chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Herpes zoster, Rash
Clinical narrative: Information has been received from a 67 year old consumer reporting on herself with type 2 diabetes, multiple sclerosis, neurogenic bladder, lichen planus, allergy to amantadine hydrochloride, KEFLEX, BYETTA, LEVAQUIN, lovastatin (manufacturer unknown, WAES#1105usa02111), MOBIC, CRESTOR, sitagliptin phosphate (MSD) (WAES#1105usa02112), BACTRIM DS, DESYREL and BEXTRA who in June 2009, was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (lot number not reported). Concomitant therapy included PRISTIQ, hydroxyzine (manufacturer unknown), GLUCOPHAGE, nitrofurantoin (MSD), DIOVAN, KLONOPIN, baclofen, DITROPAN, ALLEGRA, AMARYL, modafinil (MSD), lorazepam (MSD), ACTOS, spironolactone (MSD), LANTUS and XYZAL. "On 20-APR-2011 or 21-APR-2011" the consumer developed lower right quadrant abdominal pain. On 23-APR-2011 the consumer stated the pain became severe and she went to the emergency room, where the consumer was evaluated and discharged with a prescription for TYLENOL with codeine. On 25-APR-2011, the consumer saw the physician and was sent to the emergency room. On 28-APR-2011, the consumer developed a rash on her abdomen, the consumer saw the physician at that time and was diagnosed with shingles. The patient received acyclovir as treatment for the event. On an unknown date, were performed a Computerized Axial Tomography (CAT scan) and unspecified blood tests (no results were provided). At the time of the report the patient had not recovered. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 91 year old female patient with no allergies or drug reactions and with arthritis who on 29-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (lot number 667609/1354Z, Exp: 26-OCT-2011) at the pharmacy. Concomitant therapy included LODINE. On 01-MAY-2011, the pharmacist stated that the patient began experiencing "pain in both of her arms and shoulders, as well as in her fingers". The pharmacist noted the patient said she was diagnosed with arthritis 30 years ago, but noted that the patient had not had a problem until now. The patient contacted the pharmacist via phone. No laboratories were performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a male patient in his 60's (also reported as at least 60 years old) with a history of genital herpes who in approximately March 2011 ("about 1 or 2 months ago on an unspecified date"), was vaccinated with ZOSTAVAX (Merck) (lot # not reported). In 2011 the patient developed axillary lymphadenopathy within a few days after receiving the vaccine. The patient was seen by physician. It lasted several days and then resolved. The patient had been taking VALTREX for genital herpes but it was stopped prior to the patient receiving the vaccine. It was unknown how long VALTREX was held for. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist (Pharm. D.) concerning a 63 year old female with prediabetes and allergic to sulfa who on 25-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z, exp: 28-JAN-2012). The reporter stated that the patient called the pharmacy on 30-APR-2011 stating she had soreness at the injection site since the day of the injection on 25-APR-2011 and that on 30-APR-2011 the area was swollen, itchy and painful. The pharmacist recommended BENADRYL and ice. On 03-MAY-2011 the pharmacist called her for follow up and the patient reported a burning sensation and a red rash with no blisters or open areas at the injection site. None lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. Follow up information has been received from the pharmacist (Pharm. D.) concerning a 63 year old female allergic to sulfa who at 3:00 pm on 25-APR-2011 was subcutaneously vaccinated with the first dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z) into right arm. The reporter stated that there was no illness at time of vaccination. The patient experienced arm sore at the first day. By Wednesday am the patient experienced arm swollen, itchy, painful. The patient applied ice and BENADRYL. There were no blisters but red rash, little burning sensation. The patient went to the doctor a few days later. The doctor determined it was not shingles. On 09-MAY-2011 the patient had recovered (it also reported "much improved"). Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a pharmacist (Pharm. D.) concerning a 63 year old female with prediabetes and allergic to sulfa who on 25-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z, exp: 28-JAN-2012). The reporter stated that the patient called the pharmacy on 30-APR-2011 stating she had soreness at the injection site since the day of the injection on 25-APR-2011 and that on 30-APR-2011 the area was swollen, itchy and painful. The pharmacist recommended BENADRYL and ice. On 03-MAY-2011 the pharmacist called her for follow up and the patient reported a burning sensation and a red rash with no blisters or open areas at the injection site. None lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. Follow up information has been received from the pharmacist (Pharm. D.) concerning a 63 year old female allergic to sulfa who at 3:00 pm on 25-APR-2011 was subcutaneously vaccinated with the first dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z) into right arm. The reporter stated that there was no illness at time of vaccination. The patient experienced arm sore at the first day. By Wednesday am the patient experienced arm swollen, itchy, painful. The patient applied ice and BENADRYL. There were no blisters but red rash, little burning sensation. The patient went to the doctor a few days later. The doctor determined it was not shingles. On 09-MAY-2011 the patient had recovered (it also reported "much improved"). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster, Neuralgia, Rash, Stomatitis
