chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Measles post vaccine, Rash morbilliform
Clinical narrative: Information has been received from a nurse concerning a "13 1/2 month old" patient (gender unknown) who on 10-MAR-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently"approximately six weeks after being vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process), the patient experienced a measles-like rash. The patient sought unspecified medical attention. As of the date of this report, the outcome of the patient was not known. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning an 85 year old female with hypertension, osteoporosis and no known drug reactions or allergies who on 23-MAR-2007 was vaccinated subcutaneously with 0.65 mL of zoster vaccine live (Oka/Merck) (Lot # 656607/0163U). Concomitant therapy included hydrochlorothiazide, losartan potassium (MSD), CRESTOR, amlodipine besylate, aspirin and omeprazole. On 28-FEB-2008, the patient sought medical treatment for left hip pain that was described as a mild eruption of a shingles rash at the L1 dermatome. The patient was prescribed FAMVIR, VICODIN, and LYRICA. At the time of the reporting the patient had not yet recovered. The physician was not interested in VZV Analysis by PCR. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 08-SEP-2003  was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 644974/0196N). It was noted that on 17 AUG 2007 the patient was vaccinated subcutaneously into the left arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 657749/0616U). On 24 MAR 2008 the mother reported that she had noticed a little lesion on the patient's inner thigh. She reported that she did not think much of it at the time because the patient has had problems with dry skin. On the evening of 25 MAR 2008, the mother reported she noticed that the lesions were starting to spread. The patient complained of a little bit of itching. The patient had not had a temperature. Upon examination the physician noted that patient to be alert and cooperative. The patient presented with scattered small erythematous papular lesions. Some of the lesions had a little whitish dot in the center. The original lesion that she had was actually scabbed ever. In the opinion of the physician this was highly suspicious for atypical varicella. Treatment included BENADRYL and TYLENOL, as long as the patient does not run a temperature, a review of routine care with the mother, and abstinence from school for one day. At the time of reporting the patient had recovered, on an unspecified date. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12-month-old male with epilepsy who on 13-DEC-2007 was vaccinated subcutaneously with a first 0.5 ml dose of PROQUAD. It was reported that "1-2 days after vaccination" the patient experienced "fever and seizures lasting 1-2 weeks". Unspecified medical attention was sought. The patient saw a neurologist "last month" (approximately March of 2008) who reported that the patient was "doing fine". On an unspecified date the patient recovered. No product quality complaint was involved. Follow-up information has been received concerning a male with a history of seizures, who on 13-Dec-2007 at 1630 was vaccinated in the left thigh with a first dose of PROQUAD (lot # "05414"). Concomitant vaccinations at 1630 included a fourth dose in the right thigh of PREVNAR (Lot# B540164) and FLUZONE (Lot# UT2459). Concomitant medications included TRILEPTAL. The patient had cold symptoms at the time of vaccination. It was reported that the patient was having small seizures that were lasting 1 minute. On 15-Dec-2007 at 1734 the patient had a seizure that lasted 5 minutes. He continued to have repeated seizures and was sent to the ER. The patient was observed for a day before discharge. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: Information has been received from a 62 year old female consumer with no known allergies, cholesterol and hypertension who on 25-FEB-2008 was vaccinated with 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and bisoprolol fumarate/HCTZ (ZIAC). On the same day that she was administered zoster vaccine live (Oka/Merck), 25-FEB-2008 the patient developed shingles. On 01-MAR-2008 patient reported she started taking famciclovir (FAMVIR) and experienced a headache. Unspecified medical attention was sought. There were no lab studies performed. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13 month old male, weight 23lb, who on 31-MAR-2008 at 10:45 was vaccinated with the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) in the left thigh (lot#:657780/0617U). On 20-APR-2008, the patient developed chickenpox. On
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: Information has been received from a physician concerning a 15 month old male with otitis media and no known allergies who on approximately 30-APR-2008 was vaccinated with PROQUAD. Concomitant therapy included amoxicillin for the treatment of otitis media. On 06-MAY-2008 the patient developed a febrile seizure and was hospitalized, and given ceftriaxone sodium (ROCEPHIN). It was noted that the patients two uncles had a history of febrile seizures. The patient subsequently recovered and was discharged on 7 May 2007. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 6-year-old female with no pertinent medical history and no allergies who on 20-APR-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot# 654835/0823F). On 02-JUN-2008, the patient was seen in the office  for a breakthrough rash. The patient had about 15 raised lesions with no fever, no other conditions, and no treatment was provided. There were no laboratory or diagnostic studies performed. No product quality complaint was involved. The outcome was unknown. It was reported that the patient had a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and varicella virus vaccine live (Oka/Merck) as the initial vaccinations. