chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: FEVER, MALAISE, CHEST PAIN, SHORT OF BREATH.  12/7/07 Reviewed hospital medical records which reveal patient experienced HA, diffuse arthralgias, chest pain, SOB, shaking & fevers following dTaP.  Admitted 9/20-9/24/2007.  Neuro consult done.  HA & back pain resolved & d/c to home. FINAL DX: aseptic meningitis.
Age: 31.0
Sex: M
Vaccine: HEP, TDAP, HEP, TDAP
Symptoms: Chest pain, Dyspnoea, Malaise, Pyrexia
Clinical narrative: FEVER, MALAISE, CHEST PAIN, SHORT OF BREATH.  12/7/07 Reviewed hospital medical records which reveal patient experienced HA, diffuse arthralgias, chest pain, SOB, shaking & fevers following dTaP.  Admitted 9/20-9/24/2007.  Neuro consult done.  HA & back pain resolved & d/c to home. FINAL DX: aseptic meningitis.
Age: 19.0
Sex: F
Vaccine: YF, HEPA, MNQ, YF
Symptoms: Asthenia, Blood pressure, Body temperature increased, Chills, Full blood count normal
Clinical narrative: This case was received from a health professional on 19 October 2007. A 19-year-old female patient, with a history of rheumatoid arthritis and allergies to sulfa and amoxicillin, received the following vaccinations on 28 September 2007: YF-Vax subcutaneously in the right arm (lot number UF044AA), Menactra intramuscularly in the right arm (lot number U2419AA), and Hepatitis A intramuscularly in the left arm (GlaxoSmithKline, lot number AHAVB195AB). Ten days post-vaccination, on 08 October 2007, the patient was admitted to the hospital with "possible viremia caused by YF-Vax". A spinal tap, MRI, and bloodwork were negative. Concomitant medications were Celebrex and Prednisone "as needed". The patient recovered; no other information was provided.
Age: 19.0
Sex: F
Vaccine: YF, HEPA, MNQ, YF
Symptoms: Headache, Heart rate normal, International normalised ratio decreased, Laboratory test normal, Liver function test normal
Clinical narrative: This case was received from a health professional on 19 October 2007. A 19-year-old female patient, with a history of rheumatoid arthritis and allergies to sulfa and amoxicillin, received the following vaccinations on 28 September 2007: YF-Vax subcutaneously in the right arm (lot number UF044AA), Menactra intramuscularly in the right arm (lot number U2419AA), and Hepatitis A intramuscularly in the left arm (GlaxoSmithKline, lot number AHAVB195AB). Ten days post-vaccination, on 08 October 2007, the patient was admitted to the hospital with "possible viremia caused by YF-Vax". A spinal tap, MRI, and bloodwork were negative. Concomitant medications were Celebrex and Prednisone "as needed". The patient recovered; no other information was provided.
Age: 19.0
Sex: F
Vaccine: YF, HEPA, MNQ, YF
Symptoms: Lumbar puncture, Meningitis, Musculoskeletal stiffness, Nausea, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was received from a health professional on 19 October 2007. A 19-year-old female patient, with a history of rheumatoid arthritis and allergies to sulfa and amoxicillin, received the following vaccinations on 28 September 2007: YF-Vax subcutaneously in the right arm (lot number UF044AA), Menactra intramuscularly in the right arm (lot number U2419AA), and Hepatitis A intramuscularly in the left arm (GlaxoSmithKline, lot number AHAVB195AB). Ten days post-vaccination, on 08 October 2007, the patient was admitted to the hospital with "possible viremia caused by YF-Vax". A spinal tap, MRI, and bloodwork were negative. Concomitant medications were Celebrex and Prednisone "as needed". The patient recovered; no other information was provided.
Age: 19.0
Sex: F
Vaccine: YF, HEPA, MNQ, YF
Symptoms: Oxygen saturation, Pyrexia, Respiratory rate
Clinical narrative: This case was received from a health professional on 19 October 2007. A 19-year-old female patient, with a history of rheumatoid arthritis and allergies to sulfa and amoxicillin, received the following vaccinations on 28 September 2007: YF-Vax subcutaneously in the right arm (lot number UF044AA), Menactra intramuscularly in the right arm (lot number U2419AA), and Hepatitis A intramuscularly in the left arm (GlaxoSmithKline, lot number AHAVB195AB). Ten days post-vaccination, on 08 October 2007, the patient was admitted to the hospital with "possible viremia caused by YF-Vax". A spinal tap, MRI, and bloodwork were negative. Concomitant medications were Celebrex and Prednisone "as needed". The patient recovered; no other information was provided.
