chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Radiotherapy, Vaccination site pain
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: BCL-2 gene status assay, Biopsy bone marrow normal, Biopsy muscle abnormal, Blood lactate dehydrogenase normal, Computerised tomogram abdomen normal
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Computerised tomogram normal, Computerised tomogram thorax normal, Extranodal marginal zone B-cell lymphoma (MALT type) stage I, Immunohistochemistry, Injection site mass
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Injection site pain, Injection site reaction, Laboratory test abnormal, Muscle mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Radiotherapy
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
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: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 67.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Muscle mass, Nuclear magnetic resonance imaging abnormal, Radiotherapy
Clinical narrative: Case number PHHY2012US035536 is an initial literature report received on 24 Apr 2012. The author presented the rare case of an adult female patient with MALT (mucosa-associated lymphoid tissue) lymphoma of the right triceps muscle after the influenza vaccination at the same site one month earlier. This report refers to a 67-year-old female patient whose medical history, current conditions and concomitant medications were not specified. She was vaccinated with influenza vaccine (manufacturer and batch number: unspecified hence conservatively taken as influenza unknown INN) through unspecified route in right arm on an unspecified date in 2009. One month later, she developed pain and lump in the right arm reportedly in the same area which was vaccinated. Upon initial presentation, her symptoms were presumed to be secondary to a torn triceps muscle. She was 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 performed revealed low grade lymphoma of small B-cell type. Additional tissue sampling was recommended for further classification and immunophenotyping. She 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 (IPI) score of 1 by virtue of her age. After multidisciplinary consultations, a course of definitive radiation therapy was recommended. She underwent CT stimulation in the supine position with alpha-cradle for immobilization. The target lesion was contoured as the gross tumor volume (GTV). The GTV was expanding by 2 cm to create the planned treatment volume. She received 40Gy in 20 fractions with 6MV photons utilizing 3D conformal radiation therapy. It was reported that she tolerated the treatment well without any unexpected side effects. Physical examination at first and six months and first year after treatment revealed no palpable residual mass, swelling or skin erythema or range of motion deficits. After six months of treatment, MRI of the right upper arm demonstrated excellent response with no evidence of residual disease. Computerized tomography of the chest, abdomen and pelvis at first year showed no evidence of disease. The author commented that relationship between Influenza vaccine injection and the development of MALT lymphoma in this patient was speculative but was, undeniably, an interesting confluence of events.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, localize soreness at injection site.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Diffused urticarial reaction no wheezing or difficulty in breathing per physician patient seen 30 Apr 12.
Age: 0.22
Sex: F
Vaccine: HEP, PNC13
Symptoms: Apparent life threatening event, Choking, Depressed level of consciousness, Respiratory arrest
Clinical narrative: 4-24-12 Mom walked the baby outside (baby in stroller) & mom said baby sounded choking & seemed not breathing. Took her out of stroller & run to the clinic. On exam baby appeared sl. dazed but recovered soon. Exam normal. No neuro deficit. Imp. apparent life threatening event.
Age: 66.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old patient who on 04-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old patient who on 17-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old patient who on 04-NOV-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old patient who on 12-NOV-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old who on 17-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 87.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 87 year old patient who on 04-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old patient who on 28-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Audiogram abnormal, Deafness
Clinical narrative: Complete hearing loss in three days and partially recovered. Still has had PO steroid 7 dys. No severe sensory-neural hearing loss.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Burning pain through right arm and shoulder, severe headaches with pain, swollen lymph node in right neck, chills, fatigue and arthralgias.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Burning pain through right arm and shoulder, severe headaches with pain, swollen lymph node in right neck, chills, fatigue and arthralgias.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Erythema, swelling, hardness, pain, pruritis. area about 3" by 2".
