chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood iron decreased, Borrelia burgdorferi serology negative
Clinical narrative: SM received a seasonal influenza vaccine in his R) arm on the morning of 10/30/09. By the evening of 10/31/09, he noted significant twitching, mostly in legs. He later noted muscle twitching in both legs, which occurred several times over the next several days. Between November and present, SM has noted muscle twitching in mid-to-late August 2004. This was after returning from a foreign country. Twitching was primarily noted in the lower extremities (60% of time affected calves, 40% of time affected thighs), buttocks and back, but also noted in face (upper lip, along jaw line, and eyelids) and deltoids and shoulders (primarily left upper arm until after recent flu vaccine; after his recent flu vaccine, SM began to note twitching in his right arm). With muscle twitching in left shoulder, when his arm was in a raised position, he noted uncontrollable spasms. The spasms continued as long as his arm stayed in that position and then lasted for a brief period after lowering his arm, for up to 5-6 more spasms. From December 2009 to present, he developed positional twitching in right shoulder similar to twitching previously experienced in left shoulder, but not as intense. After the end of 2004, he noted the twitching significantly improved ("about 98% improved"). Between early 2005 and Oct 2009, the twitching occurred randomly with frequency about once every 2 months, mostly in legs or arms. He would note 2-3 episodes of twitching over a period of 1/2 to 1 day and would then stop. He has not had related muscle weakness. He had no related bowel or bladder problems. Around the same time as the initial onset of muscle twitching (July or August 2004), SM first noted altered sensation on his feet, and later on his perineal area, and then on his hands and face. This was almost constant until June 2005. This is described as "bug landing on skin". It occurs randomly and sporadically on the hands and feet now, but still occurs daily on the perineal area. The altered sensation might be noted several times during the course of the day "from time to time", with sensation most often noted in perineal/groin area and on feet, but can be noted on all parts of his body (e.g., face, scalp, hands, back).
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram normal, Glycosylated haemoglobin normal, Immunoglobulins increased, Iron binding capacity total increased, Muscle spasms
Clinical narrative: SM received a seasonal influenza vaccine in his R) arm on the morning of 10/30/09. By the evening of 10/31/09, he noted significant twitching, mostly in legs. He later noted muscle twitching in both legs, which occurred several times over the next several days. Between November and present, SM has noted muscle twitching in mid-to-late August 2004. This was after returning from a foreign country. Twitching was primarily noted in the lower extremities (60% of time affected calves, 40% of time affected thighs), buttocks and back, but also noted in face (upper lip, along jaw line, and eyelids) and deltoids and shoulders (primarily left upper arm until after recent flu vaccine; after his recent flu vaccine, SM began to note twitching in his right arm). With muscle twitching in left shoulder, when his arm was in a raised position, he noted uncontrollable spasms. The spasms continued as long as his arm stayed in that position and then lasted for a brief period after lowering his arm, for up to 5-6 more spasms. From December 2009 to present, he developed positional twitching in right shoulder similar to twitching previously experienced in left shoulder, but not as intense. After the end of 2004, he noted the twitching significantly improved ("about 98% improved"). Between early 2005 and Oct 2009, the twitching occurred randomly with frequency about once every 2 months, mostly in legs or arms. He would note 2-3 episodes of twitching over a period of 1/2 to 1 day and would then stop. He has not had related muscle weakness. He had no related bowel or bladder problems. Around the same time as the initial onset of muscle twitching (July or August 2004), SM first noted altered sensation on his feet, and later on his perineal area, and then on his hands and face. This was almost constant until June 2005. This is described as "bug landing on skin". It occurs randomly and sporadically on the hands and feet now, but still occurs daily on the perineal area. The altered sensation might be noted several times during the course of the day "from time to time", with sensation most often noted in perineal/groin area and on feet, but can be noted on all parts of his body (e.g., face, scalp, hands, back).
