chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blister, Cough, Pyrexia, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 30-JUN-1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 622969/0423E). Concomitant vaccines given the same day included a SC in the right arm with a fourth dose of Hib conj vaccine (tet toxoid) (ACTHIB) (lot number 7C91567) and an IM in the right arm with a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid(TRIPEDIA) (lot number 7H81515). There was no illness at the time of vaccination. Concomitant therapy included montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC) as needed for allergies. The patient came into the physician's office because of fever and rash. The patient had a cough for one week and then a fever and rash developed on 16-MAY-2007 or 17-MAY-2007. The rash was itchy and thee were 50 to 75 vesicular lesions on the face, neck, chest and back. "The physician has diagnosed this as breakthrough chicken pox." The patient's fever and itchy rash with 50 to 75 vesicular lesions persisted. The patient sought unspecified medical attention. No product quality complaint was involved. Follow up information was received from a health professional reporting that on 17-MAY-2007 the patient developed 50-75 vesicles on her face, neck, chest and head. On 24-MAY-2007 the patient recovered. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 30-JUN-1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 622969/0423E). Concomitant vaccines given the same day included a SC in the right arm with a fourth dose of Hib conj vaccine (tet toxoid) (ACTHIB) (lot number 7C91567) and an IM in the right arm with a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid(TRIPEDIA) (lot number 7H81515). There was no illness at the time of vaccination. Concomitant therapy included montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC) as needed for allergies. The patient came into the physician's office because of fever and rash. The patient had a cough for one week and then a fever and rash developed on 16-MAY-2007 or 17-MAY-2007. The rash was itchy and thee were 50 to 75 vesicular lesions on the face, neck, chest and back. "The physician has diagnosed this as breakthrough chicken pox." The patient's fever and itchy rash with 50 to 75 vesicular lesions persisted. The patient sought unspecified medical attention. No product quality complaint was involved. Follow up information was received from a health professional reporting that on 17-MAY-2007 the patient developed 50-75 vesicles on her face, neck, chest and head. On 24-MAY-2007 the patient recovered. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pharyngitis, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 3 year old female who on 28-DEC-2004 was vaccinated, 0.5mL subcutaneously, first dose, with varicella virus vaccine live (Oka/Merck) (lot#647715/0190P). On 15-May it was reported, "the patient had lesions on her face, around her mouth, and sporadic lesions all over her body." On 16-MAY-2007, the patient's mother reported this to the physician. The patient's chickenpox persisted. Follow-up information received by the health care professional indicated that the patient is a 3 year old female, 36 lbs., and 37.5 inches tall. The patient also received Prevnar (lot# A74404K) at the same time in the left thigh. She received 2 previous doses of Prevnar. On 16-May-2007 (previously reported as 15-May-2007), the patient presented with rash around mouth-rare-red occasional at other spots on the body. Patient was also itchy. Diagnosis was varicella and pharyngitis. There was no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions. Informed consent was obtained. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 31 month old female who on 14-NOV-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 01-MAY-2007, the patient developed a mild breakthrough of less than 50 lesions after receiving varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. Unknown patient recovery status reported. No product quality complaint reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects or medical conditions who on 11-AUG-2003 (the patient was 12 months of age) was vaccinated subcutaneously in the right arm with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 645290/0326N). Concomitant vaccinations given the same day included: a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot# 645262/0098N) given subcutaneously in the left arm and a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (lot# 646073/0367N) given intramuscularly in the left thigh. There was no illness at the time of vaccination. Concomitant medication included Omnicef. On 10-SEP-2006, the patient visited the ER due to painful rash on right arm. No laboratory or diagnostic tests were performed. On 11-SEP-2006 it was determined to be shingles. Subsequently, the patient recovered from painful rash on right arm and shingles. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 42-year-old female with no medical history or allergies who on 23-APR-2007 at 10:00 am was vaccinated subcutaneously in the right upper arm with the first dose of VARIVAX (lot# 652725/0249F).  