chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Paraesthesia, Sinus disorder
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Diplopia, Dysarthria, Facial paresis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: FLUN3, HEPAB, MNQ, TDAP, FLUN3, HEPAB, MNQ, TDAP
Symptoms: Paraesthesia, Paresis
Clinical narrative: Initial case received from the CDC on 11 January 2010, under VAERS ID number 351888. A 21-year-old male patient received the following vaccinations on 25 February 2009: ADACEL (lot number C3057AA), MENACTRA (U2846AA), FLUMIST (Medimmune, lot number 500589P), and TWINRIX (GlaxoSmithKline, lot number AHABB160AA). The patient received the vaccines during basic training in the military, and at the time of vaccination had an upper respiratory infection. On 27 March 2009, 30 days post-vaccination, the patient presented with neuropathy, weakness, hyporeflexia, headache, migraine, and muscle pain. He was admitted to the hospital on 03 April 2009, with the additional complaints of weakness in legs, lower back pain, stumbling gait, diplopia, dysarthria, and paresthesias of the fingertips. A physical exam was positive for facial nerve paresis, leg weakness, wide-based gait, and ataxia with absent deep tendon reflexes. Autoantibody testing was positive, indicating a Miller Fisher variant of Guillain-Barre Syndrome. An MRI of the brain showed sinus thickening, and a lumbar puncture was normal. The patient was treated with intravenous immunoglobulin with partial resolution of symptoms. He was transferred to a rehabilitation facility on 06 April 2009 with ongoing headache and back pain. The event was considered to be not recovered. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Chills, Feeling cold
Clinical narrative: This report was received from a health care professional on 28 July 2009. A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009. The patient awoke that evening feeling cold. The next morning, the patient awoke with the following symptoms: severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid. The patient also had pain in the left arm which prevented her from being able to lift it. There was no redness or swelling of the left arm. The patient's temperature was reported as 99.1 degrees Fahrenheit orally. The patient's medical history includes allergies which were treated with NASONEX and ZYRTEC. At the time of the report, the patient was being evaluated by a health care provider. Follow-up information was received from the health care professional on 16 September 2009. The patient was diagnosed with a viral illness. No treatment was indicated, and the subject recovered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Pain
Clinical narrative: This report was received from a health care professional on 28 July 2009. A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009. The patient awoke that evening feeling cold. The next morning, the patient awoke with the following symptoms: severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid. The patient also had pain in the left arm which prevented her from being able to lift it. There was no redness or swelling of the left arm. The patient's temperature was reported as 99.1 degrees Fahrenheit orally. The patient's medical history includes allergies which were treated with NASONEX and ZYRTEC. At the time of the report, the patient was being evaluated by a health care provider. Follow-up information was received from the health care professional on 16 September 2009. The patient was diagnosed with a viral illness. No treatment was indicated, and the subject recovered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Pyrexia, Viral infection
Clinical narrative: This report was received from a health care professional on 28 July 2009. A 13 year old female patient received MENACTRA (lot number U2926AA) in the left deltoid on 27 July 2009. The patient awoke that evening feeling cold. The next morning, the patient awoke with the following symptoms: severe headache, chills, feeling cold, nausea, feeling achy all over, joint pain, pain in her back, knees, foot and injection site on left deltoid. The patient also had pain in the left arm which prevented her from being able to lift it. There was no redness or swelling of the left arm. The patient's temperature was reported as 99.1 degrees Fahrenheit orally. The patient's medical history includes allergies which were treated with NASONEX and ZYRTEC. At the time of the report, the patient was being evaluated by a health care provider. Follow-up information was received from the health care professional on 16 September 2009. The patient was diagnosed with a viral illness. No treatment was indicated, and the subject recovered.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Arthralgia, Blood test abnormal, Disability, Hypersensitivity, Impaired work ability
