chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Gastrointestinal hypomotility, Haemangioma, Haemangioma of liver, Hepatobiliary scan, Impaired gastric emptying
Clinical narrative: Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety.  The symptoms never resolved and that patient has chronic nausea and early satiety.  Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and imparied Gastric Accomodation.  After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety. 03/29/07-records received from patient/reporter. Dates of service for multiple ED visits, PCP visits and GI procedures. 01/20/04-9/10/06 DX: Nausea, vomiting and anorexia of unclear etiology. weight loss, liver hemangiomas. Chronic nausea with dyspeptic symptoms with impaired gastric accommodation. HX: chronic mild episodic nausea for years without significant vomiting. Idiopathic gastroparesis with pacemaker placement. Per information received from annual follow up: My husband continues to suffer from gastroparesis; unfortunately, he recently developed POT syndrome immediately after surgery. This could also be due to a damaged vagus nurve, which in theory, could have occurred during a temporary autoimmune response after the vaccination.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Nerve injury, Neurostimulator implantation, Postural orthostatic tachycardia syndrome, Viral infection
Clinical narrative: Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety.  The symptoms never resolved and that patient has chronic nausea and early satiety.  Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and imparied Gastric Accomodation.  After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety. 03/29/07-records received from patient/reporter. Dates of service for multiple ED visits, PCP visits and GI procedures. 01/20/04-9/10/06 DX: Nausea, vomiting and anorexia of unclear etiology. weight loss, liver hemangiomas. Chronic nausea with dyspeptic symptoms with impaired gastric accommodation. HX: chronic mild episodic nausea for years without significant vomiting. Idiopathic gastroparesis with pacemaker placement. Per information received from annual follow up: My husband continues to suffer from gastroparesis; unfortunately, he recently developed POT syndrome immediately after surgery. This could also be due to a damaged vagus nurve, which in theory, could have occurred during a temporary autoimmune response after the vaccination.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety.  The symptoms never resolved and that patient has chronic nausea and early satiety.  Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and imparied Gastric Accomodation.  After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety. 03/29/07-records received from patient/reporter. Dates of service for multiple ED visits, PCP visits and GI procedures. 01/20/04-9/10/06 DX: Nausea, vomiting and anorexia of unclear etiology. weight loss, liver hemangiomas. Chronic nausea with dyspeptic symptoms with impaired gastric accommodation. HX: chronic mild episodic nausea for years without significant vomiting. Idiopathic gastroparesis with pacemaker placement. Per information received from annual follow up: My husband continues to suffer from gastroparesis; unfortunately, he recently developed POT syndrome immediately after surgery. This could also be due to a damaged vagus nurve, which in theory, could have occurred during a temporary autoimmune response after the vaccination.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoxia, Respiratory disorder, Respiratory distress
Clinical narrative: Initial report received on 21 December 2006 from a health care professional. A 51 year old male patient had received a right deltoid injection of Fluzone SV 2006-2007, lot number U2280AA, on 30 November 2006. Fourteen days later, the patient developed weakness and was examined in an emergency room. The site of the weakness was not identified. He was discharged to home and returned the following day with complaints of weakness and respiratory distress. He was admitted to the hospital and diagnosed with Guillain Barre syndrome. Per the reporter, the patient is currently on a ventilator with respiratory complications. There had been no illness at the time of vaccination. and no prior history of Guillain Barre syndrome. Other past medical history and other medications were unknown. At the time of this report, the patient had not recovered.
Sex: F
Vaccine: TYP
Symptoms: Erythema, Flushing, Injection site erythema, Oedema, Pruritus
Clinical narrative: Vaccine dispersed 12/11/06. First dose taken 12/21 at 2PM, Pt felt flushed 2 hours after, needle area red, resolved on it's own. 2nd dose on 12/24 at 2am, woke up at 7am SX included bilateral swollen knees, red as well. Palms itchy, red, arms itchy resolved with Benadryl. No hives appeared. Knee swelling resolved after 3 days Benadryl.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Crying, Screaming, Sleep disorder
Clinical narrative: In 12/01/06, child received Dtap, Hib, Prevnar and Hep A. Child had received all of these vaccines in past without problems. Within 24 hours of vaccines, child with screaming fits daily lasting 30 min to 1 hour and frequent night waking. Behavior continues child seen for issues on 12/29/06.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Laboratory test abnormal, Lymphadenopathy, Pharyngolaryngeal pain, Pruritus
Clinical narrative: L groin itching, raised rash. Spread to entire Abd, chest, buttock, lower back and both arms, Left ear ache and sore throat, swollen neck glands.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: L groin itching, raised rash. Spread to entire Abd, chest, buttock, lower back and both arms, Left ear ache and sore throat, swollen neck glands.