There was no illness at the time of vaccination.  There were no concomitant medications.  On 17-MAY-2007 the patient experienced a rash on her belly and back that was itchy.  Unspecified medical attention was sought.  No diagnostic/laboratory tests were performed.  Also reported by the nurse that in 1993 the patient was immune to varicella, then in 2002 was negative for varicella.  The patient never had the chicken pox and never received the varicella virus vaccine in the past.  No product quality complaint was involved.  Information was received from the registered nurse who reported that on 17-May-2007 the patient's rash was on her stomach and back with 10 vesicles noted.  The patient recovered 21-May-2007.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 30-APR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Lot number was not available at the time of this report. The patient developed a baseball sized red, hot, swollen and painful area at the injection site. Other information was not available at the time of this report. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Varicella
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old female who on 08-JAN-2001 was vaccinated with one 0.5ml subcutaneous dose of VARIVAX (Lot # 636571/0928K).  Concomitant vaccines administered on the same day included a dose of MMR.  On 14-MAY-2007 the patient developed a chickenpox rash with 10 to 12 chickenpox vesicular lesions on her abdomen, back and arm.  She also had a low grade fever of 99.7 degrees Fahrenheit.  Unspecified medical attention was sought and the patient was treated with calamine lotion and TYLENOL.  Subsequently, the patient recovered.  No further information was available at the time of this report.  No product quality complaint was involved.  Additional information has been requested.  Follow-up information stated that this patient was vaccinated with VARIVAX in her left arm and with MMR (Lot # "099K") in her right arm.  The patient developed 10-20 vesicular lesions on her abdomen, back, and arms.  No medical attention was sought.  The patient had no prior medical history and no allergies.  The patient had no illness at the time of vaccination.
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from an office manager concerning a 15 month old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number 656572/0115U). It was reported that after receiving the vaccine the patient developed varicella like lesions, less than 50 on the trunk and legs. A lot check has been initiated. Follow up information was received from a health care professional requesting a lot check on varicella virus vaccine live (Oka/Merck) (lot number 656572/0115U). This is one report from the same source. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old white male who on 31-JAN-2005 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot# 649847/0768P) in the left thigh. There was no illness at the time of vaccination. on 22-MAY-2007 the patient was diagnosed with varicella for "breakthrough chickenpox characterized by 50 to 75 lesions." No labs or diagnostic studies were performed. Subsequently the patient recovered. No further information was available. No further information is available.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Rash papular, Scab
Clinical narrative: Information has been received from a physician concerning a 20 year old male with a history of a transplant X 2, as an infant and on 05-JUN-2002, and no allergies who on 04-MAY-2007 was vaccinated with a first 0.5ml subcutaneous dose of VARIVAX.  There was no concomitant medication.  On 04-MAY-2007, after being vaccinated with VARIVAX, the patient developed 15 small vesiculopapular lesions and a sore throat.  The physician examined the patient on 23-MAY-2007 and some of the lesions had scabs and the patient looked well.  At the time of this report, the patient was recovering.  The patient did not have varicella titers prior to vaccination.  No further information was available.  No product quality complaint was involved.  Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a "7 or 9 year old" female who in "the last couple of months in" approximately March of 2007 was vaccinated subcutaneously with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck). Subsequently, "in the last couple of months," in approximately March 2007, the patient developed a softball size swelling and itching at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no other information provided. There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chills, Injection site swelling, Swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 08-JUL-1998 was vaccinated with a first dose of 0.5ml VARIVAX and received the second 0.5ml dose of VARIVAX (Lot # 656286/1507F) on 17-MAY-2007.  Concomitant vaccines administered on 17-MAY-2007 included VAQTA.  Three days after vaccination with the second dose of VARIVAX, on 20-MAY-2007, the patient developed moderate swelling and swelling at the injection site and chills.  Unspecified medical attention was sought.  No further information was available at the time of this report.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Varicella
