chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 65 year old female patient via physician refers to herself. Patient's medical history included reactions to past unspecified flu vaccines, including getting the flu after vaccination. Patient's drug reaction or allergies included Swelling and weight gain from LYRICA. On 20-FEB-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included hydrochlorothiazide (manufacturer unknown) and pantoprazole sodium. On 21-FEB-2014, the patient developed swelling, redness, and tenderness around the injection site in an approximately 3 inch x 2 inch area. The patient also stated that the area was uncomfortable, however due to her level of tolerance she had not felt a need to seek out medical attention or treatment. The outcome of events was reported as not recovered/not resolved. Causality of the events was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to herself, a 61 year old female patient. On 15-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, route not reported) for vaccination. On 16-AUG-2013 ("the next day"), the patient developed redness at the injection site that was 3 to 4 inches in area. The patient did not seek medical attention. There was no treatment given for the event. The reaction lasted for 3 weeks and the patient recovered on approximately 06-SEP-2013. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia
Clinical narrative: Serious pain in muscles and, particularly joints. Treated with Celebrex, aspirin, ibuprofen. At this time (03/02/2014) pain has subsided but still present.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy, raised, pink rash 1-1 1/2" in diameter.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Pt called me to report she got the flu 4-5 days after she got the vaccine. PNEUMOVAX was administered at the same time.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None-given 1mL instead of 0.5mL at age 18. No adverse reaction reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Dizziness, Ear pain, Fatigue, Feeling abnormal
Clinical narrative: Headache, right side of head with shooting pain into ear. Muffled hearing in right ear. Swelling right side face ...pox, under right side chin and right cheek, blood pressure increase, extreme fatigue, dizziness, foggy.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoacusis, Pain, Swelling face
Clinical narrative: Headache, right side of head with shooting pain into ear. Muffled hearing in right ear. Swelling right side face ...pox, under right side chin and right cheek, blood pressure increase, extreme fatigue, dizziness, foggy.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: Stabbing pain in R. neck and shoulder.  Also felt like needles pricking all around.  Has gone on for 2 1/2 weeks with no permanent relief.  Have tried extra strength Tylenol, naproxen sodium, ibuprofen with partial  temporary relief.  Used moist heat, massaging, etc.  Dr. is unfamiliar with any such side effects and dismissed it.  It feels like the shingles did when I had them about 5 years ago, but no rash or blisters.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Loss of consciousness, Posturing, Seizure like phenomena, Syncope
Clinical narrative: After first dose of HPV vaccine, fainted in reception area, but no one witnessed it. Got half way thru second dose in January of 2014 and passed out, postured, red face and seizure like symptoms.  Witnessed by the nurse giving the vaccine.  So she should have reported this.  She suggested not getting another dose, due to her extreme concern.
Age: 44.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Prolonged fever for 24 hours to 104.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Developed Guillain-Barre syndrome approximately 1 week after vaccination with nasal flu vaccine. She required admission to PICU and received IVIG but is recovering nicely, should make full recovery.  Never required intubation but had tachycardia requiring monitoring.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Intensive care, Nuclear magnetic resonance imaging brain normal, Red blood cells CSF positive, Tachycardia
Clinical narrative: Developed Guillain-Barre syndrome approximately 1 week after vaccination with nasal flu vaccine. She required admission to PICU and received IVIG but is recovering nicely, should make full recovery.  Never required intubation but had tachycardia requiring monitoring.
