chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Pt received VARIVAX 12/18/12 on 12/26/12 noticed Lt upper outer arm had rash & itching 12/31/12 red bumps not fluid filled on face  & trunk itchy.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Few minutes after MMR vaccine adm hives present on leg near site with redness. BENADRYL given in office/no further reaction.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Large local reaction. Initial PNEUMOVAX given in 2001 at age 68. This vaccination was "booster."
Age: 10.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Pt. came to clinic after receiving intranasal flu & ADACEL w/ (R) foot swelling & pain w/ weight bearing & swelling (L) ring finger & pain with movement.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site pain, Pain
Clinical narrative: Pt. stated he had some itching & soreness 48 hrs post vaccine - then had gradual redness/soreness at site. Swelling occur up until visit 12/26/12. Cellulitis entire (L) upper/lower arm below injection site.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: Pt. stated he had some itching & soreness 48 hrs post vaccine - then had gradual redness/soreness at site. Swelling occur up until visit 12/26/12. Cellulitis entire (L) upper/lower arm below injection site.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site cellulitis, Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Pt. stated he had some itching & soreness 48 hrs post vaccine - then had gradual redness/soreness at site. Swelling occur up until visit 12/26/12. Cellulitis entire (L) upper/lower arm below injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (dose and route unknown), Lot # H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 27-NOV-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 04-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 29-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 04-DEC-2012 was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 14-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 11-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 13-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 18-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date; 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 10-DEC-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. 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 the receptionist refers to a patient of unknown age and gender who was administered the first dose of GARDASIL 0.5mL IM (lot # not reported) on 22-NOV-2011, and the second dose of GARDASIL 0.5mL IM (lot # not reported) on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 30-NOV-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 07-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-NOV-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 14-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. Additional information is not expected. This is one of several reports from the same source.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 15-NOV-2012 was vaccinated with an improperly stored (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 19-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 16-NOV-2012 was vaccinated with an improperly stored PROQUAD (dose and route unknown, Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 1.53
Sex: M
Vaccine: VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had a fever when he woke up in the morning. He was given ibuprofen for the fever. Approximately 45 minutes after waking, he had a febrile seizure.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information regarding the patient's pertinent medical history was not provided. The patient was vaccinated with a dose of ZOSTAVAX (lot number not specified) on 14-DEC-2012. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. After receiving ZOSTAVAX the patient experienced pain, swelling, itching and soreness around injection site. No treatment was provided for the events. The patient sought medical attention; she spoke to the pharmacist. The outcome of the events was not reported. The reporter did not provide a causality assessment. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 71 years old female consumer refers to herself. The patient was vaccinated with her second dose of 0.5 ml PNEUMOVAX23 (lot number not provided) intramuscularly three years ago, in approximately December 2009. No other co-suspects were reported. No concomitant medications were reported. The patient reported the localized injection site reaction. She saw her physician and was given a five day rapid taper prednisone. It was painful and red, and swollen. The outcome of adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (merck) in December 2008 (four years ago). No other co-suspects were reported. No concomitant medications were reported. The nurse stated on an unknown date the patient came into office with a case of chickenpox. The outcome of chickenpox was unknown. Additional information is not expected.
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 and gender. On 18-DEC-2012, the patient was vaccinated subcutaneously with lot # (671610/1164AA) ZOSTAVAX on 18-DEC-2012. The anatomical location was not reported. No other co-suspects or concomitant medications were reported. On an unknown date it was discovered that the patient was administered expired ZOSTAVAX. The patient experienced no adverse event. No treatment information was reported. This case was linked to case 1212USA008170 which was received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist who refers to an unspecified number of patients. The pharmacist reported that the patient's experienced mild injection site reaction (onset date was not provided) after vaccination with ZOSTAVAX (vaccination dates, doses, route, lot numbers were not reported). The outcome of adverse events were not reported. Additional information has been requested. This is one of several reports from the same source.