chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated wth the first and second doses of hepatitis B virus vaccine. Subsequently, the patient experienced increased LFT's (they went from 40u/L to 120u/L). No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, increased LFT's was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Fatigue, Headache, Hepatitis B surface antigen positive, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female nurse with no allergies or medical history who in 08/2000 and 11/2000 was vaccinated with a first and second dose of hepatitis b virus vaccine rHBsAg(yeast)(manufacturer unknown). There was no concomitant medication. It was noted that the vaccinations were received at another facility. The nurse reported that the patient developed fever, myalgia, fatigue, and a headache for five to seven consecutive days after each immunization. Unspecified medical attention was sought and it was unknown if treatment was required. Subsequently, the patient recovered. It was also reported that the patient had a negative titer in 08/2003 and in 06/2004 and she had no antibodies. A product quality complaint was not involved. No further information is expected.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female nurse with no allergies or medical history who in 08/2000 and 11/2000 was vaccinated with a first and second dose of hepatitis b virus vaccine rHBsAg(yeast)(manufacturer unknown). There was no concomitant medication. It was noted that the vaccinations were received at another facility. The nurse reported that the patient developed fever, myalgia, fatigue, and a headache for five to seven consecutive days after each immunization. Unspecified medical attention was sought and it was unknown if treatment was required. Subsequently, the patient recovered. It was also reported that the patient had a negative titer in 08/2003 and in 06/2004 and she had no antibodies. A product quality complaint was not involved. No further information is expected.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Lymphoedema, Tremor
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 01/02/2002 was vaccinated in the left arm with a first dose of hepatitis B virus vaccine rHBsAg(yeast). One week later, on approximately 01/09/2002, the patient developed lumps under the left armpit and a slight tremor in right hand when raised. The mother told the reporter that the swelling under the armpit lasted for one year. The patient was never brought into the office to be examined and there was never a specific visit for that issue. The physician stated that the child is "fine now". A product quality complaint was not involved. Additonal information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a lawyer concerning a minor female patient who on 01/22/2002 was vaccinated with an unspecified vaccine. Subsequently, the patient experienced an unspecified injury. Additional information was received concerning hepatitis B virus vaccine rHBsAg(yeast)(MSD) lot #'s 638570/1700K and 640327/0754L, but it was not indicated if the patient received lot no. 638570/1700K or 640327/0754L. Additonal information was not provided.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Joint swelling, Liver function test abnormal, Lymphoedema, Pyrexia
Clinical narrative: Information has been received from a 41 year old healthy female pharmacist who on 06/01/2004 and was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg(yeast). Concomitatnt therapy included cetirizine hydrochloride (Zyrtec). On approximately 07/01/2004. the patient had flu like symptoms, a fever of 102 degrees Fahrenheit and swollen nodes. Blood work determined that she was positive for "parvo" On 07/07/2004 the patient received a second dose of hepatitis B virus vaccine rHBsAg(yeast). That day she developed swelling in her ankles and joints. On 07/08/2004 liver function tests were done and were "7x normal" It was reported that she is taking azithromycin(Zithromax) acetaminophen (tylenol) and ibuprofen (Motrin). Medical attention was sought and treatment was required, No product quality complaint was involved. Additional infomation has been requested.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Ventricular extrasystoles
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male patient with a seasonal allergy who on 11/12/1998, 12/15/1998, and 05/18/1999 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast) There was no concomitant medication. On 04/25/2002, The patient developed benign premature ventricular contractions, which was reported as medical "history" On 07/12/2004, a titer was - for surface antigen and antibodies. Unspecified medical attention was sought but treatment was not required for the negative titer A product, quality complaint was not involved. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Malignant melanoma