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Burning, itching, redness, swelling at around injection site. Ended up calling MD, who sent pt to urgent care. Pt received DECADRON shot & Z-PAK for allergic reaction. No other symptoms.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus, Skin exfoliation
Clinical narrative: 4/24/12 - 1 x 2 inch area raised redness with pain. 4/26/12 - 1 x 2 inch area scaly raised redness with 4 inch (diameter) round redness & hardness with pain/itching - saw private MD - using OTC topical itch cream.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: 4/24/12 - 1 x 2 inch area raised redness with pain. 4/26/12 - 1 x 2 inch area scaly raised redness with 4 inch (diameter) round redness & hardness with pain/itching - saw private MD - using OTC topical itch cream.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approx 2 inch red, raised, warm area on (R) upper arm.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Arm red, very tender to touch (redness approx. softball size as per patient). Swelling at site. Fever, chills, malaise. Reported 2 days after vaccine. Patient was sent to emergency room.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Arm red, very tender to touch (redness approx. softball size as per patient). Swelling at site. Fever, chills, malaise. Reported 2 days after vaccine. Patient was sent to emergency room.
Age: 29.0
Sex: M
Vaccine: DT
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Initial report was received from a health care professional on 03 February 2012. A 29-year-old male patient had received an intramuscular injection in the right deltoid of DECAVAC, sanofi pasteur Inc. lot number U3696BA on 31 January 2012 at 12:50 PM. On 02 February 2012 at 5:00 AM, the patient's whole right arm and back had a sensation of being on fire. There was no redness at the vaccination site or arm. The patient had no illness at the time of vaccination. The patient had a penicillin (PCN) allergy and no other medical history. The patient took no concomitant medications and had no adverse events to prior vaccinations. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced local redness and swelling at injection site that continued to spread down arm. Two days post-vaccination she noticed pain and tingling up to her shoulder and down to her hand. Went to PCP and was given Rx for KEFLEX 500 one tid x 10d. Pt also experienced chills but no fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Asthenia, Borrelia test, Borrelia test negative, Epstein-Barr virus test positive, Eyelid disorder
Clinical narrative: (L) eyelid - excessively; droop of (L) face; decreased strength. Dx'd Bell's Palsy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: VIIth nerve paralysis
Clinical narrative: (L) eyelid - excessively; droop of (L) face; decreased strength. Dx'd Bell's Palsy.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Presyncope, Tremor
Clinical narrative: Case number PHEH2012US007397 is a spontaneous report initially received from a nurse on 30 Mar 2012 with a follow-up received on 20 Apr 2012: This report refers to an 11-years old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10130/ X10130 and expiry date: 01 Feb 2013) intramuscularly and with GARDASIL vaccine (other manufacturer, batch number: unspecified) on 20 Mar 2012. It was reported that he became shaky after getting the shots and experienced a near fainting episode on 20 Mar 2012. The final outcome of the events was reported as complete recovery of the patient on 20 Mar 2012. No additional information was available. Follow-up received from the nurse on 20 Apr 2012: Updated events, onset date and outcome.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Fever x 3 days (Tmax 100.9). Joint pain, diffuse.
