chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.02
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth, Rash macular
Clinical narrative: Legs became reddened, blotchy and black and bluish. Warm to touch. Pt recovered within 30 minute and leg went back to normal.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Cough, Decreased appetite, Fatigue, Fluid intake reduced
Clinical narrative: Mom states child was tired and irritable with T. 99 degree F evening of immun. This persisted until 10/5/13 when temp went to 102 degree F, then on 10/6/13 temp went to 103.2 degree F. Child had poor appetite and fluid intake throughout. Evening of 10.7/13 started eating and drinking. Had fever med at 9PM. 10/8/13. No fever. Appetite good. Some coughing now.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Mom states child was tired and irritable with T. 99 degree F evening of immun. This persisted until 10/5/13 when temp went to 102 degree F, then on 10/6/13 temp went to 103.2 degree F. Child had poor appetite and fluid intake throughout. Evening of 10.7/13 started eating and drinking. Had fever med at 9PM. 10/8/13. No fever. Appetite good. Some coughing now.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Crying hard intermittently for two days after vaccines.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Local swelling, Paraesthesia, Peripheral coldness, Skin discolouration
Clinical narrative: Hep B given L deltoid at approx 9:30A-drove to work-noticed L hand seemed swollen and purplish in color and L arm felt tingly. Ret' d to health dept at 12:15. L arm still feels tingling and cole- hand sl. swollen and darker color than R hand - had been keeping hand hanging at site. L hand elevated to chest level and normal color after 10 min. No swelling or redness at injection site. No systemic symptoms.
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARZOS
Symptoms: Erythema, Papule
Clinical narrative: Possible attenuated VZV rash noted approx 9/12/13, papulae's on erythremia base starting on chest - R arm pit and along back of R shoulder in some what ine or/dermatomal distribution.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood test, Herpes zoster, Insomnia, Rash
Clinical narrative: This spontaneous report as received from a 69 year old male patient with cholesterol abnormal, diabetes and no known drug reactions or allergies refers to himself. The patient's medical history included chicken pox as a boy. In approximately July 2013, "2 to 3 months ago", the patient was vaccinated with a dose of ZOSTAVAX for to prevent shingles. Concomitant medications included unspecified cholesterol and diabetes medication. On approximately 03-OCT-2013, about a week ago, the patient had shingles. It started with soreness on the right side of his abdomen, then a rash that spread to the navel area. He had sharp pain internally and externally and could not sleep for 4 days. Currently the pain was gone but he still had some rash and soreness. The patient sought medical attention by doctor visit. CALAMINE LOTION, unspecified psychotropic was given for the patient. Blood work was performed but the result was unknown. At the time of the report, the outcome of events was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer (the patient's mother) refers to a female non-pregnant patient of unknown age with no pertinent medical history and no drug reactions/allergies. On an unknown dates the patient was vaccinated with five doses of GARDASIL (lot number, doses and routes not reported). Concomitant therapies included ADDERALL tablets. (15mg, bid, manufacturer unknown). On an unknown date, after the fifth dose of GARDASIL, the patient was experiencing pain at the injection site. There was no treatment given for the event. Routine blood work was done (results not reported). The patient sought unspecified medical attention. The outcome of pain at the injection site was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with asthma, blood pressure abnormal, penicillin allergy, unspecified ACE inhibitors allergy. on 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H021941, expiration date: 11-JUL-2014, intramuscular, dose not reported). On the same date the patient was vaccinated concomitantly with a dose of FLUZONE (lot number, dose and route not reported) in the opposite arm than PNEUMOVAX23. Other concomitant therapies included PROAIR and SYNTHROID and unspecified blood pressure medication. On 24-SEP-2013, the patient experienced chills, swollen and arm area on her arm about 3 inches below the PNEUMOVAX23 injection site, fever, malaise and has been in bed since the injections due to not feeling well. No other lab diagnostic studies were performed. The patient called pharmacy. The outcome of swollen and warm area on her arm about 3 inches below the PNEUMOVAX23, injection site, fever, chills, malaise and has been in bed since the injections due to not feeling well, was reported as recovering/resolving. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with asthma, blood pressure abnormal, penicillin allergy, unspecified ACE inhibitors allergy. on 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H021941, expiration date: 11-JUL-2014, intramuscular, dose not reported). On the same date the patient was vaccinated concomitantly with a dose of FLUZONE (lot number, dose and route not reported) in the opposite arm than PNEUMOVAX23. Other concomitant therapies included PROAIR and SYNTHROID and unspecified blood pressure medication. On 24-SEP-2013, the patient experienced chills, swollen and arm area on her arm about 3 inches below the PNEUMOVAX23 injection site, fever, malaise and has been in bed since the injections due to not feeling well. No other lab diagnostic studies were performed. The patient called pharmacy. The outcome of swollen and warm area on her arm about 3 inches below the PNEUMOVAX23, injection site, fever, chills, malaise and has been in bed since the injections due to not feeling well, was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown age and gender. On an unknown date the patients might have been vaccinated with a dose of PNEUMOVAX23 (lot number, dose and route not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source (related MARRS # 1310USA000403). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect storage of drug, Mobility decreased
