chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Patient presented to ER at 8:24 pm on 1/21/05 with fever and leg swelling in right thigh.  Child had received Pneumovax vaccine yesterday (1/20/05) in right thigh.  On 1/21/05 in the am patient had minimal swelling, redness and tenderness present.  Redness, pain, and swelling increased throughout the day and fever developed.   Patient now walks with limp due to pain.  Admitted to hospital and was treated with Acetaminophen for the pain and cefazolin for the infection. Was on cefazolin IV for 2.5 days.  Over weekend patient clinically improved with redness and swelling decreasing.  He was discharged on 1/24/05 with a prescription for 7 days of oral cephalexin. Medical records received on 4/20/2005 states cellulitis and injection site reaction.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac arrest, Medication error
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 49 year old female hospitalized with pneumonia who on 1/14/05 was given a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported) via a central line (the physician orders were to give it IM). Subsequently, the patient coded but did not die. The patient required intervention of the crash cart (therapies not specified). It was noted that the patient was to be discharged from the hospital that day, but her hospital stay would now be extended. There was no product quality complaint involved. The patient's outcome was unknown. Patient coded but did not die was considered to be immediately life threatening. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: DTAPH, FLU3, HEP, IPV, VARCEL
Symptoms: Chills, Depressed level of consciousness, Dyspnoea, Pyrexia
Clinical narrative: Fever 104, altered consciousness, dyspnea, chills on 1/9/05. Vaccines given 1/6/05. Blood, CSF, Urine cultures, IV fluids, IV Rocephin one dose in ER. Follow up 02/03/2005: Diagnosis: Fever no focus, R/o Bacteremia, altered mental status. Physician's letter requesting financial help.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia macrocytic, Anorexia, Dizziness, Erythema, Hyponatraemia
Clinical narrative: Dizziness, redness and rash around injection site, now developing a constant blinking process of the eyes. Medical Records received on 2/02/2005 states appetite poor. Information from Discharge summary states hyponatremia. msv
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Laboratory test abnormal, Muscle twitching
Clinical narrative: Dizziness, redness and rash around injection site, now developing a constant blinking process of the eyes. Medical Records received on 2/02/2005 states appetite poor. Information from Discharge summary states hyponatremia. msv
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Vomiting
Clinical narrative: On 12/7/04 09:15 child's mother telephoned office stating pt had started throwing up, coughing and running mild temp. She asked if it could be from the flu shot she received on 11/29/04. In my absence, secretary advised her to take pt to Dr. Pt is special needs child with multiple disabilities. I was unable to make contact with parents until 12/14/04. Mom related that child was spitting a little before she saw Dr in
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Urticaria
Clinical narrative: Welts, urticaria rash starting under arms 2 hours after flu mist given. It spread to inner thighs, hairline and wrists the same evening. The next day rash spread to breasts. Visited doctor 12/3/04 and placed on Benadryl and Zertec. Still has rash on breasts as of 12/7/04 symmetrical rashes.
Age: 48.0
Sex: M
Vaccine: FLUN3, HEPAB
Symptoms: Flushing, Headache, Paraesthesia, Pruritus
Clinical narrative: Administered FluMist 20 minutes past administration client had itchy palms and tingling fingers bilaterally with a flushed face and a R sided headache. He was given diphenhydryl PO and acetaminophen, 1hr later symptoms resolved.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Erythema, Feeling hot, Injection site pain, Irritability, Oedema
Clinical narrative: Rectal T 102.6. Erythema, swelling, warmth, and pain around injection site. Irritable began 8-10 hrs after injection. Seen about 24 hrs. Left lateral thigh
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blister, Dry skin
Clinical narrative: Vesicular lesions entire body scabbed over 5-7 days 50-500 lesions. Clinic reports all vaccine storage temp WNL's.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Decreased appetite, Dehydration, Medication error
Clinical narrative: Vaccine failure. Seen by public health nurse at Dr. Noted 10 spots. She was started on an antibiotic at that time. Mom said they did take her to Dr on 12/07/04. She was sent back home but kept getting worse. The next evening she was taken to ER and admitted to hospital for dehydration. Mom said they took chest x-rays and tests. No pneumonia and to pt's knowledge they never told them a cause at reason. She was released on Friday AM, still not eating very much but. Mom though she would eat better at home. I asked if Dr said anything about a reaction to flu med or antibiotic and she said it was never mentioned. Child had began eating again.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Insomnia, Irritability, Laboratory test abnormal, Lymphocytosis, Retching
Clinical narrative: Monday night didn't sleep well. Tuesday ( following day), patient was cranky, clingy, had dry heaves and not sleeping well. No fever or rash.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Monday night didn't sleep well. Tuesday ( following day), patient was cranky, clingy, had dry heaves and not sleeping well. No fever or rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness and swelling of an injection. Had DTaP thursday along with other immunizations. Mom said he had a low grade fever at home. Swelling is about 4" in circumferance, leg is warm to touch. Patient given Ibuprofen and Triamcinolone cream.
