chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 years old male patient without pertinent medical history and drug reaction/allergies. The patient was vaccinated with VARIVAX (lot #648550/0284P, expiration date 03-MAR-2006, dose and route not reported) on 24-SEP-2004 and 26-DEC-2008 (lot # 1397Y, expiration date October 2010). No other co-suspects were reported. No concomitant medications were reported. On 12-AUG-2012 the patient experienced shingles, unspecified antiviral medication was given as treatment for adverse event. At the time of the report the outcome of shingles is unknown. The patient sought medical attention via office visiting. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated 3 patients had already been back to the clinic and vaccinated with ZOSTAVAX. And this is one of the 3 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 62 years old female patient. The patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported) on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient called the pharmacy to report that she had developed a warm, hard lump at the site of injection, No treatment was prescribed. Whether sought medical attention not reported. The pharmacist suggested to the patient to call back if the symptoms persisted. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report has been received from the doctor's office manager refers to a 35 years old female patient. The patient was vaccinated with the three dose of 0.5 ml GARDASIL but since had been diagnosed with HPV. The vaccine had been administered by the patient's family doctor, whose name was unspecified. The patient sought unspecified medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number, dosage, route and injection site were not known) injection in 2010. No other co-suspects were reported. No concomitant medications were reported. In the year of 2010 the reporter informed that the patient used GARDASIL back in 2010 and the patient felt faint for one week after receiving the vaccine. The patient was recovered at the time of report. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 86 years old female patient with arthritis, cholesterolemia and hypothyroid. The patient was vaccinated subcutaneously in her left arm with 0.65 ml once ZOSTAVAX (lot number 0422AE, expiration date 27-MAR-2013) on 11-AUG-2012. No other co-suspects were reported. Concomitant medications included ADVIL, calcium supplement, simvastatin and "thyroid medication". On 12-AUG-2012 the patient experienced redness at the injection site. On 15-AUG-2012 the patient experienced "a baseball-sized area that is swollen, red and warm". The pharmacist stated that she did not see and vesicles in the area, and there did not seem to be a rash. While the pharmacist was providing the report the patient stated that she felt otherwise "OK". No treatment was given. The patient's physician prescribed ZOSTAVAX for the patient, and the patient had not notified her physician of this adverse experience. Varicella Zoster Virus Identification Progarm(VZVIP) faxed to physician. No treatment was given for adverse event. The outcome was not recovered. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # not reported) about a week before the time of reporting, on approximately 13-AUG-2012. It was reported that a couple of days later the patient got Zoster and developed shingles. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL (dose and lot # not reported) on 15-AUG-2011 and the second dose of GARDASIL on 16-AUG-2012. No adverse effect has been reported or observed. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age who on 25-APR-2012, was vaccinated with a dose of VARIVAX (Merck) (lot number 669557/1700Z, Exp. Date: 09-DEC-2012 (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 7 almost 8 year old female patient with amoxicillin allergy who in 2005 was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot # not reported) and in 2009 was vaccinated with the second dose (dose, route and lot # not reported) and on 24-APR-2012 was vaccinated subcutaneously with the third 0.5 ml dose (lot # 143AA is an invalid lot number for VARIVAX (Merck)). On 26-APR-2012 the patient experienced a rash. On 26-APR-2012 the patient was seen in the office for the rash. She was given erythromycin and over the counter ZYRTEC. At the time of report, the patient's outcome was unknown. Follow-up information has been received from other healthcare professional refers to a 7 years old (currently 8 year old) female patient (child). On 24-APR-2012 at 10:00 AM, the patient was vaccinated in right upper arm with the third dose of VARIVAX (Merck) lot number "143AA" (route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 24-APR-2012 (previously reported as on 26-APR-2012), the patient experienced rash on trunk, no fever, no malaise, no loss appetite or nausea, rash not painful. At the time of report, the outcome of "rash/rash on trunk/rash not painful" was unknown. The relatedness for the patient's event was not reported for VARIVAX (Merck). This is one of several reports from the same source. Additional information is not expected.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, VARCEL
