chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Platelet count increased, Red blood cell count increased, Serology test, Temporomandibular joint syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Anthrax was administered on the Left Arm. Patient reports rash of 50mm x 60mm, pain. No induration, no blisters.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Antibody test positive, Antinuclear antibody positive, Arthralgia, Asthenia, Fatigue
Clinical narrative: Initial report was received 06 August 2008 from a health care professional. A 54 year-old female patient with a history of codeine sensitivity, had received a Tetanus and Diphtheria Toxoids injection January 2008 (manufacturer, exact date, lot number, route and site not reported) and a few days later, she developed joint pain and fatigue. Two months later, her symptoms continued and laboratory test results showed an increased erythrosedimentation rate, ANA (+) and SCL 70 Antibody (+). The patient was seen by a rheumatologist (date and results not provided) and eight months post vaccination, she continued with symptoms of fatigue, decreased visual focus and a "debilitated condition" at the time of the report. No further information was provided.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Red blood cell sedimentation rate increased, Vision blurred
Clinical narrative: Initial report was received 06 August 2008 from a health care professional. A 54 year-old female patient with a history of codeine sensitivity, had received a Tetanus and Diphtheria Toxoids injection January 2008 (manufacturer, exact date, lot number, route and site not reported) and a few days later, she developed joint pain and fatigue. Two months later, her symptoms continued and laboratory test results showed an increased erythrosedimentation rate, ANA (+) and SCL 70 Antibody (+). The patient was seen by a rheumatologist (date and results not provided) and eight months post vaccination, she continued with symptoms of fatigue, decreased visual focus and a "debilitated condition" at the time of the report. No further information was provided.
Age: 18.0
Sex: F
Vaccine: HBHEPB
Symptoms: Blood test, Computerised tomogram, Convulsion, Haemorrhage, Neurological examination
Clinical narrative: Information has been received from an 18 year old female with sulfonamide allergy, who in December 2007, was vaccinated with a first dose of COMVAX. Concomitant therapy included hormonal contraceptives (unspecified). In April or May 2008, after her third vaccination with COMVAX, the patient experienced about 6-7 seizures before she was hospitalized for a few hours. The patient also experienced abdominal bleeding. MRI, "catscan", nervous system tests and blood work were performed (results not reported). No lot number was provided. Subsequently, the patient recovered in July 2008 (date not specified). No further information is available.
Age: 18.0
Sex: F
Vaccine: HBHEPB
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from an 18 year old female with sulfonamide allergy, who in December 2007, was vaccinated with a first dose of COMVAX. Concomitant therapy included hormonal contraceptives (unspecified). In April or May 2008, after her third vaccination with COMVAX, the patient experienced about 6-7 seizures before she was hospitalized for a few hours. The patient also experienced abdominal bleeding. MRI, "catscan", nervous system tests and blood work were performed (results not reported). No lot number was provided. Subsequently, the patient recovered in July 2008 (date not specified). No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Pyrexia, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a 25 year old female, with a weak immune system and respiratory tract infection, who is a medical assistant at the physician's office, on 03-JUN-2008 was vaccinated with the first dose of GARDASIL.  On 05-AUG-2008 the patient went to the physician's office and received the second dose of GARDASIL in the deltoid.  The physician reported that about 40 minutes after receiving the vaccination her arm became very numb and heavy, like something or someone was pulling on her arm, and her fingers were tingling.  The physician reported that throughout the day her arm felt like a dead arm.  The patient had her blood pressure taken that day which was fine.  The physician reported that night the patient could not even move her arm; she had chills and a fever so she called the physician at 2:00 in the morning.  The patient had then seen her primary care physician the next morning on 6-AUG-2008 who gave her an emergency referral to a neurologist.  A CT scan, bloodwork and an X-ray were performed (results not provided).  The patient was diagnosed with paralysis of the arm and was admitted to the hospital.  The physician reported that the patient was still hospitalized on 07-AUG-2008 and still had the symptoms, but she was having more test done and had been given PROTONIX (manufacturer unspecified) and prednisone (manufacturer unspecified).  Paralysis of the arm and chills and fever were considered to be disabling.  Additional information has been requested.  9/5/08 Reviewed hospital medical records of 8/6-8/8/2008. FINAL DX: left acute brachial plexus neuritis; obesity Records reveal patient experienced flaccid paralysis of the LUE the day after the second HPV vaccination in LUE.  Started w/numbness, tingling & weakness of LUE approx 15 min s/p vaccination & progressing to being unable to move her LUE.  Exam revealed LUE 1-/5 strength diffusely.  Neuro consult done.  Tx w/prednisone & PT in hospital & to be continued as outpatient.  