Age: 1.19
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Coma
Clinical narrative: Pt found unresponsive in bed at end of a nap, unable to resuscitate, went to ER and death pronounced.  4/6/07 Received Autopsy Report which reveals COD as Undetermined.  Had flu like symptoms for few days prior to death.  Found face down on mattress on floor of nursery in home.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Emphysema, Feeling cold, Pyrexia
Clinical narrative: 90 minutes after receipt of flu vaccine, pt complained of SOB and felt cold. Pt with prior diagnosis of COPD. Refused medical treatment. Took breathing Rx as prescribed for chronic condition. Next day had fever 100.2 F and persistent complaints of SOB. Refused to seek medical treatment. Expired later in day approximately 29 hours after immunization.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Sudden onset severe headache lasting approximately 48 hrs, which aspirin did not help.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Muscle spasms, Pain
Clinical narrative: That night I started aching up left arm and into neck next am. Then each day following it felt like spasms in back, shoulder working all down my back for nearly 1 week. The neck stayed for 2 weeks. Got headaches towards end. Bed rest.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Pt called 12/20/06 and reported that on the evening of 12/18/06 she developed generalized itching and hives, no other symptoms. She was instructed to take 25mg Benadryl Q 6H when needed. No further vaccinations will be administered per Dr.p report has been received from a registered nurse concernng a 31 year old female with drug allergies to DEPAKOTE, LORTAS, NEURONTIN, VALIUM and FIORICET. On 18-DEC-2006 (also reported as 18-DEC-1976) the patient was vaccinated with her first dose of GARDASIL (Lot number 65450/1161F) intramuscularly in the left deltoid. On 18-DEC-2006 in the eveneing, the patient experienced generalized itching and hives. The patient was instructed to take BENADRYL 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional informationis not expected.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt called 12/20/06 and reported that on the evening of 12/18/06 she developed generalized itching and hives, no other symptoms. She was instructed to take 25mg Benadryl Q 6H when needed. No further vaccinations will be administered per Dr.p report has been received from a registered nurse concernng a 31 year old female with drug allergies to DEPAKOTE, LORTAS, NEURONTIN, VALIUM and FIORICET. On 18-DEC-2006 (also reported as 18-DEC-1976) the patient was vaccinated with her first dose of GARDASIL (Lot number 65450/1161F) intramuscularly in the left deltoid. On 18-DEC-2006 in the eveneing, the patient experienced generalized itching and hives. The patient was instructed to take BENADRYL 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional informationis not expected.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Infection, Injection site erythema, Injection site pustule, Malaise, Rash maculo-papular
Clinical narrative: Received vaccine 12/05/06 read a major RX 12/12/06, on 12/14 developed macular papular rash arms legs, neck, face, scalp, vaccine site erythematous with 3" surrounding pustule, malaise , RX with Zytec/2pack. Re eval 12/18 no significant healing of lesions, few new lesions neck, forehead, scalp. Meds to Rifanpril. Bactrim R/O MRSA, Reval 12/21 lesions healing, no new lesions. Diag Skin infection. R/O MRSA. Unclear if related to vaccine.
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Skin disorder, Skin ulcer
Clinical narrative: Received vaccine 12/05/06 read a major RX 12/12/06, on 12/14 developed macular papular rash arms legs, neck, face, scalp, vaccine site erythematous with 3" surrounding pustule, malaise , RX with Zytec/2pack. Re eval 12/18 no significant healing of lesions, few new lesions neck, forehead, scalp. Meds to Rifanpril. Bactrim R/O MRSA, Reval 12/21 lesions healing, no new lesions. Diag Skin infection. R/O MRSA. Unclear if related to vaccine.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Rash, Rash macular, Rash pruritic
Clinical narrative: Mom reported that pt broke out with rashes from his torso down to his legs. Blotchy red itching, burning sensation. Mom stated at 2pm, he was also weak. This am all rashes resolved and not feeling weak anymore.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Mom reported that pt broke out with rashes from his torso down to his legs. Blotchy red itching, burning sensation. Mom stated at 2pm, he was also weak. This am all rashes resolved and not feeling weak anymore.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Rash
Clinical narrative: Pain, redness, swelling right upper arm. Pt saw her doctor on 12/20/06 and placed on Cipro 500 mg PO X07 days and Motrin 800 mg PO. Pt states she is better has rash, has very sensitive skin.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin disorder
Clinical narrative: Pain, redness, swelling right upper arm. Pt saw her doctor on 12/20/06 and placed on Cipro 500 mg PO X07 days and Motrin 800 mg PO. Pt states she is better has rash, has very sensitive skin.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Varicella disease about 200 lesions.
