chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema, Tenderness
Clinical narrative: Information has been received from a mother and a physician concerning a 13 year old boy with asthma, allergy to penicillin and severe allergies to milk, beef and pork, who on an unspecified date was vaccinated with the first dose of  VARIVAX (Oka/Merck) and on 15-APR-2008 was vaccinated with the second dose 0.5 ml injection. Concomitant therapy included montelukast sodium (MSD). The patient's mother reported her son experienced cellulitis infection after getting the second dose of  VARIVAX (Oka/Merck). The patient did not experience an adverse event from the first dose The physician called afterwards and mentioned the patient had enormous red indurated area on the left thigh. The area was tender and went from the "puncture towards the feet". There was an expanded levels of redness and dependent edema. The physician initially thought this reaction was cellulitis but the physician now thinks it was an allergic reaction. The patient had no anaphylaxis and no hives. The physician mentioned pork was recently reintroduced and the patient did not experience any7 problems. As of 29-APR-2008, the patient's allergic reaction to varivax persisted. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Rash vesicular, Respiratory tract infection
Clinical narrative: Information has been received from a dermatologist concerning a 20 month old male who on approximately 10-APR-2008 was vaccinated with a 0.5 ml first dose of  VARIVAX (Oka/Merck). Three weeks within receiving the vaccination, the patient developed 12 lesions on his trunk, arms, legs and groin. The patient was afebrile. The patient also had otitis ear infection and respiratory infection since receiving  VARIVAX (Oka/Merck). It was unspecified if the patient sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history and no known drug reactions/allergies who on 28-AUG-2001 was vaccinated intramuscularly (previously reported as subcutaneously) in his left leg with a 0.5 ml initial dose of  VARIVAX (Oka/Merck) (Lot# 638907/0560L). On the same day, the patient was also vaccinated with PEDVAX HIB (MSD) and MMR II (MSD). Concomitant therapy included DTP (manufacturer unknown). There was no illness at time of vaccination. On 20-JUN-2005 the patient got shingles, he never had chickenpox (as previously reported). Subsequently, the patient recovered from shingles. The patient did not require any medical treatment. The patient sought medical attention at the office visit. There was not product quality complaint. A hospital vaccine specialist advised this patient to receive the  VARIVAX (Oka/Merck) again. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 7 year old female child, with no known drug allergies, who on 17-APR-2008, at 4:42 pm, was vaccinated with the second dose, SC in the left thigh, of  VARIVAX (Oka/Merck) (lot # 660080/1975U). There was no illness at the time of vaccination. On 17-APR-2008, at 11:45 am, the patient developed a red and swollen left lateral thigh (3.25 x 1.5 in central induration with overall 7.5 x 4.5 in. redness). Treatment included cetirizine (manufacturer not specified), 1.5 tsp at bedtime. On 22-APR-2008, the child recovered from the symptoms. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Genital rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no pertinent medical history of known allergies who on 08-APR-2008 was vaccinated with her first dose of  VARIVAX (Oka/Merck) (lot# 659357/1567U). On 28-APR-2008 an onset of symptoms began with sores that developed in the patient's private area and sores on her head. There was no fever, decreased appetite and the patient was diagnosed with varicella. The patient was seen in the physician's office for medical attention. No labs or diagnostic studies were performed. No treatment was noted. The child was noted to be recovering but still had spots. No other information reported. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no drug reactions/allergies who on 19-OCT-1995 was vaccinated with a 0.5 ml first dose of  VARIVAX (Oka/Merck) and on 10-Jul-2007 was vaccinated with a 0.5 ml subcutaneous second dose of  VARIVAX (Oka/Merck) (LOT# 657791/0720U). There was no concomitant medication. Subsequently, the patient failed to seroconvert after receiving 2 doses of  VARIVAX. The patient received the first dose from another office so lot number was not available. Titer test was performed and no result was provided. The patient was seen by physician and there was not product quality complaint. Additional information has been requested.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a company representative concerning his child's piano teacher's daughter a 20 month old female who in the end of March 2008 was vaccinated with  VARIVAX (Oka/Merck) and another unnamed vaccine. On 26-APR-2008 the patient experienced a rash all over her body. The patient was seen by her doctor who diagnosed it as chicken pox. The patient's symptoms persisted. The was no product quality complaint. No further information is available