9/16/08 Reviewed neurologist medical records of 8/15-8/22/08 which included additional hospital labs. FINAL DX: brachioplexopathy Records reveal patient LUE paralysis after second HPV vaccination.  Initially had tingling sensation during injection from shoulder to hand & then developed weakness that evening which progressed to complete paralysis by next day.  Exam revealed decreased LUE muscle strength & hyporeflexia.  Tx w/steroids & admitted to hospital.  PT & continued steroids upon d/c but remained hyporeflexic w/decreased muscle strength & nerve pain.  Has had very slow improvement.    9/16/08 Reviewed PCP medical records of 8/6-8/21/2008. FINAL DX:  LUE paralysis, no movement, secondary to nerve inflammatory reaction to Gardasil Records reveal patient LUE was weak & unable to move on 8/21 & gradually was improving, having a great deal of nerve pain.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy, Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a 19 year old female patient with a history of allergic reaction to FLAGYL who on 30-OCT-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 659437/1266U). An ultrasound performed on 30-OCT-2007, following vaccination with GARDASIL, confirmed that the patient was pregnant (LMP= end of September). No other symptoms were noted. The patient sought unspecified medical attention. This is a consolidation of reports regarding the same patient. Follow up information was received. The patient miscarried at the end of December 2007. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Pregnancy test positive, Uterine dilation and curettage
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry of GARDASIL, concerning her 17 year old daughter who in February 2008 was vaccinated with the first dose of GARDASIL.  The patient had ectopic pregnancy and dilation and evacuation in February 2008.  Upon internal review ectopic pregnancy considered to be other important medical event.  Subsequently the patient was pregnant while vaccinated with the second dose of GARDASIL (WAES 0808USA01038).  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Appendicectomy, Arthralgia, Blindness, Blood immunoglobulin G increased, Blood immunoglobulin M decreased
Clinical narrative: On 7-1-07 mom picked up patient at volleyball practice with HA and tremors.  Mom states since then patient has had severe HA right behind eyes, mouth sores, tremors on a daily basis.  She has also had severe joint pain and swelling.  Recently had appendix removed. 8/29/08 Reviewed neuro medical records of 7/9-8/4/2008. FINAL DX: migraine headaches; benign familial tremor. Records reveal patient experienced severe HA & shaking x 1 year, localized behing eyes & relieved only by sleep.  Tx w/meds.   9/12/08 Reviewed PCP medical records of 6/21/07-7/31/2008. FINAL DX: none provided Records reveal patient experienced good health on day of vaccination.  RTC 6/23 for HA which caused visual loss & jittery/shaking spells.  Referred to Neuro.  RTC 11/8 w/abdominal pain esp in RLT & anorexia.  Admittd for Surgical consult & appendectomy done 11/8/2007.  RTC 1/15/08 for HA x 3 wks, mouth blisters, tired, excessive sleeping, generalized aching. HA resolved w/antibiotics for sinus infection. RTC 7/31/08 for migraines being f/u w/neuro, canker sores & sports injuries of foot pain & swelling & knee pain. 1/26/2010 Follow-up: Patient still with tremors. Negative EEG/MRI per patient's mom.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Joint swelling, Pain in extremity, Stomatitis, Tremor
Clinical narrative: On 7-1-07 mom picked up patient at volleyball practice with HA and tremors.  Mom states since then patient has had severe HA right behind eyes, mouth sores, tremors on a daily basis.  She has also had severe joint pain and swelling.  Recently had appendix removed. 8/29/08 Reviewed neuro medical records of 7/9-8/4/2008. FINAL DX: migraine headaches; benign familial tremor. Records reveal patient experienced severe HA & shaking x 1 year, localized behing eyes & relieved only by sleep.  Tx w/meds.   9/12/08 Reviewed PCP medical records of 6/21/07-7/31/2008. FINAL DX: none provided Records reveal patient experienced good health on day of vaccination.  RTC 6/23 for HA which caused visual loss & jittery/shaking spells.  Referred to Neuro.  RTC 11/8 w/abdominal pain esp in RLT & anorexia.  Admittd for Surgical consult & appendectomy done 11/8/2007.  RTC 1/15/08 for HA x 3 wks, mouth blisters, tired, excessive sleeping, generalized aching. HA resolved w/antibiotics for sinus infection. RTC 7/31/08 for migraines being f/u w/neuro, canker sores & sports injuries of foot pain & swelling & knee pain. 1/26/2010 Follow-up: Patient still with tremors. Negative EEG/MRI per patient's mom.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthroscopic surgery, Blood culture positive, Computerised tomogram abnormal, Gram stain positive, Osteonecrosis
Clinical narrative: Right shoulder arthroscopic I & D with resection of necrotic bone performed 8/5/08.  Hx: patient c/o pain and swelling since 48 hrs after injection.  ER visit x 2.  9/26/08 Reviewed hospital medical records of 8/5-8/25/2008. FINAL DX: no d/c summary dictated yet.  H&P & consults states septic arthritis/osteomyelitis right humerus, secondary to IM injection. Records reveal patient experienced septic osteomyelitis of right shoulder s/p arthroscopic I&D with debridement.  Pain in right arm developed immediately s/p HPV vax 7/16.  Seen by PCP & tx w/pain med.  Pain persisted & developed low grade fever.  Seen in ER on 7/23, x-ray neg & d/c to home on pain meds.  Began to have swelling of right shoulder/arm, low grade fever, worsening pain & refusal to move arm.  Was pale & ill-appearing, sent home from school & taken to ER.  CT scan & x-ray revealed right humerus osteomyelitis.  Taken to OR for I&D with debridement to remove necrotic bone.  Tx w/IV antibiotics.  Did well initially then developed tacycardia & hypotension.  Tx w/fluid & transferrred to higher level of care ICU.  ID, ortho, neuro consults done.  Intubated until 8/15.  Initially did well post extubation then had altered mental status thought to be ICU psychosis.  Had repeat surgery x 2.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Swelling
