chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient. Pertinent medical history was none. Allergic reaction included hives for chocolate. On 23-JUL-2012, the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX. Lot number was 671775/0466AE and expiration date was 28-FEB-2013. Other suspect therapies included PNEUMOVAX 23 on 23-JUL-2012. Concomitant medications included aspirin, FOSAMAX and PEPCID. Approximately on 25-JUL-2012 (reported as 2 days after vaccination), the patient experienced nodule in her deltoid area of injection. On 25-JUL-2012, the patient had called the physician's office to report the same and was told by the physician over the telephone to apply a warm compress and to take BENADRYL and ADVIL if needed. Later the patient never called back and on an unspecified date had recovered from the event. On 12-SEP-2012, the patient reported that she went numb and tingly on the right side for which she went to the emergency room. On an unspecified date in September 2012, laboratory tests were performed which included MRI which showed demyelination of C2 area. Lumbar test and other unspecified tests were performed and the results were pending. The patient was treated with steroid and was responding to the treatment. On an unspecified date the patient was hospitalized. The outcome of the event of she went numb and tingly on the right side was reported as recovering/resolving. The patient's events were considered to be disabling by the reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Middle insomnia, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included: cephalexin. The consumer stated that her sister had developed shingles many years ago in her mouth and throat and wanted to avoid this disease so on 28-AUG-2012 she received the injection of ZOSTAVAX single dose vial 10 pk. The next day during the afternoon on 29-AUG-2012 she stated that she had reactions to the injection. Her arm began to itch really bad. She placed an ice and heat pack on it to reduce the itching. Later on that evening, her arm swelled up as she stated in her own words "like the size of a lemon". As she rested for bed, she stated in her own words "that it swelled up like a size of a baseball". Later, her rest was interrupted 5 o'clock am, from the itching and pain when her arm as she stated was "the size of a grapefruit". Since her doctor could not observe her, she then decided to go to the emergency room for treatment. She was hospitalized and was prescribed an antibiotic cephalexin 500mg but did not take the treatment. Soon after she was driving back home and noticed on her waist a rash that developed with small red spots with blisters. This rash had a painful and terrible itch. At the time of the report the patient had not recovered from the events. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included: cephalexin. The consumer stated that her sister had developed shingles many years ago in her mouth and throat and wanted to avoid this disease so on 28-AUG-2012 she received the injection of ZOSTAVAX single dose vial 10 pk. The next day during the afternoon on 29-AUG-2012 she stated that she had reactions to the injection. Her arm began to itch really bad. She placed an ice and heat pack on it to reduce the itching. Later on that evening, her arm swelled up as she stated in her own words "like the size of a lemon". As she rested for bed, she stated in her own words "that it swelled up like a size of a baseball". Later, her rest was interrupted 5 o'clock am, from the itching and pain when her arm as she stated was "the size of a grapefruit". Since her doctor could not observe her, she then decided to go to the emergency room for treatment. She was hospitalized and was prescribed an antibiotic cephalexin 500mg but did not take the treatment. Soon after she was driving back home and noticed on her waist a rash that developed with small red spots with blisters. This rash had a painful and terrible itch. At the time of the report the patient had not recovered from the events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Tenderness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 years old female patient who on 29-AUG-2012 was vaccinated intramuscular (IM) with a dose of 0.5 PNEUMOVAX 23 (lot number H013581 in validation process, expiration date: 03-MAR-20124). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient experienced redness and pain in the lower arm region near the elbow of her right arm on 30-AUG-2012. No treatment information was reported. Labs diagnostics studies were not performed. The patient sought medical attention, contacted the physician's office. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for PNEUMOVAX 23. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 years old female patient who on 29-AUG-2012 was vaccinated intramuscular (IM) with a dose of 0.5 PNEUMOVAX 23 (lot number H013581 in validation process, expiration date: 03-MAR-20124). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient experienced redness and pain in the lower arm region near the elbow of her right arm on 30-AUG-2012. No treatment information was reported. Labs diagnostics studies were not performed. The patient sought medical attention, contacted the physician's office. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for PNEUMOVAX 23. This is one of the several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with, 1 vial dose ZOSTAVAX (lot # was unknown) (injection) on 19-SEP-2012 for chicken-pox prevention. Other suspect therapies included VARIVAX (Merck) (lot # was unknown). Concomitant medications included: INFLUENZA (manufacturer was unknown, not AFLURIA. On 19-SEP-2012 the patient was "accidentally given the ZOSTAVAX vaccine instead of the VARIVAX (Merck) vaccine". "The patient was scheduled to receive the VARIVAX (Merck) and an unspecified flu vaccine (not AFLURIA) on the same day". There were no adverse reactions involved. This adverse event was also technically an overdose to the patient since ZOSTAVAX was a higher dose that the VARIVAX (Merck) as reported. It was not specified if the patient sought medical attention, no treatment was given for adverse events. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old female patient who on 04-SEP-2012, was vaccinated IM in the upper right deltoid with the first 0.5 ml dose of GARDASIL (lot # 0555AE, exp 14-DEC-2012). No concomitant medications were reported. It was reported that the patient was vaccinated with improperly stored GARDASIL. No adverse effects were reported at this time. Additional information has been requested.