Age: 1.27
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Received varicella vaccine left thigh on 12/12/06. PT RTO 12/22/06 with redness left thigh size of quarter.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fracture, Injury, Nausea, Syncope
Clinical narrative: Information has been received from a 21 year old female with no pertinent medical history or drug reactions/allergies, who on 13 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. Concomitant therapy included Zyrtec and Yasmin. On 13 Nov 2006, following vaccination, the patient felt nauseous and dizzy. As she went out of the room to check out, the patient fainted and broke her nose and got a cut under eye. The patient reported that she was on the floor for seven to eight minutes before she woke up. The patient reported that she had to get her nose fixed and received some stitches afterward. At the time of this report, the patient was recovering. Upon internal review, the facial bones fracture which required surgery was felt to be an other important medical event (OMIC). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Joint swelling, Myalgia, Urinary tract infection, Viral infection
Clinical narrative: Information has been received from a physician concerning her 18 year old daughter with a history of HPV and acne who at the beginning of October 2006, was vaccinated with a dose of HPV vaccine. Concomitant therapy included Yasmin and Minocin. One week later, the patient developed a urinary tract infection. Two weeks after vaccination, she had an acute onset of arthritis. She had significant swelling of her finger joints and generalized myalgia. She had blood work to include viral antibody titers which were positive for parvo virus, Epstein Barr and Cytomegalovirus. The patient was treated with steroids and anti inflammatory drugs. At the time of the report she had not recovered. The reporter considered the events to be disabling and other important medical events (OMIC). Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye irritation, Eye oedema, Face oedema
Clinical narrative: Initial report received on 20 December 2006, from the patient. A 34 year old female patient with no known allergies, no concurrent illnesses, no pre existing medical history, and who was not taking any medications, had received a right deltoid (route of administration not reported) dose of Fluzone SV 2006-2007 USP, lot number U2199AA on 14 December 2006, around 4:00 to 5:00 pm. Approximately two to three hours post immunization, the patient developed a fever, burning eyes, cough, difficulty breathing, and swelling of her eyes and lips. She was treated in the emergency room with Epinephrine, steroids, and Benadryl. The patient denied having any other vaccinations within four weeks of the vaccination on 14 December 2006. The reporter was unsure of the number of past flu vaccinations the patient had received, but did report there were no adverse events with any past vaccinations. At the time of this report, the patient had recovered.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received on 20 December 2006, from the patient. A 34 year old female patient with no known allergies, no concurrent illnesses, no pre existing medical history, and who was not taking any medications, had received a right deltoid (route of administration not reported) dose of Fluzone SV 2006-2007 USP, lot number U2199AA on 14 December 2006, around 4:00 to 5:00 pm. Approximately two to three hours post immunization, the patient developed a fever, burning eyes, cough, difficulty breathing, and swelling of her eyes and lips. She was treated in the emergency room with Epinephrine, steroids, and Benadryl. The patient denied having any other vaccinations within four weeks of the vaccination on 14 December 2006. The reporter was unsure of the number of past flu vaccinations the patient had received, but did report there were no adverse events with any past vaccinations. At the time of this report, the patient had recovered.
Sex: M
Vaccine: FLU3
Symptoms: Encephalitis, Influenza like illness
Clinical narrative: Initial report received on 22 December 2006 from a healthcare professional. A male patient received on 22 November 2006 Fluzone (lot number not provided). 2 days later, on 24 November 2006, the patient experienced flu like symptoms. 21 days post vaccination, on 13 December 2006, the patient was admitted to the hospital and diagnosed with encephalitis. Patient's outcome was not reported. No other information was provided.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac arrest
Clinical narrative: 11-12-06 Cardiac Arrest 3/26/07 Received Death Certificate which reveals COD as cardiac dysrhythymia & myocardial infarction with contributing factor of diabetes.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Convulsion, Hypoxia, Musculoskeletal stiffness, Tremor
Clinical narrative: Per pt's mother around 6PM the child developed seizure like activity. She became stiff then started shaking and stopped breathing for about a minutes. Medic was called and came. The baby received oxygen and was not transported to the hospital. 01/22/07-records received and reviewed from Dr. for DOS 12/27/06-Assessment:possible seizure reaction to vaccines.  HX:seizure like episode at 6pm parents state she became pale, eyes shifting in the back of her head body became stiffened. Highest fever through the night 100.7.  Plan: She may have had a reaction to the DTAP component of the vaccine. Will not give her the Pediarix combination and just separate the vaccines.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, TDAP
Symptoms: Heart rate irregular, Syncope
Clinical narrative: Client here for school vaccines. Administered vaccines per protocols. After vaccines adm, client fainted. Pulse 40 and thready. BP 60/? faint. 911 called. Paramedics transported pt to ER b/c recovery time prolonged.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Vesicles/Rash probable vaccine related per Dr provider, examined in hospital ER to clear for return to work. Rash noted back of neck, forehead, arms and thighs. Seen by ER doctor.