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient who on 19-MAY-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). The physician reported that, on 28-MAY-2008, the patient developed a rash. The patient's mother called the office to inform them that her child developed chickenpox on the torso. The physician had not seen the patient no product quality complaint was involved. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a male consumer who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). In March 2008, the patient experienced urticaria. It was unspecified if medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a 62-year-old male consumer with "heart problems" who on Thursday or Friday of last week (20-MAR-2008 or 21-MAR-2008) was vaccinated SQ with a first 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included "heart medication." The patient also reported he received a cortisone injection a couple of days prior to receiving the vaccination. Subsequently, "this weekend" on approximately 29-MAR-2008 the patient reported having a rapid heart beat. Unspecified medical attention was sought. There were no lab studies performed. The patient recovered "this morning" on 31-MAR-2008. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Pain, Pruritus
Clinical narrative: Information has been received from a 57 year old female consumer with no known allergies and high cholesterol who on 27-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 28-MAR-2008 the patient experienced flu like symptoms including rhinitis, body aches, fever and pruritus. Medical attention was sought, the patient spoke to the physician. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 1.1
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 month old consumer who on 06-FEB-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The physician stated this was staff error and not product confusion. No adverse experience is related to this event. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician indicated that it was totally staff error. They are a general family practice and have both pediatric and adult vaccines in storage. Because these vaccines are both stored at the same temperature, the wrong vaccine was obtained and administered. Because of the incident, they have instituted a new policy, that all physicians' must check the labels on the vials before the nurses administer the medication. They are planning on using bright fluorescent labels on the medicine labeled for adult and pediatric. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 64 year old female who, "two days ago" on 26-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (Lot 658602/1080U). The physician noted the patient was now presenting (date unspecified) with a unilateral rash under her neck that looked like shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female consumer who on 13-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 25-MAR-2008 the patient called the office and reported blisters on her trunk. The nurse diagnosed the blisters as shingles from the patient's description over the phone. The patient was referred to her physician. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was not tested because she recovered on an unspecified date. Additional information has been requested. This is one of several reports from the same source.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial, Paraesthesia oral
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 63 year old female with no known allergies, gastrooesophageal reflux disease and rheumatoid arthritis and a history of Bell's palsy 20 years ago and diverticulitis who on 12-MAR-2008 was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included methotrexate, LOTREL and PLAQUENIL. Subsequently, after vaccination the patient presented with numbness in her face and the right side of her nose (in the area where she was affected by Bell's palsy), and intermittent tingling on her lips and nose. Unspecified medical attention was sought. There were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 68 year old female consumer with no known allergies who on 07-AUG-2007 was vaccinated SQ with a dose of zoster vaccine live (Oka/Merck). On 24-MAR-2008, the patient developed shingles. The patient had rashes on her back, side of her head, and on her neck. She also complained of pain on the head and neck. On an unspecified date the patient was seen by the physician. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician's office concerning a 68 year old consumer with no known allergies who on 07-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) indicated there was no illness at the time of vaccination, and the patient did not have any lab studies performed. The patient's outcome was not reported. Follow-up information has been received from a physician concerning this 68 year old female consumer with no known allergies or pertinent medical history who on 07-AUG-2007 was vaccinated IM right side (also reported as SQ) with a first dose of zoster vaccine live (Oka/Merck) (lot # "07334'). There was no illness at the time of vaccination. On 29-MAR-2008 the patient was diagnosed with shingles. There were no lab studies performed. At the time of the report the patient's status was reported as recovered. (The patient does not have pain, but still has marks). It was noted that the patient did not have a rash at the site of injection or elsewhere within 42 days of the vaccination. The patient did developed lesions at the C3 location. The patient also developed pain (rated 4 on a scale of 0 to 10). It was also note that there was no recent exposure to chickenpox or herpes zoster. It was unspecified if the patient had a history of chickenpox. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old male consumer who on 27-MAR-2008 was vaccinated IM with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659326/1824U). Concomitant therapy included allopurinol, ACCUPRIL, THEO-DUR, ezetimibe (+) simvastatin (MSD), and MOBIC. Subsequently, after the vaccination the patient developed pain at the injection site. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site rash, Viral DNA test negative