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Incorrect dose administered, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician who between 1996-1997 was vaccinated with her first, second and third doses of  VARIVAX (Oka/Merck). The physician stated that she was administered her third dose because her VZV titers were low. Her antibody titers were 0.85 IgG. The outcome was unknown. There was not product quality complaint. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 11 year old male with no medical history of drug allergies who on 17-JUN-2008 was vaccinated with the second dose of  VARIVAX (Oka/Merck) in the left arm (lot # 660337/098X). There was no illness at the time of vaccination. On 19-JUN-2008, the patient experienced injection site complaints and erythema of left arm. The injection site reactions were reported as heat and swelling. Swelling and erythema of left arm measuring 4.5 x 5.0. Area was warm to the touch. The patient was observed and used cold compress and TYLENOL for comfort. At the time of the report the children recovered on unspecified dates. There was no product quality complaint involved. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 13-MAR-2008 was vaccinated into the thigh with a second dose of  VARIVAX (Oka/Merck) (lot # 658566/1652U). The physician reported that on 15-MAR-2008, the patient developed a 8 x 10 centimeter swelling and tenderness at the injection site of the thigh. The patient was treated with SEPTRA. The patient recovered from the 8 x 10 centimeter swelling and tenderness at the injection site of the thigh. The patient sought medical attention, he was seen in the physician office. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 22-APR-2008 was vaccinated into the thigh with a second dose of  VARIVAX (Oka/Merck) (Lot # 659735/1785U). The physician reported that after vaccination, the patient developed redness at the injection site. On an unspecified date the patient recovered from redness at the injection site. The patient sought medical attention, he was seen in the physician office. Additional information has been requested. This is one of several reports from the same source.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site rash, No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female with eczema on buttocks and no known drug reactions/allergies who on 07-MAY-2008 at 12:29PM was vaccinated subcutaneous in left arm with a 0.5 ml first dose of  VARIVAX (Oka/Merck) (Lot# 647090/0883N) and on 02-MAY-2008 at 12:20PM was vaccinated subcutaneous in left arm with a 0.5 ml second dose of  VARIVAX (Oka/Merck) (LOT# 659169/1500U). Concomitant therapy included IPOL (LOT# A03422), DAPTACEL (LOT# C2950AA), HAVRIX (LOT# AHAVB256BA) and MMR II (MSD) (LOT# 656616/0871U). The patient developed a reaction less than two minutes after vaccinated with  VARIVAX (Oka/Merck) on 02-MAY-2008. The reaction was described as a 11cm red rash on the upper left deltoid, a 2cm x 2cm welt on the left arm (posterior of the injection site) and another welt on the anterior left deltoid. The patient was given one teaspoonful of BENADRYL. The patient did not experience a reaction after the first dose of  VARIVAX (Oka/Merck) on 07-May-2007. The patient sought medical attention at the physician's office and there was no product quality complaint. Subsequently, the patient recovered from the rash and welt on the left arm. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male who on 24-APR-2008 was vaccinated with his second dose of  VARIVAX (Oka/Merck) (lot# 659735/1785U). Post vaccination, unspecified when, the patient developed redness and some swelling at the injection site of the thigh. The patient sought medical attention in the physician's office. Subsequently, the patient recovered. No other information. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Acne, Rash
Clinical narrative: Information has been received from a registered nurse concerning her friend's child who was vaccinated with VARIVAX (Oka/Merck) about 6 or 7 years ago approximately 2001 from another office. Subsequent 2008 the child developed a small rash on the child's chest that looked like pimples. The patient had seen a physician. from a different office, about the small pimples on the patient's chest. But the nurse reported that they were unsure if the pimples were chicken pox or not and what had caused the small pimples that had happened. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician assistant concerning  her son who was vaccinated with VARIVAX (Oka/Merck). The physician assistant reported that her son received a second dose of VARIVAX (Oka/Merck) a couple years ago and a couple months after receiving the dose he developed a severe case of shingles. Her son reported pain prior to any visible symptoms. The analysis of the vesicles were not done at that time. At the time of the report, the physician assistant's son had fully recovered. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Culture positive, Herpes zoster, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 9 year old patient who on an unspecified date was vaccinated with VARIVAX (Oka/Merck). Subsequently, the patient developed herpes zoster. It was noted that the lesion was cultured and found by the CDC to be the vaccine strain that the patient received as a child. At the time of the report the patient's status was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M, Injection site erythema, Injection site pain, Injection site papule
