chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient feels sick like a flu and pain at injection site (area is red and warm to touch).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Back pain, pain down arm
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: He has recurrent vomiting, fever, decreased ability.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Pt received PNEUMOVAX shot 11/3/14. She called Monday night 11/3/14 and stated she was having a reaction. Arm was swollen. I told her to take NSAIDS, use ice and take BENADRYL which she said she would do. She came into store today. Arm swollen - inside arm and low breast clean area. I told her to see a doctor but she said she was getting better. ph told her to continue BENADRYL.
Age: 31.0
Sex: F
Vaccine: PPV, 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 31 year old female patient. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not provided). Also on 28-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (route, lot # and expiration daft were not provided). On 28-OCT-2014, the pharmacist administered both ZOSTAVAX and PNEUMOVAX23 to the 31 year  old breastfeeding patient. It was unknown if the patient sought medical attention. No adverse effects were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: Office visit 9-18-14-ER-visit.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacist Technician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 26-JAN-2010, the patient was vaccinated with a first dose of VAQTA intramuscular, (dose and lot number were not reported). On 10-DEC-2012, the patient was vaccinated with a second dose of VAQTA intramuscular, (dose and lot number were not reported). No known adverse effects. Concomitant medication were not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old male patient without drug reactions and allergies. On 28-OCT-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot # reported as K003603, expiration date reported as 20-MAR-2015 (strength was not reported). On 30-OCT-2014 the patient experienced redness and itching at the injection site. He saw his pharmacist on unknown date and di not receive any treatment of the adverse events. There were not laboratory diagnostics studies performed. The outcome of the events was unknown. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Location of vaccine administration became red, warm to the touch, and raised. Within 5 minutes of administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient without pertinent medical history. On 18-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # K009769, expiration date 09-OCT-2015, 0.65 ml, subcutaneous. Secondary and concomitant therapies were not reported. Pharmacist reported that the patient developed redness at the injection site after receiving ZOSTAVAX (on an unknown date 2014). The outcome of redness at the injection site was reported as not recovered/not resolved. The patient went into the pharmacy on 20-OCT-2014 and showed the pharmacist the redness at the injection site. No treatment was given for the event. No labs diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 31-OCT-2014 the patient was vaccinated with and expired dose of ZOSTAVAX lot # J006156, expiration date: 30-AUG-2014 (strength, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. Since 30-JUL-2014, doses of ZOSTAVAX, which were exposed to a supported temperature excursion, were administered to unspecified patients on unspecified dates (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). At the time of this report, the nurse was not aware of any adverse experiences. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient with no pertinent medical history or drug reaction/allergies. On 23-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose number not reported) lot # K007262, expiration date November 2015, 0.5 ml, intramuscular on the arm. Other suspect therapies included Influenza virus vaccine (unspecified) (dose, dose number, lot number, expiration date and route were not reported). Concomitant therapies included SYNTHROID. The pharmacist reported that a patient received a dose of PNEUMOVAX 23 and an unspecified flu shot in separate arms in the same vaccination session on 23-OCT-2014. On 24-OCT-2014 (reported as the next day) the patient called to the pharmacy to report that the PNEUMOVAX 23 injection site was "inflamed" and hot to the touch. The pharmacist reported that the patient came into the pharmacy on 25-OCT-2014 (reproted as two days after injection) and the site was red and swollen. The pharmacist suggested to the patient to used "ice and BENADRYL if tolerable, or ibuprofen to manage discomfort". At the time of the report the outcome was reported as recovering. No treatment given at the time of the report. Patient seek medical attention at the pharmacy (by phone call and at the visit). None lab test were performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.86
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever/rash/BENADRYL.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Patient reported severe skin reaction at site of injection that had spread over large portion of upper arm. Patient visited doctor and received steroid injection.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-SEP-2014, the patient was vaccinated with an unspecified live intranasal flu vaccine. On 14-OCT-2014 the patient was vaccinated with VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified) and M-M-R II (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. The outcome of the events as unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness, inflammation at injection site.