Sex: M
Vaccine: DTP, HEPA, HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a pharmacist. The pharmacist reported a male high school sophomore was vaccinated with GARDASIL, Hepatitis A vaccine ("name unspecified but VAQTA could not be ruled out") and DTP (manufactured unknown) about a year ago. The male has been suffering from chronic fatigue. No additional information provided. No additional information expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. The patient was vaccinated with dose 1 GARDASIL injection 20 micrograms (mcg)-40 mcg-40 mcg-20 mcg/0.5 millimeters (ML) 1 standard package syringe of 0.5 on 15-JUN-2011. No concomitant medications were reported. Nurse reported that patient received second dose of GARDASIL outside of recommended dosing schedule on 14-JUN-2012. No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a consumer refers to her son of unknown age who on 18-JUN-2012, was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot number not reported). The consumer reported that the dose had been stored at room temperature for a three week period. The consumer and her son would be speaking with the physician's office to determine if the series would have to be re-started at this point. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 14 years old female patient with pertinent medical history and no drug reactions/allergies who on 17-JUL-2012, was vaccinated with the first dose of GARDASIL (route and lot # not reported). No other co-suspects were reported. There was no concomitant medication. It was reported that the patient experienced headache, nausea and vomiting and dizziness on a daily basis, since shortly after the vaccination "approximately in July 2012". The physician reported that the patient was continuing to play sports. The patient did not receive any treatment. The patient contacted the physician. The outcome of headache, dizziness, vomiting and nausea was reported as not recovered/not resolved. The relatedness for headache, dizziness, vomiting and nausea was unknown for GARDASIL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 years old female patient with drug allergy to AUGMENTIN. The patient's medical history included anemia in 2008 and "passing out" seen by cardiologist in 2010. The patient was vaccinated with the first and second dose of GARDASIL (lot number reported as h011350, EXP 21-FEB-2015) intramuscular 0.5 ml respectively on 12-JUL-2012 and 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012 the patient complained of nausea, vomiting, and severe stomach pain. The patient had sought medical attention via got to urgent care clinic. No treatment was given for the adverse event. There were no laboratory diagnostics studies performed. The outcome of severe stomach pain, vomiting and nausea was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health care professional regarding a female who was vaccinated with GARDASIL (lot number 672547/1745AA, expiration 13-SEP-2012, dose 1 on 07-JUN-2012; dose 2 on 09-AUG-2012 and dose 3 on 13-SEP-2012 (inappropriate schedule of drug administration). The health care professional reported no adverse effect has been observed or reported. No additional information currently available. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a consumer regarding her daughter who was vaccinated with her first dose of GARDASIL (date, route of administration and lot number not reported). The consumer's mother reported her daughter experienced mononucleosis one month (no onset date reported) after she was administered her first dose of GARDASIL and sought medical attention (unspecified). The consumer's mother said her daughter will not be administered her second dose of GARDASIL. The consumer's mother said she does not have anything else to say and refused to provide additional adverse event information. No additional information is expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient, who was vaccinated with GARDASIL. The patient has a history of unspecified reactions to unspecified vaccines in the past. The physician reported that on 19-SEP-2012, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml in her left arm (Lot number not reported). The physician reported that the patient experienced warmth and swelling at the injection site a few hours after administration. The patient was referred for evaluation on 20-SEP-2012 due to the area of reaction was worsening. It was reported that the patient had not recovered. Additional information has been requested