Age: 1.26
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Blister, Dermatitis bullous, Diarrhoea, Injection site vesicles, Skin disorder
Clinical narrative: Vesicles on face, abdomen and right thigh (at injection site). Diarrhea (beginning on 12/31/06).
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Injection site area erythema, inflammation, and warm/tender to the touch. Area raised and "size of a softball" (approx. 5 inches in diameter, circular). Reaction started 24 hours post vaccination, worsening through 48 hours post. Denies any systemic reactions. Office visit at 48 hours post, treated with Benadryl, ibuprofen, and ice.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: 12/05/06 Pt. called had flu shot on 11/29/06.  Has had muscle soreness in left upper arm down to forearm since.  Denies redness, swelling, fever.  Pt. said she exercised arm after injection and I told her this could have aggravated area.  Pt. to call back if she continues to have problems.  1/2/07 Called pt. back re: left arm.  Says she is still having muscular pain, described as a "toothache" type pain that has awakened her at night-she describes this as a deep muscle ache.  She says that pain has gotten better, but she notices it more when she goes to put on her seat belt and has to reach across to put on her seat belt.  Advised pt. to see her PCP, but she has Medicare and says that the co-pay is too much (when inquired, pt. told me it is $15)-she is concerned about cost of any tests that may be incurred.  Explained that it was very important to see a physician, especially since it has been over a month since the injection was given.  Pt. voiced understanding, but is afraid of costs she may incur.  She says it has not affected her work (she is retired and only works occasionally).  Asked pt. to call me back in 2 weeks if I had not called her back.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Condition aggravated, Hemiparesis
Clinical narrative: Stable and quiescent myesthenia gravis became active with right-sided weakness, pt. now unable to walk. 02/13/07-records received and reviewed for DOS 11/14-11/22/06 DC DX:Myasthenia gravis crisis Progressive weakness Respiratory distress Ileus Treated with IVIG, prednisone and mestinon. Reguired intubation and ventilator support. History of IgA deficiency. History of present illness; 24 hours after flu shot, right droopy eyelid and some left hand weakness. Has received flu shots for past 10 years without any problems. On 11/4 Seen in urgent care and treated with Mestinon. REsolved quickly. 11/6 seen in neurolgoist office with right upper extremity weakness, right ptosis and started on steroids. Weaknesses continued, unable to walk, diplopia. bilateral lower extremity weakness no complaint of headache, most recent seizure in September. PE:decreased grip strength on right, decreased strength of flexion and extension of biceps on right. Unable to move lower extremities bilaterally except for wiggling of toes. Slight abduction at hips bilaterally. Unable to produce any other movement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Swelling
Clinical narrative: Child had MMR & IPV in right arm on 7/19/06.  Mom called 7/20/06 said child had swelling & redness on his right arm.  Discussed to use ice packs and to call Dr. if it got any worse.  7/21/06 Mom took child to the Dr.  R. arm was red & swollen from shoulder to elbow.  Child was given an antihistamine and a steroid for relief.  7/25/06, spoke with Mom by phone.  States his arm is much better.  No sign of his reaction is left.  Immune records were sent to doctor.  Mom aware of which shots were given in each arm.
Age: 60.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Patient called on 1/02/07, to report having a rx to the Hepatitis A & B, Adult Dose vaccination she received on 12/29/07. The patient reported seeing hives appear on each arm around the vaccination area the evening of the vaccination; however, she denies any problems with the hives itching.  The vaccinations were given 12/29/07 approx. 8:45 AM. No unusual events were indicated or reported during the vaccination appointment.
Age: 1.16
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Multiple vesicular lesions in different stages of healing on trunk and thigh - crust on two - less than 10 lesions total.
Age: 1.0
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Erythema, Rash vesicular, Skin ulcer
Clinical narrative: Mulitple vesicular lesions on an erythematous base on trunk.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Cough, Fatigue, Injection site swelling, Respiratory disorder
Clinical narrative: Swollen at injection. Respiratory problems. Tightness in chest & coughing. Fatigue.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Muscle twitching, Screaming
Clinical narrative: Immunes given at noon.  Child woke at 4:15 pm screaming for 1 hour.  Tylenol given.  Very sensitive to touch remainder of evening.  Mom noted some "twitchy" activity.  Tylenol given q4h no further screaming and seems normal 9/12/06 am.
