chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: B-lymphocyte count decreased, Biopsy thymus gland abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: CD4 lymphocytes, Candida test negative, Chest X-ray abnormal, Chest discomfort, Clostridium test negative
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Corynebacterium test positive, Cough, HIV test negative, Immunoglobulin therapy
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Mediastinal mass, Onychomycosis, Oral lichen planus, Otitis media, Plasma cell count
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Sinusitis, Sternotomy, Thymectomy, Thymoma
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Thymoma malignant, Ultrasound Doppler normal
Clinical narrative: Introduction: Good's syndrome was a rare association with thymoma and acquired immunodeficiency. Selective IgM deficiency was very rare and usually accompanies malignancies or auto immune conditions. Lichen planus was a chronic inflammatory mucocutaneous disease with autoimmunity as a possible underlying mechanism. We report a case of Good's syndrome characterized by thymoma, lichen planus and a selective IgM deficiency. Case Report: A 49 year old male presented with a lichen planus on his tongue. A few months later, he presented again complaining of a dry cough and vague chest discomfort that had worsened over the previous 3 weeks. His chest x-ray revealed a large mediastinal mass. A chest CT confirmed the finding with a high degree of suspicion for a thymus malignancy. The patient underwent a sternotomy with complete thymectomy. Biopsy was consistent with a B1 thymoma. Shortly after his thymectomy and over the following two years, the patient suffered from recurrent otitis media, sinusitis, pneumonias and onychomycosis. Lab work showed markedly decreased IgM level at <4 mg/dL and CD 19 cell count at 2/uL. However, his IgG, IgA, CD4, and CDS were within normal limits. His IgG level was retained at normal level despite low level of IgM. His post PNEUMOVAX 23 were not in the protective range. Antibodies to candida and tetanus were undetectable but protective for diphtheria. His HIV test was negative. The patient was then started on IVIG. He was reassessed 6 months later and reported that he was doing very well with no recurrence of any infections. He also noted a slight improvement of his oral lichen planus. Conclusion: The incidence of immunodeficiency of thymoma patients ranges between 6-11%. It was recommended for all patient's with a thymoma to check immunoglobulin levels and B and T cell subsets at the time of diagnosis and every other year thereafter. Despite a successful thymectomy, most Good's syndrome patients would retain their immunodeficiency status and require life-long treatment and monitoring. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Influenza like illness, Pain, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N014283 exp date 17-APR-2014; dose and route not reported) on 28-NOV-2012. No other co-suspects were reported. Concomitant medication included lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). The registered nurse reported that on 28-NOV-2012, after being administered PNEUMOVAX 23 the patient slept for 2 hrs straight. When the patient woke up, she noticed that her body was achy all over and that she had a feeling of malice. The patient sought medical attention by calling the office. No treatment information was reported. The outcome of had a feeling of malice, body was achy all over and slept for two hours straight was unknown. The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Abnormal behaviour, Pain, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N014283 exp date 17-APR-2014; dose and route not reported) on 28-NOV-2012. No other co-suspects were reported. Concomitant medication included lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). The registered nurse reported that on 28-NOV-2012, after being administered PNEUMOVAX 23 the patient slept for 2 hrs straight. When the patient woke up, she noticed that her body was achy all over and that she had a feeling of malice. The patient sought medical attention by calling the office. No treatment information was reported. The outcome of had a feeling of malice, body was achy all over and slept for two hours straight was unknown. The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: LARGE LOCAL REACTION W/ SWELLING, ERYTHEMA & INDURATION.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: C-reactive protein, Full blood count, Musculoskeletal pain, Red blood cell sedimentation rate, Tenderness
Clinical narrative: Superficial shoulder pain and tenderness.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Back pain, Chills
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Eye pain, Fatigue, Headache, Hypersomnia