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 63 year old female consumer with hypertension, hypothyroidism, rheumatism and allergies to codeine and HYDROCODONE and a history of chickenpox who on 26-MAR-2008 was vaccinated SQ on the back of her left upper arm with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no illness at the time of vaccination and no recent exposure to chickenpox or to shingles. Concomitant therapy included ATACAND, PLEXION, XANAX, CRESTOR, PLAVIX, TOPROL XL TABLETS and PLETAL. Subsequently, on 27-MAR-2008 the patient experienced an injection site reaction and blisters on her chest. She woke up to find that the injection site was red and "sunken in." The size of the rash at the injection site was about the size of a nickel. The patient also noticed that she had three blisters which looked like chickenpox on her chest. Medical attention was sought, the patient was seen in the office. On an unspecified date the patient recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to verify if the VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with The OKA/Merck vaccine strain. The sample of the lesion was collected on 27-MAR-2008 and sent to the laboratory on 27-MAR-2008. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicular lesion were negative for both the wild-type varicella zoster virus and the vaccine strain. Follow-up information indicated no new information. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Tenderness
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 62 year old female consumer with cholesterol high, blood pressure high, penicillin and codeine allergies who on 26-FEB-2008 was vaccinated SQ in the left arm with one dose of 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659267/1836U) at 1300 hours. Concomitant therapy included ezetimibe (MSD), NORVASC and aspirin. The patient denied any illness at the time of zoster vaccination. On 29-FEB-2008, the patient developed an unspecified rash and experienced pain on her right side. The rash started on the right side of the patient's neck and spread down to the right side of her chest "with straight lines and bumps." She had tenderness in the right kidney area. The patient's sister felt it looked like shingles. The rash did not itch or hurt. The patient spoke to the physician on the phone but was not seen in the office. On 30-MAR-2008, the patient was recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female consumer who on 25-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 27-MAR-2008 the patient experienced swelling, redness, warmth and pruritis at the injection site. Medical attention was sought, the patient called the office. It was unspecified if lab studies were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female who on 04-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658396/0967U). Concomitant therapy included BACTRIM and CIPRO. In March 2008, the patient had a urinary tract infection and was taking BACTRIM at the time of vaccination. The patient was switched to CIPRO for the UTI that does not seem to be responding to treatment. Medical attention was sought in the doctor's office. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 26-MAR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) in place of the booster dose of varicella virus vaccine live (Oka/Merck) (MSD). No adverse symptoms reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Additional information is not expected. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Information has been received from a female physician with a history of herpes zoster who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, "a couple of hours after vaccination," the arm that she was vaccinated in was "very painful and very sore." The evening after vaccination, she developed a very large 4-6 inch wheal and flare with possible ARTHUS reaction. Unspecified medical attention was sought. The patient recovered on an unspecified date. She stated it "went away after a couple of weeks." There was no product quality complaint involved. Additional information requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a 74 year old female consumer who on 12-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, starting that evening, she had "flu" like symptoms (bad headache, fever, sore throat, muscle pain, running nose, cough, etc.). Medical attention was sought, the patient called her doctor. The doctor told the patient "let's watch it, drink more water and take good rest. If it gets worse, come to my office." The patient report she "stayed home and took good rest," after about ten days on approximately 22-NOV-2007 the symptoms were gone. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Information has been received from a 74 year old female consumer who on 12-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, starting that evening, she had "flu" like symptoms (bad headache, fever, sore throat, muscle pain, running nose, cough, etc.). Medical attention was sought, the patient called her doctor. The doctor told the patient "let's watch it, drink more water and take good rest. If it gets worse, come to my office." The patient report she "stayed home and took good rest," after about ten days on approximately 22-NOV-2007 the symptoms were gone. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Herpes zoster