Age: 19.0
Sex: F
Vaccine: YF, HEPA, MNQ, YF
Symptoms: Blood test normal, Lumbar puncture, Nuclear magnetic resonance imaging normal, Viraemia
Clinical narrative: This case was received from a health professional on 19 October 2007. A 19-year-old female patient, with a history of rheumatoid arthritis and allergies to sulfa and amoxicillin, received the following vaccinations on 28 September 2007: YF-Vax subcutaneously in the right arm (lot number UF044AA), Menactra intramuscularly in the right arm (lot number U2419AA), and Hepatitis A intramuscularly in the left arm (GlaxoSmithKline, lot number AHAVB195AB). Ten days post-vaccination, on 08 October 2007, the patient was admitted to the hospital with "possible viremia caused by YF-Vax". A spinal tap, MRI, and bloodwork were negative. Concomitant medications were Celebrex and Prednisone "as needed". The patient recovered; no other information was provided.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Headache, Meningitis viral, Migraine, Nausea, Tenderness
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vertigo
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness transient, Deafness unilateral, Dizziness, Headache, Malaise
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Meningitis viral, Vomiting
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Ear discomfort, Headache, Intracranial pressure increased, Meningitis aseptic
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: We received from a consumer on 19 OCT 2007: A 38-year-old woman, was vaccinated with Fluvirin, batch-no. 78990, i.m. on 02 OCT 2007 at 06:00 p.m. Four hours after the vaccination she began having ringing in the ears, clogging of the ears, vomiting and vertigo. Saw MD next day. Had another episode of above on 04 OCT 2007. Saw MD on 05 OCT 2007 who gave her some Antivert for the dizziness. She began to experience extreme pressure in her head so her husband took her to the emergency room and she was admitted to the hospital for 10 days (05 to 15 OCT 2007). Diagnostic: aseptic meningitis. The patient still continues to have some pressure in her head but it is being managed by pain medication. Company assessment: Seriousness criterion: hospitalisation. Causality: unrelated. Causality excluded due to short onset interval and nature of disease. Expectedness assessment according to label: The reported symptoms are not expected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Influenza like illness, Insomnia, Neck pain, Pain in extremity
Clinical narrative: I awoke 12 hrs later with an arm so painful that I didn't sleep the rest of the night. Any motion, not even involving my arm, was painful. In spite of aspirin, my temp was 102 on Wed. and 100 on Thursday. I phoned my doctor at 9 am Wed morning.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Body temperature increased, Pain in extremity, Sleep disorder
Clinical narrative: I awoke 12 hrs later with an arm so painful that I didn't sleep the rest of the night. Any motion, not even involving my arm, was painful. In spite of aspirin, my temp was 102 on Wed. and 100 on Thursday. I phoned my doctor at 9 am Wed morning.
