chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Asthenia, Autoimmune disorder
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Bartonella test positive, Blood test, Borrelia test negative, Cat scratch disease, Cognitive disorder
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Disease susceptibility, Dizziness, Ear pain, Fatigue
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Formication, Headache, Human herpesvirus 6 infection, Hyperacusis, Hypersensitivity
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia, Hypoaesthesia, Hypocoagulable state, Immunology test abnormal, Lyme disease
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Migraine, Mycoplasma test positive, Mycotic allergy, Nausea
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain, Palpitations, Paraesthesia
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Rash, Skin striae, Streptococcal infection, Syncope
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder, Vaccination complication, Visual impairment
Clinical narrative: Information has been received from a healthcare worker through a company representative via social media referring to an 11 year old female patient. No relevant medical history or concurrent conditions were reported. On 02-SEP-2010 the patient was vaccinated with her first dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-SEP-2010, the patient experienced symptoms such as fatigue, headaches, migraines, stabbing ear pain, hyperacusis, abdominal pain, nausea, all over joint pain, constant sore throat, visual disturbances, light sensitivity, cognitive issues such as memory and severe comprehension problems, random numbness and tingling, weird "bug crawling" skin sensations, generalized weakness throughout her body (it was difficult for the patient to just sit in the shower to bathe), dizziness, fainting and heart palpitations. She slept long hours and stayed in her bedroom shielding herself from the noise of everyday living. On unknown dates the patient made several visits to the Emergency Room. The drugs prescribed to alleviate her symptoms only made her feel worse. On unknown dates, many blood tests, computerized axial tomography (CAT) scans and a Magnetic Resonance Imaging (MRI) were performed (results not provided). In October 2010, the patient was first tested for Lyme disease and the results were negative as were two later rounds of testing. In April 2011, the patient could no longer go to school due to the fatigue and pain. In May 2011, tick-borne disease testings were performed which showed that the patient was highly positive for Bartonella Henselae. She was also highly positive for Mycoplasma Pneumonia and the testing showed that her immune system was struggling. The patient's Western Blot for Lyme disease was negative. The patient even had the classic Bartonella rash (looked like purple and red stretch marks) surrounding her breasts and hips which was confirmation of an active Bartonella infection. Then the patient was referred to the Lyme specialists and in June 2011, the patient was clinically diagnosed as Lyme disease. Since that time, patient was also diagnosed with chronic Strep, human herpesvirus 6 (HHV6), hypocoagulation, susceptibility to biotoxin illness (mold and environmental sensitivities) and had acquired autoimmune thyroid disease. The patient's Lyme specialist and primary care physician considered the patient's immune system was injured by the GARDASIL vaccine and that it was the catalyst to her cascading health problems and chronic illness. The patient's Lyme specialist was now treating her for a vaccine injury in addition to treating multiple tick-borne diseases, other infections/viruses and autoimmune thyroid disease. Outcome of the events was unknown. Causal relationship was not reported by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Information has been received from the authors in a published literature regarding to a patient of an unknown age and gender enrolled in a study. The subject's current condition included human immunodeficiency virus (HIV) infection. Medical history was not reported. This was a clinical trial, the patient was randomized in a 1:1.5 ratio to the immediate and delayed vaccinations groups (Immediate group and Delayed group, respectively) by a computer-generated random list. The 1:1.5 ratio was chosen to account for the likelihood for increased rate of lost to follow up in the Delayed group. Those in the Immediate group received, on an unknown date, pneumococcal vaccine (Manufacturer unknown) (dosage, route, lot# and expiration date were not reported) at the time of enrollment and placebo 9-12 months later. The Delayed group received placebo at the time of enrollment and pneumococcal vaccine (Manufacturer unknown) 9-12 months post-enrollment (after 6 months of antiretroviral treatment (ART)). All participants were followed up 1 month (4-6 weeks), 6 months (+/-1), and 12 months (+/-3) after each intervention. The authors reported that on an unknown date 7 subjects were hospitalized with diagnosis of pneumonia. One case was confirmed as pneumococcal pneumonia (a patient randomized to the Delayed group and prior to PPV23 administration). The outcome of Pneumonia pneumococcal was unknown. The investigator considered Pneumonia pneumococcal to be related to Pneumococcal Vaccine (Manufacturer unknown). Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Fever. Varicella rash.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Urticarial rash on left arm, erythema, swelling, warmth, fluid filled bullae.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Urticarial rash on left arm, erythema, swelling, warmth, fluid filled bullae.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg swollen, red approximately 3 hours after 2 month shots given.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Crying, Disorientation, Erythema, Eye movement disorder
Clinical narrative: Patient fainted, stopped breathing momentarily. She turned white, then red and her eyes rolled to the back of her head. The patient then became rigored and slid out of the chair. When she "came to" she started screaming and crying and was very disoriented and didn't know where she was.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Respiratory arrest, Screaming, Syncope
Clinical narrative: Patient fainted, stopped breathing momentarily. She turned white, then red and her eyes rolled to the back of her head. The patient then became rigored and slid out of the chair. When she "came to" she started screaming and crying and was very disoriented and didn't know where she was.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pruritus, Rash, Rash erythematous
Clinical narrative: Small white bumps on lower leg, became red, raised, some appear to have lighter color in center, approx 8 to 10 spots on ea. leg (red nodules), 1 or 2 on back as well, moderately itching, says will be following up with doctor on 7-6 following holiday weekend.