Clinical narrative: Information has been received from a 57 year old male pharmacist with no allergies or medical history who in 2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg(yeast) Concomitant therapy  included aspirin and vitamins (unspecified) In approximately 04/2004 the patient had a titer drawn that was negative. Unspecified medical attention was sought and no treatment was required. He also reported that he had a melanoma on his forehead removed on 07/19/2004 with a follow up procedure needed on 07/22/2004. The reporter did not feel that this was related to therapy with hep B vaccine rHBsAg(yeast) A product quality complaint was not involved. Additional information has been requested. The pharmacist also reported that three other employees had negative titers after therapy with Hep B virus vaccine rHBsAg(yeast) Reference:WAERS0407USA02237, 0407USA02240, 0407USA02241.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 01/02/2002 was vaccinated with in the left arm with a first dose hepatitis B virus vaccine rHBsAg(yeast) On 01/02/2002 the patient experienced swelling under arm which lasted a year. In approximately January 2003 the patient recovered. The patient was not seen by the physicain. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Respiratory disorder
Clinical narrative: Information has been received from a nurse in employee health concerning a 47 year old female patient who in 1989 was vaccinated with a first series of hepatitis B virus vaccine rHBsAG (yeast). Manufacturer and lot number unknown. On 07/16/04, the patient had a titer result of 4.4, which is considered negative by the lab doing the test. The nurse reported that recently (approximately August 2004) the patient had received treatment with steroids for a respiratory disorder. There was no product quality complaint reported. Follow up information was received from a RN who reported that there is no additional information available as the vaccine had been administered at three different organizations. The patient sought unspecified medical attention. No additional information is expected.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Gallbladder disorder, Jaundice
Clinical narrative: Information has been received from an employee health nurse concerning a 51 year old male who on 06/07/04 was vaccinated with a 10 mcg second dose of hepatitis B virus vaccine rHBsAg (yeast). On 08/01/04, presented to the emergency room with jaundice. It was determined that the patient had a gallstone. He was not admitted to the hospital. A product quality complaint was not involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic function abnormal, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 31 year old female who on 05/04/04 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAG (yeast) (lot 644078/0940M). Subsequently the patient experienced elevated liver function tests. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her daughter who several years ago was vaccinated with a dose of hepatitis B virus vaccine. The reporter indicated that after vaccination, the patient suffered seizures. Unspecified medical attention was sought. It was noted that the patient has not had any more seizures and has subsequently recovered on an unknown date. A product quality complaint was not involved. Upon internal review, the seizures were considered to be an other important medical event (OMIC). No further information is available.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chest pain, Feeling abnormal, Musculoskeletal discomfort
Clinical narrative: Information has been received from a 53 year old female with no pertinent medical history and no known allergies who on 07/25/04 was vaccinated SC with a single dose of hepatitis B virus vaccine rHBsAG (yeast). There was no concomitant medication. On 07/26/04, on day after receiving the shot, the patient experienced muscle tension, chest pain, increased blood pressure, and generally feeling bad. It was noted that the patient has seen some improvement after day two, but is not fully recovered. She does not plan to get another dose of the vaccine. She sought medical attention and her physician did not recommend any treatment. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Face oedema, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a male patient who was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast). Seven to toen days post vaccination with the first dose, the patient developed swelling of the left eye brow and upper lip. He went to his primary doctor and was treated with oral Benadryl and prednisone. The physician thought that this may be an allergy to orange juice or orange Koolaid. Seven to ten days post vaccination with the second dose the patient developed hives all over her back. He was again treated with Benadryl and prednisone. It was reported that the event improved on therapy and the patient has recovered. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Malaise, Vision blurred
Clinical narrative: Information has been received from a clinic nurse concerning a male dialysis patient who was vaccinated IM with a 40 mcg first dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently, the patient developed blurred vision and malaise which lasted for several hours. Unspecified medical attention was sought. It was not known if he was hospitalized or if any treatment was given. Subsequently, the patient recovered from blurred vision and malaise. A product quality complaint was not involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Headache, Medication error, Mouth ulceration, Myalgia