Clinical narrative: Information has been received from a 83 year old female consumer with a penicillin allergy and a history of shingles "several years ago, and they reoccur every so often," who about two months ago on approximately 05-JAN-2008 was vaccinated with single dose of series of zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medication and NEXIUM. Subsequently, after receiving zoster vaccine live (Oka/Merck) her shingles reoccurred and have gotten worse. The patient reported that the shingles reoccurred on her upper back, between her shoulder blades and on her bottom, and she stated her shingles are really itchy and they sting. In addition, she stated after receiving zoster vaccine live (Oka/Merck) she has been losing her hair and also some hair from her eyebrows. Unspecified medical attention was sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information from the registered nurse indicated she had no additional information to provide for this case because the patient had not yet contacted or returned to their office since the vaccine was administered. Follow-up information from the patient indicated "she still had shingles and her hair was still falling out." Follow-up information from the registered nurse indicated no further information is available. No additional information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 80 year old female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed a zoster rash over her entire body 2 weeks after vaccination. Medical attention was sought in the office with a specialist. It was unspecified if lab studies were performed. The specialist diagnosed the rash as zoster. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning a friends' friend who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse who reported one case involving a household contact of a person vaccinated with zoster vaccine live (Oka/Merck) who developed shingles. She confirmed that the vaccinee in this case did not develop a rash or shingles. She did not have any other details about the household contact, including whether they had a history of chickenpox. The possibility of PCR for this case was discussed, but the nurse explained that she learned of this case several weeks ago and thought that the household contact might have recovered. The VZVIP program and specimen collection was discussed. It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with zoster vaccine live (Oka/Merck). It was reported that the patient developed shingles after receiving zoster vaccine live (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. The nurse mentioned that some of the cases were reported to VAERS. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female consumer who on 05-MAR-2008 was to be vaccinated with her second dose of varicella virus vaccine live (MSD), but was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead. The patient was administered her first dose of varicella virus vaccine live (MSD) on 09-AUG-1996. The LPN stated the zoster vaccine live (Oka/Merck) vial was placed in the varicella virus vaccine live (MSD) box by mistake and the nurse did not notice it because varicella virus vaccine live (MSD) and zoster vaccine live (Oka/Merck) vials look similar. No adverse experience was related to this event. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. Follow-up information form LPN indicated she was unable to provide patient information, and she said it was "honest mistake."
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 84 year old male consumer with no known allergies, a history of chickenpox and mumps who on approximately 20-FEB-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) once. Concomitant therapy included primidone, isosorbide, benazepril HCL, LIPITOR, omeprazole (MDS), PAXIL and alprazolam. On approximately 21-FEB-2008 the day after he was vaccinated he developed shingles. Medical attention was sought and he was prescribed a topical cream, "halobetasol proportionate cream.05 (glades)." There were no lab studies performed. The patient stated when he applied the cream to his rash it would go away and reappear on a different part of his body. This happened each time he applied the cream to the rash whit it appeared. The patient also stated that he purchased the vaccine a week before it was administered and stored it in his freezer until it was administered. At the time of the report the patient's status was unknown. The patient stated he thinks that it is all gone, but there might be some on his back. There was no product quality complaint involved. Follow-up information from the physician's office indicated that patient was last seen in their office on 20-NOV-2007. The physician's office indicated they did not buy or administer the vaccine to the patient. Follow-up information from the patient indicated he has another "bout of shingles." He reported he has lesions on his back, abdomen, and both of his elbows. He indicated he has not notified his physician thus far about this latest event. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Viral DNA test positive
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 69 year old male consumer with no known allergies and a history of childhood chickenpox who on 22-FEB-2007 was vaccinated in the left upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 656413/1477F). Concomitant therapy included allopurinol, simvastatin (MSD), HYTRIN, NORVASC, TOPROL XL TABLETS) and furosemide. Subsequently, on 28-FEB-2008 the patient developed a "severe case of zoster" and experienced pain. Unspecified medical attention was sought. At the time of the report the patient was no recovered. There was no product quality complaint involved. New information from the physician indicated he would be collecting a specimen for VZVIP on 10-Mar-2008. At the time of the report update, the patient's status was reported as uncomfortable and the patient was started on on FAMVIR at the time he was diagnosed with shingles. Follow-up information from the physician indicated that there was no rash at the site of injection or elsewhere within 42 days of vaccination. The patient's pain was reported as 8 on a scale of 0 to 10 and the patient's maximum temperature was reported as 100 degrees F. There was no recent exposure to chickenpox or herpes zoster. The patient developed 8 clusters of vesicular lesions up to 3.5 cm in diameter on the right T12 location. 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 strain. The sample of the lesion was collected on 10-MAR-2008 and sent to the laboratory on 10-MAR-2008. The sample was taken from a crusted lesion. The PCR results for the specimen from a crusted lesion identified the presence of WT VZV. Follow-up information from the physician indicated that the patient recovered on an unspecified date. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Activities of daily living impaired, C-reactive protein, Erythema, Laboratory test normal
