chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 56 year old female patient with a past history of shingles and no allergies who on 03-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# reported as "1824Y"). Concomitant therapy included LAMICTAL. It was reported that the patient had been experiencing shingles on her left elbow every 3 weeks after getting ZOSTAVAX (Merck). Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Follow up information has been received which reported that they obtained a sample from the patient and they would be sending the sample on 13-SEP-2010. Follow up information has been received from the physician concerning the 56 year old female patient with a history of chickenpox as a child who on 03-JUN-2008, in the morning, was vaccinated subcutaneously with a 0.5ml dose of ZOSTAVAX (Merck) (lot#659326/1824U) into her deltoid. There was no illness at time of vaccination. Concomitant therapy also included VALTREX. On 09-SEP-2010, in the morning, the patient developed vesicle rash at the right trunk and abdomen. There were less than 10 lesions. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 3 on a scale of 1 to 10. She had no other systemic symptoms. No rash occurred at the injection site or elsewhere within 42 days of the vaccination. No photos had been taken. At the time of this report, the patient had recovered. 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 the Merck vaccine strain. On 10-SEP-2010, vesicle lesion sample was collected and on 13-SEP-2010, the sample was sent to laboratory. The PCR result for the vesicular specimen was negative for varicella zoster virus, B-globin DNA was amplified. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 56 year old female patient with a past history of shingles and no allergies who on 03-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# reported as "1824Y"). Concomitant therapy included LAMICTAL. It was reported that the patient had been experiencing shingles on her left elbow every 3 weeks after getting ZOSTAVAX (Merck). Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Follow up information has been received which reported that they obtained a sample from the patient and they would be sending the sample on 13-SEP-2010. Follow up information has been received from the physician concerning the 56 year old female patient with a history of chickenpox as a child who on 03-JUN-2008, in the morning, was vaccinated subcutaneously with a 0.5ml dose of ZOSTAVAX (Merck) (lot#659326/1824U) into her deltoid. There was no illness at time of vaccination. Concomitant therapy also included VALTREX. On 09-SEP-2010, in the morning, the patient developed vesicle rash at the right trunk and abdomen. There were less than 10 lesions. The patient had no recent exposure to chickenpox or shingles. The patient reported her pain to be 3 on a scale of 1 to 10. She had no other systemic symptoms. No rash occurred at the injection site or elsewhere within 42 days of the vaccination. No photos had been taken. At the time of this report, the patient had recovered. 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 the Merck vaccine strain. On 10-SEP-2010, vesicle lesion sample was collected and on 13-SEP-2010, the sample was sent to laboratory. The PCR result for the vesicular specimen was negative for varicella zoster virus, B-globin DNA was amplified. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 71 year old female with diabetes who "about a year ago" was vaccinated with a "single dose" of ZOSTAVAX (Merck). Recently ("about 12 days ago") the patient started experiencing pain across the ribcage area (that feels like post-herpetic pain) which after 4 days moved to the back of the patient's body. The physician stated that there are no lesions or redness however still diagnosed it as shingles and prescribed medications for treatment of shingles (names and manufacturer unspecified). The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from a 71 year old female who on 3 weeks ago was vaccinated with a 1 time dose of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR and alcohol. The patient experienced joint pain on her wrist and ankles after the vaccination, and soreness at the injection site that "passed away in a few days". The patient was still experiencing the joint pain and had not spoken with her doctor yet. At the time of the reporting, the patient was recovering. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 11 year old patient who on 11-AUG-2010 was vaccinated with ZOSTAVAX (Merck) into the right deltoid. On 11-AUG-2010 the patient was to receive VARIVAX (Merck), but received ZOSTAVAX (Merck) instead. No adverse effect noted as of the reporting. Follow-up information from a nurse indicating that the patient had no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions. The administering nurse had inadvertently taken the wrong box of vaccine out of the freezer. No adverse events were reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an approximately 75 to 80 years old male patient who on an unspecified date was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot number unknown). The nurse stated that on unspecified date the patient received ZOSTAVAX (Merck) and after receiving it he experienced shingles. On unspecified date, the patient recovered from shingles. The patient sought unspecified medical attention. No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 66 year old male patient with no known drug reactions or allergies and not recent exposure to chickenpox or shingles and a history of chickenpox who "approximately 6 to 12 months ago" in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown) at an unspecified pharmacy. On 11-AUG-2010 the patient experienced herpes zoster virus rash. The rash was not in the site of injection. The distribution of the lesion was the dermatome. The patient was seen by the physician "this week" where the patient was diagnosed with shingles. At the time of the report, the patient had recovered. The patient sought medical attention by a doctor visit. 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 Merck vaccine strain. The lesion samples were collected on 18-AUG-2010. Two samples were taken from vesicles in the thigh. A Varicella Zoster Virus Identification Polymerase Chain Reaction Test was performed on 20-AUG-2010. The PCR result from the scab specimen identified the presence of WT VZV. No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included simvastatin (manufacturer unknown). On an unspecified date, the patient experienced polymyalgia rheumatica. No further information was provided at this time of reporting. The physician would like additional information on the incidence and resolution of polymyalgia rheumatica associated with ZOSTAVAX (Merck) from clinical studies and post marketing events. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Pruritus, Rash
Clinical narrative: Information has been received from a 76 year old female patient with sulfonamide allergy and with no pertinent medical history who in October 2009 was vaccinated with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot number and exp date unspecified) SC. There was no concomitant therapy. The patient started itching tremendously 4 to 5 days after getting the ZOSTAVAX (Merck) injection. The patient had been to 3 dermatologists. At the time of report the patient's status was not recovered. Follow up information has been received from a registered nurse concerning the 76 year old female patient with pre existing allergy on sulfa and nitrofurantoin who on 08-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Two weeks after vaccination, on approximately 22-OCT-2009, she complained of rash. She had seen two dermatologists and stated that she might be allergic to neomycin and then had eczema. Follow-up information has been received from a registered nurse concerning the patient who 08-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapies included vaccination on 23-Oct-2010 intramuscularly into the left deltoid with a dose of FLUZONE (Lot # U3194AA) at 16:26. No illness at time of vaccination. The nurse reported that the patient developed rash in November 2009 (also reported as October 2009) after receiving vaccine which was persistent. Patient had been treated with steroids and cream (unspecified). The patient saw dermatologist. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a pharmacy student concerning a 64 year old male with allergy to Tdap vaccine which caused widespread body swelling, who on 04-AUG-2010 was vaccinated with a single dose of ZOSTAVAX (Merck) (lot # 665522/1765Y, SC) in the left upper arm. On 06-AUG-2010 the patient developed a red, raised, itchy rash on his right foot. The rash spread to the left foot and the back of the left thigh. The patient was evaluated in the office on 10-AUG-2010. No treatment was initiated. The patient not recovered. Follow-up information received from nurse practitioner (also registered nurse) concerning a 64 year old male with history of rash swelling to Tdap in past, right foot fracture, and no illness at time of vaccination, who at AM on 06-OCT-2007 (previously reported on 04-AUG-2010) was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 665522/1765y, SC) in the left arm. On 06-AUG-2010 the patient developed itchy rash on the lateral aspects of the right foot which went to medial aspect. The patient had been wearing boot on the right foot. Rash then was centralized to left leg/foot and back of both thighs. Rash was raised erythema rash on both legs and back of the thighs. There were no labs or diagnostic tests performed. No pustules. The outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old male patient who on 09-AUG-2010 was accidentally vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) instead of a dose of VARIVAX (Merck). The patient had not relevant medical history, concomitant medications, and past drug history. On 09-AUG-2010, the patient was scheduled to received a VARIVAX (Merck) dose, but was accidentally given ZOSTAVAX (Merck). It was unknown if there was any relevant laboratory data. As of 09-AUG-2010, the patient would no longer receive the ZOSTAVAX (Merck) and he had not experienced any adverse events from the accidental administration. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Polymerase chain reaction, Rash erythematous, Varicella virus test positive
