chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Hypersensitivity, Inflammation, Injection site pain
Clinical narrative: Injection site rash, severe pain at injection site, severe body pain, generalized muscle pain and weakness, generalized inflammation response, fever 101+, sleeplessness, irritability, began day after injection for a duration 4 or more days, treated with Vicodin, bed rest, Tylenol; diarrhea, headache, migraine, generalized inflammation and pain, generalized hypersensitivity (food, chemical, allergens), continues after 3 weeks post injection with some improvement.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site rash, Insomnia, Irritability, Migraine, Muscular weakness
Clinical narrative: Injection site rash, severe pain at injection site, severe body pain, generalized muscle pain and weakness, generalized inflammation response, fever 101+, sleeplessness, irritability, began day after injection for a duration 4 or more days, treated with Vicodin, bed rest, Tylenol; diarrhea, headache, migraine, generalized inflammation and pain, generalized hypersensitivity (food, chemical, allergens), continues after 3 weeks post injection with some improvement.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Injection site rash, severe pain at injection site, severe body pain, generalized muscle pain and weakness, generalized inflammation response, fever 101+, sleeplessness, irritability, began day after injection for a duration 4 or more days, treated with Vicodin, bed rest, Tylenol; diarrhea, headache, migraine, generalized inflammation and pain, generalized hypersensitivity (food, chemical, allergens), continues after 3 weeks post injection with some improvement.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Dx herpes zoster 3-7-11.
Age: 0.55
Sex: M
Vaccine: RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Decreased appetite, Hypotonia, Injection site reaction, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Received vaccinations on 3/4/11. On 3/6/11 PM woke up from nap and parents noticed dropping of left side of face, asymmetric smile, also decreased use of left arm. Mom noticed occasional stiffness of (R) leg, which has improved. No fever. Slightly decreased appetite. Facial palsy (L) only affecting (L) side, not affecting eyes. (L) arm is hypotonic, no volunteer motion with (L) arm on 3/7/11. Baby active, no distress.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: VIIth nerve paralysis
Clinical narrative: Received vaccinations on 3/4/11. On 3/6/11 PM woke up from nap and parents noticed dropping of left side of face, asymmetric smile, also decreased use of left arm. Mom noticed occasional stiffness of (R) leg, which has improved. No fever. Slightly decreased appetite. Facial palsy (L) only affecting (L) side, not affecting eyes. (L) arm is hypotonic, no volunteer motion with (L) arm on 3/7/11. Baby active, no distress.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Coordination abnormal, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Started 11-9-10 pain, sensation "fleas" on Rt hip. E.M.G, MRI, lumbar puncture. 3/7/11 continues to have problems with coordination.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Started 11-9-10 pain, sensation "fleas" on Rt hip. E.M.G, MRI, lumbar puncture. 3/7/11 continues to have problems with coordination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Numbing pain starting from her shoulder to arm, hard to lift her arm freely.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Hypoaesthesia facial, Paraesthesia, Tinnitus
Clinical narrative: Ringing in ears/head - Tingling/numbness on (L) side of face.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Ever since my flu shot on 1/13/11 my upper arm, where my shot was, has been very sore and hurts every time I move my arm. (section 7 -completed by patient)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site inflammation, Pain in extremity, Rash, Urticaria
Clinical narrative: Painful rash on left arm & left arm hurts, wheal-like spot on lower left arm. Bruising & inflammation at injection.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: L/D became red & swollen 7 days after vaccine. Pt went to Urgent Care and saw Pt 3/6/11 - Dx rash.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Rt. arm swelling/redness.