Symptoms: Blister, Rash maculo-papular, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a other health professional refers to a 21 months old male patient with atopic dermatitis upper extremity, no adverse events following prior vaccination and no pre-existing allergies, birth defects or medical conditions who on 03-FEB-2012, was vaccinated with the first dose of VARIVAX (Merck) (lot number 671029/1065AA, Exp. Date: 05-JUL-2013) on his right thigh. Suspect therapy included third dose of PEDVAXHIB (lot number 1225AA), administered on right thigh. No other co-suspects were reported. Concomitant vaccines administered on 03-FEB-2012, included third dose of PEDIARIX (Lot AC21B315AA) on left thigh and first dose of HAVRIX (lot number AHAVB539CA) administered on left thigh. It was stated that on 17-JUN-2012, the patient noted to have developed maculopapular rash with fluid filled vesicles in crops on upper extremity face/abdomen, the patient was diagnosed with varicella (date unspecified). No treatment information was reported. The patient recovered after 3 weeks (date not provided). The relatedness for patient was diagnosed with varicella was unknown for VARIVAX (Merck). This is one of several reports from the same source. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hepatitis viral test negative, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning her coworker an "early 30s" female healthcare worker who on unspecified dates was vaccinated with two series of hepatitis B virus vaccine rHBsAg (Lot#, dose and route not reported). It was reported that the patient continued to test negative for blood titers. The patient was performed physician examination for medical attention. No adverse effect had been reported or observed. The patient was not given any treatment. Follow up information was received from a physician reporting that the female patient on an unknown dates received 2 doses of hepatitis b vaccine (manufacturer unknown) on schedule but did not received the third dose. In 2008 she received three doses on schedule of RECOMBIVAX HB and still had a negative hepatitis B titer. No adverse effects were reported. No treatment was given for the experience. Follow up information was received from a physician reporting that the 31 years old female medical assistant with diabetes mellitus and no illness at time of vaccination who on 25-NOV-2008, 23-DEC-2008 and 10-JUN-2009, was vaccinated on her left deltoid with the three doses of RECOMBIVAX HB (lot numbers 659669/0062X, Exp. Date: 16-AUG-2010, 1355X and 663282/0086Y, Exp. Date: 28-AUG-20119) respectively (doses and route not reported). It was reported that the patient had also two shots of hepatitis B vaccine (manufacturer unknown) in 2005 (she missed one dose) and she had not developed immunity to it. On 21-JUL-2011 a hepatitis B surface antigens were performed and < 0.1 was showed as a result and hepatitis panel was within normal limits. On 12-JUL-2012, a rechecked was performed and still negative. At the time of the report, the patient's outcome was unknown. The relatedness for patient received three doses on scheduled of hepatitis b vaccine and still has a negative hepatitis b titer was unknown for RECOMBIVAX HB. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated IM with dose 1, 0.5 ml GARDASIL (Lot number not reported) in July 2011. On 17-AUG-2012, the patient received IM, dose 2, 0.5 ml GARDASIL (Lot number not reported). No adverse effect was reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash macular, Rash papular, Rash pustular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 13 month old patient who on 16-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 669795/1381AA). The nurse mentioned that on 09-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow up information has been received from the registered nurse concerning the male patient with infantile seborrheic dermatitis and no illness at the time of vaccination. The patient's medical history included bronchiolitis. The patient was vaccinated subcutaneously in the left leg with lot # (669795/1381AA) of VARIVAX (Merck) on 16-MAR-2012 at 6pm. The nurse reported that the patient went to the clinic on 08-MAY-2012 with a rash. The patient returned on 09-MAY-2012 for rash follow up, with a rash described as "mild generalized macular, papulae, vesicles and pustules" and diagnosed with varicella. No treatment information was reported and there was no testing done. At the time of the report the outcome of patient had outbreaks of varicella was unknown. The relatedness for varicella was not provided for VARIVAX (Merck). A lot check has been initiated. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of 60 years old. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneously left arm, lot # not reported) on 18-AUG-2012 and had injection site reaction. Pharmacist stated the patient came into pharmacy today (20-AUG-2012), with hard, red, sore bump and rash at injection site of left arm. No other co-suspects were reported. No concomitant medications were reported. At the time of report the outcome was reported as not recovered/not resolved. The patient sought medical attention via coming into the pharmacy. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to herself a female patient of unknown age. The medical assistant reported that she received. GARDASIL herself in the past (Lot #, dose/frequency, route, date and duration were unspecified) and experienced pain at the injection site but it was "not severe" and she had recovered (date not provided). It was unspecified whether she had sought medical attention or not. No treatment information was reported. This is one of the several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later.  