chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chlamydial infection, Delivery, Live birth, Maternal exposure during pregnancy, Meconium in amniotic fluid
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with drug reactions/allergies to BACTRIM and penicillin and no pertinent medical history who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first dose of GARDASIL (lot# not reported), 0.5 mL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL (lot# 668262/0841AA, expired on 08-APR-2013), 0.5 mL. There was no concomitant medication. The nurse reported that the patient called the doctor office on 10-NOV-2011 stating she took a home pregnancy test and it was positive. The patient was seen at the office on 21-NOV-2011 and ultrasound performed on that day confirmed pregnancy at 5 weeks 6 days gestation. The patient's LMP was 13-SEP-2011 and estimated delivery date is 19-JUN-2012 (also reported as 17-JUL-2012). The nurse confirmed the patient was not experiencing any adverse effects. Follow up information has been received from the physician concerning the patient with no pertinent medical history, no pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths and with chlamydia infection, equivocal RPR and FTA Ab (negative) during pregnancy. Concomitant medications used during pregnancy included prenatal vitamins and TYLENOL. The physician reported that on 23-JUL-2012, at 40 weeks, the patient gave birth a normal baby boy with no congenital anomalies, complications or abnormalities, who weighed 6 pounds. Apgar score was 9/9. The physician reported that the patient did not have complications during pregnancy. During labor the patient experienced a placental abruption of 10%, light meconium and it was needed the use of forceps assisted vaginal delivery (FAVD). There was not diagnostic test during pregnancy. The baby's experience was capture in (MARRS # 1209USA009632). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test positive, Premature separation of placenta, Treponema test negative, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with drug reactions/allergies to BACTRIM and penicillin and no pertinent medical history who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first dose of GARDASIL (lot# not reported), 0.5 mL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL (lot# 668262/0841AA, expired on 08-APR-2013), 0.5 mL. There was no concomitant medication. The nurse reported that the patient called the doctor office on 10-NOV-2011 stating she took a home pregnancy test and it was positive. The patient was seen at the office on 21-NOV-2011 and ultrasound performed on that day confirmed pregnancy at 5 weeks 6 days gestation. The patient's LMP was 13-SEP-2011 and estimated delivery date is 19-JUN-2012 (also reported as 17-JUL-2012). The nurse confirmed the patient was not experiencing any adverse effects. Follow up information has been received from the physician concerning the patient with no pertinent medical history, no pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths and with chlamydia infection, equivocal RPR and FTA Ab (negative) during pregnancy. Concomitant medications used during pregnancy included prenatal vitamins and TYLENOL. The physician reported that on 23-JUL-2012, at 40 weeks, the patient gave birth a normal baby boy with no congenital anomalies, complications or abnormalities, who weighed 6 pounds. Apgar score was 9/9. The physician reported that the patient did not have complications during pregnancy. During labor the patient experienced a placental abruption of 10%, light meconium and it was needed the use of forceps assisted vaginal delivery (FAVD). There was not diagnostic test during pregnancy. The baby's experience was capture in (MARRS # 1209USA009632). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Foetal exposure during pregnancy, Forceps delivery, Meconium stain, Premature separation of placenta
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with drug reactions/allergies to BACTRIM and penicillin and no pertinent medical history who on 19-JUL-2011 was vaccinated intramuscularly on left deltoid with the first dose of GARDASIL (lot# not reported), 0.5 mL and on 03-OCT-2011 was vaccinated intramuscularly on left deltoid with the second dose of GARDASIL (lot# 668262/0841AA, expired on 08-APR-2013), 0.5 mL. There was no concomitant medication. The nurse reported that the patient called the doctor office on 10-NOV-2011 stating she took a home pregnancy test and it was positive. The patient was seen at the office on 21-NOV-2011 and ultrasound performed on that day confirmed pregnancy at 5 weeks 6 days gestation. The patient's LMP was 13-SEP-2011 and estimated delivery date is 19-JUN-2012 (also reported as 17-JUL-2012). The nurse confirmed the patient was not experiencing any adverse effects. Follow up information has been received from the physician concerning the patient with no pertinent medical history, no pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths and with chlamydia infection, equivocal RPR and FTA Ab (negative) during pregnancy. Concomitant medications used during pregnancy included prenatal vitamins and TYLENOL. The physician reported that on 23-JUL-2012, at 40 weeks, the patient gave birth a normal baby boy with no congenital anomalies, complications or abnormalities, who weighed 6 pounds. Apgar score was 9/9. The physician reported that the patient did not have complications during pregnancy. During labor the patient experienced a placental abruption of 10%, light meconium and it was needed the use of forceps assisted vaginal delivery (FAVD). There was not diagnostic test during pregnancy. The baby's experience was capture in (MARRS # 1209USA009632). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age who on 22-AUG-2007 and 12-JAN-2008 was vaccinated with GARDASIL (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient did not get the third dose yet. No adverse effect reported. The adverse event was not related to GARDASIL. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cyanosis, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old male patient with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a 0.5 ml third dose of GARDASIL (Lot # 0459AE, expiration date 13-DEC-2014) IM and with a dose of HAVRIX (Lot # AHAVB515AA) on an unspecified date. The physician reported that on 28-AUG-2012, the patient experienced blood pressure dropped, his lips turned blue and he vomited. The doctor had him lay down for 15 minutes and he recovered. The physician stated that the patient did not have any adverse event after the first 2 doses. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Laboratory test, Nasopharyngitis, Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer concerning her 5 years old male son who on 25-APR-2012 was vaccinated with MMR II (dose and lot number not reported). The patient's mother reported that by mistake was given another dose of MMR II on 18-AUG-2012. The intention was to have the child get the VARIVAX (Merck) vaccine that day. The mother was reporting that the child had been tested twice for autism and had had a cold and cough since getting the second vaccine. The mother did not want to continue to report and chose to answer no further questions. The patient sought medical attention. At the time of the report, the patient's outcome was unknown. The relatedness for the adverse events were unknown for MMR II. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (age, sex unknown). The patient was vaccinated with PNEUMOVAX 23 (lot # 669379/0453AA, expired date 03-AUG-2012) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients who were vaccinated with lot # (669579/0595AA) PNEUMOVAX23 on 19-SEP-2012 (expired date: 31-AUG-2012). On 19-SEP-2012 the expired lot of vaccine was inadvertently administered. The same lot was also administered on 14-SEP-2012 and on 18-SEP-2012. The pharmacist wanted to know if this dose was valid or if these patients needed to be revaccinated. The outcome for the event was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 65 year old female patient. On an unknown date approximately in September 2012, the patient was vaccinated with lot # (669579/0595AA), 0.5 ml PNEUMOVAX23 which expired on 30-AUG-2012. No concomitant medications were reported. No adverse event were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Pain, Polymerase chain reaction
Clinical narrative: This spontaneous report was received from a physician and pharmacist refers to a 69-year-old female patient. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain and a completed form was received on 10-SEP-2012. The patient's medical history included chickenpox and shingles. On 28-AUG-2012 (also reported as 31-AUG-2012) the patient was vaccinated with, 0.65 millilitre (ml) ZOSTAVAX lot number 0421AE (validation request sent), expiration date 21-MAR-2013 subcutaneously. Concomitant medications included VERAMYST, Methyltestosterone, cyanocobalamin (reported as B12) and ZANTAC. The pharmacist reported that on an unknown date in 2012 the patient developed painful shingles after receiving ZOSTAVAX. She developed rash under her arms, breasts, chest and back. Itching and blisters were associated with Herpes Zoster (event). Treatment was not given for the event. Medical attention was sought for the event, the patient called the pharmacist. On 07-SEP-2012 a nasal swab specimen was collected and was sent to the laboratory on 10-SEP-2012 for Varicella Zoster Virus (VZV) Strain Identification Polymerase Chain Reaction (PCR). Results were pending at the time of this report. The event did not resolve at the time of this report. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella virus test
Clinical narrative: This spontaneous report was received from a physician and pharmacist refers to a 69-year-old female patient. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain and a completed form was received on 10-SEP-2012. The patient's medical history included chickenpox and shingles. On 28-AUG-2012 (also reported as 31-AUG-2012) the patient was vaccinated with, 0.65 millilitre (ml) ZOSTAVAX lot number 0421AE (validation request sent), expiration date 21-MAR-2013 subcutaneously. Concomitant medications included VERAMYST, Methyltestosterone, cyanocobalamin (reported as B12) and ZANTAC. The pharmacist reported that on an unknown date in 2012 the patient developed painful shingles after receiving ZOSTAVAX. She developed rash under her arms, breasts, chest and back. Itching and blisters were associated with Herpes Zoster (event). Treatment was not given for the event. Medical attention was sought for the event, the patient called the pharmacist. On 07-SEP-2012 a nasal swab specimen was collected and was sent to the laboratory on 10-SEP-2012 for Varicella Zoster Virus (VZV) Strain Identification Polymerase Chain Reaction (PCR). Results were pending at the time of this report. The event did not resolve at the time of this report. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
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. The patient was vaccinated intramuscularly with lot # (669579/0595AA; exp date 30-AUG-2012), 0.5 ml dose of PNEUMOVAX 23 on 14-SEP-2012. The patient received the dose 14 days after it expired. The patient did not experience any adverse effects. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 years old male patient with allergy to penicillin and none pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) in "late 2011". No other co-suspects were reported. Concomitant medications included BENICAR and TOPROL XL tablets. In June 2012 ("3 months ago"), the patient experienced tingling sensation in the lumbar region of the back spine and insomnolence. The patient saw the pharmacist. Unknown treatment was given for the adverse events. The outcome of tingling sensation in the lumbar region of the back spine and insomnolence was reported as not recovered/not resolved. The relatedness for insomnolence and tingling sensation in the lumbar region of the back spine was unknown for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Oedema peripheral, Rash, Rash macular