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle twitching, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Protein total normal
Clinical narrative: SM received a seasonal influenza vaccine in his R) arm on the morning of 10/30/09. By the evening of 10/31/09, he noted significant twitching, mostly in legs. He later noted muscle twitching in both legs, which occurred several times over the next several days. Between November and present, SM has noted muscle twitching in mid-to-late August 2004. This was after returning from a foreign country. Twitching was primarily noted in the lower extremities (60% of time affected calves, 40% of time affected thighs), buttocks and back, but also noted in face (upper lip, along jaw line, and eyelids) and deltoids and shoulders (primarily left upper arm until after recent flu vaccine; after his recent flu vaccine, SM began to note twitching in his right arm). With muscle twitching in left shoulder, when his arm was in a raised position, he noted uncontrollable spasms. The spasms continued as long as his arm stayed in that position and then lasted for a brief period after lowering his arm, for up to 5-6 more spasms. From December 2009 to present, he developed positional twitching in right shoulder similar to twitching previously experienced in left shoulder, but not as intense. After the end of 2004, he noted the twitching significantly improved ("about 98% improved"). Between early 2005 and Oct 2009, the twitching occurred randomly with frequency about once every 2 months, mostly in legs or arms. He would note 2-3 episodes of twitching over a period of 1/2 to 1 day and would then stop. He has not had related muscle weakness. He had no related bowel or bladder problems. Around the same time as the initial onset of muscle twitching (July or August 2004), SM first noted altered sensation on his feet, and later on his perineal area, and then on his hands and face. This was almost constant until June 2005. This is described as "bug landing on skin". It occurs randomly and sporadically on the hands and feet now, but still occurs daily on the perineal area. The altered sensation might be noted several times during the course of the day "from time to time", with sensation most often noted in perineal/groin area and on feet, but can be noted on all parts of his body (e.g., face, scalp, hands, back).
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Spinal X-ray, Spinal X-ray normal, Transferrin saturation decreased, Vitamin B12 normal
Clinical narrative: SM received a seasonal influenza vaccine in his R) arm on the morning of 10/30/09. By the evening of 10/31/09, he noted significant twitching, mostly in legs. He later noted muscle twitching in both legs, which occurred several times over the next several days. Between November and present, SM has noted muscle twitching in mid-to-late August 2004. This was after returning from a foreign country. Twitching was primarily noted in the lower extremities (60% of time affected calves, 40% of time affected thighs), buttocks and back, but also noted in face (upper lip, along jaw line, and eyelids) and deltoids and shoulders (primarily left upper arm until after recent flu vaccine; after his recent flu vaccine, SM began to note twitching in his right arm). With muscle twitching in left shoulder, when his arm was in a raised position, he noted uncontrollable spasms. The spasms continued as long as his arm stayed in that position and then lasted for a brief period after lowering his arm, for up to 5-6 more spasms. From December 2009 to present, he developed positional twitching in right shoulder similar to twitching previously experienced in left shoulder, but not as intense. After the end of 2004, he noted the twitching significantly improved ("about 98% improved"). Between early 2005 and Oct 2009, the twitching occurred randomly with frequency about once every 2 months, mostly in legs or arms. He would note 2-3 episodes of twitching over a period of 1/2 to 1 day and would then stop. He has not had related muscle weakness. He had no related bowel or bladder problems. Around the same time as the initial onset of muscle twitching (July or August 2004), SM first noted altered sensation on his feet, and later on his perineal area, and then on his hands and face. This was almost constant until June 2005. This is described as "bug landing on skin". It occurs randomly and sporadically on the hands and feet now, but still occurs daily on the perineal area. The altered sensation might be noted several times during the course of the day "from time to time", with sensation most often noted in perineal/groin area and on feet, but can be noted on all parts of his body (e.g., face, scalp, hands, back).