Age: 1.29
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: She first got a fever for more than 24 hours and then a rash five days later on her chest and stomach.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician assistant refers to a 25 year old female patient. The patient was vaccinated with GARDASIL injection, dose 1 on 21-JUL-2010, dose 2 on 07-OCT-2010, dose 3 on 07-OCT-2011, respectively (each dose's lot #, expiry date, dose, route and indication unknown). The physician assistant reported that the patient was given the third dose of GARDASIL which she was pregnant. The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) were unknown. No adverse events reported. Follow up information was received from the physician assistant's office. The pregnancy outcome was a full term vaginal delivery of a normal healthy newborn. Additional information is not expected.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and a registered nurse refers to a 2 month old patient of unknown gender. On 25-FEB-2014, the patient was vaccinated with an expired dose of ROTATEQ (lot # H012974, expiry date 07-FEB-2014), first dose, 2 ml, orally (indication not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician's assistant refers to a female patient of unknown age with hereditary spherocytosis. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (lot #, expiry not reported). On an unknown date, the patient developed shingles. The outcome of shingles was unknown. The causality was unknown. This is 1 of 2 reports from the same reporter. 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 an unspecified patient. On 20-FEB-2014 ("yesterday") the patient was vaccinated with an expired dose of ZOSTAVAX (lot # H019996, expiration date 02-FEB-2014) (dose and route unspecified). No adverse effects provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Hot flush, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report as received from a healthcare worker (C.M.A.) refers to a 50 year old female patient with psoriasis and no drug reactions/allergies. On 21-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J006158, expiry date 30-AUG-2014, 0.65 ml, subcutaneous. There was no concomitant medication. The patient felt dizzy "right away" after receiving the ZOSTAVAX and then a "short time after" developed hot flashes and diarrhea. She reported that "later that night" on 21-FEB-2014, the patient developed redness, swelling, and "warm to touch" at the injection site. She reported that the redness at the injection site has gotten "a little bit better" since an unspecified date. The patient was seen by physician on 25-FEB-2014, no treatment was given and no lab test was performed. The outcome of adverse event (dizzy, hot flashes, diarrhea, swelling and warm to touch at injection site) was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare worker (C.M.A.) refers to a 50 year old female patient with psoriasis and no drug reactions/allergies. On 21-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J006158, expiry date 30-AUG-2014, 0.65 ml, subcutaneous. There was no concomitant medication. The patient felt dizzy "right away" after receiving the ZOSTAVAX and then a "short time after" developed hot flashes and diarrhea. She reported that "later that night" on 21-FEB-2014, the patient developed redness, swelling, and "warm to touch" at the injection site. She reported that the redness at the injection site has gotten "a little bit better" since an unspecified date. The patient was seen by physician on 25-FEB-2014, no treatment was given and no lab test was performed. The outcome of adverse event (dizzy, hot flashes, diarrhea, swelling and warm to touch at injection site) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that he was only able to draw up 0.64mL from a STERILE DILUENT vial today on 24-FEB-2014, so he used an additional STERILE WATER DILUENT vial to draw out at least a total volume of 0.7mL, and used this amount of diluent from both vials to reconstitute a ZOSTAVAX vial and administered this dose to an unspecified patient. No adverse effect reported. PQC filed. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist refers to 2 unspecified patients of unknown age and gender. Pharmacist reported that she had two separate occasions where she was only able to withdraw up 0.6mL and 0.61mL from each sterile water diluent, and so she also used an additional sterile water diluent for each under filled via to draw out at least a total volume of 0.7mL, and used this amount of diluent from these vials to reconstitute the ZOSTAVAX vials and administered these doses to two unspecified patients a few months ago on unspecified dates. PQC filed. No adverse effect reported. PQC filed. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA, JEV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PATIENT WAS ADMINISTERED HEP A VACCINE EARLIER THAN SCHEDULED.
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (lot# not reported) (dose and route not reported). The pharmacist reported that the patient had an unspecified reaction to RECOMBIVAX HB (date unspecified, but described as years ago, strength unspecified). The pharmacist reported that the unspecified reaction to RECOMBIVAX HB was due to an allergy to yeast. The outcome was reported as recovered/resolved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Exposure during pregnancy, Human chorionic gonadotropin positive, Menstruation delayed