Clinical narrative: Information has been received from a 64 year female with allergic reaction to antibiotics and intestinal problems, weakened immune system and "possibly had Ecoli" whose husband "about two weeks ago", on approximately 20-APR-2011 was vaccinated a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). Concomitant therapy included "blood pressure" drug. "On this past Sunday", 01-MAY-2011 the patient was diagnosed with shingles. Patient reported that she had a one-inch rash on her face that had little tiny sores on it. On the inside of her mouth where her jaw was, there were white pussy sores and she horrible pained. The pain shot down and hit nerves. She went to the doctor and the doctor said right away that she had shingles. Patient also reported that their 9-month old granddaughter was exposed and had also visited her doctor. Patient was treated with ADVIL and VALTREX. No lab diagnostics studies were performed. Patient sought medical attention by visiting the doctor. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 55 year old male who on approximately 19-OCT-2010 (6 month ago") was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) into his non dominant left arm. The reporter stated that he had a "very benign headache" after getting vaccinated with ZOSTAVAX (Merck) 6 months ago. He stated he did not need to take any medication and the headache resolved. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a female patient with hypothyroidism who on 23-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) at a local pharmacy (unspecified). Concomitant therapy included SYNTHROID, fenofibrate and QUESTRAN. The reporter stated that about a weeks after being vaccinated ("on 02-MAR-2010") she developed a 2 inch diameter, red, solid (not patchy), itchy, rash just below the "needle entry site". The reporter stated no fever and said there was no treatment was given for the rash and it resolved on its own in "about a week". The patient went to pharmacy to show pharmacist. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: Information has been received from a pharmacist (R. Ph) concerning her 61 year old mother with no medical history and no previous history of shingles and no drug allergies/reactions who on 23-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 670381/0171AA, exp: 07-MAY-2012) into right arm. Concomitant therapy included DTaP, ATACAND and LIPITOR. The reporter stated that at time of administration her mother experienced stinging and burning and then felt hot across her upper arms to her shoulders with the heat spreading to her spine. The heat stopped at the spine. Both arms and legs felt very weak and heavy. The reporter had her mother sit down, and she performed standard of care. Her mother's blood pressure was 133/82 and her pulse was 77. The reporter stated that she monitored her mother until she felt better. The reporter stated she followed up and phoned her mother and she was recovering, "everything was fine". Her mother just had some soreness at the injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sensation of heaviness
Clinical narrative: Information has been received from a pharmacist (R. Ph) concerning her 61 year old mother with no medical history and no previous history of shingles and no drug allergies/reactions who on 23-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 670381/0171AA, exp: 07-MAY-2012) into right arm. Concomitant therapy included DTaP, ATACAND and LIPITOR. The reporter stated that at time of administration her mother experienced stinging and burning and then felt hot across her upper arms to her shoulders with the heat spreading to her spine. The heat stopped at the spine. Both arms and legs felt very weak and heavy. The reporter had her mother sit down, and she performed standard of care. Her mother's blood pressure was 133/82 and her pulse was 77. The reporter stated that she monitored her mother until she felt better. The reporter stated she followed up and phoned her mother and she was recovering, "everything was fine". Her mother just had some soreness at the injection site. The patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 67 year old female patient who on 20-APR-2011 was vaccinated with ZOSTAVAX (Merck) by other immunizing pharmacist (dose, route and lot # not specified). The pharmacist stated that the patient thought some of the vaccine leaked out at the injection site. At the time of the report patient's outcome was not reported. It was unspecified if patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist (R. Ph.) concerning an approximately 66 year old male with allergy to contrast media dye who on 24-JAN-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669191/1456Z, exp: 28-JAN-2012). The reporter stated that the patient phoned her to report that he developed shingles on the left side of his face in February 2011. The patient mentioned he had no rash or facial pain. LST lab work was performed with no results provided. On 04-APR-2011 the patient had recovered from shingles on the left side of his face. The reporter also mentioned that the patient developed nausea and vomiting while using the pravastatin sodium (manufacturer unspecified). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Information has been received from a pharmacist and a 69 year old female patient with thyroid disorder and high blood pressure and no drug allergy who on 11-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z). Concomitant therapy included NAFTIN, LAMISIL, unspecified thyroid medication and unspecified high blood pressure medication. A few days after the vaccination (also reported as on 11-MAR-2011) the patient experienced small blister on both arms/a rash on both arms. No lab test was performed. The patient had sought medical attention by calling pharmacy. The patient also said she would be visiting the next day. At the time of reporting, the patient had not recovered from the adverse event. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning an approximately 83 year old female with sulfa allergy and no medical history who on 12-DEC-2009 was vaccinated SQ with 0.65 ml ZOSTAVAX (Merck) (lot # 664626/0875Y). Concomitant therapy included timolol (manufacturer unknown) eye drops, omeprazole and LEVOXYL. Subsequently on an unspecified date the patient developed zoster. She first experienced back pain which was similar to a pulled muscle and then developed a zoster rash on her back and side. The patient sought medical attention via office visit. The patient was treated with prescribed VALTREX and prednisone. At the time of reporting, the patient's zoster persisted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Information has been received from a registered nurse concerning herself who in April 2011, was vaccinated IM with a dose of ZOSTAVAX (Merck) (lot # not provided). In April 2011, the patient developed redness, swelling and several pock marks on her forehead. She placed ice on the area and the symptoms resolved in 3 to 5 days. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a physician concerning a 61 year old patient who on 14-FEB-2011 was vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # not reported). On 14-MAR-2011 the patient developed Bells palsy. At the time of the report, Bells palsy was not improved and the patient's status was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a 72 year old male physician who on 16-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number: 669404/1359Z; Expiration date: 15-JAN-2012). Concomitant therapy included LIPITOR, hydrochlorothiazide (Manufacturer unknown) and NORVASC. On 23-APR-2011 the patient developed a case of Bell's palsy. The patient sought unspecified medical attention and was given prednisone and VALTREX for treatment. "Within the last week or so", approximately on 24-APR-2011, the patient recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 68 year old consumer reporting on herself with sulfa allergy and no pertinent medical history who on 08-AUG-2010, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65 ml, subcutaneously (lot number not reported). Concomitant therapy included EXTRADOL. In October 2010, the consumer was diagnosed with shingles. The consumer sought unspecified medical attention. The consumer did not receive any treatment for the event and no laboratories were performed. At the time of the report the patient was recovered. Follow up information has been received from a registered nurse informing that she was unfamiliar with the patient and did not have any additional information on the adverse event. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dermatitis contact
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a female patient who on 21-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). On 23-APR-2011, the patient experienced water blisters on her face, arm and leg. The patient only had the "rash" on the left side of the body. Also, it was noticed that the rash that was believed to be caused by ZOSTAVAX was a poison ivy rash, not related to the ZOSTAVAX. The patient received unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning a 69 year old female patient with allergic to penicillin and a history of laminectomy in 2008 who on 26-AUG-2010 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) (exp:29-APR-2011, lot # reported as 10711Z which is not valid for ZOSTAVAX (Merck)). Concomitant therapy included ANALPRAM-HC cream, estradiol, hydrochlorothiazide, PRAVOCHOL, prednisone, triamcinolone acetonide and cholestyramine resin. The reporter stated that the patient was given ZOSTAVAX (Merck) in her right arm and ADACEL (Sanofi) in her left arm concomitantly, and after the vaccinations she experienced moderate to severe swelling in her right arm. The reporter also stated that one week after getting the vaccines, the patient complained of pain in her left leg, which the doctor described as "L4 distribution" because it came from her L4 vertebrae. The patient was sent to a specialist who diagnosed her with post herpetic neuralgia. The specialist thought that it was due to ZOSTAVAX (Merck), but the doctor did not think so. At the time of reporting, the patient had recovered from moderate to severe swelling on her right arm, the outcome of post herpetic neuralgia was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Varicella
