chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Radiotherapy
Clinical narrative: This literature report (initial receipt: 24-Apr-2012) concerns a 67-year-old female patient. In summer 2009, the patient received INFLUENZA vaccination (manufacturer unknown). One month later the patient developed pain and lump in the right arm reportedly in the same area that was vaccinated. Upon initial presentation her symptoms were presumed to be secondary to a torn triceps muscle. She was thus referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. The patient underwent incisional biopsy that demonstrated B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. The patient underwent CT (computed tomography) simulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanded by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. She tolerated the treatment well without any unexpected side effects. Physical examination at 1 and 6 months and 1 year after treatment revealed no palpable residual mass, swelling or skin erythema, or range of motion deficits. 6-month post treatment MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis (CT CAP) at 1 year showed no evidence of disease. Reporters comment: The relationship between influenza vaccine injection and the development of MALT lymphoma in this patient is speculative but is, undeniably, an interesting confluence of events. Although the available literature suggests that primary skeletal muscle non-Hodgkin lymphoma is associated with poor prognosis, the case presented here suggests that involved field radiation therapy alone can be an effective treatment for early stage primary skeletal marginal zone lymphoma.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Biopsy muscle abnormal, Extranodal marginal zone B-cell lymphoma (MALT type) stage I, Immunohistochemistry, Injection site mass, Injection site pain
Clinical narrative: This literature report (initial receipt: 24-Apr-2012) concerns a 67-year-old female patient. In summer 2009, the patient received INFLUENZA vaccination (manufacturer unknown). One month later the patient developed pain and lump in the right arm reportedly in the same area that was vaccinated. Upon initial presentation her symptoms were presumed to be secondary to a torn triceps muscle. She was thus referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. The patient underwent incisional biopsy that demonstrated B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. The patient underwent CT (computed tomography) simulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanded by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. She tolerated the treatment well without any unexpected side effects. Physical examination at 1 and 6 months and 1 year after treatment revealed no palpable residual mass, swelling or skin erythema, or range of motion deficits. 6-month post treatment MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis (CT CAP) at 1 year showed no evidence of disease. Reporters comment: The relationship between influenza vaccine injection and the development of MALT lymphoma in this patient is speculative but is, undeniably, an interesting confluence of events. Although the available literature suggests that primary skeletal muscle non-Hodgkin lymphoma is associated with poor prognosis, the case presented here suggests that involved field radiation therapy alone can be an effective treatment for early stage primary skeletal marginal zone lymphoma.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Muscle mass, Nuclear magnetic resonance imaging abnormal, Radiotherapy
Clinical narrative: This literature report (initial receipt: 24-Apr-2012) concerns a 67-year-old female patient. In summer 2009, the patient received INFLUENZA vaccination (manufacturer unknown). One month later the patient developed pain and lump in the right arm reportedly in the same area that was vaccinated. Upon initial presentation her symptoms were presumed to be secondary to a torn triceps muscle. She was thus referred to an orthopedist who recommended imaging workup. Magnetic resonance imaging (MRI) of the right upper arm showed a 4.3 x 1.1 x 7.5 cm enhancing mass in the posterior lateral aspect of the long head of the right triceps muscle. Core biopsy revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. The patient underwent incisional biopsy that demonstrated B-cell-type lymphoma infiltrating the skeletal muscle. Immunohistochemical staining was positive for CD 20, BCL2 and pax-5 and negative for CD3, CD5, CD10, CD 23, BCL 6, and cyclin D1, consistent with marginal zone lymphoma. Bone marrow biopsy was negative. Lactate dehydrogenase was within normal limits. She was therefore staged I E with International Prognostic Index score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. The patient underwent CT (computed tomography) simulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanded by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. She tolerated the treatment well without any unexpected side effects. Physical examination at 1 and 6 months and 1 year after treatment revealed no palpable residual mass, swelling or skin erythema, or range of motion deficits. 