Sex: U
Vaccine: RV5
Symptoms: Diet refusal, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first oral dose of Rotateq. It was reported that 3 days post vaccination; the patient developed vomiting, refused to eat and was hospitalized. Diagnostics, treatment, and current patient status were not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Information has been received from a physician concerning an 8 month old patient who was vaccinated with a complete series of Rotateq. Subsequently, a complete series of the patient experienced intussusception, sought unspecified medical attention and recovered. No product quality complaint was reported. No further information was available. Upon internal review intussuception was considered an other important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Erythema, Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a patient who received a single oral dose of Rotateq. The physician reported that while they were giving the dose to the baby, he stopped breathing for a few seconds and the baby's face turned red. He was seen by the physician in the office. It was reported that he improved "after stopping therapy". At the time of this report, it was reported that the patient recovered. A product quality complaint was not reported. No further information was available. Upon internal review it was determined that respiratory arrest was an other important medical event. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Pyrexia, Rotavirus infection, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female with gastroesophageal reflux, allergic colitis and protein allergy (milk), who on 20-SEP-2007, received a first time 2.0ml oral dose of Rotateq (lot# 657522/0769U). Concomitant vaccinations included Pediarix, Prevnar, and Pedvax HIB generic (manufacturer unknown). Concomitant therapy included lansoprazole (PREVACID). She developed vomiting, fever, and diarrhea and was hospitalized on 26-SEP-2007, with a diagnosis of rotavirus. Diagnostics, treatment, and current patient status were not reported. A product quality complaint was not reported. No further information was available. Rotavirus was considered to be life threatening by the reporter, as the patient was dehydrated. A lot check was requested. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from two Licensed Practical Nurses concerning a 24 year old female with seasonal allergies and allergies to penicillin, codeine, z pak, and ceftan who on 27-MAR-2007 was vaccinated IM with 0.5 mL of the first dose of Gardasil (Lot #655503/0012U). On 25-MAY-2007 the patient received the second dose of Gardasil (lot #657622/0388U). Concomitant medication included prenatal vitamins. The patient reported that she is now pregnant. Unspecified medical attention was sought. On 13-JUL-2007 the patient had an ultrasound reported as within normal limits. The patient's last menstrual period was 20-MAY-2007. The estimated date of delivery was 24-FEB-2008. Follow-up information indicated that in October 2007 the patient had an elective termination 20 weeks from her last menstrual period. The products of conception were underprocess of being examined. The fetus was not normal due to anencephaly with a heart defect. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Type 1 diabetes mellitus
Clinical narrative: Information has been received from a nurse practitioner concerning her 25 year old daughter with Graves' disease (onset age 13) and no known allergies, who on unknown dates was vaccinated IM, with the first and second dose, 0.5 ml, of Gardasil (lot # not provided). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). One month after the second vaccination was administered, her daughter required a visit to the emergency room (details not specified). She was found to have a blood pressure glucose of over 500 (unit not specified), and was diagnosed with Type I diabetes. Insulin was administered as treatment, and she was hospitalized for 1 week. At the time of this report, her daughter had not recovered. The nurse practitioner considered Type I Diabetes to be immediately life-threatening, disabling/incapacitating and also an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Acute lymphocytic leukaemia
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 11 year old female patient with no known allergies and no pertinent medical history, who on 29-JUL-2007 was vaccinated with a dose of Gardasil (lot #658556/1060U). The physician noted that the patient was healthy at the time of vaccination, and no other vaccines were administered. On 28-SEP-2007, the patient had unspecified blood work drawn and was diagnosed with "acute lymphocytic leukemia (ALL) Pre-B cell." The patient visited the hospital, but it was unknown if she was hospitalized. At the time of this report, the patient had not recovered. The physician considered ALL B-cell leukemia be immediately life-threatening. Additional information has been requested.  08/13/2008 Vax rec and labs received from PCP. Labs c/w acute leukemia.   Referred to regional med ctr. 8/28/08 MR received for DOS 9/29-10/15/2007 with DX: Acute Lymphblastic Leukemia. Pt presented with 2 week hx of bruising and hematoma formation on sacral area, knees, groin. Labs concerning for Leukemia done by PCP, sent to ER for eval and tx. PE (+) for large hematomas on lower extremities and groin.  