chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Ophthalmological examination normal
Clinical narrative: This is in follow-up to report (s) previously submitted on 06/14/2007. Information has been received from a mid 70's year old female consumer with hypertension and hypercholesterolaemia and food allergies who on 14-MAY-2007 (also reported as 15-MAY-2007) was vaccinated IM with a dose of Zostavax. It was reported that on 14-MAY-2007 (also reported as 15-MAY-2007), 1 to 2 hours after vaccination, the patient experienced headache lasting from 4:30 PM 14-MAY-2007 until 19-MAY-2007. The consumer said she had called the physician on 15-MAY-2007 and saw him on 18-MAY-2008. Patient underwent a MRI on 18-MAY-2007 because of continuing headache pain. Blood test were undertaken. The results of both tests were normal. The consumer does not have past history of headache. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient developed a headache within 1-2 hours after vaccination. The headache persisted for 1 week. The patient was treated with a "mild liquid acetaminophen (TYLENOL) type" pain reliever. Additional information has been requested. Additional information has been received from the physician who stated that patient developed fronal headache within 2 hours on inoculation. Headach lasted for 6 days with no sequelae. Ophthalmological exam was undertaken by patient and the result was negative. The patient recovered in 1 week. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. The patient developed an upper respiratory infection after vaccination. At the time of report the patient was recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Exposure to vaccinated person, Herpes zoster, Rash papular
Clinical narrative: Information has been received from a physician who was vaccinated with a dose of Zostavax on approximately 07-MAY-2007. The physician reported that his 58 year old wife developed a pruritic rash about T12 dermatome on the left on approximately 27-MAY-2007 after exposure to the reporter. It was reported that the lesions were sparse and significantly less intense than "the usual lesions of zoster". The lesions were reported to be very bothersome to the patient. The physician suspected that patient developed herpes zoster from being exposed to him. Additional information has been received from the physician who reported that his wife was still developing lesions as of 30-MAY-2007. The physician was not able to pinpoint whether or not the lesions were similar to chickenpox or zoster and described as "mini chickenpox". He also reported that lesions were appearing in formation on a dermatome similar to a zoster outbreak and they were papules with no fluid. Additional information has been requested. Follow- up received 03/27/2009. Approximately 4 week or 10 days after he received the vaccine his 58 year old wife developed a small area of pruritus with a burning sensation and a circumscribed rash which looked like it might contain tiny vesicles at about T12 dermatome on the left.  Additional information has been received from the physician. He stated that after talking to infectious disease physician in his practice whom he also queried, that this was something that had not been reported and was extremely unlikely. He was not sure this represented a form of herpes and in fact, from all the information he thought it was entirely different.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a physician who was vaccinated with a dose of Zostavax on approximately 07-MAY-2007. The physician reported that his 58 year old wife developed a pruritic rash about T12 dermatome on the left on approximately 27-MAY-2007 after exposure to the reporter. It was reported that the lesions were sparse and significantly less intense than "the usual lesions of zoster". The lesions were reported to be very bothersome to the patient. The physician suspected that patient developed herpes zoster from being exposed to him. Additional information has been received from the physician who reported that his wife was still developing lesions as of 30-MAY-2007. The physician was not able to pinpoint whether or not the lesions were similar to chickenpox or zoster and described as "mini chickenpox". He also reported that lesions were appearing in formation on a dermatome similar to a zoster outbreak and they were papules with no fluid. Additional information has been requested. Follow- up received 03/27/2009. Approximately 4 week or 10 days after he received the vaccine his 58 year old wife developed a small area of pruritus with a burning sensation and a circumscribed rash which looked like it might contain tiny vesicles at about T12 dermatome on the left.  Additional information has been received from the physician. He stated that after talking to infectious disease physician in his practice whom he also queried, that this was something that had not been reported and was extremely unlikely. He was not sure this represented a form of herpes and in fact, from all the information he thought it was entirely different.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from a registered nurse concerning a female in her "mid 60's" who on 17-MAY-200 was vaccinated with Zostavax and on that same day developed redness and burning around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 70 year old female with no medical history or allergies who in March 2007, was vaccinated with a dose of Zostavax. Concomitant therapy included PULMOCORT and montelukast sodium. In March 2007, two days after vaccination, the patient developed an orange colored rash on the back of her arm. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 35 year old female who on 21-MAY-2007 was vaccinated with a dose of Zostavax instead of a dose of varicella virus vaccine live. She had no ill effects from this. A product quality complaint was not involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Injection site haematoma, Injection site induration, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a pharmacist concerning an 80 year old female patient who was previously enrolled in a clinical trial and received placebo. On 22-MAY-2007 was vaccinated SQ in the left arm with a dose of ZOSTAVAX (Merck) (LOt #656395/0290U). On 22-MAY-2007, about one hour after vaccination, the patient experienced lightheadedness and stumbling. The patient had no symptoms for 20 minutes after the vaccination. It was noted that the patient traveled by car which did not have air conditioning and the temperatures that day reached 85 degrees Fahrenheit. It was unknown whether the symptoms have resolved. Additional information has been requested. Follow-up information was received from the pharmacist who reported that the patient received the vaccine and was vaccinated after 20 minutes. The site appeared normal for a SQ shot, little bruising and hard. The patient then left with her grandson. Two hours after the vaccination, the patient's daughter called to review any adverse effects with the vaccine because her mother had a spell of light-headedness. The daughter wanted to see if it was the vaccine or riding in an 95 degree car with her grandson. After reviewing the reaction list, the pharmacist told the daughter that he did not feel that this was due to the vaccination and was not listed as a common side effect and that the patient did not report feeling unwell prior to leaving the office. No further information is expected. Information has been received from an 81 year old female consumer with a history of fainting due to heat exhaustion and no allergies, who on 23-MAY-2007 was vaccinated SC with first dose of ZOSTAVAX (Merck).  Concomitant therapy included simvastatin (MSD), alendronate sodium (MSD) and DIOVAN.  On 23-MAY-2007, after vaccination the patient fainted twice.  It was reported that it was 92 degrees in her area and the fainting spell occurred after a 25 minute ride home.  On 24-MAY-2007, the patient recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a health professional concerning her aunt who was vaccinated with a dose of Zostavax. It was reported that the patient experienced a reaction and went to the ER. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 65 year old female who was vaccinated with a 0.65 ml dose of Zostavax. It was reported that "1-2 days after vaccination", the patient experienced fever, nausea, rash and swelling around injection site. At the time of report, the patient was recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a male infant who was vaccinated IM with a "full" dose of Zostavax instead a dose of varicella virus vaccine live. The vaccination was reported to be given as a routine vaccination. The event was a result of human error, not product confusion. No symptoms were reported. No diagnostic laboratory procedures were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 35 year old female who on 22-MAY-2007 was vaccinated with a dose of Zostavax. It was reported that the patient had never had chicken pox and wishes to become pregnant. The physician ordered varicella virus vaccine live to be given to the patient. The nurse rushed and inadvertently vaccinated the patient with Zostavax. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning her mother with a history of shingles who was vaccinated with a dose of Zostavax. Subsequently approximately one week after vaccination, she developed a mild case of shingles. The patient did not develop vesicles and the shingles only lasted for 3 days and she fully recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a consumer concerning her 67 year old husband with no known medical history who in "late" February 2007, was vaccinated with a dose of Zostavax. There was no concomitant medication. Subsequently one week after vaccination in approximately March 2007, the patient experienced a rash with lesions on both of his arms. The patient sought medical attention, but was not diagnosed as having shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Herpes zoster, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who in early 2007 was vaccinated with a dose of Zostavax. In 2007 the patient experienced scarring due to the injection in her arm. "A few months later", the patient got an outbreak of shingles in the arm where she was vaccinated and is still suffering post-herpetic neuralgia. About 1 week ago she came in for an outbreak of zoster on another part of her body. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Follow-up information was received from the physician indicating that the patient was a 77 year old female that received a subcutaneous dose of ZOSTAVAX (Oka/Merck) (lot# 654603/1405F) on 15-JAN-2007. The physician indicated that the patient had, "redness and scarring with persistent pain at the site of injection. Recurrence of HZV at a different site". The results of the questionnaire are as follows: The patient received the dose on her left side. The patient developed a rash at the site of injection approximately 3 weeks after vaccination. Pain was rated 10, on a scale of 1 to 10. The patient had a history of chicken pox. No recent exposure to chicken pox or herpes zoster. No direct fluorescent antibody was performed, no specimen for PCR was collected nor was a photo taken of the site. A biopsy was taken. No further information is expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scar, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who in early 2007 was vaccinated with a dose of Zostavax. In 2007 the patient experienced scarring due to the injection in her arm. "A few months later", the patient got an outbreak of shingles in the arm where she was vaccinated and is still suffering post-herpetic neuralgia. About 1 week ago she came in for an outbreak of zoster on another part of her body. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Follow-up information was received from the physician indicating that the patient was a 77 year old female that received a subcutaneous dose of ZOSTAVAX (Oka/Merck) (lot# 654603/1405F) on 15-JAN-2007. The physician indicated that the patient had, "redness and scarring with persistent pain at the site of injection. Recurrence of HZV at a different site". The results of the questionnaire are as follows: The patient received the dose on her left side. The patient developed a rash at the site of injection approximately 3 weeks after vaccination. Pain was rated 10, on a scale of 1 to 10. The patient had a history of chicken pox. No recent exposure to chicken pox or herpes zoster. No direct fluorescent antibody was performed, no specimen for PCR was collected nor was a photo taken of the site. A biopsy was taken. No further information is expected.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an over 60 year old patient who in February 2007, was vaccinated with a dose of Zostavax. In February 2007, 1 week after vaccination the patient developed zoster rash on the torso front to back on one side. The present status of patient was unknown. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant concerning a 19 year old female who on 23-MAY-2007 was mistakenly vaccinated with a dose of Zostavax instead of human papillomavirus vaccine. It was human error no product confusion. No symptoms or problems noted. No product quality complaint. No further information is available.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Information has been received from a consumer concerning her 78 year old husband with "cholesterol" and no allergies who on 15-MAY-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included simvastatin and ezetimibe. On approximately 15-MAY-2007, after vaccination the patient experienced hearing loss in the right ear. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of report, the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Erythema, Pyrexia, Rash, Respiratory disorder
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a Registered Nurse (RN) and a 69 year old female consumer with no known medical history or allergies who on 04-MAY-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 656859/0357U). There was no concomitant medication. On 07-MAY-2007 the patient experienced "upper respiratory problems" and was coughing and then she developed a fever. About ten days after vaccination, on 11-MAY-2007, the patient thought she "might may have developed shingles". She had a "3x6" patch on her waistline that feels "like it was on fire" when anything touches it, no rash was noted. She reported that heat makes it feel better. She felt like this may be shingles because her sister had shingles in the past and had the same burning feeling. The nurse reported that he patient "got shingles" and the rash was present for 2 weeks. The patient did not seek medical attention. The patient was seen in the physician's office, at the time of the appointment there were no vesicles present, her skin was just red. The rash was fairly light and very small. No specimens were collected as the rash had already dried up. As of 29-May-2007, the patient was considered to have recovered from the shingles. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a Registered Nurse (RN) and a 69 year old female consumer with no known medical history or allergies who on 04-MAY-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 656859/0357U). There was no concomitant medication. On 07-MAY-2007 the patient experienced "upper respiratory problems" and was coughing and then she developed a fever. About ten days after vaccination, on 11-MAY-2007, the patient thought she "might may have developed shingles". She had a "3x6" patch on her waistline that feels "like it was on fire" when anything touches it, no rash was noted. She reported that heat makes it feel better. She felt like this may be shingles because her sister had shingles in the past and had the same burning feeling. The nurse reported that he patient "got shingles" and the rash was present for 2 weeks. The patient did not seek medical attention. The patient was seen in the physician's office, at the time of the appointment there were no vesicles present, her skin was just red. The rash was fairly light and very small. No specimens were collected as the rash had already dried up. As of 29-May-2007, the patient was considered to have recovered from the shingles. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 18-MAY-2007 was vaccinated with a dose of Zostavax. On 23-MAY-2007 the patient developed a rash on her face and  on her arm. It was reported by the physician that no pain was associated with shingles like rash. At the time of report, the patient was not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a "single dose" of Zostavax. Subsequently the patient experienced a "shingles reaction" on his shoulder. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chest discomfort, Chills, Herpes zoster, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with hypercholesterolaemia, coronary artery disease and hypertension and history of chickenpox as a child and coronary artery bypass and no allergies who on 16-MAY-2007 was vaccinated SC in the left arm deltoid muscle with 0.65 ml dose of Zostavax (Lot # 656606/0033U). Concomitant therapy included LIPITOR, NIASPAN, aspirin (unspecified), DIOVAN and TOPROL XL TABLETS. The patient did not have any recent exposure to chickenpox and shingles. On 17-MAY-2007, day after vaccination, the patient developed "virus symptoms". Approximately 2 to 3 days later the patient developed a rash on his back. The patient was seen in office on 24-MAY-2007 and it was noted that the rash was on the back at T7. The patient was diagnosed with shingles. The patient was treated with VALTREX. At the time of report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient presently on 30-MAY-2007 had welts but not vesicular lesions. The physician reported that the patient developed cold and runny nose, one day after vaccination. By 19-MAY-2007, the patient developed a slight rash and an uncomfortable feeling on left front side of chest around T7. The patient also felt welts on his back. The physician stated that he would wait a few days and bring the patient back into the office to obtain a specimen. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if ZVZ is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the vaccine VZV strain. The specimen was sent to the laboratory on 01-JUN-2007 and the source of specimen, was from vesicular lesions. It was reported that on 24-MAY-2007 the patient developed shingles and had body temperature of 101 degree Fahrenheit. Other systemic symptoms were coryza, fever, chills and flu like illness. Herpes zoster was marked by vesicular rash with 50 lesions on left lower chest dermatome (T7) from the back to the left on left side of the sternum. The rash did not occur at the site of injection. The patient rated his pain a 10 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. A specimen for polymerase chain reaction test was collected and the results were pending. A photo of lesions was also taken. The patient was recovering on VALTREX. Additional information has been requested. Follow-up received on 03/27/2009. The physician stated that PCR test was done and it was wild type.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain, Polymerase chain reaction, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with hypercholesterolaemia, coronary artery disease and hypertension and history of chickenpox as a child and coronary artery bypass and no allergies who on 16-MAY-2007 was vaccinated SC in the left arm deltoid muscle with 0.65 ml dose of Zostavax (Lot # 656606/0033U). Concomitant therapy included LIPITOR, NIASPAN, aspirin (unspecified), DIOVAN and TOPROL XL TABLETS. The patient did not have any recent exposure to chickenpox and shingles. On 17-MAY-2007, day after vaccination, the patient developed "virus symptoms". Approximately 2 to 3 days later the patient developed a rash on his back. The patient was seen in office on 24-MAY-2007 and it was noted that the rash was on the back at T7. The patient was diagnosed with shingles. The patient was treated with VALTREX. At the time of report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient presently on 30-MAY-2007 had welts but not vesicular lesions. The physician reported that the patient developed cold and runny nose, one day after vaccination. By 19-MAY-2007, the patient developed a slight rash and an uncomfortable feeling on left front side of chest around T7. The patient also felt welts on his back. The physician stated that he would wait a few days and bring the patient back into the office to obtain a specimen. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if ZVZ is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the vaccine VZV strain. The specimen was sent to the laboratory on 01-JUN-2007 and the source of specimen, was from vesicular lesions. It was reported that on 24-MAY-2007 the patient developed shingles and had body temperature of 101 degree Fahrenheit. Other systemic symptoms were coryza, fever, chills and flu like illness. Herpes zoster was marked by vesicular rash with 50 lesions on left lower chest dermatome (T7) from the back to the left on left side of the sternum. The rash did not occur at the site of injection. The patient rated his pain a 10 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. A specimen for polymerase chain reaction test was collected and the results were pending. A photo of lesions was also taken. The patient was recovering on VALTREX. Additional information has been requested. Follow-up received on 03/27/2009. The physician stated that PCR test was done and it was wild type.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Rhinitis, Rhinorrhoea, Skin lesion, Urticaria