Age: 0.62
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 7 month old patient of unknown gender. Information about patient's concomitant conditions and medical history was not reported. On 19-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported), lot # K025002 with expiration date 20-JUL-2017, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.22
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 11 week old patient of unknown gender. information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored PEDVAXHIB (lot #, expiration dates, doses and routes were not reported). No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a License Practical Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (dosage, lot # and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an 8 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Mobility decreased, Pain, Pyrexia, Tachycardia
Clinical narrative: Information has been received from a nurse referring to a 53 years old male patient with HIV infection and drug reaction to STRIBILD (unspecified reaction). On 17-JUN-2015 the patient was vaccinated with PNEUMOVAX23, lot # K021881, expiry date 30-JUL-2016, 0.5 ml, intramuscular. On an unspecified date in June 2015, the patient developed  pain, soreness and difficulty moving the arm. The patient was evaluated at an unspecified emergency room, on an unspecified date in June 2015, due to fever of 101.5 F, sweating, and tachycardia. The patient was treated in the emergency room with SOLUMEDROL and TORADOL. The patient was sent home with a prescription for TORADOL. The patient was now recovering. The nurse was requesting a lot check.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Colonoscopy, Condition aggravated, Gastrointestinal disorder, Herpes zoster
Clinical narrative: This spontaneous report has been received from a currently 75 year old female patient regarding herself. Patient's medical history included shingles, that started when was 62 years old. Shingles was diagnosed in approximately 2009 (2-3 years before patient was vaccinated with ZOSTAVAX in 2012). Other historical conditions included swollen eyes. Patient was not sleeping well at night and had to go through 7 years of the most horrifying experience with doctors, and a psychiatrist who tried to put  her on something that would have killed her or put her in a coma. The patient took antibiotics for 10 years that totally destroyed her immune system. Three years ago, in approximately 2012, patient was vaccinated with ZOSTAVAX (strength, dose and route of administration were not reported). The patient reported that she had shingles at the time of the shot. Concomitant medications included about 12 different supplements and monolaurin coconut oil but no prescription drugs. After receiving ZOSTAVAX, that patient still had shingles (vaccination failure). When she would get stressed out, it would flare up or get a lot worse. She had been to 7 dermatologists and 2 general practitioners who thought she had an intestinal problem (gastrointestinal disorder) and had her get 3 colonoscopies. On 27-JUN-2015, the patient reported that her shingles was terrible, which it was every other day. Her shingles was so painful that when she got in the shower, she would stand there screaming and crying like her skin was on fire (skin burning sensation). On the night of 27-JUN-2015, she got a good night's sleep. As of 28-JUN-2015, the shingles was better. On unknown dates, she had all kinds of lab work and blood tests that came back negative (normal). As of 28-JUN-2015, it was unknown if the therapy with ZOSTAVAX was continued. The outcome of gastrointestinal disorder, vaccination failure and skin burning sensation was unknown. The outcome of shingles, poor quality sleep and pain was reported as recovering/resolving. Causality assessment was not provided. Additional information is not expected since the reporter declined physician contact.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Pain, Screaming, Skin burning sensation, Vaccination failure
Clinical narrative: This spontaneous report has been received from a currently 75 year old female patient regarding herself. Patient's medical history included shingles, that started when was 62 years old. Shingles was diagnosed in approximately 2009 (2-3 years before patient was vaccinated with ZOSTAVAX in 2012). Other historical conditions included swollen eyes. Patient was not sleeping well at night and had to go through 7 years of the most horrifying experience with doctors, and a psychiatrist who tried to put  her on something that would have killed her or put her in a coma. The patient took antibiotics for 10 years that totally destroyed her immune system. Three years ago, in approximately 2012, patient was vaccinated with ZOSTAVAX (strength, dose and route of administration were not reported). The patient reported that she had shingles at the time of the shot. Concomitant medications included about 12 different supplements and monolaurin coconut oil but no prescription drugs. After receiving ZOSTAVAX, that patient still had shingles (vaccination failure). When she would get stressed out, it would flare up or get a lot worse. She had been to 7 dermatologists and 2 general practitioners who thought she had an intestinal problem (gastrointestinal disorder) and had her get 3 colonoscopies. On 27-JUN-2015, the patient reported that her shingles was terrible, which it was every other day. Her shingles was so painful that when she got in the shower, she would stand there screaming and crying like her skin was on fire (skin burning sensation). On the night of 27-JUN-2015, she got a good night's sleep. As of 28-JUN-2015, the shingles was better. On unknown dates, she had all kinds of lab work and blood tests that came back negative (normal). As of 28-JUN-2015, it was unknown if the therapy with ZOSTAVAX was continued. The outcome of gastrointestinal disorder, vaccination failure and skin burning sensation was unknown. The outcome of shingles, poor quality sleep and pain was reported as recovering/resolving. Causality assessment was not provided. Additional information is not expected since the reporter declined physician contact.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Underdose