Clinical narrative: Right shoulder arthroscopic I & D with resection of necrotic bone performed 8/5/08.  Hx: patient c/o pain and swelling since 48 hrs after injection.  ER visit x 2.  9/26/08 Reviewed hospital medical records of 8/5-8/25/2008. FINAL DX: no d/c summary dictated yet.  H&P & consults states septic arthritis/osteomyelitis right humerus, secondary to IM injection. Records reveal patient experienced septic osteomyelitis of right shoulder s/p arthroscopic I&D with debridement.  Pain in right arm developed immediately s/p HPV vax 7/16.  Seen by PCP & tx w/pain med.  Pain persisted & developed low grade fever.  Seen in ER on 7/23, x-ray neg & d/c to home on pain meds.  Began to have swelling of right shoulder/arm, low grade fever, worsening pain & refusal to move arm.  Was pale & ill-appearing, sent home from school & taken to ER.  CT scan & x-ray revealed right humerus osteomyelitis.  Taken to OR for I&D with debridement to remove necrotic bone.  Tx w/IV antibiotics.  Did well initially then developed tacycardia & hypotension.  Tx w/fluid & transferrred to higher level of care ICU.  ID, ortho, neuro consults done.  Intubated until 8/15.  Initially did well post extubation then had altered mental status thought to be ICU psychosis.  Had repeat surgery x 2.
Age: 2.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Convulsion, Lymphadenopathy, Pyrexia, Staring
Clinical narrative: Patient and mom came into immunization clinic for shots. Mom reported that after last set of shots, patient was in emergency room for: swollen glands, temp 104 degrees, seizure like symptoms, and bland stare. He was treated and released. Upon further questioning it was determined he immunizations 1st MMR, 1st varicella and 4th PREVNAR on 08/31/2007 and he did well. Until suddenly mom states he had the above symptoms and was take for treatment in ER. He has recovered completely. 08/11/08 numerous attempts to get this mom to sign authorization to obtain more medical information have been ignored.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure, Dizziness
Clinical narrative: Patient received three immunizations Tdap, MENACTRA & Hep A.  After third immunization patient felt dizziness & felt better in 5 to 10 sec.  BP was 90/60.  Elevated legs, called 911.  Pt was taken to ER.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Gaze palsy, Syncope
Clinical narrative: Within seconds of receiving the shot father said patient collapsed onto table legs kicked and eyes rolled back. Lasted only a few seconds.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Injection site with 2x3 inch localized reaction, warmth, swelling.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted w/in a few minutes after receiving vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Family called next day stating fever 104.4 & leg sore.  Advised to take to PCP/ER to have baby checked.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Oedema peripheral, Rash
Clinical narrative: Left arm edema, syncope, rash - presented to ER 08-02-08.  Immun given on 07-31-2008.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope, Urine analysis
Clinical narrative: Left arm edema, syncope, rash - presented to ER 08-02-08.  Immun given on 07-31-2008.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Patient became pale, diaphoretic, weak. Patient never lost consciousness and was able to verbalize not feeling well. Symptoms came on after given vaccine within  4-6min and passed after approx 4-6min. *Patient had nothing to eat prior to injections
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Arthralgia, X-ray abnormal
Clinical narrative: Developed bilateral elbow pain without swelling or redness within a few weeks of receiving the anthrax vaccine during war in 1991.  The pain was severe enough that he could not fly (pt was a pilot).  He reports that the pain continues TO THE PRESENT - 17 years - with lifting objects.  Symptoms: Joint Pain, isolated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood pressure, Crying, Heart rate increased, Hyperhidrosis, Injection site erythema
Clinical narrative: After receiving her vaccines, child was sitting on side of table; nurse noted that she looked very pale and went to lay her back; when she did that, she stiffened her arms and legs and her eyes were not focused; nurse had mother stay by child and she came to get me. When I entered the room, child was lying on exam table and crying. She was pale and diaphoretic and complaining of needing to go to the bathroom, her pulse was rapid but weak at that point, initial BP 70/p about 5 min after the onset of the symptoms. She continued to cry that she needed to use the BR but when mother started to sit her up, she became even more pale. Mother had a diaper in the room and she put that on her. After that, child was calmer and answered questions appropriately. Her BP was check ever 5 min and was better each time, her color returned to normal after about 10 min and she was able to sit without assistance. BP remained stable with sitting and she was then able to ambulate without assistance. She reported feeling great. She had some mild erythema at injection site but no hives or other rashes. MD talked with mom at 5:15, she has felt well the rest of day, no further episodes, is playing and has had no fever or other symptoms, told mom to call if any concerns.