Clinical narrative: Information has been received from a physician concerning a 68 year old female patient ("one of the physician's patient's") who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 15-APR-2011 the patient developed a rash. The rash was unremarkable to start, but at the time of reporting the patient had developed vesicles, consistent with varicella on her left ear. The patient sought medical attention via calling a doctor. The physician had not yet started any kind of treatment and was sending the patient to a specialist for a consult. At the time of reporting, the outcome of the events was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 78 year old female patient who on 10-DEC-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). On 30-MAR-2011 the patient was seen by an unspecified physician and was diagnosed with a mild case of shingles. On the same day, the patient was treated with tramadol hydrochloride (manufacturer unspecified) and VALTREX which was ordered by the physician for the event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Blister, Cough, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Information has been received from a registered nurse concerning herself, a 64 year old female with drug allergies to DARVOCET, DEMEROL and TALWIN who on 29-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). On 29-APR-2011 she was also vaccinated with a dose of tetanus toxoid (manufacturer unknown). Concomitant therapy included FIORICET, ROBITUSSIN, DIMETAPP and guaifenesin. On 29-APR-2011 the patient developed headache, cough, congestion, fever (102 degrees F) and a single vesicle on her leg after receiving ZOSTAVAX (Merck) and an unspecified tetanus booster shot from her physician. Patient reported that she was "not feeling well" at the time of the injection. Patient sought unspecified medical attention. Treatment given for the adverse event included AUGMENTIN. At the time of reporting, the patient had not recovered. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: Information has been received from a 72 year old male with high blood pressure and no drug reactions or allergies who on 09-MAR-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin (manufacturer unknown). On 19-APR-2011 the patient developed a rash, which had gone away but was still sensitive around the skin. The patient sought unspecified medical attention. No treatment was given for the event. No lab diagnostics studies were performed. Follow-up information was received from the patient indicating that since 19-APR-2011 he had had itching on his ankles, legs and in-steps of his feet. He went to see a dermatologist. There was no visible rash or skin irritation. The dermatologist said it "was dry skin". The patient reported constant itching and "sensation" of itching. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a physician concerning a 72 year old female with breast cancer, hypertension, high cholesterol and acyclovir, famciclovir, synthetic opiates allergies (diffused rash) who in December 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included AROMASIN, CRESTOR and atenolol. The physician reported the patient came down with shingles in January 2011. The physician stated that the onset of shingles was noticed on 24-JAN-2011. The patient complained of painful rash on her left chest. As per physician, the patient first thought that the chest pain was due to her hypertension and she went to ER to be examined. At present time, the patient had no active lesion but she suffers from post herpetic neuralgia (PHN). The physician prescribed acyclovir to the patient to treat shingles but the patient developed diffused rash and was not able to complete the treatment. Famciclovir was prescribed instead and the patient developed diffused rash with famciclovir as well and the treatment was discontinued. The patient was treated with gabapentin too. No lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Herpes zoster, Hyperlipidaemia, Hypertension, Rash
Clinical narrative: Information has been received from a physician concerning an approximately 64 year old male with no drug or other allergies who on 28-NOV-2007 was vaccinated with  0.65ml dose of ZOSTAVAX (Merck). On 03-MAY-2011 the patient might have a mild case of shingles. The physician stated that if the patient had the shingles virus it was a very mild case and had already crusted over and "It was too late to give the patient anything to help, like an antibiotic." Unspecified medical attention had been sought. The patient was treated with prednisone and LIDODERM for rash. No blood work was done. At the time of the report, the patient's outcome was unknown. The patient currently being treated for gastrooesophageal reflux disease, hypertension and hyperlipidaemia. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Information has been received from a physician concerning an approximately 64 year old male with no drug or other allergies who on 28-NOV-2007 was vaccinated with  0.65ml dose of ZOSTAVAX (Merck). On 03-MAY-2011 the patient might have a mild case of shingles. The physician stated that if the patient had the shingles virus it was a very mild case and had already crusted over and "It was too late to give the patient anything to help, like an antibiotic." Unspecified medical attention had been sought. The patient was treated with prednisone and LIDODERM for rash. No blood work was done. At the time of the report, the patient's outcome was unknown. The patient currently being treated for gastrooesophageal reflux disease, hypertension and hyperlipidaemia. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female with no pertinent medical history and no known drug allergies who on 03-MAY-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot#: 669865/0362AA) (Expiration: 09-Jun-2012). There was no concomitant medication. On 05-MAY-2011 the patient developed 3 inch wide injection site reaction, skin was not broken but the redness was hard and hot. There was no lab diagnostic performed. On an unspecified date, the patient called the pharmacist. No treatment was given. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist (R. Ph)concerning a patient who an unspecified date earlier this year on approximately in January 2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). On unknown date, the patient experienced soreness and an unspecified lump at injection site, both of which had already resolved, at the time the patient mentioned it to the pharmacist. It was unknown if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise, Nausea