Age: 1.55
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Allergy to vaccine, Body temperature increased, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: After receiving vaccinations on 3/2/11, child broke out in head to toe red rash on 3/4/11. Temperature of 102.7. Child taken to Hospital emergency room. Mother stated physician diagnosed allergic reaction to vaccines. Given course of Prednisone. No difficulty breathing. Rash itchy and red. Child recuperating at home.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, UNK
Symptoms: Blood culture negative, Computerised tomogram head, Computerised tomogram normal, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Baby "turned grey" and was non-responsive approx. 3-4 hrs after receiving 2 month vaccines at PCP. EMS was called and reported baby had HR to 45. Baby was given BENADRYL and O2 and transferred to inpatient facility. Back to baseline at admission.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, UNK
Symptoms: Urine analysis normal, Viral test negative
Clinical narrative: Baby "turned grey" and was non-responsive approx. 3-4 hrs after receiving 2 month vaccines at PCP. EMS was called and reported baby had HR to 45. Baby was given BENADRYL and O2 and transferred to inpatient facility. Back to baseline at admission.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, UNK
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: Baby "turned grey" and was non-responsive approx. 3-4 hrs after receiving 2 month vaccines at PCP. EMS was called and reported baby had HR to 45. Baby was given BENADRYL and O2 and transferred to inpatient facility. Back to baseline at admission.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Initial case received on 10 September 2010 from a consumer, who is also the patient. A male patient received on 10 September 2010, an injection of DAPTACEL (lot number not reported) and an injection of IPOL (lot number not reported). He reported an "eye splash after syringe became disconnected from needle" and experienced "eyes burning sensation". He was not sure which vaccine was in the syringe. Treatment included an eyewash with saline. No further information was given. It was unknown if the patient recovered. Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Feeling abnormal, Irritability, Vomiting projectile
Clinical narrative: Initial report received on 22 July 2010 from a consumer, who is the patient's parent. An 8 week old female patient, with no medical history, received a first dose of ACTHIB (lot number UF813AA, which corresponds to sanofi pasteur SA lot number D0259-1) and a dose of DAPTACEL (lot number C3192AA) on 25 February 2010. Two to three hours post-vaccination, the patient began crying a high-pitched continuous cry for 2.5 hours. Afterward, the patient slept for six to seven hours and when she woke, she was dazed and cranky for the remainder of the day. That evening, the patient also had projectile vomiting twice. The patient recovered. This case is linked to case 2010-03965, in which this patient also experienced high-pitched crying, sleeping for six to seven hours and waking up dazed and cranky after receiving a second dose of ACTHIB on 03 May 2010.
Age: 1.53
Sex: M
Vaccine: DTP, FLU3, IPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Initial case was received on 04 October 2010 from a health care professional. An 18 month old female patient received on an unspecified date, an injection of FLUZONE "0.5mL Pre-filled Syringes" (lot number not reported). She also received within 4 weeks prior to FLUZONE, on 13 September 2010, a dose 2 intramuscular injection of DAPTACEL (lot number C3473AA) and a dose 2 subcutaneous injection of IPOL (lot number E0123). The patient became "ill after receiving a flu shot". The patient experienced a fever of 102 degrees. However, a fever of 102 degrees is also reported as an illness at the time of the vaccination. No other pre-existing medical conditions, no allergies and no concomitant medications were reported. The patient recovered on an unspecified date. Follow-up information received from a nurse in on 02 December 2010. The patient was male. The FLUZONE (lot number U3579AA) was administered intramuscular in the left deltoid on 13 September 2010. Per the reporter, the patient had no concurrent illnesses at time of vaccination on 13 September 2010. No further information is expected. The reporter for this case is the same as for cases 2010-05048, 2010-05746, and 2010-05747 and is part of a cluster of four patients. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abnormal behaviour, Anxiety, Blood thyroid stimulating hormone, Borrelia test negative, Crying
Clinical narrative: Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection (route and site not reported) of TUBERSOL 5 TU, lot number C3586AA, and an injection (route and site not reported) of MMR II, Merck lot number MSD05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm, and the MMR II subcutaneously in the left upper arm. The patient had not received any other vaccines within 4 weeks of 29 September 2010, and had not previously experienced any adverse events following vaccination. His birth weight was 7 pounds 2 ounces, and he had 2 siblings (1 brother and 1 sister); neither sibling had ever experienced adverse events following vaccination. He was seen by his physician on 05 November 2010, and underwent a strep culture which was normal. On 08 November 2010 the patient underwent the following testing, all of which was within normal limits: Epstein Barr Virus, Lyme serology, complete metabolic panel, CBC with differential, mono serology, and A1C. He had also undergone Thyroid testing (free T4, TSH, and total T4); results were not yet available. The patient had not received any treatment for the event. The reporter noted that, per the patient's mother, the patient was "better re: anxiety", and was "a little less tired". Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Culture negative, Differential white blood cell count normal, Epstein-Barr virus test negative, Fatigue, Fear
