chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blister, Herpes zoster, Injection site erythema, Neuralgia
Clinical narrative: Information has been received from a 71 year old male with no pertinent medical history and drug allergies who on 28-JAN-2009 was vaccinated into the left arm with a dose of ZOSTER vaccine live (Oka/Merck).  Concomitant medications included "unspecified blood pressure and cholesterol medications".  On 31-JAN-2009 the patient experienced low grade fever and soon developed a rash of red blisters on the left side of his chest and back and his left arm.  The patient also experienced nerve pain.  It was reported that the patient developed shingles a few days after the vaccination.  The patient sought medical attention.  No lab tests were performed.  As of 09-FEB-2009, the patient was not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009. Follow-up information was received from the nurse practitioner on 26-Feb-2009. It was reported that on 26-Jan-2009 the patient was vaccinated into the left upper arm (not deltoid) with a 0.65 ml dose of roster vaccine live (Merck) (lot # 661200/1704X). On 29-Jan-2009 the patient developed redness around the injection site. On 01-Feb-2009 "vesicles visible to provider". The vesicles were lcoated on the T4 dematome on the left side of chest, left upper back and left upper arm near the injection site. The patient's pain rated an 4 out of 10. There were no other systamic symptoms. The patient's recent exposure to chickenpox or herpes zoster and the history of chickenpox were unknown. As of 26-Feb-2009, the patient has recovered. No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a 71 year old male with no pertinent medical history and drug allergies who on 28-JAN-2009 was vaccinated into the left arm with a dose of ZOSTER vaccine live (Oka/Merck).  Concomitant medications included "unspecified blood pressure and cholesterol medications".  On 31-JAN-2009 the patient experienced low grade fever and soon developed a rash of red blisters on the left side of his chest and back and his left arm.  The patient also experienced nerve pain.  It was reported that the patient developed shingles a few days after the vaccination.  The patient sought medical attention.  No lab tests were performed.  As of 09-FEB-2009, the patient was not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009. Follow-up information was received from the nurse practitioner on 26-Feb-2009. It was reported that on 26-Jan-2009 the patient was vaccinated into the left upper arm (not deltoid) with a 0.65 ml dose of roster vaccine live (Merck) (lot # 661200/1704X). On 29-Jan-2009 the patient developed redness around the injection site. On 01-Feb-2009 "vesicles visible to provider". The vesicles were lcoated on the T4 dematome on the left side of chest, left upper back and left upper arm near the injection site. The patient's pain rated an 4 out of 10. There were no other systamic symptoms. The patient's recent exposure to chickenpox or herpes zoster and the history of chickenpox were unknown. As of 26-Feb-2009, the patient has recovered. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEPAB, IPV, PNC, RV5
Symptoms: Ascites, Barium double contrast abnormal, Enema administration, Intussusception, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 29-JAN-2009, a 2 month old female patient was vaccinated with the first dose of ROTATEQ (Lot # 662824/1357X), orally. Concomitant medication included the first dose of DTAP-IPV (Lot # C3243AA) given intramuscularly in the left leg, the first dose of PREVNAR (Lot # D03124) given intramuscularly in the left leg and the second dose of TWINRIX (Lot # AHBVB531AA) given intramuscularly in the right leg. On 02-FEB-2009, the patient experienced a sudden onset of lethargy and vomiting. It was reported that the patient was hospitalized for lethargy and to rule out sepsis. Continued vomiting of the patient lead to the diagnosis of intussusception. It was successfully reduced by a contrast enema. On 05-MAR-2009, medical records were received for date of service from 03 to 05-FEB-2009 with discharge diagnosis intussusception. The patient presented lethargy and emesis. Physical examination was positive for apathy, systolic murmur, increased bowel tone and petechiae on legs. Ileocolic intussusception diagnosed by ultrasound and reduced by contrast enema. The patient was discharged when oral taking was well. The listing indicated that one or more of the events required hospitalization and was considered to be life-threatening. No further information is available. The original reporting source was not provided. The VAERS # is 339106. A standard lot check investigation was performed on Lot # 1357X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEPAB, IPV, PNC, RV5