Age: 0.82
Sex: M
Vaccine: PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: Parents stated that on 9/7/06 that they did not want may more pneumococcal shots because child had gotten very ill after first 2 injections.  After first injection within 12 hjours infant had tmep of 103-104 and was very lethargic.  After second injection temp didn't go up as quickly but went to 103-104 again and child became lethargic again.  The first time it lasted about a week.  The second time 3 to 4 days.  On the date of the sencond set of immunizations the parents told me he had had a high fever and that he had been seen in the E.R.  Dr. told them his illness had nothing to do with the immunizations.  I went ahead & gave the second prevnar on 5/2/06.  That is the only vaccine he received that day.  The parents did not notify me of any problem after that immunization until 9/7/06 when they brought him in for his MMR & Varicella vaccines and said they didn't want anymore pneumococcal vaccine.  Infant's grandmother is an R.N. and had observed behavior following both sets of immunizations and had advised them not to give him any more pneumococcal vaccine.  I do not believe they took him to Dr. following second dose.
Age: 45.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Hypokinesia, Injury, Pain, Swelling
Clinical narrative: I HAD A 2ND DEGREE BURN ON MY RIGHT FOOT DUE TO HOT WATER AND WENT TO THE EMERGENCY ROOM. I GOT A TETANUS SHOT( I DON'T KNOW WHICH KIND TETANUS SHOT) ON MY RIGHT ARM AND OMNICEF FOR THE INFECTION AND HYDROCODONE  FOR THE PAIN. AFTER ONE WEEK MY RIGHT ARM SWOLLEN WITH REDNESS AND A LOT OF PAIN. I HAVE NO IDEA WHY I GOT THE PAIN AND THE SWOLLINING AFTER A WEEK. MY RIGHT ARM IS STILL SWOLLEN AND I CAN'T DO ANYTHING USING MY RIGHT ARM.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Hypokinesia, Pain
Clinical narrative: According to patient, approximately 5 hours post immunization experienced chills, fatigue, fever (101.2) and redness, swelling and soreness in the affected arm;unable to raise arm above her head. Saw her personal MD who placed her on antibiotics (Bactrim). By the following day, the arm was less swollen and red and the patient was released by her physician to go on vacation.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: According to patient, approximately 5 hours post immunization experienced chills, fatigue, fever (101.2) and redness, swelling and soreness in the affected arm;unable to raise arm above her head. Saw her personal MD who placed her on antibiotics (Bactrim). By the following day, the arm was less swollen and red and the patient was released by her physician to go on vacation.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: According to patient, approximately 5 hours post immunization experienced chills, fatigue, fever (101.2) and redness, swelling and soreness in the affected arm;unable to raise arm above her head. Saw her personal MD who placed her on antibiotics (Bactrim). By the following day, the arm was less swollen and red and the patient was released by her physician to go on vacation.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: According to patient, approximately 5 hours post immunization experienced chills, fatigue, fever (101.2) and redness, swelling and soreness in the affected arm;unable to raise arm above her head. Saw her personal MD who placed her on antibiotics (Bactrim). By the following day, the arm was less swollen and red and the patient was released by her physician to go on vacation.
Age: 17.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Injection site warmth, Muscle spasms, Pyrexia, Swelling
Clinical narrative: Pt. received the MCV4 vaccine on Wednesday 12-06-06 and Thursday AM Pt. had a low grade temp of 99.3. By Thursday PM he had a temp of 102. Friday he had muscle spasms in his arm, swelling of 4", and area was very warm. Friday PM Temp was 99.3 By Saturday AM all swelling was gone no further muscle spasms, and no temp.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Erythema, Feeling hot, Skin nodule
Clinical narrative: KNOT ON LEFT THIGH REDNESS, WARM TO TOUCH.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Oedema peripheral
Clinical narrative: Mom called 9/28/06 at 1520 states left arm red, hard, swollen from shoulder to almost the elbow.  To Dr 9/28/06 at 1700.  Given Benadryl.  10/03/06 Mom states arm o.k. now.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: 10/2/06 seen.  Diagnosed with Varicella Had Varicella vaccine 5/10/06.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: Just learned of this reaction today 10-19-06.  Guardian reported adverse reaction to 3rd DtaP given 9/11/06.  Fever 103-104 - muscle aches and lethargy.  Was taken to ER 9-12-06.  Guardian was adament that her reactions were d/t the immunizations not the sore throat seen in the E.R.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles-like rash over body started 12/21/06.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Anaemia, Blood testosterone decreased, Cachexia, Drug ineffective, Fatigue