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #656262/1497F). Within three days after vaccination, the patients developed redness and papule. The papule was confirmed to be chickenpox. This is one of two reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 06-MAY-1999 was vaccinated with a first 0.5ml dose of VARIVAX.  The date of the second 0.5ml dose of VARIVAX (Lot # 656286/1507F) was not provided.  The patient developed a large and red swelling of the injection site from her shoulder up to her elbow after receiving the second dose of VARIVAX.  Unspecified medical attention was sought.  No product quality complaint was involved.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5-year-old male with no medical history, who on 27-AUG-2002 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot#642991/0489M). Concomitant therapy included HIB conj-hepatitis B vaccine (MSD), measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-MAY-2007, approximately 5 years after receiving varicella virus vaccine live (Oka/Merck) (Lot #642991/0489M) the "patient experienced a breakthrough case of chickenpox. Patient has 50-100 lesions on mouth and trunk." Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old patient with seasonal allergies who on 30-JAN-1999 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628694/1663H). Concomitant therapy included a SC first dose on left thigh with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 628901/1547H). At the time of vaccination, the patient did not have any illness. It was reported that on 04-MAY-2007 the patient developed less than 50 lesions for 5 days. The patient did not experience any problems and not itching. On 08-MAY-2007, the patient recovered. No medical attention was sought and no diagnostic laboratory tests were undertaken. It was also noted that the patient did not have any adverse events following prior vaccination. No further information is expected. This is one of several reports received from the same source. It was also reported that the patient's sister had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0705USA03994).
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with allergic rhinitis and asthma on 14-SEP-1996 was vaccinated SC on right thigh with first dose of varicella vaccine live (Oka/Merck) (Lot# 617690/0568D). Concomitant therapy included a SC first dose on left thigh with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 619015/0471D). At the time of vaccination, the patient did not have any illness. It was reported that on 17-MAY-2007 the patient  developed less than 50 lesions on her torso and legs after returning from camp. The lesions were reported to be very itchy. On 18-MAY-2007, the patient recovered. No medical attention was sought and no diagnostic laboratory tests were undertaken. It was also noted that the patient did not have any adverse events following prior vaccination. No further information is expected. This is one of the several reports received from the same source. It was also reported that the patient's sibling had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0705USA03993).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 27-MAY-1999 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 629263/0308J). It was reported that the patient developed less than 50 lesions. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a Registered Nurse concerning a 13 month old male who on 02-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 19-MAY-2007 the patient developed a maculopapular rash on his trunk and arms. He had 25 lesions. No other information was reported. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a now 7 year old male who on 12-JUL-1996 was vaccinated, 0.5mL subcutaneously in his left leg, with varicella virus vaccine live (Oka/Merck) (lot# 617073/1662B). On 19-JUN-2002, the patient experienced breakthrough chickenpox on his face, chest, and back. Symptoms were relieved with Tylenol and Benadryl. Subsequently, the patient recovered from breakthrough chickenpox. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 5-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccinations administered on 25 April 2007 included inactivated poliomyelitis virus vaccine (left deltoid) and live attenuated measles, mumps (strain not specified), rubella vaccine (subcutaneous; right deltoid). Concurrent medications included hydrochloride (Zyrtec). On 25 April 2007 the subject received the fifth dose of Infanrix (0.5 mL, unknown, right deltoid). On 26 April 2007, 1 day after vaccination with Infanrix, the subject experienced cellulitis that was characterized as a local reaction. On 27 April 2007, the subject presented to the physician's office and was diagnosed with cellulitis in his right arm. It was unspecified whether the subject received treatment for cellulitis. This case was assessed as medically serious by GSK. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with Infanrix. Comment: the event "arm cellulitis" is considered to be medically significant by GSK.