Bone marrow bx c/w leukemia. Broviac cath placed. Hepatosplenomegaly on exam with high LDH. Chemo initiated on 104/07 completed on day 12.  Required platelet transfusions. D/C 10/15/07 to f/u as outpt.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure, Chills, Condition aggravated, Dizziness, Gait disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female (weight 75.4 kg, height 162.5 cm) with ibuprofen (MOTRIN) and Duloxetine HCl (CYMBALTA) intolerance, lipids increased, diabetes mellitus, obesity and hypothyroidism and a history of relapsing-remitting multiple sclerosis, pain in elbow, pain in foot, nausea, chronic back pain, diverticulosis and lipoma who on 25-SEP-207 was vaccinated with a dose of Pneumovax 23 (lot #655290/0959F), IM in the left deltoid. Concomitant therapy included acetaminophen (APAP), cyanocobalamin, interferon deta-la (REBIF), metformin HCl, levothyroxine Na, lisinopril-HCTZ (MSD), omeprazole, red yeast, estradiol (CLIMARA), psyllium husk (METAMUCIL), calcium (unspecified), pyridoxine and vitamin D (unspecified). On 26-SEP-2007, the patient awoke that morning with chills, lightheadness and general body aching. On 02-OCT-2007, the patient was seen by a neurologist who reported that the patient had a clinical relapse of multiple sclerosis. The patient also perceived weakness in her right leg with a heavy sensation, which required her to use a cane for the last 3 to 4 days in order to ambulate with security. The patient was treated with IV steroids for her quit impairment. The outcome of the events was not reported. Chills, lightheadness, general body aching and clinical relapse of multiple sclerosis were considered to be other important medical events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Multiple sclerosis relapse, Muscular weakness, Pain, Respiratory rate, Sensation of heaviness
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female (weight 75.4 kg, height 162.5 cm) with ibuprofen (MOTRIN) and Duloxetine HCl (CYMBALTA) intolerance, lipids increased, diabetes mellitus, obesity and hypothyroidism and a history of relapsing-remitting multiple sclerosis, pain in elbow, pain in foot, nausea, chronic back pain, diverticulosis and lipoma who on 25-SEP-207 was vaccinated with a dose of Pneumovax 23 (lot #655290/0959F), IM in the left deltoid. Concomitant therapy included acetaminophen (APAP), cyanocobalamin, interferon deta-la (REBIF), metformin HCl, levothyroxine Na, lisinopril-HCTZ (MSD), omeprazole, red yeast, estradiol (CLIMARA), psyllium husk (METAMUCIL), calcium (unspecified), pyridoxine and vitamin D (unspecified). On 26-SEP-2007, the patient awoke that morning with chills, lightheadness and general body aching. On 02-OCT-2007, the patient was seen by a neurologist who reported that the patient had a clinical relapse of multiple sclerosis. The patient also perceived weakness in her right leg with a heavy sensation, which required her to use a cane for the last 3 to 4 days in order to ambulate with security. The patient was treated with IV steroids for her quit impairment. The outcome of the events was not reported. Chills, lightheadness, general body aching and clinical relapse of multiple sclerosis were considered to be other important medical events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Walking aid user
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female (weight 75.4 kg, height 162.5 cm) with ibuprofen (MOTRIN) and Duloxetine HCl (CYMBALTA) intolerance, lipids increased, diabetes mellitus, obesity and hypothyroidism and a history of relapsing-remitting multiple sclerosis, pain in elbow, pain in foot, nausea, chronic back pain, diverticulosis and lipoma who on 25-SEP-207 was vaccinated with a dose of Pneumovax 23 (lot #655290/0959F), IM in the left deltoid. Concomitant therapy included acetaminophen (APAP), cyanocobalamin, interferon deta-la (REBIF), metformin HCl, levothyroxine Na, lisinopril-HCTZ (MSD), omeprazole, red yeast, estradiol (CLIMARA), psyllium husk (METAMUCIL), calcium (unspecified), pyridoxine and vitamin D (unspecified). On 26-SEP-2007, the patient awoke that morning with chills, lightheadness and general body aching. On 02-OCT-2007, the patient was seen by a neurologist who reported that the patient had a clinical relapse of multiple sclerosis. The patient also perceived weakness in her right leg with a heavy sensation, which required her to use a cane for the last 3 to 4 days in order to ambulate with security. The patient was treated with IV steroids for her quit impairment. The outcome of the events was not reported. Chills, lightheadness, general body aching and clinical relapse of multiple sclerosis were considered to be other important medical events. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 week old male with allergies to milk, peanuts, soy, peas, and chicken, who on 16-OCT-2007, received a 0.5 ml subcutaneous dose in his right thigh of Varivax (Oka/Merck) (lot #658024/0833U). Concomitant vaccination included a 0.5 ml subcutaneous dose in his left thigh of MMR II (lot #655487/0749U). It was reported that 8 hours after vaccination on 16-OCT-2007, he developed symptoms of facial swelling, swollen lips, and hives all over the body. He was treated in the emergency room with adrenalin and steroids plus diphenhydramine (BENADRYL). It was reported that the patient did not develop wheezing. He was not admitted to the hospital. At the time of the report, the reporter felt that the patient was currently recovering, but he continued to take steroids and diphenhydramine (BENADRYL) for the hives that had not yet resolved. A product quality complaint was not reported. No further information was available. The reporter felt that the events were life threatening (facial swelling), disabling, and other important medical events. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Adrenal neoplasm, Cataract nuclear, Cataract subcapsular, Surgery