Clinical narrative: Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection (route and site not reported) of TUBERSOL 5 TU, lot number C3586AA, and an injection (route and site not reported) of MMR II, Merck lot number MSD05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm, and the MMR II subcutaneously in the left upper arm. The patient had not received any other vaccines within 4 weeks of 29 September 2010, and had not previously experienced any adverse events following vaccination. His birth weight was 7 pounds 2 ounces, and he had 2 siblings (1 brother and 1 sister); neither sibling had ever experienced adverse events following vaccination. He was seen by his physician on 05 November 2010, and underwent a strep culture which was normal. On 08 November 2010 the patient underwent the following testing, all of which was within normal limits: Epstein Barr Virus, Lyme serology, complete metabolic panel, CBC with differential, mono serology, and A1C. He had also undergone Thyroid testing (free T4, TSH, and total T4); results were not yet available. The patient had not received any treatment for the event. The reporter noted that, per the patient's mother, the patient was "better re: anxiety", and was "a little less tired". Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Full blood count normal, Glycosylated haemoglobin, Laboratory test normal, Metabolic function test, Thyroxine
Clinical narrative: Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection (route and site not reported) of TUBERSOL 5 TU, lot number C3586AA, and an injection (route and site not reported) of MMR II, Merck lot number MSD05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm, and the MMR II subcutaneously in the left upper arm. The patient had not received any other vaccines within 4 weeks of 29 September 2010, and had not previously experienced any adverse events following vaccination. His birth weight was 7 pounds 2 ounces, and he had 2 siblings (1 brother and 1 sister); neither sibling had ever experienced adverse events following vaccination. He was seen by his physician on 05 November 2010, and underwent a strep culture which was normal. On 08 November 2010 the patient underwent the following testing, all of which was within normal limits: Epstein Barr Virus, Lyme serology, complete metabolic panel, CBC with differential, mono serology, and A1C. He had also undergone Thyroid testing (free T4, TSH, and total T4); results were not yet available. The patient had not received any treatment for the event. The reporter noted that, per the patient's mother, the patient was "better re: anxiety", and was "a little less tired". Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Thyroxine free
Clinical narrative: Initial report received from a health care professional on 03 November 2010. A 4-year-old child, with no medical history or concomitant medications, received on 29 September 2010 an injection (route and site not reported) of DAPTACEL, lot number C3142AA, an injection (route and site not reported) of TUBERSOL 5 TU, lot number C3586AA, and an injection (route and site not reported) of MMR II, Merck lot number MSD05322. The patient developed behavior changes on an unknown date after the vaccines in 2010. The patient's mother reported that the child became difficult in the morning, clings and cries at school and also now was afraid of the wind. The symptoms were reported first to the health care provider on 01 November 2010. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 10 January 2011. The DAPTACEL was given intramuscularly in the left deltoid, the TUBERSOL 5TU intradermally in the left forearm, and the MMR II subcutaneously in the left upper arm. The patient had not received any other vaccines within 4 weeks of 29 September 2010, and had not previously experienced any adverse events following vaccination. His birth weight was 7 pounds 2 ounces, and he had 2 siblings (1 brother and 1 sister); neither sibling had ever experienced adverse events following vaccination. He was seen by his physician on 05 November 2010, and underwent a strep culture which was normal. On 08 November 2010 the patient underwent the following testing, all of which was within normal limits: Epstein Barr Virus, Lyme serology, complete metabolic panel, CBC with differential, mono serology, and A1C. He had also undergone Thyroid testing (free T4, TSH, and total T4); results were not yet available. The patient had not received any treatment for the event. The reporter noted that, per the patient's mother, the patient was "better re: anxiety", and was "a little less tired". Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Condition aggravated, Fatigue, Injection site haematoma, Pyrexia, Rash erythematous