Age: 1.8
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 21-month-old female subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccinations administered on 25 April 2007 included varicella virus vaccine (Merck); subcutaneous; right deltoid. On 25 April 2007, the subject received 4th dose of Infanrix (.5 mL, unknown, left deltoid). On 26 April 2007, one day after vaccination with Infanrix, the subject presented at the physician's office with swelling and redness in her left arm, which was diagnosed as cellulitis. This case was assessed as medically serious by GSK. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. It was unspecified if the subject received treatment for cellulitis. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Incorrect route of drug administration, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported. On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Infanrix in an unspecified thigh. At an unspecified time after vaccination with Infanrix, the subject experienced welt injection site. The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly." At the time of initial reporting the outcome of the events was unspecified. Follow-up information received on 11 May 2007 indicated that Infanrix was administered to the subject subcutaneously. The events resolved and according to the reporter, they were related to administration of Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. The subject's relevant medical history and concurrent medications were unknown. On an unspecified date, the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experience injection site redness. At the time of reporting the outcome of the event was unspecified.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: This case was reported by a nurse, via a sales representative, and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 4 May 2007 the subject received unspecified dose of Infanrix (unknown, unknown thigh). On 4 May 2007, immediately after vaccination with Infanrix, the subject experience injection site redness. Possible incorrect of administration may have occurred. The nurse reported that the Infanrix may have been injected subcutaneously rather than the intended intramuscular route, because the child is a thin little boy and he tensed up at the last minute before the injection and this may have affected the injection angle. It was unknown if the redness reaction was due to the Infanrix itself or the technique error that may have resulted in subcutaneous administration. Due to the evens, the subject required medical attention at the health department. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with Infanrix.
Age: 5.0
Sex: U
Vaccine: DTAP, HEP, IPV
Symptoms: Petechiae
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of petechiae in a 5 year old subject of unspecified gender who was vaccinated Pediarix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included poliomyelitis vaccine inactivated given on the same date as suspect Infanrix. On an unspecified date, the subject received a dose of Infanrix in an unknown deltoid. At an unspecified time after vaccination with Infanrix, the subject experienced petechiae on the right cheek. The event resolved within one day without treatment.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling arm in a 5 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Previous vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis 3 recombinant and inactivated poliovirus vaccine combined (Pediarix, GlaxoSmithKline). Three doses of Pediarix were given on unspecified dates prior to two doses of Infanrix. On 18 July 2007 the subject received 2nd dose of Infanrix at 0.5 ml in an unknown arm. On the same day of vaccination with Infanrix, the subject returned with a swelling arm. At the time of reporting the outcome of the event was unspecified. Follow up information was received on 01 August 2007 via the nurse, who reported that the event was resolved at the time of reporting.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling leg in an 18 month old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Previous vaccination included Pediarix (GlaxoSmithKline). Three doses of Pediarix were given on unspecified dates prior to Infanrix. On 18 July 2007, the subject received 1st dose of Infanrix at 0.5 mL in an unknown leg. On the same day of vaccination with Infanrix, the subject returned with a swelling leg. At the time of reporting the outcome of the event was unspecified. Follow up information was received on 01 August 2007 via the nurse, who reported that the event was resolved at the time of reporting.
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Malaise
Clinical narrative: This case was reported by the wife of a consumer and described the occurrence of feeling unwell in a male subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Diphtheria tetanus acellular pertussis, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Diphtheria tetanus acellular pertussis. At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced feeling bad/unwell. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, OPV
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling of arm following injection in a subject aged between 0 and 9 years old ("kindergarten age") of unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given on the same date as Infanrix. On an unspecified date the subject received unspecified dose of Infanrix (unknown, unknown arm). At an unspecified time after vaccination with Infanrix, the subject experienced swelling of the arm in which the injection was administered. The physician noted that the affected arm was three centimeters larger than the subject's other arm, and that the arm swelling extended past the elbow. The physician questioned whether there was a "problem with this lot of Infanrix" due to a similar reaction in a second patient (see GSK reference number A0670231A). Medical attention was required at a doctor's office. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination Infanrix.