Symptoms: Small intestinal obstruction, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 29-JAN-2009, a 2 month old female patient was vaccinated with the first dose of ROTATEQ (Lot # 662824/1357X), orally. Concomitant medication included the first dose of DTAP-IPV (Lot # C3243AA) given intramuscularly in the left leg, the first dose of PREVNAR (Lot # D03124) given intramuscularly in the left leg and the second dose of TWINRIX (Lot # AHBVB531AA) given intramuscularly in the right leg. On 02-FEB-2009, the patient experienced a sudden onset of lethargy and vomiting. It was reported that the patient was hospitalized for lethargy and to rule out sepsis. Continued vomiting of the patient lead to the diagnosis of intussusception. It was successfully reduced by a contrast enema. On 05-MAR-2009, medical records were received for date of service from 03 to 05-FEB-2009 with discharge diagnosis intussusception. The patient presented lethargy and emesis. Physical examination was positive for apathy, systolic murmur, increased bowel tone and petechiae on legs. Ileocolic intussusception diagnosed by ultrasound and reduced by contrast enema. The patient was discharged when oral taking was well. The listing indicated that one or more of the events required hospitalization and was considered to be life-threatening. No further information is available. The original reporting source was not provided. The VAERS # is 339106. A standard lot check investigation was performed on Lot # 1357X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEPAB, IPV, PNC, RV5
Symptoms: Apathy, Ascites, Barium enema abnormal, Blood culture positive, Cardiac murmur
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 29-JAN-2009, a 2 month old female patient was vaccinated with the first dose of ROTATEQ (Lot # 662824/1357X), orally. Concomitant medication included the first dose of DTAP-IPV (Lot # C3243AA) given intramuscularly in the left leg, the first dose of PREVNAR (Lot # D03124) given intramuscularly in the left leg and the second dose of TWINRIX (Lot # AHBVB531AA) given intramuscularly in the right leg. On 02-FEB-2009, the patient experienced a sudden onset of lethargy and vomiting. It was reported that the patient was hospitalized for lethargy and to rule out sepsis. Continued vomiting of the patient lead to the diagnosis of intussusception. It was successfully reduced by a contrast enema. On 05-MAR-2009, medical records were received for date of service from 03 to 05-FEB-2009 with discharge diagnosis intussusception. The patient presented lethargy and emesis. Physical examination was positive for apathy, systolic murmur, increased bowel tone and petechiae on legs. Ileocolic intussusception diagnosed by ultrasound and reduced by contrast enema. The patient was discharged when oral taking was well. The listing indicated that one or more of the events required hospitalization and was considered to be life-threatening. No further information is available. The original reporting source was not provided. The VAERS # is 339106. A standard lot check investigation was performed on Lot # 1357X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEPAB, IPV, PNC, RV5
Symptoms: Gastrointestinal sounds abnormal, Intussusception, Lethargy, Petechiae, Small intestinal obstruction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 29-JAN-2009, a 2 month old female patient was vaccinated with the first dose of ROTATEQ (Lot # 662824/1357X), orally. Concomitant medication included the first dose of DTAP-IPV (Lot # C3243AA) given intramuscularly in the left leg, the first dose of PREVNAR (Lot # D03124) given intramuscularly in the left leg and the second dose of TWINRIX (Lot # AHBVB531AA) given intramuscularly in the right leg. On 02-FEB-2009, the patient experienced a sudden onset of lethargy and vomiting. It was reported that the patient was hospitalized for lethargy and to rule out sepsis. Continued vomiting of the patient lead to the diagnosis of intussusception. It was successfully reduced by a contrast enema. On 05-MAR-2009, medical records were received for date of service from 03 to 05-FEB-2009 with discharge diagnosis intussusception. The patient presented lethargy and emesis. Physical examination was positive for apathy, systolic murmur, increased bowel tone and petechiae on legs. Ileocolic intussusception diagnosed by ultrasound and reduced by contrast enema. The patient was discharged when oral taking was well. The listing indicated that one or more of the events required hospitalization and was considered to be life-threatening. No further information is available. The original reporting source was not provided. The VAERS # is 339106. A standard lot check investigation was performed on Lot # 1357X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAP, HEPAB, IPV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Ultrasound kidney abnormal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 29-JAN-2009, a 2 month old female patient was vaccinated with the first dose of ROTATEQ (Lot # 662824/1357X), orally. Concomitant