Clinical narrative: This case was received from a consumer on 17 October 2007. A female patient, date of birth 09 June 1940, received five injections of Imovax (lot number unknown) and one injection of RIG (lot number unknown) following bat exposure. RIG was given on 27 August 1997. Imovax injections were given on 27 August 1997, 30 August 1997, 03 September 1997, 10 September 1997, and 24 September 1997. In 2001, the patient was found to have an adrenal tumor, which was removed and determined to be benign. In 2007, the patient was diagnosed with "post. subcapsular cataract and nuclear oil droplet cataract". Medical history included spring and fall allergies, increased blood pressure, and underactive thyroid. At the time of vaccination, the patient was taking Synthroid, Avapro, and Cardizem CD concomitantly. Outcome was not reported.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 19 October 2007. A 28-year-old female patient with no significant past medical history received an intramuscular injection of Adacel, lot number C2824AA, in the left deltoid on 28 September 2007. At the time of vaccination the patient was diagnosed with a bacterial sinus infection and was treated with amoxicillin. The Adacel was administered at the same visit. The patient returned to the office on 08 October 2007 complaining of numbness and tingling in her feet. She was admitted to the hospital on 11 October 2007 with progressive symptoms and was diagnosed with Guillain-Barre syndrome. She was treated with IVIG in the hospital and was discharged on 14 October 2007. She was evaluated by a physician on 19 October 2007 and her symptoms had resolved. The patient recovered from the events.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Pain, Skin warm, Vomiting
Clinical narrative: Patient received a Pneumococcal 23 vaccine in left deltoid on 10/16/07. Patient returned to the office 10/19/07 with 15cm x 10cm red area at site of injection.Painful,hot to the touch,vomitting, 101 temp. Patient was put on a Z-Pak and Claritin 10mg.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Sensory loss, Skin exfoliation
Clinical narrative: Patient received the Tdap vaccine on October 2, 2007.  On October 3, 2007, patient developed red spots on her fingers and thumbs.  Patient then lost sensation in these digits for approximately 5 days.  Patient regained sensation but fingers began peeling and this continued until October 17, 2007.  Unknown if skin sloughing has resolved.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Asthenia, Cellulitis, Intensive care, Mechanical ventilation
Clinical narrative: No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Cellulitis, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Injection site warmth, Multi-organ failure, Surgery
Clinical narrative: No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.
Age: 59.0
Sex: F
Vaccine: FLU3, FLUX, FLU3
Symptoms: Cellulitis, Intensive care, Mechanical ventilation, Pain in extremity
Clinical narrative: No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Hypoaesthesia, Local swelling, Ocular hyperaemia
Clinical narrative: Immunization was on Friday October 26 at about 3:30pm. Around 8pm becane a mild cough with irritation in throat and trachea. By 8:30pm neck felt swollen and some numbness below corners of mouth. Continued coughing, eyes red and yellow substance "oozing" from corners of eyes. General achey feeling in legs. At about 9PM took 50 mg of diphenhydramine. About 40 minutes late began breathing easier, "swelling" seemed to get better. Coughing stopped. Numbness in corners of mouth eased. Slept through the night. Saturday morning about 8am, still had throath "thickness" sensation, took 25mg of diphenhydramine. 10am Saturday morning all symptems were gone. Symptems did not return.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Throat irritation
Clinical narrative: Immunization was on Friday October 26 at about 3:30pm. Around 8pm becane a mild cough with irritation in throat and trachea. By 8:30pm neck felt swollen and some numbness below corners of mouth. Continued coughing, eyes red and yellow substance "oozing" from corners of eyes. General achey feeling in legs. At about 9PM took 50 mg of diphenhydramine. About 40 minutes late began breathing easier, "swelling" seemed to get better. Coughing stopped. Numbness in corners of mouth eased. Slept through the night. Saturday morning about 8am, still had throath "thickness" sensation, took 25mg of diphenhydramine. 10am Saturday morning all symptems were gone. Symptems did not return.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Loss of consciousness, Migraine