6-month post treatment MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis (CT CAP) at 1 year showed no evidence of disease. Reporters comment: The relationship between influenza vaccine injection and the development of MALT lymphoma in this patient is speculative but is, undeniably, an interesting confluence of events. Although the available literature suggests that primary skeletal muscle non-Hodgkin lymphoma is associated with poor prognosis, the case presented here suggests that involved field radiation therapy alone can be an effective treatment for early stage primary skeletal marginal zone lymphoma.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: On April 23, 2012, staff from epidemiological conference of the hospital called the office of the nurse to notify that the patient had been hospitalized since Sunday with cellulitis in the right arm and started to show symptoms since she was vaccinated.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt developed a warm tender lump on her (R) delt, the location of the imm, which developed within hours of the imm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site urticaria, Injection site warmth, Pain
Clinical narrative: Over all flu-like symptoms - body aches, at injection site pt had a 3 inch circular red - warm wheal, then around that was a "pinkish" patch about 7 inches circular.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Confusional state, Lethargy, Muscular weakness
Clinical narrative: This spontaneous medically confirmed (initial receipt 23-Apr-2012) concerns an elderly male patient with a medical history of hypertension, hypercholesterolaemia, prostate cancer, osteoarthritis, arthritis and possible CHF (congestive heart failure). The patient was concomitantly taking CAPTOPRIL and  CARVEDILOL for hypertension, bicalutamide for prostate cancer, simvastatin for cholesterol and warfarin for blood thinning. He was also taking ezetimibe, diclofenac, finasteride and furosemide. On an unknown date in the fall of 2011, the patient received suspect vaccine 'flu shot' (influenza vaccine) with an unknown batch number. Co-suspect vaccine PNEUMOVAX 0.5 mL given intramuscularly on the same day. On the same day as vaccination the patient developed muscle weakness, was lethargic and confused. The reporter stated that the patient was 'out of it' and was very weak. Symptoms lasted 18-24 hours after receiving the shot then he was fine. There were no symptoms of fever or flu-like illness. Symptoms abated after stopping the drug; did not experience symptoms after reintroduction. Patient outcome was reported as recovered.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema
Clinical narrative: 4 cm circle of erythema located on the (L) deltoid.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash erythematous, Rash macular
Clinical narrative: Vaccines given approximately 1:30pm. Mother brought to nurse's attention a red, blotchy rash on child's extremities and back, face also red; mother thought reaction started within 5-10 minutes of injections.  No respiratory distress, child taking a bottle.  Child given .25ml of Benadryl, 50mg/ml, IM, right thigh at 1:50 pm. Discussed with mother having child seen by medical provider. Mother planned to go to her family medical provider directly from the Health Department. Family left with child in stable condition at 2:05pm.  Nurse called family 8:10 am 5/1/12, mother reports child doing well; rash was completely gone by the time they arrived at the medical provider's office, provider would not see child but instructed to use oral Benadryl as needed.  No further rash occurrence.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Blood test, Cellulitis, Dyspnoea, Erythema, Swelling
Clinical narrative: Swelling (size of a half dollar per mother), redness the next morning; 4/25/12 increased swelling, problems breathing - EMS transport (family without transportation); antibiotic therapy.  Child admitted to hospital x4 days for IV antibiotic therapy dx: cellulitis.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Diagnosed on 4/13/2012 with shingles/Herpes Zoster NOS in a varicella-vaccinated child; treatment acyclovia (Zovirax) 200mg/5ml oral suspension.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Pt c/o swollen lymph nodes in neck/collar bone area with redness, pain, and swelling at injection site. Evaluated by Dr. and treated with ice pack therapy, Ibuprofen 400-600mg TID, and Keflex 500 mg TID.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Dizziness, Dysgeusia, Dysphagia, Feeling abnormal
Clinical narrative: EE called office and c/o jaw tightness, and was advised to RTC. Arrived at 07:55 c/o nausea, lightheaded, c/o excessive saliva, refusing to swallow due to medicine-like taste. Denied swelling of mouth or tongue. Able to swallow without difficulty. BP at 0810 144/86 P 69, longer EE sat the more anxious she became and she c/o touble swallowing at 0815 BP 170/100 p 70. Give Benadryl 25 mg and taken by WC to ED When she arrived in ED denied swelling or inability to swallow, but did not want to swallow because she felt her neck was "Swollen" No distress, given Ranitidine 50mg O at 0821, Solu-Medrol 125mg IV, Epi-Pen 0.5 IM and diphendydramine 25 mg po. Kept in ED for observation for 6 hours and Dc'd to home. Followed up with internal medicine on 4/23/12 for possible allergic reaction to MMR #2.  MMR #1 given 2006.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Muscle tightness, Nausea, Salivary hypersecretion