medication included the first dose of DTAP-IPV (Lot # C3243AA) given intramuscularly in the left leg, the first dose of PREVNAR (Lot # D03124) given intramuscularly in the left leg and the second dose of TWINRIX (Lot # AHBVB531AA) given intramuscularly in the right leg. On 02-FEB-2009, the patient experienced a sudden onset of lethargy and vomiting. It was reported that the patient was hospitalized for lethargy and to rule out sepsis. Continued vomiting of the patient lead to the diagnosis of intussusception. It was successfully reduced by a contrast enema. On 05-MAR-2009, medical records were received for date of service from 03 to 05-FEB-2009 with discharge diagnosis intussusception. The patient presented lethargy and emesis. Physical examination was positive for apathy, systolic murmur, increased bowel tone and petechiae on legs. Ileocolic intussusception diagnosed by ultrasound and reduced by contrast enema. The patient was discharged when oral taking was well. The listing indicated that one or more of the events required hospitalization and was considered to be life-threatening. No further information is available. The original reporting source was not provided. The VAERS # is 339106. A standard lot check investigation was performed on Lot # 1357X. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female with hypertension, hypocholesterolaemia, hypothyroidism, migraine, SULFONAMIDE allergy, CODEINE allergy, ROBITUSSIN DM allergy and Shellfish allergy who on 14-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 663175/1553X), 0.65 mL, subcutaneously, on left arm.  Concomitant therapy included VERAPAMIL, SYNTHROID, LIPITOR, DIOVAN, EZETIMIBE (+) SIMVASTATIN (MSD) and FIORINAL.  It was reported that the patient developed a rash that was diagnosed as shingles after receiving the vaccine.  The nurse stated that the rash in on the patient's left lower back, buttocks, and left upper leg and groin.  The patient required an office visit on 17-JAN-2009.  Patient recovered.  Follow up information has been receive from a physician concerning the patient, who also had a LISINOPRIL (manufacturer not reported) allergy (WAES #0902USA00866).  Shingles developed on 16-JAN-2009 along the left L1 dermatome.  The rash was described as a full blown shingles episode with numerous lesions.  The patient did not remember if there was a history of chicken pox, however there was no recent exposure to chicken pox.  The patient's recovery was "in progress".  The patient was enrolled in the VARICELLA ZOSTER Identification Program to identify if VZV is present, and if present, to identify whether it is associated with the wild type (WT) VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain.  The sample of the lesion was collected on 23-JAN-2009.  The sample was taken from a vesicular lesion on the left L1 dermatome.  No photograph was taken.  The sample was sent to the laboratory on 26-JAN-2009.  The PCR results received on 05-FEB-2009 for two specimens taken from vesicle fluid in sacral area and a vesicular lesion on the left buttock sacral area were wild type strain.  Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Viral DNA test positive
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female with hypertension, hypocholesterolaemia, hypothyroidism, migraine, SULFONAMIDE allergy, CODEINE allergy, ROBITUSSIN DM allergy and Shellfish allergy who on 14-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 663175/1553X), 0.65 mL, subcutaneously, on left arm.  Concomitant therapy included VERAPAMIL, SYNTHROID, LIPITOR, DIOVAN, EZETIMIBE (+) SIMVASTATIN (MSD) and FIORINAL.  It was reported that the patient developed a rash that was diagnosed as shingles after receiving the vaccine.  The nurse stated that the rash in on the patient's left lower back, buttocks, and left upper leg and groin.  The patient required an office visit on 17-JAN-2009.  Patient recovered.  Follow up information has been receive from a physician concerning the patient, who also had a LISINOPRIL (manufacturer not reported) allergy (WAES #0902USA00866).  Shingles developed on 16-JAN-2009 along the left L1 dermatome.  The rash was described as a full blown shingles episode with numerous lesions.  The patient did not remember if there was a history of chicken pox, however there was no recent exposure to chicken pox.  The patient's recovery was "in progress".  The patient was enrolled in the VARICELLA ZOSTER Identification Program to identify if VZV is present, and if present, to identify whether it is associated with the wild type (WT) VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain.  The sample of the lesion was collected on 23-JAN-2009.  The sample was taken from a vesicular lesion on the left L1 dermatome.  No photograph was taken.  The sample was sent to the laboratory on 26-JAN-2009.  