chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Inappropriate schedule of drug administration, Incorrect route of drug administration, Pain
Clinical narrative: Information has been received from a 57 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-JUL-2007 at 10:45 AM was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot#652965/0622F). Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and estrogens conjugated (PREMARIN). On 25-AUG-2007 the patient developed shingles. The outbreak was on her abdomen, side and back. She had pain, burning, and lesions in the area. The patient sought unspecified medical attention. As of 30-AUG-2007, the patient's shingles persisted. Follow up information from the nurse indicated that the patient was seen on 30-AUG-2007 complaining of a rash for 5 days. The doctor observed 1 pustule or lesion on the front of the abdomen. No other lesions were seen. The patient also complained of increased stress. The physician prescribed alprazolam (XANAX), valacyclovir (VALTREX) and cephalexin (KEFLEX). The patient was instructed to follow up if the symptoms persisted. The diagnosis was infected lesion vs. shingles. The prescribed made covered both. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Skin lesion, Stress
Clinical narrative: Information has been received from a 57 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-JUL-2007 at 10:45 AM was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot#652965/0622F). Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and estrogens conjugated (PREMARIN). On 25-AUG-2007 the patient developed shingles. The outbreak was on her abdomen, side and back. She had pain, burning, and lesions in the area. The patient sought unspecified medical attention. As of 30-AUG-2007, the patient's shingles persisted. Follow up information from the nurse indicated that the patient was seen on 30-AUG-2007 complaining of a rash for 5 days. The doctor observed 1 pustule or lesion on the front of the abdomen. No other lesions were seen. The patient also complained of increased stress. The physician prescribed alprazolam (XANAX), valacyclovir (VALTREX) and cephalexin (KEFLEX). The patient was instructed to follow up if the symptoms persisted. The diagnosis was infected lesion vs. shingles. The prescribed made covered both. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a physician and an other health care professional concerning a 71 year old white female with hypertension and no known allergies who on 13-AUG-2007 at 13:00 was vaccinated SC with a 0.65 ml first dose of Zostavax (Lot#656858/0356U). There was no illness at the time of injection. On 14-AUG-2007 the patient developed injection site redness, swelling and mild pain. The patient contacted the physician's office. No lab studies were performed. The patient was prescribed AVELOX 400mg for 7 days accompanied by warm compresses as a precaution. The patient did not have an infection. As of 20-AUG-2007 the patient recovered. No further information was provided. There was no product quality complete involved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female in her 70's with a history of knee surgery who was vaccinated subcutaneously with Zostavax (Oka/Merck).  Twenty-one days post injection, the patient developed a rash that started on her leg, but then formed all over her body.  The rash resembled chicken pox.  The rash resolved within 4 days, it had dried up.  Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Epididymitis, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male with benign prostatic hyperplasia, coronary artery disease, lyme disease and actinic keratosis who on 13-AUG-2007 was vaccinated with Zostavax (lot # 658081/0743U). Concomitant therapy included BENICAR, FLOMAX, LIPITOR. On 27-AUG-2007 the patient experienced tingling and loss of feeling in his hand and fingers. The patient was on vacation at the time and went to the ER to be evaluated. In the ER, he was given a diagnosis of epididymitis and treated with an unspecified antibiotic. As of 30-AUG-2007, the patient was recovering. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Information has been received from a licensed practical nurse concerning her 62 year old female friend who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced herpes simplex around the mouth.  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a physician concerning a 79 year old retired white female with hypertension, hyperlipidemia and a codeine allergy who on approximately 16-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  On 28-AUG-2007 (originally reported as approximately 16-AUG-2007) the patient experienced non painful, non pruritic, slightly erythematous macular rash.  The rash was bilateral on the patient's arms and legs.  There were no lesions on the trunk.  The physician stated that the rash was neither zoster-like or varicella-like.  Unspecified medical attention was sought.  As of 11-OCT-2007, the patient was recovered.  Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Haemorrhage, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning an 85-year-old male with a history of muscle ache and fatigue with the use of niacin, ezetimibe (MSD) (WAES #0712USA02106), fenofibrate (Tricor), amlodipine besylate (Norvasc), and a history of hives with an unknown agent.  On 27-Aug-2007 he was vaccinated in the left bicep with a dose of Zostavax.  