chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: REDNESS AND ITCHING AT INJECTION SITE OF ZOSTAVAX. NODULE AT INJECTION SITE OF ZOSTAVAX. HEADACHE AND DIZZINESS WITH NO FEVER.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site swelling, Local swelling, Swelling
Clinical narrative: ARM VERY RED AND SWOLLEN. AREA AROUND INJECTION RAISED AND SWOLLEN AND EXTENDED DOWN THE ARM TOWARD THE HAND AND UP TO THE ARMPIT LYMPH NODE AREA.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium double contrast, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: 1 week after receiving oral Rotateq, this 4 month old developed intussusception.  This was successfully reduced with an air contrast barium enema without further complication.  Discharged after 48 hours on regular diet.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Migraine, Migraine with aura
Clinical narrative: Experiencing visual migraine and migraine headache for two days following flu shot.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Migraine
Clinical narrative: Experiencing visual migraine and migraine headache for two days following flu shot.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blindness unilateral, Migraine
Clinical narrative: LOSS OF VISION IN ONE EYE AND WENT TO ER BECAUSE HE THOUGHT HE WAS HAVING A STROKE.  DX BY MD WAS MIGRAINES.  PATIENT STATES THAT HE HASN'T HAD MIGRAINES IN 20 YEARS.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin hypertrophy
Clinical narrative: Swelling 2 inches around shot area; thickening of skin; 1/4 inch radius redness; pain for 5 days; sensitive to touch for couple of days but not unbearable.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Aspiration, Barium swallow, Croup infectious, Decreased appetite, Failure to thrive
Clinical narrative: Started to scream while feeding instead of eating normally. Then started to lose weight from not feeding despite all attempts to get him to eat.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gastrointestinal tube insertion, Hypotonia, Nuclear magnetic resonance imaging, Oesophageal motility test, Pneumonia
Clinical narrative: Started to scream while feeding instead of eating normally. Then started to lose weight from not feeding despite all attempts to get him to eat.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Stridor, Weight decreased, X-ray
Clinical narrative: Started to scream while feeding instead of eating normally. Then started to lose weight from not feeding despite all attempts to get him to eat.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bed rest, Chills, Injection site pain, Injection site swelling
Clinical narrative: Chills, fever (100 to 103.4), weakness & malaise, severe generalized aches, swollen & tender left arm (including injection site).  Treatment was hydration, analgesis, antipyretics, bed rest for 72 hours before fever began to break.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Malaise, Pain, Pyrexia, Tenderness
Clinical narrative: Chills, fever (100 to 103.4), weakness & malaise, severe generalized aches, swollen & tender left arm (including injection site).  Treatment was hydration, analgesis, antipyretics, bed rest for 72 hours before fever began to break.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Angioedema, Antinuclear antibody negative, Culture throat, Full blood count normal, Laboratory test normal
Clinical narrative: GARDASIL #1 given on 2-10-14. Hives on 2-12-14. Fever, angioedema on 2-13-14.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Metabolic function test normal, Pyrexia, Red blood cell sedimentation rate normal, Urine analysis normal, Urticaria
Clinical narrative: GARDASIL #1 given on 2-10-14. Hives on 2-12-14. Fever, angioedema on 2-13-14.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Viral test negative
Clinical narrative: GARDASIL #1 given on 2-10-14. Hives on 2-12-14. Fever, angioedema on 2-13-14.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Apparent life threatening event, Cyanosis, Hypotonia, Respiratory syncytial virus test negative
Clinical narrative: Pt. received shots in office - that evening had an acute life threatening event with cyanosis, limp, apnea and vomiting. Pt. taken to local ER within 5-10 mins. Oxygen saturation was WNLs by then BS 119, was awake and alert. Had another spell in ER witnessed by FNP. Pt. vomited up a mucous plug.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Pt. received shots in office - that evening had an acute life threatening event with cyanosis, limp, apnea and vomiting. Pt. taken to local ER within 5-10 mins. Oxygen saturation was WNLs by then BS 119, was awake and alert. Had another spell in ER witnessed by FNP. Pt. vomited up a mucous plug.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Rash
Clinical narrative: Pt developed active case of shingles. Rash on whole back, under arms, chest - burning tingling pain in these areas - sore to touch.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Angiotensin converting enzyme, Bell's phenomenon, Borrelia test negative, CSF lymphocyte count increased, CSF monocyte count increased