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse reporting on a patient of unknown age and gender who on an unspecified date was vaccinated with an expired dose of GARDASIL (lot# not reported, exp June/July 2012). No other co-suspects were reported. No concomitant medications were reported. No adverse reaction was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 24 years old female patient with leukodystrophy. The patient was vaccinated with PNEUMOVAX23 (Lot#, dose/frequency, route unspecified) in December 2007 and again second dose (Lot#, dose/frequency, route unspecified) on 05-NOV-2012. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date. No other co-suspected were reported. No concomitant medications were reported. The patient developed shingles "3 years" after receipt of ZOSTAVAX and unhappy with developing shingles. The patient sought medical attention via physician examination. The outcome of shingles was unknown. This is one of several reports received from the same source. Addition informational has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a female patient, age unknown. The patient was vaccinated with a single dose of ZOSTAVAX (dosage information not provided) on 14-SEP-2012. The pharmacist reported that the patient experienced redness and warmth around the injection site after administration of ZOSTAVAX on 14-SEP-2012. No treatment information or further details were reported. The outcome of redness and warmth around the injection site is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported that a patient may have received a dose of expired PNEUMOVAX 23. The pharmacist declined to provide any additional information. No adverse effect reported. No other information is available at this time. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Pain, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to his wife a patient of unknown age. On unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). Concomitant therapy included valacyclovir 1 g daily. The consumer, stated that on unspecified date he and his wife received ZOSTAVAX while he was taking Valacyclovir 1 g daily, and he did not experienced any type of injection site reaction like his wife did. The consumer reported that his wife got the shot and had a normal live virus reaction. But on unspecified date, his wife developed a 100 mm hot spot with mild swelling, also experienced a little bit of pain. At the time of the report the patient was fine. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Echocardiogram, Pruritus, Ultrasound scan
Clinical narrative: This spontaneous report as received from a 77 years old female patient refers to herself (140 lbs, 62 inch) with high blood pressure, allergy to penicillin and allergy to LIPITOR. The patient's medical history included heart attack in 2002. The patient was vaccinated under the skin of the left arm with a dose of ZOSTAVAX (lot # not reported) on 09-MAR-2012. Concomitant medications included LIPITOR, generic atorvastatin calcium and unspecified blood pressure medicine. It was reported that after the patient got ZOSTAVAX on 15-MAR-2012 she had had an incident of burning and itching all around her neck. The patient also stated that she had gotten an ultrasound this same time (in March of 2012) that produced a horrible burn around her neck. However she said this came and gone. She said she also took LIPITOR and stopped taking it for 3 days and the pain and itching stopped. She took the LIPITOR again this Sunday and today she had the itching and burning had come back. She called her cardiologist today and he advised her to discontinue the LIPITOR. She said she had been using LIPITOR for about a year, but switch to the generic version (atorvastatin Calcium) in 13-MAR-2012. Unspecified treatment was given for the adverse events. On 11-SEP-2012 echocardiogram was performed and the result was not reported. The patient was not pregnant. The outcome of the adverse events was unknown. Additional information is not expected.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information was received from a 83 year old male with cholesterol and a history of valve replacement and transient ischemia attack x 3 who on 06-SEP-2012 was vaccinated with ZOSTAVAX. Concomitant medications included lovastatin and PLAVIX. The patient stated he was told by nurse in the health care physician's office that he would be vaccinated with ZOSTAVAX and the flu vaccine when he came in. The patient reported on 06-SEP-2012, he was given one injection and billed for ZOSTAVAX and flu vaccine (unspecified). The patient reported he had read an article that vaccines should be given four weeks apart and was concerned regarding having been vaccinated with ZOSTAVAX and flu vaccine (unspecified) in one injection. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist via field representative regarding to few patients of unknown ages and genders. On an unspecified date, the patients were vaccinated with, 0.65 ml dose of ZOSTAVAX (route and lot number were not provided), injection. No other co-suspects were reported. No concomitant medications were reported. On an unknown date,  the patients developed cellulitis after got ZOSTAVAX. No rash was reported. Some of these patients visited their doctors because of their adverse event. No treatment information was reported. The patients outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site reaction, Livedo reticularis, Pallor