And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that 3 patients had already been back to the clinic and vaccinated with ZOSTAVAX. And this is one of the 3 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported) on 28-JUN-2012. On 28-JUN-2012, the patient was vaccinated again with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). No symptoms were reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report as received from a registered pharmacist refers to a 75 year old male patient who on 23-SEP-2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot number 665512/0144Z, Exp. Date: 21-APR-2011). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 18-JAN-2012, the patient developed a case of shingles. No treatment information was reported. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed a case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age who on 19-JUL-2012, was vaccinated with a dose of ZOSTAVAX that was expired (dose, route, lot number and expiration date not reported). No symptoms were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to an 82 years old female patient with a previous history if cancer approximately six years ago, who on 11-JUL-2012, was vaccinated subcutaneously on her right arm with a 0.65 ml dose of ZOSTAVAX (lot number 0364AE, Exp. Date 16-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacy stated that patient's daughter called to the pharmacy today, on 30-JUL-2012, to let him know that her mother had been seen by the physician and had shingles. The pharmacist stated that he did not know which physician the patient saw. No treatment information was reported. At the time of the report, the patient had not recovered, had shingles. The relatedness for patient had shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 65 years old consumer reporting on herself who in 2009, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that she had just in approximately 2012 gotten a case of shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The consumer sought medical attention by seeing an urologist. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician via field representative concerning a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unspecified date, the patient was vaccinated with, a 0.65 ml dose of ZOSTAVAX, subcutaneous, to prevent shingles as prophylaxis. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced an injection site reaction after got ZOSTAVAX. The injection site became red, swollen and painful more severely and than physician and patient thought it should be. No rash was reported. Treatment was not given for the adverse event. The patient recovered from the adverse event. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age who in 2011, was vaccinated with the first dose of GARDASIL and today, on 12-JUL-2012, received the second dose of GARDASIL (Doses, route and lot number not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 16-MAY-2012, was vaccinated with a dose of VARIVAX (lot number 669557/1700Z, Exp. Date: 12-SEP-2012) (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 81 years old female consumer reporting on herself, with allergy to penicillin, sulfa, iodine and most unspecified antibiotics and a history of by-pass surgery thirteen years ago, in approximately 1999 and a few transient ischemic attacks, who on 24-JUL-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included PLAVIX, clonidine, timolol (manufacturer unknown), LOVAZA and insulin. The consumer reported that on 28-JUL-2012, she experienced a rash after getting ZOSTAVAX. No treatment was given for the experience. Lab diagnostics studies performed included annual check-ups and cardiologist. At the time of the report, the consumer was recovering. The patient did not seek medical attention. The relatedness for patient experienced a rash was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who on 09-AUG-2012, was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number 670547/0659AA) that was expired. The vaccine expired on 04-AUG-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 years old female patient with diabetes, hypercholesterolaemia and hypothyroidism and penicillin allergy (rash). The patient was vaccinated with a dose, 0.65 ml ZOSTAVAX (lot # not reported) on 30-JUL-2012. Concomitant medications included insulin, SYNTHROID and statin (unspecified). The pharmacist stated that the patient who received a dose of ZOSTAVAX on 30-JUL-2012, returned to the pharmacist on 01-AUG-2012 to report that her arm was red, warm, and itchy. Pharmacist noted that a roughly 3 inch oval near the injection site was red and warm to the touch. Pharmacist reported that she called the patient on Friday, 03-AUG-2012 to follow up and that the patient reported that the area was painful and felt like there was a knot under the skin. Treatment for the adverse event included BENADRYL and ice. At the time of the report all the patient's events persisted. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from other health professional referring to a 13 years old male patient with asthma. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid on 22-DEC-2011 at 15:10. No other co-suspects were reported. Concomitant medications included HAVRIX (lot # AHAVB5348A, second dose administered in proximal right deltoid) and FLUZONE (lot # 441899, first dose administered in left deltoid). It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at temperature of 32 degrees F or less. No adverse reaction occurred. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 83 years old female patient. The patient was vaccinated with ZOSTAVAX on 03-AUG-2012. Pharmacist reporting that the patient, received a dose of ZOSTAVAX (lot # 0619AA) on 03-AUG-2012, that expired on 26-JUL-2012. At the time of the report the patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional and administering HCP refers to a 17 years old female patient with no preexisting allergies, birth defects or medical conditions. On 04-JAN-2012 at 15:14, the patient was vaccinated with lot # (670048/0963AA) dose 1 GARDASIL in her right deltoid, FLUMIST and HAVRIX. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 2.7