Clinical narrative: Information has been received from a pharmacist concerning a 47 year old female with a ppd allergy who on 08/06/04 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 646867/0179P). No other vaccinations were given at the same time. On 08/07/04, "within 2 to 4 hours of vaccination", the patient developed a headache, back and neck aches, rash nausea, vomiting, sores on her tongue and myalgia. She was treated with Ativan, Compazine, Toradol, Lortab. It was reported that the injection was not given in her deltoid, but slightly below the muscle. The injection site bled for a while. Unspecified medical attention was sought. The patient was considered not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Neck pain, Rash, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 47 year old female with a ppd allergy who on 08/06/04 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 646867/0179P). No other vaccinations were given at the same time. On 08/07/04, "within 2 to 4 hours of vaccination", the patient developed a headache, back and neck aches, rash nausea, vomiting, sores on her tongue and myalgia. She was treated with Ativan, Compazine, Toradol, Lortab. It was reported that the injection was not given in her deltoid, but slightly below the muscle. The injection site bled for a while. Unspecified medical attention was sought. The patient was considered not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: It was reported that an adult patient was vaccinated with a first, second, and third dose of hepatitis B virus vaccine. Subsequently, after the third dose, the patient's liver function tests were elevated. This case has not been verified by a health care professional. The outcome of the event was unknown. Elevated liver function tests was considered an other important medical event (OMIC). This was originally reported by a consumer.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). subsequently, 2 weeks later, the patient experienced a false positive for hepatitis b on a blood screen. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning an approximately 40 year old female with a yeast allergy who "approximately 5 years ago" in approximately 1999, was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg(yeast). It was reported that she had an allergic reaction to the vaccine. It was noted that the first dose was received but no additional doses were given. Medical attention was sought. The patient was considered recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hypersensitivity, Laboratory test abnormal, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning an adult female with no known allergies who last year, in 2003, was vaccinated with a three dose series of hepatitis B virus vaccine (lot # unknown). This year, in 2004, the patient's titer showed a low result so the patient began a second dose series of vaccinations. One month ago, in approximately July 2004, the patient received the first dose of the second series (lot 643399/0367P). There were no problems after this vaccination. On 8/31/04, at 2 PM, the patient received the second dose of the second series (lot 647274/0426P). Approximately 7 hours later the patient developed hives and reported to the ER. The patient was not hospitalized and it was unknown if the patient was treated. It was reported that she is recovering. The reporter has expressed a concern with the lot 647274/0426P. No product quality complaint was involved. Additional information from the pharmacist indicated that this experience was being treated as an allergic reaction and that the third dose in the series was not going to be given. He reported that the patient has recovered with no other adverse effects or consequences from the experience. No additional information is known. The reporter considered the patient's hives an other important medical event (OMIC). A lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Fibromyalgia
Clinical narrative: Information has been received from a physical therapist(PT) concerning an adult patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast). The pt reported that the patient subsequently developed secondary fibromyalgia. Unspecified medical attention was sought. At the time of the time of this report, the outcome was unknown. The Pt felt  that the secondary fibromyalgia was related to the hepatitis b virus vaccine rHBsAg (yeast). Additional infomation has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) Subsequently the patient developed HBsAG during the series. The physician reported that the patient tested positive for HBsAG while in  the midst of the series. Unspecified medical attention was sought. there was no product quality complaint. Follow up information indicated that on 11/27/2001 the patient donated blood which was  HBsAg positive. It was noted that he had "just received a dose of hepatitis B virus vaccine rHBsAg (yeast). No additional information is expected.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Joint stiffness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female dialysis patient who on approximately 08/21/2004 was vaccinated with a first 40 mcg dose of hepatitis b virus vaccine rHBsAg (yeast) subsequently the patient had arm shoulder and neck pain and stiffness. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received from a female consumer, who is a registered nurse, who in 1992 was vaccinated with a dose of hepatitis B virus vaccine. Subsequently, the nurse developed thrombocytopenia and was hospitalized for one week. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 5 year old female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy that day included a dose of tetanus toxoid. Subsequently the patient experienced syncope approximately 15 minutes after receiving the vaccinations. The patient has since recovered, but was never revaccianted with Hepatitits B virus vaccine rHBsAg(yeast). No other information was provided. Unspecified medical attention was sought. There was no product quality complaint provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Information has been received from a 51 year old female with no known medical history or allergies who on 07/2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg(yeast). Concomitant therapy included cimifuga(Remifemin). She reported that she experienced elevated liver enzyme levels after her last injection in 07/2003 and that "either AST or ALT is elevated slightly. Unspecified medical attention was sought and diagnostic lab tests were all negative. At the time of the report, the patient was recovering . There were no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis B Virus vaccine rHBsAg (yeast) (manufacturer unknown). Subsequently the patient experienced an adverse reaction. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Injection site rash, Rash erythematous, Rash macular, Skin warm, Urticaria
Clinical narrative: Information has been received from a consumer her 14 year old son with allergies to penicillin and sulfa and a history of tonsils removed at 8 years of age and some sinus problems who on 9/29/04, at 4:00 PM was vaccinated IM in the left leg with a second dose of hepatitis B virus vaccine (lot # 646145/0624N). At the time of vaccination, he was noted to have some sinus drainage. Concomitant therapy included paroxetine HCl, however this was not received that day because he was going to be receiving the vaccination. Later that day, he developed small bumps at the injection site, which spread to his sides, his arms, his groin, and his legs. The bumps developed into large welts, some of which were as large as saucers. The patient was brought to the emergency room, where he was given a shot of diphenhydramine hydrochloride. The welts continued to get larger, so he was given epinephrine and hydroxyzine pamoate. The welts seemed to stop getting bigger, so he was sent home. When he got home, the welts started to get bigger again. The next day, the mother brought him to the physician, and he was given prednisone. Two days after he finished the prednisone, the welts started to fade away. It was noted that they had not totally disappeared. The outcome was reported as recovering. There was no product quality complaint. Follow up information received from a consumer concerning her son indicated that after the vaccination was administered, the patient was taken home, and 2 hours later, at 6:30 PM, his left arm started breaking out in red raised bumps circled in white. They spread down the left side of the other arm and both groin areas. It kept getting worse, and the bumps turned into red raised welts. He was taken to the emergency room, and was administered a shot of diphenhydramine hydrochloride. After 30 minutes the rash and welts continued to worsen, and the patient was administered a shot of hydroxyzine pamoate and epinephrine. After another 30 minutes, the breaking out seemed to be somewhat better, and the patient was sent home. At 10:30 PM, the patient had just arrived home when the welts started to get bigger, bu8t by 7:30 AM, the red raised welts were larger and more pronounced and there were more of them. The patient's mother than took him to his regular physician, who ordered a prednisone packet and advised that he not be revaccinated with hepatitis B virus vaccine. On 10/1/04, the red raised welts were noted to be huge blotches. At 9:00 PM, on 10/1/04, some of the centers of the huge raised welts were going down, but they were leaving dark blotches in the center. It was noted that the red raised welts were hot to the touch, and his face was hot to the touch. No temperature was noted. Upon internal review, the welts were considered to be other important medical events (OMIC). Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) subcutaneously instead of intramuscularly and subsequently developed a small raised bump under her skin at the site of injection. Unspecified medical attention was sought. The patient was recovering at the time of this report and no further information was given. There was no product quality complaint involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who in 09/04, was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Four to five hours post vaccination she developed a fever, malaise and dizziness that lasted up to 48 hours. Subsequently the patient "felt fine". Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Eczema, Granuloma, Laboratory test abnormal, Rash
Clinical narrative: Information has been received from a register nurse concerning a 57 year old female who in 1992 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). In 1999 the patient developed a rash which started on her elbows, but was currently a generalized rash. "Recently" a biopsy was performed by the patients dermatologist on her lesions and the rash was found to be granuloma annulare. The dermatologist felt that granuloma annulare was related to therapy with hepatitis B virus vaccine rHBsAg (yeast). Treatment included dapsone for the lesions. There was no product quality complaint involved. Follow up information indicated that the event was not related to vaccination with hepatitis B virus vaccine rHBsAg (yeast), it was an eczema.