Clinical narrative: This case was received from a health care professional, via another manufacturer (reference number WAES 0906USA00846), on 25 August 2009. "Initial and follow-up information has been received from a nurse practitioner concerning her daughter, a 18 year old female student who on 06-MAR-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscularly into her right deltoid (LOT# 661703/0651X) at 10:40 am." "On 03-MAR-2009, the patient was vaccinated with her third dose of VARIVAX (Lot: 659845/0270X) intramuscularly into her right deltoid at 15:00 pm and with her first dose of MENACTRA (lot # U2669AA) intramuscularly into her left deltoid at 15:00 pm. Concomitant therapy included an unspecified birth control pill." "Subsequently the patient had an " allergic reaction, where you could write on her skin with a pen and still see it 3 hours later". However it was not specified if she meant that she could still saw ink on her skin 3 hours later or if she could still saw indentation on her skin 3 hours later. The reporter's daughter also experienced joint pain. The nurse practitioner said that her daughter's allergist thought that it was an allergic reaction to MENACTRA (manufacturer unspecified). At the time of reporting the patient's present status was unknown." "Additional information has been received from the medical assistant and provided the following additional details." "The patient has a past medical history of acne, no known drug allergies." "The exact AE onset date is unknown, but the chart notes show an ER visit on approximately 22-MAR-2009. The patient went into the office on 23-MAR-2009 for blood work (values mostly within normal limits; WBC slightly elevated. The patient was treated with a MEDROL dose pack and Benadryl. The medical assistant couldn't say if the events were disabling or life threatening. The patient's status was unknown." "The health care professional contacted during telephone follow up could not supply the following information: date of event and recovery status." "Additional information has been received from the nurse practitioner who reported that the adverse events onset date was on 15-MAR-2009, the conditions were diagnosed on approximately 01-MAY-2009 by the physician as "serum sickness and dermographism probably due to MENACTRA." The nurse practitioner reported that the conditions were not life threatening but joint pain was disabling. (The patient missed a week of work): currently the patient is being treated with H2 blockers and antihistamines, she was recovering (the nurse reporter that the physician stated that the full recovery would take about six months)." "Follow-up information has been received which reported that the patient with focal seizures experienced joint pain, dermographism and serum sickness on 22-MAR-2009. The outcome of the patient was not reported but she was still taking meds." "No further information is available." Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Mechanical urticaria, Serum sickness, White blood cell count increased
Clinical narrative: This case was received from a health care professional, via another manufacturer (reference number WAES 0906USA00846), on 25 August 2009. "Initial and follow-up information has been received from a nurse practitioner concerning her daughter, a 18 year old female student who on 06-MAR-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscularly into her right deltoid (LOT# 661703/0651X) at 10:40 am." "On 03-MAR-2009, the patient was vaccinated with her third dose of VARIVAX (Lot: 659845/0270X) intramuscularly into her right deltoid at 15:00 pm and with her first dose of MENACTRA (lot # U2669AA) intramuscularly into her left deltoid at 15:00 pm. Concomitant therapy included an unspecified birth control pill." "Subsequently the patient had an " allergic reaction, where you could write on her skin with a pen and still see it 3 hours later". However it was not specified if she meant that she could still saw ink on her skin 3 hours later or if she could still saw indentation on her skin 3 hours later. The reporter's daughter also experienced joint pain. The nurse practitioner said that her daughter's allergist thought that it was an allergic reaction to MENACTRA (manufacturer unspecified). At the time of reporting the patient's present status was unknown." "Additional information has been received from the medical assistant and provided the following additional details." "The patient has a past medical history of acne, no known drug allergies." "The exact AE onset date is unknown, but the chart notes show an ER visit on approximately 22-MAR-2009. The patient went into the office on 23-MAR-2009 for blood work (values mostly within normal limits; WBC slightly elevated. The patient was treated with a MEDROL dose pack and Benadryl. The medical assistant couldn't say if the events were disabling or life threatening. The patient's status was unknown." "The health care professional contacted during telephone follow up could not supply the following information: date of event and recovery status." "Additional information has been received from the nurse practitioner who reported that the adverse events onset date was on 15-MAR-2009, the conditions were diagnosed on approximately 01-MAY-2009 by the physician as "serum sickness and dermographism probably due to MENACTRA." The nurse practitioner reported that the conditions were not life threatening but joint pain was disabling. (The patient missed a week of work): currently the patient is being treated with H2 blockers and antihistamines, she was recovering (the nurse reporter that the physician stated that the full recovery would take about six months)." "Follow-up information has been received which reported that the patient with focal seizures experienced joint pain, dermographism and serum sickness on 22-MAR-2009. The outcome of the patient was not reported but she was still taking meds." "No further information is available." Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blister, Inappropriate schedule of drug administration, Tenderness