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates were vaccinated subcutaneously with a dose of M-M-R II, 0.5 mL (lot # not provided) in the anterior thigh region. The nurse reported that an unspecified number of unspecified patients had blanching of the skin and a marbling effect at injection site area after administration of M-M-R II. The nurse stated that she noted that the reaction went away in all patients after a few minutes. The relatedness for the events was unknown for M-M-R II. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 years old male patient. The patient was vaccinated with (Merck) VARIVAX (Lot# reported as H007704, dose/frequency, route and duration were unspecified) on an unknown date. Subsequently the patient experienced inflammation and swelling at the injection site on an unknown date. The location of where injection on the body was unspecified by the reporter. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 20.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 10 patients of unknown age. Approximately after 29-AUG-2012, 10 patients were vaccinated with doses of improperly stored MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2012, Lot number: 1003AA, expiry date: 28-JUN-2013). It was reported that MMR II was stored at 47 Fahrenheit for 13 hours on 29-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated with a dose of (Merck) VARIVAX (lot#, dose and route not reported) on 17-SEP-2012 instead of ZOSTAVAX. No concomitant medications were reported. There was no adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 59 years old male patient with gastrooesophageal reflux disease (GERD), asthma, high blood pressure, high cholesterol, diabetes and allergy to CYMBALTA and DEMEROL who on 06-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0422AE, Exp. Date: 27-MAR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included tramadol hydrochloride, ibuprofen, gabapentin, metoprolol, VENTOLIN, SPIRIVA, fluticasone propionate, ADVAIR, lisinopril (manufacturer unknown), gemfibrozil, oxycodone and omeprazole. The pharmacist reported that at some point after vaccination but before on 17-SEP-2012, the patient developed shingles on an unspecified area of the body. It was reported that on approximately 07-SEP-2012, the patient developed a rash on the chest that was 1/4 to half dollar size. By approximately 09-SEP-2012, there were circular rashes all over the chest and back. On an unspecified date, in September 2012, the patient was seen at general medicine at the hospital and was diagnosed with shingles with wild-type varicella-zoster virus. No treatment information was reported. At the time of the report, the patient had not recovered. The physician was confident that shingles from wild-type varicella-zoster virus was not a result from ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Rash, Skin discolouration, Urticaria
Clinical narrative: Information has been received from a physician concerning a 53 year old female patient, who on 19-APR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) 0.65 ml, SQ. Physician reported that in April 2012, after getting ZOSTAVAX (Merck), the patient experienced itchiness and swelling at the injection site. It was also reported that on 21-APR-2012, two days after getting the vaccination, the patient broke out in hives which spread from her waist her legs on both sides of her body. No treatment was given for the events. On an unspecified date, the hives, itchiness and swelling at the injection went away on its own without medical treatment. It was unknown if the patient sought medical attention. Follow up information has been received from the physician concerning the 53 year old female patient with a history of chicken pox and not known drug allergies, who on 19-APR-2012, was vaccinated into the right arm with a dose of ZOSTAVAX (Merck) (Lot # 671022/0745AA). Concomitant therapy included lisinopril (manufacturer unknown) and eye drops (unspecified). The physician reported that the patient stated that on 20-APR-2012 the patient developed a rash (also reported as "rash did not occur at the site of injection post-vaccination"). The patient al stated that on an unspecified date she notice bluish color lines across thigh area from knee up. The patient did not see MD for this. The patient did not have other discomfort. At the time of the report the outcome of the rash and bluish color lines across thigh area from knee up was unknown. The physician stated that the patient did not have recent exposure to the chicken pox or shingles. Additional information has been received from a registered nurse refers to a 53 year old female patient with none noted pre-existing allergies, birth defects and medical conditions who on 19-APR-2012 at 09:30 was vaccinated subcutaneously in left arm with a dose (number not none) of ZOSTAVAX (Merck) (Lot # 671022/0745AA). It was reported that the patient broken out in hives. The patient experienced itchiness at the injection site, she also stated there was swelling at the injection site. The patient also stated that on an unspecified date she notice bluish color lines across thigh area from knee up. The onset for mentioned adverse events was not reported. The patient did not see MD for this. The outcome was for all mentioned adverse events were not reported. Additional information is not expected.