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: After receiving her vaccines, child was sitting on side of table; nurse noted that she looked very pale and went to lay her back; when she did that, she stiffened her arms and legs and her eyes were not focused; nurse had mother stay by child and she came to get me. When I entered the room, child was lying on exam table and crying. She was pale and diaphoretic and complaining of needing to go to the bathroom, her pulse was rapid but weak at that point, initial BP 70/p about 5 min after the onset of the symptoms. She continued to cry that she needed to use the BR but when mother started to sit her up, she became even more pale. Mother had a diaper in the room and she put that on her. After that, child was calmer and answered questions appropriately. Her BP was check ever 5 min and was better each time, her color returned to normal after about 10 min and she was able to sit without assistance. BP remained stable with sitting and she was then able to ambulate without assistance. She reported feeling great. She had some mild erythema at injection site but no hives or other rashes. MD talked with mom at 5:15, she has felt well the rest of day, no further episodes, is playing and has had no fever or other symptoms, told mom to call if any concerns.
Age: 0.66
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Anorexia
Clinical narrative: Mom states child didn't act right.  Layed around.  No appetite for 2 days.  States called someone (no record).  Wouldn't let anyone else give immunization.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Erythema, Headache, Pain in extremity, Pyrexia
Clinical narrative: Gave varicella vaccine on 8/11/08.  On 8/12/08 patient reported fever, chills, headache.  Sore, red, tender arm.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Gave varicella vaccine on 8/11/08.  On 8/12/08 patient reported fever, chills, headache.  Sore, red, tender arm.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Body temperature increased, Injection site pain, Pain in extremity
Clinical narrative: 8/13/08 Mother called health dept-concerned with increased temp with excessive pain in arm.  RN questioned mother clarified T 102.  Td arm sore; no localized reaction.  8/14/08 - Pt okay upon rising - no fever - min. soreness at site.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site warmth, Oedema peripheral
Clinical narrative: Patient has swelling from shoulder to elbow for 3-4 days after injections were given skin at injection site hot to touch. Patient feels reaction from HPV - no MENACTRA.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Here for reaction to anthrax vaccine had AVA #3 on Mon.  Had injection tenderness, chills, bodyaches, and HA.  72 hours later developed hives on arms and neck.  Took BENADRYL and hives disappeared, but that evening they returned.  Resolved again with BENADRYL.  Had hives this am again on neck and took BENADRYL.  Body aches are gone.  No SOB, lip swelling, nausea.  Large area of erythema and tenderness and pruritis at injection site.  Does not feel her throat closing.  Did not have reactions like this to prior 2 immunizations.  No other new exposures to account for this.  Symptoms: Urticaria, Fever, Headache, general, Muscle Pain, Edema at Injection site 30-50mm, Erythema.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: No reaction on previous exposure to drug, Pain, Urticaria
Clinical narrative: Here for reaction to anthrax vaccine had AVA #3 on Mon.  Had injection tenderness, chills, bodyaches, and HA.  72 hours later developed hives on arms and neck.  Took BENADRYL and hives disappeared, but that evening they returned.  Resolved again with BENADRYL.  Had hives this am again on neck and took BENADRYL.  Body aches are gone.  No SOB, lip swelling, nausea.  Large area of erythema and tenderness and pruritis at injection site.  Does not feel her throat closing.  Did not have reactions like this to prior 2 immunizations.  No other new exposures to account for this.  Symptoms: Urticaria, Fever, Headache, general, Muscle Pain, Edema at Injection site 30-50mm, Erythema.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: L anterior thigh erythema 5 1/2 by 6 inches.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None, dose given inappropriate for age.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: 8/6 - received anthrax shot. 8/8 developed swelling and redness at site. No F/C 4x5cm size erythema and redness; The Patient is a 26-year-old female who received her anthrax vaccine on August 6, 2008 at 2:15 p.m. She started having some swelling and redness at the site on August 8, 2008 at 7:30 a.m. Some pain. Mild itching. Currently she has no other illnesses.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site induration, Rash, Urticaria
Clinical narrative: Hard area at the site with an urticarial rash throughout her trunk and extremities. Advised to give low dose of BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Injection site swelling
Clinical narrative: Swelling left arm around vaccine site 5 x 5cm erythema, non tender.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythematous swelling left arm arm puncture site (DTaP) non-tender.