Clinical narrative: Information has been received from a Registered Pharmacist concerning a female patient with migraines who on 04-MAY-2011, was vaccinated subcutaneously in the right arm tricep with a dose of ZOSTAVAX (Merck) (lot # unspecified). Concomitant therapy included PAMELOR and IMITREX. The pharmacist reported that the "next evening" (on 05-MAY-2011), the patient called the pharmacy to report that she developed a swelling at the injection site that was the size of a "softball". The patient reported to the pharmacist over the phone that the injection site was warm to the touch and painful. On 06-MAY-2011, two days after she received the vaccine, the patient called to report that she was "not feeling well". She also reported nausea. No treatment was given to the patient. At the time of the report it was reported that the adverse events had not improved. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist reporting on herself, who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported, Route not provided). It was reported that one day after vaccination, she developed a "huge, swollen and red bump" at injection site which resolved after several days without requiring medical intervention. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist reported that a 51 year old female patient was administered 0.6ml of ZOSTAVAX (Merck) (lot # 669408/1384Z) subcutaneously in the upper left deltoid on 06-MAY-2011, for vaccination The consumer reported no relevant medical history, concomitant medications, or past drug history. On 07-MAY-2011, the patient had redness around the injection site. There was no relevant laboratory data. As of 08-MAY-2011, the patient continued to experience redness around the injection site and stated that the redness was worse on 08-MAY-2011, and then it was on 07-MAY-2011. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's nurse concerning a male patient who on 26-APR-2011 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck). On 07-MAY-2011 the patient developed a case of shingles. At the time of the report, the patient was recovering and working with their healthcare provider. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 93 year old female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported) at a local store and then showed up at her physician's office 3 days later with the shingles. The patient was treated with steroidal therapy. At the time of the report, the patient was recovering. No further information is available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old male who on 28-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669590/1507Z). On 05-MAY-2011 the patient had a rash 10 days after the vaccine given. The rash was red, itchy, vertical and under the arms. The patient called pharmacist to seek medical attention. No treatment was given for the events. At the time of the report, the patient was not recovered. Follow-up information was received from the physician indicating the patient had itchy papular rash on axilla bilateral after vaccinated by outside pharmacy This lasted 4 days and spontaneously subsided. No further information is available.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 54 year old male patient in her practice who on 03-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669406/1357Z, Exp 15-JAN-2012). The nurse reported that the patient experienced low grade fever, injection site redness and pain after receipt of ZOSTAVAX (Merck), the patient went to see doctor. At the time of the report, the status of the patient was not reported. This is one of several reports received from the same source. The nurse requested a lot check for this lot number. A lot check has been initiated. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a 62 year old female patient who in February 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included "calcium channel blocker" and "thyroid medication". The patient reported that on 25-FEB-2011 she came down with "shingles". The patient never went to her physician for a "diagnosis". The patient stated that she had had shingles every year for the 5 years before she received ZOSTAVAX (Merck) so she "knew what it looked like". The patient stated that the rash was between buttocks on the left side. She reported it as a "small patch". The patient reported 3 weeks of pain (unspecified nature) leading up to the onset of the rash. The patient said rash resolved on its own with no treatment. No further information is available.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from an 81 year old male consumer with diabetes and hypertension and no known allergies who on approximately 06-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). Concomitant therapy included multiple unspecified medications. On approximately 06-APR-2011, shortly after receiving the vaccination the patient's skin began to itch and turn red, in various areas of the body, on a transient basis. The patient sought medical attention by calling unspecified pharmacy. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating that the 81 year old male's skin began to itch in various areas of the body and began to turn red as well in various areas of the body. At the time of the report, the patient had recovered. No further information is available.