Concomitant therapy included valsartan (Diovan) 160 milligrams, aspirin 81 milligrams and fexofenadine hydrochloride (Allegra) 180 milligrams.  On 29-Aug-2007 the patient developed a bruise, signs of hemorrhage, and swelling of the right hand.  There was also redness and itching on the palm of the right hand.  The patient used hydrocortisone cream and the adverse experiences improved but did not resolve.  It was unspecified if medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 66 year old female patient with no known medical history or allergies who on 28-AUG-2007 was vaccinated with Zostavax (Oka/Merck), 0.65 ml.  Concomitant therapy included thyroid and water pill medication (therapy unspecified).  On 28-AUG-2007 the patient experienced a mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy.  The patient's mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy persisted.  The patient sought unspecified medical attention.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a 66 year old female patient with no known medical history or allergies who on 28-AUG-2007 was vaccinated with Zostavax (Oka/Merck), 0.65 ml.  Concomitant therapy included thyroid and water pill medication (therapy unspecified).  On 28-AUG-2007 the patient experienced a mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy.  The patient's mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy persisted.  The patient sought unspecified medical attention.  No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male who on 19-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 26-MAY-2007 the patient developed an unknown rash across his abdomen and lower rib.  "The rash also went away from under the armpit to the chest".  At the time of the report the patient was still experiencing a mild case of postherpetic neuralgia (PHN).  The patient sought unspecified medical attention.  The physician reported that the patient was not sure if he had chickenpox before.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested. Follow-up received 04/16/2008. Follow-up information received on 27-NOV-2007 indicated the patient was vaccinated subcutaneous in the right upper arm on 19-MAY-2007 at 16:00 with his first dose of zoster vaccine live (Oka/Merck) (lot # 65B08Z/0744U). The patient was well at the time of vaccination and had no pre-existing allergies or medical conditions. On 26-MAY-2007 the patient developed a zoster like rash - herpes zoster like rash, shingles rash on upper right chest in a 8" x 6" area. Burning and pain were the chief complaints with post herpetic pain that lasted several weeks. In September 2007 the patient recovered. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a pharmacist concerning an adult male patient whose wife was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient developed shingles in his eye. At the time of the report, the patient had not recovered. A product complaint was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who was vaccinated with a first 0.5 ml dose of Zostavax. It was reported that in a day or two after vaccination the patient developed "bumps that resembled a rash" around the injection site. The patient rubbed BENADRYL on the "bumps" and it went away. Unspecified medical attention was sought. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated SC with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed a rash that resembled that of shingles.  That patient was treated with valacyclovir HCl (Valtrex).  Unspecified medical attention was sought.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 79 year old white female who on 29-MAY-2007 was vaccinated with Zostavax. On 30-JUN-2007 the patient developed shingles on her left ophthalmic branch of the trigimenal nerve. It was a fairly mild case but the patient went to the emergency room and was started on drops and pills. The physician explained to the patient that Zostavax did not bring on her shingles and may well have lessened the severity of her attack. Unspecified medical attention was sought. In follow-up, the physician indicated that one month after Zostavax, the patient developed a mild case of shingles. As of 27-SEP-2007, the patient was recovered. No additional information is expected.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Groin pain, Pain, Stomach discomfort
Clinical narrative: Information has been received from a 67 year old female who on 30-Aug-2007 was vaccinated with Zostavax.  Concomitant therapy included a dose of Pneumovax 23 (manufacturer unknown) and simvastatin (manufacturer unknown).  The patient reported that on approximately 01-Sep-2007 two days after she received the Zostavax she experienced pain in her groin after taking a walk.  She reported that her left side ached before the right side.  She took an aspirin and the groin pain disapated on the one side.  The patient also reported that she experienced an upset stomach.  She started feeling better but did not want to take her walk until she talked to her physician.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Diarrhoea, Inappropriate schedule of drug administration, Irritability, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old male with no medical history or allergies who on 23-AUG-2007 was vaccinated IM on left thigh with a 0.65 ml dose of Zostavax (Lot # 656858/0356U) instead of a dose of Varivax. There were no concomitant medications. On 03-SEP-2007 the patient was seen in physician's office for possible chickenpox (irritability, fever and rash). The physician stated that the patient's rash was very subtle and small (estimates 10-12 pimple like elevations). The patient ran a low grade fever and experienced diarrhea. The pediatrician started the patient on acyclovir 200 mg four times daily 02-SEP-2007. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient had come to their office for childhood vaccination. Typically the office only kept Varivax in their freezer and kept Zostavax specifically for certain patients. On the day, the patient came in for his routine childhood vaccination; there was a vial of Zostavax which was ordered for another patient. But the nurse administered Zostavax without reading the vial. The error was noticed when the patient for whom the Zostavax was ordered came in and the office realized that it was given to the wrong patient. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old male with no medical history or allergies who on 23-AUG-2007 was vaccinated IM on left thigh with a 0.65 ml dose of Zostavax (Lot # 656858/0356U) instead of a dose of Varivax. There were no concomitant medications. On 03-SEP-2007 the patient was seen in physician's office for possible chickenpox (irritability, fever and rash). The physician stated that the patient's rash was very subtle and small (estimates 10-12 pimple like elevations). The patient ran a low grade fever and experienced diarrhea. The pediatrician started the patient on acyclovir 200 mg four times daily 02-SEP-2007. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient had come to their office for childhood vaccination. Typically the office only kept Varivax in their freezer and kept Zostavax specifically for certain patients. On the day, the patient came in for his routine childhood vaccination; there was a vial of Zostavax which was ordered for another patient. But the nurse administered Zostavax without reading the vial. The error was noticed when the patient for whom the Zostavax was ordered came in and the office realized that it was given to the wrong patient. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Information has been received from a pharmacy student concerning an over 60 year old female consumer who "3 weeks ago" on approximately 15-AUG-2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently, the patient developed unspecified hip pain.  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash macular
Clinical narrative: Information has been received from a female consumer concerning her 76 year old husband with hypertension and hypercholesterolaemia and a history of convulsion and lennox-gastaut syndrome, and no known drug allergies, who on 31-AUG-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck). Concomitant therapy included propafenone HCl, carbamazepine, clonazepam, simvastatin (manufacturer unknown) and atenolol. On 04-SEP-2007 the patient developed a rash on his thighs. The rash consisted of about 5 to 6 "very tiny red blotches with a blister in the center" between his knees to his groin. Medical attention was not sought. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 71 year old female with shingles who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  It was reported that the patient's shingles got worse.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 0.65 ml Zostavax (Oka/Merck).  It was reported that after 4 days of vaccination the patient experienced shingles in the eyes.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 76 year old male who in November 2006, was vaccinated with a dose of Zostavax (Oka/Merck).  In December 2006, one month after vaccination the patient broke out in a rash on his knees and elbows.  At the time of report the patient had not recovered.  No medical attention was sought by the patient.  No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated at this colleague's office with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed chickenpox after vaccination.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a female with an allergy to neomycin who, on an unspecified date was vaccinated with a "single dose" of Zostavax. On an unspecified date the patient developed a very large red "indurated" area at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a 66 year old female with high cholesterol and hypertension and a history of knee replacement who on 30-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included diclofenac sodium (+) misoprostol (Arthrotec), ezetimibe (MSD), "Demfri Brazil" and hydrochlorothiazide (+) valsartan (Diovan HCT).  On 30-JUL-2007 the patient developed a lump at the injection site that was very sore.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  On 4-AUG-2007 that patient had recovered.  A product quality complaint had not been involved.  No further information is expected.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who on 05-SEP-2007 was vaccinated SC with a 0.65 ml of Zostavax (Oka/Merck) (Lot # 658211/0884U) instead of a dose of Varivax (Oka/Merck) (MSD). It was reported that the vials looks alike. No adverse event was reported. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated the product confusion occurred because both the vaccine's vials looked alike and both were stored in the same freezer. There were no adverse symptoms. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 66 year old male who on 23-Aug-2007 was vaccinated with a 0.65 ml dose of Zostavax.  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 29-Aug-2007 the patient developed a blistering rash around the injection site.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Biopsy skin, Erythema, Pruritus