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with thyroiditis and no known drug reactions/allergies who on 21-SEP-2011, was vaccinated with the first dose of GARDASIL (Lot #669285/0691AA; Exp. Date: 17-AUG-2013) (dose not reported), intramuscularly. Concomitant therapy included levothyroxine. The physician reported that on 21-SEP-2011, later after receiving the vaccine, the patient revealed that she was five days later for her menstrual period. On an unspecified date, urine pregnancy test was performed and it was confirmed the patient was pregnant. The patient last menstrual period was 15-AUG-2011. Estimated date of delivery would be 21-MAY-2012. Follow up information has been received from a Nurse practitioner. The reporter stated that she pulled the patient's chart and reported that the pregnancy was electively terminated. The causality of the event was unspecified. The action taken of the event with the suspect product was not applicable. The pregnancy outcome was elective termination. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Condition aggravated, Dehydration, Exposure during pregnancy, Hypothyroidism
Clinical narrative: Information has been received from a certified physician's assistant, for HPV vaccine, a Pregnancy Registry product concerning a 16 year old female patient with hypothyroidism who on 25-MAY-2012 was vaccinated with her third dose of HPV (lot # 671463/1359AA). Concomitant therapy included SYNTHROID. On an unspecified date, the patient became pregnant. The patient's LMP (last menstrual period was 20-APR-2012 and EDD (estimated date of delivery) was 27-JAN-2013. The patient had never been pregnancy before. Additional information has been requested. Follow up has been received on 26-JAN-2014, a phone was placed to physician Assistant. The phone call was answered by Certified Medical Assistant (CMA). The CMA stated that on 26-OCT-2012, the patient had a Caesarean Section, and twin boys were delivered at 26 weeks gestational age. There were no congenital anomalies listed and the birth weights were 2 pounds 3 ounces and 2 pounds respectively. There were no indications for the early delivery listed in the patients chart; however at 23 weeks pregnant, the patient was seen at hospital for dehydration and hypothyroidism. Fluids and synthroid were given and patient was instructed to follow up at hospital. There was no information on the infants pediatrician, it was noted that in May 2013 the patient was pregnant again and moved out of the state. No further information was available at that time. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Premature delivery
Clinical narrative: Information has been received from a certified physician's assistant, for HPV vaccine, a Pregnancy Registry product concerning a 16 year old female patient with hypothyroidism who on 25-MAY-2012 was vaccinated with her third dose of HPV (lot # 671463/1359AA). Concomitant therapy included SYNTHROID. On an unspecified date, the patient became pregnant. The patient's LMP (last menstrual period was 20-APR-2012 and EDD (estimated date of delivery) was 27-JAN-2013. The patient had never been pregnancy before. Additional information has been requested. Follow up has been received on 26-JAN-2014, a phone was placed to physician Assistant. The phone call was answered by Certified Medical Assistant (CMA). The CMA stated that on 26-OCT-2012, the patient had a Caesarean Section, and twin boys were delivered at 26 weeks gestational age. There were no congenital anomalies listed and the birth weights were 2 pounds 3 ounces and 2 pounds respectively. There were no indications for the early delivery listed in the patients chart; however at 23 weeks pregnant, the patient was seen at hospital for dehydration and hypothyroidism. Fluids and synthroid were given and patient was instructed to follow up at hospital. There was no information on the infants pediatrician, it was noted that in May 2013 the patient was pregnant again and moved out of the state. No further information was available at that time. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Autism, Convulsion, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her son. Drug allergies, reactions or medical history were not reported. On an unknown date, when the patient was 15 months old he was vaccinated with a dose of M-M-R II (lot#, expiration date, route of administration and dose were not reported). Other suspect therapies included flu vaccine (manufacturer unknown) (lot#, expiration date, route of administration and dose were not reported) and VARIVAX (Merck) (lot#, expiration date, route of administration and dose were not reported), both received at the age of 15 months. No concomitant medications were reported. The reporter stated that on an unknown date, after immunization the patient experienced seizures, a fever for two months and was later diagnosed with autism. The outcome of seizures, fever for two months and autism was reported as not recovered. The relatedness between the events and suspect drugs was not reported. Upon internal review the seizures were considered to be medically significant. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pharmacist reported that on 26-FEB-2014 the patient was vaccinated with PROQUAD (Merck), lot number H015623 with an expiry date of 21-FEB-2014. No adverse event was reported. The outcome of expired vaccine used was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no drug reactions/allergies. In September 2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, VIAL 19400 PFU, (lot #, expiration date unspecified) subcutaneous in the left arm. In 2013, a few days after receiving the ZOSTAVAX, she had pain in the left arm at the injection site. The patient reported to the pharmacist that the pain had stayed consistent since then, and had started to move up through her shoulder into her neck. Pharmacist stated that patient reported that she was seen by an unspecified nurse practitioner, but it was unclear whether she received any treatment. No Lab Diagnostics Studies Performed. The event outcome was reported as not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a healthcare worker concerning a 23 year old female with penicillin allergy who on 11-JAN-2012 was vaccinated with her first dose of GARDASIL (lot # 668554/0306AA expiration date: 10-MAY-2013). Concomitant therapy included LOESTRIN. Subsequently the patient became pregnant after receiving GARDASIL (last menstrual period (LMP) was 19-DEC-2011, and estimated due date (EDD) was 24-SEP-2012). Laboratory studies performed included pregnancy test with Positive result. The patient had office visit for seeking medical attention. Follow-up information as received from the healthcare worker (medical assistant). Significant Information was provided. The date of birth for baby. There was no mention in patients records of any congenital anomaly or any problems with baby or birth. This case was lost to follow up. The pregnancy outcome was made as lost to follow-up. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to a male patient of unknown age, who was reported as the son of consumer's friend. Drug reactions, allergies or medical history were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose or route of administration were not reported). No concomitant medications were reported. On an unknown date, reported as recently, the patient was diagnosed with autism, after receiving measles, mumps, and rubella virus vaccine, live (manufacturer unknown). The outcome of the event was not reported. The relatedness between the event and therapy was not reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female who was vaccinated with the first and second dose of GARDASIL (lot #, dose and route not reported) in January 2009 and on 13-SEP-2011, respectively. The physician reported that the patient had a positive home pregnancy test on 20-SEP-2011, and the pregnancy was confirmed by physician exam on 21-SEP-2011. The physician stated that no adverse effects had been reported by the patient. All telephone attempts to obtain follow-up information have been unsuccessful. The pregnancy outcome was lost to follow up. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female who in November 2011, was intramuscularly vaccinated with a first, 0.5 mL dose of GARDASIL (lot #not reported). The physician reported that he just saw the patient who was from another clinic who reported receiving the first dose of GARDASIL when she was pregnant (last menstrual period was on 30-AUG-2011). The series were being held while patient was pregnant. Patient sought medical attention by visiting the physician. Follow up information was received from a registered nurse. The registered nurse stated that the patient gave birth on 29-MAY-2012; the gestational age at birth was 38 weeks 5 days. The infant had no congenital anomalies and birth weight was 7 pounds 6 ounces. There were no complications during the pregnancy. The patient had not received any further GARDASIL vaccines. There was no information regarding the infant's pediatrician. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. Medical assitant mentioned that in the past an unspecified number of patients had experienced nausea and dizziness after receiving GARDASIL injection (lot #, expiry date, dose, route and indication unknown). All patients recovered in less than 15 minutes while in the office. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Irritability, Screaming
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On an unknown date in February 1997 (also reported as 17 years ago) the patient was vaccinated with RECOMBIVAX HB (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patient was screaming, fussy and irritable. The outcome of screaming, fussy and irritable was reported as reported as recovered. The action taken with the therapy with RECOMBIVAX HB was unknown. The relatedness of the events to the therapy RECOMBIVAX HB was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blood cholesterol, Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. Current condition of the patient included drug allergy with penicillin and blood pressure. On an unknown date in 2007 the patient was vaccinated with ZOSTAVAX dose 1 (as mentioned one time vaccine) at clinic. Concomitant medication reported was unspecified blood pressure pill. On an unknown date, the patient broke out with shingles around her tailbone. Treatment given for event was acyclovir ointment 30 grams. Patient's blood work was done a month ago approximately in January 2014 for cholesterol test. The outcome of broke out with shingles around her tailbone was unknown. Relation between the ZOSTAVAX and the event was unknown. Product quality complaint was not reported. Patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 18 year old female patient who on 23-FEB-2012, before vaccination, presented to the office with "genital bumps" which were diagnosed to be HPV, after she was vaccinated with the first dose of GARDASIL (batch number: 12329AA was an invalid lot number for GARDASIL, expiry 12-NOV-2013, dose and route not reported). On the same day, the patient had a negative pregnancy test. According to the nurse, the patient had a positive pregnancy test on 29-FEB-2012. The last menstrual period was reported as 13-SEP-2012. The patient sought medical attention by visit to the office. Follow up information was received which reported that the patient's last menstrual period was on 13-SEP-2012 and the estimated delivery date would be on 19-JUN-2012. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old female patient with lactose intolerant and TRIAMINIC allergy. On 10-FEB-2014 the patient was vaccinated with the first dose of GARDASIL injection (lot # J009788, expiry date 17-MAR-2016), 0.5 ml, intramuscular. There was no concomitant medication or pertinent medical history. Immediately after administration (while still in the office) the patient experienced nausea, dizziness and low blood pressure. The patient became pale and possibly fainted. The physician observed the patient and the patient recovered 15 to 20 minutes later. No treatment was given for the event. Lab diagnostics studies were not performed. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Musculoskeletal pain, Skin lesion, Viral test positive