Sex: F
Vaccine: FLU3
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of polydactyly of fingers in a neonate male subject who was exposed to FLULAVAL (GlaxoSmithKline) transplacentally when his mother was vaccinated during pregnancy. A physician or other health care professional has not verified this report. On 21 September 2011 the 29-year-old mother of the subject received a dose of FLULAVAL (intramuscular, left arm). The mother's last menstrual period was 18 July 2011 and estimated date of birth was unknown. The neonate was exposed to FLULAVAL at 8 weeks gestation during the first trimester. Ultrasound performed in December 2011 was normal; there was no evidence of a defect from prenatal testing. on 21 April 2012, after 39.5 weeks gestation the neonate was born by unknown delivery method and weighed 3.43 kilograms. Apgar score was not provided. Birth defects were noted. The neonate was born with congenital anomaly of variant polydactyl. "Variant polydactyl neonate was born with two nails on his right thumb. His right thumb looked like two digits glued tighter. Everything else seems ok with with the baby so far". At the time of reporting the outcome of the polydactyl was unspecified. For details regarding the mother case please see A0975588A.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human chorionic gonadotropin positive, Menstruation irregular, Pregnancy
Clinical narrative: Pt received HPV #1 3/17/12 and AVA#4 on 4/3/12. LMP (light) was sometime between 25 Feb12. The pt has a history of irregular menses. She uses condoms for birth control (not consistently). On the pt demonstrated how to perform a home pregnancy test for a friend which was positive. The pt repeated the home pregnancy test 4 more times which were all positive. The pt was given TAD orders off the ship on 4/13/12. The pt contacted the center on 4/19/12 and desired pregnancy follow-up.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Menstruation irregular, Pregnancy test positive
Clinical narrative: Pt received HPV #1 3/17/12 and AVA#4 on 4/3/12. LMP (light) was sometime between 25 Feb12. The pt has a history of irregular menses. She uses condoms for birth control (not consistently). On the pt demonstrated how to perform a home pregnancy test for a friend which was positive. The pt repeated the home pregnancy test 4 more times which were all positive. The pt was given TAD orders off the ship on 4/13/12. The pt contacted the center on 4/19/12 and desired pregnancy follow-up.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Tremor
Clinical narrative: Patient experienced shaking for 3 hours following vaccination and nausea for 24 hours following vaccination.
Age: 93.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Nausea
Clinical narrative: Nausea, unable to take oral medications. Pain to touch around area of injection site.
Age: 20.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site haematoma, Injection site pruritus, Injection site rash
Clinical narrative: Rash with bruising and itchiness at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Feeling hot, Pain, Rash erythematous, Swelling
Clinical narrative: Cellulitis. Went to doctor with large red swollen rash under skin, it was hot and hurt... Doctor prescribed antibiotic 4 times a day for 10 days...will return to doctor in 3 days.
Age: 15.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Injection site joint pain
Clinical narrative: Child reports "right arm, at shoulder still hurts where shot was given."  Right deltoid is the site of a Tdap injection only.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Lip swelling
Clinical narrative: Clients lips started to swell, then his breathing became labored.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Headache
Clinical narrative: Woke up with a severe headache and chills.  Ibuprofen seemed to help at first, but continued throughout the day to have the severe headache and chills. Unsure if the chills were due to a fever- didn't take temp.  Called in the afternoon concerned because the headache wasn't easing.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dehydration, Headache, Muscle fatigue, Nausea
Clinical narrative: Swollen left and nauseous, felt weak. Monday April 30th went to doctor. Patient was given a Kenalog shot, RX's for Bacterium and Ultram. Patient throw-up several times. Tuesday May 1st went to ER C/O nausea, muscle fatigue, and headache. Patient was given another steroid shot, bag of Normal Saline was infused for severe dehydration. ER doctor Discontinued the Bactrium and Ultram. May 2nd Patient still complaining of headache and nausea. Tueday May 1st; went to ER.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling, Vomiting
Clinical narrative: Swollen left and nauseous, felt weak. Monday April 30th went to doctor. Patient was given a Kenalog shot, RX's for Bacterium and Ultram. Patient throw-up several times. Tuesday May 1st went to ER C/O nausea, muscle fatigue, and headache. Patient was given another steroid shot, bag of Normal Saline was infused for severe dehydration. ER doctor Discontinued the Bactrium and Ultram. May 2nd Patient still complaining of headache and nausea. Tueday May 1st; went to ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Pt. developed erythematous, pruritic rash that started at elbow and continued to site of injection. Pt. contacted pharmacy and then went to primary care physician for treatment.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Nausea for 3 hours, headache, muscle aches.
Age: 7.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given #2 dose Hep A at 2 months instead of 6 months.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Sudden infant death syndrome
Clinical narrative: Unknown, coroner suspected SIDS.
Age: 58.0
Sex: M
Vaccine: DTAP, HEPAB, IPV, HEPAB, IPV
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antigen positive
Clinical narrative: Pt tested Hep B Sag pos, then when retested 4/27/2012 tested negative; no other pos labs seen.