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 32 month old patient who on 09-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 666869/0469Z). The nurse mentioned that on 29-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. 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 physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that 3 patients had already been back to the clinic and vaccinated with ZOSTAVAX. And this is one of the 3 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a Doctor pharmacist refers to a female patient of unknown age who was vaccinated with an unspecified dose if ZOSTAVAX (dose, route and lot number not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 19-AUG-2012 the patient was itchy all over after receiving ZOSTAVAX. The pharmacist noted that the patient did not have hives. The patient was treated with BENADRYL. Patient called pharmacist. The outcome of "was itchy all over" af was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Please see attached. Five days after receiving ZOSTAVAX (shingles vaccine), I started with a headache above my right eye. I also had a tingling and itching sensation in the right side of my face. Upon waking up the next morning (day six), the right side of my nose and under my right eye was red and swollen. The gland in front of my right ear was painful. I immediately called my doctor and made an appointment for that afternoon. I was seen by his nurse practitioner, who confirmed my suspicion that I had contacted shingles. After conferring with dr, it was decided to prescribed Valacyclovir (VALTREX) 1 gm tablets (3 times daily for 7 days). By day seven, small blisters had formed on the side of my nose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Headache, Herpes zoster, Lymph node pain
Clinical narrative: Please see attached. Five days after receiving ZOSTAVAX (shingles vaccine), I started with a headache above my right eye. I also had a tingling and itching sensation in the right side of my face. Upon waking up the next morning (day six), the right side of my nose and under my right eye was red and swollen. The gland in front of my right ear was painful. I immediately called my doctor and made an appointment for that afternoon. I was seen by his nurse practitioner, who confirmed my suspicion that I had contacted shingles. After conferring with dr, it was decided to prescribed Valacyclovir (VALTREX) 1 gm tablets (3 times daily for 7 days). By day seven, small blisters had formed on the side of my nose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Swelling face
Clinical narrative: Please see attached. Five days after receiving ZOSTAVAX (shingles vaccine), I started with a headache above my right eye. I also had a tingling and itching sensation in the right side of my face. Upon waking up the next morning (day six), the right side of my nose and under my right eye was red and swollen. The gland in front of my right ear was painful. I immediately called my doctor and made an appointment for that afternoon. I was seen by his nurse practitioner, who confirmed my suspicion that I had contacted shingles. After conferring with dr, it was decided to prescribed Valacyclovir (VALTREX) 1 gm tablets (3 times daily for 7 days). By day seven, small blisters had formed on the side of my nose.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: PNEUMOVAX 23 given 8/16. 15 hrs post vaccine pt. developed swelling and pain throughout the (L) injection arm. Swelling is spreading throughout the arm w/ pain associated. Have advised pt. to take OTC BENADRYL and monitor and if swelling continues, see PCP.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: After giving pt her vaccine, I had her fill out a teen questionnaire & I noticed her face expressions changed. I asked her if she was okay? She mentioned her head hurt & she was feeling nausea. I gave pt water & had her lay down & took 2 sets of BP. Pt. waited x 20 minutes. Dr okayed for them to leave.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, hot to touch & redness at injection site, outside of what would be viewed as "normal". Pt. did not seek medical attention, but complained of "flu-like" symptoms.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Nausea
Clinical narrative: Patient experienced chest pains & nausea bad enough she thought she would have to go to ER. She called her primary doctor & was told we should have waited 28 days from her RECLAST inj that dr gave at office.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Tenderness, Vaccination complication
Clinical narrative: (L) arm, erythema, swelling, tender to touch. Local Rxn to vaccine.