Sex: U
Vaccine: DTAP, OPV
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling of arm following injection in a subject aged between 0 and 9 years old ("kindergarten age") of unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given on the same date as Infanrix. On an unspecified date the subject received unspecified dose of Infanrix (unknown, unknown arm). At the unspecified time after vaccination with Infanrix, the subject experienced swelling of the arm in which the injection was given. The arm swelling extended to the elbow. The physician questioned whether there was a "problem with this lot of Infanrix" due to a similar reaction in a second patient (see GSK reference number A0670229A). Medical attention was required at a doctor's office. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possible related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling at injection site in a subject of unspecified age and gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 09 August 2007, the subject received unspecified dose of Infanrix (.5 mL, unknown). On 9 August 2007, less than one day after vaccination with Infanrix, the subject experienced swelling at injection site. The physician noted that the Infanrix was "from a particular lot" (lot number not provided), and that two to three other patients had also developed injection site swelling after receiving Infanrix from the same lot (please reference GSK reference number A0670239A). At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with Infanrix.
Sex: U
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling at injection site in a two or three subjects of unspecified age and gender who were vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On unspecified dates prior to 09 August 2007 the subjects received unspecified dose of Infanrix (.5 mL, unknown). At an unspecified time after vaccination physician noted that the Infanrix was "from a particular lot" (lot number not provided), and that another patient had also developed injection site swelling after receiving Infanrix from the same lot (please reference GSK reference number A0670238A). At the time of reporting events were resolved. The physician considered the events were probably related to vaccination with Infanrix.
Age: 0.1
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Irritability, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 1st dose of DTaP (unknown). At an unspecified time after vaccination with DTaP, the subject experienced fever and irritability. Her fever was 103-103 degrees Fahrenheit. At the time of reporting the outcome of the events were unspecified. The subject only received diphtheria and tetanus for the next doses and did not receive any pertussis following these events. The reporter also stated that this reaction occurred when the subject was a patient at another office.
Sex: U
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of inconsolable crying in a subject aged between two months and  fifteen months of age unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On unspecified dates, at two months of age, four months  of age, six months of age and 15 months of age, the subject received the first, second, third and fourth doses of Infanrix (.5 mL, unknown). At an unspecified time after vaccination with Infanrix, the subject experienced inconsolable crying lasting four to five hours, and a fever of 104 degrees Fahrenheit. It was not reported whether the events occurred following each Infanrix vaccination, or if the events occurred following only one Infanrix vaccination. At the time of reporting the events were resolved.
Sex: M
Vaccine: DTP
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via an other manufacturer and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine (DTP (A or W not known), manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of DTP (A or W not known) (unknown). At an unspecified time after vaccination with DTP (A or W not known), the subject experienced a reaction to DTP (A or W not known) and was not able to receive additional pertussis vaccines. At the time of reporting the outcome of the event was unspecified.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine (right arm), live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine (right arm) all given on 28 March 2007, same day as the 5th dose of Infanrix. On 28 March 2007, the subject received 5th dose of Infanrix at 0.5 mL in the left arm. One day later, on 29 March 2007, the subject experienced erythema, swelling and warm to touch at the site of injection. The subject was treated with Benadryl and cold compresses. At the time of reporting the outcome of the events was resolved. The healthcare professional considered the events were related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a 5-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine (right arm), live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine (right arm) all given on 26 March 2007, same day as the 5th dose of Infanrix. On 26 March 2007, the subject received 5th dose of Infanrix at 0.5 mL in the left arm. On 28 March 2007, two days after the 5th dose of Infanrix, the subject experienced erythema, swelling and warm to touch at the site of injection. The subject was treated with Benadryl. At the time of reporting the outcome of the events was resolved. The healthcare professional considered the events were related to vaccination with Infanrix. Follow-up information received on 30 March 2007 indicated that the events were improved. The reporter expressed concern over this lot of Infanrix causing the events.