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 14 months old male grandson with slight cold at time of vaccination. The patient was vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not provided) approximately on 15-DEC-2012 "11 days ago". No other co-suspects were reported. No concomitant medications were reported. On 25-DEC-2012 the child developed about 25 red raised rash like areas and the lesions were in groups of about 3 lesions. On 26-DEC-2012 "today" the lesions appeared to be drying over the top. It was unspecified if the patient had sought medical attention. The treatment of BENADRYL and cortisone cream were given for the adverse events. There were no laboratory diagnostics studies performed. The outcome of the child developed about 25 red raised rash like areas and the lesions were in groups of about 3 lesions was reported as not recovered/not resolved. The relatedness between therapy with VARIVAX (merck) and the events was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a currently 54 year old female handicapped (unspecified type of handicap) patient. The patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot# reported as H013017, exp 10/2013) on 06-DEC-2012. The pharmacist reported that pink changing to bright red injection site reaction (onset date was not provided). The patient sought medical attention by contacting with a pharmacist. She did not receive any treatment for adverse event. At the time of the report patient's state was not recovered. Additional information is not expected. This is one of several reports from the same source.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 17 years old patient. On 21-DEC-2012 the patient who was intended to receive VARIVAX (Merck) was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (lot # not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-DEC-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 670038/0761AA; expiry date 09-APR-2012) on 27-DEC-2012. Route was not reported. No concomitant medications were reported. No adverse effect was reported. No further information was available at the time of report. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash pruritic, Skin warm
Clinical narrative: This spontaneous report as received from a 64 years old female consumer with diabetes and allergy to CIPRIL. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant medications included minerals (unspecified), CENTRUM SILVER, OS-CAL + D, DEXILANT, ONGLYZA, CRESTOR, ASPIRIN and enalapril maleate (manufacturer unknown). The consumer stated that she had a silver dollar shaped itchy and raised spot about six inches long after getting the vaccination (onset date was not provided). The consumer also stated that it was warm to the touch. The consumer did not seek medical attention and not treatment was given for adverse events. It was reported that in September or October 2012 the patient underwent unspecified blood work tests (results not provided). The outcome for adverse events was reported as not recovered. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Contusion, Erythema, Laboratory test
Clinical narrative: This spontaneous report was received from a 75 years old female consumer with fungus on chest (from living on a farm), high blood pressure, nerve pain, cholesterol and no drug reactions/allergies who refers to herself. The patient was vaccinated subcutaneously in left side with a dose of ZOSTAVAX (dose and lot# was not reported) on 20-NOV-2012. Concomitant medications: sulfamethoxazole (reported as "she takes a 7 day sulfur medication-for a chest fungus - 1 tablet twice a day 7 days-1st week of each month"). On 27-NOV-2012 the patient experienced bad reaction to the vaccine (reported also as reaction to the vaccine). The consumer stated that she had redness and soreness on both her breasts, which she described as purple red. The redness had spread to the face on the left side. The patient did not seek medical attention (on the other hand it was reported that both a family friend who was an OB GYN, and the local ER, through that she was having bad reaction to the vaccine, but it was not shingles). She was given antibiotics and pain pills for the adverse event treatment. No lab diagnostic tests were performed. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated with M-M-R II (lot# unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient's recent titer revealed a "borderline" (0.80) titer for rubeola. No treatment information was reported. The outcome of the event was unknown. This is one of two reports regarding the same patient. The other report is 1212USA006317. 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 (linked to case 1212USA009419, same reporter). The patient was subcutaneously vaccinated with ZOSTAVAX (lot number 671610/1164AA and expiration date 19-OCT-2012) on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-DEC-2012 the patient received expired ZOSTAVAX. No adverse event was reported. No treatment information was reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of VARIVAX (merck) (lot# unspecified) in her right forearm "under the skin" on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient had received M-M-R at some time in the past. This is one of the two reports regarding the same patient. The other report is 1301SUSA000105. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with lot # (670237/0919AA), oral ROTATEQ on 19-DEC-2012. Discrepancy noted: reported expiration date is 12-DEC-2012 and the system expiration date is 12-DEC-2013. No other co-suspects were reported. No concomitant medications were reported. On 19-DEC-2012 the patient received expired ROTATEQ, 1 day after onset of therapy and had no known adverse effect. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a female patient 5 year old with contact allergy to neomycin and no pertinent medical history. The patient was vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not provided) on an unspecified day in July 2012 (reported as 5 months ago) in an unspecified pediatricians office. No other co-suspects were reported. There was no concomitant medication. Patient was sent to him by pediatrician. Physician stated that patient needed to visit emergency room shortly after being vaccinated upon developing giant hives, itching and facial swelling. The patient was BENADRYL in the emergency room and monitored for several hours. Physician reported that he did not have records from initial VARIVAX (merck) vaccination. Patient was seen in physicians office last week to evaluate allergies and the patient was doing fine now. No lab diagnostics studies were performed. The relatedness between therapy with VARIVAX (merck) and the events was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Computerised tomogram, Computerised tomogram abnormal, Neoplasm, Upper extremity mass