Sex: U
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Blood homocysteine, Chest X-ray, Dyspnoea, Echocardiogram
Clinical narrative: Patient had extensive rash and now has viral syndrome, fatigue, and shortness of breath. Still off work.
Sex: U
Vaccine: VARCEL
Symptoms: Fatigue, Laboratory test, Rash, Viral infection
Clinical narrative: Patient had extensive rash and now has viral syndrome, fatigue, and shortness of breath. Still off work.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Pharyngeal oedema
Clinical narrative: Pt was administered Smallpox vaccine as part of the SRP mobilization process, and within 15 minutes of vaccination Pt presented with difficulty breathing, increased heart rate, elevated BP, and swelling in the throat.  Pt completed smallpox screening and had no contraindications to recieving the vaccine.  At time EMS was called and epi and Benadryl was administered.  Pt was transported to Medical clinic for further evaluation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Rash, Rash papular
Clinical narrative: Expanding warm red circular area around injection site on Left arm-covering much on upper arm. Patient came for an office visit 5 days later, rash on arm improved but with new bump and new rash on face.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Clt. received the first 2 GARDASIL'S at Dr's office. 1st injection on 05/10/2007, the 2nd was given on 07/16/2007. Clt. states that she told the Dr. about her symptoms and was told that is was a normal reaction. Clt.noted numbness after the 1st gardasil. Her symptoms began approx. 2 days after the 1st injection. She C/O  tingling and weakness in both arms, more weakness in the left arm/hand. The 3rd injection was given at county health dept. on 11/16/2007 along with recieving Menningococcol vaccine.  Client did not mention any of her symptoms at that time. We became aware of her C/O until 08/06/2008. S/S continue.  10/31/08 Reviewed PCP medical records provided by CDC of 3/20/2007-4/17/2008. FINAL DX:  allergic reaction Records reveal patient experienced good health on 5/10/07 for HPX #1, lot # 0011U.  Seen 5/31 for school physical & all WNL.  RTC 7/16/07 for HPV #2, lot # 0011U.  RTC 8/15/07 for persistent epigastric, LLQ pain, bloating, gas, nauseous & pain getting up.  Dx w/gastritis & tx w/meds.  RTC 4/14 w/lips, eyes & hands swollen, rash on neck follwing tylenol, motrin & alka seltzer,  Dx urticaria & tx w/steroids & antihistamine.  RTC 4/17 for itchy body rash/hives.  Dx w/allergic reaction & tx w/IM steroids & antihistamine.  Sent home w/tapering steroids.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Feeling abnormal, Hypoaesthesia oral, Immediate post-injection reaction, Laboratory test
Clinical narrative: Within seconds after vaccine was administered (2:20 pm) patient stated that her arm felt funny and that she couldn't see.  Patient stated that she wasn't feeling right.  Patient started to faint in the chair and was held up by nurse.  Patient began to turn gray/blue until nurse stated her name and grabbed her shoulders.  Color returned and with assistance from staff patient was laid on the floor. Color was pale.  Patient was alert and talking.  BP 92/54 P 84.  Patient stated that her lips felt numb; Benedryl 25 mg po given at 2:27 pm.  Patients hands were postured and she was unable to move them.  Ambulance arrived at 2:35 pm.  Oxygen was administered by paramedic and was taken to local emergency department.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Pallor, Posturing, Syncope
Clinical narrative: Within seconds after vaccine was administered (2:20 pm) patient stated that her arm felt funny and that she couldn't see.  Patient stated that she wasn't feeling right.  Patient started to faint in the chair and was held up by nurse.  Patient began to turn gray/blue until nurse stated her name and grabbed her shoulders.  Color returned and with assistance from staff patient was laid on the floor. Color was pale.  Patient was alert and talking.  BP 92/54 P 84.  Patient stated that her lips felt numb; Benedryl 25 mg po given at 2:27 pm.  Patients hands were postured and she was unable to move them.  Ambulance arrived at 2:35 pm.  Oxygen was administered by paramedic and was taken to local emergency department.