Clinical narrative: EE called office and c/o jaw tightness, and was advised to RTC. Arrived at 07:55 c/o nausea, lightheaded, c/o excessive saliva, refusing to swallow due to medicine-like taste. Denied swelling of mouth or tongue. Able to swallow without difficulty. BP at 0810 144/86 P 69, longer EE sat the more anxious she became and she c/o touble swallowing at 0815 BP 170/100 p 70. Give Benadryl 25 mg and taken by WC to ED When she arrived in ED denied swelling or inability to swallow, but did not want to swallow because she felt her neck was "Swollen" No distress, given Ranitidine 50mg O at 0821, Solu-Medrol 125mg IV, Epi-Pen 0.5 IM and diphendydramine 25 mg po. Kept in ED for observation for 6 hours and Dc'd to home. Followed up with internal medicine on 4/23/12 for possible allergic reaction to MMR #2.  MMR #1 given 2006.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe Headache, Fever of 102+, Chills, Body Aches.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Differential white blood cell count, Dizziness, Electrocardiogram
Clinical narrative: Patient describes feeling light headed since the time of the injection but she thought it was from being hungry, since she did not eat breakfast.  She also described her heartbeat feeling irregular.  After she ate lunch and the symptoms got worse, she was advised to go to the doctor.  An EKG was done and it was noted she had an irregular sinus bradycardia & PVC's.  The clinic doctor sent her to the emergency room for atypical reaction post MMR vaccination.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Heart rate irregular, Sinus bradycardia, Thyroxine free, Tri-iodothyronine
Clinical narrative: Patient describes feeling light headed since the time of the injection but she thought it was from being hungry, since she did not eat breakfast.  She also described her heartbeat feeling irregular.  After she ate lunch and the symptoms got worse, she was advised to go to the doctor.  An EKG was done and it was noted she had an irregular sinus bradycardia & PVC's.  The clinic doctor sent her to the emergency room for atypical reaction post MMR vaccination.
Age: 41.0
Sex: M
Vaccine: MMR
Symptoms: Ventricular extrasystoles
Clinical narrative: Patient describes feeling light headed since the time of the injection but she thought it was from being hungry, since she did not eat breakfast.  She also described her heartbeat feeling irregular.  After she ate lunch and the symptoms got worse, she was advised to go to the doctor.  An EKG was done and it was noted she had an irregular sinus bradycardia & PVC's.  The clinic doctor sent her to the emergency room for atypical reaction post MMR vaccination.
Age: 1.28
Sex: F
Vaccine: HIBV, PPV
Symptoms: Crying, Fatigue, Irritability, Pyrexia, Rash
Clinical narrative: Fever, extremely tired, fussy, crying, administered acetaminophen.  Fever worsened throughout night, child vomited twice, unable to administer acetaminophen.  Maintained fever of 101 for 12 hours.  Child stayed fussy/irritable for three days following.  Broke out in terrible rash over arms and legs, and face.  Rash still present a week later.
Age: 1.28
Sex: F
Vaccine: HIBV, PPV
Symptoms: Vomiting
Clinical narrative: Fever, extremely tired, fussy, crying, administered acetaminophen.  Fever worsened throughout night, child vomited twice, unable to administer acetaminophen.  Maintained fever of 101 for 12 hours.  Child stayed fussy/irritable for three days following.  Broke out in terrible rash over arms and legs, and face.  Rash still present a week later.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Face oedema, Urticaria, Vomiting
Clinical narrative: 4/21/12 Hives-generalized and mild developed, then on 4/27/12 hives worsened. On 4/30/12 hives continued, edema of face & lips developed and vomiting occurred. Pt was seen in ER on 4/30/12 and was treated with Benedryl and Zantac. 5/1/12 Pt reports improvement in symptoms.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Platelet count
Clinical narrative: Patient had local swelling after infection at site of injection. No discoloring, fever, or pain. Swelling seemed to improve with increased circulation of arm. Patient returned to pharmacy 5 days later with large bruising at site of injection and towards elbow. After 7 days patient visited doctor and PCP found bruise non-threatening, but ran some platelet tests to be certain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis due to vaccine on affected area ((L) deltoid). KEFLEX 250/5 1 tsp PO TID # 75cc. MOTRIN 1 1/2 tsp PO q 6 hours.
Age: 34.0
Sex: U
Vaccine: TDAP
Symptoms: Dehydration, Pyrexia, Syncope, Vomiting
Clinical narrative: Fever to 102. 7 8 hours after Tdap. Vomiting, syncope, dehydrations, head impact, IV fluids & doctor's visit.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site pain, Pain in extremity, Somnolence
Clinical narrative: 1 day after injection experienced severe shooting pain from upper arm to fingers for about 4 hours. Symptoms resolved spontaneously. At same time had somnolence symptoms regularly.
