chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Metabolic function test normal, Nausea, Presyncope, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, C-reactive protein normal, Chest pain, Dyspnoea
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram P wave biphasic, Electrocardiogram normal, Extrasystoles, Full blood count normal, Metabolic function test normal
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myopericarditis, Nausea, Presyncope, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Vaccinia virus infection
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncope and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L: CKMB of 5.0 U/L within normal limits; CRP 0.1 within normal limits and ESR was 6 within normal limits. The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptoms appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Abdominal pain upper, Chills, Injection site pustule, Nausea, Pain
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428804. A 18-year-old male patient with a history of seasonal allergies and a tonsillectomy as a child had received the following vaccinations on 18 July 2011: a left arm injection of ACAM2000 (lot number not reported), a right arm injection of TYPHIM VI (lot number and route of administration not reported), a right arm injection of Anthrax (manufacturer, lot number and route of administration not reported) and a right arm injection of Hepatitis B (manufacturer, lot number and route of administration not reported) and eight days later reported two new pustular lesions forming below and medial to central SPV Jennerian pustule on left upper arm. The patient also experienced chills, fever (T 99.6F), nausea, stomach ache and general body ache (coded by VAERS as pain). The patient was evaluated in the emergency room. It was reported the patient had no hives, facial edema, lip swelling, eye swelling, breathing difficulty or swallowing difficulty within the first 15 minutes or three hours post vaccination. The patient also denied any chest pain, SOB (shortness of breath), no pain radiating from chest to neck, throat, or left arm. The patient denied taking any OTC (over the counter) medications. The patient was using an occlusive square dressing over the SPV site, not permitting air circulation. According to the report, the satellite lesions were from vaccinia drainage on bandage. No further information was available at the time of the report. The patient's outcome was recovered. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428804. A 18-year-old male patient with a history of seasonal allergies and a tonsillectomy as a child had received the following vaccinations on 18 July 2011: a left arm injection of ACAM2000 (lot number not reported), a right arm injection of TYPHIM VI (lot number and route of administration not reported), a right arm injection of Anthrax (manufacturer, lot number and route of administration not reported) and a right arm injection of Hepatitis B (manufacturer, lot number and route of administration not reported) and eight days later reported two new pustular lesions forming below and medial to central SPV Jennerian pustule on left upper arm. The patient also experienced chills, fever (T 99.6F), nausea, stomach ache and general body ache (coded by VAERS as pain). The patient was evaluated in the emergency room. It was reported the patient had no hives, facial edema, lip swelling, eye swelling, breathing difficulty or swallowing difficulty within the first 15 minutes or three hours post vaccination. The patient also denied any chest pain, SOB (shortness of breath), no pain radiating from chest to neck, throat, or left arm. The patient denied taking any OTC (over the counter) medications. The patient was using an occlusive square dressing over the SPV site, not permitting air circulation. According to the report, the satellite lesions were from vaccinia drainage on bandage. No further information was available at the time of the report. The patient's outcome was recovered. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Adverse drug reaction, Auricular swelling, Biopsy site unspecified normal, Joint swelling, Rash erythematous
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 429242. A 28-year-old male patient received the following vaccinations on 26 July 2011: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number EO4421), and BIOTHRAX (lot number FAV282). The patient had a history of otitis media diagnosed 20 July 2011 and that same day began a ten day regimen of AUGMENTIN 875 mg bid. The patient had no known allergies. On 03 August 2011, eight days post vaccination, the patient developed an itchy rash spreading to arms, face, chest and knees. Approximately 24 hours later, the patient was seen in the emergency clinic. Following assessment, the patient received corrective treatment with a MEDROL dose pack and ATARAX and was instructed to follow-up the next day with their primary care clinic. The primary care clinic evaluated the patient and noted the patient complained that itching increased and there was swelling of the ears and elbows. The patient was scheduled to travel abroad so they received a same day appointment with a dermatology clinic. The dermatologist stated the patient had diffuse, erythematous, maculopapular, morbilliform rash of the face, ears, neck, chest, back and all four extremities. The smallpox vaccination site was assessed as a normal reaction. The patient had a biopsy performed and was hospitalized with isolation and respiratory caution for continued observation of the rash. Biopsy results were consistent with non-specific drug reaction and the patient was discharged from the hospital. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash maculo-papular, Rash morbilliform, Rash pruritic