Clinical narrative: This spontaneous report as received from a physician and unspecified specialist refers to a 72 year old female patient of unknown age with dyslipidemia, arthritis, acid reflux, tetracycline and neomycin allergy and latex allergy. on 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H014653, expiration date: 19-APR-2014, reported as 10-APR-2014, 0.5 ml, intramuscular) that was improperly stored (post non-supported excursion). Concomitant therapies included baby aspirin (manufacturer unknown), calcium (unspecified) CHONDROITIN SULFATE SODIUM (+) GLUCOSAMINE SULFATE, omeprazole (manufacturer unknown), simvastatin (manufacturer unknown) and trazodone hydrochloride. On an unspecified date in approximately September 2013 the patient couldn't hardly move her unspecified arm after vaccination. The outcome of couldn't hardly move her unspecified arm was unknown. No lab diagnostic tests were performed. This is one of several reports received from the same source (related MARRS#: 1310USA006418). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, via a company representative, refers to an unspecified number of patients of unknown age and gender. The company representative learned from medical assistant that most healthcare professionals routinely administer PNEUMOVAX23 to their patients every 5 years, resulting in patients receiving more than 2 doses of PNEUMOVAX23. Dosing information, route of administration and lot numbers were not provided. No adverse effects were reported. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with sulfa allergy. On 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot number and expiration date not reported). In September 2013 the patient had developed an injection site reaction. The affected area was red, hot and swollen. The patient sought medical attention -called pharmacist. The outcome of injection site reaction, affected area was red, hot and swollen was reported as not recovered/not resolved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as rreceived from a 81 year old female patient with allergies refers to herself. On 25-SEP-2006 the patient was vaccinated with ZOSTAVAX injection for shingles prevention. On 02-OCT-2009, the patient developed shiingles in her genital area. The patient recovered 6 weeks later (13-NOV-2009) after receiving the shingles on 02-OCT-2009. The physician in the physician AE drop down field was not the one who gave the patient the ZOSTAVAX vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 12-SEP-2013, was vaccinated with a dose of VARIVAX (Lot No. H007608, exp. 29-MAR-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 06-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J003483, exp. 29-JUN-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a Licensed Practical Nurse via sales representative regarding an unspecified number of patients of unknown age. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not provided). On an unknown date, the patients developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a 68 years old female consumer, with emphysema and an unspecified allergy, reporting on herself. Consumer noted that she had previously been under the care of a chiropractor for pain unrelated to this event. On 20-AUG-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) injection in the left arm for prevention of shingles. Concomitant medications included unspecified allergy to medications. About three days after receiving ZOSTAVAX vaccine, on approximately 23-AUG-2013, the patient developed a headache which intensified over the following days. This headache was accompanied by overall pain along the patient's right side (torso). The pain was not accompanied by any rash and continued through time of the report. For one week following administration of the vaccine, since approximately 20-AUG-2013, the patient also experienced significant injection site pain and swelling, which has improved. The relationship between ZOSTAVAX and the events was not reported. Patient was treated with two tramadol hydrochloride, 50 mg tablets, every six hours. Patient sought medical attention: two appointments. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient had no pertinent medical history  or drug reactions/allergies. On 26-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J000434, expiration date: 10-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications. The pharmacist reported that on an unspecified date in September 2013, after patient was administered ZOSTAVAX, the patient developed swelling and warmth in an area with a circumference of about 3 to 4 inches around the injection site. The pharmacist stated that the patient spoke to an unspecified nurse that told her to ice the injection site periodically, however, the pharmacist was unsure if the patient had begun to ice the injection site. The outcome of swelling and warmth in an area around the injection site was not reported. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Patient sought medical attention. Called physician. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 41 year old female patient (also reported as: in her late 40's). The patient's medical history included shingles. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (Subcutaneous, 0.65 ml, single dose, lot# J003808 exp 03-JUL-2014). The pharmacist reported a patient in her "late forties" received ZOSTAVAX based on past history of shingles. No adverse effects reports. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a 70 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 24-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# J000443, expiration date: 11-APR-2014) 0.65 ml, subcutaneous. There were no concomitant medications. On 28-SEP-2013, the patient experienced shingles on her face. The outcome of  shingles on her face was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the singles on her face was not reported. No lab diagnostics studies were performed. Patient sought medical attention: office visit on 30-SEP-2013. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 16-JUL-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot number and thimerosal status were not reported), and on 01-OCT-2013 the patient was vaccinated with the second dose of RECOMBIVAX HB inj 10 (dose, route, lot number and thimerosal status were not reported). No adverse symptoms reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Narcolepsy
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Medical assistant reported that the patient had received two doses of GARDASIL and, on an unknown date, had a diagnosis of Narcolepsy. She reported that she was not sure whether the patient suffered from narcolepsy before the GARDASIL series started. The nurse reported that the mother wanted to hold the third dose, until safety information could be obtained about GARDASIL use in narcoleptic patient, so the patient had not yet completed the series. The outcome of narcolepsy was reported as not recovered/not resolved. The relationship between GARDASIL and the narcolepsy was not reported. Patient sought medical attention. Had an office visit. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to 4 months old patient (gender not reported). Nurse reported that an expired dose of ROTATEQ lot# 0210AE (exp. date 29-SEP-2013) (route and dose not reported). went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several report from the same source (MARRS# 1310USA004161, 1310USA006562). Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an approximately 2 months old patient (reported as 2 months and 10 days, gender not reported). Nurse reported that an expired dose of ROTATEQ lot #0210AE (exp. date 29-SEP-2013) (route and dose not reported) went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several reports from the same source (MARRS # 1310USA006562, 1310USA006563). Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to 6 month old patient (gender not reported). Nurse reported that an expired dose of ROTATEQ lot # 0210AE (exp. date 29-SEP-2013) (route and dose not reported) went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several reports from the same source (MARRS # 1310USA004161, 1310USA006563). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Arthralgia, Blister, Full blood count normal, Injected limb mobility decreased, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient with amoxicillin (oral) allergy (body hives). No pertinent medical history was reported. On 06-AUG-2013 the patient was vaccinated with PROQUAD injection, (subcutaneous, 0.5 ml, in the left arm, dose number and lot number unknown). Other suspect therapies included IPV (Sanofi) in her left leg and DTAP (GlaxoSmithKline) in her left thigh. No concomitant medications were reported. On 22-AUG-2013 the patient sought medical attention at an unspecified emergency room for a sore left knee and a maculopapular rash with bullae down both legs. The results of Complete Blood Count (CBC), erythrocyte sedimentation rate (ESR and antistreptolysin-0 test (ASO) titer drawn on 22-AUG-2013 were normal. The patient was treated with a short course of oral steroids (manufacturer unspecified) begun on an unspecified date. Patient was treated and released from emergency room and not admitted. On 23-AUG-2013 the patient was seen at Physician's office for a follow up visit. The physician reported that the rash had improved and the patient's range of motion for left knee had improved. On 28-AUG-2013 the patient sought medical attention again at an unspecified emergency room for left hip pain. Patient was released from emergency room and not admitted to the hospital. No treatment was reported for left hip pain. Physician reported that left hip pain improved and rash had resolved on an unspecified date within 36 hours of emergency room visit on 28-AUG-2013. No further information was reported. The patient was reported as recovered from the events on 30-AUG-2013. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash, Rash maculo-papular, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient with amoxicillin (oral) allergy (body hives). No pertinent medical history was reported. On 06-AUG-2013 the patient was vaccinated with PROQUAD injection, (subcutaneous, 0.5 ml, in the left arm, dose number and lot number unknown). Other suspect therapies included IPV (Sanofi) in her left leg and DTAP (GlaxoSmithKline) in her left thigh. No concomitant medications were reported. On 22-AUG-2013 the patient sought medical attention at an unspecified emergency room for a sore left knee and a maculopapular rash with bullae down both legs. The results of Complete Blood Count (CBC), erythrocyte sedimentation rate (ESR and antistreptolysin-0 test (ASO) titer drawn on 22-AUG-2013 were normal. The patient was treated with a short course of oral steroids (manufacturer unspecified) begun on an unspecified date. Patient was treated and released from emergency room and not admitted. On 23-AUG-2013 the patient was seen at Physician's office for a follow up visit. The physician reported that the rash had improved and the patient's range of motion for left knee had improved. On 28-AUG-2013 the patient sought medical attention again at an unspecified emergency room for left hip pain. Patient was released from emergency room and not admitted to the hospital. No treatment was reported for left hip pain. Physician reported that left hip pain improved and rash had resolved on an unspecified date within 36 hours of emergency room visit on 28-AUG-2013. No further information was reported. The patient was reported as recovered from the events on 30-AUG-2013. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 13-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot# 0087AE, expiration date 18-AUG-2013) 0.5 ml, intramuscular. The patient received a dose of expired dose PNEUMOVAX23. No adverse effects were reported. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: HIBV, MMR, MMRV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 01-OCT-2013, the patient was vaccinated (route not provided) with M-M-R II (lot number and expiry date not provided). Other suspect therapies included PROQUAD (Merck), PREVNAR 13 and PEDVAXHIB on 01-OCT-2013, 1 day after onset of therapy the child was administered PROQUAD and M-M-R II. The outcome of child was administered PROQUAD and M-M-R II was unknown. The action taken was M-M-R II was not provided. Additional information has been requested.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: This spontaneous report as received from a physician refers to a 91 year old male patient with dementia and no drug reactions or allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, site and route of administration not reported). No concomitant therapies reported. On 20-AUG-2013 the patient was seen by the physician for a rash which a dose of had developed, which was diagnosed as pemphigoid vulgaris. No lab diagnostics performed. The patient was treated with prednisone (manufacturer unknown). The outcome of pemphigoid vulgaris was unknown. The relatedness between ZOSTAVAX and adverse event was not reported. The patient sought medical attention via office visit. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. It was possibly a senior patient. Relevant medical history and concomitant medication were not provided. On an unknown date the patient developed pain in the shoulder that received the vaccine. The pain lasted for 5 days and was said to be very severe to the point that the patient was unable to lift the arm. The patient was recommended to use a cold compress. The outcome of developed pain in the shoulder that received the vaccine was reported as recovered/resolved on an unknown date. The reporter causality was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 13-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J004266, exp. 12-JUL-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician refers to a 84 year old patient. On unknown date the patient was vaccinated with ZOSTAVAX (dose, route unknown). On unknown date, the patient experienced zoster-like rash at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Swelling
Clinical narrative: Rash and itching at site. Slight swelling.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via a company representative refers to a 1 year old patient. On 10-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) lot# H019521 (Lot # in validation) expiry date 24-OCT-2014. The Nurse Practitioner reported that the patient experienced a rash after the administration of VARVIAX (Merck) on 10-SEP-2013 and the patients parents called to the Nurse Practitioner on 17-SEP-2013 to report a rash on the patient's trunk (onset date; 17-SEP-2013). The patient's parents report that there was only a rash but no vesicles. The nurse practitioner had scheduled the patient to go to the office at the time of reporting (19-SEP-2013) to be evaluated. The patient sought medical attention. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. Nurse practitioner reported that on an unknown date, an unspecified number of patients may have received ROTATEQ exposed to 55F for 2 months, which has been found to be an unsupported excursion using in-house stability data. Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 year old (approximately) female patient with asthma and drug allergy to NUBAIN. The patient was administered a 3 doses series of RECOMBIVAX HB on an unspecified date as a child (dose, route, and lot number were not reported). Concomitant therapies included SINGULAIR, ADVAIR, and albuterol. The nurse was reported that the patient was then administered does of RECOMBIVAX HB on 01-APR-1993, 17-MAY-1993, 02-NOV-1993, 15-SEP-2010, 09-DEC-2010 and 11-APR-2011 (dose, route and lot number were not reported. The nurse was also reported that a hospital employee had failed to seroconvert after receiving nine doses of RECOMBIVAX HB. It was reported that the Hepatitis B antibody test was negative. The patient received unspecified treatment for the adverse event. The patient's present status was reported as other negative antibody titers. The patient sought medical attention by office visit. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse events was unknown for RECOMBIVAX HB. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Pyrexia