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with no pertinent medical history of allergies, who on 04-APR-2008 was vaccinated subcutaneously in her right upper arm with 0.5 ml dose of VARIVAX (Oka/Merck) (Lot# 658587/1520U). There was no concomitant medication. The nurse reported that on 18-APR-2008, the patient had a rash at the injection site. On 19-APR-2008 the patient had 10 papules (non fluid filled) over her whole body but no pain and no complaints. At the injection site there were papules that were fluid filled. The patient complained on 21-APR-2008 of areas being itchy and the area at the vaccination site was redder, larger and blistering. On 23-APR-2009, the patient had an IgG and IgM done and they were both negative. On 25-APR-2008, the nurse saw the patient and there was not a mark on her. The injection site was a little red but very diminished. At the time of the report the patient had recovered since 24-APR-2008.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with no pertinent medical history of allergies, who on 04-APR-2008 was vaccinated subcutaneously in her right upper arm with 0.5 ml dose of VARIVAX (Oka/Merck) (Lot# 658587/1520U). There was no concomitant medication. The nurse reported that on 18-APR-2008, the patient had a rash at the injection site. On 19-APR-2008 the patient had 10 papules (non fluid filled) over her whole body but no pain and no complaints. At the injection site there were papules that were fluid filled. The patient complained on 21-APR-2008 of areas being itchy and the area at the vaccination site was redder, larger and blistering. On 23-APR-2009, the patient had an IgG and IgM done and they were both negative. On 25-APR-2008, the nurse saw the patient and there was not a mark on her. The injection site was a little red but very diminished. At the time of the report the patient had recovered since 24-APR-2008.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella zoster serology negative
Clinical narrative: Information haws been received from a physician assistant concerning a 19 year old patient who on 15-MAR-2008 was vaccinated SQ with a second dose of 0.5ml of VARIVAX (Oka/Merck). the first dose was administered on 27-SEP-1997. It was noted that based on titer results on 07-FEB-2008 (no response) and on 29-APR-2008 (unequivocal) the patient did not seroconvert. No other symptoms were noted. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Incorrect route of drug administration, Rash pruritic, Vaccination failure
Clinical narrative: Information has been received from a medical assistant concerning a 24 month old female with no known allergies who on 04-JUN-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). The medical assistant reported that on 05-MAY-2008 the patient presented to the office with break through chicken pox. The patient had blisters, red, itchy spots on her legs, arms and back. There was no treatment. The patient's chicken pox persisted. Follow up information was from the physician who reported that the patient was vaccinated intramuscularly with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). There were no concomitant medications (noted as observation). On 05-MAY-2008 presented with vesicle of different stages consistent with acute chickenpox infection. Subsequently, the patient recovered. The physician thought that it would be a vaccine failure. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 24 month old female with no known allergies who on 04-JUN-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). The medical assistant reported that on 05-MAY-2008 the patient presented to the office with break through chicken pox. The patient had blisters, red, itchy spots on her legs, arms and back. There was no treatment. The patient's chicken pox persisted. Follow up information was from the physician who reported that the patient was vaccinated intramuscularly with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). There were no concomitant medications (noted as observation). On 05-MAY-2008 presented with vesicle of different stages consistent with acute chickenpox infection. Subsequently, the patient recovered. The physician thought that it would be a vaccine failure. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 3 year old male who was vaccinated with the 2nd dose of VARIVAX (Oka/Merck). On 30-APR-2008 the patient had a chickenpox breakthrough. AT the time of report, it was unknown if the patient recovered or not. Follow up information was received which reported that a 4 (previous reported a 3) year old male who on 05-APR-2005 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) in his left thigh. On 04-FEB-2008 the patient was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #658935/1349U) in the right thigh. On 02-MAY-2008, the patient developed classical symptoms of chickenpox which was verified by the physician. At the time of report, the patient recovered. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 9 year old male with no pertinent medical history or history of drug allergies or reactions who on 03-AUG-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 12-JUN-2008 at 9:15 AM the patient was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. 660661/0176X) into the right arm. After receiving his second dose of VARIVAX (Oka/Merck) the patient felt pale, lightheaded, dizzy and passed out less than 30 seconds. On the same day as the second dose, the patient was recovered. On an unknown date P.D.D. test was preformed and no result provided. The patient sought unspecified medical attention. Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 60 year old patient who was vaccinated subcutaneously with a dose of VARIVAX (Oka/Merck) (lot# 659250/1474U) in lieu of ZOSTAVAX (Oak/Merck) (MSD). The physician thought that that VARIVAX (Oka/Merck) was indicated to prevent Varicella and Zoster virus. No adverse experience was reported thus far. Follow-up information was received from the C.M.A. on 23-JUN-2008. She indicated that the doctor thought VARIVAX (Oka/Merck) was the vaccine to prevent shingles.