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 429242. A 28-year-old male patient received the following vaccinations on 26 July 2011: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number EO4421), and BIOTHRAX (lot number FAV282). The patient had a history of otitis media diagnosed 20 July 2011 and that same day began a ten day regimen of AUGMENTIN 875 mg bid. The patient had no known allergies. On 03 August 2011, eight days post vaccination, the patient developed an itchy rash spreading to arms, face, chest and knees. Approximately 24 hours later, the patient was seen in the emergency clinic. Following assessment, the patient received corrective treatment with a MEDROL dose pack and ATARAX and was instructed to follow-up the next day with their primary care clinic. The primary care clinic evaluated the patient and noted the patient complained that itching increased and there was swelling of the ears and elbows. The patient was scheduled to travel abroad so they received a same day appointment with a dermatology clinic. The dermatologist stated the patient had diffuse, erythematous, maculopapular, morbilliform rash of the face, ears, neck, chest, back and all four extremities. The smallpox vaccination site was assessed as a normal reaction. The patient had a biopsy performed and was hospitalized with isolation and respiratory caution for continued observation of the rash. Biopsy results were consistent with non-specific drug reaction and the patient was discharged from the hospital. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Alopecia
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 429494. A 25-year-old male patient with no reported medical history received the following vaccinations on 06 January 2011: ACAM2000 (lot number VV04-003-A), BIOTHRAX (lot number FAV242), and TYPHIM VI (lot number D0412). At an unspecified amount of time later the patient experienced alopecia requiring treatment with Minoxidil 5% topical solution. Recovery status was unknown. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Eye pain, Ocular hyperaemia
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 430902. A 23-year-old male patient with no reported medical history had received the following vaccinations on 04 August 2011: ACAM2000 (lot number VV04-003-A), TYPHIM VI (lot number E0442), and BIOTHRAX (lot number FAV268) and 14 days later the patient started having redness and pain in the right eye. Recovery status was unknown. Documents held by sender: None.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Deafness, Dysphonia, Laboratory test
Clinical narrative: Information has been received from a patient's wife concerning an 86 year old male patient with chronic obstructive pulmonary disease, cholesterol and no drug reactions/allergies who on 29-AUG-2011, was vaccinated subcutaneous with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 671019/0749AA). Concomitant therapy included a lot of unspecified heart medications and other unspecified medications for cholesterol and chronic obstructive pulmonary disease (COPD). Within a day, on 30-AUG-2011, the patient's throat got really hoarse, a day after that, on 31-AUG-2011, he started coughing. 2.5 months later, on approximately 15-NOV-2011, the patient has lost his hearing. The patient sought unspecified medical attention and had all kinds of unspecified laboratory testing performed. The patient received prednisone, doxycycline and other antibiotics as the treatment for the AEs. At the time of the report, the patient did not recover. Upon internal review, loss of hearing was determined to be an other important medical event. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Pneumonia, Vomiting
Clinical narrative: Initial report was received from a risk management department associated with the pharmacy where the patient was immunized on 23 January 2012. A 78-year-old male patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc., lot number UH458AA on 03 October 2011 and an unspecified amount of time later was hospitalized with pneumonia for a month. The patient had a tetanus shot 10 years ago, received the pneumonia vaccine in 2005 and had a shingles vaccine. The patient was not sick at the time of vaccination and had not received any vaccinations in the prior 4 weeks. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pneumonia
