chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Disorientation, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: Information has been received from both a 68 year old male patient and his wife concerning the patient who on 29-JUN-2009 and 24-SEP-2009 separately was vaccinated with a dose of ZOSTAVAX (Merck) and a dose of influenza virus vaccine (unspecified, not H1N1). Concomitant therapy included SYNTHROID. Subsequently the patient was experiencing a burning, prickly feeling all over his body. This happened at the nerve endings, from his toes to his head; he stated he felt like his skin was on fire. The patient had been tested for Guillain-Barre syndrome (negative), Valley Fever (negative) and a brain MRI (normal). He stated he had large needles stuck into him, and he was treated for post herpetic neuralgia even though he "never had shingles or been diagnosed with shingles." The patient was treated with prednisone and LYRICA. The wife said her husband had a severe reaction; he did not know what day it was or time of day when taking those two medications. Wife said her husband had been referred to an internist, neurologist, hematologist, and nothing was found. The patient was not recovered at the time of reporting. The patient would have a followup visit with his physician the first of July, 2010. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Skin burning sensation
Clinical narrative: Information has been received from both a 68 year old male patient and his wife concerning the patient who on 29-JUN-2009 and 24-SEP-2009 separately was vaccinated with a dose of ZOSTAVAX (Merck) and a dose of influenza virus vaccine (unspecified, not H1N1). Concomitant therapy included SYNTHROID. Subsequently the patient was experiencing a burning, prickly feeling all over his body. This happened at the nerve endings, from his toes to his head; he stated he felt like his skin was on fire. The patient had been tested for Guillain-Barre syndrome (negative), Valley Fever (negative) and a brain MRI (normal). He stated he had large needles stuck into him, and he was treated for post herpetic neuralgia even though he "never had shingles or been diagnosed with shingles." The patient was treated with prednisone and LYRICA. The wife said her husband had a severe reaction; he did not know what day it was or time of day when taking those two medications. Wife said her husband had been referred to an internist, neurologist, hematologist, and nothing was found. The patient was not recovered at the time of reporting. The patient would have a followup visit with his physician the first of July, 2010. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an unknown age female patient who on 16-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# 665524/1374Y). On 18-JUN-2010, 48 hour after received the ZOSTAVAX (Merck), the patient reported a reaction described as a silver dollar in size, which included redness, swelling and inflammation. It was noted that the patient's relevant history, concomitant medications and past drug history were unknown. It was unspecified if lab tests were performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her husband who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, and lot# not reported). Subsequently the patient experienced rash. The patient sought unspecified medical attention. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the physician's office and other health professional concerning a 61 year old female patient with "immunocompromised" immune system disorder and with CELEBREX, AGGRENOX, sulfonamide and statin allergy who was advised on 04-DEC-2009 (also reported in December 2009) at 11:30 was vaccinated subcutaneously with the first 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 665293/1175Y). Concomitant medication included: prescribed VALTREX during office visit. It was reported that the patient still had shingles. On 14-OCT-2010 the patient was treated for shingles. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 13 year old patient who on 19-OCT-2010 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (Lot # not reported) instead of VARIVAX (Merck). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). It was reported that on an unspecified date, the patient developed redness at the site of injection after the administration of the vaccine. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Decreased appetite, Erythema, Headache, Induration
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) at the right triceps. At an unspecified interval after zoster vaccination the patient developed a large area of erythema and perhaps a lesser area of induration. The erythema was somewhat lower than the shoulder and somewhat higher than the elbow. At the time of this report the patient's outcome was unknown. Follow up information has been received from the physician concerning the 61 year old female patient with no illness at the time of vaccination who on 22-OCT-2010 (at 14:30) was vaccinated subcutaneously into the right arm with the first dose of ZOSTAVAX (Merck) (Lot # 665527/0696Z). The physician reported that after receiving the vaccine on an unspecified date, the patient experienced severe redness and irritation at site of injection, swelling from shoulder to elbow, heat noticed about 15 cm temp of 101.4, severe headache and malaise. It