Clinical narrative: Initial report received from a consumer's parent on 06 May 2010. A 3-year-old male patient, with a medical history of insulin dependent diabetes mellitus controlled with insulin pump and no known drug allergies, experienced fever, fatigue, sleepiness, a need to increase NOVOLOG regular insulin, bruising at the injection site of right deltoid and mildly raised erythema rash after he received a right deltoid injection of DAPTACEL, batch number C3322A on 03 May 2010. The patient had to increase the basal rate of NOVOLOG regular insulin and bolus doses of NOVOLOG insulin via insulin pump. He had a slight bruise at the injection site of the right deltoid and a rectangular area of mildly raised erythema rash which was 2 inches by 3 inches and located 1 1/4 inch from the injection site. The patient had a history of fever and a need to increase basal insulin rate via pump when he received doses 1 and 2 of DTaP at possible age 2 years. The outcome for the events was reported as unknown. Follow-up information was received 24 May 2010 from a health care professional. The patient received DAPTACEL as an intramuscular right deltoid injection. The reported events began on 03 May 2010 and did not require a doctor's visit. The patient received corrective treatment with ice at home. According to the reporter, the patient recovered. Follow-up information was received on 10 June 2010 from a healthcare professional. The first dose of DTaP the patient received was DAPTACEL (lot number C3083AA) given intramuscularly in the deltoid and the second dose of DTaP was DAPTACEL (lot number C2999AA) given intramuscularly in the thigh. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Therapy regimen changed, Vaccine positive rechallenge
Clinical narrative: Initial report received from a consumer's parent on 06 May 2010. A 3-year-old male patient, with a medical history of insulin dependent diabetes mellitus controlled with insulin pump and no known drug allergies, experienced fever, fatigue, sleepiness, a need to increase NOVOLOG regular insulin, bruising at the injection site of right deltoid and mildly raised erythema rash after he received a right deltoid injection of DAPTACEL, batch number C3322A on 03 May 2010. The patient had to increase the basal rate of NOVOLOG regular insulin and bolus doses of NOVOLOG insulin via insulin pump. He had a slight bruise at the injection site of the right deltoid and a rectangular area of mildly raised erythema rash which was 2 inches by 3 inches and located 1 1/4 inch from the injection site. The patient had a history of fever and a need to increase basal insulin rate via pump when he received doses 1 and 2 of DTaP at possible age 2 years. The outcome for the events was reported as unknown. Follow-up information was received 24 May 2010 from a health care professional. The patient received DAPTACEL as an intramuscular right deltoid injection. The reported events began on 03 May 2010 and did not require a doctor's visit. The patient received corrective treatment with ice at home. According to the reporter, the patient recovered. Follow-up information was received on 10 June 2010 from a healthcare professional. The first dose of DTaP the patient received was DAPTACEL (lot number C3083AA) given intramuscularly in the deltoid and the second dose of DTaP was DAPTACEL (lot number C2999AA) given intramuscularly in the thigh. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, FLUN(H1N1)
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Initial case received on 29 January 2010 from a healthcare professional. A 5 year old female patient received a left deltoid intramuscular injection of DAPTACEL (lot number C3141AA), a right deltoid intramuscular injection of FLUVIRIN (Novartis no lot number reported) and nasal "H1N1" (Medimmune no lot number reported) on 25 January 2010. On 26 January 2010, the patient experienced left arm swelling from the elbow to shoulder and into lower neck. There were no other complaints. The patient's medical history included allergic rhinitis. She had no illness at the time of the vaccination. There were no known allergies and no concomitant medications. The patient was seen by a physician on 29 January 2010 and treatment included BENADRYL and ice. As of this report the patient had not recovered. Follow-up information received on 19 March 2010 from a healthcare professional. The swelling of the left arm and neck resolved by 29 January 2010. No further treatment for these adverse events was needed. No additional information was provided. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain, Gait disturbance, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 25 August 2010. A male patient (age not reported), with no medical history and no illness at the time of vaccination, received on 23 August 2010 a right thigh injection of DTAP (lot number not provided) and a right thigh injection of IPV (lot number not provided). On 24 August 2010, the patient complained of leg pain and difficulty walking. While in the doctor's office on the 24 August 2010 at 9:15 AM, the patient appeared to be mildly ill, pale, walking slowly and favors right leg. He complained of abdominal pain and vomited once in the doctor's office. The right thigh was tender to palpation with an indurated but with no warmth or erythema. No relevant diagnostic testing was performed. The outcome was reported as unknown. Follow-up information was received on 17 September 2010 from a healthcare professional. The patient was 5 years old. The lot numbers were provided for DAPTACEL (C3473AA) and for IPOL (E0204). The route of both vaccines was intramuscular. Treatment included oral ibuprofen, given in the office. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pallor, Vomiting
