chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blood test, Immediate post-injection reaction, Incorrect dose administered, Nausea
Clinical narrative: Information has been received from an approximately 79 year old female consumer with "allergies to a lot of medications" and no pertinent medical history who at the "end of November 2007" was vaccinated with .5ml of zoster vaccine live (Oka/Merck). Concomitant therapy included ZYRTEC and LIDEX cream. It was noted that "almost immediately" after vaccination the patient developed a rash on her arm that was very hot and painful. The rash healed within a few weeks of taking ZYRETEC and using a cream. There were however, 2 other breakouts about 2 months after she recovered, for a total of 3 breakouts. It was also noted that the breakouts had spread all over the patient's body and that the patient had become very nauseous. Unspecified medical attention was sought. The patient had "lab, blood work" and a biopsy performed (results not reported). At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Information has been received from an approximately 79 year old female consumer with "allergies to a lot of medications" and no pertinent medical history who at the "end of November 2007" was vaccinated with .5ml of zoster vaccine live (Oka/Merck). Concomitant therapy included ZYRTEC and LIDEX cream. It was noted that "almost immediately" after vaccination the patient developed a rash on her arm that was very hot and painful. The rash healed within a few weeks of taking ZYRETEC and using a cream. There were however, 2 other breakouts about 2 months after she recovered, for a total of 3 breakouts. It was also noted that the breakouts had spread all over the patient's body and that the patient had become very nauseous. Unspecified medical attention was sought. The patient had "lab, blood work" and a biopsy performed (results not reported). At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 73 year old female consumer with penicillin allergy and no pertinent medical history who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 659614/0161X). Concomitant therapy included VOLTAREN, atenolol and glucosamine. Subsequently, on 23-APR-2008 the patient developed redness, swelling, itching, and a 4 inch hard lump at the injection site on the back surface of her arm after receiving a singe dose of the vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no quality complaint involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a pharmacy intern concerning a 76 year old female with no medical history or known drug allergies who on 24-APR-2008 was vaccinated subcutaneously into the right arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot #659614/0161X). There was no concomitant medication or other vaccinations administered on that day. On 24-APR-2008, by the time the patient arrived home, she had numbness and tingling of both hands. An hour later, she called the pharmacy and stated she had developed swelling, redness and itching of both hands. The patient denied any allergies including neomycin and gelatin. No laboratory diagnostic studies were performed. As of 24-APR-2008, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information was received on 30-JUN-2008 from a doctor of pharmacy concerning a 76 year old female with no known pre-existing allergies, birth defects or medical conditions who on 24-APR-2008 was vaccinated in the right arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot #659614/0161X). On 24-APR-2008, after administering the vaccine, the patient called to say she had redness, swelling, numbness, tingling and itching in both hands. Within 24 hours the patient recovered from the events. The patient also claimed that her daughter had "similar" reactions when receiving any type of shot. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female with no medical history or known drug allergies who on 21-MAR-2008 was vaccinated subcutaneously into the left arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 659615/0162X). There was no concomitant medication. Subsequently, on an unspecified date, the patient developed a "singles like rash" on her left arm. The patient was seen by her physician. No laboratory diagnostic studies were performed. As of 24-APR-2007, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Appendicitis, Rhinorrhoea
Clinical narrative: A female consumer with no known allergies reported that on 27-MAR-2008 she was vaccinated with zoster vaccine live (Oka/Merck), (dose was not reported). The patient developed a clear runny nose since she was given the vaccine. The consumer also reported that she transported the vaccine from the pharmacy to the physician's office over a 30 minute time span. She reports that she was given this vaccine, but does not report any other adverse reactions. The patient's clear runny nose persisted. The consumer contacted the physician. Additional information was requested. Additional information was received from the physician who reported that this 69-year-old female developed appendicitis on 16-Apr-2008. Concomitant therapy included MICARDIS. The reporting physician felt that appendicitis was not related to zoster vaccine live (Oka/Merck). The lot number 1286U was reported as not valid for this product.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 31 year old female who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (Lot # 658325/1429U) rather than varicella virus vaccine live (Oka/Merck). The nurse researched zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and was not clear about the differences, and thought that they could be used interchangeably. No other problems were reported. No other information was available at the time of this report. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a 76 year old female with a penicillin allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # and dose were not provided). On 21-APR-2008, the patient was diagnosed with shingles when she visited her physician's office. The patient mentioned that she never had shingles prior to receiving ZOSTAVAX (Oka/Merck). The patient reported that she developed rashes and pain on her trunk. The consumer was seen by a medical doctor on 21-Apr-2008. No further information is available. Information has been received from a physician concerning a 76 year old female with a penicillin and KEFLEX allergy who on 21-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) subcutaneously in the right deltoid (Lot # 565607/01E3U). On 21-APR-2008 the patient developed rashes and pain on her trunk. On