Age: 34.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: Device malfunction, Injection site erythema, Injection site pain, X-ray
Clinical narrative: On 1/29, client called for advice regarding injection site swelling, redness and warmth since 4-5 days after visit for injection.  Instructed client to see PCP for evaluation.  Client called back 2/14/10 and states she was diagnosed with an infection and possible foreign body in wound.  She states MD removed a microscopic foreign body from area.  Unsure what type of material.  Client on antibiotics for 2 days when she called and states symptoms were resolving.
Age: 34.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: Foreign body reaction, Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 1/29, client called for advice regarding injection site swelling, redness and warmth since 4-5 days after visit for injection.  Instructed client to see PCP for evaluation.  Client called back 2/14/10 and states she was diagnosed with an infection and possible foreign body in wound.  She states MD removed a microscopic foreign body from area.  Unsure what type of material.  Client on antibiotics for 2 days when she called and states symptoms were resolving.
Age: 34.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: X-ray
Clinical narrative: On 1/29, client called for advice regarding injection site swelling, redness and warmth since 4-5 days after visit for injection.  Instructed client to see PCP for evaluation.  Client called back 2/14/10 and states she was diagnosed with an infection and possible foreign body in wound.  She states MD removed a microscopic foreign body from area.  Unsure what type of material.  Client on antibiotics for 2 days when she called and states symptoms were resolving.
Age: 34.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth, Removal of foreign body
Clinical narrative: On 1/29, client called for advice regarding injection site swelling, redness and warmth since 4-5 days after visit for injection.  Instructed client to see PCP for evaluation.  Client called back 2/14/10 and states she was diagnosed with an infection and possible foreign body in wound.  She states MD removed a microscopic foreign body from area.  Unsure what type of material.  Client on antibiotics for 2 days when she called and states symptoms were resolving.
Age: 34.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth, Removal of foreign body
Clinical narrative: On 1/29, client called for advice regarding injection site swelling, redness and warmth since 4-5 days after visit for injection.  Instructed client to see PCP for evaluation.  Client called back 2/14/10 and states she was diagnosed with an infection and possible foreign body in wound.  She states MD removed a microscopic foreign body from area.  Unsure what type of material.  Client on antibiotics for 2 days when she called and states symptoms were resolving.
Age: 34.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oedema, Oedema peripheral
Clinical narrative: SWOLLEN FEET EDEMA
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Alopecia
Clinical narrative: After receiving the H1N1 vaccine on 1/9/10 excessive amounts of hair began to fall out of patient's head on 1/10/10.  This has continued for four weeks and the affected area has a fist size amount of hair loss (left rear) of head.
Age: 66.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: 6 days after injection - pt calls with complaints and is seen at 7 days: L upper arm red, warm, min tender, swollen, and warm lateral upper L arm extending from over the lateral margin deltoid medially over the bicep muscle. AMOXICILLIN 500mg  TID x 10 days. Will use warm compress 10 min TID. Will elev arm.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram head, Fall, Head injury, Syncope
Clinical narrative: Pt. had Hgb checked in room-then was administered MCV4 and HPV vaccines. Shortly after rcving vaccines was talking-then fainted fell off exam table and fell onto floor hitting her head. LOC-20 sec. 911 called. Sent to ER-DC'ed after CAT scan.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Decreased appetite, Idiopathic thrombocytopenic purpura, Irritability, Platelet count decreased, White blood cell count decreased
Clinical narrative: Patient received his vaccinations on 1/18/10, and presented to the hospital with a 2-day history of fussiness and decreased appetite on 2/2/10. Patient had developed Idiopathic thrombocytopenia (ITP).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat in injection site LD. Painful blistered. Rx'd BENADRYL and KEXAFOLIN.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Barium enema, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception on 1-19-10. Had Barium enema and it resolved.