Clinical narrative: Initial report received from a health care professional on 25 August 2010. A male patient (age not reported), with no medical history and no illness at the time of vaccination, received on 23 August 2010 a right thigh injection of DTAP (lot number not provided) and a right thigh injection of IPV (lot number not provided). On 24 August 2010, the patient complained of leg pain and difficulty walking. While in the doctor's office on the 24 August 2010 at 9:15 AM, the patient appeared to be mildly ill, pale, walking slowly and favors right leg. He complained of abdominal pain and vomited once in the doctor's office. The right thigh was tender to palpation with an indurated but with no warmth or erythema. No relevant diagnostic testing was performed. The outcome was reported as unknown. Follow-up information was received on 17 September 2010 from a healthcare professional. The patient was 5 years old. The lot numbers were provided for DAPTACEL (C3473AA) and for IPOL (E0204). The route of both vaccines was intramuscular. Treatment included oral ibuprofen, given in the office. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Guillain-Barre syndrome
Clinical narrative: Combined Initial consumer (patient) reports received via an insurance company on 18 Jan 2011 and 19 Jan 2011: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: 111775P1, expiry date 31 Mar 2011) from a multi dose vial on an unknown date. The patient developed Guillain-Barre syndrome on an unknown date. The outcome and causality were not reported. Follow up physician report received on 23 Feb 2011. This poly medicated patient had a medical history of deep vein thrombosis, prostate neoplasm malignant since 2003, prostatectomy in 2003, obstructive sleep apnea since 2006, inferior vena cava filter in 2006, bleeding disorder in 2006, pneumonia bacterial since Mar 2008, dyspnea on exertion since 03 Jul 2008, progressive neuropathic symptoms and family history of coronary artery disease for father and leukemia for mother. The patient had hernia repair done 4-5 months ago and also had minor peripheral arterial disease. The patient received FLUVIRIN 0.5 ml in lower arm on 11 Oct 2010. On an unknown date, one week after the vaccination, the patient experienced decreased sensation in his feet with progressive weakness in the legs, decreasing grip and palmar paresthesias. On an unknown date, the patient was hospitalized. It was reported that the patient progressed from no assistive device a month prior to needing a cane a week prior to admission to hospital to non-ambulatory at the time of admission. On an unknown date, the patient had physical examination done where the patient's other vital stats were normal other than sensation where the patient experienced reduced sensation, reduced vibration in the distal extremities and was wheelchair dependent. The patient also experienced chronic venous stasis dermatitis, chronic pain in the left leg and generalized weakness. In the extremities the patient had arthritic changes in his hands along with some interosseous wastings. The patient was assessed to have deep vein thrombosis, latrogenic pulmonary embolism and infarction, leukemia and Guillain-Barre syndrome (GBS). GBS was treated with plasmapheresis. The outcome and causality of the events were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Asthenia, Condition aggravated, Deep vein thrombosis, Grip strength decreased
Clinical narrative: Combined Initial consumer (patient) reports received via an insurance company on 18 Jan 2011 and 19 Jan 2011: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: 111775P1, expiry date 31 Mar 2011) from a multi dose vial on an unknown date. The patient developed Guillain-Barre syndrome on an unknown date. The outcome and causality were not reported. Follow up physician report received on 23 Feb 2011. This poly medicated patient had a medical history of deep vein thrombosis, prostate neoplasm malignant since 2003, prostatectomy in 2003, obstructive sleep apnea since 2006, inferior vena cava filter in 2006, bleeding disorder in 2006, pneumonia bacterial since Mar 2008, dyspnea on exertion since 03 Jul 2008, progressive neuropathic symptoms and family history of coronary artery disease for father and leukemia for mother. The patient had hernia repair done 4-5 months ago and also had minor peripheral arterial disease. The patient received FLUVIRIN 0.5 ml in lower arm on 11 Oct 2010. On an unknown date, one week after the vaccination, the patient experienced decreased sensation in his feet with progressive weakness in the legs, decreasing grip and palmar paresthesias. On an unknown date, the patient was hospitalized. It was reported that the patient progressed from no assistive device a month prior to needing a cane a week prior to admission to hospital to non-ambulatory at the time of admission. On an unknown date, the patient had physical examination done where the patient's other vital stats were normal other than sensation where the patient experienced reduced sensation, reduced vibration in the distal extremities and was wheelchair dependent. The patient also experienced chronic venous stasis dermatitis, chronic pain in the left leg and generalized weakness. In the extremities the patient had arthritic changes in his hands along with some interosseous wastings. The patient was assessed to have deep vein thrombosis, latrogenic pulmonary embolism and infarction, leukemia and Guillain-Barre syndrome (GBS). GBS was treated with plasmapheresis. The outcome and causality of the events were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Leukaemia, Muscle atrophy, Muscular weakness, Pain