Clinical narrative: Feverish, chills, could not warm up. She also had a red 2" x 1" mark at the injection site one week after injection. The symptoms started 1-2 days after injection and still continuing 1 week later. 100 - 101 degrees F fever.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up information was received from   a pharmacist concerning a patient (age and gender not reported) who on 20-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J004266, exp. 12-JUL-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash - Diphenhydramine HCL 12.5 mg/5mL 1 teaspoon PO every 6 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 18-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J004266, exp. 12-JUL-2014) (dose and route not reported) which was exposed to 26F for 480  hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. 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 registered nurse refers to a patient of unknown age and gender. Nurse reported that, on 12-SEP-2013, the patient received the second dose of GARDASIL (dose, lot number and route were not reported) late. Nurse reported that the first dose of GARDASIL (dose, lot number and route were not reported) was given on 08-SEP-2011. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 100, very sore arm, headache, nausea. Rt deltoid.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Day after immunization, was painful, redness, warm to touch. Increased redness and temperature migrating down arm over next several days. APAP helped somewhat, but still some pain 5 days later.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Neck pain, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 72 year old male patient. Medical history and drug allergies/reactions were not reported. On 07-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 09-MAR-2013, the patient experienced painful, zoster-like rash on his neck. The patient sought for medical attention (office visit). The physician scraped the lesion but the results were not provided. The outcome of painful, zoster-like rash was not reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Culture, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 72 year old male patient. Medical history and drug allergies/reactions were not reported. On 07-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 09-MAR-2013, the patient experienced painful, zoster-like rash on his neck. The patient sought for medical attention (office visit). The physician scraped the lesion but the results were not provided. The outcome of painful, zoster-like rash was not reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 72 year old male patient. Medical history and drug allergies/reactions were not reported. On 07-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 09-MAR-2013, the patient experienced painful, zoster-like rash on his neck. The patient sought for medical attention (office visit). The physician scraped the lesion but the results were not provided. The outcome of painful, zoster-like rash was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Headache, Hypoaesthesia, Musculoskeletal pain, Oedema
Clinical narrative: This non-medically confirmed report (initial receipt 20-Aug-2013) concerns a 53 year old female patient. The patient had a medical history of asthma and diabetes. The patient had no allergies to medications, food or vaccines. She was not feeling sick on the day of vaccination. She had not received any vaccinations or skin test in the past four weeks and had not ever had a serious reaction to an influenza vaccine or any other vaccination the past. She had never had a seizure disorder, brain disorder, Guillain Barre Syndrome or other nervous system problem. The patient was a non-smoker. The patient had previously had a pneumonia vaccination. On 15 Apr 2013, the patient was administered two vaccines - intramuscular AFLURIA (batch number: 08149211A) at a dose of 0.5 ml in the right deltoid and PNEUMOVAX (Batch number: H015749), also administered in the right arm. Both vaccines were injected simultaneously on the same arm (right arm) which was an incorrect determination as they should not have been injected on the same arm. On an unspecified date after vaccination, the patient developed strong discomfort on her right side, swelling on her arm and strong pain on her shoulder, chest and head and the pain reached to the fingers of her right hand. The patient developed severe side effects which included inflammation, severe pain in shoulder, chest and headache. The pain radiated to her fingers and the patient was referred to a 'physiatrist'. Days after, her arm conditions worsened as her arm turned red all over and also got swelled. On 17-Apr-2013, the patient was attended by pharmacist who indicated that the administration of both vaccines on the same arm was not "an appropriate one". The patient went to the physician. She was prescribed ciprofloxacin 500 mg and nabumetone 750 mg. The patient was recommended to rest from 18 Apr 2013 to 23 Apr-2013, during which the patient was absent from her job. The patient was re-evaluated on 22 Apr 2013 by the physician and was authorized to return to work on 23 Apr 2013 and was continued on her medications. Once back at her job, the patient started to feel discomfort when she tried to grab using her thumb, index and middle hand fingers and this discomfort continued intermittently. On 1 Jun 2013, the patient was examined by the physician and referred to a physiotherapist for evaluation. She was diagnosed with 'right radial nerve palsy'. Outcome of the events were unknown. Follow-up (01-Oct-2013): upgraded to serious, country changed, medical history, patient details, details of suspect drug, new events, company causality updated to 'possible', clinical course, treatment.