Clinical narrative: This case was reported by a physician and described the occurrence of transverse myelitis in a 55 year old male subject who was vaccinated with Engerix B. The reporter is the subject. The subject's medical history included asthma, back disc problems, benign prostatic hyperplasia, elevated blood pressure, elevated cholesterol, and meningioma which was removed in 2004. Concurrent medications included Lipitor that the subject has taken for 10 years, Levoxyl, Norvasc, Flomax, Altace, Singulair, Avodart, Advil. On an unspecified date 15 to 20 years prior to the date of reporting, 20 December 2006, the subject received the 3rd dose of Hepatitis B vaccine (unknown manufacturer( with no problems. On an unspecified date in 2005, a Hepatitis B surface antibody titer was negative. On 15 December 2005, the subject received the 4th dose of Engerix B. On an unspecified date in May 2006, approximately 4 months after the 4th dose of Engerix B, a hepatitis B surface antibody titer was again negative. On 07 June 2006, the subject received the 5th dose of Engerix B. On 07 July 2006 and the subject received 6th dose of Engerix B. On an unspecified date in late July 2006, less than one month after the 6th dose of Engerix, the subject experienced weight loss which ultimately resulted in a loss of 15 pounds, fatigue, muscle pain, and muscle wasting. The subject also experienced a loss of sense of well being, and was unable to perform surgery. The subject was seen by a rheumatologist, infectious disease physician, neurologist, and endocrinologist. On an unspecified date after July 2006, the subject had an extensive work up including a computed tomography scan, magnetic resonance imaging, myelogram, bone marrow biopsy, and blood work, which ruled out cancer, Amyotrophic lateral sclerosis, adrenal insufficiency, pituitary insufficiency, and Lyme disease. The blood work was notable for low testosterone. The subject was diagnosed with transverse myelitis. The physician considered the events were disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with testosterone, the subject subsequently experienced anemia and was treated with epcetin alfa (Procrit). The weight loss resolved on an unspecified date in November 2006. At the time of initial reporting 28 December 2006, the other events were improved and the subject "feels 80 percent better." On an unspecified date in 2006, after July 2006, a hepatitis B surface antibody titer was "300." The physician reported that, the timing and onset of the symptoms is consistent with receiving the vaccine. The subject discontinued therapy with Lipitor in October 2006. The physician feels the issues may not be related to Lipitor because there were no creatine phosphokinase elevations.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Muscle disorder, Myalgia, Myelitis transverse, Weight decreased
Clinical narrative: This case was reported by a physician and described the occurrence of transverse myelitis in a 55 year old male subject who was vaccinated with Engerix B. The reporter is the subject. The subject's medical history included asthma, back disc problems, benign prostatic hyperplasia, elevated blood pressure, elevated cholesterol, and meningioma which was removed in 2004. Concurrent medications included Lipitor that the subject has taken for 10 years, Levoxyl, Norvasc, Flomax, Altace, Singulair, Avodart, Advil. On an unspecified date 15 to 20 years prior to the date of reporting, 20 December 2006, the subject received the 3rd dose of Hepatitis B vaccine (unknown manufacturer( with no problems. On an unspecified date in 2005, a Hepatitis B surface antibody titer was negative. On 15 December 2005, the subject received the 4th dose of Engerix B. On an unspecified date in May 2006, approximately 4 months after the 4th dose of Engerix B, a hepatitis B surface antibody titer was again negative. On 07 June 2006, the subject received the 5th dose of Engerix B. On 07 July 2006 and the subject received 6th dose of Engerix B. On an unspecified date in late July 2006, less than one month after the 6th dose of Engerix, the subject experienced weight loss which ultimately resulted in a loss of 15 pounds, fatigue, muscle pain, and muscle wasting. The subject also experienced a loss of sense of well being, and was unable to perform surgery. The subject was seen by a rheumatologist, infectious disease physician, neurologist, and endocrinologist. On an unspecified date after July 2006, the subject had an extensive work up including a computed tomography scan, magnetic resonance imaging, myelogram, bone marrow biopsy, and blood work, which ruled out cancer, Amyotrophic lateral sclerosis, adrenal insufficiency, pituitary insufficiency, and Lyme disease. The blood work was notable for low testosterone. The subject was diagnosed with transverse myelitis. The physician considered the events were disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with testosterone, the subject subsequently experienced anemia and was treated with epcetin alfa (Procrit). The weight loss resolved on an unspecified date in November 2006. At the time of initial reporting 28 December 2006, the other events were improved and the subject "feels 80 percent better." On an unspecified date in 2006, after July 2006, a hepatitis B surface antibody titer was "300." The physician reported that, the timing and onset of the symptoms is consistent with receiving the vaccine. The subject discontinued therapy with Lipitor in October 2006. The physician feels the issues may not be related to Lipitor because there were no creatine phosphokinase elevations.
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of mercury poisoning in a male subject aged between 0 and 9 years old who was vaccinated with Engerix B. A physician or other health care professional has not verified this report. The subject was also vaccinated with Hib vaccine, Dtap, OPV, Tetramune, and MMR vaccine. The subject was vaccinated with Engerix B vaccine on 09 April 1993, 13 May 1993 and 19 November 1993. At an unspecified time after vaccination, the subject experienced mercury poisoning. According to the legal complaint, the subject suffered and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were unresolved.