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 60 year old female with no medical history or allergies who on 26-FEB-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified thyroid medication, blood pressure medication, and vitamin supplements. A few weeks after vaccination, on 18-APR-2008, the patient experienced a rash on her left side underneath her breast that extended down to her waist. No product quality complaint was involved. No diagnostic laboratory tests were performed. At the time of this report, the patient had not recovered. No further information was provided. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male patient with a history of resolved cancer who on 25-MAR-2008 was vaccinated SC with a .65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658602/1080U). Concomitant therapy included LIPITOR and FLOMAX. Subsequently, on an unspecified date the patient developed large bruise in deltoid area described as 3-4 inches in diameter. The bruise was still present on 23-APR-2008 but was smaller. The bruise was observed by a pharmacy technician, not the pharmacist who administered the vaccine. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. No further information is available. The patient's also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA03492).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female who on 17-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL subcutaneously (lot # 659760/0159X). On 22-APR-2008, the patient developed an area of redness that was also itchy at the injection site. The area was about 2" X 4" in size. No other symptoms were noted. The patient called the medical doctor. The nurse reported that the patient was recovering.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Additional information was received from the nurse concerning a retired female with a history of chickenpox with increased itchiness as a child who reported that the patient was vaccinated in the left arm with a first dose of ZOSTAVAX. It was reported that the patient called the office and reported that on 18-APR-2008 she got a reaction of redness, swelling, increased itchiness and a 2 x 3 area of hardness. The patient did seek medical attention in the doctor's office. The reaction lasted for ten days and the patient recovered on 28-APR-2008.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who in approximately April 2007 was vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and lot number were not reported). On an unspecified date soon after vaccination, the patient developed a mild shingles-like rash. The physician reported that the patient did not experience post herpetic neuralgia. Subsequently, the patient recovered from the shingles like rash. Further information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 30-JAN-2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (Lot # 659323/1613U). On 02-FEB-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. At the time of this report, the outcome of the adverse event was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 65 year old female with penicillin allergy and hypersensitivity to benzocaine, thimerosal, and quinine who on 28-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 ml subcutaneous (SC) (Lot # was not provided). Concomitant therapy included fexofenadine hydrochloride (ALLEGRA), spironolactone (ALEXAN (spironolactone), hydrochlorothiazide (HYDRAZIDE (hydrochlorothiazide)), atorvastatin calcium (LIPITOR) and potassium (unspecified). On 30-APR-2008 the patient experienced "an injection site after receiving Zostavax. The site was red, hard, swollen, three or four inches across, and itches". At the time of this report, the patient had not recovered. No further information is available. This is in follow-up to report (s) previously submitted on 6/24/2008. Additional information is not expected. The patient is not interested in pursuing this case.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Cough, Dyspnoea, Erythema, Nasopharyngitis
Clinical narrative: Information has been received from a 73 year old male who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 ml subcutaneous (SC) (Lot # not provided). Concomitant therapy included montelukast sodium (MSD), tiotropium bromide (SPIRIVA), hydrochlorothiazide (HYDREX (hydrochlorothiazide)), atenolol (TONOCOR (atenolol), potassium (unspecified), fexofenadine hydrochloride (ALLEGRA) and ranitidine HCL (ZANTAC). On that same day, the patient developed red face and eyes, red spots on body and arms, bottom of feet burning and peeling, difficulty breathing, cold like symptoms, coughing, and sensitivity to sunlight. At the time of this report, the patient was recovering from the events. Unspecified medical information was sought.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Photosensitivity reaction, Skin exfoliation
Clinical narrative: Information has been received from a 73 year old male who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 ml subcutaneous (SC) (Lot # not provided). Concomitant therapy included montelukast sodium (MSD), tiotropium bromide (SPIRIVA), hydrochlorothiazide (HYDREX (hydrochlorothiazide)), atenolol (TONOCOR (atenolol), potassium (unspecified), fexofenadine hydrochloride (ALLEGRA) and ranitidine HCL (ZANTAC). On that same day, the patient developed red face and eyes, red spots on body and arms, bottom of feet burning and peeling, difficulty breathing, cold like symptoms, coughing, and sensitivity to sunlight. At the time of this report, the patient was recovering from the events. Unspecified medical information was sought.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an 82 year old female who "about 2 months ago", in approximately February 2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. On 24-APR-2008, the patient developed facial pain. Over the next few days, the patient developed shingles on her eyelid and the side of her face and sought medical treatment at the physician's office. No laboratory/diagnostic tests were performed. She was being treated with Neurontin and Percocet. As of 29-APR-200, the patient was recovering from shingles on her eyelid and the side of her face. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 2 year old patient who in September 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) due to a nursing error. No adverse effect reported. There was no product quality complaint. Additional information has been requested..