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with hypercholesterolaemia, coronary artery disease and hypertension and history of chickenpox as a child and coronary artery bypass and no allergies who on 16-MAY-2007 was vaccinated SC in the left arm deltoid muscle with 0.65 ml dose of Zostavax (Lot # 656606/0033U). Concomitant therapy included LIPITOR, NIASPAN, aspirin (unspecified), DIOVAN and TOPROL XL TABLETS. The patient did not have any recent exposure to chickenpox and shingles. On 17-MAY-2007, day after vaccination, the patient developed "virus symptoms". Approximately 2 to 3 days later the patient developed a rash on his back. The patient was seen in office on 24-MAY-2007 and it was noted that the rash was on the back at T7. The patient was diagnosed with shingles. The patient was treated with VALTREX. At the time of report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient presently on 30-MAY-2007 had welts but not vesicular lesions. The physician reported that the patient developed cold and runny nose, one day after vaccination. By 19-MAY-2007, the patient developed a slight rash and an uncomfortable feeling on left front side of chest around T7. The patient also felt welts on his back. The physician stated that he would wait a few days and bring the patient back into the office to obtain a specimen. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if ZVZ is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the vaccine VZV strain. The specimen was sent to the laboratory on 01-JUN-2007 and the source of specimen, was from vesicular lesions. It was reported that on 24-MAY-2007 the patient developed shingles and had body temperature of 101 degree Fahrenheit. Other systemic symptoms were coryza, fever, chills and flu like illness. Herpes zoster was marked by vesicular rash with 50 lesions on left lower chest dermatome (T7) from the back to the left on left side of the sternum. The rash did not occur at the site of injection. The patient rated his pain a 10 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. A specimen for polymerase chain reaction test was collected and the results were pending. A photo of lesions was also taken. The patient was recovering on VALTREX. Additional information has been requested. Follow-up received on 03/27/2009. The physician stated that PCR test was done and it was wild type.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella virus test positive, Viral infection
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with hypercholesterolaemia, coronary artery disease and hypertension and history of chickenpox as a child and coronary artery bypass and no allergies who on 16-MAY-2007 was vaccinated SC in the left arm deltoid muscle with 0.65 ml dose of Zostavax (Lot # 656606/0033U). Concomitant therapy included LIPITOR, NIASPAN, aspirin (unspecified), DIOVAN and TOPROL XL TABLETS. The patient did not have any recent exposure to chickenpox and shingles. On 17-MAY-2007, day after vaccination, the patient developed "virus symptoms". Approximately 2 to 3 days later the patient developed a rash on his back. The patient was seen in office on 24-MAY-2007 and it was noted that the rash was on the back at T7. The patient was diagnosed with shingles. The patient was treated with VALTREX. At the time of report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient presently on 30-MAY-2007 had welts but not vesicular lesions. The physician reported that the patient developed cold and runny nose, one day after vaccination. By 19-MAY-2007, the patient developed a slight rash and an uncomfortable feeling on left front side of chest around T7. The patient also felt welts on his back. The physician stated that he would wait a few days and bring the patient back into the office to obtain a specimen. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if ZVZ is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the vaccine VZV strain. The specimen was sent to the laboratory on 01-JUN-2007 and the source of specimen, was from vesicular lesions. It was reported that on 24-MAY-2007 the patient developed shingles and had body temperature of 101 degree Fahrenheit. Other systemic symptoms were coryza, fever, chills and flu like illness. Herpes zoster was marked by vesicular rash with 50 lesions on left lower chest dermatome (T7) from the back to the left on left side of the sternum. The rash did not occur at the site of injection. The patient rated his pain a 10 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. A specimen for polymerase chain reaction test was collected and the results were pending. A photo of lesions was also taken. The patient was recovering on VALTREX. Additional information has been requested. Follow-up received on 03/27/2009. The physician stated that PCR test was done and it was wild type.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a health professional concerning a female patient over 60 years of age who on 22-MAY-2007 was vaccinated with a dose of Zostavax. On 22-MAY-2007, the patient developed Bell's Palsy. Unspecified medical attention was sought and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested. 