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from an agency (Local Reference# MK2843, Local Reference# US12-044559), for VARIVAX (Merck), a Pregnancy Registry product, refers to a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient in third trimester pregnant was vaccinated with a dose of VARIVAX (Merck) (Lot#, dose, indication and route not reported) on an unknown date. The LMP and EDD were not known. It was not known if the patient sought for medical attention. Follow up information was received from the physician who reported that he had no specific information available at the time. He did not remember the patient had difficulties during pregnancy and delivered a healthy baby. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Other demographics were not reported. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date the patient developed shingles after the vaccination with ZOSTAVAX reported as "developed shingles afterwards a couple of years ago". The outcome of patient developed shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), exposed to -11.8C for seven hours. No adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), exposed to -11.8C for seven hours. No adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. In approximately 2013, about a year ago also reported as at least a year ago, the patient was vaccinated with a dose of ZOSTAVAX, intramuscular (lot # and expiration date were not provided). There was no concomitant medication. About two weeks ago, on approximately 20-OCT-2014, the patient experienced mild pain to the shoulder blade with no blisters. The patient's doctor prescribed anti-itch cream. There were no laboratory diagnostics studies performed. The patient sought medical attention. The outcome of mild pain to the shoulder blade with no blisters was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 04-APR-2014 the patient was vaccinated with first does of GARDASIL (dose and frequency unspecified). The reporter stated that the patient was in the office on 03-NOV-2014 to receive her second dose of GARDASIL. Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Low grade fever 99.2, pain at injection site and warm to the touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's drug allergies and pertinent medical history was unspecified. On 25-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (Dose/Frequency: 0.5 ml, Subcutaneously, lot # K004281 and expiry date: 22-MAR-2015). Concomitant medications were unspecified. On 25-OCT-2014, the patient experienced swelling, hardening, warmth, redness and soreness around injection site after receiving PNEUMOVAX 23. The patient sought medical attention (spoke to pharmacist) and no treatment was provided for the events. Lab studies performed were unspecified. The outcome of swelling, hardening, warmth, redness and soreness around injection site was reported as not recovered/not resolved. The causality of the events was not reported. No product complaint was reported for PNEUMOVAX 23. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL which was exposed to 1 degrees centigrade for 18.5 hours (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality issue was reported. This is one of the many reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 29-MAY-2014 the patient was vaccinated with GARDASIL dose 1, intramuscular. On an unknown date the patient missed her second dose of GARDASIL due to a product quality issue. No adverse experience was reported. The patient planned to receive the second dose of GARDASIL as soon as possible. Therapy with GARDASIL was not discontinued. A product quality complaint has been filed. Additional information has been requested. This case is linked to 1411USA002149 (same reporter link).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored oral, ROTATEQ which was exposed to 1 degrees centigrade for 18.5 hours (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with oral, ROTATEQ was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. No product quality issue was reproted. This is one of the many reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 22-APR-2014 the patient was vaccinated with GARDASIL dose 1, intramuscular. On an unknown date the patient missed her second dose of GARDASIL due to a product quality issue. No adverse experience was reported. The patient planned to receive the second dose of GARDASIL as soon as possible. Therapy with GARDASIL was not discontinued. A product quality complaint has been filed. Additional information has been requested. This case is linked to 1411USA002040 (same reporter link).
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-Nov-2009 the patient was vaccinated with the first dose of PNEUMOVAX23 0.5 ml, intramuscular (lot number, site of administration not reported). Subsequently, on 28-OCT-2014 the patient received the second dose of PNEUMOVAX23 0.5 ml, intramuscularly (lot number, site of administration not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were not provided. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml administered subcutaneously (lot# reported as J008526 with expiry date 19-OCT-2014). No concomitant medications were reported. No adverse effect was reported. Lot number J008526 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as health care worker) refers to a male patient of unknown age. The patient's medical history included Asperger syndrome and attention deficit hyperactivity disorder. On 21-NOV-2012 the patient was vaccinated with GARDASIL dose 1 (lot # H013831 and expiry date 6-MAR-2015), 0.5 ml, via intramuscular route in the left arm. Other co-suspects and concomitant medication were not reported. On an unknown date the patient experienced dizziness on receiving dose 1 of GARDASIL while in the office. He was kept in the office for 30 minutes for observation and then was sent home. When he went home he experienced nausea and vomiting. There was no fever and diarrhea. He recovered 3 days later. The parent of the patient did not seek medical attention for the vomiting and nausea and only recently mentioned to the office what had happened. Also reported that the patient will not be receiving further doses of GARDASIL. Cancer and overdose was not reported. The outcome of dizziness, nausea and vomiting was reported as recovered/resolved. Causality was not specified by the reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph node under left arm, redness, swelling. Cellulitis treated w/ doxycycline.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Rash erythematous, Rash generalised