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin induration
Clinical narrative: Information has been received from a physician concerning an 81 year old female with penicillin allergy and no other pertinent medical history who on 25-APR-2008 was vaccinated in the right deltoid with zoster vaccine live (Oka/Merck) (lot number 659323/0164X). Concomitant therapy included simvastatin (MSD) and alendroanate sodium (MSD). On 27-APR-2009 the patient developed two itchy spots on her left forearm,. One of the two spots resolved. The other spot was 1.5 cm in diameter and centrally, about 1 cm, and there was a mild induration. The reporting physician indicated the spot looked like a bug bite. There were no vesicles and no crusting. At the time of the report, the second spot was improving. The reporting physician further indicated the patient had been home bound since she did not want to transmit the vaccine virus to others. No laboratory/diagnostic studies were performed. The patient sought medical attention through the reporting physician. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a 60-year-old female with a history of herpes zoster and no known drug allergies who on 15-AUG-2007 was vaccinated subcutaneously with a dose of 0.65 mL of zoster vaccine live (Oka/Merck) (656395/0290U). On 22-AUG-2007, seven days post vaccination, the patient developed shingles. There were lesions under her left breast, and on her buttocks. Medical attention was sought at the office. No treatment was given. There were no laboratory tests or diagnostic procedures. The outcome was reported as improving, "the patient is better, but the lesions remain." No product quality complaint was involved. The nurse practitioner is interested in the VZV program. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008.  No additional information is available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Anorexia, Asthenia, Back pain, Erythema, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 26-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658207/0883U). Concomitant therapy included CRESTOR and vitamins (unspecified). On 27-APR-2008, the patient experienced back pain and went to an emergency room (ER). On 28-APR-2008, the patient was seen in a doctor's office and diagnosed with shingles. The patient was place on treatment therapy PERCOCET and VALTREX. As of 29-APR-2008, the patient's shingles persisted. Follow-up information from the patient indicated that she had a dry rash which cleared up with the use of VALTREX. It was noted that the patient's current symptoms included redness and pain. It was also noted that the patient takes oxycodone (unspecified manufacturer) and ibuprofen (unspecified manufacturer). The patient reported that the pain caused nausea and weakness; therefore, she cannot eat and has lost weight. It was noted that the pain intensifies at certain times. The patient stated she does not want to become addicted to medication so she tries to avoid taking pain medication whenever possible. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the nurse indicated that as of 04-JUN-2008 the patient was still having Post-Herpetic Neuralgia (PHN) and had not called since. The patient was having issues with pain and was switched from PERCOCET to DARVOCET. The nurse explained that the patient did not have blisters or vesicles as her shingles presentation and the patient stated that she "knew the vaccine was not 100% effective". Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Post herpetic neuralgia, Weight decreased
Clinical narrative: Information has been received from a physician concerning an 82 year old female who on 26-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658207/0883U). Concomitant therapy included CRESTOR and vitamins (unspecified). On 27-APR-2008, the patient experienced back pain and went to an emergency room (ER). On 28-APR-2008, the patient was seen in a doctor's office and diagnosed with shingles. The patient was place on treatment therapy PERCOCET and VALTREX. As of 29-APR-2008, the patient's shingles persisted. Follow-up information from the patient indicated that she had a dry rash which cleared up with the use of VALTREX. It was noted that the patient's current symptoms included redness and pain. It was also noted that the patient takes oxycodone (unspecified manufacturer) and ibuprofen (unspecified manufacturer). The patient reported that the pain caused nausea and weakness; therefore, she cannot eat and has lost weight. It was noted that the pain intensifies at certain times. The patient stated she does not want to become addicted to medication so she tries to avoid taking pain medication whenever possible. At the time of the report the patient's status was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the nurse indicated that as of 04-JUN-2008 the patient was still having Post-Herpetic Neuralgia (PHN) and had not called since. The patient was having issues with pain and was switched from PERCOCET to DARVOCET. The nurse explained that the patient did not have blisters or vesicles as her shingles presentation and the patient stated that she "knew the vaccine was not 100% effective". Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: Information has been received from a 72 year old female consumer with high blood pressure "(medication controlled)," penicillin and TYLENOL allergies who on 18-APR-2008 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck). Concomitant therapy included ZOCOR, EFFEXOR and verapamil. Subsequently, on 26-APR-2008 the patient developed back pain. On 29-APR-2008 medical attention was sought in the office. There were no lab studies performed. The patient was diagnosed with shingles. The patient was prescribed VALTREX for treatment of the shingles. No other symptoms or treatment reported. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female with a history of shingles who in February 2008, was vaccinated SC with a 0.65 mL dose of zoster vaccine live (Oka/Merck). The patient presented with shingles two weeks after the vaccine was given. The pharmacist stated that the patient still had a lesion on her back. The patient stated to the pharmacist that the shingles were not "as bad" as they had been in the past for her. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/24/2008. The patient's shingles resolved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a patient (demographics unknown) who on 11-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). On 28-APR-2008, the patient developed shingles. At the time of the report, the patient's shingles persisted. Unspecified medical attention was sought. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Information has been received from a pharmacy student concerning a 67 year old female with urinary tract infection who on 25-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot number 659761/0157X). Concomitant therapy included MACROBID. On 25-APR-2008, the patient experienced extreme headache, aches in her neck, aches in her shoulders, aches in her wrists, inflammation of her knees and nausea. At the time of the report, the outcome of the events were unknown. The patient sought medical attention by calling the pharmacy. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Information has been received from a pharmacy student concerning a 67 year old female with urinary tract infection who on 25-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot number 659761/0157X). Concomitant therapy included MACROBID. On 25-APR-2008, the patient experienced extreme headache, aches in her neck, aches in her shoulders, aches in her wrists, inflammation of her knees and nausea. At the time of the report, the outcome of the events were unknown. The patient sought medical attention by calling the pharmacy. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 21-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The next day, on 22-APR-2008, when the patient tried to get up she had a headache and felt dizzy. The patient lied back down and she tried to get up again she "started throwing up profusely." No medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received from a health professional, concerning a 70-year-old retired female with GERD, high cholesterol, hypertension and arthritis. On 21-Apr-2008 at 10:15 the patient was vaccinated subcutaneously with a first dose of zoster vaccine live (Oka/Merck: 659404/1826U). It was reported that at the time of vaccination the patient was recovering from a fractured rib. On 22-Apr-2008 (also reported as 22-May-2008) the patient notified the physician's office that she had nausea and vomiting which improved within 24 hours. There was no fever and no abdominal pain. There were no diagnostic or laboratory tests performed. The patient recovered from the nausea and vomiting on 23-Apr-2008. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture positive, Herpes zoster, Tenderness
Clinical narrative: Information has been received from a nurse concerning an approximately 74 year old male consumer with no known allergies, high cholesterol and a history of "arterial flutter corrected with ablation" who on 09-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 659762/1874U). Concomitant therapy included CARDIZEM CD, ezetimibe (MSD), FLOMAX, saw palmetto, aspirin, niacin, SYNTHROID, simvastatin (MSD), PAXIL, folic acid and RISPERDAL. Subsequently, the patient developed a tender area on his scalp. On 22-APR-2008 or 23-APR-2008 the patient was seen by a dermatologist and a culture of the area was performed. The results can back as shingles. At the time of the report this patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. Follow-up information from the registered nurse indicated no new information. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 62 year old male patient with hypothyroidism, hypertension, hypercholesterolaemia, glaucoma and no allergies who on 28-APR-2008 was vaccinated SC in the  left arm with a dose of zoster vaccine live (Oka/Merck) (Lot # 659614/0161X). Concomitant therapy included hydrochlorothiazide, unspecified glaucoma drops and levothyroxine Na (SYNTHROID). On 01-MAY-2008 the patient experienced itching, redness, warmth and pain at the injection site. The patient was examined and prescribed cephalexin (KEFLEX), ice, ibuprofen (MOTRIN), and diphenhydramine hydrochloride (BENADRYL). The patient was instructed to call the physician if the symptoms persisted. The patient had not contacted the provider as of 05-MAY-2008. No additional symptoms or treatment were provided. No diagnostic laboratory tests were performed. As of this report, the patient was recovering. No product quality complaints were involved. Additional information has been requested.  