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Night sweats, Pain, Pain in extremity, Painful respiration, Photophobia
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tenderness
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Abdominal pain, Asthenia, Back pain, Fatigue
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pain, Paraesthesia, Somnolence
Clinical narrative: Extreme fatigue all day 12/2 & 12/2 combines with dizziness.  12/2 body was very tender, felt like it had been beaten all over and weak, no energy.  Slept for sixteen hours on 12/2. Morning of 12/3 had a little more energy and was able to make it to work.  Was still a little fatigued and experiencing dizziness.  Around 3pm got very tired and had to lay down.  Body began aching and chills set in.  Slept for one hour and left home early from work.  Eyes were hurting and very sensitive. Found myself closing them any opportunity I had; if traffic would stop, at stop signs and red lights.  Was shivering uncontrollably and my fingers were very achy.  Once home slept for 3 more hours.  Woke up in a sweat.  Was able to eat and leave to get some Advil.  Was experiencing a horrible headache that 800mg of ibuprofen did not alleviate.  Went to sleep around 10pm and at 3:00 on 12/4 woke up in terrible sweats with extremely bad lower back pain the moved down into my legs as well as an aching headache.  Again took 800mg that did nothing.  An hour later took a Tylenol 3 and still no help. Fell back asleep around 6am to wake up at 8am in the worst pain I've ever felt in my lower back and legs.  Called student health services who brought me in that morning at 10:45AM.  I was given a shot for pain and observed for 30 min. The shot minimized the headache while not eliminating it and did nothing I help with the back pain.  Have been in bed with pain meds and a heating pad. Starting night of 12/5 stomach began to ache and there was pain on my left side when taking a deep breath.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Fatigue, Lacrimation increased, Migraine, Muscle twitching
Clinical narrative: Started with very loud buzzing of ears that lasted approx 24 hrs. then developed migraine headache. 24 hours after vaccine extreme fatigue and twitching of nerves in face. Especially around eyes. Tearing of eyes and increased trigeminal neuralgia pain which continues.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Trigeminal neuralgia
Clinical narrative: Started with very loud buzzing of ears that lasted approx 24 hrs. then developed migraine headache. 24 hours after vaccine extreme fatigue and twitching of nerves in face. Especially around eyes. Tearing of eyes and increased trigeminal neuralgia pain which continues.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Bone scan, Computerised tomogram, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old female patient. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL on an unknown date in July 2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in August 2011 the patient experienced debilitating muscle weakness and pain (hospitalization and disability). The events were treated with KEPPRA, fentanyl and PAXIL. MRI, CT Scan, Blood Labs and Bone scans were performed, but no results were reported. The outcome of debilitating muscle weakness and pain was reported as not recovered/not resolved. The relatedness for debilitating muscle weakness and pain was not reported for GARDASIL. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old female patient. The patient was vaccinated intramuscularly with 0.5 ml GARDASIL on an unknown date in July 2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in August 2011 the patient experienced debilitating muscle weakness and pain (hospitalization and disability). The events were treated with KEPPRA, fentanyl and PAXIL. MRI, CT Scan, Blood Labs and Bone scans were performed, but no results were reported. The outcome of debilitating muscle weakness and pain was reported as not recovered/not resolved. The relatedness for debilitating muscle weakness and pain was not reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Rash
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age in her area (not from her office). On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # not reported). The nurse heard that the patient developed flu like symptoms, rash and cellulitis after receiving PNEUMOVAX 23. The patient was hospitalized. It was unspecified whether the patient sought for medical attention. The nurse had no information on the patient. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Headache, Malaise, Periorbital oedema
Clinical narrative: Within 5 minutes post vaccine administration began to feel as if I was having an asthma attack. Went home and used rescue inhaler (VENTOLIN ?). Follow day had periorbital edema, headache generalized "not feeling well".