Clinical narrative: This spontaneous report as received from a Registered Nurse to a 10 year, 6 months old female patient without pertinent medical history, drug reactions or allergies. The nurse reported that the patient received two doses of (oka/merck) VARIVAX (0.5 ml, lot number and expiration date no reported) subcutaneous on an unknown date in 2008. There was no concomitant medication. Nurse reported that on 23-FEB-2014 (two days ago) the patient was seen in the office with lesions oh her right arm. Nurse stated that the patient did not have any pain with the lesions, but that the patient did complain of pain right shoulder blade. Nurse stated that the lesions were cultured and were confirmed to be herpes zoster. Nurse also stated that the patient was not receiving treatment, as she was not having any pain. The nurse stated that the lesions had begun to resolve. At the time of the report, the patient was recovering from the adverse events. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients may have received improperly stored PNEUMOVAX 23 (dose, route, lot number and expiration date not provided). No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and sex. No pertinent medical history, drug reactions or allergies were reported. On 25-FEB-2014, the patient received a dose of PROQUAD (lot #, expiration date, dose, frequency, route of administration were not reported) injection and a dose of VARIVAX (Merck) (lot #, expiration date, dose, frequency, route of administration were not reported) injection. No adverse symptoms were reported. No concomitant medications were reported. It was not reported if patient was given any treatment. It was not reported if any lab diagnostic studies were performed. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Child received Tdap, MENACTRA and GARDASIL on 2/26/14. Mom noticed redness and swelling on 2/27/14 after playing baseball, some warmness to the touch also.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: 2 minutes after administration of GARDASIL, the patient developed dizziness, diaphoresis, cold clammy skin and hypotension (BP: 75/38 2 min / 2 min 79/48). The patient was continuously monitored until fully recovered. Last vitals.
Age: 1.32
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased activity, Dyskinesia, Eating disorder, Head banging, Speech disorder
Clinical narrative: Patient received DTaP, MMR, varicella on 02-24-2014. Mother states that on that on that evening and since until visit on 02-28-2014. He has had an increase in previous head-banging and rocking behavior, he is less active and less verbal and is not eating as well. No fever or other symptoms seen in office 02-28-2014 with normal exam. Has been referred for developmental evaluation.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot
Clinical narrative: I got really hot and my face, arms, ears, neck and chest were red from about 3 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative who was aware of the information from one of the direct reports of the pharmacist, refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route of administration, dose and lot number were not reported) for prevention of shingles. No other concomitant medications were reported. The patient developed shingles on an unknown date, reported as 2-3 weeks after vaccination with ZOSTAVAX. The outcome of shingles is unknown. No product quality complaints (PQC) were filed. The causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 05-FEB-2014, the patient was vaccinated with expired dose of GARDASIL (lot # 669285/0691AA, 0.5 ml, intramuscular). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report was received from a Pharmacy technician refers to a patient of unknown demography. On 05-DEC-2013, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). It was reported that on 20-FEB-2014, at 8 PM, the patient told the pharmacist that at the injection site there is still small purple raised area that is oval shaped, very red and irritated after the shot on an unknown date in December 2013. The outcome of the events was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a practice manager refers to an unspecified number of patients of unknown age and gender. On 25-FEB-2014 the unspecified number of patient might have been vaccinated with a doses of M-M-R II (hsa) (lot number, dose, frequency, route and site of administration were not reported) that were exposed to temperatures outside of prescribing information that were not supported. No adverse events were reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 30.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: On 2-24-2014 3:20 pm patient received a Tdap in his left deltoid area; he noticed 2-27-14 area below vaccine site red, warm, tender - to doctor's office - evaluated - to return if area expands - 2-28-14 back to office - area expanded below vaccine site - continues to be red, warm, tender antibiotics started 2-28-14.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Severe swelling and tenderness at injection site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Sore arm comes and goes 7 weeks. No treatment. Mentionaed to MD on 2/7/2014.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Convulsion, Dizziness, Electroencephalogram abnormal, Fatigue