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Right arm red, swollen, sore & itchy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus, Swelling
Clinical narrative: Immediate redness, swollen, itching, about size of 2 in circle, quite sore. Nurse did not notice any irritation.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Induration, Local reaction, Skin warm, Urticaria
Clinical narrative: Localized half dollar size welt, red, warm to touch, hard.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Blood test, Dizziness, Epstein-Barr virus infection, Fatigue
Clinical narrative: Information has been received from a 68 year old female patient with high blood pressure and no drug reaction/allergies who on 09-AUG-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669692/0615AA, EXP 02-JUL-2012) once. A month after injection received, on approximately 09-SEP-2011 the patient experienced light headedness, extreme fatigue and tingling in feet and legs. The patient believed that ZOSTAVAX (Merck) caused light headedness, extreme fatigue and tingling in feet and legs. Patient sought unspecified medical attention. Blood work was performed (result not provided). The outcome of light headedness, extreme fatigue and tingling in feet and legs were unknown at the time of the report. Follow-up information has been received from the patient concerning she was given her shingles injection at a pharmacy. On 09-AUG-2011 she was feeling fine. She had left the gym, stopped at the pharmacy, and had the shot. She had "now" (in approximately October, 2011) been diagnosed with Epstein Barr. She had been very ill for 2 months. She could not help feel that the injection caused this. They are too closely related. She was still not normal. This had been debilitating. 2-3 weeks after this hit. Not a good thing. She drove her car for the first time "yesterday" (16-OCT-2011). Follow-up information has been received from the patient stating that she continued to experience nerve complications (tingling, twitching and numbness) in her feet and legs which affected her ability to walk and her general quality of life (considered disabling). The patient reported that she had had numerous tests completed (numerous unspecified blood tests, magnetic resonance imaging (MRI's), unspecified tests for cancer, unspecified nerve and muscle test). The patient stated she believes ZOSTAVAX (Merck) caused her problems. The patient reported she experienced everything three weeks after receiving ZOSTAVAX (Merck). The patient stated she had "all extensive testing" yet they can not find a specific reason why she is experiencing her feet are numb and nerve damage. She stated she can walk but her legs are weak. The patient stated "This has completely changed my life. I have gone to five specialists and they all say the same thing, it was the shot. I do not have multiple sclerosis, I do not have cancer and have been doctoring since last September 2011. I had three heart stents March of the previous year (2010). I did not finish two sessions for rehabilitation because of extreme fatigue. I had to crawl to bathroom. I have this virus in my blood now." At the time of this report, the conditions were not recovered. Nerve complications (tingling, numbness and twitching in feet and legs) affect ability to walk and general quality of life, Epstein Barr, extreme fatigue, light headedness and very ill were considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Hypoaesthesia, Impaired driving ability, Laboratory test
Clinical narrative: Information has been received from a 68 year old female patient with high blood pressure and no drug reaction/allergies who on 09-AUG-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669692/0615AA, EXP 02-JUL-2012) once. A month after injection received, on approximately 09-SEP-2011 the patient experienced light headedness, extreme fatigue and tingling in feet and legs. The patient believed that ZOSTAVAX (Merck) caused light headedness, extreme fatigue and tingling in feet and legs. Patient sought unspecified medical attention. Blood work was performed (result not provided). The outcome of light headedness, extreme fatigue and tingling in feet and legs were unknown at the time of the report. Follow-up information has been received from the patient concerning she was given her shingles injection at a pharmacy. On 09-AUG-2011 she was feeling fine. She had left the gym, stopped at the pharmacy, and had the shot. She had "now" (in approximately October, 2011) been diagnosed with Epstein Barr. She had been very ill for 2 months. She could not help feel that the injection caused this. They are too closely related. She was still not normal. This had been debilitating. 