Clinical narrative: Initial information received on 04 September 2009 from a health care professional. A ten year old male patient with an allergy to amoxicillin developed a reaction seven days post vaccination after he received MENACTRA (lot number U2818AA) intramuscularly in the right deltoid and BOOSTRIX (manufacturer GSK, lot number AC52B036BA) in the left deltoid on 13 August 2009. On August 2009, the patient developed fluid filled vesicles between his fingers and on his fingertips. Per reporter, the vesicles burst, dried up, and would restart vesicle formation. The patient also reported tenderness in his hands. Two weeks later (specific date not reported), the patient received a varicella vaccine (lot number 03434, manufacturer not provided) subcutaneously in the left arm and hepatitis A vaccine (lot number AHAVB311AA, manufacturer not provided) in the left deltoid. The recovery status was unknown. No further information was provided. Follow-up information was received from a health care professional on 30 September 2009. A first dose of MENACTRA was administered intramuscularly in the right deltoid and a first dose of BOOSTRIX was administered intramuscularly in the left deltoid. The events subsequently resolved. On 27 August 2009, two weeks after vaccination, the patient received a second subcutaneous left arm injection of Varicella (Merck, lot number 0343Y) and a first intramuscular left deltoid injection of Hepatitis A (SKB, AHAVB311AA). List of Documents held by Sender: none.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Blister, Pain, Rash, Skin ulcer
Clinical narrative: Initial information received on 04 September 2009 from a health care professional. A ten year old male patient with an allergy to amoxicillin developed a reaction seven days post vaccination after he received MENACTRA (lot number U2818AA) intramuscularly in the right deltoid and BOOSTRIX (manufacturer GSK, lot number AC52B036BA) in the left deltoid on 13 August 2009. On August 2009, the patient developed fluid filled vesicles between his fingers and on his fingertips. Per reporter, the vesicles burst, dried up, and would restart vesicle formation. The patient also reported tenderness in his hands. Two weeks later (specific date not reported), the patient received a varicella vaccine (lot number 03434, manufacturer not provided) subcutaneously in the left arm and hepatitis A vaccine (lot number AHAVB311AA, manufacturer not provided) in the left deltoid. The recovery status was unknown. No further information was provided. Follow-up information was received from a health care professional on 30 September 2009. A first dose of MENACTRA was administered intramuscularly in the right deltoid and a first dose of BOOSTRIX was administered intramuscularly in the left deltoid. The events subsequently resolved. On 27 August 2009, two weeks after vaccination, the patient received a second subcutaneous left arm injection of Varicella (Merck, lot number 0343Y) and a first intramuscular left deltoid injection of Hepatitis A (SKB, AHAVB311AA). List of Documents held by Sender: none.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Lethargy, Lymphadenopathy, Oedema peripheral
Clinical narrative: Initial report was received 10 August 2009 from a health care professional. A 14-year-old male patient had received a first dose right arm injection of ADACEL, lot number C3250AA and a first dose left arm injection of MENACTRA, lot number U29057BA (lot number invalid) on 06 August 2009 and two days later, the patient was lethargic, sleepy, he had a large axillary lymph node, and his right arm was red, swollen and tender. He had no known allergies and no history of medical conditions. The patient was scheduled to be evaluated byhis physician on 10 August 2009, and at the time of the report, his recovery status was unknown. Follow up information received on 31 August 2009 from health care professional. The patient did not have an illness at the time of vaccination. The reporter clarified that the patient had swelling to the right axilla. The swelling, lethargy, and sleepiness lasted for one week. The patient was treated with antibiotics, medication name not specified. Labs and diagnostics were not performed. The patient fully recovered. The reporter verified that the lot number for the MENACTRA which was administered was U2907BA. No further information was provided. Follow-up information was received from the health care professional on 16 September 2009. In addition to the symptoms previously reported, the patient also experienced swelling under the left axilla and nodes. He was treated with a Z-pak, and diagnosed with an allergic reaction. He was seen on 25 August 2009, and had improved at that time. Documents held by sender: None
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Somnolence, Tenderness