Clinical narrative: Combined Initial consumer (patient) reports received via an insurance company on 18 Jan 2011 and 19 Jan 2011: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: 111775P1, expiry date 31 Mar 2011) from a multi dose vial on an unknown date. The patient developed Guillain-Barre syndrome on an unknown date. The outcome and causality were not reported. Follow up physician report received on 23 Feb 2011. This poly medicated patient had a medical history of deep vein thrombosis, prostate neoplasm malignant since 2003, prostatectomy in 2003, obstructive sleep apnea since 2006, inferior vena cava filter in 2006, bleeding disorder in 2006, pneumonia bacterial since Mar 2008, dyspnea on exertion since 03 Jul 2008, progressive neuropathic symptoms and family history of coronary artery disease for father and leukemia for mother. The patient had hernia repair done 4-5 months ago and also had minor peripheral arterial disease. The patient received FLUVIRIN 0.5 ml in lower arm on 11 Oct 2010. On an unknown date, one week after the vaccination, the patient experienced decreased sensation in his feet with progressive weakness in the legs, decreasing grip and palmar paresthesias. On an unknown date, the patient was hospitalized. It was reported that the patient progressed from no assistive device a month prior to needing a cane a week prior to admission to hospital to non-ambulatory at the time of admission. On an unknown date, the patient had physical examination done where the patient's other vital stats were normal other than sensation where the patient experienced reduced sensation, reduced vibration in the distal extremities and was wheelchair dependent. The patient also experienced chronic venous stasis dermatitis, chronic pain in the left leg and generalized weakness. In the extremities the patient had arthritic changes in his hands along with some interosseous wastings. The patient was assessed to have deep vein thrombosis, latrogenic pulmonary embolism and infarction, leukemia and Guillain-Barre syndrome (GBS). GBS was treated with plasmapheresis. The outcome and causality of the events were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paraesthesia, Plasmapheresis, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Combined Initial consumer (patient) reports received via an insurance company on 18 Jan 2011 and 19 Jan 2011: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: 111775P1, expiry date 31 Mar 2011) from a multi dose vial on an unknown date. The patient developed Guillain-Barre syndrome on an unknown date. The outcome and causality were not reported. Follow up physician report received on 23 Feb 2011. This poly medicated patient had a medical history of deep vein thrombosis, prostate neoplasm malignant since 2003, prostatectomy in 2003, obstructive sleep apnea since 2006, inferior vena cava filter in 2006, bleeding disorder in 2006, pneumonia bacterial since Mar 2008, dyspnea on exertion since 03 Jul 2008, progressive neuropathic symptoms and family history of coronary artery disease for father and leukemia for mother. The patient had hernia repair done 4-5 months ago and also had minor peripheral arterial disease. The patient received FLUVIRIN 0.5 ml in lower arm on 11 Oct 2010. On an unknown date, one week after the vaccination, the patient experienced decreased sensation in his feet with progressive weakness in the legs, decreasing grip and palmar paresthesias. On an unknown date, the patient was hospitalized. It was reported that the patient progressed from no assistive device a month prior to needing a cane a week prior to admission to hospital to non-ambulatory at the time of admission. On an unknown date, the patient had physical examination done where the patient's other vital stats were normal other than sensation where the patient experienced reduced sensation, reduced vibration in the distal extremities and was wheelchair dependent. The patient also experienced chronic venous stasis dermatitis, chronic pain in the left leg and generalized weakness. In the extremities the patient had arthritic changes in his hands along with some interosseous wastings. The patient was assessed to have deep vein thrombosis, latrogenic pulmonary embolism and infarction, leukemia and Guillain-Barre syndrome (GBS). GBS was treated with plasmapheresis. The outcome and causality of the events were not reported.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sensory loss, Stasis dermatitis, Walking aid user, Wheelchair user