was reported that it was daily progression of inflammation until 27-OCT-2010, but the physician could not see progression from 26-OCT-2010, probably it was beginning to subside. The erythema extended but the induration was somewhat less, on 27-OCT-2010 was better. At the exact injection site there was a nodular area deeper in the arm that was tender that suggested a fluid collection or abscess possibly. The patient had fever elevation to 101.4 on 25-OCT-2010 then to 100.4 each day until 27-OCT-2010. The patient was still feeling sick. On 29-OCT-2010 the physician reported that on an unspecified date all the warmth and erythema were gone and the induration had subsided to about 3-5 cm around the injection side, tenderness was also much better, her skin had more of a look of darkened sunburn but no desquamation. In addition to the reaction in the arm, however she also had marked flu like symptoms with fever to 101.4, severe malaise, anorexia, marked headache. She was in bed for almost four days. As of 29-OCT-2010 the arm was as described above but the flu type symptoms were still present but improved. The patient sought unspecified medical attention. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site irritation, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) at the right triceps. At an unspecified interval after zoster vaccination the patient developed a large area of erythema and perhaps a lesser area of induration. The erythema was somewhat lower than the shoulder and somewhat higher than the elbow. At the time of this report the patient's outcome was unknown. Follow up information has been received from the physician concerning the 61 year old female patient with no illness at the time of vaccination who on 22-OCT-2010 (at 14:30) was vaccinated subcutaneously into the right arm with the first dose of ZOSTAVAX (Merck) (Lot # 665527/0696Z). The physician reported that after receiving the vaccine on an unspecified date, the patient experienced severe redness and irritation at site of injection, swelling from shoulder to elbow, heat noticed about 15 cm temp of 101.4, severe headache and malaise. It was reported that it was daily progression of inflammation until 27-OCT-2010, but the physician could not see progression from 26-OCT-2010, probably it was beginning to subside. The erythema extended but the induration was somewhat less, on 27-OCT-2010 was better. At the exact injection site there was a nodular area deeper in the arm that was tender that suggested a fluid collection or abscess possibly. The patient had fever elevation to 101.4 on 25-OCT-2010 then to 100.4 each day until 27-OCT-2010. The patient was still feeling sick. On 29-OCT-2010 the physician reported that on an unspecified date all the warmth and erythema were gone and the induration had subsided to about 3-5 cm around the injection side, tenderness was also much better, her skin had more of a look of darkened sunburn but no desquamation. In addition to the reaction in the arm, however she also had marked flu like symptoms with fever to 101.4, severe malaise, anorexia, marked headache. She was in bed for almost four days. As of 29-OCT-2010 the arm was as described above but the flu type symptoms were still present but improved. The patient sought unspecified medical attention. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pyrexia, Skin warm
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) at the right triceps. At an unspecified interval after zoster vaccination the patient developed a large area of erythema and perhaps a lesser area of induration. The erythema was somewhat lower than the shoulder and somewhat higher than the elbow. At the time of this report the patient's outcome was unknown. Follow up information has been received from the physician concerning the 61 year old female patient with no illness at the time of vaccination who on 22-OCT-2010 (at 14:30) was vaccinated subcutaneously into the right arm with the first dose of ZOSTAVAX (Merck) (Lot # 665527/0696Z). The physician reported that after receiving the vaccine on an unspecified date, the patient experienced severe redness and irritation at site of injection, swelling from shoulder to elbow, heat noticed about 15 cm temp of 101.4, severe headache and malaise. It was reported that it was daily progression of inflammation until 27-OCT-2010, but the physician could not see progression from 26-OCT-2010, probably it was beginning to subside. The erythema extended but the induration was somewhat less, on 27-OCT-2010 was better. At the exact injection site there was a nodular area deeper in the arm that was tender that suggested a fluid collection or abscess possibly. The patient had fever elevation to 101.4 on 25-OCT-2010 then to 100.4 each day until 27-OCT-2010. The patient was still feeling sick. On 29-OCT-2010 the physician reported that on an unspecified date all the warmth and erythema were gone and the induration had subsided to about 3-5 cm around the injection side, tenderness was also much better, her skin had more of a look of darkened sunburn but no desquamation. In addition to the reaction in the arm, however she also had marked flu like symptoms with fever to 101.4, severe malaise, anorexia, marked headache. She was in bed for almost four days. As of 29-OCT-2010 the arm was as described above but the flu type symptoms were still present but improved. The patient sought unspecified medical attention. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) and developed hives 2-3 weeks after receiving the vaccine. The patient's outcome was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 year old male with unspecified eye problem who was scheduled to receive PROQUAD (Merck upgrade process) on 05-NOV-2010, was accidentally vaccinated with a dose of ZOSTAVAX (Merck) 0.5 ml. There was no concomitant medication. It was unknown if there was any relevant laboratory data. As of 05-NOV-2010, it was unknown if the patient has experienced any adverse event from the inadvertent administration of ZOSTAVAX (Merck). Follow up information from the physician concerning the six year old patient who received ZOSTAVAX (Merck) instead of the scheduled PROQUAD (Merck upgrade process). The physician stated that it was a case of the wrong product was grabbed by mistake. It was not a case of product confusion. The physician explained that there was an internal medicine group next door that was sharing their pediatrics freezer, so ZOSTAVAX (Merck) was in the freezer when it would not normally be in the pediatrics office. The internal medicine group was getting their own freezer so this will not occur again in the future. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a 61 year old female patient with atrial fibrillation and allergy to DIFLUCAN, who on 03-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) in the left arm. The patient also received a dose of influenza virus vaccine (unspecified) (Lot # not provided) on the right arm. Concomitant therapy included clindamycin, flecainide acetate, diltiazem HCL, generic simvastatin, vitamins (unspecified), magnesium (unspecified), vitamin B complex, calcium (unspecified), and "CIMUDEN" (therapy unspecified). The patient stated that after receiving the vaccine, by that evening she noticed itching, burning, and warmth on her left arm where the injection was given. The spot started out as quarter size and was not 6-7 inches long and 3-4 inches wide, and the redness was getting bigger. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the female retired patient with dyslipidemia, chest pain, osteoarthritis and allergy to codeine who on 03-NOV-2010 at 10:40 was vaccinated SQ in the left upper with a first dose of ZOSTAVAX (Merck) (Lot # 665527/0696Z) (Expiration date: 21-APR-2011). The physician reported that the patient developed a rash patch over the site of injection which lasted for more than 1 week. The physician stated that the patient was treated conservatively. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 72 year old female patient, with no pertinent medical history and no drug reactions or allergies, who on 05-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664628/1018Y, expire date 16-JAN-2011), intramuscularly. On 05-NOV-2010, while the patient was still at the office, she developed a "3 centimeter round circle of redness that was painful at the site." There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site haematoma
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who, "recently" (on an unspecified date), was vaccinated with a dose of ZOSTAVAX (Merck) (lot # and expire date not reported), intramuscularly instead of subcutaneously (also reported as sucutaneously). The registered pharmacist stated physician told him, "recently" (on unspecified date), the patient had some local bruising at the injection site. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Insomnia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old male patient with cholesterol high, blood pressure high and possible gastrooesophageal reflux disease (GERD) and tree pollen allergy who on the morning of 07-DEC-2010 was vaccinated SC with ZOSTAVAX (Merck) 0.65 ml, in left arm (lot # 669405/1416Z, expiration date 21-JAN-2012). Concomitant therapy included simvastatin (manufacturer unknown), omeprazole (manufacturer unspecified), benazepril HCl, atenolol and chlorthalidone. That evening (on 07-DEC-2010) the patient's large toe of the right foot felt "stiff and different". The toe was very sore the next morning, 08-DEC-2010. It looked fine but very painful, no redness, rash or swelling noted. The patient returned to the pharmacy today, 09-DEC-2010, to report this but did not want the pharmacist to see his toe. The patient was taking MOTRIN but "it was not helping". The patient's large toe of the right foot "stiff and different" and very painful persisted. No lab diagnostic studies performed. Follow up information has been received from the pharmacist who stated that the patient with no illness at the time of vaccination, and no pre-existing allergies, birth defects and medical conditions on 07-DEC-2010 received the vaccine into the left arm. The pharmacist reported that on 07-DEC-2010 on an unspecified hour (reported as P.M.) the patient's left large toe began hurting so intensely making him difficult to walk and sleep. There were no redness, no injury and no visual changes to skin. The pain went away after about 2 days. Approximately on 10-DEC-2010, the patient had recovered. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated SQ with one 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The nurse reported that on an unspecified date, the patient developed shingles in the scalp area. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. It was reported that an unspecified treatment was given for the adverse event. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury associated with device, Local swelling