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: This non-medically confirmed report (initial receipt 20-Aug-2013) concerns a 53 year old female patient. The patient had a medical history of asthma and diabetes. The patient had no allergies to medications, food or vaccines. She was not feeling sick on the day of vaccination. She had not received any vaccinations or skin test in the past four weeks and had not ever had a serious reaction to an influenza vaccine or any other vaccination the past. She had never had a seizure disorder, brain disorder, Guillain Barre Syndrome or other nervous system problem. The patient was a non-smoker. The patient had previously had a pneumonia vaccination. On 15 Apr 2013, the patient was administered two vaccines - intramuscular AFLURIA (batch number: 08149211A) at a dose of 0.5 ml in the right deltoid and PNEUMOVAX (Batch number: H015749), also administered in the right arm. Both vaccines were injected simultaneously on the same arm (right arm) which was an incorrect determination as they should not have been injected on the same arm. On an unspecified date after vaccination, the patient developed strong discomfort on her right side, swelling on her arm and strong pain on her shoulder, chest and head and the pain reached to the fingers of her right hand. The patient developed severe side effects which included inflammation, severe pain in shoulder, chest and headache. The pain radiated to her fingers and the patient was referred to a 'physiatrist'. Days after, her arm conditions worsened as her arm turned red all over and also got swelled. On 17-Apr-2013, the patient was attended by pharmacist who indicated that the administration of both vaccines on the same arm was not "an appropriate one". The patient went to the physician. She was prescribed ciprofloxacin 500 mg and nabumetone 750 mg. The patient was recommended to rest from 18 Apr 2013 to 23 Apr-2013, during which the patient was absent from her job. The patient was re-evaluated on 22 Apr 2013 by the physician and was authorized to return to work on 23 Apr 2013 and was continued on her medications. Once back at her job, the patient started to feel discomfort when she tried to grab using her thumb, index and middle hand fingers and this discomfort continued intermittently. On 1 Jun 2013, the patient was examined by the physician and referred to a physiotherapist for evaluation. She was diagnosed with 'right radial nerve palsy'. Outcome of the events were unknown. Follow-up (01-Oct-2013): upgraded to serious, country changed, medical history, patient details, details of suspect drug, new events, company causality updated to 'possible', clinical course, treatment.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chest pain, Discomfort, Erythema, Headache, Inflammation
Clinical narrative: This non-medically confirmed report (initial receipt 20-Aug-2013) concerns a 53 year old female patient. The patient had a medical history of asthma and diabetes. The patient had no allergies to medications, food or vaccines. She was not feeling sick on the day of vaccination. She had not received any vaccinations or skin test in the past four weeks and had not ever had a serious reaction to an influenza vaccine or any other vaccination the past. She had never had a seizure disorder, brain disorder, Guillain Barre Syndrome or other nervous system problem. The patient was a non-smoker. The patient had previously had a pneumonia vaccination. On 15 Apr 2013, the patient was administered two vaccines - intramuscular AFLURIA (batch number: 08149211A) at a dose of 0.5 ml in the right deltoid and PNEUMOVAX (Batch number: H015749), also administered in the right arm. Both vaccines were injected simultaneously on the same arm (right arm) which was an incorrect determination as they should not have been injected on the same arm. On an unspecified date after vaccination, the patient developed strong discomfort on her right side, swelling on her arm and strong pain on her shoulder, chest and head and the pain reached to the fingers of her right hand. The patient developed severe side effects which included inflammation, severe pain in shoulder, chest and headache. The pain radiated to her fingers and the patient was referred to a 'physiatrist'. Days after, her arm conditions worsened as her arm turned red all over and also got swelled. On 17-Apr-2013, the patient was attended by pharmacist who indicated that the administration of both vaccines on the same arm was not "an appropriate one". The patient went to the physician. She was prescribed ciprofloxacin 500 mg and nabumetone 750 mg. The patient was recommended to rest from 18 Apr 2013 to 23 Apr-2013, during which the patient was absent from her job. The patient was re-evaluated on 22 Apr 2013 by the physician and was authorized to return to work on 23 Apr 2013 and was continued on her medications. Once back at her job, the patient started to feel discomfort when she tried to grab using her thumb, index and middle hand fingers and this discomfort continued intermittently. On 1 Jun 2013, the patient was examined by the physician and referred to a physiotherapist for evaluation. She was diagnosed with 'right radial nerve palsy'. Outcome of the events were unknown. Follow-up (01-Oct-2013): upgraded to serious, country changed, medical history, patient details, details of suspect drug, new events, company causality updated to 'possible', clinical course, treatment.