Clinical narrative: Chill and fever (102).  Extreme pain in arm of injection, unable to lift arm for 2 days.  Extreme nausea and lightheadedness for two days.  Migraraine headache, which is still continuing.  Passed out for the first day.  Onset of symptoms about 5 hours after injection.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Chill and fever (102).  Extreme pain in arm of injection, unable to lift arm for 2 days.  Extreme nausea and lightheadedness for two days.  Migraraine headache, which is still continuing.  Passed out for the first day.  Onset of symptoms about 5 hours after injection.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: High Fever, fussiness.  Tmax =104.9
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Cough, Pain
Clinical narrative: On the day that I receieved my flu shot I developed aches and pain by that afternoon. The following day I hurt even worse and I started coughing. That day I aslo, lost my voice and have since not gotten it back to normal. I still have a cough and aches. Today would be the seventh day since I received the shot.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hemiparesis, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: unilateral lymphadenopathy on side of injection, nerve pain, weakness in foot and leg side of injection, chills, muscle aches, nausea
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia
Clinical narrative: unilateral lymphadenopathy on side of injection, nerve pain, weakness in foot and leg side of injection, chills, muscle aches, nausea
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Lip swelling, Pharyngeal oedema, Swelling face, Swollen tongue
Clinical narrative: Within 24 hours of flu vaccine,began with hives.  Started antihistamine immediately and prednisone the following day.  That night, face began to swell, lips, mouth, tongue and then throat. Visited ER and was given IV with prednisone and antihistamine and Zantax.  Admitted to hospital for  the next 24 hours. Went home and continued on Prednisone for one week. Still taking the antihistamine.  11/7/07 Received vax record from provider.  VAERS database updated w/same./ss 12/7/07 Reviewed hospital medical records which reveal patient experienced new onset hives. Saw pcp & tx w/steroids & antihistamine.  Worsened & admitted 10/13-10/14/2007.  On admit had hives, facial swelling & throat constriction.  Tx w/IV steroids & antihistamine.  Had 1 further episode of hives that responded to steroids.  D/C to home on tapering steroids & antihistamine.  Also prescribed epi-pen. FINAL DX: Hives.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Within 24 hours of flu vaccine,began with hives.  Started antihistamine immediately and prednisone the following day.  That night, face began to swell, lips, mouth, tongue and then throat. Visited ER and was given IV with prednisone and antihistamine and Zantax.  Admitted to hospital for  the next 24 hours. Went home and continued on Prednisone for one week. Still taking the antihistamine.  11/7/07 Received vax record from provider.  VAERS database updated w/same./ss 12/7/07 Reviewed hospital medical records which reveal patient experienced new onset hives. Saw pcp & tx w/steroids & antihistamine.  Worsened & admitted 10/13-10/14/2007.  On admit had hives, facial swelling & throat constriction.  Tx w/IV steroids & antihistamine.  Had 1 further episode of hives that responded to steroids.  D/C to home on tapering steroids & antihistamine.  Also prescribed epi-pen. FINAL DX: Hives.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient received the shot from intern and the injection site was slightly swelled up.  We asked her to check back with us 15 minutes later and the swelling was decreased. Patient said there was no pain.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEP, SMALL, TYP
Symptoms: Injection site rash, Injection site swelling, Oedema peripheral, Swelling
Clinical narrative: swelling/rash at immunizations site, above site on shoulder radiating around entire arm.  swelling in neck and armpit
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin discolouration
Clinical narrative: Redness, swelling, painful in the whole entire swollen area, bluish in color about the size of a half dollar, itching, hot to the touch.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: Redness, swelling, painful in the whole entire swollen area, bluish in color about the size of a half dollar, itching, hot to the touch.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Extensive maculopapular rash on trunk/extremities/head and diaper area.  Rash started 10/28/07.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Death, Irritability, Respiratory arrest, Rhinorrhoea, Unresponsive to stimuli
Clinical narrative: My child was very fussy with a runny nose for two days then she was very unresponsive on the third.  On the fourth day she stopped breathing.  The on call physicians only advice for treatment was baby tylenol.  11/18 Death certificate states COD as severe hypoxic ischemic injury w/cardiac arrest & complex cyanotic heart disease as contributing factors. 11/13/07 Reviewed hospital medical records which also included birth records. Admitted 5/29-5/30/2007 s/p cardiopulmonary arrest at home.  Seen initially in outlying ER & transferred for higher level of care s/p resuscitation, intubation & interosseus dopamine drip.  IV & a-line established & placed on ventilator.  Transfused PRBCs & FFP.  Acidotic, hypoglycemic & hypocalcemic on admit.  Tx w/antibiotics.  EEG showed very low voltage activity.  Extubated & patient expired quickly w/parents in attendance.