The PCR results received on 05-FEB-2009 for two specimens taken from vesicle fluid in sacral area and a vesicular lesion on the left buttock sacral area were wild type strain.  Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old female patient with an allergy to PENICILLIN, SULFA and NORVASC and no pertinent medical history who on 27-JAN-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (Lot # 663672/1709X).  Concomitant therapy included amitriptyline hydrochloride, XANAX, hydrochlorothiazide (manufacturer unknown), NAPROSYN, lovastatin, lisinopril (manufacturer unknown), ARANESP, CLARITIN and SOMA.  On 02-FEB-2009 the patient had an outbreak of shingles.  On 03-FEB-2009 she called the physician's office because of significant pain.  On 05-FEB-2009 she was seen for an office visit and she still had the rash.  This one of two cases from the same source.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old female patient with an allergy to PENICILLIN, SULFA and NORVASC and no pertinent medical history who on 27-JAN-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (Lot # 663672/1709X).  Concomitant therapy included amitriptyline hydrochloride, XANAX, hydrochlorothiazide (manufacturer unknown), NAPROSYN, lovastatin, lisinopril (manufacturer unknown), ARANESP, CLARITIN and SOMA.  On 02-FEB-2009 the patient had an outbreak of shingles.  On 03-FEB-2009 she called the physician's office because of significant pain.  On 05-FEB-2009 she was seen for an office visit and she still had the rash.  This one of two cases from the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Neck pain, Pain, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female patient with sulfonamide allergy who in August 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 659673/0557X).  Concomitant therapy included WELLBUTRIN), clorazepate dipotassium, TOPAMAX, carisoprodol, ACTONEL, IMITREX SUMATRIPTAN, AMBIEN and LIPITOR.  In January 2009, the patient had a breakout of shingles.  It was reported that the patient had "HERPES ZOSTER non specific".  The patient was seen for an office visit.  At the time of reporting it is unknown if the patient recovered.  This is one of two cases reported from the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female patient with sulfonamide allergy who in August 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 659673/0557X).  Concomitant therapy included WELLBUTRIN), clorazepate dipotassium, TOPAMAX, carisoprodol, ACTONEL, IMITREX SUMATRIPTAN, AMBIEN and LIPITOR.  In January 2009, the patient had a breakout of shingles.  It was reported that the patient had "HERPES ZOSTER non specific".  The patient was seen for an office visit.  At the time of reporting it is unknown if the patient recovered.  This is one of two cases reported from the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female patient with sulfonamide allergy who in August 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 659673/0557X).  Concomitant therapy included WELLBUTRIN), clorazepate dipotassium, TOPAMAX, carisoprodol, ACTONEL, IMITREX SUMATRIPTAN, AMBIEN and LIPITOR.  In January 2009, the patient had a breakout of shingles.  It was reported that the patient had "HERPES ZOSTER non specific".  The patient was seen for an office visit.  At the time of reporting it is unknown if the patient recovered.  This is one of two cases reported from the same source.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a 62 year old male consumer who stated that he received a dose of ZOSTAVAX (Oka/Merck) on his left arm in July 2007, and in February 2009 was diagnosed with shingles on his left arm in the same area he received the vaccine shot.  The consumer was stiff and sore from the shingles.  The patient sought unspecified medical attention.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 62 year old male consumer who stated that he received a dose of ZOSTAVAX (Merck) on his left arm in July 2007, and in February 2009 was diagnosed with shingles on his left arm in the same area he received the vaccine shot.  The consumer was stiff and sore from the shingles.  The patient sought unspecific medical attention.  Additional information is not available.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a 62 year old male consumer who stated that he received a dose of ZOSTAVAX (Oka/Merck) on his left arm in July 2007, and in February 2009 was diagnosed with shingles on his left arm in the same area he received the vaccine shot.  The consumer was stiff and sore from the shingles.  The patient sought unspecified medical attention.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 62 year old male consumer who stated that he received a dose of ZOSTAVAX (Merck) on his left arm in July 2007, and in February 2009 was diagnosed with shingles on his left arm in the same area he received the vaccine shot.  The consumer was stiff and sore from the shingles.  The patient sought unspecific medical attention.  Additional information is not available.