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine (right arm), live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine (right arm) all given on 26 March 2007, same day as the 5th dose of Infanrix. On 26 March 2007 the subject received 5th dose of Infanrix at 0.5 ml in the left arm. Two days later, on 28 March 2007, the subject experienced erythema, swelling and warm to touch at the injection site. The subject was treated with diphenhydramine hydrochloride (BENADRYL). At the time of reporting the outcome of the events was resolved. The healthcare professional considered the events were related to vaccination with Infanrix. The reporter expressed concern over this lot of Infanrix causing the events.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine, live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine all given on 28 March 2007, same day as the 5th dose of Infanrix. On 28 March 2007 the subject received 5th dose of Infanrix at 0.5 ml in the left arm. Two days after vaccination with Infanrix, on 30 March 2007, the subject experienced erythema, swelling and warm to touch at the injection site. The subject was treated with diphenhydramine hydrochloride (Benadryl), acetaminophen and cold compresses. At the time of reporting the events were resolved. The healthcare professional considered the events were related to vaccination with Infanrix. Of note, the reporter had concerns that the events were related to this particular lot of Infanrix.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administration error, Erythema, Injection site swelling, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of erythema in a 7-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. In April 2007 the subject received an unspecified dose of Dtpa (.5 ml, unknown, left arm). At an unspecified time after vaccination with Dtpa, the subject experienced erythema, extensive swelling of vaccinated limb, itching and drug maladministration. A physician reported that during a conversation he heard another physician mention that they vaccinated a female subject who was 7 years and 4 months old with a diphtheria, tetanus and pertussis (Dtpa) vaccine. At the site of administration, the subject developed swelling (extensive swelling of vaccinated limb) and redness in a 4 by 6 inch area. The physician stated that he did not think the subject received any other vaccinations on the same day that Dtpa was administered. However, the reporting physician was not the physician who administered the vaccine, nor was it administered at his practice. Unspecified medical attention was required at the physician's office.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, via Merck, and described the occurrence of diffuse swelling of arm following injection in a male subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. Co-suspect vaccine included injectable poliomyelitis vaccine inactivated, manufacturer unspecified given on an unspecified date. On an unspecified date the subject received an unspecified dose of Dtpa (unknown). At an unspecified time after vaccination with Dtpa and polio vaccine, the subject developed a diffuse swelling of the injected arm. The swelling went from his mid to upper foreman and was red and non-tender. On an unspecified date, the subject sought medical attention. At the time of reporting the outcome of the events were was unspecified.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site discolouration
Clinical narrative: Two weeks of painless dusky discoloration around shot site
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site pain
Clinical narrative: Left thigh 10 cm x 8 cm.  No pain with palpation but child states it hurts a little.  Treatment given to the child included Tlenol and Benadryl.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 cm, circular reddened.  left thigh.  slightly warm to the touch.  does not appear to be painful  benadryl and tylenol given for pain and discomfort
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Nausea
Clinical narrative: Soreness/ pain at injection site, redness, hard lump, nausea. reporting this pain 48 hrs after injection. Please call Dr. for exact vaccine info. Tetanus and whooping cough in one shot.
Age: 1.58
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Febrile convulsion
Clinical narrative: Had a febrile seizure within 24 hrs.  No focal source for the seizure identified.  Sent home with conservative treatment only.
Age: 23.0
Sex: M
Vaccine: TTOX
Symptoms: Induration, Nodule, Pain in extremity, Rash macular
Clinical narrative: Donor received a tetanus injection on 4-29-08, he stated he developed pain and a hard nodule in the same arm appx 4 days later then he developed a blotchy rash down both arms and across his chest.  No itching or irritation noted.
