consultation notes pending.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Optic neuropathy
Clinical narrative: Reported that started with eye scleritis bilateral shortly after 1st HPV vaccine and on 11/2/10 had #2 HPV. Almost given 9/2/2010. Immediately had lightheaded dizziness and numbness in (L) UE radiating down arm. Patient seen in ER as numbness radiated to trunk and LE. Has been seen by neurology and persists with symptoms. Scleritis treated by Dr., patient was placed on Indomethacin prior to #2 HPV and symptoms had improved. On 11/2/2010 patient had #2 HPV vaccine and developed symptoms as reported above within minutes. On 12/9/10 patient developed loss of peripheral vision and was seen at clinic diagnosis of optic neuritis/neuropathy. MRI was done and patient also had reaction to "Gad" (vomiting/warmth and itching). Mother reported above events to PCP. Specialist consultation notes pending.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dizziness, Feeling hot, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Reported that started with eye scleritis bilateral shortly after 1st HPV vaccine and on 11/2/10 had #2 HPV. Almost given 9/2/2010. Immediately had lightheaded dizziness and numbness in (L) UE radiating down arm. Patient seen in ER as numbness radiated to trunk and LE. Has been seen by neurology and persists with symptoms. Scleritis treated by Dr., patient was placed on Indomethacin prior to #2 HPV and symptoms had improved. On 11/2/2010 patient had #2 HPV vaccine and developed symptoms as reported above within minutes. On 12/9/10 patient developed loss of peripheral vision and was seen at clinic diagnosis of optic neuritis/neuropathy. MRI was done and patient also had reaction to "Gad" (vomiting/warmth and itching). Mother reported above events to PCP. Specialist consultation notes pending.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Optic neuritis, Pruritus, Visual field defect, Vomiting
Clinical narrative: Reported that started with eye scleritis bilateral shortly after 1st HPV vaccine and on 11/2/10 had #2 HPV. Almost given 9/2/2010. Immediately had lightheaded dizziness and numbness in (L) UE radiating down arm. Patient seen in ER as numbness radiated to trunk and LE. Has been seen by neurology and persists with symptoms. Scleritis treated by Dr., patient was placed on Indomethacin prior to #2 HPV and symptoms had improved. On 11/2/2010 patient had #2 HPV vaccine and developed symptoms as reported above within minutes. On 12/9/10 patient developed loss of peripheral vision and was seen at clinic diagnosis of optic neuritis/neuropathy. MRI was done and patient also had reaction to "Gad" (vomiting/warmth and itching). Mother reported above events to PCP. Specialist consultation notes pending.