Clinical narrative: Initial report was received from a risk management department associated with the pharmacy where the patient was immunized on 23 January 2012. A 78-year-old male patient had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc., lot number UH458AA on 03 October 2011 and an unspecified amount of time later was hospitalized with pneumonia for a month. The patient had a tetanus shot 10 years ago, received the pneumonia vaccine in 2005 and had a shingles vaccine. The patient was not sick at the time of vaccination and had not received any vaccinations in the prior 4 weeks. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: TYP, YF
Symptoms: Dysphagia, Nausea, Rash, Vomiting
Clinical narrative: Initial report was received on 07 November 2011 from a health care professional. A child (name, gender and date of birth not reported) had received TYPHIM VI (lot number, route, site and date of administration not reported) and YF VAX (lot number, route, site and date of administration not reported) and an unspecified amount of time following vaccination, experienced difficulty swallowing, rash, nausea and vomiting. The patient was evaluated in the ER (emergency room). Treatment included Prednisone. No further information was available at the time of the report. The patient's outcome was recovered. The reporter for this case is the same as for case 2011-10830. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry Product, concerning a 16 year old female patient, fainting frequently, who on 03-APR-2011, was vaccinated with the first dose of GARDASIL (route reported as injection) (dose and lot number not reported), and on 01-DEC-2011, was vaccinated with the second dose of GARDASIL (route reported as injection) (dose and lot number not reported). Secondary suspect therapy included a Pregnancy Registry Product, VARIVAX (Merck) (route reported as injection) (dose and lot number not reported), administered on 01-DEC-2012. The registered nurse reported that the patient received the GARDASIL and VARIVAX (Merck) and later ("about a week ago") found out she was pregnant at the time. When she went to that physician after she found out the physician could not hear a heartbeat. The reporter stated, that the DNC (Dilation and Curettage) was to be performed on 27-JAN-2012 ("tomorrow"). The reported gestation period was 10 weeks. The estimated Last Menstrual Period was approximately 17-NOV-2011. The Estimated Delivery Date would be approximately 23-AUG-2012. Upon internal review the indication for DNC was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Foetal heart rate abnormal, Maternal exposure during pregnancy, Syncope
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry Product, concerning a 16 year old female patient, fainting frequently, who on 03-APR-2011, was vaccinated with the first dose of GARDASIL (route reported as injection) (dose and lot number not reported), and on 01-DEC-2011, was vaccinated with the second dose of GARDASIL (route reported as injection) (dose and lot number not reported). Secondary suspect therapy included a Pregnancy Registry Product, VARIVAX (Merck) (route reported as injection) (dose and lot number not reported), administered on 01-DEC-2012. The registered nurse reported that the patient received the GARDASIL and VARIVAX (Merck) and later ("about a week ago") found out she was pregnant at the time. When she went to that physician after she found out the physician could not hear a heartbeat. The reporter stated, that the DNC (Dilation and Curettage) was to be performed on 27-JAN-2012 ("tomorrow"). The reported gestation period was 10 weeks. The estimated Last Menstrual Period was approximately 17-NOV-2011. The Estimated Delivery Date would be approximately 23-AUG-2012. Upon internal review the indication for DNC was determined to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Abortion missed, Gynaecological examination abnormal, Intra-uterine death, Maternal exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry Product, concerning a 16 year old female patient, fainting frequently, who on 03-APR-2011, was vaccinated with the first dose of GARDASIL (route reported as injection) (dose and lot number not reported), and on 01-DEC-2011, was vaccinated with the second dose of GARDASIL (route reported as injection) (dose and lot number not reported). Secondary suspect therapy included a Pregnancy Registry Product, VARIVAX (Merck) (route reported as injection) (dose and lot number not reported), administered on 01-DEC-2012. The registered nurse reported that the patient received the GARDASIL and VARIVAX (Merck) and later ("about a week ago") found out she was pregnant at the time. When she went to that physician after she found out the physician could not hear a heartbeat. The reporter stated, that the DNC (Dilation and Curettage) was to be performed on 27-JAN-2012 ("tomorrow"). The reported gestation period was 10 weeks. The estimated Last Menstrual Period was approximately 17-NOV-2011. The Estimated Delivery Date would be approximately 23-AUG-2012. Upon internal review the indication for DNC was determined to be an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Burning sensation, Immediate post-injection reaction, Injection site pain