Clinical narrative: This spontaneous report as received from a physician refers to a 11 years old boy with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated SQ with the first dose of 0.5 ml (Merck) VARIVAX (lot# not reported) years ago. The patient was vaccinated SQ with the second dose of 0.5 ml (Merck) VARIVAX (lot# not reported) on 13-SEP-2012. No concomitant medication was reported. On 13-SEP-2012 the patient returned to the practice, with a macular rash on the entire arm where the vaccine was administered. The physician reported that the patient's entire arm was also swollen, and that he was treating the patient for infection. The outcome of the adverse events was reported as not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-SEP-2012 the patient was vaccinated with an expired dose of 0.65 ml ZOSTAVAX (lot # 669260/0152AA; exp. 01-MAY-2012). It was unknown if the patient had sought medical attention. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Rash generalised, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 82 years old female patient, with none pertinent medical history and none reactions/allergies, who on 19-AUG-2012 (reported as "two days ago') was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). No other co-suspects were reported. Concomitant medications included TENORMIN, MIACALCIN, FOLVITE, NEURONTIN, vitamin D (unspecified), LIPITOR and MIRALAX. Following the vaccination the patient experienced redness, body rash, itching, burning and hot to touch. The patient sought medical attention by an office visit. No treatment was given. None lab diagnostics were performed. The outcome of patient was reported as not recovered/not resolved. The relatedness for redness, body rash, itching, burning and hot to touch was not reported for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated with first dose of VARIVAX (Merck) (lot number, route not reported) two years ago approximately in September 2010 and in the office "today" on 18-SEP-2012 for the second dose. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27 years old female patient. The patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 16-JUL-2012 and received a second 0.5 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 17-SEP-2012. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex. On 30-AUG-2012, the patient was vaccinated with a dose of VARIVAX (merck) (dose, route and frequency were not reported) (lot#: 0140AE; Expiration date:10-JAN-2012) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects 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: Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex. On 23-APR-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and frequency were not reported) (lot #: 670322/0608AA. Expiration date: 26-APR-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects 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: Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex. On 05-JUN-2012, the patient was vaccinated with a dose of VARIVAX (merck) (dose, route and frequency were not reported) (lot #: 1434AA; Expiration date: 13-SEP-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex, who on 26-JUN-2012, was vaccinated with a dose of VARIVAX (Merck) (dose, route and frequency were not reported) (lot #: 1434AA; Expiration date: 13-SEP-2013) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Licensed practical nurse (L.P.N.) concerning a patient of unknown age and sex. On 05-SEP-2012, the patient was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (dose, route and frequency were not reported) (lot# not reported), while patient was intended to received the second dose of VARIVAX (Merck). There were no adverse effects. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
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 IM with a dose of PNEUMOVAX 23 in 2010 (Lot # and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012, the patient received IM a dose of PNEUMOVAX 23 (Lot # and dose not reported). There were no known adverse effects. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 84 years old mother with hypertension and no drug reactions or allergies who approximately one year ago, in 2011, was vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not reported) at her unspecified primary care physician's office, following an initial dose of an unspecified pneumococcal vaccine about 26 years ago, in approximately 1986 (dose, route and lot number not reported). No other co-suspects were reported. Concomitant therapy included high blood pressure medication. The registered nurse reported that approximately one year ago, in 2011, she believed that PNEUMOVAX 23 was administered intradermally-like tuberculin skin test -as there was a bubble under the skin of her mother's arm. The registered nurse reported that the administration site was at the back of the arm, not in the deltoid muscle and that her mother's arm turned red and swelled, in almost total circumference, from elbow to shoulder. Ibuprofen and compresses were given as a treatment for the experience. No lab diagnostics studies were performed. The patient recovered on an unspecified date, it was reported that the swelling tool many weeks to subside. The relatedness for patient's arm turned red and swelled in almost total circumference, from elbow to shoulder and there was a bubble under the skin was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 27 year old female patient. On 05-SEP-2012, the patient was vaccinated with a dose of M-M-R II (Lot #: 1251AA; Expiration date: 01-AUG-2013) intramuscularly instead of subcutaneously. Pharmacist reported that when the patient received the M-M-R II, she reported that she experienced some stinging at the injection site on 05-SEP-2012 which quickly resolved. The patient did not seek medical attention. No treatment was given for the event. On the same date "05-SEP-2012", the patient had recovered from the stinging at the injection site. 