Clinical narrative: This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, CSF white blood cell count increased, Central nervous system lesion, Cryptococcus test, Dysphagia
Clinical narrative: This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Dysstasia, Facial paresis, HIV test negative, Laboratory test normal, Lyme disease
Clinical narrative: This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Polymerase chain reaction, Serology normal
Clinical narrative: This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Treponema test negative, VIIth nerve paralysis, Varicella virus test negative, West Nile virus test negative, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 04-Feb-2014) concerns a 34 year old male patient who had no history of recent travel or exposure to insects. His sibling had a history of HIV (human immunodeficiency virus) with Hodgkin's lymphoma. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient presented with bilateral facial weakness and difficulty drinking. He had lower extremity tingling sensation and was evaluated at the emergency department one week before presenting. He had no complaints of extremity weakness, no changes in vision and hearing and no history of fever or headache. He received the flu shot ten days before presentation. On examination, the patient was found to have bilateral lower motor neuron facial palsy with Bell's phenomenon but no other focal neurological deficits. His white blood cell count was elevated to 13.18. An MRI (Magnetic Resonance Imaging) of the brain showed four millimetre lesions in the left centrum semiovale demonstrating enhancement and two other non-enhancing lesions in the body and splenium of the corpus callosum. A lumbar puncture showed a high white cell count containing all lymphocytes and monocytes with elevated protein. A presumptive diagnosis of neurological Lyme's disease was made and the patient was started on intravenous ceftriaxone. However Lyme antibody, blood and CSF (cerebrospinal fluid) Lyme PCR (polymerase chain reaction) were negative. Serology for syphilis, West Nile virus, HIV, VZV (varicella zoster virus) were also negative. Cryptococcal CSF antigen was also negative. Serum ACE (angiotensin converting enzyme) level was within normal limits. The patient had gradual improvement of his facial weakness. He was treated with a rapidly tapering course of prednisolone for six days. He received ceftriaxone for 14 days intravenously. His facial palsy had nearly completely resolved. Outcome was reported as recovering. Reporter comments: Literature reviews showed most of bilateral Bell's palsy are caused by Lyme disease, sarcoidosis, HIV and EBV. There was a single case reported after intranasal influenza vaccine but no case reported after inactivated flu vaccine injection.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Psoriasis, Rash generalised
Clinical narrative: Got a shingles shot in September. 2 days after started with bumps on arm that spread all over. Still present but better, Is on insulin. Dermatologist said it is Psoriasis, she thinks it was from insulin-switched insulin type. Is on an antibiotic - bumps are better.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Psoriasis, Rash
Clinical narrative: Got a shingles shot in September. 2 days after started with bumps on arm that spread all over. Still present but better, Is on insulin. Dermatologist said it is Psoriasis, she thinks it was from insulin-switched insulin type. Is on an antibiotic - bumps are better.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: Pt went to ER with complaints of chest pain on 2/16/14 - shot given on 2/14/14.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient was in lobby waiting 15 minutes after imm. given when approx. 3 mins after imm was given he felt lightheaded and fainted. Was brought to back to be monitored. Waited 15 mins in room, and was okay to leave.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Erythema, induration, urticaria. Greater than 4 weeks after administration.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a patient grandmother refers to a 12 year old female patient. On unknown dates, the patient was vaccinated with first two doses of GARDASIL (dose, route, lot # and expiry not reported) and had not had any reactions to those shots. On an unknown date, the patient was vaccinated with her third shot in the GARDASIL, lot # J007354, expiration date 20-FEB-2016 (dose and route not reported), vaccine series, from the recalled lot of medicine. The reporter stated that, on an unknown date, the patient had an "adverse reaction from this third shot." The reporter did not specify what the reaction was, but the patient was put on some unspecified medication for that reaction. The patient sought unspecified what type of medical attention. The outcome of the event was unknown. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Flow cytometry, Immunoglobulins decreased