Age: 73.0
Sex: F
Vaccine: TD, VARZOS, VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a registered pharmacist concerning a 73 year old female patient with no pertinent medical history and no known drug allergies who on 19-FEB-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 663637/1705X) SQ.  There was no concomitant medication.  On 22-FEB-2009 the patient developed a 2 inch erythematous circle around the site of injection after administration of ZOSTER vaccine live (Oka/Merck).  The patient had sought unspecified medical attention.  As of 24-FEB-2009, the patient's 2 inch erythematous circle around the site of injection persisted.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: TD, VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a 73 year old female patient with no pertinent medical history and no known drug allergies who on 19-FEB-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 663637/1705X) SQ.  There was no concomitant medication.  On 22-FEB-2009 the patient developed a 2 inch erythematous circle around the site of injection after administration of ZOSTER vaccine live (Oka/Merck).  The patient had sought unspecified medical attention.  As of 24-FEB-2009, the patient's 2 inch erythematous circle around the site of injection persisted.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis
Clinical narrative: Information has been received from a registered pharmacist concerning an 81 year old female with no drug allergies who on 27-JAN-2009 was vaccinated SQ with a 0.65ml dose of ZOSTER vaccine live (Oka/Merck) (lot #: 662755/1621X).  On or around 04-FEB-2009 the patient developed herpes simplex on her mouth/lips.  The patient was prescribed ACYCLOVIR on 06-FEB-2009 and took it for 1 day.  She discontinued because she just received ZOSTER vaccine live (Oka/Merck).  The patient was recovered on 17-FEB-2009.  The patient was seen by the dentist.  Follow-up information was received from the registered pharmacist concerning an 81 year old female with no illness at time of vaccination who on 27-JAN-2009 was vaccinated SQ with the first dose of ZOSTAVAX (Lot # 662755/1621X) into the keft tricep. On 06-FEB-2009, the patient experienced sores in her mouth. The patient complained to the dentist about sores in her mouth. The dentist prescribed VALTREX made it to not get fall immunization of ZOSTAVAX. At the time of this report, the patient was recovered. No further information is available.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex, Oral herpes, Stomatitis
Clinical narrative: Information has been received from a registered pharmacist concerning an 81 year old female with no drug allergies who on 27-JAN-2009 was vaccinated SQ with a 0.65ml dose of ZOSTER vaccine live (Oka/Merck) (lot #: 662755/1621X).  On or around 04-FEB-2009 the patient developed herpes simplex on her mouth/lips.  The patient was prescribed ACYCLOVIR on 06-FEB-2009 and took it for 1 day.  She discontinued because she just received ZOSTER vaccine live (Oka/Merck).  The patient was recovered on 17-FEB-2009.  The patient was seen by the dentist.  Follow-up information was received from the registered pharmacist concerning an 81 year old female with no illness at time of vaccination who on 27-JAN-2009 was vaccinated SQ with the first dose of ZOSTAVAX (Lot # 662755/1621X) into the keft tricep. On 06-FEB-2009, the patient experienced sores in her mouth. The patient complained to the dentist about sores in her mouth. The dentist prescribed VALTREX made it to not get fall immunization of ZOSTAVAX. At the time of this report, the patient was recovered. No further information is available.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 93 year old female with heart problems who on 06-NOV-2008 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) and developed severe joint pain that she cannot even move her arm on 04-JAN-2009.  On 5-JAN-2009 the patient went to see her physician.  At the time of reporting the patient had not recovered.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from an unidentified health professional concerning the patient.  It was reported that the patient had been treated for inflammaotry arthritis before and after the ZOSTAVAX (Merck).  No further information is available.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Information has been received from a 93 year old female with heart problems who on 06-NOV-2008 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) and developed severe joint pain that she cannot even move her arm on 04-JAN-2009.  On 5-JAN-2009 the patient went to see her physician.  At the time of reporting the patient had not recovered.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from an unidentified health professional concerning the patient.  It was reported that the patient had been treated for inflammaotry arthritis before and after the ZOSTAVAX (Merck).  No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning an 85 year old female with a history of "lung cancer surgery" who on 08-FEB-2008 was vaccinated with ZOSTER vaccine live (Oka/Merck) SQ (lot # 659326/1824U).  Concomitant therapy included NORITATE, LIPITOR and OMEPRAZOLE (MSD).  On 07-FEB-2009 the patient developed a case of the shingles.  The physician reported that the patient was prescribed VALTREX for treatment.  Unspecified medical attention was sough.  Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 85 year old female with a history of "lung cancer surgery" who on 08-FEB-2008 was vaccinated with ZOSTER vaccine live (Oka/Merck) SQ (lot # 659326/1824U).  Concomitant therapy included NORITATE, LIPITOR and OMEPRAZOLE (MSD).  On 07-FEB-2009 the patient developed a case of the shingles.  The physician reported that the patient was prescribed VALTREX for treatment.  Unspecified medical attention was sough.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast pain, Injection site pain, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a 61 year old female patient who on 22-DEC-2008 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  On 23-Dec-2008 the patient experienced swelling, some pain at the injection site and pain under the left side of the breast.  The patient's injection site pain is better but the breast pain was still the same.  As of 29-DEC-2008, the patient had not recovered from the swelling.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast pain, Injection site pain, Swelling
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a 61 year old female patient who on 22-DEC-2008 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  On 23-Dec-2008 the patient experienced swelling, some pain at the injection site and pain under the left side of the breast.  The patient's injection site pain is better but the breast pain was still the same.  As of 29-DEC-2008, the patient had not recovered from the swelling.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Polymerase chain reaction, Rash papular
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with no pertinent medical history, who on approximately 16-FEB-2009, "about one week ago" was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  On an unspecified date, the patient developed a painful papular-vesicular rash on her right abdomen radiating to the right flank area.  The patient had scheduled an appointment in the office of 23-FEB-2009.  There were no laboratory or diagnostic tests performed, the nurse practitioner was interested in collecting isolates from the lesions for Polymerase Chain Reaction testing.  At the time of reporting, the patient had not recovered.  Follow up information has been received from a completed questionnaire by a nurse practitioner.  It was reported that the 62 year old female patient with hypertension, hypercholesterolaemia, arteriosclerotic heart disease, asthma, gastrooesophageal reflux disease, shellfish allergy, diabetes mellitus maturity onset and degenerative joint disease and a history of stent placement who on 17-FEB-2009 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (Lot # 663673/1710X).  Concomitant therapy included AVANDIA, vitamin B complex vitamins (unspecified), potassium (unspecified), DYAZIDE, metformin, LIPITOR, TOPROL XL TABLETS, CAPOTEN, LOPRESSOR and cyanocobalamin.  On 21-FEB-2009, the patient developed a papulo-vesular rash with 8 papular- vesicular rash lesions on her right abdomen to flank to vertebral line, the patient had a maximum temperature of 97.  The patient also had HERPES ZOSTER DERMATOMA T 11.  At the time of reporting, the patient had recovered.  Additional information has been requested. Follow up information has been received from an advanced nurse practitioner on 09-MAR-2009.  It was reproted that the patient with no illness at the time of vaccination, on 17-FEB-2009 was vaccinated subcutaneously in the left deltoid area with a dose of ZOSTAVAX (Merck) (Lot # 663673/1710X) at 11:00 a.m.  On 21-FEB-2009, 4 days after ZOSTAVAX (Merck) vaccine, the patient woke up with itchy lesions on right flank which continued the next 24 hours to extend across right abdomen and right back to midline.  Papulovesicular lesions that were pruritic and painful became more painful next day and the patient came to the physician's office on 23-FEB-2009.  A swab from lesion was sent for testing.  At the time of reporting, the patient had not recovered (previously reported as recovered).  Follow up information has been received on 13-MAR-2009.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present to identify if it was associated wit hthe wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 23-FEB-2009.  The sample was taken from a papulovesicular lesion from the abdomen.  On 12-MAR-2009, the PCR results for the specimen identified the presence of WILD TYPE STRAIN VZV.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with no pertinent medical history, who on approximately 16-FEB-2009, "about one week ago" was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  On an unspecified date, the patient developed a painful papular-vesicular rash on her right abdomen radiating to the right flank area.  The patient had scheduled an appointment in the office of 23-FEB-2009.  There were no laboratory or diagnostic tests performed, the nurse practitioner was interested in collecting isolates from the lesions for Polymerase Chain Reaction testing.  At the time of reporting, the patient had not recovered.  Follow up information has been received from a completed questionnaire by a nurse practitioner.  It was reported that the 62 year old female patient with hypertension, hypercholesterolaemia, arteriosclerotic heart disease, asthma, gastrooesophageal reflux disease, shellfish allergy, diabetes mellitus maturity onset and degenerative joint disease and a history of stent placement who on 17-FEB-2009 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (Lot # 663673/1710X).  