Clinical narrative: In the evening of 1/24/12, the patient complained to her mother of arthralgias in both her knees and upper legs. This continued through the night and into 1/25/12. Muscle rub and ALEVE were used for the discomfort.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging normal, Pain in extremity, Vision blurred
Clinical narrative: In the evening of 1/24/12, the patient complained to her mother of arthralgias in both her knees and upper legs. This continued through the night and into 1/25/12. Muscle rub and ALEVE were used for the discomfort.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Discomfort
Clinical narrative: In the evening of 1/24/12, the patient complained to her mother of arthralgias in both her knees and upper legs. This continued through the night and into 1/25/12. Muscle rub and ALEVE were used for the discomfort.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abasia, Computerised tomogram, Nuclear magnetic resonance imaging brain, Pain, Tremor
Clinical narrative: In the evening of 1/24/12, the patient complained to her mother of arthralgias in both her knees and upper legs. This continued through the night and into 1/25/12. Muscle rub and ALEVE were used for the discomfort.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: In the evening of 1/24/12, the patient complained to her mother of arthralgias in both her knees and upper legs. This continued through the night and into 1/25/12. Muscle rub and ALEVE were used for the discomfort.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Severe onset of sharp pain in deltoid muscle where vaccine was administered. Continued shoulder/muscle pain and altered mobility/strength x3 months.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Mother reported diaphoresis, pallor, nausea & dizziness occurring approximately 3 hrs after receiving typhoid & yellow fever vaccines. The incident occurred in pt's home. No rash, SOB or redness at injection site. Pt recovered spontaneously required no intervention.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Adverse event, Blood culture, Blood electrolytes, C-reactive protein, Culture urine
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 10 week female patient with no pertinent medical history and no drug reactions or allergies, who on 23-JAN-2012, was vaccinated with ROTATEQ (lot number 671724/1543AA; exp. date 06-DEC-2013, dose and route not reported) and RECOMBIVAX HB (lot number 669599/0231AA, exp. date 04-OCT-2013, dose and route not reported). Concomitant therapy included PREVENAR (lot number F65442) and PENTACEL (lot number lot# C4074AA). Physician reported that on 23-JAN-2012, three hours after receiving ROTATEQ, RECOMBIVAX HB, PREVENAR, and PENTACEL the patient was lethargic, became extremely pale and was unresponsive. It was reported that "adverse event was congenital anomaly" (no otherwise specified). The patient sought medical attention. The patient was hospitalized from 23-JAN-2012 to 24-JAN-2012. Treatment therapy for adverse events included unspecified antibiotics as a precautionary measure. Performed lab studies included: urine culture test, blood culture test, electrolyte test, oxygen monitoring and a CRP test. On 24-JAN-2012 the patient's outcome was recovered. The patient's adverse events were considered to be life-threatening and disabling. Priority LOT check has been initiated. Additional information has been requested. It was reported that the patient was hospitalized for approximately one-day as a precautionary measure.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lethargy, Pallor, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 10 week female patient with no pertinent medical history and no drug reactions or allergies, who on 23-JAN-2012, was vaccinated with ROTATEQ (lot number 671724/1543AA; exp. date 06-DEC-2013, dose and route not reported) and RECOMBIVAX HB (lot number 669599/0231AA, exp. date 04-OCT-2013, dose and route not reported). Concomitant therapy included PREVENAR (lot number F65442) and PENTACEL (lot number lot# C4074AA). Physician reported that on 23-JAN-2012, three hours after receiving ROTATEQ, RECOMBIVAX HB, PREVENAR, and PENTACEL the patient was lethargic, became extremely pale and was unresponsive. It was reported that "adverse event was congenital anomaly" (no otherwise specified). The patient sought medical attention. The patient was hospitalized from 23-JAN-2012 to 24-JAN-2012. Treatment therapy for adverse events included unspecified antibiotics as a precautionary measure. Performed lab studies included: urine culture test, blood culture test, electrolyte test, oxygen monitoring and a CRP test. On 24-JAN-2012 the patient's outcome was recovered. The patient's adverse events were considered to be life-threatening and disabling. Priority LOT check has been initiated. Additional information has been requested. It was reported that the patient was hospitalized for approximately one-day as a precautionary measure.