Clinical narrative: Information has been received from an 89 year old male who in mid of July 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck).  There were "several" concomitant therapy.  In mid of July 2007, the patient developed 2 to 5 itchy red bumps on his arms.  A biopsy of lesions revealed that they were bug bites.  Unspecified medical attention was sought.  A product quality complaint was not involved.  No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a female who on 04-Sep-2007 was vaccinated with Zostavax.  On 06-Sep-2007 the patient experienced injection site elevation with redness.  The elevation was swollen and itchy.  As of 06-Sep-2007, the patient's adverse experiences persisted.  No further information is available.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female who on 05-SEP-2007 was vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  The physician stated it was just a human error.  On 13-SEP-2007 additional information was received from the nurse at the physician's office.  The nurse indicated that the patient was born in 1979 so she was 28 or 29 years old.  The nurse was not the one who gave the patient's injection.  The patient was given a prescription by the physician for Varivax (Oka/Merck) (MSD).  The patient took the prescription to the pharmacy.  The physician received a call from the pharmacy indicating that they had Varivax (Oka/Merck) (MSD) and questioned if the physician wanted the pharmacy to give that to the patient.  A new prescription was faxed to the pharmacy.  The patient filled the prescription for Zostavax (Oka/Merck) and she was vaccinated with the Zostavax (Oka/Merck) at the physician's office.  The patient read the product circular and realized she had received the incorrect vaccine.  The patient was concerned because she will be trying to get pregnant.  There was no adverse event.  No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with a dose of Zostavax.  The RN reported that the patient subsequently developed cellulitis after vaccination.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  No further information is available.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient who on 04-SEP-2007 was administered a 0.5ml dose of Zostavax instead of Varicella. This was human error and not product confusion. No symptoms reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Rash vesicular, Scab
Clinical narrative: Information has been received from a physician concerning a 68 year old female who in 2007 was vaccinated with Zostavax (Oka/Merck).  In 2007, the patient developed zoster-like rash around her left face and eyelid.  The rash was red and painful with some crusting.  The physician stated that he was prescribing an antiviral medication (therapy unspecified).  The patient was scheduled for evaluation by an ophthalmologist.  The patient's zoster-like rash persisted.  Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning an "over 60 year old" male consumer who was on an unspecified date vaccinated with a dose of Zostavax.  Subsequently the patient broke out in four vesicles or lesions around the injection site.  Unspecified medical attention was sought.  The patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a male physician over 50 years old who was vaccinated with Zostavax (Oka/Merck). The patient received the Zostavax intramuscularly instead of subcutaneously and he got a red arm. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a pharmacist and a pharmacy technician concerning a 68 year old Caucasian female with no known allergies and no pertinent medical history who on 04-SEP-2007 was vaccinated with Zostavax to prevent shingles (Lot # 658085/0882U) SQ. Concomitant therapy included TOPROL XL and ezetimibe. On 04-SEP-2007 the patient developed a red spot at the injection site. As of 07-SEP-2007, the patient was recovering. In follow-up the pharmacist reported that on 05-SEP-2007 the patient experience "rash, fever at injection site" until 08-SEP-2007. Additional information was requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain
Clinical narrative: Information has been received from an 82 year old female with no known allergies with diabetes, high cholesterol and high blood pressure who on 14-AUG-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included unspecified diabetic and cholesterol pill and multivitamins (unspecified). The patient reported that she developed shingles on 04-SEP-2007 as diagnosed by her physician. The patient reported she experienced pain under her arm and on the side of her breast where also 6 to 7 lesions were present. Diagnostic tests were performed periodically. The patient's shingles persisted. Additional information was requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Stool analysis, Weight decreased
Clinical narrative: Information has been received from an 85 year old female with a penicillin allergy, allergies to dyes and fillers in unspecified medications, and a reaction to "generic premarin" (manufacturer unknown) which the patient reports "almost killed her". In June 2007, the patient was vaccinated with Zostavax. Concomitant therapy included LANOXIN. Four to five days post vaccination, the patient developed diarrhea. The patient had a stool test (results not reported). The patient reported "getting very tired and feeling washed out". The patient reported that the diarrhea persisted for three months and that she lost ten pounds in less than one month. The patient reported "after three months I am beginning to feel like my old self". At the time of reporting the patient was not yet recovered. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Erythema, Feeling of body temperature change, Hypertension, Oedema peripheral