Clinical narrative: Information has been received from a 44 year old female registered pharmacist, with no pertinent medical history and no drug reactions or allergies, who on 29-OCT-2010 after finishing injecting a dose of ZOSTAVAX (Merck), (lot # 664669/0152Z, expire date 28-MAR-2011) into a patient 5 minutes ago, inadvertently stuck the needle into her left thumb. There was not concomitant medication. The thumb was swelling. The patient did not seek medical attention. At the time of the report the patient had not recovered. There were no laboratories diagnostics studies performed. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 65 year old male patient who on 28-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck), (lot # and expire date not reported), subcutaneously. On 29-OCT-2010, the patient developed an injection site reaction after receiving ZOSTAVAX. The area around the injection site was hard, red and sore. The patient sought unspecified medical attention. At the time of the report, the patient's events had not resolved. Follow-up information has been received from a registered pharmacist concerning a 65 year old male patient with no pre-existing allergies, birth defects or medical conditions who on 28-OCT-2010 was vaccinated with the first dose of ZOSTAVAX (Merck), subcutaneously into the left arm in the morning. Concomitant therapies included the first dose of FLUVIRIN (Lot n. 111796P1), intramuscularly into the left arm and the first dose of PNEUMOVAX 23 (lot n. 665708/0651Z) subcutaneously into the right arm. Pharmacist reported that on 29-OCT-2010, injection site and radiating down to the elbow was red, tender and hot to the touch. The patient was advised to call back if it did not resolve. The patient did not seek medical attention. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone, Full blood count, Herpes zoster, Lipids, Red blood cell sedimentation rate
Clinical narrative: Information has been received from a medical assistant concerning a 61 year old female patient with fibromyalgia, basal cell carcinoma of the nose, obesity and sulfa allergy and lactose allergy and a history of childhood measles and chickenpox who on 15-JAN-2010 was vaccinated IM with a dose of ZOSTAVAX (Merck) (lot # 664633/0741Y). There was no concomitant medication. In January 2010, the patient developed a "flare-up of shingles" after administration of ZOSTAVAX (Merck). The patient ordered the complete blood cell count (CBC), lipid profile, sed rate, thyroid-stimulating hormone test (TSH), vitamin D, urinalysis test (UA) on 20-OCT-2010, no results received yet. At the time of reporting, the patient had not recovered. Patient sought unspecified medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis, Vitamin D
Clinical narrative: Information has been received from a medical assistant concerning a 61 year old female patient with fibromyalgia, basal cell carcinoma of the nose, obesity and sulfa allergy and lactose allergy and a history of childhood measles and chickenpox who on 15-JAN-2010 was vaccinated IM with a dose of ZOSTAVAX (Merck) (lot # 664633/0741Y). There was no concomitant medication. In January 2010, the patient developed a "flare-up of shingles" after administration of ZOSTAVAX (Merck). The patient ordered the complete blood cell count (CBC), lipid profile, sed rate, thyroid-stimulating hormone test (TSH), vitamin D, urinalysis test (UA) on 20-OCT-2010, no results received yet. At the time of reporting, the patient had not recovered. Patient sought unspecified medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: Information has been received from a pharmacy technician concerning a 69 year old female with allergy to codeine and no medical history who on 23-DEC-2008 was vaccinated with  ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On 24-OCT-2010, the patient developed a shingles rash under her right breast and side. Site was also painful. The patient's rash and pain persisted. The patient stated she went to the emergency room where she was treated and released. The patient was prescribed prednisone, acyclovir and LYRICA. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Rash generalised
Clinical narrative: Information has been received from a consumer concerning his 74 year old wife with penicillin allergy and arthritis who in November 2009, was vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). Suspected therapy included HUMIRA. Concomitant therapy included methotrexate, prednisone and folic acid. In November 2009, shortly after the administration the reporter noted that the patient developed small spots all over her body-her arms, cheeks, legs, stomach and back. They had been to several physicians and no one had been able to figure out what was going on. Every lab test that was possible including bone marrow test had been done (results unspecified). The reporter thought there may be some issue with the shingles vaccine and the HUMIRA shots she got every two weeks. There were no pustules or open lesions. This was not an outbreak. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a medical assistant concerning an 86 year old female patient with hyperlipidaemia, hypertension, coronary artery disease, hypothyroidism, non-Hodgkin's lymphoma and not drug reactions or allergies who on 28-SEPT-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 658211/0884U, Exp date 02-DEC-2008) (route not reported). Concomitant therapy included vitamin D (unspecified), simvastatin (manufactured unknown), hydrochlorothiazide, SYNTHROID, aspirin, allopurinol and NORVASC. The medical assistant reported that on 22-OCT-2010 the patient developed shingles. The patient developed rash underneath arm. At the time of the report, the outcome of the patient was not reported. There were not laboratories performed. The patient sought unspecified medical attention. Follow up information has been received from the physician concerning the retired female patient who on 28-SEP-2007 was vaccinated with the second dose of ZOSTAVAX (Merck). On 25-OCT-2010 the patient was diagnosed with herpes zoster (previously reported as 22-OCT-2010). At the time of this report, the patient recovered. No further information is available.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARZOS
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female with no pertinent medical history and no drug allergies, who on 24-OCT-2010 was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). Concomitant therapy included MENACTRA and Tdap (also report as no concomitant therapy). On 26-OCT-2010 the patient experienced erythema at the injection site which presented 2 days post vaccination. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. At the time of the reporting, the patient not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: Information has been received from a pharmacist concerning a female who on 09-NOV-2010 might have been vaccinated with a partial dose of ZOSTAVAX (Merck) (lot # 665524/1374Y, expiration date: March 2011) subcutaneously into her left arm. It was reported that at the time of administration on 09-NOV-2010, "a drop" of vaccine leaked from the injection site of the left upper arm. Overnight on 09-NOV-2010, the patient noticed "some wetness" on her arm which the pharmacist stated "might have been vaccine". It was unspecified if the patient sought medical attention. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site anaesthesia, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female patient with no drug allergies or pertinent medical history who on 21-SEP-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number 664673/0150Z, expiration date 01-APR-2010) in the left arm. There was no concomitant medication. The pharmacist reported that a few days after vaccination, the patient presented with redness and numbness at the injection site. The patient went to the emergency room where she was given an IV of unknown origin and was sent home. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Scab
Clinical narrative: Information has been received from an 81 year old female consumer with diabetes and no drug reactions or allergies who on 29-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included insulin. About a week ago, on approximately 02-NOV-2010, the patient experienced shingles on her face. They were painful, scabby and ugly. At the time of the report the patient had not recovered. Patient sought unspecified medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTAVAX (Merck) (lot # not reported). One week later the patient developed shingles. The outcome of shingles was unknown. The patient was treated with unknown antivirals. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning his 72 year old brother, with no pertinent medical history and drug reactions and allergies reported as "I don't know for sure", who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). In "last Spring" (in approximately March 2010), the patient experienced rash after receiving ZOSTAVAX (Merck). The rash was not at the injection site. The consumer did not believe his brother had itching. The patient did not seek medical attention. On an unspecified date, the patient had recovered from rash. No further information is available. This is one of two reports from the same source.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning his sister in law 68 year old, with no pertinent medical history, who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included vitamins (unspecified). In "last Spring" (in approximately March 2010), the patient experienced rash after receiving ZOSTAVAX (Merck). The rash was not at the injection site. The consumer did not believe his sister in law had itching. The patient did not seek medical attention. On an unspecified date, the patient had recovered from rash. No further information is available. This is one of two reports from the same source.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Jaw disorder, Pyrexia, Swelling face
Clinical narrative: Information has been received from a consumer concerning her 60 year old brother, with hypertension and allergy to bee stings, who "a few weeks ago" was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included vitamins (unspecified) and unknown hypertension medications. On an unspecified date the patient experienced a headache that lasted two weeks post vaccination. After those two weeks the patient reported that his jaw would not open, one side of his face was swollen and he had fever. The patient was seen by his physician a few days ago and was put on unknown antibiotic for treatment. At the time of the report, the patient had recovered from headache and was recovering from his jaw did not open, his face was swollen and the fever. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Erythema, Injection site reaction, Rash