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Laboratory test, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning her 18 month old grandson with no known relevant medical history who on 28-MAY-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported), and a dose of PREVNAR and DTAP. On approximately 04-JUN-2008 the patient developed a fever of 105F. On approximately 09-JUN-2008, also reported as 12 days after receiving the vaccine, the patient developed varicella like rash. The patient went to the doctor's office and sought unspecified medical attention. Lab diagnostic studied included unspecified blood work and lab cultures (results not reported). Subsequently, the patient's fever resolved and the patient is recovering from the rash. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 11 year old female with a history of attention deficit disorder and no allergies who on 03-NOV-2007 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) (lot #658762/1340U). Concomitant therapy included Clonidine and RITALIN. On 11-JAN-2008 the patient was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #658522/1252U). Recently, the patient developed varicella rash of over 100 lesions (most of the lesions were on her trunk) and she also had a fever and itching. The patient was treated with OTC BENADRYL, TYLENOL and oat meal baths. At the time of report, the patient was recovering. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male (the doctor's son) with no relevant medical history who on 10-JUN-2008 was vaccinated with 0.5 ml VARIVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported) and a dose of MMR vaccine and "other vaccinations" at another physician's office. On 13-JUN-2008 the patient experienced a fever of 102F. On 14-JUN-2008 the patient experienced a rash on trunk and back, Unspecified medical attention was sought. On 16-JUN-2008, the patient's rash was clearing and no fever noted. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from pharmacy student concerning a 60 year old patient who was vaccinated with VARIVAX. The pharmacy student reported that the patient was given VARIVAX instead of ZOSTAVAX. Medical error. The patient is not experiencing  any known symptoms. There was no product quality complaint. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Body temperature increased, Dizziness, Dyspnoea
Clinical narrative: Pt. stated he had vaccine on May 20. On May 21st - pt. c/o dizziness, joints aching, T. 102, SOB, "heart racing". Took 2 acetaminophen, stayed in bed x 2 days. Then symptoms better by May 23, 2009.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Pt. stated he had vaccine on May 20. On May 21st - pt. c/o dizziness, joints aching, T. 102, SOB, "heart racing". Took 2 acetaminophen, stayed in bed x 2 days. Then symptoms better by May 23, 2009.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Influenza like illness, Polymerase chain reaction, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX. On an unspecified date the patient developed a generalized rash. Specimens from the rash was sent to the CDC for PCR analysis. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX. She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first does. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX were stored and administered appropriately, and all patients involved were normal healthy children. Follow-up information was received on 01-JUL-2008 from a nurse practitioner concerning a ten year old male student with autism and allergy (hives) to AUGMENTIN who on 16-DEC-1998 and 30-APR-2008 was vaccinated subcutaneously with a first and second 0.5 ml doses, respectively, of VARIVAX (Lot # of second dose 659429/1917U, expiration November, 2009). Concomitant therapy included FOCALIN and therapy unspecified. "3-4 days" after receiving the second dose of VARIVAX (also reported as 03-MAY-2008) the patient developed fever and flu-like symptoms. On 06-MAY-2008 the patient developed erythematous, maculo-papular rash and a few vesicles. At the time of the report the patient had not recovered from the events yet. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX. On an unspecified date the patient developed a generalized rash. Specimens from the rash was sent to the CDC for PCR analysis. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX. She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first does. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX were stored and administered appropriately, and all patients involved were normal healthy children. Follow-up information was received on 01-JUL-2008 from a nurse practitioner concerning a ten year old male student with autism and allergy (hives) to AUGMENTIN who on 16-DEC-1998 and 30-APR-2008 was vaccinated subcutaneously with a first and second 0.5 ml doses, respectively, of VARIVAX (Lot # of second dose 659429/1917U, expiration November, 2009). Concomitant therapy included FOCALIN and therapy unspecified. "3-4 days" after receiving the second dose of VARIVAX (also reported as 03-MAY-2008) the patient developed fever and flu-like symptoms. On 06-MAY-2008 the patient developed erythematous, maculo-papular rash and a few vesicles. At the time of the report the patient had not recovered from the events yet. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Angiogram, Computerised tomogram, Condition aggravated, Conversion disorder, Deafness
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Echocardiogram, Electroencephalogram, Epistaxis, Gait disturbance, Lumbar puncture
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Palpitations, Regressive behaviour, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Alopecia, Angiogram cerebral normal, Autism spectrum disorder, Blood testosterone increased
