chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 63 year old female smoker with allergic to codeine, gastrointestinal problems, and benign adrenal adenoma who on 05-MAY-2011 was vaccinated SC with a 0.5 ml dose of ZOSTAVAX (Merck) (Lot number: 670384/0253AA; Expiration date: 18-MAY-2012) in left upper arm. Concomitant therapy included simvastatin (manufacturer unknown). Subsequently the patient developed an injection site reaction following vaccination with ZOSTAVAX (Merck). The injection site reaction was described as a red, swollen, itchy (no rash) lump at the injection site. It was not clear at the time of the call when the injection site reaction started. The patient called the office on 09-MAY-2011 to report the injection site reaction and that the swelling and redness was diminishing. The injection site reaction (red, swollen, itchy (no rash) lump) was reported to have resolved after a week to 10 days, but currently there was a dark brown discoloration where the injection site reaction was. The dark brown discoloration was described as 10 to 12 cm in length and 7 to 8 cm in width. The patient called the office and was not given treatment. No lab diagnostics study was performed. At the time of the report, the patient's dark brown discoloration was not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Information has been received from a 56 year old female pharmacist with no pertinent medical history and with no drug allergy or reaction who on 19-MAY-2011 was vaccinated SC with a dose of ZOSTAVAX (Merck). Concomitant therapy included diclofenac and CRESTOR. On 19-MAY-2011 the patient had a local reaction to a ZOSTAVAX (Merck). Shortly after receiving the immunization the patient noticed a red area around the injection site. As the day proceeded, the area got bigger and redder. The next day, on 20-MAY-2011, it was the size of a softball and extended to her elbow. The area had a circumscribed white area around the outside. On 24-MAY-2011, the area was back to the original small red area and was improving. The patient did not seek medical attention and was not  given treatment. No lab diagnostics study was performed. No future information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 19-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 19-MAY-2011 the patient experienced large localized reaction in her arm and underarm after receiving ZOSTAVAX (Merck). Right or left arm was not specified. She was advised to go to her physician. It was unspecified whether the patient sought medical attention. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old male patient who on 23-MAY-2011, was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (lot number 670381/0171AA, Exp: 07-MAY-2012). On 23-MAY-2011, the patient experienced hive-like reaction to ZOSTAVAX (Merck). The reaction was at the injection site and appeared immediately upon injection and looked like a mosquito bite. It was red but there was no itching. The pharmacist reported that the patient "did not mind it at all". The patient did not sought medical attention. No treatment was given for the event. The patient called the pharmacist and said that his arm was fine, the pharmacist had the patient come in so she could look at the injection site and reported that the mosquito bite-like hive was completely resolved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Pruritus generalised
Clinical narrative: Information has been received from an 84 year old female consumer reporting on herself with no allergies or drug reactions and no pertinent medical history who in July 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). The patient stated as concomitant medication "creams". In September 2010, the consumer experienced itching all over her body after receiving ZOSTAVAX (Merck). The patient sought unspecified medical attention. The patient received as treatment for the event "heat treatments" and 3 biopsies were performed (no results were provided). At the time of the report the patient had not recovered. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a 41 year old female consumer reporting on herself with diabetes and a history of shingles who a couple of months ago was subcutaneously vaccinated with one dose of 0.65 mL ZOSTAVAX (Merck) (lot# and expiration not reported). The consumer reported that she got ZOSTAVAX (Merck) a couple of months ago and four weeks later got a painful case of shingles. It was unspecified if the patient sought medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist concerning a patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). It was unknown if the patients sought medical attention. At the time of the reporting, the patients' statuses were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date was vaccinated with the dose of ZOSTAVAX (Merck) (LOT# not reported). On unspecified date, the patient experienced shingles. The physician did not report the patient's outcome at this time. It was unspecified if the patient sought medical attention. The physician stated that he did not consider the adverse