Age: 41.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Lymphadenopathy, Pain, Rash papular
Clinical narrative: Information has been received from a RN concerning a 41 year old white female with no known medical history or allergies, who on 10/30/04 at 10:30 am was vaccinated Im in her left deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #643721/0552M). Concomitant vaccination that day included an IM second dose of hepatitis A vaccine (inactive) (MSD) (lot # 642331/0928m) in her right deltoid at 10:30 am. There was no illness at the time of vaccination. It was reported that on 10/25/03 the patient was vaccinated with a first dose of hepatitis A virus vaccine inactivated (+) hepatitis B virus rHBsAg (yeast) (Twinrix) (previously reported as a first does of Hepatitis B virus vaccine rHBsAg (yeast) (Engerix-B) about one year ago). On 10/31/04 the patient experienced soreness in her left arm and broke out in a rash with some little bumps from head to toe. It was reported that the rash was not sore or itchy. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the registered nurse indicated that on 11/10/04 the patient reported that her lymph nodes had been swollen but by 11/10/04, the rash and lymphadenopathy had resolved. On 11/10/04, the patient was considered to be recovered.  No further information is available. This is in follow-up to report(s) previously submitted on 3/7/2005-  Information has been received from a registered nurse concerning a 41 year old female with no known medical history or allergies who on 30-OCT-2004 at 10:30 am was vaccinated IM in her left deltoid with a second dose of RECOMBIVAX HB (lot# 643721/0552M).  Concomitant vaccination that day included an IM second dose of VAQTA (lot# 642331/0928M) in her right deltoid at 10:30 am.  There was no illness at the time of vaccination.  It was reported that on 25-OCT-2003 the patient was vaccinated with a first dose of TWINRIX (previously reported as a first dose of ENGERIX-B about one year ago).  On 31-OCT-2004 the patient experienced soreness in her left arm and broke out in a rash with some little bumps from head to toe.  It was reported that the rash was not sore or itchy.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Follow-up information from the registered nurse indicated that on 10-NOV-2004 the patient reported that her lymph nodes had been swollen but by 10-NOV-2004 the rash ans lymphadenopathy had resolved.  On 10-NOV-2004 the patient was considered to be recovered.  No further information is available.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Hypoaesthesia, Laboratory test abnormal, Lymphadenopathy, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female zoo hoofstock/P.T., who on 05/27/04 was vaccinated with her third dose of the first series of hepatitis B virus vaccine rHBsAg (yeast). the does was given five years after the second dose. The employee did not experience any adverse reactions. However, following completion of the first of hepatitis B virus vaccine a titer was drawn and the result was 9.8, indeterminate. On 11/06/04 the employee, who had a recent sinus infection and antibiotic treatment, was again vaccinated intramuscularly in the left arm with a booster dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy may have included Keflex. The employee called health services on Monday, 11/08/04, stating that she experienced transient numbness and tingling of left arm, left pinky and ring finger. The transient numbness and tingling was reportedly improved by 12:00 noon on 11/08/04. By Monday night, she experienced nausea without vomiting and went to bed. On Tuesday, 11/09/04 she had a temperature of 100 degrees, developed a sore throat, swollen glands, aches all over, tired and urinary symptoms. Over the counter flu medication was used. It has been reported that as of 11/16/04, the patient was recovered from the adverse experiences. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia, Pharyngolaryngeal pain, Pyrexia, Urinary tract disorder
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female zoo hoofstock/P.T., who on 05/27/04 was vaccinated with her third dose of the first series of hepatitis B virus vaccine rHBsAg (yeast). the does was given five years after the second dose. The employee did not experience any adverse reactions. However, following completion of the first of hepatitis B virus vaccine a titer was drawn and the result was 9.8, indeterminate. On 11/06/04 the employee, who had a recent sinus infection and antibiotic treatment, was again vaccinated intramuscularly in the left arm with a booster dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy may have included Keflex. The employee called health services on Monday, 11/08/04, stating that she experienced transient numbness and tingling of left arm, left pinky and ring finger. The transient numbness and tingling was reportedly improved by 12:00 noon on 11/08/04. By Monday night, she experienced nausea without vomiting and went to bed. On Tuesday, 11/09/04 she had a temperature of 100 degrees, developed a sore throat, swollen glands, aches all over, tired and urinary symptoms. Over the counter flu medication was used. It has been reported that as of 11/16/04, the patient was recovered from the adverse experiences. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a  26 year old black female  healthcare worker with no known allergies who was vaccinated with a first, second, and third dose of Hepatitis B virus vaccine rHBsAg(yeast)on 05/05/2004, 06/02/2004, and at 3 pm in her left deltoid on 11/03/2004 (lot#648123/0596P)(thimersol-free). There was no illness at the time of vaccination. On 11/03/2004 the patient experienced a knot at the injection site, pin pricking sensation with pain, swelling and ithching at the injection site and redness in the area of injection site. There were no systemtic reactions. It was reported that the previous vaccinations in this series were well tolerated and that there were no adverse reactions to other previous vaccinations. The patient stated that the symptoms lasted until 11/07/2004. The nurse saw the patient on 11/08/2004 and her arm was feeling better, and there was no knot or redness. There were no relevant diagnostic tests/laboratory data. On 11/08/2004 the patient was considered to be recovered. There was no product quality complaint involved. No furhter information is available.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood cholesterol increased, Laboratory test abnormal, Medication error, Myalgia
Clinical narrative: Information has been received from a LPN concerning a 36 year old white female social worker with no pertinent medical history and no known drug allergies who on 15Nov04 in the PM was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 647301/0433P). At the time of vaccination, the pt c/o not feeling well, and noted he felt crappy. While the nurse was vaccinating the pt, the hub came loose and some vaccine squirted out. The nurse indicated that the hub of the vial was not tightened properly. The pt was then revaccinated IM in the left arm with a dose of hep B virus vaccine rHBsAg (yeast) lot 647301/0433P). On 16Nov04, the reporter indicated that the pt was feeling better at the time of the report. the outcome was reported as recovering. There was no product quality complaint. Follow up information received from a LPN indicated that on 16Nov04 the pt c/o muscle aches, nausea, vomiting, and generalized weakness for 2-3 days. The outcome was reported as recovered on 19Nov04. On 23Nov04, the pt had a comprehensive metabolic panel (ALT 66 IU/L high), a urinalysis normal, lipids (total cholesterol 238 mg/dl high; HDL cholesterol 11mg/dl high; LDL cholesterol 115mg/dl high), and a TSH. There were no adverse events following prior vaccinations of the pt or her siblings. No additional information is expected.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a LPN concerning a 36 year old white female social worker with no pertinent medical history and no known drug allergies who on 15Nov04 in the PM was vaccinated IM in the deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 647301/0433P). At the time of vaccination, the pt c/o not feeling well, and noted he felt crappy. While the nurse was vaccinating the pt, the hub came loose and some vaccine squirted out. The nurse indicated that the hub of the vial was not tightened properly. The pt was then revaccinated IM in the left arm with a dose of hep B virus vaccine rHBsAg (yeast) lot 647301/0433P). On 16Nov04, the reporter indicated that the pt was feeling better at the time of the report. the outcome was reported as recovering. There was no product quality complaint. Follow up information received from a LPN indicated that on 16Nov04 the pt c/o muscle aches, nausea, vomiting, and generalized weakness for 2-3 days. The outcome was reported as recovered on 19Nov04. On 23Nov04, the pt had a comprehensive metabolic panel (ALT 66 IU/L high), a urinalysis normal, lipids (total cholesterol 238 mg/dl high; HDL cholesterol 11mg/dl high; LDL cholesterol 115mg/dl high), and a TSH. There were no adverse events following prior vaccinations of the pt or her siblings. No additional information is expected.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Disorientation
Clinical narrative: Information has been received from a health professional concerning a 43 year old female who on 11/23/2004 was vaccinated with a dose of RECOMBIVAX HB "That evening' on 11/23/2004 the patient experienced disorientation and confusion. It was noted that "she called her son daddy" subsequently, in morning she was fine. It was reported that no other vaccines were administered, there were no new medications, and there was no past history of similar symptoms. The patient did not consult a physician or go  to the ER. No product quality complaint was involved. No additional information has been requested. This is a follow-up to report(s) from a health professional concerning a 43 year old female with hypertension and seasonal allergies, who on 23-NOV-2004 was vaccinated with RECOMBIVAX HB (Lot# 647987/0865P and "9510700"). "That evening," on 23-NOV-2004 the patient experienced disorientation and confusion. It was noted that "she called her son Daddy." Subsequently in the morning she was fine. It was reported that no other vaccines were administered, there were no new medications, and there was no past history of similar symptoms. The patient did not consult a physician or go to the ER. No product quality complaint was involved. Follow-up information from the consumer indicated that the patient felf disoriented, had a headache, and was slightly nauseated that evening that she received her first dose of vaccine. It was noted a second dose of RECOMBIVAX HB (Lot# 647987/0865P and"9510700") was administered intramuscularly in the left deltoid on 10-JAN-2005 and the patient had no difficulty.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Coronary artery disease, Dialysis, Drug hypersensitivity, Hypertension, Lip swelling