Concomitant therapy included AVANDIA, vitamin B complex vitamins (unspecified), potassium (unspecified), DYAZIDE, metformin, LIPITOR, TOPROL XL TABLETS, CAPOTEN, LOPRESSOR and cyanocobalamin.  On 21-FEB-2009, the patient developed a papulo-vesular rash with 8 papular- vesicular rash lesions on her right abdomen to flank to vertebral line, the patient had a maximum temperature of 97.  The patient also had HERPES ZOSTER DERMATOMA T 11.  At the time of reporting, the patient had recovered.  Additional information has been requested. Follow up information has been received from an advanced nurse practitioner on 09-MAR-2009.  It was reproted that the patient with no illness at the time of vaccination, on 17-FEB-2009 was vaccinated subcutaneously in the left deltoid area with a dose of ZOSTAVAX (Merck) (Lot # 663673/1710X) at 11:00 a.m.  On 21-FEB-2009, 4 days after ZOSTAVAX (Merck) vaccine, the patient woke up with itchy lesions on right flank which continued the next 24 hours to extend across right abdomen and right back to midline.  Papulovesicular lesions that were pruritic and painful became more painful next day and the patient came to the physician's office on 23-FEB-2009.  A swab from lesion was sent for testing.  At the time of reporting, the patient had not recovered (previously reported as recovered).  Follow up information has been received on 13-MAR-2009.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present to identify if it was associated wit hthe wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 23-FEB-2009.  The sample was taken from a papulovesicular lesion from the abdomen.  On 12-MAR-2009, the PCR results for the specimen identified the presence of WILD TYPE STRAIN VZV.  Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Pyrexia
Clinical narrative: High fever for 3 days (T.MAX. 103.7 degrees F)
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Blood culture negative, Blood test abnormal, CSF culture negative, CSF protein increased, CSF test abnormal
Clinical narrative: Initial report was received from a health care professional. An 11-year-old female patient had received MENACTRA (lot number, route/site and date of administration not reported) and ten days later, she was diagnosed with bacterial meningitis and had been hospitalized. At the time of the report, the specific bacterial type and strain were unknown and the patient's recovery status was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Headache, Intensive care, Meningitis meningococcal, Polymerase chain reaction, Purpura
Clinical narrative: Initial report was received from a health care professional. An 11-year-old female patient had received MENACTRA (lot number, route/site and date of administration not reported) and ten days later, she was diagnosed with bacterial meningitis and had been hospitalized. At the time of the report, the specific bacterial type and strain were unknown and the patient's recovery status was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial report was received from a health care professional. An 11-year-old female patient had received MENACTRA (lot number, route/site and date of administration not reported) and ten days later, she was diagnosed with bacterial meningitis and had been hospitalized. At the time of the report, the specific bacterial type and strain were unknown and the patient's recovery status was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Meningitis bacterial
Clinical narrative: Initial report was received from a health care professional. An 11-year-old female patient had received MENACTRA (lot number, route/site and date of administration not reported) and ten days later, she was diagnosed with bacterial meningitis and had been hospitalized. At the time of the report, the specific bacterial type and strain were unknown and the patient's recovery status was not reported. Documents held by sender: none.
Sex: F
Vaccine: HPV4
Symptoms: Basedow's disease, Facial palsy
Clinical narrative: Information has been received via an internet blog from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL. In the middle of the patient's series she "had a bout of Bell's palsy that paralyzed the right side of her face". Two months later, patient was diagnosed with Grave's disease. The doctor says an immune reaction to something he can't determine is most likely responsible. Upon internal review, a bout of Bell's palsy and Grave's disease were considered to be other important medical events. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dysarthria, Flank pain, Hypoaesthesia, Local reaction, Loss of consciousness