Clinical narrative: This spontaneous report has been received from a 61 year old male consumer with allergy to catscan dye and no pertinent medical history, reporting on himself. On 05-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). No other co-suspects were reported. Concomitant medications included blood pressure medical, fish oil, multi vitamins (unspecified), "PREGNAZONE", metformin, hydrocodone, pain killers, "tablet aspirin". On 19-NOV-2012, the patient developed a fleshy tumor and growth on the back of his left arm after the administration of ZOSTAVAX. The results of his catscan came back as a palpable mass on the arm 4 cm. He stated that it was the size of golf ball. The patient sought medical attention. At the time of the report the patient's outcome was unknown. On an unknown date, the patient also experienced raised blood sugar levels for "PREGNAZONE" and splitting the tablets of "aspirin". The relatedness for the adverse event was not reported for ZOSTAVAX. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 6 months old female patient. The patient was vaccinated with her first dose of 0.2 ml, oral ROTATEQ (lot# reported as 0529aa, exp date 13-DEC-2012, oral) on 17-OCT-2012. On 27-DEC-2012 the patient was given an expired dose of ROTATEQ, oral (lot# reported as 0529aa, exp date 13-DEC-2012, the same lot as her first dose). No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a pharmacist refers to a 71 years old female patient. The patient's medical history included chickenpox when was a child, chad carcinoma insitu left breast (June 2008) and chat bilateral mastectomy. On 23-FEB-2012, the patient was vaccinated with ZOSTAVAX (lot # 672476/1605AA), 1 ml, right deltoid, subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The patient did not presented illness at the time of vaccination. The patient was not exposure to chickenpox or herpes zoster. It was noted that the patient did not experienced a rash at the injection site or elsewhere within 42 days of the vaccination. On 04-DEC-2012 in the afternoon, the patient experienced herpes zoster. Blisters started on 16-DEC-2012, and had pain that kept when awake. The patient was seen in the office on 17-DEC-2012 and had stated to breakout with pain along bra line from midline center front to mid line back on the left, 6 cm at greatest, lesions to numerous to count and was diagnosed with herpes zoster the same day. Tried to obtain some fluids but blisters were too small. The pain was level 8 (from 1 to 10). No treatment information was reported. The patient required medical attention. The patient was not performed fluorescent antibody test. Was unable to collected specimen for PCR test. Photo was not taken. At the time of the report, the outcome of herpes zoster was unknown. The relatedness for herpes zoster was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 months old female patient. The patient was vaccinated with dose 1 live, oral, ROTATEQ (route and lot number unknown) on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On18-DEC-2012 the patient received a first dose at 6 months of age. No adverse symptoms reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site atrophy, Injection site pain
Clinical narrative: I noticed a hole in my arm where the fat had been eaten away. The shot hurt when it was administered much more so then I ever remembered and it was very sore for weeks afterward.
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Nausea, Vomiting
Clinical narrative: Client took her 1st dose of oral typhoid vaccine 12-18-12 & experienced "mild nausea" 2 hrs afterward, 12-20-12 approx. hrs after taking dose #2 she vomited & continued to do so every 1/2 hrs x4. She denies any diarrhea but c/o "intense" stomach cramping. Denies fever but states "chills". She rested and hydrated herself with H2O & contacted this office 12-21-12.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Maternal exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: This spontaneous prospective pregnancy report as received from 23 year old female consumer with penicillin allergy, for GARDASIL, a pregnancy registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of GARDASIL (dose, route and lot # not provided) on 02-OCT-2012 and on an unknown date she had spotting. The patient also indicated she was pregnant. The LMP and EDD were not known. Initial exposure to GARDASIL was not reported. On 20-DEC-2012 blood work was performed (result unknown). No treatment was given for the events. The patient did not seek medical attention. Therapy was discontinued. The outcome of spotting and pregnancy was unknown. The relatedness between the spotting and GARDASIL was unknown. 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 physician refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot number not reported) on 16-AUG-2012, the second dose of GARDASIL on 16-NOV-2012 and third dose on 12-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. 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. The patient was vaccinated with the first dose of GARDASIL on 21-DEC-2006, with the second dose on 07-MAR-2008, with the third dose on 07-JUN-2012 and with the fourth dose on 28-AUG-2012, respectively (doses, routes, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Product quality control issue