2-3 weeks after this hit. Not a good thing. She drove her car for the first time "yesterday" (16-OCT-2011). Follow-up information has been received from the patient stating that she continued to experience nerve complications (tingling, twitching and numbness) in her feet and legs which affected her ability to walk and her general quality of life (considered disabling). The patient reported that she had had numerous tests completed (numerous unspecified blood tests, magnetic resonance imaging (MRI's), unspecified tests for cancer, unspecified nerve and muscle test). The patient stated she believes ZOSTAVAX (Merck) caused her problems. The patient reported she experienced everything three weeks after receiving ZOSTAVAX (Merck). The patient stated she had "all extensive testing" yet they can not find a specific reason why she is experiencing her feet are numb and nerve damage. She stated she can walk but her legs are weak. The patient stated "This has completely changed my life. I have gone to five specialists and they all say the same thing, it was the shot. I do not have multiple sclerosis, I do not have cancer and have been doctoring since last September 2011. I had three heart stents March of the previous year (2010). I did not finish two sessions for rehabilitation because of extreme fatigue. I had to crawl to bathroom. I have this virus in my blood now." At the time of this report, the conditions were not recovered. Nerve complications (tingling, numbness and twitching in feet and legs) affect ability to walk and general quality of life, Epstein Barr, extreme fatigue, light headedness and very ill were considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Muscle twitching, Muscular weakness, Nerve injury, Nerve stimulation test
Clinical narrative: Information has been received from a 68 year old female patient with high blood pressure and no drug reaction/allergies who on 09-AUG-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669692/0615AA, EXP 02-JUL-2012) once. A month after injection received, on approximately 09-SEP-2011 the patient experienced light headedness, extreme fatigue and tingling in feet and legs. The patient believed that ZOSTAVAX (Merck) caused light headedness, extreme fatigue and tingling in feet and legs. Patient sought unspecified medical attention. Blood work was performed (result not provided). The outcome of light headedness, extreme fatigue and tingling in feet and legs were unknown at the time of the report. Follow-up information has been received from the patient concerning she was given her shingles injection at a pharmacy. On 09-AUG-2011 she was feeling fine. She had left the gym, stopped at the pharmacy, and had the shot. She had "now" (in approximately October, 2011) been diagnosed with Epstein Barr. She had been very ill for 2 months. She could not help feel that the injection caused this. They are too closely related. She was still not normal. This had been debilitating. 2-3 weeks after this hit. Not a good thing. She drove her car for the first time "yesterday" (16-OCT-2011). Follow-up information has been received from the patient stating that she continued to experience nerve complications (tingling, twitching and numbness) in her feet and legs which affected her ability to walk and her general quality of life (considered disabling). The patient reported that she had had numerous tests completed (numerous unspecified blood tests, magnetic resonance imaging (MRI's), unspecified tests for cancer, unspecified nerve and muscle test). The patient stated she believes ZOSTAVAX (Merck) caused her problems. The patient reported she experienced everything three weeks after receiving ZOSTAVAX (Merck). The patient stated she had "all extensive testing" yet they can not find a specific reason why she is experiencing her feet are numb and nerve damage. She stated she can walk but her legs are weak. The patient stated "This has completely changed my life. I have gone to five specialists and they all say the same thing, it was the shot. I do not have multiple sclerosis, I do not have cancer and have been doctoring since last September 2011. I had three heart stents March of the previous year (2010). I did not finish two sessions for rehabilitation because of extreme fatigue. I had to crawl to bathroom. I have this virus in my blood now." At the time of this report, the conditions were not recovered. Nerve complications (tingling, numbness and twitching in feet and legs) affect ability to walk and general quality of life, Epstein Barr, extreme fatigue, light headedness and very ill were considered disabling. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Quality of life decreased
Clinical narrative: Information has been received from a 68 year old female patient with high blood pressure and no drug reaction/allergies who on 09-AUG-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669692/0615AA, EXP 02-JUL-2012) once. A month after injection received, on approximately 09-SEP-2011 the patient experienced light headedness, extreme fatigue and tingling in feet and legs. The patient believed that ZOSTAVAX (Merck) caused light headedness, extreme fatigue and tingling in feet and legs. Patient sought unspecified medical attention. Blood work was performed (result not provided). The outcome of light headedness, extreme fatigue and tingling in feet and legs were unknown at the time of the report. Follow-up information has been received from the patient concerning she was given her shingles injection at a pharmacy. On 09-AUG-2011 she was feeling fine. She had left the gym, stopped at the pharmacy, and had the shot. She had "now" (in approximately October, 2011) been diagnosed with Epstein Barr. She had been very ill for 2 months. She could not help feel that the injection caused this. They are too closely related. She was still not normal. This had been debilitating. 