Clinical narrative: Combined Initial consumer (patient) reports received via an insurance company on 18 Jan 2011 and 19 Jan 2011: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: 111775P1, expiry date 31 Mar 2011) from a multi dose vial on an unknown date. The patient developed Guillain-Barre syndrome on an unknown date. The outcome and causality were not reported. Follow up physician report received on 23 Feb 2011. This poly medicated patient had a medical history of deep vein thrombosis, prostate neoplasm malignant since 2003, prostatectomy in 2003, obstructive sleep apnea since 2006, inferior vena cava filter in 2006, bleeding disorder in 2006, pneumonia bacterial since Mar 2008, dyspnea on exertion since 03 Jul 2008, progressive neuropathic symptoms and family history of coronary artery disease for father and leukemia for mother. The patient had hernia repair done 4-5 months ago and also had minor peripheral arterial disease. The patient received FLUVIRIN 0.5 ml in lower arm on 11 Oct 2010. On an unknown date, one week after the vaccination, the patient experienced decreased sensation in his feet with progressive weakness in the legs, decreasing grip and palmar paresthesias. On an unknown date, the patient was hospitalized. It was reported that the patient progressed from no assistive device a month prior to needing a cane a week prior to admission to hospital to non-ambulatory at the time of admission. On an unknown date, the patient had physical examination done where the patient's other vital stats were normal other than sensation where the patient experienced reduced sensation, reduced vibration in the distal extremities and was wheelchair dependent. The patient also experienced chronic venous stasis dermatitis, chronic pain in the left leg and generalized weakness. In the extremities the patient had arthritic changes in his hands along with some interosseous wastings. The patient was assessed to have deep vein thrombosis, latrogenic pulmonary embolism and infarction, leukemia and Guillain-Barre syndrome (GBS). GBS was treated with plasmapheresis. The outcome and causality of the events were not reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, erythema at site, hot, tender  Warm compress, Motrin, Benadryl
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile convulsion
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning multiple young children patients who on an unspecified date, were vaccinated orally with a 2ml dose of ROTATEQ (doses and lot # were unspecified). Physician reported that in December 2010 there was a hospital outbreak of Rotavirus that was seen where in over 12 cases and over half had been fully immunized with "3 doses series" of ROTATEQ. Patients were hospitalized for an unknown amount of days. It was reported that on an unspecified date a "serotype analysis" was made (results not reported). At the time of the report patients' outcomes were not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Large erythematous warm raised area in 2/3 of R thigh approx 6x8 inches.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Injection site erythema, Lethargy, Nausea
Clinical narrative: Lethargy and sore arm with redness from top of right arm and underneath armpit 24 hours after immunization. About 2 days after, while on a flight, had dizziness, nausea and vomiting.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Lethargy and sore arm with redness from top of right arm and underneath armpit 24 hours after immunization. About 2 days after, while on a flight, had dizziness, nausea and vomiting.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash generalised
Clinical narrative: Tenderness, redness, swelling at administration site, rash on body - appeared & lasted 2/23/11 to 2/27/11. Pt did not report to ED & symptoms resolved by 2/28/11. She used one dose of Ibuprofen 250mg.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Head injury, Syncope
Clinical narrative: Initial health care professional report received via license partner CSL Limited on 25 Feb 2011: This patient with an unknown medical history was vaccinated with MENVEO (manufacturer, strain and batch number: unknown), FLUVIRIN (manufacturer and batch number: unknown) and VARIVAX (batch number: unknown) on unspecified date (all on same day). After receiving the vaccinations the nurse also drew blood from patient. After drawing blood the patient fainted. He hit his head while fainting and was sent to emergency room (ER). The outcome was not reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: left arm rash, warm, erythema, hard at site Benadryl given
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines.  This is one of 13 cases received during the surveillance period from 01 January 2010 to 23 February 2011.  Incident ID# 431223.  Initial report received on 23 February 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16.  A case of pertussis disease in a six-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Surveillance System.  The subject's vaccine history included 3 doses of PENTACEL; lot number C3541AA received on 23 February 2010, lot number C3579AA received on 23 April 2010, and lot number C3633AA received on 22 June 2010 (routes and sites of administration not reported).  On 13 August 2010, 52 days after the last dose, she developed a cough.  On 16 August 2010, the subject developed a paroxysmal cough with a whoop.  The subject also experienced sleep disturbance.  Chest x-ray findings were negative for pneumonia.  Corrective treatments consisted of azithromycin starting on 17 August 2010 for five days.  The subject was not hospitalized.  At the time of final contact on 14 September 2010, the subject's cough had resolved.  The duration of the cough was reported at that time as 28 days.  Laboratory testing for PCR was not reported.  However, this case was epidemiologically linked to a laboratory confirmed case.  Investigator causality assessment is not required as per protocol.  Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Pertussis, Sleep disorder