Age: 3.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Antinuclear antibody negative, Arthralgia, Complement factor C3, Complement factor C4, Complement factor normal
Clinical narrative: 2 days after MMR (right arm) and IPV (left arm)this patient had daily fevers and right shoulder and right hip pain (without arthritis - arthalgia only.)  ESR = 63, Nomral C3,C4. ANA-neg, RF-neg, ASO titer=0. 11/30/07 Reviewed pcp med records which included vax dose & lot #s.  Note of 10/9/07 reveals patient was in good health on day of vax. 1/18/08 Reviewed hospital medical records which reveal patient experienced right arm pain x 2 wks & right leg pain x 10 days & fever x 2 wks.  All symptoms began 2 days s/p vax.  Admitted 10/25-10/29/2007.  Exam revealed restricted ROM right shoulder, shotty inguinal lymphadenopathy, right axillary lymph node swelling.  Peds Rheum, ID, Heme/Onc FINAL DX: Fever & arthritis.
Age: 3.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Streptococcal identification test
Clinical narrative: 2 days after MMR (right arm) and IPV (left arm)this patient had daily fevers and right shoulder and right hip pain (without arthritis - arthalgia only.)  ESR = 63, Nomral C3,C4. ANA-neg, RF-neg, ASO titer=0. 11/30/07 Reviewed pcp med records which included vax dose & lot #s.  Note of 10/9/07 reveals patient was in good health on day of vax. 1/18/08 Reviewed hospital medical records which reveal patient experienced right arm pain x 2 wks & right leg pain x 10 days & fever x 2 wks.  All symptoms began 2 days s/p vax.  Admitted 10/25-10/29/2007.  Exam revealed restricted ROM right shoulder, shotty inguinal lymphadenopathy, right axillary lymph node swelling.  Peds Rheum, ID, Heme/Onc FINAL DX: Fever & arthritis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Skin warm
Clinical narrative: Immunizations given at 10:30 am.  Mom reports that baby felt warm at 3pm, but she did not take his temperature until 5pm and it was 103.  Baby went to ER and had blood and urine cultures done and was given tylenol and pedialyte. No infection found and no further follow up done.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: States that she developed a maculopapular rash on both arms and legs.  Rash was nonpuretic. No swelling at site. It is still slightly visible.  States she had no changes in diet, laudry soap, or medications prior to vaccination.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Patient's wife developed shingles immediately following injection of o.patient.  Patient's wife has had lymphoma of thyroid about 5 years ago.eular doctor She was taken to emergency room on Saturday October 27, 2007 about 11 AM and was treated by Dr.  Her regular doctor is MD.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Cold compress therapy, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Client had Pneumonia and Flu vaccine on 10-25-07.  Site of Pneumonia vaccine (R) arm became painful and swollen that evening.  Over the weekend Oct 27 &28 states it hurt to move her arm and red streaks were coming from the area where shot was given.  Today has temp of 97.9 and edema to deltoid area and upper arm. Some limitation of movement due to pain and edema. Advised to see MD for evaluation.  Use cool compresses and APAP as needed.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site streaking, Injection site swelling, Oedema
Clinical narrative: Client had Pneumonia and Flu vaccine on 10-25-07.  Site of Pneumonia vaccine (R) arm became painful and swollen that evening.  Over the weekend Oct 27 &28 states it hurt to move her arm and red streaks were coming from the area where shot was given.  Today has temp of 97.9 and edema to deltoid area and upper arm. Some limitation of movement due to pain and edema. Advised to see MD for evaluation.  Use cool compresses and APAP as needed.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Culture, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm red, hot to touch, swollen - started afternoon of imm.  Progressed to emcompass shoulder to elbow by Wednesday afternoon.  Fluid filled blisters by evening of 10/17/07; on antibiotic (Keflex)