experiences but considered them part of the 48% of patients who could potentially got shingles after receiving ZOSTAVAX (Merck). He said that no vaccine was 100% and that at least the cases of shingles that patients got after ZOSTAVAX (Merck) were milder. The physician reported that he could only remember one patient's name (had captured in WAES # 1009USA01617), stating that the patient for this report and other patient (WAES # 1008USA03480) were not his patients but were patient's of other people in the practice. Follow-up information has been received on 14-SEP-2010 from the physician who on 07-SEP-2010 reported that the occurrence of this episode of shingles occurred 1.5 to 3 years after ZOSTAVAX (Merck) vaccination so the physician did not consider this to be reportable adverse event. Follow-up inconsistently information has been received from the physician who stated that the patient had no adverse reaction. This is one of several reports from same source. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female patient with no pertinent medical history, who in December 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported). There was no concomitant medication. The registered pharmacist reported that in May 2011, the patient developed shingles on her face and in her eye. At the time of the report, the patient was recovering. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Information has been received from a 75 year old male physician who on 20-MAY-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). Two days later, on 22-MAY-2011 the patient developed generalized myalgia and arthralgia. The physician reported he was otherwise healthy and took no medications. It was unspecified whether the patient sought medical attention. The patient was given unspecified treatment. At the time of the report, the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a registered pharmacist (R. Ph.) concerning a female patient who on or about 04-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669535/1506Z and expiration: 02-FEB-2012). The pharmacist reported that the patient was vaccinated and several days later (approximately 5 to 6 days, in May 2011), one or both of the patient's arms (reporting pharmacist was not sure of this) turned red ("like sunburn") and became itchy. The patient went to her physician and was treated with BENADRYL. The pharmacist maintained that this was not a rash, just itchy and red. The patient sought medical attention by a called to the physician. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 70 year old patient who on 12-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck). The patient presented to the physician office on 24-MAY-2011 with shingles. The patient was not treated. There was no hospitalization and the patient was taking no medication. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a female healthcare worker from a physician's office who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (therapy dose, route and site unknown). About 3 days later her body was covered with chickenpox lesions. The patient was afebrile and had not experienced body aches. At the time of this report, the patient had not recovered. On 20-JAN-2010 a follow up call was placed. The reporting nurse verified that they received the VZVIP packet and explained that the patient was in the office on 19-JAN-2010 with a fine rash. The patient did not have any vesicles, lesions, scabs or anything that they could un-roof to send a specimen. Since the rash was not vesicular the physician did not think that it was related to the vaccine. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Mobility decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 57 year old female patient with hypertension and environmental concerns who on 03-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Concomitant therapy included lisinopril (manufacturer unknown), HCTZ/triamterene and VALTREX. Nurse practitioner reported that a patient who received ZOSTAVAX (Merck) developed a large, red, indurated and painful injection site reaction. Nurse practitioner stated that on 06-JAN-2011, the patient reported that her arm was very painful and a 6-8 cm area of hot induration surrounding the injection site, which was approximately midway down the patient's arm below the deltoid muscle. Nurse practitioner reported that the patient was in so much pain that she was unable to move her arm. Since the site was so "angry", the nurse practitioner prescribed a MEDROL dose pack and ZYRTEC (daily for 10 days), as well as an antibiotic, KEFLEX (500mg BID for 5 days) since, according to the nurse practitioner's judgement, it looked as if it might develop into a cellulitis. Nurse practitioner said that there was no evidence of a rash. There were no laboratory diagnostics studies performed. Nurse practitioner also reported that on 10-JAN-2011, the patient had fully recovered. Follow-up information was received from the nurse practitioner concerning the female patient with allergy to CELEBREX, wasp stings and no illness at time of vaccination. The nurse practitioner stated that on 03-JAN-2011 after receiving ZOSTAVAX, the patient developed an approximately 6 cm, red, hot, indurated area at injection site, inferior to deltoid muscle on right arm. The patient was treated with KEFLEX, ZYRTEC and MEDROL dose pack. The events resolved on 3 days and the patient recovered on 06-JAN-2011. The patient did not seek medical attention. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 57 year old female patient with hypertension and environmental concerns who on 03-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Concomitant therapy included lisinopril (manufacturer unknown), HCTZ/triamterene and VALTREX. Nurse practitioner reported that a patient who received ZOSTAVAX (Merck) developed a large, red, indurated and painful injection site reaction. Nurse practitioner stated that on 06-JAN-2011, the patient reported that her arm was very painful and a 6-8 cm area of hot induration surrounding the injection site, which was approximately midway down the patient's arm below the deltoid muscle. Nurse practitioner reported that the patient was in so much pain that she was unable to move her arm. Since the site was so "angry", the nurse practitioner prescribed a MEDROL dose pack and ZYRTEC (daily for 10 days), as well as an antibiotic, KEFLEX (500mg BID for 5 days) since, according to the nurse practitioner's judgement, it looked as if it might develop into a cellulitis. Nurse practitioner said that there was no evidence of a rash. There were no laboratory diagnostics studies performed. Nurse practitioner also reported that on 10-JAN-2011, the patient had fully recovered. Follow-up information was received from the nurse practitioner concerning the female patient with allergy to CELEBREX, wasp stings and no illness at time of vaccination. The nurse practitioner stated that on 03-JAN-2011 after receiving ZOSTAVAX, the patient developed an approximately 6 cm, red, hot, indurated area at injection site, inferior to deltoid muscle on right arm. The patient was treated with KEFLEX, ZYRTEC and MEDROL dose pack. The events resolved on 3 days and the patient recovered on 06-JAN-2011. The patient did not seek medical attention. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Erythema multiforme, Oral herpes, Paraesthesia oral
Clinical narrative: Information has been received from an approximately 60 year old female registered pharmacist with no pertinent medical history and no drug reactions or allergies, who in approximately 2007, "about three and a half years ago", was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. Concomitant therapy included losartan potassium-HCTZ, FLOVENT, albuterol, levothyroxine sodium and CLARITIN-D. The pharmacist reported that in approximately 2007, since she was vaccinated she had experienced 5 or 6 episodes where she developed pruritic, fluid filled lesions around her mouth. These lesions formed a crusty surface and then healed. The pharmacist mentioned that the lesions around her mouth caused a tingling sensation. The pharmacist also developed two deep pink spots on either side of her neck just below her chin that had not resolved. On approximately 05-JAN-2011, "two weeks ago", the patient experienced an episode where she developed the mouth lesions, and she also developed flat, pruritic, non fluid filled lesions on the back of her knee, her arm and the palm of her hand. The pharmacist stated that she knew this was called erythema multiforme. She stated that VALTREX 1 gram twice daily for two days had helped to improve the healing time, especially during the most recent episode when she started the VALTREX immediately. She was also treated with hydrocortisone 2.5% cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The patient sought medical attention by seeing the physician. Follow up information has been received from a physician indicating that the patient was vaccinated in 2009 and on 09-MAR-2010 developed herpes stomatitis. At the time of the report, the patient had recovered. This is one of two reports received from the same source. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Scab, Skin lesion
Clinical narrative: Information has been received from an approximately 60 year old female registered pharmacist with no pertinent medical history and no drug reactions or allergies, who in approximately 2007, "about three and a half years ago", was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. Concomitant therapy included losartan potassium-HCTZ, FLOVENT, albuterol, levothyroxine sodium and CLARITIN-D. The pharmacist reported that in approximately 2007, since she was vaccinated she had experienced 5 or 6 episodes where she developed pruritic, fluid filled lesions around her mouth. These lesions formed a crusty surface and then healed. The pharmacist mentioned that the lesions around her mouth caused a tingling sensation. The pharmacist also developed two deep pink spots on either side of her neck just below her chin that had not resolved. On approximately 05-JAN-2011, "two weeks ago", the patient