Clinical narrative: Information has been received from Healthcare Worker concerning to a female patient (age unknown). On unknown date, the patient was exposed to GARDASIL (lot number and expiration date not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient was removing a GARDASIL via from a carton but the vial was cracked, so her hand got wet from exposure to the product from the cracked vial on an unspecified date. No adverse effect reported. Product quality compliance involved. The outcome of her hand got wet from exposure to the product from the cracked vial was unknown. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a project coordinator (not further specified) from another company refers to a 27 years old female patient. On an unknown date, the 27 old patient was vaccinated with GARDASIL. Lot number, expiry date, route of administration and anatomical location of the vaccination were not reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old female patient. On 21-DEC-2012 the patient was inadvertently vaccinated with a 0.5 ml dose of (Merck) PROQUAD (Lot# reported as 0689AE, expired on 05-MAY-2014) subcutaneously and a dose of (Merck) VARIVAX (Lot# reported as H015631, expired on 23-FEB-2014, dose and route not reported). It was staff error only. Both vaccines were administered in the patient's left thigh. No adverse effects were reported as this time. It was not known if the patient sought medical attention. 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 certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on an unspecified day in 2010. And the patient was in the office now to receive the second dose. No adverse symptoms reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on an unknown dates was vaccinated with: the first dose of GARDASIL (dose, route and lot # not reported), the second dose of GARDASIL (dose, route and lot # not reported) and with the third dose of GARDASIL (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. Nurse reported that the patient received the 1st and 2nd doses of GARDASIL 1 year apart, and the patient received the 3rd dose 1 month after the 2nd dose. No adverse effect reported. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Secondary transmission
Clinical narrative: This spontaneous report as received from a consumer (the recipient of ZOSTAVAX) refers to 83 years old male patient (caller's father) with congestive heart failure, kidney failure, penicillin allergy and IV dye allergy. It was reported that in an approximately October 2012 (reported as in October 2012 or in November 2012) the caller (the patient's daughter) received a dose of ZOSTAVAX (dose, route and lot number were not reported) and within a week or 2 weeks later (in an approximately October 2012), her father had extreme pain on his side and broke out into rash (also reported as shingles). No other co-suspects were reported. It was reported that the patient was on unspecified concomitant medications. The patient did not seek medical attention for shingles. It was also reported that in an unspecified date in 2012, the patient was hospitalized. It was reported that the patient received unspecified treatment at center where he was receiving treatment for heart problems. At the time of report the patient recovered from shingles (unspecified date in 2012). The relatedness for the patient's shingles was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age who on 29-JUN-2012 was vaccinated intramuscularly (IM) with the first 0.5 ml dose of GARDASIL (Lot number not reported) and on 01-OCT-2012 was vaccinated intramuscularly (IM) with the second 0.5 ml dose of GARDASIL (Lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician also noted that the patient was in the office today to receive the third dose of GARDASIL on 28-DEC-2012. No adverse event reported. Patient's outcome was unknown. Additional information is not expected.
Age: 22.0
Sex: M
Vaccine: HEPAB, HPV4
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Approx 3-4 days after his vaccines client noticed rash on right chest. Superior to armpit. Slightly down arm. It began as red bumps. Now there are many vesicular rash on the area. Some spots have opened. Client expresses it is itchy. He was going to contact his physician.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Influenza A virus test positive
Clinical narrative: Positive influenza Type A after influenza vaccine given on 10/20/12.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive
Clinical narrative: Positive influenza Type A after influenza vaccine given on 11/27/12.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza A virus test positive
Clinical narrative: Positive influenza Type A after influenza vaccine given on 10/03/12.
Age: 0.93
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: DTaP & HIB administered on 12/31/12 vomiting, onset 01/01/13. Vomiting - Recovered on 1/3/12.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Muscle spasms, Vomiting
Clinical narrative: Severe abd pain, severe vomiting T 100-101 & cramping.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Patient vomited 2nd pill. No more continued vomiting.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous complete, Vaginal haemorrhage
Clinical narrative: Began spotting by 12/28/12 complete m/c.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, aches, fatigue, hoarse, chest congestions and cough.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Fever, aches, fatigue, hoarse, chest congestions and cough.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Coagulation time prolonged, Contusion, Fatigue, Full blood count, Laboratory test
Clinical narrative: Excessive bruising, fatigue, slowed clotting. Petechial bruising/spotting.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Petechiae
Clinical narrative: Excessive bruising, fatigue, slowed clotting. Petechial bruising/spotting.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: My son reported that he woke up in the middle of the night with diarrhea, and all of a sudden he fell down (fainting/lost conscious). Second episode: 1/1/13 He had a dizzy spell in the bathroom once again, and passed out hitting his forehead on the wall.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: My son reported that he woke up in the middle of the night with diarrhea, and all of a sudden he fell down (fainting/lost conscious). Second episode: 1/1/13 He had a dizzy spell in the bathroom once again, and passed out hitting his forehead on the wall.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEP, PNC