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Convulsion, Deafness, Electroencephalogram normal, Emotional disorder
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epistaxis, Flushing, Foaming at mouth, Gastrooesophageal reflux disease, Hallucination
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Irritable bowel syndrome, Lumbar puncture normal, Malaise, Migraine, Nausea
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral, Pain, Paraesthesia, Regressive behaviour, Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tonic clonic movements, Tremor, Weight increased, Wheelchair user
Clinical narrative: Information has been received from a physician concerning a 21 year old female with partial hearing loss due to congenital sensory nerve damage, irritable bowel syndrome and gastrooesophageal reflux disease and a history of gastric ulcer perforation who was vaccinated IM with the first dose of GARDASIL, 0.5ml on 15-JUN-2007. There was no concomitant medication. Starting on 22-JUN-2007 the patient experienced migraine headaches and palpitations. In October 2007 the patient received her second IM dose of GARDASIL 0.5 ml, but has not had her third dose. In January 2008, the patient started having syncopal episodes and pseudoseizures. The patient, who was born with hearing loss due to sensory nerve damage, lost her remaining hearing in March 2008. Since the beginning of 2009, the patient had experienced episodes of behavioral regression as well as muscle pain and weakness. Due to the muscle weakness, the patient had limited ambulation. Since April 2009 the patient had recurrent nosebleeds. The patient has required multiple hospitalizations and office visits. The patient had MRI/MRA of head, CT Scan/CTA of head, EEG, echocardiogram, lumbar puncture and angiogram performed (results not reported). At the time of the report (on 18-MAY-2009) the patient was not recovered. The reporter considered the events to be disabling. Additional information has been requested.   7/9/09 Medical records received DOS 6/5/07 to 10/5/07. Patient complains of vaginal odor.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Malaise, Myalgia, Rash
Clinical narrative: Rash, Joint pain, allergy, muscle pain, memory loss.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Hypersensitivity, Myalgia, Rash
Clinical narrative: Rash, Joint pain, allergy, muscle pain, memory loss.
Age: 0.55
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Vaccination complication
Clinical narrative: Vaccine Adm.  3/18/09 for 6 mos. well visit 3/19/09 Temp. 101 degrees per mom Temp. in office 99.7 (Ax) Dx: Vaccine reaction
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Mom called starting 5/18 that Pt has a rash on arms + legs, no fever.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Rash generalised
Clinical narrative: Pt started breaking out into rash on 5/14/09 around 7:00 pm.  The rash is red round areas from head to toe.  0 blisters.  Does not seem to be itching.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site urticaria, Skin lesion
Clinical narrative: Immediate hypersensitivity reaction to MMR vacc. w/ spreading erythema and urticarial lesion at site of injection. She was comfortable & breathing easy - happy. Cool compress applied. Parents instruc. to begin BENADRYL for next 24 hours. 5/9 call w/ MOC=patient was fine.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Rash, Rash generalised
Clinical narrative: Patient broke out in a rash after ROTOVIRUS immunization given within 24 hours.  Also had a temperature of 101.  Mother gave TYLENOL rash was on whole except face.  Patient also received PENTACEL, and PREVNAR
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient stated - that after thigh vaccine (TDAP) he developed a high fever - and generalized rash. States took Benadryl & Tylenol helped symptoms - Denied difficulty breathing.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling of arm, redness, severe pain & inability to use arm for 3 days due to pain & swelling
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: Red papular rash appeared on forehead & spread to back of neck 30 min post vaccines given & lasted 48-72 hrs.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner and a healthcare worker for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with no medical history who on 26-OCT-2007 was vaccinated with the first dose of GARDASIL (lot# not reported). There was no concomitant medication. In March 2008, the patient became pregnant. It was reported that the patient did not complete the pregnancy and had TOP (termination of pregnancy) but the reason was unknown. It was unspecified if the patient sought medical attention. Upon internal review, the pregnancy termination was considered to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female with cerebral palsy, hydrocephalus and shunt which has became occluded about a year ago and who was a premature infant (24 weeks, weight 11 pounds) who "a couple of months ago" was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). Two weeks later, the patient had a "syncopal episode and possibly seizure". It was reported the patient improved, she did not have any more episodes since. The neurosurgeon told the patient's parents that he could not rule out GARDASIL as a possible cause of the episode. The patient sought unspecified medical attention. Upon internal review possibly seizure was determined to be an other important medical event. Additional information has been requested.