Age: 58.0
Sex: M
Vaccine: DTAP, HEPAB, IPV, HEPAB, IPV
Symptoms: Hepatitis B DNA assay negative, Hepatitis B core antibody negative, Hepatitis B e antigen negative, Hepatitis B surface antigen positive, Hepatitis B virus test positive
Clinical narrative: Pt tested Hep B Sag pos, then when retested 4/27/2012 tested negative; no other pos labs seen.
Age: 0.34
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Irritability
Clinical narrative: Increased fussiness.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Chest pain, Wheezing
Clinical narrative: Wheezing, chest pain; mother gave albuterol treatments at home.
Age: 34.0
Sex: F
Vaccine: PNC10
Symptoms: Erythema, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Sore arm with swelling and redness.  Felt ill.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Catatonia, Depressed level of consciousness, Feeding disorder neonatal, Unresponsive to stimuli
Clinical narrative: 7 week old baby. Born premature at 35 weeks. Administered DTaP and HIB vaccines. Within hours he became almost catatonic. He would not move, did not cry and would not nurse. It was terrifying. Believed to be a reaction to DTaP vaccine. Improved and essentially came back to alertness after 24 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral, Palmar erythema, Pruritus
Clinical narrative: Palms of both hands are itchy and red with some sweelling.  The vaccine was called Zostavax by Merck.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given first GARDASIL injection; review of records subsequently showed that pt had already received 3 doses of GARDASIL in 2009.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash macular
Clinical narrative: Patient complained of headache unrelieved by APAP, all day. Patient says she developed a series of red blotches on chin and up left cheek. Blotches not itching, not warm to touch, no itching/burning.
Age: 65.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Cellulitis, Erythema, Injection site pain, Skin warm, Wrong drug administered
Clinical narrative: Pt came in the see PCP for follow-up routine, RN pended order for Shingles & Pneumococcal vaccine, PCP signed order. RN gave the vaccine - charted but he also charted on Immunization VZV (Varicella) was given, not the shingles. No order for VZV. When pt. got the shot he stated it was sore. Sat noted redness & warm to touch, got worse Sun, redness radiated to elbow. Went to UC & was dx with cellulitis & prescribed with KEFLEX for 10 days.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Swelling, Tenderness
Clinical narrative: Hep B vac given on 5/1/12; client noticed in the evening swollen area between clavicle & trachea approx size of small plum this AM. He denies any other symptoms, SOB, difficulty breathing or swallowing. Is a little tender to touch. Advice f/u with PCP today.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Awoke this a.m. w/ redness, swelling & induration of skin over the left deltoid.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Erythema, Pain, Swelling
Clinical narrative: Vaccine given 4/27 patient came 4/30 to let us know of swelling, redness and pain radiating towards the arm and breast area. Pt went to primary doctor and was told to take OTC ibuprofen.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Have bright red patch from her shoulder down to her elbow on the next day. It doesn't hurt or itch. The symptoms subside after 4 days. Didn't take any medication for that.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site infection, Oedema peripheral
Clinical narrative: Severe swelling to left arm. Pt to see personal MD today 5/2/12. 5/2/12  Personal MD states infected varicella site. Medication given.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Severe swelling to left arm. Went to personal MD, prescribed BENADRYL and topical cortisone cream. Improved by 5/2/12.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Redness to (R) arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (L) arm with edema & redness; warmth at site of immunizations given 04/30/12. (Area app. 4 x 3 cm). Pt. also c/o H.A.'s. TX = monitor s/s & any increase in size; call if worsens. (Seen in office 05/01/12 for s/s).
Age: 1.51
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Accidental exposure
Clinical narrative: Inadvertent administration of DTaP.
Age: 1.51
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Inadvertent administration of DTaP.