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of mercury poisoning in a male subject aged between 0 and 9 years old who was vaccinated with Engerix B. A physician or other health care professional has not verified this report. The subject was also vaccinated with Hib, Dtpa, OPV, MMR vaccine. The subject was vaccinated with Engerix B vaccine on 16 September 1992, 16 October 1992, and 09 April 1993. At an unspecified time after vaccination, the subject experienced mercury poisoning. According to the legal complaint, the subject suffered and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were unresolved.
Age: 1.15
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: 12/07/2006 pt received MMR, Varivax, Prevnar in our office. No noted adverse reaction to Imm while at office. Pt presented in ER that PM with prolonged febrile seizure. After exam and labs, he was DX viral syndrome, febrile seizure.  MR received for an ER admit for new onset of seizure activity on the day of MMR, Varivax, and Prevnar.  Father noticed child was having difficulty getting off the ground and then began having seizure activity.  He was transported via EMS to the ER.  PE: WNL.  Temp=103. Pulse 179. RR 46.  Not currently having seizure activity. Admitted for observation.  Fever continued however no seizure activity was noted. Discharged home the next day. Discharge DX:  Febrile Seizure. Viral Syndrome.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Petechiae
Clinical narrative: Rt leg discrete Linear petechial rash in subcutaneous tissue spreading caudally. No fever, or systemic problems.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Headache, Myalgia, Nausea
Clinical narrative: Received TC from pt on 12/12/06 at 8:20am, c/o achy muscles, HA, nausea, sharp pains at LA/chest and SOB, stated all S/S since last NOC, at 3 hours post receiving Flu vaccine. Returned to MD ASAP. Spoke to pt after MD eval, stated was told S/S 2 hours to flu vaccine. Sent home with instructions to rest as much as possible and Motrin for pain. IF S/S worsen to ER ASAP.  12/14/06 spoke to pt by PH, states s/s reported on 12/12 now completely resolved.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received TC from pt on 12/12/06 at 8:20am, c/o achy muscles, HA, nausea, sharp pains at LA/chest and SOB, stated all S/S since last NOC, at 3 hours post receiving Flu vaccine. Returned to MD ASAP. Spoke to pt after MD eval, stated was told S/S 2 hours to flu vaccine. Sent home with instructions to rest as much as possible and Motrin for pain. IF S/S worsen to ER ASAP.  12/14/06 spoke to pt by PH, states s/s reported on 12/12 now completely resolved.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dyspnoea, Hypoxia, Vomiting
Clinical narrative: Vomiting, trouble breathing, after giving Rotavirus vaccine.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Eye disorder, Fatigue, Pain, Pruritus, Pyrexia
Clinical narrative: Pt states she developed fatigue, body aches, and rash 2 weeks after she got vaccinated. She also developed itchy eyes and a runny nose (unknown onset). She has had these symptoms for 3 weeks. No treatment intervention so far. Rash on thighs, buttocks, fever for about one month 100F - 101F.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Pt states she developed fatigue, body aches, and rash 2 weeks after she got vaccinated. She also developed itchy eyes and a runny nose (unknown onset). She has had these symptoms for 3 weeks. No treatment intervention so far. Rash on thighs, buttocks, fever for about one month 100F - 101F.
Age: 36.0
Sex: F
Vaccine: FLUX, HEP, TD
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth, Tenderness
Clinical narrative: Left upper arm pustule at site of flu with distal redness, warmth, tenderness.