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Discomfort, Pain of skin, Post herpetic neuralgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 61 years old female with hypertension and drug allergies to penicillin, cephalosporin and sulfa who on 10-MAY-2011 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot#669865/0362AA) (Expiration: 09-JUN-2012) in the right arm. Concomitant therapy included DIOVAN, TOPROL XL Tablets, LIPITOR, hydrochlorothiazide (manufacturer unknown) and ADACEL. The nurse practitioner reported that she experienced exacerbation of post herpetic neuralgia after administration of ZOSTAVAX (Merck). She was administered ADACEL during the same visit. In January of 2011 she developed zoster on her scalp and later experienced post herpetic neuralgia which lasted until beginning of March of 2011. On 14-MAY-2011, she was experiencing mild pain and discomfort at the same location on the left side of her scalp The patient was not constant. It waxed and waned. She stated on a scale of 1 to 10 her pain was a 1. No treatment was given. The patient sought medical attention via phone. There was no lab diagnostics performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 70 year old female patient with egg allergy who on 16-MAY-2011, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot #670384/0253AA; expiration date 18-MAY-2012). The pharmacist reported that the patient developed a hard, red, warm lump at the injection site at some unspecified time. The pharmacist reported that the patient returned to the pharmacy on 18-MAY-2011, to show the lump to a different pharmacist. It was reported there was no rash, urticaria or other symptoms noted by the pharmacist. At the time of the report the patient's outcome was not reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a Doctor of Pharmacy an 82 year old female patient who on 06-MAY-2011, was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (Merck) (lot# 670039/0358AA; expiration date: 09-JUN-2012). The pharmacist reported that on 07-MAY-2011, the patient developed a hot injection site rash that spread to her elbow. The pharmacist reported the patient's rash resolved on an unspecified date, without treatment. The patient sought medical attention as she was seen in the doctor's office. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male who on 28-DEC-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z exp 29-JAN-2012). On 28-DEC-2010, soon after receiving the ZOSTAVAX (Merck), the patient experienced hypersensitivity in lower back nerves, which was describes by the patient on "like the nerves were on the skin surface". The patient said it was no pain or burning. He had itchiness, but no redness or rash. The patient did not seek medical attention, but wanted to make the pharmacist aware of the situation. No treatment was given for the event and no lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Oral disorder, Urinary tract infection
Clinical narrative: Information has been received from a registered pharmacist (R. Ph.) concerning a 62 year old female patient who on 09-MAY-2011 was subcutaneously vaccinated (the pharmacist stated that the injection was given subcutaneously and the patient stated that the injection was given intramuscularly) with one dose of 0.65 mL of ZOSTAVAX (Merck) (Lot# 670384/0253AA, expiration: 18-MAY-2012). The pharmacist reported that around this week, on approximately 16-MAY-2011, the patient experienced a lesion on her lip, urinary tract infection and flu-like symptoms after ZOSTAVAX (Merck) injection. The patient sought unspecified medical attention. It was reported that the patient's physician was performing a culture on the lesion and the results would be in the next week to determine the cause. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from an 83 year old male consumer reporting on himself with no drug reactions or allergies and who had experienced peripheral neuropathy in his feet for years, who on 17-MAY-2011 was vaccinated around 3:00 p.m, with the first 0.65 ml "shot" of ZOSTAVAX (Merck) (Lot number not reported). Concomitant therapy included atenolol and terazosin. The consumer reported that on 19-MAY-2011, at 1:30 am he awoke to a burning sensation on the bottom of both feet, he had shooting pain every 10-15 seconds on the top side of his left foot. The nerves were shooting out pain. He got up several times to try to walk it off. He slept maybe 3 hours out of 6. No lab diagnostics studies performed. No treatment was given for the experience. The consumer stated that upon awakening, the shooting pain on the top of the left foot was gone but he still had the burning sensation on the bottom of both feet and was recovering. The consumer did not seek medical attention however he was advised to call his physician. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Needle issue, Paraesthesia