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Viral infection, White blood cell count normal
Clinical narrative: Pt. came to office 11-5-12 and received vaccines. Pt. came back to office 11-8-12 with temp of 105 rectal. Pt. was hospitalized 11-8-12 and discharged 11-11-12. Fever thought to be from viral process.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Computerised tomogram, Condition aggravated, Electrocardiogram, Feeling hot
Clinical narrative: Case number PHEH2012US023699 is an initial spontaneous report from consumer (patient's husband) received on 30 Nov 2012. This case refers to 60-year-old female patient. The patient's medical history included use of medicines (unspecified) for controlling blood pressure. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unspecified date. On an unspecified date, one day after the flu shot, the patient had severe blood pressure issues with blood pressure reading of 200/100 mmHg. The patient went to emergency department for her episodes. The patient's tests in emergency room included electrocardiogram (EKGs) and CT scans. The patient also experienced migraines caused by her high blood pressure. The patient started on medications for her episodes which included morphine, BENADRYL and ibuprofen on IV push (for migraines). On an unspecified date, the patient was diagnosed with tachycardia and very high blood pressure. The reporter was not sure if she had arrhythmias. The patient's episodes were described as warm feeling in her body right before her blood pressure doubled the normal rate. She would take her medicine and 3 minutes later it would go away. This occurred in waves over the past 3 months. The episodes would be lasted for one hour and then would taper down. The last episode lasted for 3 minutes. The seriousness, outcome and causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Migraine, Tachycardia
Clinical narrative: Case number PHEH2012US023699 is an initial spontaneous report from consumer (patient's husband) received on 30 Nov 2012. This case refers to 60-year-old female patient. The patient's medical history included use of medicines (unspecified) for controlling blood pressure. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unspecified date. On an unspecified date, one day after the flu shot, the patient had severe blood pressure issues with blood pressure reading of 200/100 mmHg. The patient went to emergency department for her episodes. The patient's tests in emergency room included electrocardiogram (EKGs) and CT scans. The patient also experienced migraines caused by her high blood pressure. The patient started on medications for her episodes which included morphine, BENADRYL and ibuprofen on IV push (for migraines). On an unspecified date, the patient was diagnosed with tachycardia and very high blood pressure. The reporter was not sure if she had arrhythmias. The patient's episodes were described as warm feeling in her body right before her blood pressure doubled the normal rate. She would take her medicine and 3 minutes later it would go away. This occurred in waves over the past 3 months. The episodes would be lasted for one hour and then would taper down. The last episode lasted for 3 minutes. The seriousness, outcome and causality of the events was not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Insomnia, Nausea
Clinical narrative: Dizziness - nausea. Trouble sleeping.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Nasal congestion, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Swollen eyelids, red eyes, runny nose & congestion. 1st time receiving high dose. Had low dose before with no adverse rxns per patient report.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild swelling, mild redness upper (L) arm. Diameter 25.5 c, redness 3 c x 5 c, mild tenderness to palpation.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eye swelling, Flushing, Hypoaesthesia oral, Paraesthesia
Clinical narrative: 10-3 face flushed, c/o upper lip numbness, tingling and throat scratchy. BENADRYL given as ordered. 10-3-12 after going home went to E.R. with c/o swelling worse - fluids and more BENADRYL given. 10-4-12 - back to E.R. x 2 with c/o severe itching, eyes swelling and difficulty swallowing. Treated and released. 10-5-12 visit to allergist and family doctor- both in agreeance reaction to flu shot. Patient stated on 10/3/12 during visit at time of reaction she was allergic to thermisol but had received flu vaccines before without problems patient did not report this on vaccine questionnaire. Patient has fully recovered.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Throat irritation, Vaccination complication
Clinical narrative: 10-3 face flushed, c/o upper lip numbness, tingling and throat scratchy. BENADRYL given as ordered. 10-3-12 after going home went to E.R. with c/o swelling worse - fluids and more BENADRYL given. 10-4-12 - back to E.R. x 2 with c/o severe itching, eyes swelling and difficulty swallowing. Treated and released. 10-5-12 visit to allergist and family doctor- both in agreeance reaction to flu shot. Patient stated on 10/3/12 during visit at time of reaction she was allergic to thermisol but had received flu vaccines before without problems patient did not report this on vaccine questionnaire. Patient has fully recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: (11-21-12) Red raised rash on left arm deltoid area. (11-28-12) - Dermatomal rash of vesicles erupted right dermatome. Dx'd with active shingles on 12-3-12.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had VZV / Tdap on (R )-side on 11/28/12. On 11/29/12 pt started having TTP / redness / swelling on (R) upper arm. Tx - KEFLEX, BENADRYL & icing.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Approx 10 min after admin of HPV #2 & flu, she passed out at check out. She did not lose consciousness and B/P & O2 Sat were WNL. She was escorted to the car in approx 30 min.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Pruritus, Urticaria