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Pain, Rash macular
Clinical narrative: Sore night of administration then on 12/16/04, developed a 14 x 11.5 erythema macular rash over his deltoid region. No fever. Treated with cortisone cream and Zyrtec for 10 days.
Age: 1.26
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever over 106 degrees for less than 1 day.
Age: 1.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed hives with in a few days of shots, no fever of other symptoms per mom. Child developed rash 7 to 10 days, went away but still with hives, usually occur with touching of skin. Hive have continued since. 11/24/04, Mon states nothing new in envireonment or new foods. Child behaves normally except for continual hives.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Left arm appears red, swollen and hot to touch. Patient in discomfort. Advised to apply ice to area and may give Tylenol for discomfort. If symptoms persist patient should be seen by doctor.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of R tricep area extending to elbow, non tender, no adenopathy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Warmth at site without nodule.
Age: 37.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: One week after vaccination, erythema, tenderness, swelling still present at site of Td injection. Sought evaluation by private MD, given prescription for Keflex, Anaprox and samples of Zyrtec. Client had not used any analgesic, antipyretics or cold medication post vaccination.
Age: 1.57
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: 4 cm localized erythema and inflammation at injection site, plus induration left thigh. Date time of adverse event are unknown.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 104.2 evening of vaccination
Age: 29.0
Sex: F
Vaccine: MEA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female health care employee with no past medical history or allergies, who on 03/11/02 was vaccinated with a dose of measles virus vaccine live (Moraten) (lot # reported as 0459C). In December 2003, a titer was drawn and the results were equivocal. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: MEA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female nursing student who was vaccinated with 0.5 ml subcutaneously with a booster does of measles virus vaccine live (Moraten) (lot number not available). Subsequently, the patient had a negative titer. There was no treatment required. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MEA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a female registered nurse who in 1990 was vaccinated with a dose of measles virus vaccine live (Moraten) (lot number not available). The nurse reported that a recent titer did not show that she had seroconverted after vaccination with measles virus vaccine live (Moraten) in 1990. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: MEA
Symptoms: Bronchospasm
Clinical narrative: Information has been received from a consumer concerning his approximately 16 month old daughter who had a slight cold at the time of vaccination but no fever. On 06/14/04, it was reported that approximately three months ago, at about noon time, the patient was vaccinated with a dose of measles virus vaccine live (Moraten) (lot # unknown). The father reported that by 3 a.m. the child developed bronchial spasms and was taken to the emergency room. By the time they arrived at the emergency room, 1 1/2 hours later, the child was better and no treatment was necessary. The child was not hospitalized. It was unknown if laboratory diagnostic studies were performed. No further information is available.
Age: 38.0
Sex: F
Vaccine: MEA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a 38 year old female with high blood pressure, anemia, irritable bowel syndrome and anxiety who was vaccinated with a dose of measles virus vaccine live (Moraten) (lot number not available). Concomitant therapy included Maxzide, Atenolol, iron and Buspar. It was noted that on 03/25/1971 the patient was vaccinated with a dose of rubella virus vaccine live (HPV-77) MSD. Subsequently, a titer drawn on 07/02/04 revealed a negative result for measles, and was pending for rubella. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: MEA
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a licensed practical nurse who received information from the surgeon general's office concerning a male who in 1964 was vaccinated with measles virus vaccine live (Moraten).  Subsequently the patient had a "significant reaction".  Unspecified medical attention was sought.  No product quality complaint involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MEA
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a physician concerning a 33 year old "healthy" white female patient with no known drug allergies who on 01/06/2004 was vaccinated with a dose of measles virus vaccine live (lot 3 640743/0562N).  There was no illness at the time of vaccination.  It was reported that the patient had a total of five measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live "had all childhood one prior to college".  Subsequently, on 07/06/2004, the patient was "still non-immune" to measles.  It was noted that in January 2004 the patient had transient immunity, "now gone".  Unspecified medical attention was sought.  It was noted that the vaccine was well tolerated. Additional information has been requested. The physician also reported that another patient that was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live was non-immune to the measles.