Clinical narrative: Information has been received from an 83 year old female with "stomach problems," depression, cholesterol high, fibromyalgia, sulfonamide and iodine allergies and a history of being shot in her knee and open heart surgery two years ago, who on 14-JAN-2008 was vaccinated with a "single dose of series" of zoster vaccine live (Oka/Merck). Concomitant therapy included DIGITEX, simvastatin (MSD), DIOVAN HCT, famotidine, LORAZEPAN, OS-CAL and glucosamine. Subsequently, "about a month ago" in Feb 2008 after receiving zoster vaccine live (Oka/Merck) she started to have muscle pain in her upper arms, shoulders, thighs and bottom. The patient also stated her left arm where she received the vaccination hurt and had a red spot for about a week. In addition, she stated she had little red pimples appear at her hair line and on her face that itch, but stated she would put cream on them and it would go away. About two weeks ago, the patient stated the pain had gotten so bad that she had trouble getting out of bed, combing her hair, brushing her teeth, and when lifting her arms to get things out of her cabinet. Medical attention was sought in the physician's office, "blood tests" were performed, and the results came back normal. The patient's physician told her to take extra strength TYLENOL, which she stated has not been helping. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information from the physician indicated that this 83 year old female consumer also had hypertension. There was no illness at the time of vaccination. On 31-MAR-2008 the patient recovered. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pruritus, Rash papular
Clinical narrative: Information has been received from an 83 year old female with "stomach problems," depression, cholesterol high, fibromyalgia, sulfonamide and iodine allergies and a history of being shot in her knee and open heart surgery two years ago, who on 14-JAN-2008 was vaccinated with a "single dose of series" of zoster vaccine live (Oka/Merck). Concomitant therapy included DIGITEX, simvastatin (MSD), DIOVAN HCT, famotidine, LORAZEPAN, OS-CAL and glucosamine. Subsequently, "about a month ago" in Feb 2008 after receiving zoster vaccine live (Oka/Merck) she started to have muscle pain in her upper arms, shoulders, thighs and bottom. The patient also stated her left arm where she received the vaccination hurt and had a red spot for about a week. In addition, she stated she had little red pimples appear at her hair line and on her face that itch, but stated she would put cream on them and it would go away. About two weeks ago, the patient stated the pain had gotten so bad that she had trouble getting out of bed, combing her hair, brushing her teeth, and when lifting her arms to get things out of her cabinet. Medical attention was sought in the physician's office, "blood tests" were performed, and the results came back normal. The patient's physician told her to take extra strength TYLENOL, which she stated has not been helping. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow up information from the physician indicated that this 83 year old female consumer also had hypertension. There was no illness at the time of vaccination. On 31-MAR-2008 the patient recovered. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse concerning a male between the ages of 60 and 70 who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient had a sore arm and discomfort after receiving zoster vaccine live (Oka/Merck). Additional information has been requested. This is one of several reports from the same source.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site discolouration, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 61 year old female nurse with drug hypersensitivity to codeine, BIAXIN and sulfa which causes headache, CELEBREX which causes rash, LODINE, and RELAFEN. A history of a severe case of chickenpox years ago, who on 29-FEB-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). Concomitant therapy included SYNTHORID, VIVELLE, MAXIDE prn, NASONEX, CLARITIN, BENTYL prn, DIFULCAN, glucosamine, chondroitin, calcium (unspecified), vitamins (unspecified) and omeprazole (MSD). On 29-FEB-2008, the patient felt pain during administration of the vaccination and stinging. The patient had more pain at the injection site that same evening. On 01-MAR-2008, the patient experienced chills, nausea, and "didn't fell well." The patient described a 5 inch round raised red reaction at the injection site with a 1 cm raised hard knot where the injection was given (the 1 cm area seemed to be "chickenpox like"). The entire area was hot to touch and tender. The 1 cm knot was a whitish brown color in which a couple inches around the area was hard. There was no medical attention sought. At the time of the report the patient was recovering. The patient stated the reaction seemed to be better because it looked less red but was still warm. There was no product quality complaint involved. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain
Clinical narrative: Information has been received from a 61 year old female nurse with drug hypersensitivity to codeine, BIAXIN and sulfa which causes headache, CELEBREX which causes rash, LODINE, and RELAFEN. A history of a severe case of chickenpox years ago, who on 29-FEB-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). Concomitant therapy included SYNTHORID, VIVELLE, MAXIDE prn, NASONEX, CLARITIN, BENTYL prn, DIFULCAN, glucosamine, chondroitin, calcium (unspecified), vitamins (unspecified) and omeprazole (MSD). On 29-FEB-2008, the patient felt pain during administration of the vaccination and stinging. The patient had more pain at the injection site that same evening. On 01-MAR-2008, the patient experienced chills, nausea, and "didn't fell well." The patient described a 5 inch round raised red reaction at the injection site with a 1 cm raised hard knot where the injection was given (the 1 cm area seemed to be "chickenpox like"). The entire area was hot to touch and tender. The 1 cm knot was a whitish brown color in which a couple inches around the area was hard. There was no medical attention sought. At the time of the report the patient was recovering. The patient stated the reaction seemed to be better because it looked less red but was still warm. There was no product quality complaint involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was to be vaccinated with varicella virus vaccine live (Oka/Merck) (MSD), but inadvertently received zoster vaccine live (Oka/Merck). Unspecified medical attention was sought in the office. The physician reported this was a medication error only. There was no product quality complaint involved. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 09-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the zoster vaccine live (Oka/Merck) was inadvertently stored in the varicella virus vaccine live (Oka/Merck) (MSD) storage area of the vaccine refrigerator. There were no adverse symptoms. The event occurred as a result of human error. The bottle was "not seen properly" as stated by the physician. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician felt it was simply a case of human error. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up confirmed that there was one female 5 year old patient. No additional information is expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 66 year old female consumer who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently, the patient developed shingles four months after the vaccine was given. Medical attention was sought, the patient spoke to the physician. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from this 66 year old female patient with no pertinent medical history or drug reactions, who reported that she received the vaccination sometime in November 2007. Concomitant therapy included LIPITOR. Subsequently, the patient broke out with shingles "about 6 months later, around 01-APR-2008". the patient reported she developed shingles on her left groin, and her whole left hip became numb. The patient also reported that she had a lot of pain from the shingles. Medical attention was sought. The patient stated that once she saw the shingles she went to her physician right way. There were no lab studies performed. At the time of the report the patient was recovered. The patient reported that the pain only lasted about three weeks and that the shingles have gone away at this point in time. Additional information has been requested. This is one of several reports from the same source.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old female consumer with hypertension, hyperthyroidism, osteoporosis and no known allergies who on 07-APR-2008 was vaccinated SQ in the right upper arm with a single dose of zoster vaccine live (Oka/Merck) (lot # 659268/0158X). Concomitant therapy included LOTREL, MAXZIDE, BONIVA, NEXIUM and SYNTHORID. On 08-APR-2008, the patient developed soreness at the injection site. On 09-APR-2008 the patient was examined in the office. There was no lab studies performed. The exam revealed a 4X4 cm area of redness at the injection site. There were no lesions. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 76 year old female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles within six months after the vaccine was given. Unspecified medical attention was sought and it was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a female consumer with no known allergies, high blood pressure and a history of cold sores who approximately one year ago in 2007 was vaccinated with a single dose of zoster vaccine live (Oka/Merck). Concomitant therapy included MICARDIS, atenolol, and clorazepate dipotassium. The patient stated she was very prone to getting cold sores. However, ever since she received the zoster vaccine live (Oka/Merck) vaccine she has had a single occurrence of cold sores. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the patient indicated that about a year ago while sick with the flu the usual cold sores did not form on her lips. The patient stated she could feel a big cold sore coming, but it never materialized into an "ugly blister." Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female consumer with on known drug allergies who on 10-JAN-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) (lot #658862/1415U). Subsequently, shortly after vaccination the patient experienced severe arthritic symptoms. On an unspecified date the patient was seen by her physician. There were no lab studies performed. It was noted that the patient took MOTRIN for her symptoms. However, the physician did not want the patient to take MOTRIN. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has bee received from a physician concerning a 65 year old female who on 26-FEB-2008 was vaccinated in the left arm with a single dose series of zoster vaccine live (Oka/Merck) (lot # 659326/1824U). There was no illness at the time of vaccination. The physician reported that the patient has been complaining ever since receiving the vaccination of severe pain and discomfort in the arm that she received the vaccination in. Medical attention was sought, the patient called the physician. There were no lab studies performed. The physician reported that the patient had just called in everyday for the past two weeks about pain she was having. The patient was advised to put hydrocortisone on her arm and to take TYLENOL. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the physician's office indicated the patient reported pain, swelling, and redness at the site which stared on 27-Feb-2008. The patient was not actually seen by the physician. Additional information has been requested.