Clinical narrative: Information has been received from doctor's office nurse concerning an over 60 year old female patient with a history of injection site reaction after received a dose of Tdap one month ago (approximately on 15-OCT-2010), who on approximately 07-NOV-2010 (the previous week) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided). It was reported that the patient developed an injection site reaction after receiving ZOSTAVAX (Merck). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the doctor's office nurse concerning the 68 year old female patient with sulfa allergy, high cholesterol, osteoporosis, hypertension, Parkinsonism, Mitral Valve Prolapse, hypokalaemia and a red slight warm rash at the time of vaccination. The nurse reported that on 11-NOV-2010, the patient was vaccinated subcutaneously in the left deltoid with a first dose ZOSTAVAX (Merck) (Lot# 665530/0697Z). On 11-NOV-2010, the patient developed left arm red slight warm rash with early vesicles. The patient's outcome was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from doctor's office nurse concerning an over 60 year old female patient with a history of injection site reaction after received a dose of Tdap one month ago (approximately on 15-OCT-2010), who on approximately 07-NOV-2010 (the previous week) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided). It was reported that the patient developed an injection site reaction after receiving ZOSTAVAX (Merck). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the doctor's office nurse concerning the 68 year old female patient with sulfa allergy, high cholesterol, osteoporosis, hypertension, Parkinsonism, Mitral Valve Prolapse, hypokalaemia and a red slight warm rash at the time of vaccination. The nurse reported that on 11-NOV-2010, the patient was vaccinated subcutaneously in the left deltoid with a first dose ZOSTAVAX (Merck) (Lot# 665530/0697Z). On 11-NOV-2010, the patient developed left arm red slight warm rash with early vesicles. The patient's outcome was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient who on 05-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664668/0153Z). There was no concomitant medication. On 06-NOV-2010 the patient noted a single, large, red bump at the injection site, which was inflamed and sore. The pharmacist note it was not a rash or pus-filled, and it did not look like chickenpox or shingles. Currently it has decreased in size and the area was irritated, red and itchy. At the time of this report, the patient was recovering from the adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient who on 05-NOV-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664668/0153Z). There was no concomitant medication. On 06-NOV-2010 the patient noted a single, large, red bump at the injection site, which was inflamed and sore. The pharmacist note it was not a rash or pus-filled, and it did not look like chickenpox or shingles. Currently it has decreased in size and the area was irritated, red and itchy. At the time of this report, the patient was recovering from the adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient, who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that on 12-SEP-2010 the patient was diagnosed with shingles. The pharmacist reported that the patient's lesions were dried up and the patient had minimal pain. The patient sought unspecified medical attention. At the time of the report the patient was recovering. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female with hypercholesterolemia and hypothyroidism and no drug reaction/allergies who on 25-JUN-2010 was vaccinated subcutaneously her left upper arm with a first dose of ZOSTAVAX (Merck) (dose not reported, lot # 665309/1173Y). Concomitant therapy included simvastatin and SYNTHROID. On 04-NOV-2010 the patient was diagnosed with shingles. The patient was evaluated at a local emergency room on 04-NOV-2010 and was prescribed VALTREX 1 g three times per day for 10 days. The distribution of the lesions was the right upper arm and shoulder. The patient was scheduled to be seen in the office on 12-NOV-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male who with no pertinent medical history and no known drug allergies on 24-FEB-2010 was vaccinated subcutaneously in arm with a first 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). There were no concomitant therapies. On 01-NOV-2010 the patient came into the pharmacy stating he had shingles and had prescription for VALTREX 1 gram and 5% ZOVIRAX cream. Pharmacy stated acyclovir was also prescribed for the patient on 08-NOV-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 73 year old female who in approximately 2009 (reported as "about a year ago") was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot number not provided). It was reported that in the past couple weeks the patient developed shingles in the facial region even though she had been given ZOSTAVAX (Merck). No lab diagnostics studies were performed. The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The consumer stated that "a few days after getting the vaccine" she got hives. Her doctor stated that it could be from an inactive ingredient in the vaccine, but there was no way of telling if the vaccine caused it. At the time of the report, the consumer's outcome was unknown. It was unknown if the consumer sought medical attention. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Urticaria