Age: 1.28
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Laboratory test, Rash generalised
Clinical narrative: A few days after receiving flu shot had red blistery area at site of injection. Rash followed. As blisters resolved - red, some blistery, some not. Rash has spread over past few months to hands, trunk, legs, hips, buttocks - everywhere. Seeing PCP & dermatologist.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Balance disorder, Burning sensation, Fall, Fatigue
Clinical narrative: Jan. 28, 2010 Slow-onset reaction left arm pain after given injection. Right leg & left leg burn and feel heavy. Loss of balance. Dropping things. Have had 3 falls in last year. Tired all the time, no energy.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Grip strength decreased, Pain in extremity, Sensation of heaviness
Clinical narrative: Jan. 28, 2010 Slow-onset reaction left arm pain after given injection. Right leg & left leg burn and feel heavy. Loss of balance. Dropping things. Have had 3 falls in last year. Tired all the time, no energy.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Culture, Immediate post-injection reaction, Injection site mass, Purulence
Clinical narrative: Mom reports that child got a lump on right thigh immediately after shot was given and has persisted & enlarged over last couple of months. Now has come to a head & copious amounts of purulent drainage was expressed. Cultures sent & placed on antibiotics.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, CSF test, Chills, Hypoaesthesia, Myelitis transverse
Clinical narrative: Transverse myelitis, numbness chest, feet, legs, arms chills, night sweats.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Night sweats, Nuclear magnetic resonance imaging
Clinical narrative: Transverse myelitis, numbness chest, feet, legs, arms chills, night sweats.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Axillary pain, Blood test, Lymphadenopathy
Clinical narrative: Day of - fever, swollen glands in neck and underarms, pain in underarm. Glands still swollen and severe joint pain & inflammation of knees, ankles, feet, hands, right wrist resulting in permanent RA according to Rheumatologist if symptoms don't approve within next 4 weeks.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Rheumatoid arthritis, Ultrasound scan
Clinical narrative: Day of - fever, swollen glands in neck and underarms, pain in underarm. Glands still swollen and severe joint pain & inflammation of knees, ankles, feet, hands, right wrist resulting in permanent RA according to Rheumatologist if symptoms don't approve within next 4 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Pt developed symptoms of Henoch Schonlein purpura 48 hrs after vaccine.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Arthralgia, Discomfort, Joint manipulation, Musculoskeletal pain
Clinical narrative: Within 24 hrs. of flu vaccination experienced more discomfort than usual. Over the course of winter discomfort gradually became pain, increasing over time, throbbing pain from shoulder to knuckles. Interruption of sleep, difficulty dressing, sensitive to cold. Applied heat for relief. Mentioned problem at every 3 mth. doctor visit. Sought advice from family surgeon who referred to orthopedic who diagnosed as adhesive capsulitis. Went under anesthesia 11-1-11 for shoulder manipulation. Therapy 3x daily for 2 months.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: Within 24 hrs. of flu vaccination experienced more discomfort than usual. Over the course of winter discomfort gradually became pain, increasing over time, throbbing pain from shoulder to knuckles. Interruption of sleep, difficulty dressing, sensitive to cold. Applied heat for relief. Mentioned problem at every 3 mth. doctor visit. Sought advice from family surgeon who referred to orthopedic who diagnosed as adhesive capsulitis. Went under anesthesia 11-1-11 for shoulder manipulation. Therapy 3x daily for 2 months.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Temperature intolerance
Clinical narrative: Within 24 hrs. of flu vaccination experienced more discomfort than usual. Over the course of winter discomfort gradually became pain, increasing over time, throbbing pain from shoulder to knuckles. Interruption of sleep, difficulty dressing, sensitive to cold. Applied heat for relief. Mentioned problem at every 3 mth. doctor visit. Sought advice from family surgeon who referred to orthopedic who diagnosed as adhesive capsulitis. Went under anesthesia 11-1-11 for shoulder manipulation. Therapy 3x daily for 2 months.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction shot site.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Left arm muscle pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site swelling
Clinical narrative: Pt called on 1/24/12 with symptoms of swollen upper arm on same arm as injection site. Pt was told to use MOTRIN to reduce swelling and use cold packs to relieve inflammation.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Pt stated her left arm was very sore. She said she did not have much strength to lift up her arm. Pt was referred to physical therapy.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Adhesion, Musculoskeletal pain, Nerve conduction studies normal, Nerve injury
Clinical narrative: Pt stated her left arm was very sore. She said she did not have much strength to lift up her arm. Pt was referred to physical therapy.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Musculoskeletal pain, Nerve conduction studies normal, Nerve injury
Clinical narrative: Pt stated her left arm was very sore. She said she did not have much strength to lift up her arm. Pt was referred to physical therapy.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. Vaccine given prior to designated interval date (HPV #1 7/22/11, #2 9/26/11).