Clinical narrative: 11/12/12 Received vaccine. 11/13/12 Mom noticed patient scratching a lot - abdomen/arms. 11/14/12 - Scratching continued - redness appearing; 11/15/12 - hives appeared on trunk; face; neck - cont'd to worsen throughout the day - left eye swollen in evening mom took to pediatric after hours -  oral steroid & BENADRYL given - 11/16/12 seen by NP in MD office hives, swelling & erythema face, neck, trunk, arms, & legs 4mg DECADRON IM; ZANTAC 15mg BID x 5 days; Hydroxyzine 10mg TID x 5 days cont. BENADRYL. 11/19 - All symptoms gone.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Gastroenteritis viral
Clinical narrative: Stomach flu and cramps lasting about 24 hours.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fatigue, Joint pain, headache, fever, nausea, diarrhea, lymph node swelling.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia
Clinical narrative: Fatigue, Joint pain, headache, fever, nausea, diarrhea, lymph node swelling.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid oedema, Swelling face, Urticaria
Clinical narrative: Developed intermittent hives, face swelling, and eyelid swelling approx. 6 hours after Flu mist.  Grandmother gave child Benadryl and took him to private MD office.  Was seen by RNP who diagnosed him with urticaria and referred him to see allergist.  RNP told Grandmother that she didn't think symptoms were related to Flu mist.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Axillary pain, Feeling hot, Injection site pain, Lymph node pain
Clinical narrative: Severe Pain at injection site - right arm bicep area. Severe Pain in arm pit (lymph node) at 7:00 PM. Low grade fever at 8:00 PM. Aching joints and muscles at 8:00 PM. Light sensitivity at 8:00 PM. Muscle pain in tricep area on day two. Hot red rash in tricep area on day three.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Photophobia, Pyrexia, Rash erythematous
Clinical narrative: Severe Pain at injection site - right arm bicep area. Severe Pain in arm pit (lymph node) at 7:00 PM. Low grade fever at 8:00 PM. Aching joints and muscles at 8:00 PM. Light sensitivity at 8:00 PM. Muscle pain in tricep area on day two. Hot red rash in tricep area on day three.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash erythematous, Urticaria
Clinical narrative: States "broke out in red bumps and whelps and itching all over body - back of head, back, arms, hands, in folds of skin" on Sunday afternoon after receiving flu vaccine on Thursday afternoon. Treated at home with Benadryl and Zyrtec.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Rash
Clinical narrative: Mother noticed rash (small raised bumps) on arms, chest, stomach and back approx 6 hours after Flumist.  Child given Benadryl at that time with no improvement.  Child taken to PMD on 10/30/12 and Dr. advised to continue Benadryl and Ibuprofen.  Itching has stopped but some bumps remain.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood potassium decreased, Blood test normal, Chest X-ray normal, Chest pain
Clinical narrative: Dizziness, nausea, heart beat at 124 beats per minute, feelings of passing out off and on, and weakness on 11/28/2012. On 11/29/21012 at 7:00AM, symptoms included chest pain with difficulty breathing off and on until 9:00AM, increased weakness, headache, constant nausea, dizziness and fast heart beat between 106-120 beats per minute. Went to the emergency room per primary care providers instructions around 5:00 PM. Upon arrival to ER, left arm and hand was tingling and went numb. Had temporary paralysis entire left arm for spouse minutes. CT of brain came back normal. Bloodwork came back normal. EKG was normal. Was given IV fluids, Benadryl, Phenergan, and Torodal. Symptoms subsided within couple hours but then had a reaction to one of the medications given to me per ER physician but he wasn't sure if it was from the Benedryl or Phenergan.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Dizziness, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Dizziness, nausea, heart beat at 124 beats per minute, feelings of passing out off and on, and weakness on 11/28/2012. On 11/29/21012 at 7:00AM, symptoms included chest pain with difficulty breathing off and on until 9:00AM, increased weakness, headache, constant nausea, dizziness and fast heart beat between 106-120 beats per minute. Went to the emergency room per primary care providers instructions around 5:00 PM. Upon arrival to ER, left arm and hand was tingling and went numb. Had temporary paralysis entire left arm for spouse minutes. CT of brain came back normal. Bloodwork came back normal. EKG was normal. Was given IV fluids, Benadryl, Phenergan, and Torodal. Symptoms subsided within couple hours but then had a reaction to one of the medications given to me per ER physician but he wasn't sure if it was from the Benedryl or Phenergan.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypoaesthesia, Monoplegia, Nausea, Paraesthesia