Age: 0.8
Sex: F
Vaccine: IPV
Symptoms: Condition aggravated, Nervousness
Clinical narrative: Per mom child had episodes of shaking before IPV on 6-26-07.  She felt shaking increased in month after IPV.  She was seen in office on 7-24-07.  Per Dr. exam was WNL.  She was referred to neurologist at mom's request.  Neurologist felt exam was normal & not related to IPV.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Blister, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: I received my first Anthrax shot in November 2007 prior to deploying and following the shot I had a fever with flu like symptoms and my hands and elbows broke out with blisters.  I received the small pox shot at the same time so they were unsure which shot caused the reaction.  I received my second anthrax shot on 23 May 2008 and had a similar reaction.  Almost 24 hours after receiving the shot I started feeling sick with flu like symptoms.  My body was really weak and I had a fever.  Fortunately I had the next day off so I could just lie in bed and rest.  The area around the injection is red and swollen and it is 3 inches in diameter.  Prior to receiving the second shot I told the medics I had an adverse reaction to the first shot, but they wanted me to get another to see how my body would handle it.  I returned to the medics last night and they said they would delay my next shot by one week, but I still needed to continue the cycle.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Malaise, Pyrexia, Vaccine positive rechallenge
Clinical narrative: I received my first Anthrax shot in November 2007 prior to deploying and following the shot I had a fever with flu like symptoms and my hands and elbows broke out with blisters.  I received the small pox shot at the same time so they were unsure which shot caused the reaction.  I received my second anthrax shot on 23 May 2008 and had a similar reaction.  Almost 24 hours after receiving the shot I started feeling sick with flu like symptoms.  My body was really weak and I had a fever.  Fortunately I had the next day off so I could just lie in bed and rest.  The area around the injection is red and swollen and it is 3 inches in diameter.  Prior to receiving the second shot I told the medics I had an adverse reaction to the first shot, but they wanted me to get another to see how my body would handle it.  I returned to the medics last night and they said they would delay my next shot by one week, but I still needed to continue the cycle.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: A rash and bumps begin to break out on forehead and scalp on 5-18-2008. It continued to move to my right eyebrow, nose and eyelid with no loss of vision. It was spreading and very painful. On 5-25-2008 I went to Urgent Care. I was seen by a P.A.. His diagnosis was Herpes Zoster/Shingles. I received prescriptions for Valtrex, Neurontin and Vicoprofen. I am to take the Valtrex for 10 days. The Neurontin/1 per day for one week then increase to 2 pills per day. The Vicoprofen every 6 hours for pain.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Rash, Skin irritation
Clinical narrative: suffering from extensive skin rash,very itchy' mostly upper body and arms, even scalp.  Very irritating. Have consulted doctor and also dermatologist. Treating with special skin creams which are not satisfactory
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: suffering from extensive skin rash,very itchy' mostly upper body and arms, even scalp.  Very irritating. Have consulted doctor and also dermatologist. Treating with special skin creams which are not satisfactory
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, Bundle branch block left, Cardiac enzymes normal, Chest pain, Electrocardiogram abnormal
Clinical narrative: Pt c/o chest pain and fever 10 days post-vaccination. EKG - anterior fascicular block (no old EKG for comparison. Hospitalized on ward in ship, enzymes remained normal throughout course of treatment. Treated with Motrin for presumed pericarditis. Pain resolved over 4 days, remained afebrile. PE - diffuse, multiformed papular rash, non-pruritic over trunk.  8/18/08 Email received with case summary included.  Pt presented with chest pain 12 days s/p smallpox vax. Earlier he had developed an erythema multiforme reaction several days after the vax. 12/8/08 Additional MR received. Pt presented 5/9/08 with c/o substernal chest pressure and pain, dyspnea on exertion and erythma multiform rash. ST elevations noted on EKG. PE (+) for T= 100.3'F. DX:  Pericarditis. Chest pain resolved w/in 24 hrs.  F/U 6/18/08 with c/o increasing fatigue and SOB with exertion. Unable to complete daily exercises as before. Chest soreness follwing exercise. PE (+) for raspy airway sounds, otherwise WNL. Feeling tired and poorly. Polycythemia noted 7/14/08.