Clinical narrative: 11/6/14 Gave PEDIARIX - Hib - PCV-13 - ROTATEQ at 10:35 AM. Noted pt have red spot rash - all over her - right after she received vaccines. No SOB noted. Dad took her to ER. ER noted at transfer at 10:36 AM.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 48 year old patient with unknown gender. On 13-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular). No adverse effects were reported. The outcome of the event was not reported. No product quality complaint (PQC) involved This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient with unknown gender. On 30-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular). No adverse effects were reported. The outcome of the event was not reported. No product quality complaint (PQC) involved. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 27-OCT-2014 the patient was vaccinated with an expired dose of M-M-R II (lot# reported as H018945, expiration date reported as 18-OCT-2014, dose, dose number and route unspecified). No adverse effect reported. The outcome of the event was not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In January 2014 (exact date not provided), the patient was vaccinated with the first dose of PNEUMOVAX 23 given intramuscularly (dose, lot #, batch #, expiration date and indication not provided). On 23-OCT-2014, the patient was inadvertently administered a second dose of PNEUMOVAX 23, intramuscularly (dose, lot #, batch #, expiration date, indication not provided). No adverse effects were reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling of right arm and some itching. Pain with movement. Area red and warm.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unkonwn date in January 2014, the patient was vaccinated with GARDASIL (strength, dose, route of administration, anatomical location, indication, lot # and expiration date not reported). No concomitant medication was reported. The physician reported that the patient would receive the second dose of GARDASIL on 23-OCT-2014. No adverse effects were reported. The outcomes of the events were unknown. A product quality complaint (PQC) was no involved. No further information provided. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Infantile spitting up, Vomiting projectile
Clinical narrative: Sick office visit 11-1-14. Vaccines - PENTACEL, ROTATEQ, PREVNAR given 10-23-14. Patient projectile vomited 2x 10-31-14. both times soon after eating. Spitting up since then but not more then usual. Happy, not fussy. No fever.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. From August 2014 until the time of reporting, these patients were vaccinated with PNEUMOVAX 23 (lot#, dose not reported) which were improperly stored. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. 8 months ago, in March 2014, the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (injection, lot#, expiry date, dose and route were not provided). On 04-NOV-2014 the patient was inadvertently vaccinated with a 2nd dose of PNEUMVOX 23 (injection, lot#, expiry date, dose and route were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown demographics. On 04-NOV-2014 the patient was vaccinated with M-M-R II lot # H014989; expiry: 10-AUG-2014 (dosing regimen unspecified). No concomitant medications were reported. Healthcare worker reports that an unspecified patient was inadvertently administered an expired dose of M-M-R II 04-NOV-2014. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 66 year old female patient refers to herself. Past drug included EPIPEN. On 22-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) (dosage and route not reported). Concomitant therapies included PROLIA, atenolol and valsartan. On 23-OCT-2014, the patient experienced a mild itching, swelling, and redness at the injection site. No treatment was given for the events. The outcome was unknown. Additional information is not expected since there is no patients contact information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX (Merck), (dose, route, lot number and expiration date not reported) which was exposed to -13.5 C for 45 minutes. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report as received from a Registered Nurse refers to an 18 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 08-OCT-2014 the patient was vaccinated with GARDASIL (lot # K004205) 0.5 ml once, intramuscular. The patient had no concomitant medication. On 09-OCT-2014, the patient did a home pregnancy test and found out she was pregnant. The patient sought medical attention at the office of the nurse on 09-OCT-2014 for an ultrasound which confirmed patient was pregnant. Pregnant Gestation was reported as 17 weeks. Last menstrual period was estimated as 12-JUN-2014 and the estimated date of delivery was estimated as 19-MAR-2015. No adverse events were reported. No treatment was given for the event. The outcome of the pregnancy was unknown. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 82 year old female patient with hypertension and hypoglycemia. The patient's medical history included L5 - S1 back surgery. On 11-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot # K003598, expiration date 13-MAR-2015, 0.65 ml, subcutaneous. Concomitant therapies included FLUZONE reported as high dose. The pharmacist reported that on 13-OCT-2014, the patient began to experienced  extreme back pain that extended to the gluteus and bilateral legs. The patient described the pain as a "20" based on a 0-10 pain scale. The patient further reported mild redness at the injection site, and itchiness on the hands and trunk. The patient denied that any rash or rash- like symptoms presented. At the time of the report the outcome of back pain, redness at the injection site and itchiness on the hands and trunk was reported as recovering. The outcome of pain on gluteus and bilateral legs was reported as not recovered. The patient had seen an unspecified chiropractor on, 24-OCT-2014, for treatment, who stated to the patient that this pain may have been due to the vaccine. Patient did not performed lab diagnostics studies. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Injection site erythema, Myalgia, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 82 year old female patient with hypertension and hypoglycemia. The patient's medical history included L5 - S1 back surgery. On 11-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number not reported) lot # K003598, expiration date 13-MAR-2015, 0.65 ml, subcutaneous. Concomitant therapies included FLUZONE reported as high dose. The pharmacist reported that on 13-OCT-2014, the patient began to experienced  extreme back pain that extended to the gluteus and bilateral legs. The patient described the pain as a "20" based on a 0-10 pain scale. The patient further reported mild redness at the injection site, and itchiness on the hands and trunk. The patient denied that any rash or rash- like symptoms presented. At the time of the report the outcome of back pain, redness at the injection site and itchiness on the hands and trunk was reported as recovering. The outcome of pain on gluteus and bilateral legs was reported as not recovered. The patient had seen an unspecified chiropractor on, 24-OCT-2014, for treatment, who stated to the patient that this pain may have been due to the vaccine. Patient did not performed lab diagnostics studies. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 month old female patient. Medical history and concurrent conditions were not reported. On 28-OCT-2014 the patient was vaccinated with GARDASIL lot # K004205, expiration date 12-JAN-2017. Dose and route were not reported. No adverse effects reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 month old female patient. Medical history and concurrent conditions were not reported. On 28-OCT-2014 the patient was vaccinated with GARDASIL lot # K004205, expiration date 12-JAN-2017. Dose and route were not reported. No adverse effects reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal disorder, Pain, Sleep disorder, Tendon injury
Clinical narrative: Constant pain in L arm; (+) tenderness; limited use of arm and limited range of motion due to pain.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Constant pain in L arm; (+) tenderness; limited use of arm and limited range of motion due to pain.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a female patient of unknown age. In October 2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Concomitant medications included a Flu (manufacturer unknown). The nurse stated that she administered both a Flu (manufacturer unknown) and the GARDASIL vaccines to the patient during this office visit. Shortly after both vaccinations were administered the patient then passed out (occurred during the last week of October 2014). Treatment given to the patient was not specified and the patient did not regain consciousness for two hours. Upon internal review, "the patient then passed out/the patient did not regain consciousness for two hours" was determined to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Coronary arterial stent insertion, Coronary artery disease, Diabetes mellitus, Feeling hot, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 year old female patient with dialysis started on 15-SEP-2008 for end stage renal disease and no known drug allergies or reactions. On 08-DEC-2008, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route, anatomical location, lot # and expiration date were not provided). On 31-OCT-2014, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PLAVIX, SINEQUAN, EPOGEN, HUMULIN, SYNTHROID, NEPHROCAPS, ZEMPLAR, ZANTAC, CRESTOR, RENAGEL, COUMADIN and FERRLECIT. It was also reported by the nurse that there was no reaction after first dose of PNEUMOVAX 23. However, on an unknown date, the patient experienced left ventricular (LV) thrombus, diabetes and coronary artery disease (CAD). On 11-FEB-2014, a stent was placed for CAD. On 01-NOV-2014, after the patient's second dose of PNEUMOVAX 23, the patient experienced redness and warmth at injection site, severe tenderness of the entire upper arm and edema. Nurse reported that also on 01-NOV-2014, the patient's upper arm measured 11 cm greater than opposite arm at the antecubital and mid bicep regions. Nurse reported that patient's daughter reported patient felt hot all over on 01-NOV-2014 and 02-NOV-2014, but did not have a thermometer to record temperature. Nurse reported that patient was afebrile on 03-NOV-2014 and patient completed dialysis on the same day. No treatment was given to the patient for the events after the second dose