Clinical narrative: Initial information had been received from a 49 year old female patient referring to herself. There was no pertinent medical history and drug allergy. On 02-JAN-2015, patient was vaccinated with the first dose of RECOMBIVAX HB lot # K009505 pediatric dose instead of an adult dose, intramuscularly of Hepatitis B (underdose). On 04-FEB-2015 she received her second dose of RECOMBIVAX HB (lot#, dose and route unknown). On 22-JUN-2015, the patient received her third dose of RECOMBIVAX HB (lot#, dose and route unknown) (inappropriate schedule of vaccine administered). There was no concomitant medication. On an unknown date after the series were complete (on JUN-2015), the patient's titers were test to verify immunity. The patient was currently not considered immune to Hepatitis B due to her "extremely low" titer count. The action taken and outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of improperly stored of PNEUMOVAX 23 (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, (lot #, strength, dose and frequency were unknown). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an 8 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 26-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 29-MAY-2015, the patient was vaccinated with 0.5 ml of improperly stored (Oka/Merck) VARIVAX (lot # L001334 and expiry date 13-JAN-2017) once subcutaneously. NO adverse effects were reported. No product quality complaint was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.61
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a 7 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 23-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided)). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of  unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unknown date approximately 20 years ago, the patient was vaccinated with a dose of VAQTA (concentration, dose, frequency and route unknown). On 29-JUN-2015, the pharmacist administered VAQTA to the patient (inappropriate schedule of drug administration). The patient's concomitant medication was not reported. There was no adverse symptoms reported. The outcome of these events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number, strength, dose and route were not reported). No adverse effects were reported. The outcome of the patients events were not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus
Clinical narrative: Information has been received from a 59 years old female consumer referring to herself. As medical history the patient reported an unknown disability. On 14-APR-2015 the patient was vaccinated with a dose of ZOSTAVAX injection (unspecified dose and route). Concomitant therapies included Lisinopril (manufacturer unknown) and NAPROXEN. The patient stated she did not have any adverse reactions at the moment of vaccination, but reported that recently on 25-JUN-2015, she experienced itching, redness and pain on her right side and around her neck. The patient stated the symptoms lasted about 5-6 minutes and then subsided; however she still has some blistering, so the outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous reprot as received from a pharmacist refers to a patient of unknown age and gender. The patient's drug reactions/allergies included unspecified injection site reaction following administration of PNEUMOVAX23 on an unknown date (MARRS# 1507USA001503). On 24-JUN-2015 the patient was vaccinated with ZOSTAVAX lot # L006392, dose 0.65 ml, subcutaneous. On 29-JUN-2015 the patient experienced injection site rash. The patient was seen in the pharmacy. No treatment was given for adverse event. The outcome of injection site rash was reported as not recovered. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 09-JAN-2015, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 13-MAR-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 11-JUN-2015, the patient was vaccinated with the third dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 29-MAY-2015, the patient was vaccinated with 0.5 ml of improperly stored (Oka/Merck) VARIVAX (lot # L001334 and expiry date: 13-JAN-2017) once subcutaneously. No adverse effects were reported. No product quality complaint was reported for (Oka/Merck) VARIVAX. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were inadvertently vaccinated with doses of improperly stored PROQUAD (dose and route of administration were not reported, lot # L003221 and expiry date 30-JUL-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose, route and indication were not reported). The reporter did not provide if this dose was a first, second or third dose in the GARDASIL series. No adverse symptoms were reported. Additional information has been requested.