Clinical narrative: Surveillance for Rates of Pertussis Disease Among Persons Birth through 59 months of Age Receiving PENTACEL or Other Pertussis Vaccines.  This is one of 13 cases received during the surveillance period from 01 January 2010 to 23 February 2011.  Incident ID# 431223.  Initial report received on 23 February 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16.  A case of pertussis disease in a six-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Surveillance System.  The subject's vaccine history included 3 doses of PENTACEL; lot number C3541AA received on 23 February 2010, lot number C3579AA received on 23 April 2010, and lot number C3633AA received on 22 June 2010 (routes and sites of administration not reported).  On 13 August 2010, 52 days after the last dose, she developed a cough.  On 16 August 2010, the subject developed a paroxysmal cough with a whoop.  The subject also experienced sleep disturbance.  Chest x-ray findings were negative for pneumonia.  Corrective treatments consisted of azithromycin starting on 17 August 2010 for five days.  The subject was not hospitalized.  At the time of final contact on 14 September 2010, the subject's cough had resolved.  The duration of the cough was reported at that time as 28 days.  Laboratory testing for PCR was not reported.  However, this case was epidemiologically linked to a laboratory confirmed case.  Investigator causality assessment is not required as per protocol.  Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Cognitive disorder, Developmental delay, Emotional disorder, Gross motor delay, Hypophagia
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced lost a couple pounds and eating significantly less food. At 4 years of age, the patient received a dose on 07-Sep-2010. Additional suspect medication included KEPPRA. The patient experienced lost a couple pounds in Sep-2010 or Oct-2010 and eating significantly less food in Sep-2010. Outcome for both events was not recovered. Per the reporter, patient's epilepsy physician attributed the events to levetiracetam. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case had been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. Follow-Up: 15Nov2010) This contactable physician reported that the patient had increased the dose of KEPPRA at the same time of the events, but is also currently weaning off levetiracetam. Patient is currently recovering from the events. Follow-up (02MAR2010): Follow-up information for this spontaneous case was received from a contactable physician. New information included the patient weight and height at the time of the event, lot number, new event - developmental milestones not within normal range, medical history, the explanation for the event, and outcome. The physician reported the developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were not within normal range. The child's physical growth has been normal. The physician stated: Patient had increased dose of KEPPRA at the same time. Neurologist considered that this affected eating. At the time of this report, the physician reported the patient is improving. The physician also stated: the patient is currently weaning off levetiracetam.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Motor developmental delay, Speech disorder developmental, Weight decreased
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced lost a couple pounds and eating significantly less food. At 4 years of age, the patient received a dose on 07-Sep-2010. Additional suspect medication included KEPPRA. The patient experienced lost a couple pounds in Sep-2010 or Oct-2010 and eating significantly less food in Sep-2010. Outcome for both events was not recovered. Per the reporter, patient's epilepsy physician attributed the events to levetiracetam. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case had been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. Follow-Up: 15Nov2010) This contactable physician reported that the patient had increased the dose of KEPPRA at the same time of the events, but is also currently weaning off levetiracetam. Patient is currently recovering from the events. Follow-up (02MAR2010): Follow-up information for this spontaneous case was received from a contactable physician. New information included the patient weight and height at the time of the event, lot number, new event - developmental milestones not within normal range, medical history, the explanation for the event, and outcome. The physician reported the developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were not within normal range. The child's physical growth has been normal. The physician stated: Patient had increased dose of KEPPRA at the same time. Neurologist considered that this affected eating. At the time of this report, the physician reported the patient is improving. The physician also stated: the patient is currently weaning off levetiracetam.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope 10 seconds
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Severe hives on back and legs
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reports she felt pain at site of injection (Left arm) when flu vaccine was administered on 1/14/2011.  Pain has continued intermittently. Patient has not sought M.D. care.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired drug administered
Clinical narrative: Given Hep A vaccine that expired 11/10. Given on 01/29/11.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives located on body randomly comes & goes started within 24 hours of vaccine administration.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Chills, headache, sore arm. Treatment: TYLENOL.