Age: 23.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash/itching. Went own physician. Was given Prednisone & KEFLEX. Symptoms improving. On exam today (2/8/10), mild rash on chest noted. F/u with primary MD. Pt. did not report VAE until today to this facility.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal discomfort, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Nausea x 4 days post vaccine - needed visit to MD for prescription anti-nausea meds to relieve symptoms. 1/27/10 PM - TC from mother of client who has had nausea/dizziness/headache since received Hep A immunization on 1/25/10 (also rec'd PPD test). Vomited once today. Instructed to take to PMD as not typical reaction to immunization. 1/28/10 TC to mother. Took client to doctor. C/o nausea as being worst symptom and was given 2 pills (to take 1 pill q8h). Cl. felt fine for approx 4 1/2 hrs after taking pill and then nausea started again. Took the other pill. Cl. c/o nausea yet today - some headache. Went to work today. Only had some tea. Did eat a sandwich with "hot peppers". Cl. later showed for TB reading. Did call doctor  and got 4 more pills for nausea. Plans to eat something. Discussed more bland foods to eat. Will f/u with client tomorrow. 1/29/10 Called client. Feeling better today. Stomach still "a bit sore". Ate sushi today." Instructed to F/U with doctor if need arises. Will send VAERS.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Eczema, Nasal congestion, Rash, Sinus congestion, Swelling face
Clinical narrative: 1/22/10 c/o head congestion/nasal congestion. 1/25/10 c/o facial swelling & rash; went to M.D. on Naval Base referred to Dermatologist on 1/20/10; rash resolved after treatment but eczema remain to face but c/o rash spreading from neck to chest pt remains under Dermatologist care.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Headache, Hypersensitivity, Immediate post-injection reaction, Nausea
Clinical narrative: Within 30 min child returned c/o H.A., nausea and slight dizziness, hives to upper chest and back-throat red-swollen with white patch L side-c/o slight itching off and on-beginning to scratch-Mom contacted-arrived-50 mg BENADRYL IM L deltoid-hives and rash becoming less noticeable-sent to ER with Mom-Dx as allergic reaction to H1N1-placed on steroids and BENADRYL with FU x 5-10 days.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pharyngeal erythema, Pharyngeal oedema, Pruritus, Urticaria, Vaccination complication
Clinical narrative: Within 30 min child returned c/o H.A., nausea and slight dizziness, hives to upper chest and back-throat red-swollen with white patch L side-c/o slight itching off and on-beginning to scratch-Mom contacted-arrived-50 mg BENADRYL IM L deltoid-hives and rash becoming less noticeable-sent to ER with Mom-Dx as allergic reaction to H1N1-placed on steroids and BENADRYL with FU x 5-10 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Disturbance in attention, Fatigue, Headache, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who in August 2009, was vaccinated with the second dose of GARDASIL. According to the physician, the patient developed headaches and fatigue after the second dose of GARDASIL. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit.  Follow up information has been received from the physician who indicated that the patient was a female student with no known drug allergies/reactions and no pertinent medical history who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left arm at 14:10 pm and on 13-OCT-2009 was vaccinated with her second dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left deltoid at 13:50 pm. No illnesses were reported at the time of vaccination. It was reported that on approximately 19-OCT-2009 the patient began experiencing headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate. At the time of the report the patient had not recovered. Diagnostic laboratory tests were performed included a CT scan and the US of abdomen reportedly as normal limits, other diagnostic tests were within normal limits and other labs and hospital visits per other physician.  The reporting physician considered headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate to be disabling/incapacitating events since the patient missed many days at school (additional information was not legible).  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Nausea, No reaction on previous exposure to drug, Ultrasound abdomen normal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who in August 2009, was vaccinated with the second dose of GARDASIL. According to the physician, the patient developed headaches and fatigue after the second dose of GARDASIL. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit.  Follow up information has been received from the physician who indicated that the patient was a female student with no known drug allergies/reactions and no pertinent medical history who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left arm at 14:10 pm and on 13-OCT-2009 was vaccinated with her second dose of GARDASIL (LOT # 659054/0311Y) intramuscularly into her left deltoid at 13:50 pm. No illnesses were reported at the time of vaccination. It was reported that on approximately 19-OCT-2009 the patient began experiencing headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate. At the time of the report the patient had not recovered. Diagnostic laboratory tests were performed included a CT scan and the US of abdomen reportedly as normal limits, other diagnostic tests were within normal limits and other labs and hospital visits per other physician.  The reporting physician considered headaches, daily nausea, loss of appetite, vomiting, lethargy and inability to concentrate to be disabling/incapacitating events since the patient missed many days at school (additional information was not legible).  Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Developed fever 104 F, redness and swelling of left arm. Symptoms improved in 24 hrs of antibiotic and BENADRYL.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, Arthritis, Bone pain, Borrelia burgdorferi serology positive