Clinical narrative: MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Myalgia, Vision blurred
Clinical narrative: MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Headache, Myalgia
Clinical narrative: MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, swelling, warmth at injection site.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pyrexia, Throat tightness
Clinical narrative: Throat Closing, Difficulty Breathing, Fever 103.7.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Full blood count normal, Influenza virus test negative, Pyrexia
Clinical narrative: Reported fever of 104.5 by mom, 101.5 in office.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Pain & rash resulting in a shingles diagnosis.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood calcium normal, Blood electrolytes normal
Clinical narrative: 2 minutes of seizure with eyes rolled back and to the side, body stiff then limp, not breathing right and turning blue, not responding to eye contact or his name.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood glucose normal, Blood magnesium normal, Blood phosphorus normal, Convulsion, Cyanosis
Clinical narrative: 2 minutes of seizure with eyes rolled back and to the side, body stiff then limp, not breathing right and turning blue, not responding to eye contact or his name.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased eye contact, Full blood count normal, Gaze palsy, Hypotonia, Musculoskeletal stiffness
Clinical narrative: 2 minutes of seizure with eyes rolled back and to the side, body stiff then limp, not breathing right and turning blue, not responding to eye contact or his name.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count increased, Respiration abnormal, Unresponsive to stimuli
Clinical narrative: 2 minutes of seizure with eyes rolled back and to the side, body stiff then limp, not breathing right and turning blue, not responding to eye contact or his name.
Age: 43.0
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in a herpes zoster vaccine recipient. Treated with Valtrex for 7 days. Lasted about 2 weeks. Pain, but no itching. Not hospitalized.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Chills, Rash, Vomiting projectile
Clinical narrative: BEGAN 2 HOURS AFTER VACCINATION, CHILD BEGAN PROJECTILE VOMITING, SHIVERING AND HAD RASH ON ON LEFT LEG. TAKEN TO LOCAL ER.
Age: 0.73
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Localized rash developed around injection site. Small red bumps- approx 2in x 2in.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous report was received from a nurse practitioner and a registered nurse, for GARDASIL, a pregnancy registry product, concerning a 24 year old female patient allergic to latex and cats, with drug hypersensitivity to OMNICEF and no pertinent medical history who on 01-NOV-2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL, (lot number and expiration date not reported) and on 06-MAR-2012 was vaccinated intramuscularly with the second dose 0.5 ml dose of GARDASIL, (lot number 1490AA, expiration date 15-AUG-2014). There was no concomitant therapy. On 06-MAR-2012, the patient had a negative urine pregnancy test. At some unspecified point after the second dose, the patient had sexual intercourse and the condom broke. The patient took PLAN B. Then on an unspecified date the patient had two negative and one positive urine pregnancy test. On 27-MAR-2012, the patient went to the physician's office and a urine pregnancy test confirmed pregnancy. The patient's last menstrual period was on 15-FEB-2012, the EDD was approximately 21-NOV-2012. The patient was given prenatal vitamins (manufacturer unknown). At the time of the report the patient was still pregnant. Follow up information has been received from the nurse practitioner. The reporter stated that a baby was born without incident on 04-AUG-2013. There was no mention in chart of any congenital anomalies and no complications during pregnancy. The baby was male and APGAR scores were 8 and then on second check 9. The birth weight was not available and there was no mention if the patient ever finished her GARDASIL series. There was no information pertaining to a consent form signed by mother for infant's pediatrician. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram, Computerised tomogram abdomen, Dehydration, Irritability, Vomiting
Clinical narrative: Vomiting, dehydration, irritability.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Severe itching, redness around injection site (approx. size 4 x 6 inch area) with small knot in muscle.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever of 104, feeling dizzy and nauseated, vomited 1 time.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Neuralgia, Pain in extremity
Clinical narrative: Patient says the arm was sore when given the immunization that the soreness did not go away, to the point where she can't hardly use the arm. Describes the pain as a nerve pain that was relieved partially when she was on steroids the Her dr had prescribed her on 2/17 for the pain.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Fevers, chills, myalgias, nausea, vomiting, swelling around the area of injection 5X10 cm, redness and indurated, tender and warm.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fevers, chills, myalgias, nausea, vomiting, swelling around the area of injection 5X10 cm, redness and indurated, tender and warm.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bacterial infection, Injection site cellulitis, Injection site infection, Rash papular, Rash pruritic