Clinical narrative: Dizziness, nausea, heart beat at 124 beats per minute, feelings of passing out off and on, and weakness on 11/28/2012. On 11/29/21012 at 7:00AM, symptoms included chest pain with difficulty breathing off and on until 9:00AM, increased weakness, headache, constant nausea, dizziness and fast heart beat between 106-120 beats per minute. Went to the emergency room per primary care providers instructions around 5:00 PM. Upon arrival to ER, left arm and hand was tingling and went numb. Had temporary paralysis entire left arm for spouse minutes. CT of brain came back normal. Bloodwork came back normal. EKG was normal. Was given IV fluids, Benadryl, Phenergan, and Torodal. Symptoms subsided within couple hours but then had a reaction to one of the medications given to me per ER physician but he wasn't sure if it was from the Benedryl or Phenergan.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Urine ketone body present
Clinical narrative: Dizziness, nausea, heart beat at 124 beats per minute, feelings of passing out off and on, and weakness on 11/28/2012. On 11/29/21012 at 7:00AM, symptoms included chest pain with difficulty breathing off and on until 9:00AM, increased weakness, headache, constant nausea, dizziness and fast heart beat between 106-120 beats per minute. Went to the emergency room per primary care providers instructions around 5:00 PM. Upon arrival to ER, left arm and hand was tingling and went numb. Had temporary paralysis entire left arm for spouse minutes. CT of brain came back normal. Bloodwork came back normal. EKG was normal. Was given IV fluids, Benadryl, Phenergan, and Torodal. Symptoms subsided within couple hours but then had a reaction to one of the medications given to me per ER physician but he wasn't sure if it was from the Benedryl or Phenergan.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Chills, Discomfort
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Feeling cold, Oropharyngeal discomfort, Pharyngeal oedema, Tachycardia
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Palpitations, Throat irritation
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Dizziness, Electrocardiogram abnormal, Fatigue
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuropathy peripheral, Tachycardia, Tremor
Clinical narrative: Tachycardia, shakiness, shivering from cold, jaw discomfort, throat feeling of swelling, elevated BP, dizziness - given food and water, uncomfortable laying down, when symtoms did not subside after one hour was given 25mg Benadryl which helps relieve fast heartbeat and throat discomfort.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, sore muscles, diarrhea, headache.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Blood test normal, Chills, Dizziness
Clinical narrative: Throat got tight, increased heart rate, dizzy, weak, nauseous, chills within 15 minutes of shot.  Within a day until present, have extreme anxiety, stomach acid and reflux, shaking, extreme chills, legs very weak, pain in leg muscles, continued dizziness and continued tight throat.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Gastrooesophageal reflux disease, Heart rate increased, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Throat got tight, increased heart rate, dizzy, weak, nauseous, chills within 15 minutes of shot.  Within a day until present, have extreme anxiety, stomach acid and reflux, shaking, extreme chills, legs very weak, pain in leg muscles, continued dizziness and continued tight throat.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Tremor, Urine analysis normal
Clinical narrative: Throat got tight, increased heart rate, dizzy, weak, nauseous, chills within 15 minutes of shot.  Within a day until present, have extreme anxiety, stomach acid and reflux, shaking, extreme chills, legs very weak, pain in leg muscles, continued dizziness and continued tight throat.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood glucose increased, Convulsion, White blood cell count increased
Clinical narrative: Generalized seizure.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Drug administered at inappropriate site, Pain
Clinical narrative: Shoulder joint pain.  No muscle pain, but pain when rotating joint, lifting arm.  At time of vaccine, patient thought the vaccine site was too far up on the arm - more in joint and not muscle.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Shoulder joint pain.  No muscle pain, but pain when rotating joint, lifting arm.  At time of vaccine, patient thought the vaccine site was too far up on the arm - more in joint and not muscle.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Feeling hot, Flushing
Clinical narrative: She screamed during vaccinations. Hours later she was lethargic, hot, and flushed in the face and body. She just wanted to sleep. The next day (about 26 hours later from immunizations) same symptoms however had a 103.0 rectal temperature. Doctor on-call said to bring her to the ER at the hospital. She constantly wanted to be held, just slept, seemed drowsy, lethargic, had a abnormal cry that sounded like she was in pain. She was not her normal self. Also didn't want to eat. Hospital said to continue administering infants Tylenol for the fever. She resumed to normal after 3 full days after the immunizations.