Clinical narrative: Information has been received from a registered pharmacist, a pharmacy student and a 68 year old female consumer who on 03-AUG-2010 was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (Merck) (Lot number 664672/0296Z) (Expiration date: 01-JAN-2011). The pharmacist stated that on 07-AUG-2010 the patient reported a red rash that was painful on her shoulders and upper back. On 13-AUG-2010, the patient called and stated that she got the vaccine and got the symptoms of shingles during the same week, and she had shingles on her left arm and her back on the left side. At the time of report, the patient had not recovered from shingles on her left arm and her back on the left side. The patient had not been seen by a physician (also reported as the patient sought unspecified medical attention). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 13-AUG-2010, The PCR result from the biopsy specimen identified the presence of WT VZV. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urine present, Chromaturia, Culture urine negative
Clinical narrative: Information has been received from a 71 year old male consumer with sulfur allergy and no pertinent medical history who on 10-AUG-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported). Concomitant therapy included aspirin and metoprolol. The consumer stated that on 10-AUG-2010, after receiving ZOSTAVAX (Merck) his urine was very dark. The consumer did not seek medical attention. At the time of the report, the consumer had not recovered. Follow-up information was received from a physician who stated that on 10-AUG-2010, the patient had noted brownish urine hours after the patient had received the ZOSTAVAX (Merck) vaccine; it occurred a few more times though lighter each time. On 13-SEP-2010, the patient had a urine test performed. The results showed a yellow color and a clear appearance urine (all results were in range), and a small (1+) blood in urine (out of range). On 18-AUG-2010, the patient had another urine test performed which showed negative blood in urine. The urine culture showed no growth. The diagnosis was benign and there was no evidence of malignancy identified. On an unspecified date, the patient recovered on own. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old male patient with gout, elevated blood pressure and cholesterol and allergy to an unknown antibiotic, who on 14-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 656608/0032U EXP 19-JUN-2008) SQ. Concomitant therapy included allopurinol and colchicine. The medical assistant reported that on 04-JAN-2011 the patient had an outbreak of shingles. The outbreak had appeared on the left buttocks near the hip and in the left underarm area. The left side of the chest was tender. The patient was treated with ZOVIRAX and CALADRYL. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on 11-DEC-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 04-JAN-2011 the patient was administered subcutaneously with a second 0.65 ml dose of ZOSTAVAX (Merck). No adverse effects reported. It was unknown if the patient sought medical attention. Follow up information has been received from the reporting clinical coordinator concerning the male patient who on 04-JAN-2011 received subcutaneously a 0.65 mL booster dose of ZOSTAVAX (Merck) (lot#669404/1359Z). On 04-JAN-2011, the patient experienced pain at injection site and there was no other reaction. On 04-JAN-2011, the patient had recovered from pain at injection site (duration reported as "1-2 days"). No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with seizures, hypothyroidism, allergies, arthritis and no drug reactions/allergies and a history of shingles in the past with severe post herpetic neuralgia (PNH) who in approximately July 2010 (reported as "about 7 days ago"), was vaccinated with a dose of ZOSTAVAX (Merck) at a local senior center. Concomitant therapy included SYNTHROID, NASONEX, montelukast sodium, KEPPRA and ALLEGRA. On 06-JUL-2010, the patient presented to the office with a "shingle like" rash at the 11-2 region of the left trunk. The patient also stated that she had "erthymea" at the injection site of the left arm for about 48 hours following the vaccination. No laboratory diagnostic study was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a medical assistant concerning an 87 year old male patient who on 28-AUG-2008 was vaccinated with ZOSTAVAX (Merck) (lot n. 659411/0293X) 0.65ml subcutaneously. Concomitant therapy included VALTREX. On 29-DEC-2010 the patient developed a rash diagnosed as shingles. The patient was treated for shingles with antiviral medication for seven days. Therapy with ZOSTAVAX (Merck) was not reintroduced. The patient didn't recover. The patient sought unspecified medical attention. Follow up information received on 25-JAN-2011 from a Advanced Registered Nurse Practitioner specializing in Cardiology (ARNPC) stated that the patient with history of chickenpox when child was vaccinated with ZOSTAVAX (Merck) in the right upper arm on 28-AUG-2008. On 29-DEC-2010 the patient experienced herpes zoster. The patient developed numerous severe vesicles on his left lower back across to abdomen. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. There was no exposure to chickenpox or herpes zoster recently. There was also no specimen collected for PCR and no photo taken. At the time of the report, the patient was still having pain. The pain was 10 in scale 0-10. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from an 82 year old female with blood pressure high and iodine allergy who on approximately 15-JUN-2010 and approximately 04-JUL-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Merck) respectively. Concomitant therapy included warfarin, digoxin, metoprolol and CRESTOR. On approximately 04-JUL-2010 the patient noticed a rash on her right hip and it was itching her. No medical attention was sought and no laboratory test was performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a 63 year old female nurse with SEPTRA and codeine allergy who on 06-JUL-2010, was vaccinated with a dose of ZOSTAVAX (Merck). The nurse reported that on the same day (also reported as 07-JUL-2010), she developed at the site itching, pain, blisters, swelling and a red hot rash the size of a tennis ball. The patient sought unspecified medical attention. At the time of reporting the patient's outcome was not reported. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a 63 year old female nurse with SEPTRA and codeine allergy who on 06-JUL-2010, was vaccinated with a dose of ZOSTAVAX (Merck). The nurse reported that on the same day (also reported as 07-JUL-2010), she developed at the site itching, pain, blisters, swelling and a red hot rash the size of a tennis ball. The patient sought unspecified medical attention. At the time of reporting the patient's outcome was not reported. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a female who on an unspecified date was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot# not reported). Subsequently the patient came to the pharmacy with an injection site reaction that resembled a mosquito bite and it was red and swollen. The pharmacist reported that the patient was instructed to take BENADRYL or BENADRYL cream to put on the injection site. The patient sought unspecified medical attention. There was no laboratory test performed. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with no known drug allergies who on 13-AUG-2010 was vaccinated subcutaneously with the single 0.65 mL dose of ZOSTAVAX (Merck) (LOT# not reported). On 15-AUG-2010 the patient returned to the pharmacy complaining of the experiences of a rash, warmth and itchiness at the injection site. The pharmacist also stated that the area looked red. The pharmacist did not know when the onset of symptoms occurred. The patient was treated with warm compresses and BENADRYL. The patient's outcome was unknown at this time of reporting. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Blood glucose increased, Differential white blood cell count normal, Eosinophil percentage increased, Full blood count normal
Clinical narrative: Information has been received from a consumer concerning her husband, a 69 year old male with blood pressure high, sulfonamide allergy and WELLBUTRIN allergy who on 29-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included omeprazole, oxybutynin ER, naproxen, NIFEDIAC CC and ATACAND. On 31-JUL-2010 the patient had this rash on the left side underneath the waistline that just won't go away and believed it might be shingles. The patient had not been in to see a doctor. There were no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Follow up information was received which reported that the 69 year old retired male patient with hypertension, dyspepsia, arthritis and a history of chickenpox who at 10:30 am on 22-JUL-2010 (previously reported as 29-JUL-2010) was vaccinated into the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 665528/0710Z). The patient had no illness at time of vaccination nor any recent exposure to chicken pox and herpes zoster. On 24-JUL-2010 (previously reported as 31-JUL-2010) the patient developed rash in groin area, abdomen, under bilateral arms, right side of chest and bilateral legs. The patient felt itchy but no pain. On 02-SEP-2010, "skin, left abdomen, punch biopsy" was performed which consisted of an ovoid portion of tan skin measuring 0.2 cm in greatest dimension. The microscopic description: The sections showed a superficial and mid moderately perivascular mixed inflammatory infiltrate composed primarily of lymphocytes and scattered eosinophils and neutrophils. There was slight parakeratosis with mild spongiosis of the epidermis. The diagnosis was compatible with popular urticaria (dermal hypersensitivity reaction). The differential diagnosis included one of figurate erythemas, viral exanthema or a drug reaction. Clinical correlation was recommended. The pre-op/clinical diagnosis was hypersensitivity reaction. Other lab tests were performed on 27-SEP-2010 including complete blood cell counts, differential  and platelet counts and Comprehensive Metabolic Panel. Results were within normal range except serum glucose (107, high) and absolute neutrophil count (0.6, high). At the time of the report, the patient was still on medication. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Metabolic function test normal, Platelet count normal, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning her husband, a 69 year old male with blood pressure high, sulfonamide allergy and WELLBUTRIN allergy who on 29-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included omeprazole, oxybutynin ER, naproxen, NIFEDIAC CC and ATACAND. On 31-JUL-2010 the patient had this rash on the left side underneath the waistline that just won't go away and believed it might be shingles. The patient had not been in to see a doctor. There were no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Follow up information was received which reported that the 69 year old retired male patient with hypertension, dyspepsia, arthritis and a history of chickenpox who at 10:30 am on 22-JUL-2010 (previously reported as 29-JUL-2010) was vaccinated into the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 665528/0710Z). The patient had no illness at time of vaccination nor any recent exposure to chicken pox and herpes zoster. On 24-JUL-2010 (previously reported as 31-JUL-2010) the patient developed rash in groin area, abdomen, under bilateral arms, right side of chest and bilateral legs. The patient felt itchy but no pain. On 02-SEP-2010, "skin, left abdomen, punch biopsy" was performed which consisted of an ovoid portion of tan skin measuring 0.2 cm in greatest dimension. The microscopic description: The sections showed a superficial and mid moderately perivascular mixed inflammatory infiltrate composed primarily of lymphocytes and scattered eosinophils and neutrophils. There was slight parakeratosis with mild spongiosis of the epidermis. The diagnosis was compatible with popular urticaria (dermal hypersensitivity reaction). The differential diagnosis included one of figurate erythemas, viral exanthema or a drug reaction. Clinical correlation was recommended. The pre-op/clinical diagnosis was hypersensitivity reaction. Other lab tests were performed on 27-SEP-2010 including complete blood cell counts, differential  and platelet counts and Comprehensive Metabolic Panel. Results were within normal range except serum glucose (107, high) and absolute neutrophil count (0.6, high). At the time of the report, the patient was still on medication. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her husband, a 69 year old male with blood pressure high, sulfonamide allergy and WELLBUTRIN allergy who on 29-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included omeprazole, oxybutynin ER, naproxen, NIFEDIAC CC and ATACAND. On 31-JUL-2010 the patient had this rash on the left side underneath the waistline that just won't go away and believed it might be shingles. The patient had not been in to see a doctor. There were no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Follow up information was received which reported that the 69 year old retired male patient with hypertension, dyspepsia, arthritis and a history of chickenpox who at 10:30 am on 22-JUL-2010 (previously reported as 29-JUL-2010) was vaccinated into the left deltoid with a dose of ZOSTAVAX (Merck) (lot # 665528/0710Z). The patient had no illness at time of vaccination nor any recent exposure to chicken pox and herpes zoster. On 24-JUL-2010 (previously reported as 31-JUL-2010) the patient developed rash in groin area, abdomen, under bilateral arms, right side of chest and bilateral legs. The patient felt itchy but no pain. On 02-SEP-2010, "skin, left abdomen, punch biopsy" was performed which consisted of an ovoid portion of tan skin measuring 0.2 cm in greatest dimension. The microscopic description: The sections showed a superficial and mid moderately perivascular mixed inflammatory infiltrate composed primarily of lymphocytes and scattered eosinophils and neutrophils. There was slight parakeratosis with mild spongiosis of the epidermis. The diagnosis was compatible with popular urticaria (dermal hypersensitivity reaction). The differential diagnosis included one of figurate erythemas, viral exanthema or a drug reaction. Clinical correlation was recommended. The pre-op/clinical diagnosis was hypersensitivity reaction. Other lab tests were performed on 27-SEP-2010 including complete blood cell counts, differential  and platelet counts and Comprehensive Metabolic Panel. Results were within normal range except serum glucose (107, high) and absolute neutrophil count (0.6, high). At the time of the report, the patient was still on medication. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 12 year old male who on 19-AUG-2010 was inadvertently subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664636/0874Y, exp. 20-DEC-2010) instead of VARIVAX (Merck) (human error, not PQC). The pharmacist did not know which dose in the series this administration. No adverse effects reported. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 62 year old female patient with diabetes, blood pressure high and an allergy to GANTANOL who in middle July 2010 was vaccinated a dose of with ZOSTAVAX (Merck) injection. Concomitant therapy included atorvastatin calcium (manufacture unknown), metformin, glipizide, PRINIVIL and carvedilol. On the following day, the patient experienced headaches and she had headaches everyday since. The patient did not seek medical attention. At the time of report, the patient had not recovered. The patient did not want the doctor notified. No further information is available.
Age: 12.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an employee in a physician's office concerning a 12 year old patient who several months ago was intended to receive VARIVAX (Merck) was inadvertently received ZOSTAVAX (Merck). No adverse symptoms reported. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female patient who on 13-AUG-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) on the posterior aspect of her upper left arm. On 14-AUG-2010 the patient began to develop a rash on her right arm which was warm to the touch. The rash subsequently spread to her neck and then to her right arm. The woman stated that "it was getting better," and the pharmacist stated that "it looked like she got bitten by something." The woman stated that she had not been seen by her doctor. The status of the  patient was unknown. Follow-up information has been received from a physician concerning a 79 year old female with Type 2 diabetes-controlled with diet, elevated lipids, low vitamin D, and borderline blood pressures. According to the physician, the patient told him that in August she had a dose of ZOSTAVAX (Merck) in her left arm. The next day, she had a rash on her right arm and some on her trunk. She talked to the pharmacist who gave her the shot and he recommended CORTAID cream. The rash resolved within 7-10 days and she has no other chronic sequelae. It was reported the vaccine was not given by the reporting physician but was given at a pharmacy. The physician was not able to provide the lot number. All available medical records will be provided upon request. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 66 year old male patient with no drug reactions/allergies who on 12-AUG-2010 was vaccinated SC at the left deltoid with a dose of ZOSTAVAX (Merck) (lot number reported as "0512Z" which was invalid) in the pharmacy by the pharmacist. A "couple" of days later the patient called and reported a "rash" at the site of injection. The pharmacist stated that no treatment had yet been rendered and the patient again called today on 16-AUG-2010 to say that the rash was getting larger. It was not present on any other area of the body according to the pharmacist. The patient did not seek medical attention. At the time of report the patient's status was not recovered. Follow-up information has been received from the pharmacist concerning the patient who on 12-AUG-2010, at 02:15 pm, was vaccinated SC with a dose of ZOSTAVAX (Merck). Subsequently the patient developed a large rash at the injection site which subsided eventually on 19-AUG-2010. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N) concerning an 82 year old female patient with chronic obstructive pulmonary disease, hypertension and allergy to penicillin, prednisone and clindamycin who on 24-AUG-2010 was vaccinated subcutaneously with a 0.5mL dose of ZOSTAVAX (Merck) (lot number unknown). Concomitant therapy included LIPITOR, atenolol, SPIRIVA and lisinopril (Manufacturer unknown). The nurse reported that and on 26-AUG-2010 the patient got shingles. At the time of report, the patient had not recovered from shingles. Follow-up information was received from a registered nurse who stated the female patient with a history of chicken pox when was a child on 24-AUG-1010, was vaccinated SQ with 0.5 ml dose of ZOSTAVAX (Merck) (lot# 665528/0710Z). It was reported that on 26-AUG-2010 in the afternoon, the patient developed zoster like rash "4 days after the vaccine was administered". The blisters appeared on the right buttock, extended to the left labia following dermatome pattern. The distributions of blisters were above the legs. It was also reported that the pain was quantified in 5 in a scale from 1 to 10 were 10 was the most painful. There were no other systemic symptoms. There was not a recent exposure to chicken pox or herpes zoster. There was not a direct fluorescent antibody done and there was not a specimen collected for PCR. The patient was treated with VALTREX and the patient did very well. At the time of the report, the patient recovered. The patient did not seek medical attention. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who two months ago, approximately 26-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported) and got shingles. At the time of the report, the patient's out come was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old female with no pertinent medical history and no drug allergies, who on 13-AUG-2010 was vaccinated with a standard dose of ZOSTAVAX (Merck) (lot # 664635/0836Y, SC). There was no concomitant medication. On 16-AUG-2010 the patient developed an itchy rash at the injection site, and the rash was circular and red but not raised. There were no labs or diagnostics tests performed. The patient had called the pharmacist, and had not recovered at time of report. Follow-up information was received indicating that the patient developed local reaction only and resolved in a few days. The vaccine was not administered in the office, so they do not have the data. No further information is available.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a now 59 year old patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). The reporter did not think that the patient had been hospitalized and also stated that the patient was still recovering. It was unknown if the patient sought medical attention. Addition information has been requested. This is one of several reports received from the same source.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Somnolence
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck). The patient experienced drowsiness and a fever approximately a half hours after vaccination. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Follow up information has been received from the reporting medical assistant concerning the 5 year old female with no illness at time of vaccination who at 4:15 PM on 12-JUL-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot#665519/1225Y) in arm. Secondary suspect therapy on the same day included the second dose of MMR ll (lot#665874/1335Y) subcutaneously vaccinated in left thigh. Concomitant therapy on the same day included the fifth dose if TRIPEDIA (lot#C3381AA) intramuscularly vaccinated in left thigh. On 12-JUL-2010, the patient experienced fever low grade that night. There was no other complaints or reactions. On 13-JUL-2010, the patient recovered from fever low grade. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a male who in 2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The office manager reported that "within the past two weeks", on approximately 28-JUN-2010 the patient developed a case of shingles. The outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Device leakage, Injection site swelling, Needle issue, Skin reaction
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male patient with high blood pressure, seasonal allergies, no past drug history and no drug reactions/allergies who on 12-JUN-2010 was vaccinated SC with a 0.6 ml partial dose of ZOSTAVAX (Merck) (lot# 665531/0698Z), due to leakage from the attachment of the needle to the syringe. There was no concomitant medication. On 12-JUL-2010, while receiving the injection, the needle was not screwed tightly onto the syringe and three large drops of ZOSTAVAX (Merck) dripped out of the syringe where the needle was loosely screwed in. After administering the dose , as the pharmacist pulled the syringe out of the patient's arm, the needle separated from the syringe and stayed stuck in the patient's skin. The needle was removed and immediately after administration, a local skin reaction to the shot developed "just like you would expect", a "raised area" at the site of injection. At the time of the report, the patient had not recovered. No laboratory or diagnostic studies were performed. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a female patient who "about a year ago" in approximately 2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Patient was administered ZOSTAVAX (Merck) for the herpes zoster relief, after already having shingles and shingles kept coming back. The patient did not seek medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient with hypertension and no drug reactions or allergies who on 10-JUN-2010 was vaccinated subcutaneously back of arm (unspecified which arm) with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant medication included unspecified blood pressure medication. The pharmacist stated that the patient was vaccinated on 10-JUN-2010 and 2 weeks later (on approximately 24-JUN-2010) called to pharmacist to report she had an itchy rash outbreak on one side of her face, eye and side of head, unspecified which side. Pharmacist suspected it could have been shingles. The patient recovered from the events. Lab diagnostics studies were not performed. Patient sought medical attention. Additional information has been requested.