Age: 51.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was admitted to the hospital for Pneumonia and COPD exacerbation. Vaccination took place on 1/28/2008 and admission was on 7/29/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request. Subject ID is H105098.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Intussusception, Rectal haemorrhage, Surgery, Vitello-intestinal duct remnant
Clinical narrative: on 4/26/08 patient was admitted to the Pediatric ICU for bright red blood per rectum. found to have intussuception and taken to the OR. At surgery found to have Meckles diverticulum by pathologic examination. 8/15/08-vaccination record received-documents that Rotateq was refused. 8/25/08-records received for DOS 4/26-4/30/08-DC DX: Intussusception. Lethargic on morning of 4/26/08, bright red blood per rectum. Mass down to rectum with bright red blood. Exploratory laparotomy revealed intussusception Meckel's diverticulum. Small bowel resection with primary anastomosis and appendectomy.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Neck pain
Clinical narrative: PT RECEIVED MENACTRA ON 8/12/08. SEEN IN CLINIC ON 8/13/08 C/O SEVERE HA 8/12/08 AT NIGHT, TIRED, CHILLS, NECK PAIN. MD EVALUATED, NOTED POSITIVE NECK SPASM, BUT NO RIGIDITY, NORMAL GAIT, NO FOCAL NEURO SIGNS. RXED SUPPORTIVE CARE FOR NECK SPASM-ICE/HEAT PACKS AND MOTRIN PRN, TO RETURN TO CLINIC FOR WORSENING SYMPTOMS.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Asthenia, Dysstasia, Pallor, Yawning
Clinical narrative: became very pale and weak and could not stand and had agonal yawning approximately 15 minutes after administration of immuniztions.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Oedema
Clinical narrative: Presents a 0,5cm area of edema located 1cm distance of site of vaccine administration immediately after vaccine administration.  Applied local ice in office. Adviced to follow up if any additional symptoms.
Age: 29.0
Sex: F
Vaccine: MMR, TD
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: From the recipient's phone log. Dr.'s practice manager, Dr., Pt = Patient 7/31/08 Pt called c/o pain & swelling near sight of Td left arm that began today.  Records show Td given 7/25/08.  Pt had left arm pain for 2 days following the shot that resolved.  Discussed with Dr.  Appt planned for tomorrow.  7/31/08 17:00 I spoke with Pt.  Pt now states that her left arm pain and swelling has been continuous since receiving the shot, worsened on the 29th, and even wakes her up from sleep.  I told her this is a VAERS-reportable incident and she should report it (I will also) and that she definitely should see a doctor for this.  She decided that she will keep her appt with me tomorrow.   8/1/08 I called Pt to confirm today's appt and left message.    8/1/08 Pt called back and cancelled today's appt noting that she was "too busy" to keep it.  Was advised to reschedule for early next week and to go to urgent care or ER in the interim if Pt feels that cannot wait.  Dr. aware.   Postscript:  Recipient never rescheduled her appointment to have her arm examined by Dr.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Parent called 8/14/08 to report RUA is red swollen, warm. Advised ibuprofen as needed.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Pruritus, Rash erythematous
Clinical narrative: patient felt tired (worse with 1st) after 1st and 2nd doses of anthrax-after second patient developed erythematous rash on trunk along with itching 1-2 days after 2nd dose-no other systemic symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Vomiting
Clinical narrative: PT WAS GIVEN HPV IN L-ARM ON 8/12/2008 PT THEN RETURNED TO OUR OFFICE ON 8/13/2008 C/O BEING DIZZY, VOMITING, HEADACHE, AND DIARRHEA. C/O FEELING TIRED SINCE THE SHOT. ADVISED PT TO MODIFY DIET AS TOLERATED AND TO CALL IF PT STARTS HAVING SEIZURES OR SEVERE WEAKNESS
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Malaise, Pain
Clinical narrative: 24 hours after gardisil feels unwell with abdominal pain, ackey, sore decresed energy lasting approx 1 to 2 days
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Influenza like illness, Malaise, Pain
Clinical narrative: 24 hours after 2nd HPV injection patient became ill with flu like symtoms, body aches, abdomial pain, decreased energy, generlly feeling unwell.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Malaise, Pain
Clinical narrative: 24 hours after injection patient again felt unwell with body aches,decreased energy,  and abdominal pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Oedema peripheral
Clinical narrative: One day after zostavax was administered to this patient, she called the pharmacy to talk about her "swelling arm". I asked the patient to come into the pharmacy so I could examine the injection site. The back of her left arm, where the injection was given, was slightly raised from swelling and red in an uneven circle. The diameter of the red spot was approximately 1 and 1/2 inches. I told the patient she was suffering from an injection site reaction, and not to worry terribly. I advised her to take two 500mg tablets of acetaminophen to help relieve any pain is she was experiencing any. I also told her to follow up with her physician if the area of reness got bigger and if her arm began to swell even more.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Dizziness for several days, onset the day after the vaccine was given.  No syncope.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug
Clinical narrative: Dizziness for several days, onset the day after the vaccine was given.  No syncope.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Pallor, Skin warm, Tenderness, Testicular swelling
Clinical narrative: 5IN BY 3.5IN SWELLING IN UPPER LEFT THIGH/PINK/ WARM TO TOUCH/ SURROUNED BY PALE BORDER/NEEDLE MARK IN THE MIDDLE/MINIMAL TENDERNESS TO DEEP PALPATION/NO INGUINAL LYMPH NODES TO PALPITATION
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Blood pressure orthostatic, Dizziness, Fall, Feeling hot
Clinical narrative: Per Nurse Record: Nurse Stat called to front desk. When RN arrived, found pt flat on back on floor, verbal and responding to questions. Per other observers, pt was standing at the desk, her eyes rolled back, and she fell to the floor. This was about 5 minutes after receiving Gardasil injection at 330pm. Pt was immediately evaluated by MD and NP.  BS 150; O2sat98%; Oxygen face mask was applied.  RN called 911, but the pt declined these services and the call was not completed. MD advised pt that 911 should be called and she should be evaluated for r/o seizure and for the trauma to her head. She again declined 911 services and said her boyfriend would take her to the ER.   She states she got her gardasil shot, felt fine, walked out of the room, states she became dizzy/nausea/hot, then she fell, when she came to she said it "felt like she was in a dream", then "flashes of images" orthostatics: 112/80; 80 lying 110/80; 82 sitting 110/80; 88 standing  Now pt c/o pain to back of head, slightly nauseated. Pt's boyfriend arrived within 30 minutes and spoke to both NP and MD, who both advised that pt should be seen immediately in ED. Her boyfriend states he will take her now.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Headache, Nausea, Oxygen saturation normal, Oxygen supplementation
Clinical narrative: Per Nurse Record: Nurse Stat called to front desk. When RN arrived, found pt flat on back on floor, verbal and responding to questions. Per other observers, pt was standing at the desk, her eyes rolled back, and she fell to the floor. This was about 5 minutes after receiving Gardasil injection at 330pm. Pt was immediately evaluated by MD and NP.  BS 150; O2sat98%; Oxygen face mask was applied.  RN called 911, but the pt declined these services and the call was not completed. MD advised pt that 911 should be called and she should be evaluated for r/o seizure and for the trauma to her head. She again declined 911 services and said her boyfriend would take her to the ER.   She states she got her gardasil shot, felt fine, walked out of the room, states she became dizzy/nausea/hot, then she fell, when she came to she said it "felt like she was in a dream", then "flashes of images" orthostatics: 112/80; 80 lying 110/80; 82 sitting 110/80; 88 standing  Now pt c/o pain to back of head, slightly nauseated. Pt's boyfriend arrived within 30 minutes and spoke to both NP and MD, who both advised that pt should be seen immediately in ED. Her boyfriend states he will take her now.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Patient experienced swelling of the R arm.  Denies any pain or discomfort of the limb.  No decrease in mobility.  Per CDC recommendations, mother is icing and elevating limb.  CDC also recommends follow up with family physician for treatment with NSAIDS if symptoms persist or worsen.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Feeling hot, Injected limb mobility decreased, Local swelling, Pain
Clinical narrative: Patient received vaccine the afternoon of 11 Aug 08. Patient notice local redness, warmth, swelling and pain the following morning. I evaluated the patient that day and noted normal reaction to the vaccine but advised the patient to return if his symptoms worsen. He returned to me on 14 Aug 08 with redness extending to elbow, arm limitation, increase in pain but afebrile. Patient was treating symptoms with Motrin 400mg. I started patient on anti-histamines (Hydroxyzine 25mg). Since patient also required anti-malarial medications for his deployment, he started Doxycycline 100mg earlier then expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella disease despite 2 varicella vaccines. Just to note, sibling had the varivax vaccine two weeks ago.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Child presented with rash it does not seem to be associated with the fever or itching.  Has gotten progressively worse and began about 48 hours after being immunized with her one year shots.  She seems to be otherwise well. No new foods, detergents, exposures to others with illness.    No one else has a similar rash. No known allergies.  No new medications, including no fluoride.Child treated with benadryl.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: 3 days after first primary immunization, patient developed urticaria from lower abdomen to lower extremeties. No accompanying fever, excessive crying, pruiritus.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: L deltoid area very red swollen and warm to the touch 3 days after injection per her mother's phone call report.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Local swelling