Clinical narrative: Initial information has been received from a consumer concerning her 60 year old husband with hypertension and high cholesterol and a history of kidney stone (1990) who on 11-Jun-2007 was vaccinated with Zostavax.  Concomitant therapy included blood pressure and cholesterol medicines (therapy unspecified).  The patient's wife reported that the 14 or 15 Jun 2007 the patient was vaccinated into the left arm with Zostavax.  It was also reported that the patient developed a rash on his body, particularly on his upper legs and on one arm, approximately 4-6 weeks post vaccination.  He had tingling in his fingers and his legs felt like they were going to sleep.  His feet were also swelling up and turned red.  The wife also reported that the physician did not think the patient had shingles from the look of the rash.  Follow up information was received from a physician who reported that on approximately 22-Jul-2007 the patient developed "hot, cold, numb, swelling sensation in feet and hands".  It was noted that on 11-Jun-2007 the patient was vaccinated into the left arm with Zostavax.  There were no adverse events reported with previous vaccinations.  The patient had no illness at the time of vaccination.  There was no product quality complaint.  Diagnostic lab studies, performed 22 Aug 2007, were essentially unremarkable, with the exception of Vit B12 957.7 pg/ml (211.0-946.0), fasting glucose 125 mg/dl (70-99).  At the time of reporting the patient was not yet recovered.  The physician noted it was not clear if it is secondary to vaccination.  Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Vitamin B12 abnormal
Clinical narrative: Initial information has been received from a consumer concerning her 60 year old husband with hypertension and high cholesterol and a history of kidney stone (1990) who on 11-Jun-2007 was vaccinated with Zostavax.  Concomitant therapy included blood pressure and cholesterol medicines (therapy unspecified).  The patient's wife reported that the 14 or 15 Jun 2007 the patient was vaccinated into the left arm with Zostavax.  It was also reported that the patient developed a rash on his body, particularly on his upper legs and on one arm, approximately 4-6 weeks post vaccination.  He had tingling in his fingers and his legs felt like they were going to sleep.  His feet were also swelling up and turned red.  The wife also reported that the physician did not think the patient had shingles from the look of the rash.  Follow up information was received from a physician who reported that on approximately 22-Jul-2007 the patient developed "hot, cold, numb, swelling sensation in feet and hands".  It was noted that on 11-Jun-2007 the patient was vaccinated into the left arm with Zostavax.  There were no adverse events reported with previous vaccinations.  The patient had no illness at the time of vaccination.  There was no product quality complaint.  Diagnostic lab studies, performed 22 Aug 2007, were essentially unremarkable, with the exception of Vit B12 957.7 pg/ml (211.0-946.0), fasting glucose 125 mg/dl (70-99).  At the time of reporting the patient was not yet recovered.  The physician noted it was not clear if it is secondary to vaccination.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, X-ray abnormal
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with no known allergies and arthritis, who on 29-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot# 658081/0743U) subcutaneously in the left arm. There was no concomitant medication. A couple of days after receiving the vaccination, the patient experienced odd pain in the jawline (which side unspecified) up to the ear (unspecified). The patient took amoxicillin on 03-SEP-2007 for what was thought to be an abscess. The patient saw a dentist who could not find a problem. An X-ray showed the nerves seem irritated. The X-ray showed "blackened" and cloudy appearance around the nerve. As of 10-SEP-2007, the patient's pain was better but still present. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a 60 year old female with cancer and cardiac disorder who on 13-AUG-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included cancer and heart medications.  On approximately 07-SEP-2007 the patient developed a red rash.  The rash was not itchy, painful or did not have any blisters.  No labs were performed.  As of 10-SEP-2007, the patient's red rash persisted.  The patient had not sought medical attention.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed erythematous bump at injection site.  The patient recovered on an unspecified date without any medical treatment.