2/25/08-Seen on 5/23/07-Developed pain and blurring to left eye with weakness to left face and numbness. Seen on 6/13/07-more facial symmetry noted. Information has been received from a health professional concerning a 72 year old female with no allergies or medical conditions who on 17-MAY-2007 was vaccinated SCin the left deltoid with a dose of ZOSTAVAX vaccine live (Oka/Merck) (lot # 657558/0461U). There was no illness at the time of vaccination. On 19-MAY-2007, the patient developed Bell's Palsy with pain and bluring to the left eye and weakness to the left face and numbness. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. The patient partially recovered after one month. A product quality complaint was not involved. No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain
Clinical narrative: Information has been received from a female consumer who on 22-MAY-2007 was vaccinated with a dose of Zostavax. It was reported that on 29-MAY-2007 the patient developed a "big red lump" on her arm and the lump was noted to be painful. No further information is available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Sleep apnoea syndrome
Clinical narrative: Information has been received from a physician assistant concerning an 81 year old female patient with chronic obstructive pulmonary disease and "spine problems" who on 15-MAY-2007 was vaccinated SC with 0.65 ml dose of Zostavax (Lot # 656412/01476F). It was reported that on 20-MAY-2007 the patient experienced shingles like rashes on the foot and small of back after vaccination. At the time of report the patient was not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Follow up information was received. The patient had a history of chronic obstructive pulmonary disease, spinal disorder and a history of coronary artery disease, hypertension, cardiac failure congestive, gastrooesophageal reflux disease, spintal stenosis nos, bipolar disorder and sleep apnea. The patient had no known drug allergies. On 20-MAY-2007, the patient was vaccinated at 11:02 in the left arm with a dose of ZOSTAVAX (Oka/Merck) (Lot # 656412/1476F). The patient developed "shingles like rash after vaccination. The patient developed rash at top of gluteal fold and along top of left foot and pain. The patient recovered after 24-MAY-2007 of shingles like rash and pain. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an over 80 year old female patient who on 18-MAY-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included PLAVIX. It was reported that on 22-MAY-2007 the patient developed 3 welts, 4 inches long, one on her torso and two on her arms. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Inappropriate schedule of drug administration, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female patient with Parkinson's disease and no allergies who on 22-MAY-2007 was vaccinated SC with 0.65 ml dose of Zostavax. On approximately 22-MAY-2007, the patient experienced pain, redness, swelling and bruising at injection site. It was reported that patient also experienced dizziness. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient was not recovered. A product quality complaint was not involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information has been received from the pharmacist who stated that on the day of vaccination the patient developed swelling and soreness on arm. The patient recovered 5 days after vaccination. No further information is expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female patient with Parkinson's disease and no allergies who on 22-MAY-2007 was vaccinated SC with 0.65 ml dose of Zostavax. On approximately 22-MAY-2007, the patient experienced pain, redness, swelling and bruising at injection site. It was reported that patient also experienced dizziness. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient was not recovered. A product quality complaint was not involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information has been received from the pharmacist who stated that on the day of vaccination the patient developed swelling and soreness on arm. The patient recovered 5 days after vaccination. No further information is expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male patient over 60 years of age who in January 2007, was vaccinated with a dose of Zostavax. In January 2007, two days after vaccination, the patient developed a disseminated zoster rash. Unspecified medical attention was sought and the patient recovered a "couple of weeks" after receiving the vaccine. No diagnostic laboratory tests were performed. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax (Lot # 657675/0618U) instead of varicella virus vaccine live. It was reported that the office was expecting an order of varicella virus vaccine live and an order of Zostavax and the Zostavax vaccine arrived first. According to the nurse, vaccine boxes looked similar and thus the Zostavax was put into children freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax. (Lot # 657675/0618U) instead of Varivax. It was reported that the office was expecting an order of Varivax and an order of Zostavax and the Zostavax arrived first. According to the nurse, vaccine boxed looked similar4 and thus the Zostavax was put into children freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax. (Lot # 657675/0618U) instead of Varivax. It was reported that the office was expecting an order of Varivax and an order of Zostavax and the Zostavax arrived first. According to the nurse, vaccine boxed looked similar and thus the Zostavax was put into children freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax. (Lot # 657675/0618U) instead of Varivax. It was reported that the office was expecting an order of Varivax and an order of Zostavax and the Zostavax arrived first. According to the nurse, vaccine boxed looked similar4 and thus the Zostavax was put into children freezer instead of adult freezer. The nurse also reported that the names of both vaccines sound similar. The patient did not experience any known symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Rash papular