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Scattered crusted small vesicles to thoracic area.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: C/O pain at site of injection, persisting symptoms 1 month  after with numbness and weakness of arm. No evidence of swelling or ecchymosis/infection.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 18 year old female who on 11 Dec 2006 was vaccinated with the first dose of Gardasil (yeast) (Lot # 653736/0868F). Concomitant therapy included hormonal contraceptives (unspecified). Within 48 hours post vaccination, on approximately 13 Dec 2006 the patient experienced a severe headache. The patient sought unspecified medical attention. The headache was treated with Tylenol and resolved "in one day". Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: MMRV
Symptoms: Medication error, No adverse effect
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 23 week old male who on 28 Dec 2006 was vaccinated PO with the first dose of Rotateq. It was unknown if medical attention was sought. No problems were reported. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Agitation, Crying, Haematochezia, Intussusception
Clinical narrative: Information has been received concerning a 11 week old male with a history of mild atopic dermatitis who on 03 Nov 2006 was vaccinated with an IM first dose in the left thigh of Rotavirus vaccine (lot# 655296/0979F). Concomitant vaccination administered that day included an IM first dose in the left thigh of Daptacel (lot# C249DAA), and IM first dose in the left thigh of Hib/Hep B vaccine (lot# 654802/0681F), an IM First dose in the right thigh of Ipol (lot 20420) and an IM first dose in the right thigh of Prevnar (lot# B08666H). There was no illness at the time of vaccination. On 25 Nov 2006 the patient began with persistent crying. On 26 Nov 2006 the patient awoke with a diaper of blood. Unspecified medical attention was sought. He was diagnosed with intussusception and was hospitalized. He had a partial small bowel resection performed emergently. At the time of the report the patient was still hospitalized. Her outcome was unknown. It was noted that the reporter was unable to assess if the patients adverse event resulted in permanent disability. Persistent crying and intussusception were considered to be immediately life threatening. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met requirements and were released by the regulatory agency. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Feeding disorder neonatal, Haematochezia, Intussusception, Listless, Pallor
Clinical narrative: Information has been received from the agency concerning an 11-month-old female with anemia who on the morning of 14-Nov-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#655174/0848F). Concomitant vaccinations administered on that same day included the first IM dose in the left leg of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL) (Lot#c2650AA), in first IM dose in the right leg of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot#654147/0679F), the first IM dose in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08689D) and the first IM dose in the left leg of poliovirus vaccine activated (IPOL) (Lot#41031). There was no illness or other concomitant drug allergy at the time of vaccination. Prior vaccinations administered on 15-Sep-2006 included the first IM dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). It was reported that on the morning 29-Nov-2006, the patient was noted to be listless, poorly fed and had three bloody mucousy stools. The patient was seen in a physician's office and was described as being pale and listless. The patient was referred to the Pediatric Emergency Room (ER). An air0contrast Barium enema was diagnostic and therapeutic for the patient's intussusception. The patient was subsequently hospitalized for one night. At the time of this report, the patient was considered to be recovered as she was noted to be doing well. The reporter also considered the intussusception to be life-threatening. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lots met requirements of the Center for Biologics Evaluation and Research (CBER) and were released by the regulatory agency. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Dizziness, Flushing
Clinical narrative: Sore throat, slight cough,started less than 3 hours after injection. Paleness, weakness, blurring of vision, dizziness, chills 4 1/2 hours after injection chills. , Tx. Slept 3 hours, still flush & red complexion, elevated temperature so I took 200 mg Ibuprofen. will call MD in AM to report.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Pallor, Pharyngolaryngeal pain, Pyrexia, Vision blurred
Clinical narrative: Sore throat, slight cough,started less than 3 hours after injection. Paleness, weakness, blurring of vision, dizziness, chills 4 1/2 hours after injection chills. , Tx. Slept 3 hours, still flush & red complexion, elevated temperature so I took 200 mg Ibuprofen. will call MD in AM to report.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Pneumococcal immunization (1st dose) was given 7/19/06 in the a.m. (I don't remember location?) The following day (nearly 24 hours later), the patient had developed a mild looking rash on stomach that itched. The rash then began to appear (1-2 hours later) all over the body (including face). Throughout the day it would minimize in an area and then appear again. The patient showed only signs of itching discomfort. There was no fever and no difficulity breathing. The physician's office was contacted by 4-5 p.m. that day and was seen by the physician listed above. It was determined the patient had an allegeric reaction to the vacinne and would not be getting a second dose. A liquid form medicine (steriod) was prescribed. The patient showed signs of relief following the doses, even though it appeared initially more hives were breaking out. Benadryl was administed at night and Claritin-D in the morning.  The hives disappered over the next fews days and the above medicines were given to the patient for approximately a week. The patient showed no other signs of reaction and was fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site vesicles, Swelling
Clinical narrative: Mother stated after receiving immunizations on 12/28/06 she started noticing the pts. right arm swelling that approx. sometime during the evening/night.  She had been giving Motrin for preventative fever measures and then applied cold packs to the area when noticed the swelling but it continued to swell and started radiating down to pts. elbow and noticed a blister.  She took the pt. to the ED on 12/29/06 and they treated the pt. with septra and benadryl.  The patient followed up on 01/02/07. The area where the blister occurred was approx. 1 1/2 inches below the IM deltoid site of injection.  The swelling in the arm was decreased to almost normal size.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Contusion, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain, then swelling and bruising at injection site.  Over 7 - 10 day period developed right radiculopathy (back pain with numbness right leg.)  Not responsive to conservative treatment (rest, ice, NSAID, PT).  Exam has been unremarkable, but symptoms have persisted.  Neurology consultation unrevealing.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Injection site pain
Clinical narrative: Sharp pain at injection site that persisted for 2 months.  Also with persistent cough for 2 months after injection. Symptoms started within 24 hours of injection.