Age: 51.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Bone loss, Endocrine test normal, Fluid retention, Hypoaesthesia, Laboratory test normal
Clinical narrative: 3 hours after I received the H1N1 vaccine I had the onset of left foot pain, non weightbearing, numbness, tingling, swelling, fluid, now bone loss. Left hand slight numbness, left groin discomfort. Have doctored for 2.5 years now, Clinic, etc. Clinics, Podiatrists, Orthos,  NO ONE knows what is causing this problem with my foot. They acknowledge there is a problem but say it is a mystery. When I ask about the H1N1 Vaccine they all reply, "We don't know enough about that or avoid the subject all together. I did 18 months on crutches, I now walk with a cane and live in pain daily. Last Dr. visit It was suggested it may be something I'll just have to live with.
Age: 51.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal discomfort, Nerve conduction studies, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain
Clinical narrative: 3 hours after I received the H1N1 vaccine I had the onset of left foot pain, non weightbearing, numbness, tingling, swelling, fluid, now bone loss. Left hand slight numbness, left groin discomfort. Have doctored for 2.5 years now, Clinic, etc. Clinics, Podiatrists, Orthos,  NO ONE knows what is causing this problem with my foot. They acknowledge there is a problem but say it is a mystery. When I ask about the H1N1 Vaccine they all reply, "We don't know enough about that or avoid the subject all together. I did 18 months on crutches, I now walk with a cane and live in pain daily. Last Dr. visit It was suggested it may be something I'll just have to live with.
Age: 51.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Paraesthesia, Walking aid user, Weight bearing difficulty
Clinical narrative: 3 hours after I received the H1N1 vaccine I had the onset of left foot pain, non weightbearing, numbness, tingling, swelling, fluid, now bone loss. Left hand slight numbness, left groin discomfort. Have doctored for 2.5 years now, Clinic, etc. Clinics, Podiatrists, Orthos,  NO ONE knows what is causing this problem with my foot. They acknowledge there is a problem but say it is a mystery. When I ask about the H1N1 Vaccine they all reply, "We don't know enough about that or avoid the subject all together. I did 18 months on crutches, I now walk with a cane and live in pain daily. Last Dr. visit It was suggested it may be something I'll just have to live with.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 45mm red, hot & swollen on the left side IM of arm. Pt grandmother gave her ibuprofen and hydrocortisone cream.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Local reaction, Rash
Clinical narrative: Chills and flu-like symptoms for 48 hours. Baseball size local reaction for 7 d. Rash from shoulder to elbow days 2 -> 7.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, red, swelling the size of a dollar bill near the entrance of the vaccine.  It is over a week now and very slowly getting smaller.  Redness and itchy still about 1/2 the size.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Decreased appetite, Diet refusal, Injection site erythema, Irritability
Clinical narrative: DAPTACEL (RT) PEDVAX (LT) given at 1430. Well tolerated. Arrived home - baby normal, went to sleep, woke up at 1800, cried 2 hrs. RT redness noted, went to sleep at 2030. Woke 1230 fussy, small feeds til 0500 - emesis, refused feed. Slept til 1000. Cont. to be fussy. Called physician during the night.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: DAPTACEL (RT) PEDVAX (LT) given at 1430. Well tolerated. Arrived home - baby normal, went to sleep, woke up at 1800, cried 2 hrs. RT redness noted, went to sleep at 2030. Woke 1230 fussy, small feeds til 0500 - emesis, refused feed. Slept til 1000. Cont. to be fussy. Called physician during the night.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Body temperature increased, Full blood count normal, Viral infection, Viral test positive
Clinical narrative: Mom phoned nurse triage because pt. temp up to 104 and not acting herself, no rash at site, moving extremities fine, came in 4/30/12.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Pt. got dizzy after 15 min of receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Redness hive plus or minus 3 1/2 x 2 inch (R) upper arm. Itchy - not painful given ice packs & BENADRYL & MOTRIN.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 20 April 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3800AA received on 27 May 2011, lot number C3871AA received on 24 August 2011 and lot number C3912AA received on 06 October 2011 (routes and sites of administration not reported). The subject developed a paroxysmal cough with whoop on 27 March 2012, approximately five months after the last dose. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 27 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 March 2012 for five days. The subject was not hospitalized. At the time of final contact on 18 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.