Age: 62.0
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 medical assistant concerning a 62 year old female with penicillin allergy who on 14-JUL-2010 was vaccinated with ZOSTAVAX (Merck) 0.65ml S.Q. (therapy site unknown). Concomitant therapy included aspirin and other unspecified medications. On 14-JUL-2010 the patient developed redness, swelling, warmth and itching at the injection site an hour after administration. The patient saw a physician. At the time of this report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse, concerning a child patient who may have been vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) and no adverse event was reported. The reporter stated that she was not certain who the patient was but they have a missing ZOSTAVAX (Merck) dose and only children have been in their office recently. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacy student concerning a 5 year old female patient who on 12-JUL-2010 was inadvertently given a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). There was no adverse event reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning his daughter who on an unspecified date was vaccinated accidentally by her doctor with a dose of ZOSTAVAX (Merck) (lot number not provided) instead of a dose of VARIVAX (Merck). No adverse effect was reported. It was unspecified if the patient sought medical attention. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 12 years old female who on 13-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665516/1271Y) (expiration date: 03-MAR-2011). The nurse stated that on 13-JUL-2010, the patient inadvertently received a dose of ZOSTAVAX (Merck) instead of her second dose of VARIVAX (Merck) (Human error, no PQC). The patient received her first dose of VARIVAX (Merck) at the age of 12 months. No adverse effects reported. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been successful. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Information has been received from a nurse and physician concerning a female patient who on approximately 19-JUL-2010 ("last week sometime"), was vaccinated with a single 0.65 ml dose of ZOSTAVAX (Merck). Subsequently, the patient experienced a localized reaction, swelling around the injection site. The patient was given prednisone. On an unknown date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.7
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Varicella
Clinical narrative: Information has been received from a registered pharmacist (R.Ph.) concerning a 20 month old patient whose approximately 60 year old grandfather on 30-APR-2010 was vaccinated with a first dose of ZOSTAVAX (Merck) subcutaneously (Lot number unknown). The pharmacist stated that the patient's grandfather received his dose of ZOSTAVAX (Merck) and subsequently visited his grandchildren. On 05-MAY-2010 "5 days after the visit", the 20 month old granddaughter developed a case of chickenpox (approximately 15 lesions in her upper chest and face according to the grandmother). The pharmacist stated that the recipient of the vaccine never developed a rash on his body. At the time of the report, the current status of the 20 month old granddaughter is unknown. The patient did not seek medical attention. Follow up information has been received from a registered pharmacist. It was reported that the female patient, whose grandfather was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 665515/1373Y) in the left arm on 22-MAY-2010 after noon, developed mild case of chicken pox 30 days after exposure to her grandfather (on 21-JUN-2010). The patient's grandfather had no reaction to ZOSTAVAX (Merck) (no rash developed at the injection site). At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with no drug reactions/allergies who on 08-JUL-2010 was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot number, route and site not reported). On 09-JUL-2010 the patient developed "a couple of cold sores" under her nose after receiving a dose of ZOSTAVAX (Merck). The patient's "a couple of cold sores" persisted. There was no lab diagnostics studies performed. The patient called to the pharmacist to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who in approximately 2009, about 1 year ago, was vaccinated with a dose of ZOSTAVAX (Merck). The patient complained of getting shingles a few days after the ZOSTAVAX (Merck). Additional information has been requested.