Clinical narrative: Information has been received from a health professional concerning a female dialysis patient who was vaccinated with a 3rd 40mg dose of Hepatitis B virus vaccine rHBsAg (yeast) and developed a white coating on her tongue the next day. It was reported that the patient gargled with eucalyptus oil(+) methyl salicylate (+) thy mol (Listerine) and the coating disappeared. The next day she had hives on her neck. A swollen tongue, and lips, and swelling of the face. She started taking diphenhydramine hydrochloride (Benadryl) and at the time of the report the swelling is subsiding, but not completely gone as yet. Unspecific medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information from a health professional indicated that on 10-DEC-2004 at 6:00 PM the patient developed a white coating on her tongue that went away with a LISTERINE rinse. On 11-DEC-2004 the patient developed a red mark on her neck and experienced increased tongue and facial swelling. She self medicated with BENADRYL. The swelling decreased by 13-DEC-2004 but did not go away completely until 15-DEC-2004. The patient was reported as recovered on 15-DEC-2004. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Renal failure chronic, Swelling face, Swollen tongue, Tongue discolouration, Urticaria
Clinical narrative: Information has been received from a health professional concerning a female dialysis patient who was vaccinated with a 3rd 40mg dose of Hepatitis B virus vaccine rHBsAg (yeast) and developed a white coating on her tongue the next day. It was reported that the patient gargled with eucalyptus oil(+) methyl salicylate (+) thy mol (Listerine) and the coating disappeared. The next day she had hives on her neck. A swollen tongue, and lips, and swelling of the face. She started taking diphenhydramine hydrochloride (Benadryl) and at the time of the report the swelling is subsiding, but not completely gone as yet. Unspecific medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information from a health professional indicated that on 10-DEC-2004 at 6:00 PM the patient developed a white coating on her tongue that went away with a LISTERINE rinse. On 11-DEC-2004 the patient developed a red mark on her neck and experienced increased tongue and facial swelling. She self medicated with BENADRYL. The swelling decreased by 13-DEC-2004 but did not go away completely until 15-DEC-2004. The patient was reported as recovered on 15-DEC-2004. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male who on 02/19/2002 was vaccinated with a second dose of Hepatitis B virus vaccine rHBsAg (yeast). Subsequently the patient developed hives. Unspecified medical attention was sought.  The patient recovered from the hives. It was reported that the patient did not complete the series with a third dose. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/7/2005.  Information has been received from a registered nurse concerning a 10 year old male with no known medical history or allergies who on 14-DEC-2000 was vaccinated in his left arm with a first dose of RECOMBIVAX HB (lot # 637850/1577K).  There was no illness at the time of vaccination.  Subsequently, "within 15-30 minutes after", the patient developed hives.  Unspecified medical attention was sought.  No laboratory diagnostic tests were done.  The patient recovered from the hives.  There was no product quality complaint involved.  Follow-up information from the registered nurse indicated that on 19-FEB-2002 the patient was vaccinated with a dose of ENGERIX-B (lot # KN65272A5) "without reaction".  Additional information is not expected.
Age: 1.54
Sex: M
Vaccine: DTAP, IPV
Symptoms: Antisocial behaviour, Apraxia, Autism, Febrile convulsion, Hypokinesia
Clinical narrative: Patient has autism and severe apraxia as well as sensory integration disorder. Concern is that the number of vaccines administered over the period of time from 3/13/03 (at 2 months of age) to the time of diagnosis (3/05; at 2 years, 2 months) contributed to or triggered his condition. Symptoms include severe deficits in expressive and receptive language, play skills, socialization, and motor planning. Certain signs presented themselves by the first birthday, including decreased attention, little or no gesturing, and lower arousal. Other signs presented before the second birthday, such as delayed expressive/receptive language, poor play stills, avoidance of sensory experiences and febrile seizures.