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a male who on 04-JUN-2011 was vaccinated with a second dose of VARIVAX (Merck) (Lot#664451/0693Y, route not reported) that expired on 15-MAY-2011. No adverse effects reported. Follow up information was received which reported that the 25 year old male patient on 04-JUN-2011 was vaccinated with the first dose (previously reported as second dose) of VARIVAX (Merck), intramuscular in the deltoid. It was reported that the patient did not seek medical attention. This is one of several reports received from the same source. Addition information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irrigation, Eye irritation
Clinical narrative: Information was received from a pharmacist who on 13Sep2012 while administering an injection of the ZOSTAVAX (vial 19400) (lot # 0562AE, expiration date 20Mar2013) to a patient, had gotten a few drops of the vaccine in her eyes. She immediately flushed her eyes with water. The pharmacist reported that she had a little bit of irritation but no other symptoms. No additional information was provided. No additional information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 years old male patient. The patient was vaccinated with (Merck) VARIVAX (Lot# reported as 0694AE, dose/frequency, route and duration were unspecified) on an unknown date. Subsequently the patient experienced inflammation and swelling at the injection site on an unknown date. The location of where injection on the body was unspecified by the reporter. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 65 years old female patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SC on approximately 15-SEP-2012, "2-3 days ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that after receiving the ZOSTAVAX in September 2012, the patient experienced extreme swelling in her entire arm and no feeling in her forearm. The patient went to the emergency room. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 60 years old male patient with allergy to CELEBREX who on 24-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot# 00172AE, exp date 18-APR-2013). No other co-suspects were reported. Concomitant medications included FLUTAZONE nasal spray, triazolam and etodolac. It was reported that the patient developed a rash following vaccination with ZOSTAVAX. The pharmacist reported that the rash started about 3 or 4 days following vaccination with ZOSTAVAX "approximately on 27-AUG-2012". The rash was described as on the abdomen, painful and about to blister when the pharmacist spoke with the patient. The patient did not have any treatment given. At the time of the reporting, the patient had not recovered. The patient contacted the pharmacist by phone. The relatedness for developed a rash on the abdomen, painful and about to blister following vaccination with ZOSTAVAX was unknown for ZOSTAVAX.  Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 years old female patient with drug allergy to penicillin. On about 25 days ago, approximately on 17-AUG-2012, the patient was vaccinated with ZOSTAVAX (lot# reported as 0364AE, exp 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. the Pharmacist reported that patient called the pharmacy and complained of rash around her bra strap on her trunk and burning sensation around rash after receiving ZOSTAVAX about 25 days ago. Patient noticed rash started appearing yesterday, 10-SEP-2012. There were no treatment and no laboratory information for the event. The patient had sought medical attention by spoke to the pharmacist. The outcome was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) in the left arm on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced redness, soreness and warmth at the injection site. After 2 days, the symptoms were improved and no treatment was required. The pharmacist stated that the patient did not receive any vaccination on 06-SEP-2012 other than ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Blood test normal, Pruritus generalised, Rash generalised, X-ray normal
Clinical narrative: Information was received from a 67 year old female consumer who was given PNEUMOVAX 23 (Merck), unknown dose and frequency, about two weeks ago (approximately 01SEP2012). Her relevant medical history included high blood pressure and she may have received the pneumococcal polysaccharide vaccine a few years ago, but was not sure. The patient's relevant concomitant medications included MYSOLINE, aspirin 81mg, atorvastatin, LYRICA, benazepril and an unknown antibiotic (unknown indications). Two weeks ago (approximately 01SEP2012), the patient experienced abdominal pain. Five days ago (approximately 09SEP2012), she broke out with a rash and itching on her face, arms,  ears and eyes. She had normal blood test and x-ray (not further specified) two weeks ago (approximately 01SEP2012). As of 14SEP2012, the outcome of the abdominal pain, rash and itching was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Headache, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Information has been received from a 69 year old female consumer regarding herself. Medical history included thyroid disorder and hypertension. Concomitant medication included thyroid pill (not further specified), hypertension pill (not further specified) and low dose aspirin 81mg. On 14MAR2012 the consumer received ZOSTAVAX in the right arm subcutaneously, to prevent shingles. The consumer stated she had pain at the sight of insertion, which was in the arm muscle. She states her pharmacist advised her the vaccine should be in the fatty part of the arm, not where it was given. She stated her right arm, where she go the vaccine, is still sore, it has extended into her neck and she is now having headaches since 12SEP2012. She also stated that she can not extend her right arm completely. She will follow-up with her physician. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to 2 or 3 patients who on an unknown date, were vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that in the past, on an unknown date, the patient had a slight rash at the injection site after receiving ZOSTAVAX. No treatment information was reported. The rash resolved soon afterwards on an unspecified date. It was unspecified if the patients sought medical attention. The relatedness for 2 or 3 patients had a slight rash at the injection site after receiving ZOSTAVAX was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information do distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) in approximately September 2009 "three years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that currently the patient had shingles. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 80 years old female patient who in 2008, was vaccinated subcutaneously with a 0.65 ml dose ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included SYNTHROID, LIPITOR, PLAVIX, TOPROL XL TABLETS, lisinopril (manufacturer unknown) and LEXAPRO. The physician reported that on 29-AUG-2012, the patient came to the office and was diagnosed with a case of shingles. Prednisone and VALTREX were given as a treatment for the experience. At the time of the report, the patient had not recovered.  The relatedness for patient was diagnosed with a case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm, Wheezing
Clinical narrative: Information has been received from a 70 year old female consumer with acid reflux who reported she received an injection of the ZOSTAVAX for "shingles" on 17Aug2012 and "right the next day she started to experience side effects, however, she is still experiencing a rashy and hot feeling on that arm. She mentioned she also started feeling a little wheezing. Concomitant medication included: omeprazole. The consumer refused to provide her health care professional information and mentioned that she will contact her health care professional." The patient did indicate that she had the vaccine administered at a pharmacy. It was reported the patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 20-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot # 672932/0599AE, expiration date 22-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that after received ZOSTAVAX, the patient had redness and a raised bump around the injection site. The patient did not receive treatment for the adverse event. The patient did not recover from the adverse events. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 14 years old patient. On 21-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # and dose not reported) instead of VARIVAX (Merck). No adverse event reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 62 years old male patient. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 672675/0068AE, expiration date 12-SEP-2013) SQ on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-SEP-2012, the patient went to emergency room and was diagnosed with Bell's palsy. The patient was told the Bell's palsy was caused by ZOSTAVAX. The patient was treated with unspecified treatment and was released; he was not hospitalized. The healthcare worker stated that the doctor did not think the Bell's palsy was caused by ZOSTAVAX. At the time of the report, the patient had recovered. Upon internal review Bell's palsy was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 years old patient. On 13-AUG-2007 the patient was vaccinated with dose 1 of (Merck) VARIVAX (lot#, route and dose not reported) and the 1st dose early of MMR II (lot#, route and dose not reported). the patient received the 2nd dose of (Merck) VARIVAX (lot#, route and dose not reported) on 02-JUN-2008 and the 2nd dose of MMR II (lot#, route and dose not reported) on 04-MAY-2011. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient developed bumps on both arms after receiving ZOSTAVAX. This was not a rash. No treatment information was reported. This resolved soon afterwards on an unspecified date. It was unspecified if the patient sought medical attention. The relatedness for patient developed bumps on both arms was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 64 year old female patient. The patient was vaccinated subcutaneously in unspecified arm with 0.65 ml ZOSTAVAX (lot number 672675/0068AE, expiration date 12-SEP-2013) on 27-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. Three days later, on approximately 30-AUG-2012 the patient experienced a "huge water blister the size of a lemon, at the injection site". The outcome of adverse event was reported as recovered. The patient called for office medical attention. Additional information has been requested. This is one of several reports received from the same source.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 66 years old female patient with hypertension, hyperlipidemia, allergy to doxycycline, tetracycline, LEVAQUIN and acetaminophen, PERCOCET and a history of deep vein thrombosis who on 07-NOV-2011, was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included gabapentin, furosemide (manufacturer unknown). ZYRTEC, atenolol, LOVENOX, meclizine, COUMADIN, lansoprazole, alprazolam, and doxepin hydrochloride. It was reported that in July 2012, the patient developed shingles. Acyclovir was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient was recovering, no longer had lesions. On 07-SEP-2012, the patient had an office visit because she continued to have pain. The relatedness for patient developed shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse, concerning two "college age" (unspecified) patients of unknown sex. The nurse reported that on unspecified dates "as children" the patients were vaccinated with the complete series of doses of Hep B (manufacturer unknown) (route and frequency were not reported) (lot # and expiration dates not reported). The nurse reported that in 2012, the patients underwent hepatitis B antibody titer tests and now the patients had a "non-immune" result on their hepatitis B antibody titer tests. The patient sought medical attention through office visit. At the time of the report the patients' outcomes were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles and unhappy with developing shingles after receipt of ZOSTAVAX. The patient sought medical attention via physician examination. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Culture, Pruritus
Clinical narrative: This spontaneous report refers to a 77 year old female consumer reporting on herself with skin lymphoma and drug allergy to MACRODANTIN. The patient was vaccinated with ZOSTAVAX on 01-AUG-2012 (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, spironolactone, ARIMIDEX, digoxin, CRESTOR, verapamil, warfarin, alprazolam, metronidazole and LAC LOTION. It was reported that on 03-AUG-2012, a large white pimple formed on the patient's chest that itched very bad after she received ZOSTAVAX. No treatment was given for the adverse events. On an unknown date, a sample of the pimple was taken for testing (results not provided). The patient sought medical attention, it was an office visit. The outcome of the large white pimple formed on the chest that itched very bad was reported as not recovered/not resolved. The relatedness for the large white pimple formed on the patient's chest that itched very bad was not reported for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Secondary transmission
Clinical narrative: Information has been received from a physician regarding to a female patient of unknown age. Patient's medical history was not provided. On an unknown date, the patient's husband was vaccinated with 0.65 ml one shot dose of ZOSTAVAX subcutaneous, (lot number was not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that he had a male patient, who received the ZOSTAVAX vaccine with no adverse reactions. The patient's wife presented herself with a mild rash, which was diagnosed as shingles. This happened about 2 weeks after the vaccine was given to her husband. The patient's outcome was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed Practical Nurse (L.P.N.) concerning a 54 year old female patient with diabetes mellitus and allergies to amitriptyline, antihistamine, codeine, iodine, promethazine and spironolactone. On 17SEP2012 the patient was vaccinated with 0.5 ml of PNEUMOVAX 23, intramuscularly (lot # 672370/1851AA; exp date 05AUG2013). Concomitant medications included sitagliptin phosphate (+) metformin hydrochloride (MSD), metoprolol albuterol, CELEXA and omega-3 marine triglycerides. The L.P.N. reported that the patient called the office after developing redness, soreness and warmth at the injection site on 17SEP2012 after receiving a dose of PNEUMOVAX 23. It was reported that the patient sought medical attention. She was treated with ice, TYLENOL and BENADRYL. At the time of the report the patient's outcome was recovering. Additional information is not expected. This is one of three reports from the same source.