Age: 32.0
Sex: F
Vaccine: MEA
Symptoms: Arthralgia, Headache, Myalgia, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female employee with allergies to flowers, molds and pollens, and a history of prior vaccination with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live who on 08/10/2004 was vaccinated with a dose of measles virus vaccine.  On 08/14/2004 she experienced muscle and joint pain, headache, and developed a rash on the palmer surface of her hands.  On 08/17/2004 the patient was seen, and her hands were very itchy, no pustules, and bumpy rash continued, and was also noted on the soles of her feet.  The patient was seen in emergency room, and diagnosed with a reaction to measles virus vaccine.  No laboratory or diagnostic studies were performed.  The patient was placed on therapy with diphenhydramine cream for treatment of the rash.  At the time of this report the outcome was unknown. Additional information has been received from the nurse.  The nurse reported the patient was sent to the emergency room to rule out any infection.  The emergency room doctor ruled out infection and reported that he felt the symptoms were a reaction to the vaccination measles virus vaccine.  The patient was treated with topical diphenhydramine, and subsequently, recovered within three days, without incident.  The nurse indicated that she did not feel that the patient's events would have progressed to a serious event had they gone untreated. No further information is expected.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning an approximately 30 month old twin female who on 14-sept-2004 was vaccinated with the first dose of measles virus vaccine live.  The physician reported that on 23-sep-2004 the patient developed fever and on 24-sep-2004 developed a measles like rash.  Unspecified medical attention was sought.  At the time of this report, the patient's fever and measles like rash was resolving. Additional information has been requested.   2/03/2010 follow up- follow up information received from physician stated that the patient "did not have adverse effects from vaccine". the physician also confirmed that the patient had a "fever of 102 and a measle-like rash for several days approximatelty 9 days following vaccine which was to be expected". it was also confirmed that the patient's sister did not experience the same reaction. it was noted that the patient recovered.
Age: 1.35
Sex: M
Vaccine: MEA
Symptoms: Cough, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her 16 month old son who on 10/01/2004 was vaccinated with a dose of measles virus vaccine live.  The nurse reported that her son was healthy at the time of vaccination.  On 10/06/2004, the patient developed a fever and cough.  Medical attention was not sought for the patient's experience.  At the time of this report, the patient had not recovered. Additional information has been requested. This is a follow-up to report (s) previously submitted on 1/21/2005. Information has been received from a registered nurse concerning her 14 month old son with no relevant medical history reported who on 01-OCT-2004 was vaccinated subcutaneously with a first dose of ATTENUVAX vaccine (Enders-Edmonston) (lot 647584/0906N). The nurse reported that her son was healthy at the time of vaccination. On 06-OCT-2004, the patient developed a fever and cough. Medical attention was not sought for the patient's experience. At the time of this report, the patient had not recovered. Follow-up information was received from a physician who reported that the patient did not have any reaction as a result of the vacciantion. The patient happened to have a cough at the time. No fever noted. There were no laboratory tests performed and the patient did not experience any adverse events following prior vaccinations. It was noted that the patient is well. No additional information is expected.
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Headache
Clinical narrative: An adult male (unspecified age) receiving post-exposure series RabAvert for a dog bite, experienced a headache and dizziness.  Concomitant medications included acyclovir.  The patient had received two doses of RabAvert and was due for his third vaccination.   Twelve days ago, the patient noticed a friendly, collared dog in the woods by his rural home.  He went to corrale the god and was bitten on the cheek.  The wound was washed and medicine applied.  The patient complained of headache and dizziness after the first two vaccinations.  The patient was due the third immunization.
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: A female patient bitten by a cat, and developed hives following treatment with RabAvert. The patient was bitten on the middle digit of her hand by a feral cat.  She was seen at the emergency room and given human rabies immunoglobulin and started on rabies vaccine.  At the fourth dose, the patient developed generalized hives and was seen by a primary care physician.  She was given Benadryl for treatment.  She had no other symptoms associated with the hives.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Feeling hot, Pruritus, Skin discolouration, Swelling
Clinical narrative: A 60 Year old female patient developed a local reaction after receiving RabAvert.  The patient received the first doses of RabAvert on days zero, three and seven with the fourth and final dose given on 03/26/2004.  The patient was bitten by a squirrel on 03/12/2004 and had been treated with the first doses of RabAvert without any reported adverse effects.  In addition to the RabAvert the patient was given Tetanus Toxoid and Gamma Globulin intramuscular injections. On 03/28/2004 the patient presented to the emergency department with complaints that her upper right deltoid area was discolored, red hot to the touch, swollen and very itchy.  The patient was treated with oral Keflex 500 mg to be taken four times a day for ten days.  She had a complete recovery within seven to fourteen days.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: A 30 year old female patient developed hives after receiving RabAvert therapy.  The patient received the first dose for pre-exposure prophylaxis and twelve days later she developed hives.  The patient received her second dose of RabAvert on 03/07/2004. The patient saw an allergist and was prescribed Zyrtec for the itching.  According to the patient, the Zyrtec relieved the itching but when she tried to discontinue the use, the itching returned.  She denies allergy to eggs or other medications. At the time of the report the symptoms were persisting. Follow up information received on 07/09/2004:  The patient received her first dose of RabAvert on 02/18/2004 followed by a second dose on 02/24/2004.  She did not received her third dose due to demonstrating positive titer response after the second vaccination. On 03/01/2004, she developed dermatographic hives with itching on her body and self treated with Benadryl.  Subsequently, she followed up with an allergist who initiated an allergy test that showed her being allergic to tomatoes and apples.  She was treated with Zyrtec 10mg daily with improvement and suppression of symptoms.  However, symptoms were noted to return when she missed her daily Zyrtec.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Cold sweat, Headache, Injection site induration, Nausea
Clinical narrative: A 33 year old female developed nausea, headache, clammy skin, and a small area of induration at the injection site after immunization with RabAvert.  The patient received her third dose of RabAvert for pre-exposure prophylaxis on 05/06/2004.  On 05/06/2004, thirty minutes post immunization, the patient complained of nausea, headache, clammy skin, and small induration at injection site. The patient had a complete recovery of all the adverse events.