Clinical narrative: Local reaction L upper arm with 8cmx8cm erythema, warmth and slight swelling.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Headache, Muscular weakness, Pain in extremity
Clinical narrative: Pain behind knees down back of legs into calves, arms weak, headache started around 2200 on evening of vaccine and continues to 8-13-2008 at 9:35 am time of MD visit.  MEDICATION PRESCRIBED: Analgesic antipyretics, also stay home 8-13-08 and 8-14-08  11/04 Phone call w/reporter reveals patient had completely recovered from rash by 9/2008. No further evidence of any AE.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Amnesia, Arthralgia, Arthritis, Chest pain, Diarrhoea
Clinical narrative: Headache, joint pain, arthritis, fibromyalgia, skin rashes and lesions, chronic fatigue, insomnia, severe pain, diminished vision, feeling like body being crushed, diarrhea, vomiting, extremes in weight gain and loss, unexplained rash, chest pain, shortness of breath, walk with a cane, mouth sores, memory loss, muscle cramps, just to list some of them.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Fibromyalgia, Headache
Clinical narrative: Headache, joint pain, arthritis, fibromyalgia, skin rashes and lesions, chronic fatigue, insomnia, severe pain, diminished vision, feeling like body being crushed, diarrhea, vomiting, extremes in weight gain and loss, unexplained rash, chest pain, shortness of breath, walk with a cane, mouth sores, memory loss, muscle cramps, just to list some of them.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Insomnia, Muscle spasms, Pain, Rash, Skin lesion
Clinical narrative: Headache, joint pain, arthritis, fibromyalgia, skin rashes and lesions, chronic fatigue, insomnia, severe pain, diminished vision, feeling like body being crushed, diarrhea, vomiting, extremes in weight gain and loss, unexplained rash, chest pain, shortness of breath, walk with a cane, mouth sores, memory loss, muscle cramps, just to list some of them.
Age: 42.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Stomatitis, Visual acuity reduced, Vomiting, Walking aid user, Weight fluctuation
Clinical narrative: Headache, joint pain, arthritis, fibromyalgia, skin rashes and lesions, chronic fatigue, insomnia, severe pain, diminished vision, feeling like body being crushed, diarrhea, vomiting, extremes in weight gain and loss, unexplained rash, chest pain, shortness of breath, walk with a cane, mouth sores, memory loss, muscle cramps, just to list some of them.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash, Skin lesion
Clinical narrative: Left outer leg rash/lesion.  Mother stated rash same appearance as seen on tv for rash reaction to immunization.  8/26/08 Reviewed PCP medical records of 8/4/2008. FINAL DX: vascular rash Records reveal patient experienced left outer leg & back rash x 1 week. Received Hep A & Varicella vaccines tha
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash macular, Rash pruritic
Clinical narrative: AVA # 1 and Typhoid on 11 Jul 08, SPV on 15 Jul, and AVA # 2 on 25 Jul 08. He was seen by pcm on 31 Jul for a resolving puritic rash on his forehead, neck, and arms that was described as fine tan/brown macules, received AVA # 3 on 8 Aug and to date there is no documentation of recurrence of rash. Symptoms: Lesions, macule, Pruritus.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Developed fever up to 102 degrees around 7-8 PM, vomited 4-5 times during the night until 5-6 am, has rash to both legs. No ER/MD visit.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Neck pain, Pain, Skin nodule
Clinical narrative: Tdap given IM Lt deltoid on 8-12-08.  That night she noticed dime size sore knot to Lt neck, below skull (lymph node?), also c/o joint pain, tiredness, aches.  Today, 8-14-08, continues to c/o sore, dime size knot to Lt neck.  Referred to MD for evaluation.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Mother called 8/13/08 late am said patient awoke today 8/13/08 with T-100.2 and hive rash with itching. No dyspnea. Instructed take Benadryl, Tylenol or Advil - call doctor. If problems breathing go to ER. I called mom 8/14/08 am patient took Benadryl this am rash - hives gone, no fever; itching better. Mother to call if any problems or patient not better.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abscess, Abscess drainage, Lymphadenopathy, Oedema peripheral
Clinical narrative: Sterile abscess with drainage. Swollen supraclavicular lymph nodes. Swelling right arm (mild).