Clinical narrative: A 31 year old female presented to clinic after a recent hospitalization with pancytopenia "suspected to be secondary to a viral infection. She was confirmed to have West Nile virus meningitis and presumed herpes simplex virus (HSV) meningitis. Lab work was remarkable for low immunoglobulins at that time, and she presented to author's clinic for further workup. The patient had a self-reported history of recurrent infections requiring intermittent antibiotics since childhood. Additional complaints included chronic fatigue and persistent viral infections with recurrent "cold sores" on the outside of her lips (~2 times/month) that clinically seemed to be consistent with HSV. She had no history of atopy or recurrent Cytomegalovirus (CMV), Epstein-Barr virus (EBV), or zoster infections. Humoral immunity was re-evaluated a few months after hospitalization and showed persistent abnormalities: IgG 589 mg/dL, IgA 63, and IgM 31. There was normal responses to Dt vaccines, but only 1/14 protective pneumococcal titers 18 months after receiving the PNEUMOVAX 23 (dose, route not reported). Flow cytometry was repeated multiple times which consistently showed low levels of natural killer (NK) cells: 1% and 32 cells/mcl. An NK cell cytotoxicity assay was performed and showed decreased NK cell absolute counts and cytotoxic activity. Based upon clinical history and lab results, the diagnosis of NK cell deficiency was made. She was started on prophylactic acyclovir 400mg, oral, twice a day for a 3 month trial period. After only a few weeks of treatment, the patient noted significant improvement in viral-related symptoms. Conclusion: This case report confirmed that in addition to a detailed clinical history and a high level of suspicion, flow cytometry followed by NK cell cytotoxicity testing was a simple and effective way to evaluate NK cell deficiencies. It also highlighted the importance of keeping this disorder in the differential diagnosis, especially in cases of unexplained recurrent viral infections. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Natural killer cell count decreased, Vaccination failure, Viral test
Clinical narrative: A 31 year old female presented to clinic after a recent hospitalization with pancytopenia "suspected to be secondary to a viral infection. She was confirmed to have West Nile virus meningitis and presumed herpes simplex virus (HSV) meningitis. Lab work was remarkable for low immunoglobulins at that time, and she presented to author's clinic for further workup. The patient had a self-reported history of recurrent infections requiring intermittent antibiotics since childhood. Additional complaints included chronic fatigue and persistent viral infections with recurrent "cold sores" on the outside of her lips (~2 times/month) that clinically seemed to be consistent with HSV. She had no history of atopy or recurrent Cytomegalovirus (CMV), Epstein-Barr virus (EBV), or zoster infections. Humoral immunity was re-evaluated a few months after hospitalization and showed persistent abnormalities: IgG 589 mg/dL, IgA 63, and IgM 31. There was normal responses to Dt vaccines, but only 1/14 protective pneumococcal titers 18 months after receiving the PNEUMOVAX 23 (dose, route not reported). Flow cytometry was repeated multiple times which consistently showed low levels of natural killer (NK) cells: 1% and 32 cells/mcl. An NK cell cytotoxicity assay was performed and showed decreased NK cell absolute counts and cytotoxic activity. Based upon clinical history and lab results, the diagnosis of NK cell deficiency was made. She was started on prophylactic acyclovir 400mg, oral, twice a day for a 3 month trial period. After only a few weeks of treatment, the patient noted significant improvement in viral-related symptoms. Conclusion: This case report confirmed that in addition to a detailed clinical history and a high level of suspicion, flow cytometry followed by NK cell cytotoxicity testing was a simple and effective way to evaluate NK cell deficiencies. It also highlighted the importance of keeping this disorder in the differential diagnosis, especially in cases of unexplained recurrent viral infections. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This literature marketed report as received from a health professional refers to unspecified number of female patients (<9 years old) who started therapy with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (dose, route and lot # not reported). The literature backgroup was to describe population-based rates of quadrivalent human papillomavirus (HPV40 vaccine uptake and coverage from its licensure in June 2006 through December 2008. In this period, quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was licensed for use in 9-26 year old females. Methods: Data were from 4 managed care organizations in the Vaccine Safety Data link. It was described uptake of quadrivalent human papilloma virus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (number of doses given per month) in all persons aged 0-39, and coverage (percentage of eligible persons who received 2:1 dose) in all females aged 0-39, stratified by age and history of HPV-related disease. Results: In this study period, 166,975 quadrivalent human papillomavirus (types 6,11, 16, 18) recomb. vaccine (manufacturer unknown) doses