Clinical narrative: Information has been received from an "over 60 years" registered nurse who, "had reactions to medications in general" and "about 2 years ago" (in approximately 2008) was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported), 0.65 ml. That day (in approximately 2008) the patient developed "a localized reaction". It was about 3mm in size and 'welty' in appearance. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. The patient recovered "3 days after it started". No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old male patient who on 22-NOV-2010 was vaccinated subcutaneously with a 0.65ml dose into the left arm of ZOSTAVAX (Merck) (Lot # 664670/0151Z, expiration date 28-OCT-2011). It was reported that on an unspecified date, the patient developed a rash, redness and swelling on his left arm at the injection site after receiving ZOSTAVAX (Merck). On 24-NOV-2010, the patient was evaluated at an unspecified emergency room and released. The patient was diagnosed with cellulitis and treated with KEFLEX. At the time of the report, the patient was recovering. The pharmacist reported that early this month an adverse experience from a different pharmacist at the same pharmacy was reported (WAES 1011USA01255). The pharmacist requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female patient with hypertension, hypercholestrolemia and stomach condition with no drug reactions/allergies, who on 19-NOV-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 665514/0145Z) SQ. Concomitant therapy included unspecified medications for hypertension, hypercholesterolemia and stomach condition. The pharmacist reported that on 20-NOV-2010 the patient developed a red area on her left arm at the injection site after receiving ZOSTAVAX (Merck). The pharmacist stated that this did not look like a rash, and that the patient reported that sometimes that area was itchy. The patient seek medical attention by came back to pharmacy. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Herpes zoster, Malaise
Clinical narrative: Information has been received from a 64 year old female consumer with allergy to adhesive tape and to TALWIN and a history of cancer/"vasectomy" in December 2003 and shingles approximately in May 2008 "2 and a half year ago" who in 18-OCT-2010, was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included LASIX. The consumer developed shingles shortly after receiving the vaccine. She began to felt headachy on the 18-OCT-2010. She then felt unwell on 19-OCT-2010. The doctor then diagnosed her with shingles on 23-OCT-2010. There was not lab diagnostics studies performed. At the time of the report, the consumer was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 66 year old female patient, who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that on approximately 23-NOV-2010 two weeks ago, the patient developed shingles with rash and pain. The patient called pharmacy. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse female who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The nurse developed a zoster-like rash on both sides of her mid-line after administrations of ZOSTAVAX (Merck), on 02-DEC-2010. It was also reported that the rash had resolved (date unspecified). The patient sought unspecified medical attention. Follow-up information has been received from the registered nurse who reported that the rash that she had experienced did not happen until about 18 months after receiving ZOSTAVAX (Merck). She also reported that she did not report this event to her physician and had been thinking to find a description if breakthrough a case of shingles. She mentioned that she was not even sure if the rash was shingles. The query was rule out curiosity. She did not want to take this any further. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with no drug reactions and allergies who on 18-NOV-2010 was vaccinated SQ in her left upper arm with single dose of ZOSTAVAX (Merck) (lot number 665430/1764Y, expiration date 15-MAR-2011). The patient was also administered FLUZONE on 18-NOV-2010. Concomitant therapy included levothyroxine Na, ZYRTEC and gabapentin. On 20-NOV-2010 the patient developed a bruise at the injection site of the left upper arm. The area of bruising has increased to the size of 5 centimeters in diameter. The patient came to the pharmacy and was advised to apply topical BENADRYL cream to the area of bruising. No lab diagnostics studies were performed. At time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an approximately 67 year old female with a history of shingles who in May 2009, was vaccinated with ZOSTAVAX (Merck) (lot # not reported) in the past. It was reported that the patient currently had shingles. The patient's shingles persisted. The patient sought medical attention by contacting pharmacist. Additional information has been requested.