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Gait disturbance, Immediate post-injection reaction, Infection
Clinical narrative: Initial report was received from a consumer on 23 January 2012. A female patient in her "late 60s possibly 70" had received an injection of FLUZONE, sanofi pasteur Inc., lot number UT433AA (site and route of administration not reported) in November 2011. On an unspecified date "immediately" after the vaccination, the patient developed general malaise and then developed difficulty walking and talking requiring her to use a wheelchair. The reporter stated the patient "had all kinds of test done, x-rays, CT scans and blood work and the doctors are baffled where this infection came from and the last thing she received was a flu shot." The reporter also stated that the patient "stopped breathing." At the time of the report the patient was in the ICU at a hospital. It was unknown if the patient had any illness at the time of vaccination. The reporter was unable to provide the patient's past medical history. The patient was concomitantly taking estrogen therapy. The patient had received influenza vaccines in previous years. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Malaise, Respiratory arrest, Speech disorder, Wheelchair user
Clinical narrative: Initial report was received from a consumer on 23 January 2012. A female patient in her "late 60s possibly 70" had received an injection of FLUZONE, sanofi pasteur Inc., lot number UT433AA (site and route of administration not reported) in November 2011. On an unspecified date "immediately" after the vaccination, the patient developed general malaise and then developed difficulty walking and talking requiring her to use a wheelchair. The reporter stated the patient "had all kinds of test done, x-rays, CT scans and blood work and the doctors are baffled where this infection came from and the last thing she received was a flu shot." The reporter also stated that the patient "stopped breathing." At the time of the report the patient was in the ICU at a hospital. It was unknown if the patient had any illness at the time of vaccination. The reporter was unable to provide the patient's past medical history. The patient was concomitantly taking estrogen therapy. The patient had received influenza vaccines in previous years. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Initial report was received from a consumer on 23 January 2012. A female patient in her "late 60s possibly 70" had received an injection of FLUZONE, sanofi pasteur Inc., lot number UT433AA (site and route of administration not reported) in November 2011. On an unspecified date "immediately" after the vaccination, the patient developed general malaise and then developed difficulty walking and talking requiring her to use a wheelchair. The reporter stated the patient "had all kinds of test done, x-rays, CT scans and blood work and the doctors are baffled where this infection came from and the last thing she received was a flu shot." The reporter also stated that the patient "stopped breathing." At the time of the report the patient was in the ICU at a hospital. It was unknown if the patient had any illness at the time of vaccination. The reporter was unable to provide the patient's past medical history. The patient was concomitantly taking estrogen therapy. The patient had received influenza vaccines in previous years. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Pain, Pharyngitis bacterial
Clinical narrative: Initial report was received from a health care professional on 23 January 2012. A 3-year-old male patient had received an intramuscular dose 2 injection of FLUZONE, sanofi pasteur Inc., lot number UH467AA (site of administration unknown) on 05 December 2011. The reporter reported that the patient's adverse events started on 22 December 2011. On 04 January 2012, the patient was limping, had complaints of everything hurting and went to the emergency room (ER) for bacterial pharyngitis and continued antibiotics. On 07 January 2012, the patient was limping and had unsteady gait and was hospitalized for Guillain-Barre Syndrome (GBS) on 11 January 2012. Illness at the time of vaccination and concomitant medications were reported as none. The patient had no known allergies (NKA). No adverse events to prior vaccinations were reported. The patient had previously received an influenza vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Tdap vaccine (2nd dose) given on March 7, 2011. Tdap #1 given on 8/5/2008.