experienced an episode where she developed the mouth lesions, and she also developed flat, pruritic, non fluid filled lesions on the back of her knee, her arm and the palm of her hand. The pharmacist stated that she knew this was called erythema multiforme. She stated that VALTREX 1 gram twice daily for two days had helped to improve the healing time, especially during the most recent episode when she started the VALTREX immediately. She was also treated with hydrocortisone 2.5% cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The patient sought medical attention by seeing the physician. Follow up information has been received from a physician indicating that the patient was vaccinated in 2009 and on 09-MAR-2010 developed herpes stomatitis. At the time of the report, the patient had recovered. This is one of two reports received from the same source. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an approximately 65 year old female nurse concerning herself with hypertension, Graves' disease, drug allergy to sulfa, COMPAZINE and tetracycline who sometime in 2010 was vaccinated subcutaneously with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included propranolol HCl. Subsequently the patient experienced a "red and swollen arm" in the arm where the product was administered. She could not remember how long after administration the reaction occurred. She noted this reaction lasted for one month. No treatment was given to the patient. Lab diagnostics studies were not performed. The patient had sought unspecified medical attention. Subsequently, the patient recovered from the events. Follow-up information was received from the 64 year old female nurse who on 23-MAR-2010 AM was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 664670/0151Z) in her left arm by subcutaneous injection. On the next day after receiving vaccine, the patient felt fine and no reaction was noted. On 25-MAR-2010 (the second day after receiving vaccine) large red area was noted at the site of vaccine, left arm swollen and hot which lasted approximately for 1 month. In April of 2010, the patient recovered. Lab diagnostics studies were not performed. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a female with fibromyalgia and hypersensitive to pain who on 21-JAN-2011, report as "3 days ago", was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant medication, drug reactions and allergies were all unspecified. In the night after vaccination, also reported as "3 days ago" on 21-JAN-2011, the patient experienced injection site pain, the "electric jolts" in her legs and "large toe". The pharmacist also reported that the injection might have given intramuscularly. The patient sought medical attention via calling pharmacy. The status of the patient was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain, Rash
Clinical narrative: Information has been received from a registered medical assistant concerning an 80 year old male patient with drug hypersensitivity to REGLAN and NIASPAN and no illness at time of vaccination who on 06-JAN-2011, was vaccinated SQ in the left deltoid with the first dose of ZOSTAVAX (Merck) (lot# 669187/1543Z) at 9:20. On 15-JAN-2011 at 20:00, the patient first noticed nodular, painful rash. The registered medical assistant stated that the eruption was contained on the right arm, the right trunk, the right shoulder/scapula area, which met the criteria for shingles eruption. The patient also complained of pain in areas of eruption and his skin was very sensitive. The patient's evaluation at the office was on 20-JAN-2011. The patient was treated with VALTREX and pain medication. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 64 year old female patient who on 18-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck). The pharmacist reported that on 18-JAN-2011, immediately after vaccination, the patient developed redness and itching at the injection site. The patient contacted the pharmacist for medical attention. No treatment was given for the event. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, VIIth nerve paralysis
Clinical narrative: Information has been received from a consumer concerning her 68 year old brother in law who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck). On an unknown date, the patient developed Bells Palsy immediately after receiving ZOSTAVAX (Merck). On an unknown date, palsy had resolved. It was unknown if the patient sought medical attention. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with no known drug allergies, who on 18-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669189/1389Z, expiration date 19-JAN-2012) subcutaneously. The pharmacist reported that on 20-JAN-2011 the patient developed a red, slightly raised, swollen, and warm area 2 inches in diameter at injection site after administration of ZOSTAVAX (Merck). The pharmacist stated that there might have been a localized rash as well. No labs/diagnostics studies were performed. At the time of reporting, the patient's red, slightly raised, swollen, and warm area 2 inches in diameter at injection site and a localized rash persisted. The patient was not given treatment. On an unspecified date, the patient sought medical attention by contacting the pharmacist. Follow-up information has been received from the pharmacist concerning the 70 year old (also reported as "71 year old") female patient with no illness at time of vaccination and no known allergies, who on 18-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669189/1389Z, expiration date 19-JAN-2012) subcutaneously into her lower left arm. The pharmacist reported that on 20-JAN-2011 the patient developed a red, slightly raised, swollen, and warm area 2 inches in diameter at injection site, and localized rash at the injection site area. The patient had the visual inspection at injection area (results unknown). On 25-JAN-2011, the patient recovered from the events. No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: Information has been received from a unspecified pharmacist concerning an over 65 year old male who in December 2009, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported) subcutaneously. The pharmacist reported that the patient got shingles in December 2010, 1 year after receiving ZOSTAVAX (Merck) therapy. On an unspecified date, the patient had "bloodwork" test and the result was not reported. At the time of reporting, the outcome of shingles was not reported. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pharyngeal ulceration
Clinical narrative: Information has been received from a consumer concerning a female relative of hers who on an unspecified date, was vaccinated with ZOSTAVAX (Merck) (lot# not reported). The consumer stated that the patient was inadvertently given the ZOSTAVAX (Merck) twice within 6 months and since she had developed ulcers in her throat on an unspecified date. At the time of reporting, the outcome of the events was not reported. It was unspecified if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist (R. Ph.) concerning a female who in late 2009 or early 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). In this past summer ("June, July or August 2010), the patient came in and complained that she got a case of shingles even though she had received a ZOSTAVAX (Merck). At the time of reporting, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a male who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Merck) (lot # not provided). About 2 weeks after receiving ZOSTAVAX (Merck), the patient developed a rash above his eyebrow. Patient sought unspecified medical attention. The adverse event improved after stopping vaccination. Follow-up information received from the registered nurse stated the patient was not their patient, just a friend of their patient. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Information has been received from a 60 year old female who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). On 11-JAN-2011 the patient started experiencing muscle pain in the arm injected. No treatment was given for this adverse event. Patient did not seek medical attention. At the time of reporting, the patient was not recovered. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Neuralgia, Spinal X-ray, Ulnar neuritis, Vaccination site swelling
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a 65 and a half year old female with no pertinent medical history who in approximately March 2010 ("spring 2010"), was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into right arm below the deltoid. Concomitant therapy included estrogens (unspecified). The reporter stated that the patient developed ulna neuritis in the right arm following vaccination with ZOSTAVAX (Merck). The patient noticed initial redness and swelling at the site of the ZOSTAVAX (Merck) vaccination that resolved (unspecified date of resolution). In approximately March, 2010, the patient developed nerve pain that became apparent 4 to 6 weeks after vaccination. The nerve pain has continued to the present time. The patient had no weakness in the hand or arm just the nerve pain. Right elbow and neck X-ray were performed with no result provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray limb
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a 65 and a half year old female with no pertinent medical history who in approximately March 2010 ("spring 2010"), was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into right arm below the deltoid. Concomitant therapy included estrogens (unspecified). The reporter stated that the patient developed ulna neuritis in the right arm following vaccination with ZOSTAVAX (Merck). The patient noticed initial redness and swelling at the site of the ZOSTAVAX (Merck) vaccination that resolved (unspecified date of resolution). In approximately March, 2010, the patient developed nerve pain that became apparent 4 to 6 weeks after vaccination. The nerve pain has continued to the present time. The patient had no weakness in the hand or arm just the nerve pain. Right elbow and neck X-ray were performed with no result provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eyelid