Clinical narrative: Initial report was received 10 August 2009 from a health care professional. A 14-year-old male patient had received a first dose right arm injection of ADACEL, lot number C3250AA and a first dose left arm injection of MENACTRA, lot number U29057BA (lot number invalid) on 06 August 2009 and two days later, the patient was lethargic, sleepy, he had a large axillary lymph node, and his right arm was red, swollen and tender. He had no known allergies and no history of medical conditions. The patient was scheduled to be evaluated byhis physician on 10 August 2009, and at the time of the report, his recovery status was unknown. Follow up information received on 31 August 2009 from health care professional. The patient did not have an illness at the time of vaccination. The reporter clarified that the patient had swelling to the right axilla. The swelling, lethargy, and sleepiness lasted for one week. The patient was treated with antibiotics, medication name not specified. Labs and diagnostics were not performed. The patient fully recovered. The reporter verified that the lot number for the MENACTRA which was administered was U2907BA. No further information was provided. Follow-up information was received from the health care professional on 16 September 2009. In addition to the symptoms previously reported, the patient also experienced swelling under the left axilla and nodes. He was treated with a Z-pak, and diagnosed with an allergic reaction. He was seen on 25 August 2009, and had improved at that time. Documents held by sender: None
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, UNK
Symptoms: Anxiety, Blindness transient, Immediate post-injection reaction
Clinical narrative: Initial report was received on 05 October 2009 from another manufacture; report # WAES 0909USA04206. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 14 year old female patient with no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL "approximately three years ago" in approximately September 2006. Concomitant therapies included MENACTRA and another vaccine (manufacturer unknown). Right after getting the vaccine the patient experienced anxiety and temporary loss of vision. The patient was at the office when it happened. There were no lab diagnostic studies performed. The physician told the patient to remain seated for 10 to 15 minutes and the patient recovered. Upon internal review, temporary loss of vision was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available." Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Asthenia, Dysphonia, Dyspnoea, Headache, Pallor
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Wheezing
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Headache
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Pallor, Palpitations, X-ray
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Chills, Dyspnoea, Lymphadenopathy, Nervousness, Pharyngitis streptococcal
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 26.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), FLU3, FLUN(H1N1), FLUN(H1N1), FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: A spontaneous report of serious events of trouble breathing and strep throat which was manifested by nervousness, fever of 102 F and swollen glands and a non-serious event of shivering/shaking was received from a patient/consumer, a 26-year-old female, concerning herself, subsequent to Influenza A (H1N1) Monovalent Vaccine Live, Intranasal. No medical history and concomitant medications was reported for this patient. On 06-NOV-2009, the patient received an injectable seasonal flu shot. On 06-Nov-2009, the patient received Influenza A (H1N1) Monovalent Vaccine Live, Intranasal for an unknown indication. On 13-Nov-2009, seven days after the administration of H1N1 vaccine, the patient began experiencing nervousness and trouble breathing. The patient went to the ER eight times in the last several months due to these symptoms. The patient did not have the exact dates for ER visits. On 15-Feb-2010, 101 days after administration of H1N1 vaccine, the patient experienced fever of 102 F, shivering, shaking and swollen glands. The patient went to the ER and was diagnosed with strep throat. The outcome of trouble breathing, strep throat and shivering/shaking was unknown.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Gait disturbance, Nystagmus
Clinical narrative: extremely dizzy, nystagmus, unable to walk straight, course lasted about 3 weeks, did not relate it to vaccine until found out mother had same symptoms
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Body temperature increased
Clinical narrative: temp of 103 on Sunday 02/28/2010  called 911  dx abscess Right arm  Did not go to ER or hospital  advised warm compresses  Rx for doxycycline 100mg q 12 hrs x 10 days written by ARNP
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Left ventricular hypertrophy, Troponin I increased
Clinical narrative: chest pain with shortness of breath
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site infection. Site painful, red, warm, and swollen.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1), HPV4, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse reaction. Patient was given vaccine for 18 years of age and older.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Angiogram abnormal, Blindness, Fundoscopy abnormal, Ophthalmological examination, Optic discs blurred