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was dosed with Pediarix combo vaccine (IPV+HepB+dTAP) + HepB single dose INSTEAD of Pediarix + Hib. Therefore, pt received an extra dose of HepB and no Hib. Pt tolerated vaccines well and continues to be asymptomatic per mother.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood creatine phosphokinase increased, Blood test, Chest X-ray, Chest pain
Clinical narrative: Pain in right arm, next day, pain in both arms, neck and upper back and chest. Over weekend upper and lower body in pain. By Sunday, developed weakness in legs and hands bilaterally. Increased CPK levels also.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Electrocardiogram, Muscular weakness, Neck pain, Pain
Clinical narrative: Pain in right arm, next day, pain in both arms, neck and upper back and chest. Over weekend upper and lower body in pain. By Sunday, developed weakness in legs and hands bilaterally. Increased CPK levels also.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm, next day, pain in both arms, neck and upper back and chest. Over weekend upper and lower body in pain. By Sunday, developed weakness in legs and hands bilaterally. Increased CPK levels also.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever to 101. Chills. Headache. Severe arm pain in injected arm.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, swollen and warm.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Inflammation, Nodule, Pruritus
Clinical narrative: Swelling, bruising, knot, redness, inflamed, itching.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Swelling, bruising, knot, redness, inflamed, itching.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Middle insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Emp complains of continuing left arm pain, loss of strength and reduced range of motion.  Pain wakes her up at night.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: Patient describes feeling achy all over and fatigued to the point he needed to lay down and rest.  He then reports "feeling in a funk for the next few days".
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder
Clinical narrative: Partial then complete loss of equalibrium.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Left arm hurts from elbow to shoulder.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stools.
Age: 0.38
Sex: F
Vaccine: HEP
Symptoms: Drug administration error, No adverse event
Clinical narrative: No adverse events. Parent wanted to report administration error.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: I suffered a severe vertigo attack - the only one I've ever had. It took me about 6 weeks to fully recover.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pruritus, Neck pain, Oropharyngeal pain
Clinical narrative: Sore throat, sore neck, body aches, fever, chills, itching, cough, itchy eyes.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Sore throat, sore neck, body aches, fever, chills, itching, cough, itchy eyes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Induration, Injection site erythema, Pruritus
Clinical narrative: Redness, discomfort, itching approximately 35 mm bright red indurated area right posterior arm, further light redness extending to 1" above elbow.
Age: 34.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Fatigue, Headache, Influenza virus test negative, Pain, Pruritus
Clinical narrative: Tired, headache, body ache, blurred vision, arm itching. Body ache worsened when resting.
Age: 34.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Vision blurred
Clinical narrative: Tired, headache, body ache, blurred vision, arm itching. Body ache worsened when resting.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Left shoulder erythema post varicella injection.
Age: 0.21
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Bronchiolitis, Dyspnoea, Ear infection, Pneumonia, Pyrexia
Clinical narrative: Information has been received from an investigator (Number 045/263) as part of a business agreement, concerning a 14 month old male who entered a study. On 11-DEC-2011 (also reported as 12-DEC-2011), consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2 months, 4 months and 6 months of age or ROTATEQ, PENTACEL, PREVNAR 13 at 2, 4 and 6 months of age and modified process HepB vaccine at 2 and 6 months of age (study vaccine information not provided by the site). On 19-DEC-2012, the subject experienced bronchiolitis (intensity reported as 3) and on 23-DEC-2012 pneumonia (intensity reported as 3) and was hospitalized. The subject was seen in primary medical doctor (PMD) office on 19-DEC-2012 and diagnosed with ear infection, wheezing (not reported as SAE/NSAE/symptom) and bronchiolitis. On 19-DEC-2012, subject was treated with OMNICEF po for ear infection (dosing information not reported), CIPRODEX otic suspension, ear drops for ear infection (dosing information not provided) and albuterol aerosol for wheezing in office and at home and improved (dosing information not provided) (also reported as concomitant therapies). On 20-DEC-2012, subject started with high fevers 104 to 105 (unit of measurement not reported as SEA/NSAE/symptom) and was treated with TYLENOL and ibuprofen at home (dosing information not provided). On 23-DEC-2012, subject was brought to the emergency room (ER) for increase work of breathing and fevers. In the ER subject was treated with nasal cannula oxygen and ampicillin IV (dosing information not provided). Per PMD subject was in hospital for about 48 hours. On 26-DEC-2012, subject was seen in PMD office, no further information provided. At the time of reporting, subject was recovering from bronchiolitis (grade3) and pneumonia (grade3). Action taken with study therapy was not reported. At the time of reporting, the investigator did not provide a causal relationship between study vaccine therapy and bronchiolitis (grade3) and pneumonia (grade3). Additional information has been requested.