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 doctor of pharmacy refers to a patient of unknown age who on 21-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot number 670547/0659AA) (dose and route not reported) that was expired. The vaccine expired on 04-AUG-2012. No symptoms were reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 46 years old female patient with no pertinent medical history and no drug reactions/allergies who nine years ago "in 2003" was vaccinated with the first dose of PNEUMOVAX23 (route and lot# not reported). On 13-SEP-2012, the patient received a booster IM in upper left arm 0.5 ml dose of PNEUMOVAX23 (lot# H013581, exp date: 03-MAR-2014). No other co-suspects were reported. There were no concomitant medications reported. It was reported that on 14-SEP-2012, the patient experienced redness and pain from the injection site to the elbow. The patient did not receive treatment and did not have lab diagnostics studies performed. At the time of the report, the patient had not recovered, the patient contacted the pharmacist. The relatedness for redness from the injection site to the elbow and pain from the injection to the elbow was unknown for PNEUMOVAX23. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX23 during the time period of 14-SEP-2012 thought 18-SEP-2012. The PNEUMOVAX23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PNC, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 60 years old female consumer reporting on herself with allergy to penicillin who on 18-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspect were reported. Concomitant vaccines administered on the same date included PREVNAR and unspecified flu vaccine (manufacturer unknown). The consumer reported that on 18-SEP-2012, after her vaccination she began to feel achy all over the from her hands to her legs and arms. ADVIL was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the consumer was recovering. The patient did not seek medical attention. The relatedness for the patient began to feel achy all over from her hands to her legs and arms was unknown for ZOSTAVAX. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus, Skin warm
Clinical narrative: This spontaneous report was received from an 80 years old female registered nurse reporting on herself with drug hypersensitivity to PERCOCET, ROXICET, PREMARIN tablets, medroxyprogesterone, VICODIN, lansoprazole, VIOXX (MARRS # 1209USA009591) and DEMEROL and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in September or October 2009. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that she developed mild case of shingles in March or April of 2010. The nurse reported that the shingles developed under her breast on the right side of her body and then traveled around her right side to her lower back. The shingles were described as few chicken pox like "blisters" that were itchy, red and warm to the touch. The nurse reported that about three weeks after the shingles developed it was resolved (date unspecified) the nurse reported that she went to the physician and he told her she had shingles. Health food was given as treatment for the event. The relatedness for mild shingles was not provided for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender, who on 24-AUG-2012 was vaccinated with a dose of ZOSTAVAX subcutaneously (dose not reported) (lot # 671022/0745AA) which expired on 18-AUG-2012. No known adverse effects. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 years old female patient with no drug reaction/allergies and no pertinent medical history, who on 20-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) (lot # 0423AE, Exp: 02-APR-2012 - in validation process). No other co-suspects were reported. Concomitant medications included montelukast sodium, ZESTRIL, multivitamin, CALTRATE and mometasone furoate. On 22-AUG-2012 the patient developed a rash on the opposite arm of where ZOSTAVAX was administered. The nurse described the area of the rash as "erythema, circular lesions". No treatment was given. The outcome of the events was reported as not recovered. No laboratory diagnostic studies were performed. The patient sought medical attention via office visit. The relatedness for ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a female consumer of unknown age, concerning herself. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route and frequency were not reported) (lot # and expiration date were unknown). On an unknown date the patient experienced "some side effects from it". At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on 18-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was getting a prescription for prednisone in the pharmacy on 19-SEP-2102 and was not in the pharmacy to provide information about the reason why this medication was prescribed. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from the patient's husband refers to his wife who was a 67 years old female patient. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# unspecified) on 05-SEP-2012, "two weeks ago". The reporter explained that his wife developed a red rash at the injection site after receiving ZOSTAVAX on 05-SEP-2012, "two weeks ago". The patient did not sought medical attention. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as recovering/resolving. Additional information is not expected.