2-3 weeks after this hit. Not a good thing. She drove her car for the first time "yesterday" (16-OCT-2011). Follow-up information has been received from the patient stating that she continued to experience nerve complications (tingling, twitching and numbness) in her feet and legs which affected her ability to walk and her general quality of life (considered disabling). The patient reported that she had had numerous tests completed (numerous unspecified blood tests, magnetic resonance imaging (MRI's), unspecified tests for cancer, unspecified nerve and muscle test). The patient stated she believes ZOSTAVAX (Merck) caused her problems. The patient reported she experienced everything three weeks after receiving ZOSTAVAX (Merck). The patient stated she had "all extensive testing" yet they can not find a specific reason why she is experiencing her feet are numb and nerve damage. She stated she can walk but her legs are weak. The patient stated "This has completely changed my life. I have gone to five specialists and they all say the same thing, it was the shot. I do not have multiple sclerosis, I do not have cancer and have been doctoring since last September 2011. I had three heart stents March of the previous year (2010). I did not finish two sessions for rehabilitation because of extreme fatigue. I had to crawl to bathroom. I have this virus in my blood now." At the time of this report, the conditions were not recovered. Nerve complications (tingling, numbness and twitching in feet and legs) affect ability to walk and general quality of life, Epstein Barr, extreme fatigue, light headedness and very ill were considered disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Crying, Emotional disorder, Feeling abnormal, Grip strength decreased
Clinical narrative: A few hrs after HPV #1 vaccine, pt was in school & developed uncontrollable shaking, laughing, then crying, then curled up in a ball on floor. She had no control over her emotions x 45 min. Pt's dad observed this behavior. 4/24 Next day, pt felt like "in a fog"; again felt "shaky" & unable to hold a pencil; also devel. headache lasting until 4/25 -> today felt WNL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Inappropriate affect, Tremor
Clinical narrative: A few hrs after HPV #1 vaccine, pt was in school & developed uncontrollable shaking, laughing, then crying, then curled up in a ball on floor. She had no control over her emotions x 45 min. Pt's dad observed this behavior. 4/24 Next day, pt felt like "in a fog"; again felt "shaky" & unable to hold a pencil; also devel. headache lasting until 4/25 -> today felt WNL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Crying, Feeling abnormal, Grip strength decreased, Headache
Clinical narrative: A few hrs after HPV #1 vaccine, pt was in school & developed uncontrollable shaking, laughing, then crying, then curled up in a ball on floor. She had no control over her emotions x 45 min. Pt's dad observed this behavior. 4/24 Next day, pt felt like "in a fog"; again felt "shaky" & unable to hold a pencil; also devel. headache lasting until 4/25 -> today felt WNL.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Inappropriate affect, Posture abnormal, Tremor
Clinical narrative: A few hrs after HPV #1 vaccine, pt was in school & developed uncontrollable shaking, laughing, then crying, then curled up in a ball on floor. She had no control over her emotions x 45 min. Pt's dad observed this behavior. 4/24 Next day, pt felt like "in a fog"; again felt "shaky" & unable to hold a pencil; also devel. headache lasting until 4/25 -> today felt WNL.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Asthenia, Crying, Feeding disorder of infancy or early childhood, Hypotonia, Intensive care
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0972370A for PEDIARIX, concerning a 18 weeks old female patient with no relevant medical history and no history of adverse events following previous vaccinations who on 30-MAR-2012, was vaccinated with a dose of ROTATEQ (lot #, dose and route not reported). Secondary suspect vaccines received on the same day included the second dose of PEDIARIX in the left thigh (lot # AC21B323AA, dose and route not reported). There was no other concomitant medication. It was reported that on 31-MAR-2012, 1 day after vaccination the patient experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the patient was hospitalized in the intensive care unit. At the time of the report the patient's events persisted. The physician considered poor oral feeding, severe hypotonia (weakness) decreased tone, and weak crying to be disabling, immediately life-threatening and clinically significant (or requiring intervention). This was originally reported by a health physician. Additional information is not expected.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Laboratory test, Metabolic function test, Neurological examination
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0972370A for PEDIARIX, concerning a 18 weeks old female patient with no relevant medical history and no history of adverse events following previous vaccinations who on 30-MAR-2012, was vaccinated with a dose of ROTATEQ (lot #, dose and route not reported). Secondary suspect vaccines received on the same day included the second dose of PEDIARIX in the left thigh (lot # AC21B323AA, dose and route not reported). There was no other concomitant medication. It was reported that on 31-MAR-2012, 1 day after vaccination the patient experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the patient was hospitalized in the intensive care unit. At the time of the report the patient's events persisted. The physician considered poor oral feeding, severe hypotonia (weakness) decreased tone, and weak crying to be disabling, immediately life-threatening and clinically significant (or requiring intervention). This was originally reported by a health physician. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: ANTH, IPV, SMALL, TYP, ANTH, IPV, SMALL, TYP