oedema, Facial pain, Headache, Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female with no drug reactions and no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Merck) (lot# 665306/1150Y, expired date unknown) on 06-JAN-2010. Then the patient experienced shingles around the eye and on the face on 07-JAN-2011. The patient sought unspecified medical attention and was given an unspecified treatment. At the time of the report, the patient outcome was unknown. Follow up information has been received from the nurse who reported that on 06-JAN-2010, this 64 year old patient with allergy to penicillin and a history of chickenpox at age of 9 was vaccinated with ZOSTAVAX (Merck), 0.65 ml, in her right arm, SC. Concomitant therapy included PERIOSTAT. There was no rash occurring at the site of injection post-vaccination. The nurse also reported that the patient did not have recent exposure to chickenpox or shingles. On 04-JAN-2011 (previously reported as "07-JAN-2011"), the patient developed herpes zoster, dermatome unknown; "CN2" (cranial nerve II), with systemic symptoms: tingling, hypersensitivity, pain in face, swelling eyelid and stabbing pain. The patient's maximum temperature was 101 F. The patient had no other concurrent medication at time of infection. On 07-JAN-2011, a sample was obtained from her scab lesions. It was reported that the sample was forthcoming. At the time of the report, the patient was only 50% recovered from the event. Follow-up information has been received from the registered nurse. It was reported that other concomitant therapy included NEURONTIN and oxycodone. On 04-JAN-2011 at 2:00 PM, the patient experienced stabbing pain in "nature" right forehead and eruption of vesicles in right forehead into hair and eyebrow, pain and swelling of eyelid. The patient was examined by the ophthalmologist. The results showed no corneal lesions. The patient had a fever. Follow-up information has been received and indicated that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV 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 14-FEB-2011. The sample was taken from a vesicular lesion on the patient's forehead. The patient added all specimens to one "baggie". The specimens arrived in laboratory, no VZV DNA and beta-globin DNA amplified. The final PCR specimens result was inadequate specimen. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Paraesthesia, Polymerase chain reaction, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female with no drug reactions and no pertinent medical history. The patient was vaccinated with ZOSTAVAX (Merck) (lot# 665306/1150Y, expired date unknown) on 06-JAN-2010. Then the patient experienced shingles around the eye and on the face on 07-JAN-2011. The patient sought unspecified medical attention and was given an unspecified treatment. At the time of the report, the patient outcome was unknown. Follow up information has been received from the nurse who reported that on 06-JAN-2010, this 64 year old patient with allergy to penicillin and a history of chickenpox at age of 9 was vaccinated with ZOSTAVAX (Merck), 0.65 ml, in her right arm, SC. Concomitant therapy included PERIOSTAT. There was no rash occurring at the site of injection post-vaccination. The nurse also reported that the patient did not have recent exposure to chickenpox or shingles. On 04-JAN-2011 (previously reported as "07-JAN-2011"), the patient developed herpes zoster, dermatome unknown; "CN2" (cranial nerve II), with systemic symptoms: tingling, hypersensitivity, pain in face, swelling eyelid and stabbing pain. The patient's maximum temperature was 101 F. The patient had no other concurrent medication at time of infection. On 07-JAN-2011, a sample was obtained from her scab lesions. It was reported that the sample was forthcoming. At the time of the report, the patient was only 50% recovered from the event. Follow-up information has been received from the registered nurse. It was reported that other concomitant therapy included NEURONTIN and oxycodone. On 04-JAN-2011 at 2:00 PM, the patient experienced stabbing pain in "nature" right forehead and eruption of vesicles in right forehead into hair and eyebrow, pain and swelling of eyelid. The patient was examined by the ophthalmologist. The results showed no corneal lesions. The patient had a fever. Follow-up information has been received and indicated that the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV 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 14-FEB-2011. The sample was taken from a vesicular lesion on the patient's forehead. The patient added all specimens to one "baggie". The specimens arrived in laboratory, no VZV DNA and beta-globin DNA amplified. The final PCR specimens result was inadequate specimen. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from an 81 year old female with hypertension and a history of rash when taking sulfa drugs in the past who in December 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included atenolol and DIOVAN. In April 2010, the patient experienced itchy skin on the backs of her legs, buttocks, arms, back, neck and inside of her ears. The consumer stated that when she scratched her skin she experienced a "pebble-like" red rash in the areas that she scratched. The consumer stated that she was prescribed cortisone cream (manufacturer unspecified) and "SARDYL" cream (manufacturer unspecified) and neither cream relieved the itching. At the time of reporting, the patient had not recovered. No laboratory diagnostics studies were performed. The patient sought unspecified medical attention. The physician did not believe that the events due to ZOSTAVAX (Merck). Follow up information has been received via telephone call from the physician indicating that the reported adverse experiences of rash and pruritus were not related to the ZOSTAVAX (Merck) but to atenolol. Rash and pruritus had still not resolved. No further information is available.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative, Herpes zoster, Pain
Clinical narrative: Information has been received from a pharmacist regarding a 68 year old male patient with a history of a case of shingles (6 years ago) and asthma, who on 07-JAN-2010 received a dose of ZOSTAVAX (Merck), 0.65ml, SQ on the left deltoid (lot # 1197Y, exp. date 21-FEB-2011). The patient contacted the pharmacist and reported that in the "second week of December" he came down with a case of shingles. The pharmacist reported that the patient stated the vaccine failed to protect him from shingles. The patient sought out medical treatment from his physician, who sent him for blood work on 04-JAN-2011 at 10:45 which confirmed a low antibody titer to varicella zoster IgM. The level was reported as 0.37. The patient was treated with FAMVIR. The pharmacist stated the patient reported a lot of pain with the rash. No further information provided. The patient's outcome was unknown at the time of the event. Additional information has been requested. This is an amended report. In the therapy screen was added vaccine purchased with (unknown) and vaccinated at (unknown).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with one shot of ZOSTAVAX (Merck) a year ago (approximately in January 2010). The patient currently had shingles. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a Registered pharmacist concerning a female patient in her 50's, who "several years ago" was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (dose, and lot # unspecified). The pharmacist reported that after administration of a dose of ZOSTAVAX (Merck) (length of time unknown), the patient developed a "swollen arm which went back to normal in time". The patient did not seek for medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a female patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # unspecified). Medical assistant reported that the patient developed shingles "six weeks after" receiving a dose of ZOSTAVAX (Merck) (date unspecified). At the time of the report patient's outcome was not specified. Patient sought for unspecified medical attention. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a 75 year old female patient who on 19-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 19-JAN-2011 the injection site became sore and itchy. It did not become swollen and that she did not develop a rash. She denied any other AE. The patient did not receive any medical attention. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Rash
Clinical narrative: Information has been received from a 31 year old female pharmacist who in December 2010, gave 4 doses of ZOSTAVAX (Merck). In January 2011, the pharmacist developed muscle pain and "some bumps" and was diagnosed with shingles. The pharmacist sought unspecified medical attention. The outcome was unknown. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Information has been received from a pharmacist concerning his 66 year old wife with codeine allergy and no pertinent medical history who on 19-JAN-2011 was vaccinated SC with a dose of ZOSTAVAX (Merck) in her left arm. Concomitant therapy included PREVACID. On 22-JAN-2011 the patient developed shingles after receiving ZOSTAVAX (Merck). It was reported that she received the vaccine in the left arm and painful rash developed from left knee to hip. The patient sought unspecified medical attention. The patient was treated with tramadol and acyclovir. At the time of this report, the patient's shingles persisted. Follow-up information has been received from a physician concerning the 66 year old female with no illness at the time of vaccination who on 19-JAN-2011 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included PREVACID, amitriptyline hydrochloride, vitamins (unspecified) and calcium (unspecified) (+) vitamin D (unspecified) and another unspecified medication (handwriting illegible). The physician reported that the vaccination was not given by himself. The physician wrote the patient a prescription and the vaccination was given by a pharmacy. On 21-JAN-2011 the patient experienced left knee, left low back, left lateral hip, left medial thigh upper pain, vesicular rash on left medial thigh (handwriting illegible), thigh, hip and low back pain and the developed shingles. No specimen was obtained. No diagnostic test or labs were performed. The outcome was not reported. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning his 66 year old wife with codeine allergy and no pertinent medical history who on 19-JAN-2011 was vaccinated SC with a dose of ZOSTAVAX (Merck) in her left arm. Concomitant therapy included PREVACID. On 22-JAN-2011 the patient developed shingles after receiving ZOSTAVAX (Merck). It was reported that she received the vaccine in the left arm and painful rash developed from left knee to hip. The patient sought unspecified medical attention. The patient was treated with tramadol and acyclovir. At the time of this report, the patient's shingles persisted. Follow-up information has been received from a physician concerning the 66 year old female with no illness at the time of vaccination who on 19-JAN-2011 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included PREVACID, amitriptyline hydrochloride, vitamins (unspecified) and calcium (unspecified) (+) vitamin D (unspecified) and another unspecified medication (handwriting illegible). The physician reported that the vaccination was not given by himself. The physician wrote the patient a prescription and the vaccination was given by a pharmacy. On 21-JAN-2011 the patient experienced left knee, left low back, left lateral hip, left medial thigh upper pain, vesicular rash on left medial thigh (handwriting illegible), thigh, hip and low back pain and the developed shingles. No specimen was obtained. No diagnostic test or labs were performed. The outcome was not reported. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pain, Paraesthesia oral
Clinical narrative: Information has been received from a 64 year old female with no known drug allergies and no pertinent medical history who on 18-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (route, dose and lot# unspecified). There was no concomitant medication. On 30-JAN-2011 the patient stated that she started feeling tingling on her lip which developed to a sore. The consumer mentioned she would be seeking the advice of a health care professional. The patient had sought unspecified medical attention. There was no any lab or diagnostic test performed. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female in her "late 70's" who on 28-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. On the morning of 30-JAN-2011 the patient noted a "red, raised, round, warm-to-the-touch, 2-inch by 3-inch rash, with mild stiffness at the injection site". The patient was given treatment of warm compress. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a pharmacist concerning a female in her "late 70's" who on 28-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. On the morning of 30-JAN-2011 the patient noted a "red, raised, round, warm-to-the-touch, 2-inch by 3-inch rash, with mild stiffness at the injection site". The patient was given treatment of warm compress. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site reaction, Local swelling, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 25-JAN-2011 was subcutaneously vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot # 669189/1389Z). There was no concomitant medication. On 26-JAN-2011 the patient experienced injection site reaction after receiving ZOSTAVAX (Merck). The patient had 3 inch diameter of swollen area which was very red, hot and hard. No lab diagnostics studies were performed. The patient called the pharmacist for medical attention. The patient was treated with ibuprofen and cold compress. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient with no drug reaction/allergies, and with rheumatoid arthritis active, chronic hepatitis C at low level, adult-onset of type 2 diabetes mellitus that was diet controlled and hyperlipidaemia, who in July 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy also included an antihyperlipidemic medication. The physician reported that on 26-JAN-2011, the patient reported to him with a "classic presentation" of zoster. No lab diagnostics studies were performed. The physician stated that the patient received dexamethasone 4 mg intramuscularly on 26-JAN-2011 and was prescribed VALTREX 1 gram three times a day for 10 days and a MEDROL pack. At the time of the report, the patient's classic presentation of zoster persisted. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 70 year husband with cholesterol, anxiety and high blood pressure, and no drug reactions/allergies, who on 13-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included simvastatin (manufacturer unknown), LEXAPRO and losartan potassium (manufacturer unknown). On 17-JAN-2011, the patient developed shingles. The patient sought unspecified medical attention. At the time of the report the patient was on treatment for shingles with Gabapentin 300mg and Valacyclovir 1g. No lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. No further information is available.