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction/allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. The were not lab diagnostics tests. Treatment was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from registered nurse concerning a female patient, who on 03-AUG-2012 was vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number 0491AE). It was reported that, on 04-AUG-2012, the patient experienced injection site redness, injection site pain, application site tenderness and extensive swelling of vaccinated limb. This is one of several reports from the same reporter. The other linked reports include case # 1209USA008631, 1208USA002950 and 1209USA008633. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction/allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. The were not lab diagnostics tests. Treatment was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from registered nurse concerning a female patient, who on 03-AUG-2012 was vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number 0491AE). It was reported that, on 04-AUG-2012, the patient experienced injection site redness, injection site pain, application site tenderness and extensive swelling of vaccinated limb. This is one of several reports from the same reporter. The other linked reports include case # 1209USA008631, 1208USA002950 and 1209USA008633. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction/allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. The were not lab diagnostics tests. Treatment was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from registered nurse concerning a female patient, who on 03-AUG-2012 was vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number 0491AE). It was reported that, on 04-AUG-2012, the patient experienced injection site redness, injection site pain, application site tenderness and extensive swelling of vaccinated limb. This is one of several reports from the same reporter. The other linked reports include case # 1209USA008631, 1208USA002950 and 1209USA008633. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Apparent life threatening event, Computerised tomogram normal, Convulsion, Diet refusal, Electroencephalogram normal
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Laboratory test normal, Muscle rigidity, Posture abnormal, Staring
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Dyskinesia, Electroencephalogram normal, Hypotonia, Irritability, Staring
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Tremor
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Blood culture negative, Blood electrolytes normal, Blood test normal, Carnitine increased, Complex partial seizures
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Computerised tomogram normal, Convulsion, Diet refusal, Electroencephalogram normal, Loss of consciousness
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Metabolic function test abnormal, Muscle rigidity, Nuclear magnetic resonance imaging normal, Staring, Stereotypy
Clinical narrative: Initial report was received on 13 September 2012 from a health care professional. A four month-old male patient with a history of reflux had received on 08 September 2012 an intramuscular right thigh injection of PENTACEL, lot number C4274AA; an intramuscular left thigh injection of PREVNAR, Pfizer lot number F45135 and an oral dose of ROTARIX, GSK lot number A41FB289A and 24 hours later on 09 September 2012, the patient right arm pulled upwards and began shaking and had a blank stare. The episode lasted 20 to 30 seconds and then stopped for five to ten seconds. The patient had a total of four episodes each lasting 20 to 30 seconds. After the last episode the patient's right arm flopped down and the patient became very fussy. The patient was taken to the emergency room after the mother called 911. An EEG was normal but the patient was hospitalized for a 48 hour observation. No treatments were reported. The patient was discharged with an order for an MRI. On 13 September 2012, the patient was seen by a physician for follow-up and deficits were reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fibromyalgia, Pain
Clinical narrative: Following the shot came the typical aches & pains, but they didn't go away. Instead they got worse & worse until my body was wracked in pain. It was obviously the shot. I have not had a pain free day since & rheumatologist diagnosed me with fibromyalgia.
Age: 0.55
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Seizure episode.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLUX, MMRV
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Son had low grade fever (under 100).  Son had rash (bumps over trunk area).  Son was irritable.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever 102.2 orally , chills, shaking, headache, fatigue, sweating, thirst lasting approximately 12 hrs. Tx; 2 EX strength Tylenol, bed rest, sleep.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Thirst, Tremor
Clinical narrative: Fever 102.2 orally , chills, shaking, headache, fatigue, sweating, thirst lasting approximately 12 hrs. Tx; 2 EX strength Tylenol, bed rest, sleep.
Age: 1.01
Sex: F
Vaccine: DTAP, FLUX, MMR, VARCEL
Symptoms: Dyskinesia, Fall, Muscle spasms
Clinical narrative: At least 3 episodes of lower extremity spasms, one episode of spasmodic body movement resulting in falling over backwards from a sitting position. Afebrile at the time but was premedicated with Tylenol due to history of fevers after vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: High Fever 102.4 gave her 1 tsp of Motrin.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Patient complained of itching all over body. Patient denied trouble breathing and no hives present. Patient was given 50mg Diphenhydramine IM in left deltoid. Patient was observed for 30 minutes with regular vital signs. Epinephrine was by bedside in Ambulance Services where patient was being observed. 15 minutes post Benadryl, patient stated itching has gone away. Patient was told to call 911 if symptoms came back.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt developed redness and swelling in arm accompanied by pain.