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Pain in extremity, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old female with hypertension and asthma who on 22-AUG-2007 was vaccinated with Zostavax (Lot #658086/0761U) subcutaneously in her left upper arm. Concomitant therapy included hydrochlorothiazide (manufacturer not specified), ACIPHEX, SPIRIVA, TEKTURNA, LEXAPRO, calcium (unspecified) and vitamin D (unspecified). On 23-AUG-2007 the patient developed vesicular lesions in the left anticubital fossa one day after receiving her Zostavax. The patient was first examined in the office on 31-AUG-2007 and was prescribed topical cortisone cream. The patient was examined again on 05-SEP-2007. A culture of the lesions was positive for varicella. The patient was prescribed LYRICA on 05-SEP-2007 due to left upper extremity pain. As of 10-SEP-2007, the patient's vesicular lesions culture positive for varicella persisted. The nurse noted the patient is scheduled for a follow-up appointment on 19-SEP-2007. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a female who on 24-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 24-AUG-2007 the patient had a reaction at injection site and on 03-SEP-2007 that patient still had a spot visible at the site that was a size of a half dollar.  A product quality complaint was not involved.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 65 year old male with hypertension, hypercholesterolemia and anemia and no allergies who on 26-JUN-2007 was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot #657767/0740U).  Concomitant therapy included amlodipine besylate (+) atorvastatin calcium (Caduet), lisinopril-HCTZ, "omaprezole" and fenofibrate (Tricor).  On 10-JUL-2007 (previously reported as 30-JUL-2007) the patient developed half-dozen zoster lesions and a rash in the arm pit area after vaccination.  The patient was treated with valacyclovir hydrochloride (Valtrex) and the lesions went away.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that the patient had developed erythematous rash with vesicles.  On 01-AUG-2007 the patient recovered.  The patient's experience was considered to be an other important medical event.  No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female who was vaccinated on an unspecified date with a dose of Zostavax. Subsequently the patient developed a red and itchy injection site rash. The patient sought medical attention and was instructed to apply ice. The patient's symptoms resolved within 24 hours of onset. No further information was provided. There was no product quality complaint involved. Follow-up information has been received. The patient stated that she did not have a reaction and refused to fill out paperwork. No additional information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Information has been received from a 70 year old male consumer with no pertinent medical history who on 04-SEP-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ALTACE, COREG and INSPRA. On 09-SEP-2007 (five days after vaccination) the patient developed severe dizziness. Unspecified medical attention was sought. No lab studies were performed. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male with a history of shingles on his lower back three or four times a year, who was vaccinated with Zostavax. Approximately one month after being vaccinated, the patient developed shingles on his lower back. As of 10-SEP-2007, the patient was recovering. 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 nurse who on an unspecified date developed a zoster-like rash. The nurse administered doses of Zostavax at a clinic. No further information was provided. Follow up information received from the pharmacist confirmed that a health care worker who administers the vaccine came down with a confirmed case of zoster. The worker was not previously vaccinated. Additional information is not expected. This is one of several reports from the same source.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: Initial and follow up information has been received from a 59 year old white female registered nurse and an other health professional respectively. On 01-MAY-2007 the 59 year old registered nurse was vaccinated SC in the right deltoid with a single first dose of Zostavax (lot # 656606/0033U). There was no illness at the time of vaccination. On 02-MAY-2007 the patient developed flu-like symptoms with no temp. Unspecified medical attention was sought however an ER/doctor visit was not required. On 07-MAY-2007 the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a 73 year old female with no reported medical history and a sulfonamide allergy who on 30-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (lot # 656858/0356U). Concomitant therapy included glyburide, metformin HCl (GLUCOPHAGE) and ramipril (ALTACE). The patient reported experiencing a warm, red, and swollen rash around the injection site a few days after receiving Zostavax. On approximately 03-SEP-2007 the patient experienced fever, chills, sore throat and other unspecified flu symptoms. As of 10-SEP-2007 the patient is recovering. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a 73 year old female with no reported medical history and a sulfonamide allergy who on 30-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (lot # 656858/0356U). Concomitant therapy included glyburide, metformin HCl (GLUCOPHAGE) and ramipril (ALTACE). The patient reported experiencing a warm, red, and swollen rash around the injection site a few days after receiving Zostavax. On approximately 03-SEP-2007 the patient experienced fever, chills, sore throat and other unspecified flu symptoms. As of 10-SEP-2007 the patient is recovering. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Nasal discomfort, Rash generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old male with asthma, (better after prednisone), heart/aortic valve disease, iodine allergy, AICD device implant in 2004, subacute bacterial endocarditis prophylaxis, erectile dysfunction, benign prostatic hyperplasia without obstruction, idiopathic hypertrophic subaortic stenosis and a history of presbycusis asthma which was reversed in November 2006 and catheterisation cardiac which was within normal limits, who on 06-AUG-2007 (previously reported as 24-AUG-2007) at 10:45 was vaccinated IM with a dose of Zostavax (Lot # 658082/0744U). Concomitant therapy included AVELOX, prednisone, saw palmetto, CARTIA XT, aspirin, BETAPACE, ADVAIR, and albuterol. On 10-SEP-2007 the patient presented with a full body rash (including the hands and feet), lip swelling, and mild sores in his nares. Medical attention was sought. The physician noted that the rash was urticaria, and appears "like a CARTIA rash". The patient was advised to stop CARTIA XT and consult his cardiologist for alternative therapies. The physician also noted that the rash is "less likely from AVELOX, saw palmetto, and Zostavax. No further information was provided. There was no product quality complaint involved. Additional information has been received from the registered nurse who stated that on 10-SEP-2007 the patient developed body rash, itching, lip swelling and had mild sore in his nares. At the time of report the patient had recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Secondary transmission, Skin lesion
Clinical narrative: Information has been received from a female pharmacist with a history of chickenpox as a child who administered Zostavax (Oka/Merck) to patients in the pharmacy but she herself had never been vaccinated the zoster vaccine.  She takes carbamazepine (Tegretol) for seizures.  On approximately 20-AUG-2007 the patient developed herpes zoster of her R upper back.  She felt there was an "itch mite" in that area that that was what she thought she had.  She eventually went to her physician and was diagnosed with shingles.  No treatment was prescribed.  The lesions had resolved but the pharmacist continued to have pain in the affected area.  Subsequently, the patient recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 95.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Urethral pain, Vaginal pain
Clinical narrative: Information has been received from a 95-year-old female consumer with arthritis, post herpetic neuralgia following shingles (began on 08-SEP-1992) and an allergic reaction to an antibiotic that "made her sick to her stomach", who on 25-JAN-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  She reported that the vaccine was given, "to possibly reduced the pain from post herpetic neuralgia (PHN)".  There was no concomitant medication.  On 25-JAN-2007, "one day after receiving Zostavax (Oka/Merck) the patient complained that her urethra and vagina were on fire".  It was reported that this reaction lasted for two weeks and she recovered.  The patient also reported that she still has PHN after receiving Zostavax (Oka/Merck).  No medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 66 year old female with no medical history and a penicillin allergy who on 10-Sep-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included levothyroxine Na (Synthroid).  On 12-Sep-2007 the patient developed some swelling and redness at injection site accompanied by pain.  Also she stated that she experienced a stomach ache and mild diarrhea.  The patient also had flu-like symptoms like runny nose and achy muscles.  No diagnostic laboratory tests were undertaken.  No medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Rhinorrhoea
Clinical narrative: Information has been received from a 66 year old female with no medical history and a penicillin allergy who on 10-Sep-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included levothyroxine Na (Synthroid).  On 12-Sep-2007 the patient developed some swelling and redness at injection site accompanied by pain.  Also she stated that she experienced a stomach ache and mild diarrhea.  The patient also had flu-like symptoms like runny nose and achy muscles.  No diagnostic laboratory tests were undertaken.  No medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with hypertension, and allergies to tetracycline, penicillin and sulfonamide who on 27-Aug-2007 was vaccinated with Zostavax by subcutaneous injection in a pharmacy.  Concomitant therapy included sertraline HC1, estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) and hydrochlorothiazide (manufacturer not specified).  On 29-Aug-2007 the patient developed a rash.  The patient went to the pharmacy but had not contacted her physician.  The rash consisted of red, slightly raised, itchy, tender to touch lesions on the patient's right torso.  The patient's treatment and outcome were not reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning a female who on 09-Aug-2007 was vaccinated SC with a dose of Zostavax.  Concomitant therapy included atorvastatin calcium (Lipitor).  It was reported that the patient had severe outbreak of the shingles that the office had seen in 30 years.  The patient was vaccinated at a pharmacy.  It was reported that the patient was not immunocompromised, not on longer term coritcosteroids, nor allergic to gelatin or neomycin.  The patient was prescribed a 7 days steroid pack and the patient had recovered on an unspecified date.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been requested.