were administered to 79,235 persons, with the greatest number given in the 3rd and 4th quarters of 2007. The therapy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) coverage increased steadily; by December 2008, coverage rates were 1% (females 9-10 years old), 34% (11-12), 55% (13-17), and 36% (18/26). The rate of increase in coverage was reduced by late 2008. After mid-2007, females aged 9-26 with a history of HPV-related disease had significantly lower rates of HPV4 vaccination than those without HPV disease. It was reported that minimal off-label use occurred: 6 males received vaccine; 153 doses were given to girls < 9 years old, and 3,518 doses to women 27-29 years old. This is one the several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Burning sensation, Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 year old daughter. The patient had "environmental allergies". The patient developed shingles on an unspecified date approximately one year ago (In approximately February 2013). On 19-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J008434, expiry date 11-OCT-2014) vial 19400 PFU "to prevent recurrence of shingles" (dose and route not reported). Concomitant therapies included levothyroxine, gabapentin and cetirizine. The consumer reported that her daughter received ZOSTAVAX to prevent a recurrent case of shingles and later (on 21-DEC-2013) broke out with blisters on her chin and a red, "fiery", burning rash all over her arms. The patient sought medical attention through unspecified way. An unspecified blood work was performed. VALTREX, MEDROL and clindamycin were given to treated the adverse events. At the time of reporting, the outcome of the events was not recovered. The consumer declined providing physician contact information, so a Varicella Zoster Virus Identification Program (VZVIP) packet was not sent. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to her 60 year old daughter. The patient had "environmental allergies". The patient developed shingles on an unspecified date approximately one year ago (In approximately February 2013). On 19-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J008434, expiry date 11-OCT-2014) vial 19400 PFU "to prevent recurrence of shingles" (dose and route not reported). Concomitant therapies included levothyroxine, gabapentin and cetirizine. The consumer reported that her daughter received ZOSTAVAX to prevent a recurrent case of shingles and later (on 21-DEC-2013) broke out with blisters on her chin and a red, "fiery", burning rash all over her arms. The patient sought medical attention through unspecified way. An unspecified blood work was performed. VALTREX, MEDROL and clindamycin were given to treated the adverse events. At the time of reporting, the outcome of the events was not recovered. The consumer declined providing physician contact information, so a Varicella Zoster Virus Identification Program (VZVIP) packet was not sent. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Culture, Exposure during pregnancy, No adverse event, Ultrasound scan, Urine analysis
Clinical narrative: Information has been received from a registered Nurse, for GARDASIL, a Pregnancy Registry product, concerning to a 33 years old female patient. The patient's medical history included depression and migraines. The patient's history of previous pregnancies and live births was not known. On 19-OCT-2012, the patient was vaccinated with lot # (1291AA), 0.5 ml GARDASIL. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant. The LMP and EDD were not known. Initial exposure to GARDASIL was at 34 weeks. The patient was exposed to GARDASIL during trimester 3. No adverse effects were reported. No further information provided. No treatment information was reported. Follow up prospective pregnancy report as received from a consumer refers to the female patient. The reporter stated that his wife went into the office to get a flu shot (unspecified) and inadvertently was given a first dose of 0.5 ml intramuscular GARDASIL (lot# 1291AA) on 19-OCT-2012. The patient was 35 weeks pregnant. The LMP was approximately on 24-FEB-2012 and EDD was not provided. She went back to the office of the health care professional (HCP) to have a sonogram performed, she was also given a urine test and a vaginal and rectal swab (results not provided). No adverse reactions were reported. This is one of several reports from the same source (MARRS #1210USA012790 and 1210USA012575) It has been confirmed that 1210USA013506 is a duplicate of 12010USA012540. Therefore, please void 12010USA013506 and consolidate the reports into 1210USA012540. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered Nurse, for GARDASIL, a Pregnancy Registry product, concerning to a 33 years old female patient. The patient's medical history included depression and migraines. The patient's history of previous pregnancies and live births was not known. On 19-OCT-2012, the patient was vaccinated with lot # (1291AA), 0.5 ml GARDASIL. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant. The LMP and EDD were not known. Initial exposure to GARDASIL was at 34 weeks. The patient was exposed to GARDASIL during trimester 3. No adverse effects were reported. No further information provided. No treatment information was reported. Follow up prospective pregnancy report as received from a consumer refers to the female patient. The reporter stated that his wife went into the office to get a flu shot (unspecified) and inadvertently was given a first dose of 0.5 ml intramuscular GARDASIL (lot# 1291AA) on 19-OCT-2012. The patient was 35 weeks pregnant. The LMP was approximately on 24-FEB-2012 and EDD was not provided. She went back to the office of the health care professional (HCP) to have a sonogram performed, she was also given a urine test and a vaginal and rectal swab (results not provided). No adverse reactions were reported. This is one of several reports from the same source (MARRS #1210USA012790 and 1210USA012575) It has been confirmed that 1210USA013506 is a duplicate of 12010USA012540. Therefore, please void 12010USA013506 and consolidate the reports into 1210USA012540. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Chills, Dysstasia, Weight bearing difficulty
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abscess, Bacterial test, Blood test, Cellulitis
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Dehydration, Dysstasia, Electrocardiogram, Headache
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunology test, Influenza like illness, Intensive care, Knee arthroplasty, Laboratory test
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Respiratory syncytial virus bronchiolitis, Sepsis, Vascular test, Vital capacity decreased
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: This medically confirmed report (initial receipt 05-Feb-2014) was reported by a healthcare worker who is also a recovery analyst for an insurance company. The report concerns a 64 year old female patient. On the 08-Nov-2013, the patient received AFLURIA (reported batch number '09149211a') via IM (intramuscular) route at a dose of 0.5 mL in the L/R deltoid (sic). On the 10-Nov-2013 or 11-Nov-2013, the patient experienced flu-like symptoms, became dehydrated, was very sick, had a headache and couldn't walk. Within 28 hours, the patient developed 's/s' (signs and symptoms) and within 36 hours the patient was unable to stand or bear weight. On the 11-Nov-2013, the patient sought assistance from an emergency centre, which may have been a hospital. On the same day, the patient went to a hospital and had a chest x-ray, blood tests, ICU (intensive care unit), lab tests, lab immunology, lab bacteria, paravascular (sic) lab results, EKG/ECG (electrocardiogram), a respiratory SVC (slow vital capacity) and an extremity vein study. Treatment included IV (intravenous) solution and physical therapy. The reporter had ICD9 (International Statistical Classification of Diseases) codes for septicemia, cellulitis/abscess and knee/joint replacement. Outcome was reported as recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, C-reactive protein, Full blood count normal, Headache
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Liver function test abnormal, Malaise, Pyrexia, Red blood cell sedimentation rate normal, Serum sickness-like reaction
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urine analysis normal, Vasculitic rash
Clinical narrative: Based on the second medical examination of the case during internal review on 10 February 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from healthcare professional on 03 February 2014. A 04-year-old female patient, who has no relevant medical history with no illness at the time of vaccination, had received intramuscular dose of DAPTACEL, batch number: C4457AA having expiry date 11 December 2015 in left deltoid (dose number not reported), subcutaneous dose of IPOL, batch number: J1028 having expiry date 09 February 2015 in right arm (dose number not reported), subcutaneous dose of MMR, batch number: J006955 in left arm (dose number not reported) of another manufacturer and subcutaneous dose of MEASLES/MUMPS/RUBELLA/VARICELLA-ZOSTER VACCINE, batch number: J005692 in right arm (dose number not reported) of other manufacturer on 17 January 2014. It was reported that on 27 January 2014 i.e. 10 days after receiving vaccine, the patient developed a serum sickness like reaction with symptoms of rash, fever, headache, joint aches and belly aches. Reporter stated patient was not admitted to the hospital. The corrective treatment was not reported. in Laboratory investigations, CBC was found normal; sedimentation rate was 3.7 with elevated liver function studies. At time of this report, the outcome was unknown. Documents held by sender: none. Addendum 14 February 2014: Upon second medical examination of case at time of internal review on 10 February 2014, the following has been modified in this case: The case has been identified as serious due to the event serum sickness and hence upgraded accordingly. The event developed a serum sickness like reaction had been taken as diagnosis and the other events as symptoms of serum sickness like reaction. Previously this case was processed as non-serious case.