Sex: F
Vaccine: RAB, RAB
Symptoms: Fatigue, Headache, Pain
Clinical narrative: A female patient (DT) experienced a massive headache, pain down the legs and felt tired after receiving RabAvert therapy. The patient received the first dose of post-exposure RabAvert, 1 ml into the deltoid on 05/20/2004. The patient had a history of a bat bite. At the time of the report the headache was persisting. No furhter information at the time of report
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Swelling, Urticaria
Clinical narrative: A female patient of unknown age (SB) with exposure to dog saliva with rabies developed injection site reaction, swelling of right arm and hives post immunization with RabAvert for post exposure treatment. She received her first vaccination on 05/20/2004 on her right arm followed by her second vaccination on 05/23/2004 on her left arm. Her medical history was non-contributory: she was not on any concomitant medication. On 05/20/2004, a few hours after she received her first dose of RabAvert, the patient complained of injection site reaction characterized by swelling, soreness, and horse-shoe shaped hives at the injection site. Five days following, the patient noted improvement of synptons. On 05/23/2004, the patient received her second dose of RabAvert. One week later on 05/30/2004, she developed swelling on the right arm and hives on her body which both became progressively worse by 05/31/2004. The patient reported to the emergency room where she was prescribed prednisone and Bentadyl. The oatient only took one dose of prednisone and Benadryl as needed. By 06/01/2004, the swelling and hives had reduced and by 06/03/2004, all adverse events were resolved. Follow-up information received 08/11/2004: Medical assistant from vaccination site had difficulties in withdrawing medication from one vial and only half of the medication was obtained. A second vial was used. All vials were discarded and samples were ubavailable for testing.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Injection site pain, Lethargy, Nausea, Night sweats
Clinical narrative: A 55 year old female patient (DO) experienced fever, chills, nausea, lethargy, night sweats and injection site tenderness after receiving RabAvert for post-exposure treatment. The patient has no significant medical history and is not taking any medication. She was exposed to a bat while sleeping on 06/22/2004. She received RabAvert on day three on 06/25/2004 and experienced fever, chills, nausea, lethargy and head to toe drenching night sweats that same day. She had received Imovax for her first dose, then received RabAvert 1 ml injection into her deltoid for her second dose of post exposure treatment. The symptoms had resolved by 06/25/2004 and she went in for her day seven injection the following day. Six hours post day seven injection on 06/29/2004 the patient reported tenderness at injection site in addition to another episode of drenching head to toe night sweats.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A 55 year old female patient (DO) experienced fever, chills, nausea, lethargy, night sweats and injection site tenderness after receiving RabAvert for post-exposure treatment. The patient has no significant medical history and is not taking any medication. She was exposed to a bat while sleeping on 06/22/2004. She received RabAvert on day three on 06/25/2004 and experienced fever, chills, nausea, lethargy and head to toe drenching night sweats that same day. She had received Imovax for her first dose, then received RabAvert 1 ml injection into her deltoid for her second dose of post exposure treatment. The symptoms had resolved by 06/25/2004 and she went in for her day seven injection the following day. Six hours post day seven injection on 06/29/2004 the patient reported tenderness at injection site in addition to another episode of drenching head to toe night sweats.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: A 39 year old female patient (LM) experienced headache, muscle ache and injection site tenderness after post exposure vaccination with RabAvert. The patient received a total of three doses of RabAvert 1 ml intramusclarly on 06/28/2004, 07/01/2004 and 07/06/2004. The first dose was given in her deltoid and the third dose was given on her left arm. Her past medical history was unspecified. She was significant for an emergency room visit on 06/28/2004 due to a feral cat bite and received treatment with Augmentin, human rabies immunoglobulin and tetanus booster along with RabAvert. She had no known drug allergies and was not on any concomitant medications prior to the events. On 07/06/2004, within two hours after the third immunization with RabAvert, the patient complained of a "horrendous" headach which she intervened by going to bed. The headache persisted throughout the night and to the next morning, 07/07/2004. At the time, she also noted "achy muscle" and tenderness at injection site. She self treated with Motrin 800 mg with improvement of symptoms. The patient planned to continue with RabAvert as post exposure treatment.