of PNEUMOVAX 23. On 05-NOV-2014, the patient was seen in the clinic and patient's arm was less swollen, and patient verbally described her arm as better, better. At the time of the report, the patient's status for left ventricular thrombus, diabetes, coronary artery disease with stent, redness and warmth at injection site and felt hot all over was unknown. The outcome of upper arm measured 11 cm greater than opposite arm and severe tenderness of the entire upper arm and edema was reported as recovering/resolving. Upon internal review coronary artery disease with stent and LV thrombus were considered to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Intracardiac thrombus, Local swelling, Oedema peripheral, Tenderness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 year old female patient with dialysis started on 15-SEP-2008 for end stage renal disease and no known drug allergies or reactions. On 08-DEC-2008, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route, anatomical location, lot # and expiration date were not provided). On 31-OCT-2014, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PLAVIX, SINEQUAN, EPOGEN, HUMULIN, SYNTHROID, NEPHROCAPS, ZEMPLAR, ZANTAC, CRESTOR, RENAGEL, COUMADIN and FERRLECIT. It was also reported by the nurse that there was no reaction after first dose of PNEUMOVAX 23. However, on an unknown date, the patient experienced left ventricular (LV) thrombus, diabetes and coronary artery disease (CAD). On 11-FEB-2014, a stent was placed for CAD. On 01-NOV-2014, after the patient's second dose of PNEUMOVAX 23, the patient experienced redness and warmth at injection site, severe tenderness of the entire upper arm and edema. Nurse reported that also on 01-NOV-2014, the patient's upper arm measured 11 cm greater than opposite arm at the antecubital and mid bicep regions. Nurse reported that patient's daughter reported patient felt hot all over on 01-NOV-2014 and 02-NOV-2014, but did not have a thermometer to record temperature. Nurse reported that patient was afebrile on 03-NOV-2014 and patient completed dialysis on the same day. No treatment was given to the patient for the events after the second dose of PNEUMOVAX 23. On 05-NOV-2014, the patient was seen in the clinic and patient's arm was less swollen, and patient verbally described her arm as better, better. At the time of the report, the patient's status for left ventricular thrombus, diabetes, coronary artery disease with stent, redness and warmth at injection site and felt hot all over was unknown. The outcome of upper arm measured 11 cm greater than opposite arm and severe tenderness of the entire upper arm and edema was reported as recovering/resolving. Upon internal review coronary artery disease with stent and LV thrombus were considered to be medically significant. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth, Intracardiac thrombus
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 69 year old female patient with dialysis started on 15-SEP-2008 for end stage renal disease and no known drug allergies or reactions. On 08-DEC-2008, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route, anatomical location, lot # and expiration date were not provided). On 31-OCT-2014, the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # J011799, expiration date 09-FEB-2015, 0.5 ml, intramuscular. Concomitant therapies included PLAVIX, SINEQUAN, EPOGEN, HUMULIN, SYNTHROID, NEPHROCAPS, ZEMPLAR, ZANTAC, CRESTOR, RENAGEL, COUMADIN and FERRLECIT. It was also reported by the nurse that there was no reaction after first dose of PNEUMOVAX 23. However, on an unknown date, the patient experienced left ventricular (LV) thrombus, diabetes and coronary artery disease (CAD). On 11-FEB-2014, a stent was placed for CAD. On 01-NOV-2014, after the patient's second dose of PNEUMOVAX 23, the patient experienced redness and warmth at injection site, severe tenderness of the entire upper arm and edema. Nurse reported that also on 01-NOV-2014, the patient's upper arm measured 11 cm greater than opposite arm at the antecubital and mid bicep regions. Nurse reported that patient's daughter reported patient felt hot all over on 01-NOV-2014 and 02-NOV-2014, but did not have a thermometer to record temperature. Nurse reported that patient was afebrile on 03-NOV-2014 and patient completed dialysis on the same day. No treatment was given to the patient for the events after the second dose of PNEUMOVAX 23. On 05-NOV-2014, the patient was seen in the clinic and patient's arm was less swollen, and patient verbally described her arm as better, better. At the time of the report, the patient's status for left ventricular thrombus, diabetes, coronary artery disease with stent, redness and warmth at injection site and felt hot all over was unknown. The outcome of upper arm measured 11 cm greater than opposite arm and severe tenderness of the entire upper arm and edema was reported as recovering/resolving. Upon internal review coronary artery disease with stent and LV thrombus were considered to be medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Fever, headache, nausea, rash. Rash became worse over next two days. Went to Urgent Care 11/06/2014. Diagnosed with Cellulitis.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None -- incomplete vaccination; received approximately 1/2 dose in only one nostril.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: PT complained about a lot of pain about 30 Mins after receiving injection, which approx time given 2:15pm. She continued to have a lot of pain and then reported that she could not lift left arm. Provider on site evaluated her and states sh feels that the injection was given a little high. Pt was Sent to Occupational Health. Pt continues with decreased rom, pain and numbness and tingling in arm.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: PT complained about a lot of pain about 30 Mins after receiving injection, which approx time given 2:15pm. She continued to have a lot of pain and then reported that she could not lift left arm. Provider on site evaluated her and states sh feels that the injection was given a little high. Pt was Sent to Occupational Health. Pt continues with decreased rom, pain and numbness and tingling in arm.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, VIIth nerve paralysis