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: This non-medically confirmed report (initial receipt 20-Aug-2013) concerns a 53 year old female patient. The patient had a medical history of asthma and diabetes. The patient had no allergies to medications, food or vaccines. She was not feeling sick on the day of vaccination. She had not received any vaccinations or skin test in the past four weeks and had not ever had a serious reaction to an influenza vaccine or any other vaccination the past. She had never had a seizure disorder, brain disorder, Guillain Barre Syndrome or other nervous system problem. The patient was a non-smoker. The patient had previously had a pneumonia vaccination. On 15 Apr 2013, the patient was administered two vaccines - intramuscular AFLURIA (batch number: 08149211A) at a dose of 0.5 ml in the right deltoid and PNEUMOVAX (Batch number: H015749), also administered in the right arm. Both vaccines were injected simultaneously on the same arm (right arm) which was an incorrect determination as they should not have been injected on the same arm. On an unspecified date after vaccination, the patient developed strong discomfort on her right side, swelling on her arm and strong pain on her shoulder, chest and head and the pain reached to the fingers of her right hand. The patient developed severe side effects which included inflammation, severe pain in shoulder, chest and headache. The pain radiated to her fingers and the patient was referred to a 'physiatrist'. Days after, her arm conditions worsened as her arm turned red all over and also got swelled. On 17-Apr-2013, the patient was attended by pharmacist who indicated that the administration of both vaccines on the same arm was not "an appropriate one". The patient went to the physician. She was prescribed ciprofloxacin 500 mg and nabumetone 750 mg. The patient was recommended to rest from 18 Apr 2013 to 23 Apr-2013, during which the patient was absent from her job. The patient was re-evaluated on 22 Apr 2013 by the physician and was authorized to return to work on 23 Apr 2013 and was continued on her medications. Once back at her job, the patient started to feel discomfort when she tried to grab using her thumb, index and middle hand fingers and this discomfort continued intermittently. On 1 Jun 2013, the patient was examined by the physician and referred to a physiotherapist for evaluation. She was diagnosed with 'right radial nerve palsy'. Outcome of the events were unknown. Follow-up (01-Oct-2013): upgraded to serious, country changed, medical history, patient details, details of suspect drug, new events, company causality updated to 'possible', clinical course, treatment.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient had not pertinent medical history or drug reactions/allergies. On 02-JUL-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J001692, expiration date 08-MAY-2014) 0.65 ml, subcutaneous for prevent shingles. Concomitant therapies included methylphenidate. The pharmacist reported that the patient developed itching "immediately" after receiving ZOSTAVAX. Pharmacist reported that the patient developed a red spot "a little while after" at the injections site. The patient was monitored by the pharmacist for "about a half hour" after receiving the ZOSTAVAX. During that time, the pharmacist administered an unspecified amount of Benadryl to the patient as well as an unspecified amount of prednisone due to the itching and red spot. The pharmacist requested a lot check on this ZOSTAVAX. Pharmacist reported that this ZOSTAVAX was the same lot# that another patient had an adverse reaction too, which is documented in MARRS #1306USA012301. The outcome of red spot at the injections site and itching was reported as recovered/resolved on 02-JUL-2013. The relationship between the ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient had not pertinent medical history or drug reactions/allergies. On 02-JUL-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J001692, expiration date 08-MAY-2014) 0.65 ml, subcutaneous for prevent shingles. Concomitant therapies included methylphenidate. The pharmacist reported that the patient developed itching "immediately" after receiving ZOSTAVAX. Pharmacist reported that the patient developed a red spot "a little while after" at the injections site. The patient was monitored by the pharmacist for "about a half hour" after receiving the ZOSTAVAX. During that time, the pharmacist administered an unspecified amount of Benadryl to the patient as well as an unspecified amount of prednisone due to the itching and red spot. The pharmacist requested a lot check on this ZOSTAVAX. Pharmacist reported that this ZOSTAVAX was the same lot# that another patient had an adverse reaction too, which is documented in MARRS #1306USA012301. The outcome of red spot at the injections site and itching was reported as recovered/resolved on 02-JUL-2013. The relationship between the ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.