Age: 57.0
Sex: M
Vaccine: RAB
Symptoms: Enzyme abnormality
Clinical narrative: A 58 year old male patient (RK) experienced inadequate antibody levels after prophylactic treatment with RabAvert. The patient received RabAvert on 10/03/2002, 10/10/2002, followed by a third injection 2 to 3 weeks later. On 05/01/2004, enzyme-linked immunosorbent (ELISA) testing was performed and showed inadequate antibody levels. On 06/15/2004 rapid fluorescent focus inhibition test (RFFIT) was performed and showed below acceptable levels. A booster shot was suggested due to the low post vaccination titers. The reporter stated that a booster would be obtained and follow up titers reported. Follow-up information received on 07/22/2004: The correct lot number for the RavAvert is #309011, expiration date 10/2005. The RFFIT result for this patient was 0.21U/ml. Follow-up information received 08/04/2004: The RFFIT test result was converted to dilution to compare to the CDC Advisory Committee on immunization Practices recommendation of an adequate rabies virus neutralizing antibody titer (greater or equal to a serum dilution of 1:5 resulting in complete neutralization of rabies virus in RFFIT). The first RFFIT neutralizing antibody dilution results were less than or equal to 1:11. The sample was retested to refine the values at the lower cut off. On 07/06/2004 the results of the RFFIT retesting was reported as less than or equal to 0.1 IU/ml or less then or equal to 1:5 dilution. According to the CDC Advisory Committee on Immunization Practices recommendations, the patient needed a booster dose of vaccine.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A 66 year old patient experienced inadequate antibody levels after prophylactic treatment with RabAvert. The patient received RabAvert on 10/03/02, 10/10/02, followed by a third injection 2 to 3 weeks later. On 05/01/04, enzyme-linked immunosorbent assay (ELISA) testing was performed and showed inadequate antibody levels. On 06/15/04 repaid fluorescent focus inhibition test (RFFIT) was performed and showed below acceptable levels. A Booster shot was suggested due to the low post vaccination titers. The reporter stated that a booster would be obtained and follow up titers reported. Follow up information received on 07/22/04: The correct lot number for the RabAvert is #309011, expiration date 10/2005. The RFFIT result for this patient was 0.2IU/ml. Follow up information received 08/04/04: the RFFIT test result was converted to dilution to compare to the recommendation of adequate rabies virus neutralizing antibody titer (greater or equal to a serum dilution of 1:5 resulting in complete neutralization of rabies virus in RFFIT). The first RFFIT neutralizing antibody dilution results were less than or equal to 1:11. The sample was retested to refine the values at the lower cut off. On 07/06/04 the results of the RFFIT retesting was reported as 0.1 IU/ml or 1:9 dilution. According to recommendations, the patient did not need a booster dose of vaccine.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: A 52 year old patient experienced inadequate antibody levels after prophylactic treatment with RabAvert. The patient received RabAvert 10/03/02, 10/10/02 followed by a third injection 2 to 3 weeks later. On 05/01/04, enzyme linked immunosorbent assay (ELISA) testing was performed and showed inadequate antibody levels. On 06/15/04, rapid fluorescent focus inhibition test (RFFIT) was performed and showed below acceptable antibody levels. A Booster shot was suggested due to the low post vaccination titers. The reporter stated that a booster would be obtained and follow up titers reported. Follow up information received on 07/02/04: The correct lot number for the RabAvert is 309011, expiration date 10/2005. The RFFIT result for this patient was 0.3IU/ml. Follow up information received 08/04/04: the RFFIT test results was converted to dilution to compare to the ACIP recommendation of an adequate rabies virus neutralizing antibody titer (greater or equal to a serum dilution of 1:5 resulting in complete neutralization of rabies virus in RFFIT). The first RFFIT neutralizing antibody dilution results were 1:19. No retesting was necessary. According to the ACIP recommendations, the patient did not need a booster dose of vaccine.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: An adult female patient experienced a rash after receiving RabAvert vaccinations required for her occupation. The patient received pre-exposure doses of RabAvert 1ml, intramuscularly on 05/28/04, 06/04/04 and 06/18/04. One week after receiving the first dose of RabAvert, the patient noticed little to large red, itchy bumps on areas where the skin contacted her clothes a great deal such as her waist, chest, back hips, legs and sometimes her feet. The patient had the second and third doses of RabAvert prior to honeymooning in Costa Rica where her rash worsened in severity of itching due to the humidity. Apart from time in Costa Rica, the rash was no worse nor better. The patient tried Benadryl without much effect.