Clinical narrative: Information has been received from a physician concerning a 73 year old female patient who on 21-MAY-2007 was vaccinatedSC on left arm with a dose of Zostavax (lot # 657559/0462U). On 25-MAY-2007 the patient returned to the office with red spots under her bra line radiating to the back becoming fluid filled. Additional information has been received from the registered nurse who stated that on 25-MAY-2007 patient was seen in clinic with complaints of red raised areas with yello fluid forming in several with pain and burning. Lesions were above waist line that progressed on left side to mid back. Patient was treated with ZOVIRAX. It was reported that patient had a follow up appointment on 30-MAY-2007 and shingles lesions were receding. At the time of report the patient had recovered. No further information is expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 73 year old female patient who on 21-MAY-2007 was vaccinatedSC on left arm with a dose of Zostavax (lot # 657559/0462U). On 25-MAY-2007 the patient returned to the office with red spots under her bra line radiating to the back becoming fluid filled. Additional information has been received from the registered nurse who stated that on 25-MAY-2007 patient was seen in clinic with complaints of red raised areas with yello fluid forming in several with pain and burning. Lesions were above waist line that progressed on left side to mid back. Patient was treated with ZOVIRAX. It was reported that patient had a follow up appointment on 30-MAY-2007 and shingles lesions were receding. At the time of report the patient had recovered. No further information is expected.
Age: 6.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 6 year old patient who was vaccinated with a dose of Zostavax instead of Varivax. It was reported that it was due to nursing error. No symptoms were noted. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the event occurred because both vaccines were stored in the freezer and an employee grabbed the wrong box. It was noted that the employee was new and was just confused. It was reported that they have now put a tape on Zostavax that says it is for adults only. Additional information has been requested. This is one of several reports received from the same source.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 67 year old male who was vaccinated with a dose of Zostavax. Shortly after receiving the injection, the patient developed a rash that looked like poison ivy near injection site. Subsequently, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic, Varicella virus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown) who on approximately 11-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). In May 2007, the patient experienced ocular shingles "two weeks after receiving vaccine". Unspecified medical attention was sought. No product quality complaint. Follow-up information received indicating that the physician will be doing a "DNA test" to see if the shingles virus this patient has is the "wild" type or the vaccine type. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 67 year old female with a penicillin allergy and a history of childhood chickenpox who on 16-APR-2007 (previously reported as approx. 11-MaY-2007) was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck) (Lot #656609/0015U) in her left deltoid. On 24-MAY-2007 (previously reported as in May 2007), the patient experienced ocular shingles. Unspecified medical attention was sought. No product quality complaint. The patient had no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient was rated a 10 on a scale of 0 (least) to 10 (most). Subsequently, the patient was recovering from ocular shingles. Follow-up information received indicating that the physician will be doing a "DNA test" to see if the shingles virus this patient has is the "wild" type or the vaccine type. 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. The sample of the dry scab lesion was collected on 30-MAY-2007. The PCR results for the specimen identified the presence of WT VZV.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Information has been received from a 67 year old female with an allergy to tetracycline who was vaccinated with a dose of Zostavax at the end of March 2007. Concomitant therapy included ACTONEL. The patient reported experiencing back pain shortly after receiving the vaccination. The patient did not seek medical attention. The patient's experiencing back pain persisted. There was no product quality complaint. No further information is available.