Symptoms: Papule, Rash erythematous, Rash vesicular, Sunburn
Clinical narrative: Vesicular rash with erythematous base erupted one day after receiving sunburn on face & arms at day 16 post smallpox vaccination. Rash mainly on both elbows & forearms with vesicles coalescing. Erythematous papules on forearms, hands, and few on legs.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood testosterone normal, Dizziness, Full blood count normal, Gastrooesophageal reflux disease, Headache
Clinical narrative: Information has been received from a health worker concerning a 51 year old male with drug allergy to LINCOCIN who in 2001 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). On approximately 17-FEB-2012 ("approximately 2 and 1/2 weeks ago") the patient was vaccinated with another dose of PNEUMOVAX 23 (671405/1420AA, exp 11-APR-2013), 0.5 ml, intramuscularly. Concomitant therapy included atenolol and ZOLOFT. On approximately 17-FEB-2012 ("the same day the patient received PNEUMOVAX 23") patient experienced injection-site erythema and swelling that spread from his deltoid to his elbow. These local reactions subsided in less than a week. While the local reactions were subsiding he started to develop body aches, dizziness, headaches, nausea and vomiting. The patient mentioned that he was taking ibuprofen (unspecified manufacturer) to treat his headaches but it caused him to have reflux so he stopped taking it. The patient sought medical attention by office visiting. NEXIUM, Swamp Mix containing MAALOX and lidocaine, PHENERGAN injection, ibuprofen and TYLENOL were given for the treatment. Lab diagnostics performed included: "H. pylori test was negative but bismuth was given that same day which may have interfered with the test results", testosterone result was in normal range and complete blood cell count (CBC) was within normal limits. At the time of reporting, the patient's dizziness, headaches and nausea persisted but no local symptoms. Follow up information has been received from the physician's assistant concerning the white "well adult" at the time of vaccination who on 03-FEB-2012, at 15:15hrs, was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23 (lot # 671405/1420AA). The physician's assistant reported that on 03-FEB-2012, the patient developed erythema and edema 20x10cm at the vaccination site on the left arm for a period of 10 days. Subsequently the patient developed body aches, fever, flu like symptoms, nausea, dizziness, headache for 2-4 weeks and reflux for 5 weeks. Lab diagnostic tests were performed, H-pylori and CMP resulted negative. The physician's assistant considered erythema and edema at vaccination site, body aches, fever, flu like symptoms, nausea, dizziness, headache and reflux to be other important medical events requiring medical intervention. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Helicobacter test negative, Influenza like illness, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a health worker concerning a 51 year old male with drug allergy to LINCOCIN who in 2001 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). On approximately 17-FEB-2012 ("approximately 2 and 1/2 weeks ago") the patient was vaccinated with another dose of PNEUMOVAX 23 (671405/1420AA, exp 11-APR-2013), 0.5 ml, intramuscularly. Concomitant therapy included atenolol and ZOLOFT. On approximately 17-FEB-2012 ("the same day the patient received PNEUMOVAX 23") patient experienced injection-site erythema and swelling that spread from his deltoid to his elbow. These local reactions subsided in less than a week. While the local reactions were subsiding he started to develop body aches, dizziness, headaches, nausea and vomiting. The patient mentioned that he was taking ibuprofen (unspecified manufacturer) to treat his headaches but it caused him to have reflux so he stopped taking it. The patient sought medical attention by office visiting. NEXIUM, Swamp Mix containing MAALOX and lidocaine, PHENERGAN injection, ibuprofen and TYLENOL were given for the treatment. Lab diagnostics performed included: "H. pylori test was negative but bismuth was given that same day which may have interfered with the test results", testosterone result was in normal range and complete blood cell count (CBC) was within normal limits. At the time of reporting, the patient's dizziness, headaches and nausea persisted but no local symptoms. Follow up information has been received from the physician's assistant concerning the white "well adult" at the time of vaccination who on 03-FEB-2012, at 15:15hrs, was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23 (lot # 671405/1420AA). The physician's assistant reported that on 03-FEB-2012, the patient developed erythema and edema 20x10cm at the vaccination site on the left arm for a period of 10 days. Subsequently the patient developed body aches, fever, flu like symptoms, nausea, dizziness, headache for 2-4 weeks and reflux for 5 weeks. Lab diagnostic tests were performed, H-pylori and CMP resulted negative. The physician's assistant considered erythema and edema at vaccination site, body aches, fever, flu like symptoms, nausea, dizziness, headache and reflux to be other important medical events requiring medical intervention. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test normal, Nausea, Pain, Pyrexia, Vaccination site oedema