Age: 1.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A one year old infant experienced fever after vaccination with RabAvert for post exposure prophylaxis. The dose, route, and frequency of the RabAvert was unspecified. He received his last RabAvert 07/17/04. His past medical history and concomitant medications were also unspecified. On 07/17/04, the patient developed a fever of 100.8 degrees Fahrenheit after his third vaccination with RabAvert. He was treated with Motrin with fever resolution within 12 hours time that same day.
Age: 54.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Hyperhidrosis
Clinical narrative: A 54 year old male patient experienced chills and sweats while being treated with RabAvert for a bat bite. He received his second dose of RabAvert on 07/26/04. His medical history was significant for increased cholesterol and hypertension. Concomitant medications included Prevacid, Lisinopril with HCTZ and Lipitor. On the evening of 077/26/04, after his second dose of RabAvert, the patient developed chills and sweats which lasted about 40 minutes and resolved. The patient did not require treatment for the event and was reported as doing well. He was scheduled to received his next vaccination. The reporter did not assess causality between the events and the drug.
Sex: F
Vaccine: RAB
Symptoms: Injection site swelling
Clinical narrative: A 19 year old female patient experienced swollen lymph nodes while being treated with RabAvert for pre-exposure prophylaxis. She received her first dose of RabAvert on 07/22/04. Concomitant medications included birth control pills. On 07/22/04, after the first dose of RabAvert, the patient developed swollen lymph nodes on left side and to a lesser degree some swelling on the right side. The patient took Ibuprofen and the symptoms resolved within 24 hours. The patient received the second dose of RabAvert on 07/29/04 and it is unknown if she had a recurrence of these symptoms. The reporter assessed the event as possibly related to the drug. Follow up information received on 08/16/04: Upon further inquiry the lymph nodes were not affected. The swelling occurred up into the muscle above the shoulder on the patient's back on the left side of the body. The vaccine was given in the left deltoid. The dates of all the immunizations were provided. The first does was received on 07/22/04, the second 07/29/04 and the third on 08/12/04. The lot number and expiration date were provided. There were no further recurrences of the original or different symptoms.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Feeling hot, Influenza like illness, Lymphadenopathy, Malaise, Pain
Clinical narrative: A 26 year old female patient experienced flu like symptoms and lymphadenopathy while receiving RabAvert therapy. She received RabAvert 1 ml intramuscularly on 07/24/04 and 07/14/04 for pre exposure prophylaxis. The patient had no past medical history. Concomitant medications consisted of Ortho Tri-cyclen and Chlopheniramine. On 07/14/04, the patient experienced flu like symptoms including feeling warm, an achiness all over, tiredness and malaise that lasted three days. On 07/14/04, she also noticed a slight enlargement of the left axillary lymph node, which was the same side where she received her RabAvert injection. Follow up received 08/16/04: The patient received RabAvert injections on 07/07/04, 07/14/04 and 07/28/04 in the left deltoid. A week following the second RabAvert injection (07/21/04) the patient experienced general malaise, swollen axillary lymph nodes (size of an egg), inability to left her arm and flu like symptoms. She was instructed to take Tylenol after the next RabAvert injection on 07/28/04. No adverse effects were reported after the third injection. The events resolved within approximately 10 days.