Age: 1.54
Sex: M
Vaccine: DTAP, IPV
Symptoms: Sensory disturbance, Speech disorder
Clinical narrative: Patient has autism and severe apraxia as well as sensory integration disorder. Concern is that the number of vaccines administered over the period of time from 3/13/03 (at 2 months of age) to the time of diagnosis (3/05; at 2 years, 2 months) contributed to or triggered his condition. Symptoms include severe deficits in expressive and receptive language, play skills, socialization, and motor planning. Certain signs presented themselves by the first birthday, including decreased attention, little or no gesturing, and lower arousal. Other signs presented before the second birthday, such as delayed expressive/receptive language, poor play stills, avoidance of sensory experiences and febrile seizures.
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Bedridden, Brain damage, Coma, Congenital brain damage, Convulsion
Clinical narrative: Patient's father arrived here at county health department for a appointment. He did not have his son with him. Instead the father had a prescription written by the doctor stating child could not leave home. Father explained that at 1 AM on 12/12/04, the child had to be taken to the ER due to seizure activity. Father says patient was noted to have a fever. Father continued to say child was transported to hospital with fever of 107.8. Once the child arrived at the hospital, he was placed on life support by the neurologist taking care of the patient. Patient was then removed from life support after a while and is now breathing on his own. Father states child's brain damage is severe and child is comatose and doesn't respond to any stimuli. Father says last EEG was flat; patient's BP stays low, he is fed via G-tube and receives 12 different medications via G-tube also. Patient must be suctioned every 2-3 hours. Doctor is patient's local pediatrician. Father states either doctor give them much hope but he feels son will win this battle and walk again. Father states he questioned both doctors about whether or not the immunizations the child received on 12/8/04 could have caused this episode. Father states both doctors say, "No, the child's problem was not due to the shots he received." This is the first time the father reported this to us and when asked why, he stated, "I have just been so busy with his care I didn't think about it." 60 Day follow up: father refuses to discuss the case. Per follow up report-Primary pediatrician states patients problems were not due to vaccinations. Medical doctor states patient originaly came to ER with a cough, cold, runny nose symptoms. While in ER temp rose to 107F. Child had several massive convulsions, stopped breathing 2 times. Patient had to much oxygen loss to his brain during decreased breathing episodes. Patient has a diagnosis of severe brain damage. He also has a seizure disorder. He has many other problems-he has trach and permanent G-tube. He is a total care, bed ridden patient now.
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Gastrostomy tube insertion, Hypotension, Hypoxia, Pyrexia
Clinical narrative: Patient's father arrived here at county health department for a appointment. He did not have his son with him. Instead the father had a prescription written by the doctor stating child could not leave home. Father explained that at 1 AM on 12/12/04, the child had to be taken to the ER due to seizure activity. Father says patient was noted to have a fever. Father continued to say child was transported to hospital with fever of 107.8. Once the child arrived at the hospital, he was placed on life support by the neurologist taking care of the patient. Patient was then removed from life support after a while and is now breathing on his own. Father states child's brain damage is severe and child is comatose and doesn't respond to any stimuli. Father says last EEG was flat; patient's BP stays low, he is fed via G-tube and receives 12 different medications via G-tube also. Patient must be suctioned every 2-3 hours. Doctor is patient's local pediatrician. Father states either doctor give them much hope but he feels son will win this battle and walk again. Father states he questioned both doctors about whether or not the immunizations the child received on 12/8/04 could have caused this episode. Father states both doctors say, "No, the child's problem was not due to the shots he received." This is the first time the father reported this to us and when asked why, he stated, "I have just been so busy with his care I didn't think about it." 60 Day follow up: father refuses to discuss the case. Per follow up report-Primary pediatrician states patients problems were not due to vaccinations. Medical doctor states patient originaly came to ER with a cough, cold, runny nose symptoms. While in ER temp rose to 107F. Child had several massive convulsions, stopped breathing 2 times. Patient had to much oxygen loss to his brain during decreased breathing episodes. Patient has a diagnosis of severe brain damage. He also has a seizure disorder. He has many other problems-he has trach and permanent G-tube. He is a total care, bed ridden patient now.