Clinical narrative: Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: C-reactive protein increased, Chills, Condition aggravated, Dyspnoea, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Haematocrit decreased, Lymphocyte count abnormal, Macrophages increased, Myalgia, Red blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rheumatoid factor increased, Sputum increased, Synovial fluid analysis abnormal, Synovial fluid crystal, Synovial fluid white blood cells
Clinical narrative: Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician concerning a 62 year old female with pulmonary nodules shown in a CT scan in June 2009 and that were improved over previous test, another CT scan on 30-NOV-2009 and a history of lymphoma diagnosed in 2006 that caused bone pain and was treated with radiation and is in remission who on 05-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). Physician reported that the patient received ZOSTAVAX (Merck) and influenza virus vaccine (unspecified) on 05-OCT-2009 and currently had symptoms of arthritis. She developed chills, myalgias and bone pain about 1 week after vaccines, in approximately 12-OCT-2009. On 19-OCT-2009, she developed increased mucous production in her sputum and in late October 2009, she experienced right knee pain and shortness of breath. An X-ray bone survey was negative on an unspecified date. By November 2009, her right knee was more painful and now she has shoulder arthralgias. Her fingers and thumbs were okay but wrists began to hurt. On 15-DEC-2009, the patient had blood tests: serum antinuclear antibodies test was negative, Rheumatoid arthritis Latex was 15.6 and considered abnormal (normal up to 13.9) and erythrocyte sedimentation rate was 38. On 05-JAN-2010, she had her right knee drained. The white cell count in the knee's synovial fluid was 6125, lymphocytes 71%, macrophage 22%, and polys 3%, crystal analysis was negative. This date, blood work was repeated. A serum antinuclear antibody test was negative, rheumatoid arthritis was 13.7 (barely in normal limit), sedimentation rate 91, and serum C-reactive protein test was 26.3 (normal up to 4.9). Complete blood cell count was normal except whole blood hematocrit was low. A serum Borrelia burgdorferi IgM Western blot antibody test was positive for P41 and P23 but serum Borrelia burgdorferi IgG Western blot antibody test was negative. Physician believes the Lyme test to be a false positive. At the time of reporting the patient had not recovered. The reporter felt that symptoms of arthritis, chills, myalgias, bone pain, right knee pain, shoulder arthralgias/wrist began to hurt, increased mucus production in her sputum and shortness of breath were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Knee arthroplasty
Clinical narrative: Information has been received from a male consumer who in 2001 was vaccinated with ZOSTAVAX (Merck) as part of clinical trial (protocol# 5061812). In January 2010 (also reported as last month), the patient had a knee replacement. At the time of the report, the patient's status was unknown. Upon internal review, knee replacement was determined to be an other important medical event. No further information is available.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase normal, Aspartate aminotransferase normal, Bilirubin conjugated
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood acid phosphatase, Blood albumin normal, Blood alkaline phosphatase normal, Blood amylase normal, Blood bilirubin normal
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood calcium normal, Blood chloride increased, Blood cholesterol, Blood creatine phosphokinase, Blood creatinine normal
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood glucose normal, Blood lactate dehydrogenase, Blood magnesium, Blood phosphorus, Blood potassium normal
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood sodium normal, Blood triglycerides, Blood urea increased, Blood uric acid, Carbon dioxide normal
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Feeling abnormal, Gamma-glutamyltransferase, Haematocrit, Haemoglobin
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Headache, High density lipoprotein, Laboratory test, Lipase, Lipase normal
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Low density lipoprotein, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Nausea
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 48.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pain, Protein total normal, Red blood cell count, Vomiting, White blood cell count
Clinical narrative: I felt dizzy after the shot but I stayed at work all day. Now I'm sick and home coubled up on the floor with abdominal pain and vomiting. I was able to eat supper. I probably vomited about 1/2 cup so far. I feel so bad. My wife is here with me. I can walk fine. I don't have any diarrhea. Yet states he received the H1N1 vaccine yesterday and felt dizzy afterwards but worked all day and this arm around 0130 he had a stomach ache and vomited 50 times. Yet states he has a headache, dizziness, nausea, and body aches. My hair even hurts. Yet denies diarrhea.