Age: 38.0
Sex: M
Vaccine: RAB
Symptoms: Chest pain, Muscle contractions involuntary, Muscle disorder, Muscle spasms, Myalgia
Clinical narrative: A 38 year old male patient experienced a unique high level of aching in the rib area while being treated  with RabAvert for post exposure prophylaxis after questionable exposure to a bat on 07/28/04. He received his first dose of RabAvert on 08/1/04. Concomitant medications included Protonix and nasal steroids. On 08/01/04, after the first dose of of RabAvert, the patient experienced a unique high level of aching in the area where th ribs come together. He described it as a headache in the chest, which he could feel all the way to the surface. The event was ongoing at the time of the report. Follow up information received on 08/10/04: The patient experienced muscle pain in the elbow of his left arm after the 3rd dose of RabAvert. The pain was described as an inside of the elbow muscle spasm almost like a tennis elbow. He also stated that it felt like he had been punched. The patient received the 1st and 2nd dose of RabAvert in the left arm and the 3rd dose in the right arm. Follow up information received 12/15/04: In September 2004 the patient saw a neurologist for an evaluation of muscle vibrating and twitching which had been occurring ever since stopping the RabAvert series. The vibrating and twitching were intermittent and appeared at any location of his body including eyelids and legs. The neurologist performed a physical exam and told the patient that he had fasciculations and myokymias. A MRI and electromyelogram were performed and were reportedly normal. The patient also had a rabies antibody titer test, which was reported as ok. The patient had an follow up examination one week prior to 12/15/04. He had another physical exam. An electroencephalogram was ordered. The results were reportedly normal.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash macular
Clinical narrative: A 26 year old female experienced a macular rash after receiving the first dose of RabAvert for pre-exposure prophylaxis. The medical history included allergy to tetracycline and erythromycin. Concomitant medication remained unspecified. The patient received one dose of RabAvert (dose and route unspecified). Five minutes after receiving a dose of RabAvert the patient developed a macular rash on her anterior chest and abdomen. The rash was somewhat pruritic. There were no respiratory or other associated symptoms. She was treated with Benadryl at a dose of 50 mg intravenously and the rash resolved within 10 to 15 minutes.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: A 5 year old patient experienced itching at injection site after post exposure treatment with RabAvert. The patient received RabAvert 1 ml intramuscularly on 08/17/04. His past medical history and concomitant medications were unspecified. The patient was bitten by a rabies infected cat and received treatment with RabAvert. On 08/18/04, one day after vaccination, he complained of itching at the injection site. No other signs or symptoms were noted except for redness at the site, which may be due to his rubbing the affected area. The adverse event resolved on 08/20/04 and he received his next scheduled RabAvert treatment.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Injection site hypersensitivity, Injection site swelling, Pruritus, Rash
Clinical narrative: A 32 year old female patient experienced injection site reaction with pruritus, rash and swelling after receiving her second dose of RabAvert for prophylactic vaccination. RabAvert dose and route remained unspecified. The patient had a history of unspecified allergies. Concomitant medication remained unspecified. The patient had no reaction to the first dose of RabAvert, received on 05/26/04. She received the second dose on 06/02/04 to the right deltoid. Within 24 hours she experienced itching and swelling on the injection site. The swelling increased from the size of a softball to the size of a football. No treatment was received. She was seen by an allergy and asthma specialist on 07/30/04. The reaction had completely resolved and the diagnosis was "reaction to rabies vaccine NOS". The third RabAvert does had been held pending blood titre results; if the patient had an immune response, the third dose will not be given. Follow up received 09/20/04: The patient antibody titers were found to be protective, so the third RabAvert dose was held.
Age: 8.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash
Clinical narrative: An 8 year old male patient (JC) experienced rash after receiving post exposure vaccination with RabAvert. The patient received his fourth dose of RabAbvert 1 ml on 08/25/04. His past medical history and concomitant medications were unspecified. The patient received RabAvert for post exposure from a potentially rabies infected bat. On 08/28/04, one day after his fourth dose of RabAvert, he developed a rash that appeared on hi chest, back and inner thighs. The rash consisted of small red spots and was noted to be itchy. The patient was treated with Benadryl with improvement of symptoms. The rash was noted to have resolved on 08/30/04 with minor itching remaining. The patient planned to continue with his next dose of RabAvert. Coincidentally, the patient's friend who did not receive RabAvert also developed a similar rash.
Age: 9.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: An eight year old child, gender unspecified, experienced fever after vaccination with RabAvert for post exposure prophylaxis. Details regarding the dosing of RabAvert were unspecified; however, the child was known to have received four out of five vaccinations. The child's medical history and concomitant medications were also unspecified. The day prior to receiving the last vaccination with RabAvert, the child developed a fever of 100 degrees F without other symptoms. At the time of this report, the fever remained unresolved. The child was known to have started school recently. The reporter (nurse) assessed the event as not related to RabAvert. Additional information received on 09/17/04: The patient (JB) was an eight year old male. He received RabAvert 1 ml intrmuscularly on day one, three, seven, fourteen and twenty eight (dates unspecified). His last vaccination with RabAvert was due on 09/03/04, however, he presented with fever on 09/02/04 which resulted in the delay of the vaccination till 09/07/04. The event resolved on 09/04/04. The reporter (nurse and the mother) assessed the event as not related to RabAvert.