Age: 56.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: 8/18/12 Swelling and pain in left arm. Patient went to see MD. Patient Dx cellulitis. Patient was given a rx for cephalexin 500mg on 8/18/12 - rx filled on 8/19/12.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus
Clinical narrative: Spot is very itchy. Unable to lay on the side.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Arthropod bite, Diarrhoea, Erythema, Full blood count, Local reaction
Clinical narrative: Local reaction - red, hot swollen, then developed diarrhea 8/17, insect bites - ultimately evaluated in ER 8/24.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Local reaction - red, hot swollen, then developed diarrhea 8/17, insect bites - ultimately evaluated in ER 8/24.
Age: 40.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Pain, Pruritus, Skin papilloma, Swelling
Clinical narrative: Itching, warmth, swelling, pain.
Sex: U
Vaccine: RV5
Symptoms: Intussusception, Kawasaki's disease
Clinical narrative: This spontaneous report as received from a physician (local reference #PHL/12/0048) refers to a patient of unknown age. On unknown date the patient was vaccinated with a dose of ROTATEQ (lot# and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced intussusception and Kawasaki-related disease post administration of ROTATEQ. No treatment information was reported. The outcome of intussusception and Kawasaki-related disease were not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blood test, Headache
Clinical narrative: Following vaccine on July 19th, starting having headaches on July 20th. Headaches kept getting worse went to see his P.C.P on July 24th 2012 ordered blood work. Take MOTRIN.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Blood test, Dyspnoea, Lumbar puncture
Clinical narrative: 5-10-12 - got shot. 5-16-12 - Hosp. ER. Weakness not walking, short of breath. Sore muscles.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Neurological examination
Clinical narrative: 5-10-12 - got shot. 5-16-12 - Hosp. ER. Weakness not walking, short of breath. Sore muscles.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Cardiac stress test abnormal, Echocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: This case was reported by a physician (also the subject's father) and described the occurrence of chest palpitations in a 19-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), HAVRIX. On 7 August 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route) and on 13 August 2012 the subject received 1st dose of HAVRIX (details unknown). On 19 August 2012, 6 days after vaccination with HAVRIX, 12 days after vaccination with BOOSTRIX, the subject experienced chest palpitations and less than a month after vaccination with HAVRIX and BOOSTRIX, the subject experienced premature atrial contraction. The subject developed the palpitations on 19 August 2012. The subject "has undergone test which revealed atrial premature contractions (APC) and will have a 24 hour Holter monitor and 2-D echo as well as blood tests". The physician considered the events were disabling. At the time of reporting the outcome of the events was unspecified.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Supraventricular extrasystoles
Clinical narrative: This case was reported by a physician (also the subject's father) and described the occurrence of chest palpitations in a 19-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), HAVRIX. On 7 August 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route) and on 13 August 2012 the subject received 1st dose of HAVRIX (details unknown). On 19 August 2012, 6 days after vaccination with HAVRIX, 12 days after vaccination with BOOSTRIX, the subject experienced chest palpitations and less than a month after vaccination with HAVRIX and BOOSTRIX, the subject experienced premature atrial contraction. The subject developed the palpitations on 19 August 2012. The subject "has undergone test which revealed atrial premature contractions (APC) and will have a 24 hour Holter monitor and 2-D echo as well as blood tests". The physician considered the events were disabling. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2012US016367, is an initial spontaneous report received from a pharmacist on 17 Aug 2012. This report refers to a female patient of unknown age. She was vaccinated with MENVEO (batch number: A11064, Expiry date: Dec 2013) 0.5 ml intramuscularly on an unknown date. The pharmacist reported that the patient experienced syncope episode sometime in 2012 (unspecified date) after receiving MENVEO. Event outcome, seriousness and causality were not reported.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2012US016366 is an initial spontaneous report received from a pharmacist on 17 Aug 2012. This case refers to a 23-year-old male patient. He was vaccinated with MenA component of MENVEO vaccine (batch number: A11064, expiration date: Dec 2013) reconstituted with sterile water, intramuscularly on 16 Aug 2012. The patient experienced fainting spell after receiving the MenA component of MENVEO vaccine reconstitute with sterile water. The pharmacist did not report how long the fainting spell lasted. The outcome was reported as unknown. No other information was reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Flushing, Immediate post-injection reaction, Pruritus, Vomiting