Age: 59.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient getting routine vaccination. Urticaria, Pruritus.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Came to hospital to be seen about event. Severe injection site pain and erythema.
Age: 22.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Required visit to MD office and MD prescribed antibiotics just in case rash was not due to vaccine injection. Symptoms: 1. Skin rash - 2. Severe local , erythema and pain at site of injection.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient came to ED with swelling redness and soreness of right upper arm and generally not feeling well after receiving the PNEUMOVAX vaccine the previous day. After examining him it was determined that he had a reaction to the vaccine and had cellulitis on his right upper arm around the injection site. Symptoms: Symptoms: Rash, cellulitis Suspect Drug #1 Dosing: IM once. Treatment Drugs Used: Diphenhydramine Dose: 50 Units: MG Preq: OID Route PO, Sulfamethoxa/OLE/Trimethoprim Dose: 800/160 Units: MG Preq: BID Route: PO
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient came to ED with swelling redness and soreness of right upper arm and generally not feeling well after receiving the PNEUMOVAX vaccine the previous day. After examining him it was determined that he had a reaction to the vaccine and had cellulitis on his right upper arm around the injection site. Symptoms: Symptoms: Rash, cellulitis Suspect Drug #1 Dosing: IM once. Treatment Drugs Used: Diphenhydramine Dose: 50 Units: MG Preq: OID Route PO, Sulfamethoxa/OLE/Trimethoprim Dose: 800/160 Units: MG Preq: BID Route: PO
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Blood product transfusion, Blood test abnormal, Chapped lips, Diarrhoea, Echocardiogram
Clinical narrative: 4 month old daughter was given 4 month vaccinations, including the oral ROTATEQ on Wed 1/4. On the morning of Fri 1/6 she developed a fever and rash that lasted for over a week. Her pediatrician could not determine cause of illness. Other symptoms began to show-diarrhea, vomiting, lethargy, red eyes, swollen cracked lips, red swollen soles of feet. Fever, rash and other symptoms lasted for 13 days. Finally on 1/20 her doctor diagnosed her with Kawasakis disease and she was admitted to the hospital on the same day. She was given an IVIG and high doses of aspirin to treat the illness. We believe there is a correlation between receiving the ROTATEQ and her development of fever and rash and ultimately Kawasaki disease. She was healthy on the day of receiving her vaccinations and became ill less than 48 hours after receiving the oral vaccination. She also received vaccinations for PENTACEL and pneumococcal conjugate, ped. 7 valent.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Kawasaki's disease, Lethargy, Lip swelling, Ocular hyperaemia, Oedema peripheral
Clinical narrative: 4 month old daughter was given 4 month vaccinations, including the oral ROTATEQ on Wed 1/4. On the morning of Fri 1/6 she developed a fever and rash that lasted for over a week. Her pediatrician could not determine cause of illness. Other symptoms began to show-diarrhea, vomiting, lethargy, red eyes, swollen cracked lips, red swollen soles of feet. Fever, rash and other symptoms lasted for 13 days. Finally on 1/20 her doctor diagnosed her with Kawasakis disease and she was admitted to the hospital on the same day. She was given an IVIG and high doses of aspirin to treat the illness. We believe there is a correlation between receiving the ROTATEQ and her development of fever and rash and ultimately Kawasaki disease. She was healthy on the day of receiving her vaccinations and became ill less than 48 hours after receiving the oral vaccination. She also received vaccinations for PENTACEL and pneumococcal conjugate, ped. 7 valent.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Rash, Urine analysis, Vomiting, X-ray