Age: 25.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pyrexia, Urticaria
Clinical narrative: A 25 year old female patient experienced fever and hives after post exposure treatment with RabAvert following bat exposure. The bat was found dead but not sent for testing. The patient recieved Rabies Immune Globulin and the first dose of RabAvert on 09/07/04. She was observed in the health department office for one hour and sent home. An unknown period ot time later the patient presented to the university student health services with complaint of fever and hives from head to toe. She gave a history of having finished a course of sulfa one week prior and by the fifth dose her throat had swelled shut. The patient was given Zyrtec and sent home.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: A 26 year old female patient (CR) experienced rash, pruritus and swelling of the entire body after prophylactic vaccination with RabAvert. The patient received Imovax on 08/19/04 and 08/26/04; on 09/11/04 she received 1 ml of RabAvert intramuscularly in the left deltoid. Concomitant medication remained unspecified. The medical history included a local response to fire ants bites (ankle was swollen and sore); the patient had no known allergies. Three hours after receiving RabAvert she experienced rash, itching and swelling all over her body. On 09/14/04 the patient reported the reaction and was seen by both an occupational health doctor and an allergist. The reaction had localized to involve only the neck, and she was treated with Allerga and triamcinolone cream. On 09/17/04 she was reassessed. The treating physican felt the reaction was due to an allergic reaction to an acacia tree, not RabAvert, and found that events were completely resolved.
Age: 14.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: A 14 year old female patient (FC) experienced injection site soreness, generalized muscle ache and headache after vaccination with RabAvert for post exposure prophylaxis. The patient received five doses of RabAvert (dose unspecified) with the first dose on 08/06/04 and the last on 09/04/04. Her past medical history was unspecified. She was concomitantly treated with intravenous anti-rabies immunoglobulin. The patient received RabAvert for post exposure due to a petting zoo situation. She experienced injection site soreness, generalized muscle aches and headache for three to four days following each vaccination. She self treated with aspirin. All adverse events had resolved.
Sex: F
Vaccine: RAB
Symptoms: Choking, Hypersensitivity, Laryngospasm, Muscle spasms, Nervousness
Clinical narrative: HYPERSENSITIVITY REACTION {HYPERSENSITIVITY NOS} {URTICARIA NOS} {MUSCLE SPASMS} {CHOKING SENSATION} An approximately 48 year old female patient experienced a hypersensitivity reaction while receiving RabAvert. The patient received injections of RabAvert on 09/13/2004 and 09/16/2004. Past medical history was an allergy to egg white with a reaction of cramps, nausea, and backache. Concomitant medications were not known. On 09/13/2004, the patient experienced a bite on the foot by a fox with a rabid appearance, that bit through her shoe but did not puncture the flesh. However, she then touched the saliva on her sock. Post exposure prophylaxis was initiated with human rabies immune globulin(HRIG), Tetanus toxoid and the first RabAvert dose. The patient complained of hives afterwards, assessed by the health care provider as nervousness. On 0916/2004 she was pre-medicated with 25mg oral Benadryl and received the second RabAvert injection. Two hours later while having lunch, the patient felt a choking sensation, had neck and throat spasms and spit out her sandwich. There were no other symptoms such as hives, erythema. swelling, or itching at that time. The patient was pre- medicated with 50 mg of Benadryl for the third RabAvert injection but the injection was held as the health department had no emergency resuscitative equipment on hand, and was not comfortable with administering the vaccine. The treatment plan was to finish the vaccine series with three doses of Imovax. The hives and laryngospasm resolved.
Sex: F
Vaccine: RAB
Symptoms: Nuchal rigidity, Urticaria
Clinical narrative: HYPERSENSITIVITY REACTION {HYPERSENSITIVITY NOS} {URTICARIA NOS} {MUSCLE SPASMS} {CHOKING SENSATION} An approximately 48 year old female patient experienced a hypersensitivity reaction while receiving RabAvert. The patient received injections of RabAvert on 09/13/2004 and 09/16/2004. Past medical history was an allergy to egg white with a reaction of cramps, nausea, and backache. Concomitant medications were not known. On 09/13/2004, the patient experienced a bite on the foot by a fox with a rabid appearance, that bit through her shoe but did not puncture the flesh. However, she then touched the saliva on her sock. Post exposure prophylaxis was initiated with human rabies immune globulin(HRIG), Tetanus toxoid and the first RabAvert dose. The patient complained of hives afterwards, assessed by the health care provider as nervousness. On 0916/2004 she was pre-medicated with 25mg oral Benadryl and received the second RabAvert injection. Two hours later while having lunch, the patient felt a choking sensation, had neck and throat spasms and spit out her sandwich. There were no other symptoms such as hives, erythema. swelling, or itching at that time. The patient was pre- medicated with 50 mg of Benadryl for the third RabAvert injection but the injection was held as the health department had no emergency resuscitative equipment on hand, and was not comfortable with administering the vaccine. The treatment plan was to finish the vaccine series with three doses of Imovax. The hives and laryngospasm resolved.