Clinical narrative: Information has been received from a physician via a published article title as stated above and from a website. It was reported that a previously healthy 17 year old female with myopia presented central with central and paracentral dark shimmering spots in the vision of her left eye for 3 days diagnosed as multiple evanescent [[name]] dot syndrome. The right eye was normal. She had received her first GARDASIL and meningococcal (unspecified) vaccination 1 month before the onset of visual loss. She had no history of fever or flu-like symptoms within the past year. She denied any health problems and no family history of vision problems. She had no history of neurologic problems and no pain on eye movement. The patient's maternal grandmother had psoriasis and severe rheumatoid arthritis. Best-corrected Snellen Visual acuity was 20/20 in the right eye and 20/200 in the left eye. There was no afferent pupullary defect. Amsler grid testing of the left eye showed central and paracentral scotoma. Findings on slit-lamp examination were normal except for 1+ anterior vitreous cells in the left eye. Fundus examination of left eye showed slight blurring of the optic disc margin, loss of the foveal reflex, 1+ posterior vitreous cells, and rare small [[name]] spots in the macula and nasal periphery. [[name]] 30-2 visual field testing showed enlargement of the blind spot in the left eye. Fluorescein angiography of the left eye showed subtle hyperfluorescent spots corresponding to the [[name]] spots seen on fundoscopy. Optical coherence tomography of the left eye showed loss of normal architecture of the deep retina. Findings on examination and testing of the right eye were normal. The patient was HLA-B27-positive, but was not HLA-B51-positive. On follow-up examination 2 months after the initial evaluation, visual acuity had improved to 20/20 in the left eye and the [[name]] 30-2 visual field was normal. It was reported that the association of the patient's multiple evanescent [[name]] dot syndrome with the GARDASIL and meningococcal vaccines could be coincidental. Both of these vaccines are administered to [[name]] women, and multiple evanescent [[name]] dot syndrome occurs predominantly in [[name]] women. Upon internal review, multiple evanescent [[name]] dot syndrome was considered to be an other important medical event since the patient lost vision in her left eye. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Retinal exudates, Scotoma, Slit-lamp tests abnormal, Visual field defect, Visual field tests abnormal
Clinical narrative: Information has been received from a physician via a published article title as stated above and from a website. It was reported that a previously healthy 17 year old female with myopia presented central with central and paracentral dark shimmering spots in the vision of her left eye for 3 days diagnosed as multiple evanescent [[name]] dot syndrome. The right eye was normal. She had received her first GARDASIL and meningococcal (unspecified) vaccination 1 month before the onset of visual loss. She had no history of fever or flu-like symptoms within the past year. She denied any health problems and no family history of vision problems. She had no history of neurologic problems and no pain on eye movement. The patient's maternal grandmother had psoriasis and severe rheumatoid arthritis. Best-corrected Snellen Visual acuity was 20/20 in the right eye and 20/200 in the left eye. There was no afferent pupullary defect. Amsler grid testing of the left eye showed central and paracentral scotoma. Findings on slit-lamp examination were normal except for 1+ anterior vitreous cells in the left eye. Fundus examination of left eye showed slight blurring of the optic disc margin, loss of the foveal reflex, 1+ posterior vitreous cells, and rare small [[name]] spots in the macula and nasal periphery. [[name]] 30-2 visual field testing showed enlargement of the blind spot in the left eye. Fluorescein angiography of the left eye showed subtle hyperfluorescent spots corresponding to the [[name]] spots seen on fundoscopy. Optical coherence tomography of the left eye showed loss of normal architecture of the deep retina. Findings on examination and testing of the right eye were normal. The patient was HLA-B27-positive, but was not HLA-B51-positive. On follow-up examination 2 months after the initial evaluation, visual acuity had improved to 20/20 in the left eye and the [[name]] 30-2 visual field was normal. It was reported that the association of the patient's multiple evanescent [[name]] dot syndrome with the GARDASIL and meningococcal vaccines could be coincidental. Both of these vaccines are administered to [[name]] women, and multiple evanescent [[name]] dot syndrome occurs predominantly in [[name]] women. Upon internal review, multiple evanescent [[name]] dot syndrome was considered to be an other important medical event since the patient lost vision in her left eye. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment, Vitreous disorder