Clinical narrative: 4 month old daughter was given 4 month vaccinations, including the oral ROTATEQ on Wed 1/4. On the morning of Fri 1/6 she developed a fever and rash that lasted for over a week. Her pediatrician could not determine cause of illness. Other symptoms began to show-diarrhea, vomiting, lethargy, red eyes, swollen cracked lips, red swollen soles of feet. Fever, rash and other symptoms lasted for 13 days. Finally on 1/20 her doctor diagnosed her with Kawasakis disease and she was admitted to the hospital on the same day. She was given an IVIG and high doses of aspirin to treat the illness. We believe there is a correlation between receiving the ROTATEQ and her development of fever and rash and ultimately Kawasaki disease. She was healthy on the day of receiving her vaccinations and became ill less than 48 hours after receiving the oral vaccination. She also received vaccinations for PENTACEL and pneumococcal conjugate, ped. 7 valent.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 020910- E.R. visit - Begin to have aching @ site 1930 - 2000 hours - Followed by erythema/edema entire L upper arm into axilla ET L scapular area - DX : Local-reaction to vaccine - Given BENADRYL 50mg PO in ER -Instructed to take QID x 3 day -ice to site Q3-4H PRN, TYLENOL. 021010 - DR. office visit - LT- upper arm still painful, edematous with erythema entire length ET circumference - T- 100.4 degrees F (T=97.1 degrees F on 020910)---Given Prednisone burst/taper.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Oedema
Clinical narrative: 020910- E.R. visit - Begin to have aching @ site 1930 - 2000 hours - Followed by erythema/edema entire L upper arm into axilla ET L scapular area - DX : Local-reaction to vaccine - Given BENADRYL 50mg PO in ER -Instructed to take QID x 3 day -ice to site Q3-4H PRN, TYLENOL. 021010 - DR. office visit - LT- upper arm still painful, edematous with erythema entire length ET circumference - T- 100.4 degrees F (T=97.1 degrees F on 020910)---Given Prednisone burst/taper.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: 1 hour after receiving HAVRIX, patient experienced tingling of lt. arm which subsided. 5 hours after receiving this vaccine patient felt tingling & numbness of both legs & arms. Had a hive like rash of chest, lt shoulder, lower back, & SOB lungs cl. Given BENADRYL 25 mg po.
Age: 21.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Abdominal pain, Hyperhidrosis, Injection site urticaria, Malaise, Pallor
Clinical narrative: About 20 minutes after the three vaccines client complained of "not feeling well". Visibly pale with severe abdominal cramps of very sudden onset. Also stated "I feel sweaty all over". Vital sign stable HR 60/ BP 110/80 - Yellow Fever site on right arm with large hive like area approximately 6-7 cm in diameter. 25mg IM Benadryl. Mother requested Ambulance /911/ER. Sent to Hospital recovered after observations.
Sex: U
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: R upper arm red, warm, swollen one day after DAPTACEL #5, MMR #2. BENADRYL, Ibuprofen.
Age: 63.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Diarrhoea, Muscle spasms
Clinical narrative: Achy joints, cramps, and diarrhea