Clinical narrative: Within 5 min. of vaccine got vomiting, itching, flushing and trouble breathing - gave Epipen 13:53 and BENADRYL 25mg, ORAPRED 45mg, then second Epipen - 4:30 and then went to ER for observation.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Convulsion
Clinical narrative: The day after she recieved the vaccination, she had to be rushed to the hospital, had a major seizure that lasted several minutes. Never had a seizure before or after.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Swollen tongue
Clinical narrative: Client described her tongue as feeling swolen 10-15 minutes after receiving vaccine. Epinephrine and Benadryl administered, client transported to ER. Client was observed in ER for one hour, then sent home.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Keloid scar, Pruritus
Clinical narrative: I developed a keloid, which I thought it was going to be gone but it did not It was also very itchy for a while. I reported to my doctor and he prescribed steroids to lower the bump. It went down but still there it also itches occasionally after three years of the shot.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pyrexia, Swelling face
Clinical narrative: Significant arm swelling, facial swelling, V, 104 fever, body aches.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Fall
Clinical narrative: Client received immunizations and walked outside with father and younger brother to car.  Father realized that he forgot to turn his paperwork in to immunization clerical office and turned to go back into Health Department and at this time, client became light-headed and fell down.  Received minor abrasion to left side of upper cheek - no bleeding noted.  Father states client did not lose consciousness.  Client taken to Immunization waiting room to sit down until lightheadedness subsided which took approximately 10 minutes.  Client left Health Department with his father and brother.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Dizziness, Hypoaesthesia, Vision blurred
Clinical narrative: Client just had the HPV vaccine, and after 5 minutes approximately, she had a seizure of about 20 seconds. She was sweating, and had blurry eyes. She was sitted and Nurse was holding her. She complained of numbness in the left hand, the same arm where HPV was given. At 13:13 she complained again of dizziness.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: STARTED OUT LIKE A SUMMER COLD AND PROGRESSIVE FLU-LIKE SYMPTOMS.
Age: 47.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site scab, Injection site vesicles, Pain in extremity, Rash, Skin ulcer
Clinical narrative: Patient came for her 7 day follow up. She had a robust major reaction to the SPOX vaccine about 5 mm on size and the blister was around the center of the crust was about 2.5 mm in circunference and about 1.5 mm HT. It was determined to drain the blister by taking appropiate precautions. PT had a lot of pain on arm. 15 days later patient returned with a rash on chest and arms. Yesterday 27AUG12 she reported going to the ER still have the rash plus sore on mouth and ears. Prescribed with Prednisone at ER.
Age: 47.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Stomatitis
Clinical narrative: Patient came for her 7 day follow up. She had a robust major reaction to the SPOX vaccine about 5 mm on size and the blister was around the center of the crust was about 2.5 mm in circunference and about 1.5 mm HT. It was determined to drain the blister by taking appropiate precautions. PT had a lot of pain on arm. 15 days later patient returned with a rash on chest and arms. Yesterday 27AUG12 she reported going to the ER still have the rash plus sore on mouth and ears. Prescribed with Prednisone at ER.
Age: 47.0
Sex: F
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cellulitis, Fatigue, Headache, Injection site cellulitis, Injection site vesicles
Clinical narrative: Patient came for her 7 day follow up. She had a robust major reaction to the SPOX vaccine about 5 mm on size and the blister was around the center of the crust was about 2.5 mm in circunference and about 1.5 mm HT. It was determined to drain the blister by taking appropiate precautions. PT had a lot of pain on arm. 15 days later patient returned with a rash on chest and arms. Yesterday 27AUG12 she reported going to the ER still have the rash plus sore on mouth and ears. Prescribed with Prednisone at ER.