Clinical narrative: Information has been received from a physician via a published article title as stated above and from a website. It was reported that a previously healthy 17 year old female with myopia presented central with central and paracentral dark shimmering spots in the vision of her left eye for 3 days diagnosed as multiple evanescent [[name]] dot syndrome. The right eye was normal. She had received her first GARDASIL and meningococcal (unspecified) vaccination 1 month before the onset of visual loss. She had no history of fever or flu-like symptoms within the past year. She denied any health problems and no family history of vision problems. She had no history of neurologic problems and no pain on eye movement. The patient's maternal grandmother had psoriasis and severe rheumatoid arthritis. Best-corrected Snellen Visual acuity was 20/20 in the right eye and 20/200 in the left eye. There was no afferent pupullary defect. Amsler grid testing of the left eye showed central and paracentral scotoma. Findings on slit-lamp examination were normal except for 1+ anterior vitreous cells in the left eye. Fundus examination of left eye showed slight blurring of the optic disc margin, loss of the foveal reflex, 1+ posterior vitreous cells, and rare small [[name]] spots in the macula and nasal periphery. [[name]] 30-2 visual field testing showed enlargement of the blind spot in the left eye. Fluorescein angiography of the left eye showed subtle hyperfluorescent spots corresponding to the [[name]] spots seen on fundoscopy. Optical coherence tomography of the left eye showed loss of normal architecture of the deep retina. Findings on examination and testing of the right eye were normal. The patient was HLA-B27-positive, but was not HLA-B51-positive. On follow-up examination 2 months after the initial evaluation, visual acuity had improved to 20/20 in the left eye and the [[name]] 30-2 visual field was normal. It was reported that the association of the patient's multiple evanescent [[name]] dot syndrome with the GARDASIL and meningococcal vaccines could be coincidental. Both of these vaccines are administered to [[name]] women, and multiple evanescent [[name]] dot syndrome occurs predominantly in [[name]] women. Upon internal review, multiple evanescent [[name]] dot syndrome was considered to be an other important medical event since the patient lost vision in her left eye. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Laboratory test, Pain, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 13 year old female patient who on 06-MAY-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 658282/0929U) concomitantly with a dose of MENACTRA (Lot # UF389AA). On 04-AUG-2009, the patient was vaccinated with the second dose of GARDASIL (Lot # 658282/0929U) and on 19-JAN-2010, the patient was vaccinated with the third dose of GARDASIL (Lot # 658282/0929U). According to the physician, after the patient received her third dose of GARDASIL, she reported that she was extremely sore and weak. The medical assistant reported that the patient had a physician's note to be out of school on 25-JAN-2010 and remained out of school for the rest of that week (until approximately 29-JAN-2010) for symptoms of being extremely sore and weak, it was also reported that the patient had another note to be out of school for symptoms of extremely sore and weak from 01-MAR-2010 to 12-MAR-2010 (also reported by the physician as "missed 2 months of school"). The physician also mentioned that the patient had "mild symptoms" following the first and second dose of GARDASIL (dates not reported). The medical assistant stated that the patient had not recovered. The patient sought unspecified medical attention. Diagnostic laboratories test were performed (not results provided). Upon internal review the patient remained out of school for symptoms of being extremely sore and weak, was considered disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Demyelination, Headache
Clinical narrative: It was reported in a newspaper article that a 16 year old female patient on an unspecified date, was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced a visual loss in the right eye and a left side headache. Over the next 24 hours, the patient's symptoms worsened to include her left eye and a more severe headache. Ten days after the second vaccine, the perfectly healthy patient was left almost totally blind. At the time of reporting, the outcome was unknown. The reporter stated that it was possible that human papilloma virus was the precipitant for the demyelinating event in the patient presented here. It was tempting to speculate whether there may be a specific immune mechanism initiated with human papilloma virus not yet identified, which resulted in not only acute demyelinating encephalomyelitis but also in an unusual clinical course that resulted in persistent visual loss. An expert who worked in the vaccine trials said that the majority of vaccine injuries actually occur in what she called the 'biologically plausible time frame' which was, she said, up to 42 days after the vaccine. Upon internal review, visual loss in the right eye and visual loss in the left eye were determined to be other important medical events. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Caesarean section, Drug exposure during pregnancy, Failed trial of labour, Pregnancy induced hypertension