Clinical narrative: Right Facial Palsy c/w Bell's Palsy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received a second inactivated flu within 2 months, incidentally, without adverse reaction.  CDC contacted to adverse event expected.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Severe numbness in hands and feet upon waking, by 11am numbness progressed to knees, went to family physician who admitted me to hospital, diagnosed with GBS, 2 lumbar punctures, EMG, and IVIG given during 2nd hospital admission.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Severe numbness in hands and feet upon waking, by 11am numbness progressed to knees, went to family physician who admitted me to hospital, diagnosed with GBS, 2 lumbar punctures, EMG, and IVIG given during 2nd hospital admission.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: Patient received Flu vaccine about 90 minutes later patient started to feel tingling in her tounge, her lips went completely numb, and her throat felt very tight.  Patient was given 25mg of PO Benadryl and after 20 minutes, throat felt better, tounge stopped tingling but lips still numb and a bit swollen. Patient had no other new meds.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Patient called Pharmacy on 10/11/14 and said that when she woke up she had a rash on left arm, chest, and back.  Patient went to urgent care type facility as a precaution where Nurse Practionier said it looked like hives also.  Patient took Diphenhydramine and rash/hives went away.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Patient vomited, had a low grade fever, chills, headache, flu-like symptoms, and muscle pains from head to toe. Symptoms caused her to seek medical attention.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient vomited, had a low grade fever, chills, headache, flu-like symptoms, and muscle pains from head to toe. Symptoms caused her to seek medical attention.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: Violent chills, severe headache, nausea, body aches, general ill feeling, shakes, sweating, weak, vomit one time.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Tremor, Vomiting
Clinical narrative: Violent chills, severe headache, nausea, body aches, general ill feeling, shakes, sweating, weak, vomit one time.
Age: 60.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Joint vibration
Clinical narrative: Rythmic vibrations in R foot.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Pain, Pyrexia
Clinical narrative: Feaver of 100. Body aches especially lower half of body. Painful joints hips knees lower back. Took Tylenol later ibprofen.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Arm pain and swelling from shoulder area through elbow.  Arm swelling resulted in increase in arm curcumference by at least 4 inches.  Please note the patient had received the pneumococcal vaccine in 2008 and again in November 2013 and again in 2014.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: PAIN IN RIGHT ARM AND ITCHING. INCREASED PAIN AND SWELLING.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Disorientation, Peripheral coldness, Pyrexia, Somnolence
Clinical narrative: Sudden onset of 102 fever, with cold hands and feet.  Extreme drowsiness and disorientation. No other symptoms (such as respiratory illness).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: Notified at 8:16AM that allergic reaction had occurred and pt was taken by ambulance to E.R. with swollen face/lips and difficulty breathing.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant during administration of vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Palpitations, Vaccination site induration, Vaccination site swelling
Clinical narrative: Patient woke up with arm swollen, hard at site of vaccine administration, numbness.  Patient also described feeling as though her heart was racing.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Biopsy skin abnormal, Cough, Erythema multiforme, Hypophagia, Intensive care
Clinical narrative: On Saturday 10/25/14 she had a flu mist vaccine and developed a cough that night.  Mom started giving albuterol twice a day for the cough on Sunday 10/26/14, which is per her asthma action plan with the PCP.  She was doing well, going to school, and went to a pumpkin patch on 10/29/14.  On Thursday 10/30/14 she woke up with "blood shot eyes," swollen face and lips, sores inside her mouth, and a rash on her chest that looked like "pin prick red marks."  On Friday 10/31/14 she only took in 8 oz of water and 2 popsicles, voided 3 times.  Mom gave Tylenol about 6 pm then took her to the ED. She was transferred to the PICU for further care. She was given Benadryl, Tylenol, and Zofran for supportive therapy, remains on IVFs because of mouth pain and poor PO, and Burn surgery, Ophthalmology, and Dermatology were consulted. She was placed on 1L O2 for sats in the upper 80s. She eventually was able to breath without oxygen support and was transferred to the main floor for continued management of her skin lesions with Meplex, Triamcinolone, Atarax.  Her pain continues to be managed with PCA IV push and IV Tylenol.