Clinical narrative: Information has been received from via the physician of a patient whose mother found the current case online. The current case concerns a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The mother of the other patient stated that the current patient had the "exact same problem" as her daughter: minor localized tenderness, developed a rash, dysarthria without other seizure symptoms, had loss of consciousness, complained of numbness and tingling, pain in side, burning pain, paralysis and stroke-like symptoms. The patient sought a specialist. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. This is one of several cases from the same source. Additional information has been requested.  06/04/09 Neurology received DOS 7/24/09 to 9/18/07. FINAL DIAGNOSIS: Chronic inflammatory demyelinating polyradiculoneuropathy. Post vaccination complained of bilateral distal lower extremity numbness, began in toes then spread proximally. Later numbness in fingers. Weakness when climbing stairs. Areflexia, diminshed strength all 4 extremities. Normal sensory exam. + Romberg. IVIg administered.  5/26/09 Received PCP medical records of 7/23/07-8/6/07 including hospital d/c summary for 7/24-7/29/2007 admission. FINAL DX: acute Guillain-barre syndrome; hyperlipidemia; weakness of RUE & bilateral feet. Records reveal when patient seen on 7/23 experienced tingling/burning/numbness of extremities, loss of muscle control in legs, incoordination, difficulty walking x 1 wk, & 2 wks after HPV & MCV4 given.  Admitted to hospital.  Neuro consult done & tx w/IVIG.  On 8/6 visit had improved & continued Neuro f/u.  EMG done 9/10/07 revealed worsening demyelination & axonal loss c/w CIDP.  recommended repeat tx w/IVIG.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Paraesthesia, Paralysis, Rash, Tenderness
Clinical narrative: Information has been received from via the physician of a patient whose mother found the current case online. The current case concerns a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. The mother of the other patient stated that the current patient had the "exact same problem" as her daughter: minor localized tenderness, developed a rash, dysarthria without other seizure symptoms, had loss of consciousness, complained of numbness and tingling, pain in side, burning pain, paralysis and stroke-like symptoms. The patient sought a specialist. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. This is one of several cases from the same source. Additional information has been requested.  06/04/09 Neurology received DOS 7/24/09 to 9/18/07. FINAL DIAGNOSIS: Chronic inflammatory demyelinating polyradiculoneuropathy. Post vaccination complained of bilateral distal lower extremity numbness, began in toes then spread proximally. Later numbness in fingers. Weakness when climbing stairs. Areflexia, diminshed strength all 4 extremities. Normal sensory exam. + Romberg. IVIg administered.  5/26/09 Received PCP medical records of 7/23/07-8/6/07 including hospital d/c summary for 7/24-7/29/2007 admission. FINAL DX: acute Guillain-barre syndrome; hyperlipidemia; weakness of RUE & bilateral feet. Records reveal when patient seen on 7/23 experienced tingling/burning/numbness of extremities, loss of muscle control in legs, incoordination, difficulty walking x 1 wk, & 2 wks after HPV & MCV4 given.  Admitted to hospital.  Neuro consult done & tx w/IVIG.  On 8/6 visit had improved & continued Neuro f/u.  EMG done 9/10/07 revealed worsening demyelination & axonal loss c/w CIDP.  recommended repeat tx w/IVIG.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Amino acid level normal, Analgesic drug level therapeutic, Antinuclear antibody negative, Blood culture negative, Blood folate normal
Clinical narrative: Developed focal deficits temporally associated to receipt of the spv. See attached. Diagnosis: CEREBELLAR ATAXIA/menigoencephalitis. Symptoms: Abnormal head movement, Gait abnormality, slurred speech.  4/15/09-records received-clinic notes 3/31/09 follow-up visit after hospitalization for 'cerebritis'. C/O headache, fever and vomiting on 1/20/09. Deployed overseas. C/O neck pain with forward flexion and slurred speech, gait unbalanced. PE dysdiadochokinesia and dysmetric in BE on FTN. Treated with IVIG and symptoms unchanged after IVIG. 5/12/10 Follow up: still had tremors at time according to DoD documentation not taking more (Pimozide), improved. Being medically discharged from military.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blood heavy metal normal, Blood magnesium normal, Blood phosphorus normal, Borrelia burgdorferi serology negative, C-reactive protein normal
Clinical narrative: Developed focal deficits temporally associated to receipt of the spv. See attached. Diagnosis: CEREBELLAR ATAXIA/menigoencephalitis. Symptoms: Abnormal head movement, Gait abnormality, slurred speech.  4/15/09-records received-clinic notes 3/31/09 follow-up visit after hospitalization for 'cerebritis'. C/O headache, fever and vomiting on 1/20/09. Deployed overseas. C/O neck pain with forward flexion and slurred speech, gait unbalanced. PE dysdiadochokinesia and dysmetric in BE on FTN. Treated with IVIG and symptoms unchanged after IVIG. 5/12/10 Follow up: still had tremors at time according to DoD documentation not taking more (Pimozide), improved. Being medically discharged from military.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: CSF protein increased, CSF white blood cell count increased, Cerebellar ataxia, Drug screen negative, Dysarthria
Clinical narrative: Developed focal deficits temporally associated to receipt of the spv. See attached. Diagnosis: CEREBELLAR ATAXIA/menigoencephalitis. Symptoms: Abnormal head movement, Gait abnormality, slurred speech.  4/15/09-records received-clinic notes 3/31/09 follow-up visit after hospitalization for 'cerebritis'. C/O headache, fever and vomiting on 1/20/09. Deployed overseas. C/O neck pain with forward flexion and slurred speech, gait unbalanced. PE dysdiadochokinesia and dysmetric in BE on FTN. Treated with IVIG and symptoms unchanged after IVIG. 5/12/10 Follow up: still had tremors at time according to DoD documentation not taking more (Pimozide), improved. Being medically discharged from military.