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL, from a registered nurse concerning a 21 year old female with no medical history or drugs allergies, who on 13-MAY-2009 was vaccinated with a dose of GARDASIL (lot # 661953/1130X). There was no concomitant medication. The patient is now pregnant, the pregnancy is normal to date; her LMP was 11-APR-2009. The patient had a urine pregnancy test. The patient sought medical attention through an office visit. Follow up information received on 30-JUN-2009 from a registered nurse stated that the patient was a female, who on 13-MAY-2009 was vaccinated with a first dose of GARDASIL (lot # 661953/1130X). Concomitant therapy included prenatal vitamins. It was also reported that the patient didn't have any previous pregnancies. Follow up information received from a physician indicated that the patient had a medical history of Rhesus antibodies negative. On 26-OCT-2009 the patient was given RHOGAM times 1 for RH negative and on 13-JAN-2010 the patient was placed on therapy with labetalol 100 mg twice a day for increased blood pressure. On 16-JAN-2010 at 39.6 weeks from her last menstrual period the patient gave birth to a normal baby boy who weighed 8.10; length 20. Due to failure to progress the patient had a C-section done. It was also reported that on an unspecified date the patient developed pregnancy induced hypertension. Upon internal review C-section due to failure to progress was determined to be an other important medical event. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL, from a registered nurse concerning a 21 year old female with no medical history or drugs allergies, who on 13-MAY-2009 was vaccinated with a dose of GARDASIL (lot # 661953/1130X). There was no concomitant medication. The patient is now pregnant, the pregnancy is normal to date; her LMP was 11-APR-2009. The patient had a urine pregnancy test. The patient sought medical attention through an office visit. Follow up information received on 30-JUN-2009 from a registered nurse stated that the patient was a female, who on 13-MAY-2009 was vaccinated with a first dose of GARDASIL (lot # 661953/1130X). Concomitant therapy included prenatal vitamins. It was also reported that the patient didn't have any previous pregnancies. Follow up information received from a physician indicated that the patient had a medical history of Rhesus antibodies negative. On 26-OCT-2009 the patient was given RHOGAM times 1 for RH negative and on 13-JAN-2010 the patient was placed on therapy with labetalol 100 mg twice a day for increased blood pressure. On 16-JAN-2010 at 39.6 weeks from her last menstrual period the patient gave birth to a normal baby boy who weighed 8.10; length 20. Due to failure to progress the patient had a C-section done. It was also reported that on an unspecified date the patient developed pregnancy induced hypertension. Upon internal review C-section due to failure to progress was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: Information has been received from a female consumer who on 04-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed pericarditis after she was given ZOSTAVAX (Merck). The patient stated that on 27-FEB-2010 she was hospitalized and released on 01-MAR-2010. At the time of the report it was unknown if the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reported to me that she has had extreme soreness in her injection arm ever since she received the vaccine.  (2 1/2 months) She said it is so severe she can't lift her arm to dress herself.  She saw her doctor about it, and he told her he thinks I hit a nerve when I administered the vaccine and that it will resolve itself over time.
Age: 0.43
Sex: F
Vaccine: DPP, DTAP, HEP, HIBV
Symptoms: Crying, Muscular weakness, Pyrexia, Screaming, Sleep disorder
Clinical narrative: High pitched screaming or persistent crying for hours; Extreme sleepiness or long periods of unresponsiveness;  High fever (over 103 F)  Sleep disturbances that change wake/sleep pattern;  Muscle weakness;  Swollen Soft Spot on her head;  She felt bad about three hours after recieving the standard two month vaccines. She was unconsolable and she has always been a happy baby.
Age: 0.43
Sex: F
Vaccine: DPP, DTAP, HEP, HIBV
Symptoms: Somnolence, Swelling, Unresponsive to stimuli
Clinical narrative: High pitched screaming or persistent crying for hours; Extreme sleepiness or long periods of unresponsiveness;  High fever (over 103 F)  Sleep disturbances that change wake/sleep pattern;  Muscle weakness;  Swollen Soft Spot on her head;  She felt bad about three hours after recieving the standard two month vaccines. She was unconsolable and she has always been a happy baby.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Angiogram, Computerised tomogram abnormal, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: Initially pain at site followed with swelling and Headache. Next day, 2/17, additional swelling, induration, warm to touch along with nausea/vomiting and fever, dizziness and headache. 2/18: Same symptoms with Chest Pain now and call to 911 and brought to Hospital where she was worked up for Pulmonary embolus with CT Scan of chest and CT Angio of heart. Heart showed no disease.  CT chest Pulmonary showed Pulmonary Embolus. Treated with Lovenox and Coumadin and now placed on long term coumadin therapy. Back to work 3/11/10.