Clinical narrative: Broke out into a mildly pruritic rash on the torso-papular in nature.  Secondary bacterial infection (cellulitis) at the vaccine site.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bacterial infection, Injection site cellulitis, Rash papular, Rash pruritic
Clinical narrative: Broke out into a mildly pruritic rash on the torso-papular in nature.  Secondary bacterial infection (cellulitis) at the vaccine site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingle break several months after shingles vaccine.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Headache, Pain
Clinical narrative: Varying symptoms for one week, up to and including today - weakness, chills, headache, body aches, cough.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Developed a fever of 102.5 with body aches and then 4 days later developed 6 inch patch of redness at the injection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient came in 02/27/2013 to tell me he still had pain in his left arm. Painful when lifting it up. He said it started after his flu shot in September.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever of 102 that lasted for 18 hours and extreme soreness at injection site that lasted for 2-3 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Depressed level of consciousness, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Redness, swelling. induration, at injection site, elevated temp 100.5, sensorium effect, fatigue...for three to four days...site continued to become more red & swelling with itching ...2+ weeks ongoing....skin became flaky, at and slight small rash.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Rash, Sensory disturbance, Skin exfoliation
Clinical narrative: Redness, swelling. induration, at injection site, elevated temp 100.5, sensorium effect, fatigue...for three to four days...site continued to become more red & swelling with itching ...2+ weeks ongoing....skin became flaky, at and slight small rash.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic, Skin exfoliation
Clinical narrative: Severe itchy rash, peeling skin.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 26 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 05-OCT-2011 was vaccinated with her first dose of GARDASIL (Lot number 670048/0963AA; expiration date 09-NOV-2013) (route not provided). There was no concomitant medication. The nurse practitioner reported that the patient was now 5 weeks pregnant. A home pregnancy urine test was performed, on an unkonwn date, approximately in 2011. The patient sought medical attention. There was no adverse event reported. Last menstrual period was 11-OCT-2011. Estimated delivery date was 19-JUL-2012. The pregnancy outcome was unknown. The outcome of vaccine exposure during pregnancy was unknown. Follow up information was received from the receptionist on 25-FEB-2014. The patient's first visit was on 05-OCT-2011. In September 2012, the patient had an office visit and had a 2 month old daughter. Information about the patient's obstetrics and gynecology (OB-GYN) was not available. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blister, Rash pustular
Clinical narrative: Received Smallpox vaccination and developed erythematous pustules and vesicles down (R) arm (inoculated arm).
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blister, Erythema, Rash pustular
Clinical narrative: Received Smallpox vaccination and developed erythematous pustules and vesicles down (R) arm (inoculated arm).
Sex: U
Vaccine: HIBV, RV5
Symptoms: Adverse event
Clinical narrative: Information has been received from a healthcare worker (purchasing manager) via company representative, and registered nurse regarding an unspecified number of patients of an unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (dose and rout were not provided) (lot # J009725, expiration date 04-MAR-2015) and PEDVAXHIB (dose and route were not provided) (Lot number reported as J010385, expiration date 28-MAY-2016). The registered nurse confirmed that unspecified patients experienced unspecified adverse effects after receiving ROTATEQ and PEDVAXHIB. At the time of the report, the patients outcome was unknown. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Swelling and redness of the whole upper arm to elbow and itchiness. Responded to prednisone after no response to BENADRYL.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Injection site vesicles, Rash papular
Clinical narrative: Vesicules, papular rash, started on trunk, spread to extremities, face, afebrile, happy, playful. One vesicle at approximately VARIVAX inj site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Lymphadenopathy, Upper respiratory tract infection
Clinical narrative: Pt.'s mom reported to Dr. on 02/27/14 during a sib O.V. that pt. 'developed approximately baseball size' area of redness to RA after rec'ng vaccines in office on 02/11/14. Pt. was not brought to office; also reports pt. with 99 degree F temp at same time. No tx. Also reports pt. had 'swollen' glands, but not enough to bring her in for, and dev. URI sx 1-2 days after that.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, indication, route not reported) preventing shingles. On the same day after receiving ZOSTAVAX, the patient developed swelling at the injection site. The patient took BENADRYL and put ice at the injection site on an unspecified date and the swelling went away a "couple days later". The reporter did not provide the seriousness or causality of the event. Additional information has been requested.