Follow up information was received from the physician concerning a 62 years old male patient, with thyroid cancer, hypertension, increased cholesterol, glaucoma and impaired fasting glucose, who on 28-APR-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659614/0161X). The patient developed a large area of erythema, induration, warmth and pain. The patient was placed on antibiotics because it resembled a severe cellulitis. At the time of the report, the patient recovered from the AEs. No diagnostic tests were performed. There was no illness at the time of vaccination. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Pruritus, Rash vesicular, Secondary transmission, Viral DNA test negative
Clinical narrative: Information has been received from a 62 year old female Registered pharmacist, with a history of childhood chickenpox and no allergies, whose husband was vaccinated with zoster vaccine live (Oka/Merck) on 26-APR-08. The pharmacist's concomitant medications included ramipril, levothyroxine Na and multivitamins (unspecified). On approximately 29-APR-2008 the pharmacist experienced a rash which looked like classic chickenpox. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The specimen was collected on 06-MAY-2008 from a papular lesion on the right forearm when the rash was 8 days old and the vesicles were gone. It was reported that the patient had a rash of scattered vesicles (approximately 20 in number) distributed on both flanks, right forearm, and right thigh and the patient was afebrile. It was noted that the patient had recently been exposed to a vaccinee (her husband had no rash) and was not recently exposed to chickenpox or shingles. The PCR results for the specimen from the papular lesion were reported as an inadequate specimen, negative for B-globin, no strain identified. Follow-up information was received from the pharmacist on 19-MAY-2008. She explained that she had suspected that the PCR results might be inadequate since she was recovering at the time the samples were obtained. On 19-MAY-2008, the pharmacist reported that she was totally recovered. The pharmacist explained that her rash looked like classic chickenpox, and itched frantically at every spot; however, she did not have a fever or headache at any time. She confirmed that her husband never developed a recognizable rash nor did he have any itching. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a male patient with a history of shingles who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed a rash that looked like zoster. He experienced an entire body rash which was "hive-like". The physician noted that the patient's rash was not like chickenpox or shingles. The physician noted that the patient asked for the vaccine, so he gave  it. The patient was treated with a steroid dose pack and he recovered quite quickly. The physician reported that the rash was more like a drug reaction, "he thought maybe something in the vaccine." The physician noted that this was the only patient who had a reaction, although the physician has vaccinated a number of patients with zoster vaccine live (Oka/Merck). No product quality complaint was involved. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 77 year old female with hypertension who on 30-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously in the upper arm (Lot #659267/1836U). Concomitant therapy included losartan potassium-HCTZ (MSD), ACTONEL, calcium (unspecified) and INDERAL. On 02-MAY-2008, the patient was seen in the physician's office because she had developed a swollen arm, with a 2 X 2 area at the injection site which was warm to the touch and hard. The patient was treated with over the counter TYLENOL and comfort measures as needed. At the time of this report, the patient had not recovered. Additional information was requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician and a medical assistance concerning a 77 year old female with hypertension who on 30-APR-2008 was vaccinated with ZOSTAVAX 0.65 ml. subcutaneously in the upper arm (Lot #659267/1836U). Concomitant therapy included losartan potassium-HCTZ (MSD), ACTONEL, calcium (unspecified) and INDERAL. On 01-MAY-2008, the next day, the patient was aware of a swollen area, 2 x 2, red and warm. On 02-MAY-2008 the patient was seen in the physician's office because she had developed a swollen arm, with a 2 x 2 area at the injection site which was warm to the touch and hard. The patient was treated with over the counter TYLENOL, ice and comfort measures as needed. On 14-MAY-2008 the physician noted the swelling decreased area was still slightly pink (physician also noted the redness, swollen, warm area lasted a duration of 10 days). As of 21-MAY-2008 the physician noted the patient was no longer being treated. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dark circles under eyes, Dyspnoea, Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: Information has been received from a 77 year old female with no drug reactions or allergies and a history of "blood pressure" who on 14-APR-2008 was vaccinated with a "single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included DIOVAN. On 15-APR-2008 the patient developed swelling of the eyes, redness, circles around the eyes, difficulty breathing. The patient also noted that she had swelling of the face, which lasted for about two days. The patient was seen by an opthamologist who prescribed eye drops, PATANOL. At the time of reporting the patient was recovering from swelling of the eyes, redness, circles around the eyes, and difficulty breathing. It was noted "it had improved a little bit," and that the patient still had some difficulty breathing. Unspecified medical attention was sought. There was no lab diagnostic studies performed. There was no product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a female with arthritis who "about six months ago" in approximately November 2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified therapy for arthritis. In approximately November 2007, "about six months ago" the patient developed redness swelling and a blanched area at the injection site and some aching...., which the patient noted may be related to her arthritis. The patient obtained medical attention, which included an office visit. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal chest pain
Clinical narrative: Information has been received from a physician concerning an 84 year old female with drug hypersensitivity to codeine who was vaccinated on an unspecified date with zoster vaccine live (Oka/Merck) (Lot # and dose were not specified). Concomitant therapy included ramipril (ALTACE), atorvastatin calcium (LIPITOR), acetylsalicylic acid (ASPIRIN), lansoprazole (PREVACID), sertraline HCL (ZOLOFT) and acetaminophen (TYLENOL). The physician reported that on 06-APR-2008 the patient developed burning pain on her chest wall and mild erythema at injection site. No rash was present. The patient was seen by the physician. At the time of this report, the patient had not recovered from burning pain on her chest wall and mild erythema at the injection site. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a patient who on 29-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 01-MAY-2008 the patient experienced slight redness at injection site and itching at injection site. No product quality complaint was involved. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a 77 year old female with no medical history or allergies who on 30-APR-2008 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck). There were no concomitant medications. The patient reported that on 30-APR-2008 " 2 1/2 hours after vaccine" she experienced dizziness, nausea, and vomiting. No diagnostic laboratory tests were performed. No product quality complaint was involved. At the time of this report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female patient who on 03-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was noted that the patient "picked up the zoster vaccine live (Oka/Merck) from a pharmacy approximately 25 steps down the hall from the physician's office, took the vaccine to the office for it to be administered, and had a terrible reaction." The injection site was raised, red, hot, swollen, painful, and warm to the touch. A rash was not present. At the time of this report, the patient was recovering. No product quality complaints were involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site induration, Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning a 63 year old female with a history of colonic polyps who on 25-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneous in the right arm (Lot # and dose were not reported). On 29-APR-2008 the patient returned to the physician's office and reported that she had "developed a large, not evenly indurated, bruise at the injection site. It was three inches in diameter and looked similar to a welt". The patient was treated with hydrocortisone cream to be applied three times a day (TID). At the time of this report, the patient was recovering from the adverse events of induration at the injection site, bruise at the injection site, and welt at the injection site. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 84 year old female who "approximately 6 to 8 weeks ago" in approximately March 2008 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). On 01-May-2008, the patient returned to the office with a rash around the left mid-section of the abdomen. No diagnostic laboratory studies were performed. No product quality complaint was involved. At the time of this report, the patient was recovering. Physician returned vaccine adverse experience report with no additional information entered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Information has been received from a female patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient "broke out in small bumps." No further information is available. No product quality complaint was involved. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Injection site erythema, Injection site haemorrhage