Clinical narrative: Information has been received from a health worker concerning a 51 year old male with drug allergy to LINCOCIN who in 2001 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). On approximately 17-FEB-2012 ("approximately 2 and 1/2 weeks ago") the patient was vaccinated with another dose of PNEUMOVAX 23 (671405/1420AA, exp 11-APR-2013), 0.5 ml, intramuscularly. Concomitant therapy included atenolol and ZOLOFT. On approximately 17-FEB-2012 ("the same day the patient received PNEUMOVAX 23") patient experienced injection-site erythema and swelling that spread from his deltoid to his elbow. These local reactions subsided in less than a week. While the local reactions were subsiding he started to develop body aches, dizziness, headaches, nausea and vomiting. The patient mentioned that he was taking ibuprofen (unspecified manufacturer) to treat his headaches but it caused him to have reflux so he stopped taking it. The patient sought medical attention by office visiting. NEXIUM, Swamp Mix containing MAALOX and lidocaine, PHENERGAN injection, ibuprofen and TYLENOL were given for the treatment. Lab diagnostics performed included: "H. pylori test was negative but bismuth was given that same day which may have interfered with the test results", testosterone result was in normal range and complete blood cell count (CBC) was within normal limits. At the time of reporting, the patient's dizziness, headaches and nausea persisted but no local symptoms. Follow up information has been received from the physician's assistant concerning the white "well adult" at the time of vaccination who on 03-FEB-2012, at 15:15hrs, was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23 (lot # 671405/1420AA). The physician's assistant reported that on 03-FEB-2012, the patient developed erythema and edema 20x10cm at the vaccination site on the left arm for a period of 10 days. Subsequently the patient developed body aches, fever, flu like symptoms, nausea, dizziness, headache for 2-4 weeks and reflux for 5 weeks. Lab diagnostic tests were performed, H-pylori and CMP resulted negative. The physician's assistant considered erythema and edema at vaccination site, body aches, fever, flu like symptoms, nausea, dizziness, headache and reflux to be other important medical events requiring medical intervention. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a health worker concerning a 51 year old male with drug allergy to LINCOCIN who in 2001 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). On approximately 17-FEB-2012 ("approximately 2 and 1/2 weeks ago") the patient was vaccinated with another dose of PNEUMOVAX 23 (671405/1420AA, exp 11-APR-2013), 0.5 ml, intramuscularly. Concomitant therapy included atenolol and ZOLOFT. On approximately 17-FEB-2012 ("the same day the patient received PNEUMOVAX 23") patient experienced injection-site erythema and swelling that spread from his deltoid to his elbow. These local reactions subsided in less than a week. While the local reactions were subsiding he started to develop body aches, dizziness, headaches, nausea and vomiting. The patient mentioned that he was taking ibuprofen (unspecified manufacturer) to treat his headaches but it caused him to have reflux so he stopped taking it. The patient sought medical attention by office visiting. NEXIUM, Swamp Mix containing MAALOX and lidocaine, PHENERGAN injection, ibuprofen and TYLENOL were given for the treatment. Lab diagnostics performed included: "H. pylori test was negative but bismuth was given that same day which may have interfered with the test results", testosterone result was in normal range and complete blood cell count (CBC) was within normal limits. At the time of reporting, the patient's dizziness, headaches and nausea persisted but no local symptoms. Follow up information has been received from the physician's assistant concerning the white "well adult" at the time of vaccination who on 03-FEB-2012, at 15:15hrs, was vaccinated in the left deltoid with the second dose of PNEUMOVAX 23 (lot # 671405/1420AA). The physician's assistant reported that on 03-FEB-2012, the patient developed erythema and edema 20x10cm at the vaccination site on the left arm for a period of 10 days. Subsequently the patient developed body aches, fever, flu like symptoms, nausea, dizziness, headache for 2-4 weeks and reflux for 5 weeks. Lab diagnostic tests were performed, H-pylori and CMP resulted negative. The physician's assistant considered erythema and edema at vaccination site, body aches, fever, flu like symptoms, nausea, dizziness, headache and reflux to be other important medical events requiring medical intervention. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil percentage, Basophil percentage decreased, Blood culture negative, Culture urine negative, Decreased appetite
Clinical narrative: Pt. received immunizations as indicated below at 0910 AM & pt's sitter stated pt started to be fussy around 10:00 AM & at 2:00 p.m. Mom gave TYLENOL & lukewarm bath to help with fussiness but no improvement & pt. was pulling legs up & arching back & screaming unconsolable & jerking of arms. Attempted to feed formula drank 1 oz only & would not drink anymore. At 4:00pm - temp - 102.6 rectal - last BM - yesterday. MOTRIN 100/5 1/2 tsp given at 0450 pm - came into clinic 0500 p.m. - inconsolable, screaming - rectal temp 103.1 (Tmax) - O2 Sat 100% HR - 176. Pt. sent for labwork. At 6:00 pm liquid BM & excessive gas & gastritis x 3 days - no vomiting - fever x 24 hrs.