Clinical narrative: Information has been received from a laboratory assistant concerning a female care worker who on 11-MAY-2011 splashed ZOSTAVAX (Merck) (lot# not reported) and possibly bodily fluids into both her eyes when the needle broke during ZOSTAVAX (Merck) vaccination of a patient. The health care worker reported a "feeling in both eyes like tingling". At the time of the report, the health care worker had not recovered. It was unknown if she sought medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 60 year old male with a history of several episodes of shingles with post herpetic neuralgia over the past twenty years and no allergies who on 16-MAY-2011, was vaccinated subcutaneously into the left upper arm with 0.65 ml of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included simvastatin (manufacturer unknown) and lisinopril (manufacturer unknown) and six hours after he described feeling as he was going to have an episode of shingles. Consumer reported that on 17-MAY-2011 he experienced swollen lymph nodes in his groin and his armpit, a "low grade fever", and "the beginning of shingles lesions" on his left hip, his left buttock and one lesion on the center of his low back. Consumer reported that the lesions were not fluid filled. Consumer also reported that the injection site in his left upper arm was red, swollen and "very sore". The patient was treated with aspirin. Consumer reported that he did not have a physician for follow-up. Patient sought medical attention and spoke to an advise nurse who referred him to MSD. At the time of this report, the patient status was not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a 60 year old male with a history of several episodes of shingles with post herpetic neuralgia over the past twenty years and no allergies who on 16-MAY-2011, was vaccinated subcutaneously into the left upper arm with 0.65 ml of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included simvastatin (manufacturer unknown) and lisinopril (manufacturer unknown) and six hours after he described feeling as he was going to have an episode of shingles. Consumer reported that on 17-MAY-2011 he experienced swollen lymph nodes in his groin and his armpit, a "low grade fever", and "the beginning of shingles lesions" on his left hip, his left buttock and one lesion on the center of his low back. Consumer reported that the lesions were not fluid filled. Consumer also reported that the injection site in his left upper arm was red, swollen and "very sore". The patient was treated with aspirin. Consumer reported that he did not have a physician for follow-up. Patient sought medical attention and spoke to an advise nurse who referred him to MSD. At the time of this report, the patient status was not recovered. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Blood test normal, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: Information has been received from a 78 year old male patient with a history of "heart bypass" and with no drug reactions or allergies who in May 2009 ("two years ago") was vaccinated subcutaneously with a "once" dose of ZOSTAVAX (Merck) (dose and lot # not reported). Concomitant medication included "heart, cholesterol and blood pressure medication". The patient reported that on approximately 11-APR-2011 ("the second week of April") he had experienced a lot of the same symptoms from shingles even though he had received the ZOSTAVAX (Merck) shot. The patient had had tingling sensations on the lips and face and the left side of the back. The patient had sought medical attention and the doctor was following up with the patient to discover the reason for the effects. The patient had not ruled out the possibility of shingles but there was an absence of the rash associated with the condition. The patient had ruled out brain cancer, stroke, and transient ischemic attack (TIA). The patient had consulted with ear, nose, and throat doctors, and with a dentist. The patient had had blood tests and a full range of other tests. Lab diagnostics studies included "magnetic resonance imaging (MRI), blood tests and stroke tests". At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 60 year old female patient with general sensitivity to medications who on 17-MAY-2011 was vaccinated with one dose of ZOSTAVAX (Merck) (Lot # 669865/0362AA, expiration not reported). It was unknown if the patient had concomitant medications. Physician reported that on 17-MAY-2011, immediately after received ZOSTAVAX (Merck) the patient developed swelling, pain, redness, and warmth at the injection site. The patient sought unspecified medical attention. The patient received BENADRYL as treatment for the adverse event. It was reported that the adverse event improved on therapy, but at the time of reporting the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient with a history of shingles who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Merck) (dose, route and lot number, and expiration date were not reported) for the prevention of a second case of shingles. Within a few month of receiving ZOSTAVAX (Merck) the patient developed a second case of shingles. No further information provided. Presently, the outcome of the adverse event was not unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a consumer concerning her son who last week, in May 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported) and within a week, developed a non itchy rash at the injection site. The consumer reported that the rash was gone and her son had recovered (date unspecified). It was unspecified if the consumer son sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 year old female patient who in the morning of 20-MAY-2011 was inadvertently vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (dose and lot # not reported) instead of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a Nurse Practitioner, concerning a patient who in 2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). Nurse practitioner stated that on an unknown date, the patient developed a rash at the injection site. It was unknown if the patient sought medical attention. On an unknown date, the patient recovered from the event. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, dose, lot number and date of event. This is one of several reports from the same source. Additional information has been requested.