Clinical narrative: Information has been received from a physician concerning an 80 year old male patient who on 16-AUG-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (Lot # 658085/0882U). Concomitant therapy included anticoagulant medication (unspecified). The physician stated that the patient received zoster vaccine live (Oka/Merck) last year and still has a red circular area that bleeds at the injection site. During an office visit on 08-May-2008, the patient told the physician that "one month after vaccination," on approximately 16-Sep-2007, a red area developed on his left arm. The red area bleeds periodically. The patient identified the area as the injection site, but the physician feels it is at a location that would not normally be used. The physician has a picture of the lesion and performed a biopsy (results unspecified). No other information was reported. The patient's bleeding and redness at the injection site persisted. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse, concerning an adult female "in her forties" with a history of two episodes of severe chickenpox, who on 06-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # dose and route not specified). On 07-MAY-2008 the patient developed "blisters" on her chest, and contacted the physician's office by telephone. At the time of this report, the outcome of the event was not recovered. No further information was available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus generalised, Skin lesion
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 69 year old female with no reactions/allergies who on 06-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously (lot 659760/0159X). On 06-MAY-2008, since the patient was given zoster vaccine live the patient experienced full body itching. No rash or injection site reaction was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a registered pharmacist concerning a 69 year old female patient with allergies to penicillin, CALAN and VICODIN all of which caused a rash and no environmental allergies and no illness at the time of vaccination who on the morning of 06-MAY-2008 was vaccinated subcutaneously in the left arm with a 0.65 mL first dose of ZOSTAVAX (Merck) ( Lot 659760/0159X). On 07-MAY-2008 at 14:00, the patient complained of full body itching including eyes and throat. She stated that the itching was coming from inside and her skin felt like it was burning. The patient had no fever or reaction at the injection site or rash. The patient was treated with BENADRYL for 48 hours. No diagnostic laboratory tests were performed. There was one healing lesion seen in exam on the patient's back which was located on the right L1 nerve distribution. No product quality complaint was involved. At the time of this report the patient had recovered. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 64 year old female with sulfa and epinephrine allergy who on 23-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included ibuprofen (MOTRIN) and HCTZ/triamterene (DIAZIDE). There was no illness reported at the time of vaccination. The patient experienced muscle pain, muscle spasms and cramps, lower back pain, pain in legs, numbness, injection site soreness and redness which gradually became worse since beginning therapy. The patient sought medical attention with the physician and at the ER and had unspecified blood tests (results not reported). The patient's muscle pain, muscle spasms and cramps, lower back pain, pain in legs, numbness and injection site soreness and redness persisted. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a 64 year old female with sulfa and epinephrine allergy who on 23-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included ibuprofen (MOTRIN) and HCTZ/triamterene (DIAZIDE). There was no illness reported at the time of vaccination. The patient experienced muscle pain, muscle spasms and cramps, lower back pain, pain in legs, numbness, injection site soreness and redness which gradually became worse since beginning therapy. The patient sought medical attention with the physician and at the ER and had unspecified blood tests (results not reported). The patient's muscle pain, muscle spasms and cramps, lower back pain, pain in legs, numbness and injection site soreness and redness persisted. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a female in her 60's who on approximately 07-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL. Twenty minutes after vaccination the patient developed redness and swelling at the injection site. A week later, the patient recovered from the events. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with high blood pressure, high cholesterol and diabetes who on 07-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included clonidine, ezetimibe (+) simvastatin (MSD), MICARDIS, alendronate sodium (MSD), metformin, metoprolol and minoxidil. Two weeks after injection, the patient developed a rash that went down her arm. It was indicated the patient's rash improved. Unspecified medical attention was sought. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 68 year old female with leukaemia who, on approximately 07-APR-2008, was vaccinated SQ with one dose of zoster vaccine live (Oka/Merck). On approximately 12-APR-2008, the patient experienced injection site reaction (soreness) and mild rash over different parts of her body. Subsequently, the patient recovered from injection site reaction (soreness) and mild rash over different parts of her body. VZV analysis was not necessary. Additional information has been requested.