chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Injection site bruising, Lethargy
Clinical narrative: This case was reported by a consumer and described the occurrence of sore throat in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included environmental allergy, food allergy, latex allergy and sulfa allergy. Concurrent medications included NORVASC, ALTACE and Vegetarian MVI. On 20 September 2012 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 20 September 2012, within hours of vaccination with FLUARIX, the subject experienced sore throat. On 22 September 2012, two days after vaccination with FLUARIX, the subject experienced big bruise on right arm, headache, coughing, fever and chills. On 26 September 2012, six days after vaccination with FLUARIX, the subject experienced muscle weakness of left arm. At unspecified time after vaccination with FLUARIX, the subject experienced bruise injection site and mild lethargy. The sore throat, fever and chills resolved on 22 September 2012 after treating with ADVIL. On 23 September 2012, the headache resolved. At the time of reporting the bruising of arm improved; cough, weak arm muscles were unresolved; bruise injection site and mild lethargy were unspecified.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of sore throat in a 57-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included environmental allergy, food allergy, latex allergy and sulfa allergy. Concurrent medications included NORVASC, ALTACE and Vegetarian MVI. On 20 September 2012 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 20 September 2012, within hours of vaccination with FLUARIX, the subject experienced sore throat. On 22 September 2012, two days after vaccination with FLUARIX, the subject experienced big bruise on right arm, headache, coughing, fever and chills. On 26 September 2012, six days after vaccination with FLUARIX, the subject experienced muscle weakness of left arm. At unspecified time after vaccination with FLUARIX, the subject experienced bruise injection site and mild lethargy. The sore throat, fever and chills resolved on 22 September 2012 after treating with ADVIL. On 23 September 2012, the headache resolved. At the time of reporting the bruising of arm improved; cough, weak arm muscles were unresolved; bruise injection site and mild lethargy were unspecified.
Sex: U
Vaccine: FLUX
Symptoms: Back pain, Neck pain, Pruritus
Clinical narrative: This case was reported by a healthcare professional (Nurse) and described the occurrence of neck pain in a subject of unspecified age and gender who was vaccinated with influenza vaccine (manufacturer unspecified). On unspecified date(s) in 2012, an unspecified number of subjects received dose of influenza vaccine (intramuscular, details unknown). On unspecified date(s) in 2012, less than one week after vaccination with influenza vaccine, an unspecified number subjects experienced neck pain and back pain. Less than one year after vaccination with influenza vaccine, an unspecified number of subjects experienced itching. The healthcare professional reported that several employees had made complaints regarding neck and back pains almost a week after the flu shot was given (IM). There were a few who complained of itching. At the time of reporting the outcome of the events was unspecified.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Skin test positive
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pruritus in a 54-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to gold, allergy to minocycline, allergy to thimerosal, nickel allergy and allergy to echinacea. Concurrent medications included Lisinopril + hydrochlorothiazide, Levothyroxine, Estradiol, Testosterone cream, Steroid inhaled, Rescue Inhaler and Clindamycin topical. On 9 November 2012, around 14:00 to 14:30, the subject received a dose of FLUARIX (intramuscular, left arm). In November 2012, 24 to 36 hours after vaccination with FLUARIX, the subject experienced injection site pruritus and possible allergic reaction. In November 2012, 48 to 72 hours after vaccination with FLUARIX, the subject experienced injection site rash. Relevant test results included a patch test on 28 November 2012 which "came back positive for allergy to nickel, gold, and thimerosal." The subject was treated with CLARITIN, doxepin and Clobetasol. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Hypoaesthesia, Poor peripheral circulation
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of leg numbness in a female subject of unspecified age who was vaccinated with influenza vaccine (GlaxoSmithKline). In November 2012 the subject received a dose of influenza vaccine (unknown details). In 2012, less than one week after vaccination with influenza vaccine ("about one week afterwards"), the subject experienced leg numbness and lack of blood circulation in both legs. The lack of blood circulation in both legs was described as "a sensation similar to when your circulation has been cut off from sitting on your legs too long." The healthcare professional also reported that "this numbness has made walking more difficult." At the time of reporting the outcome of the events were unspecified.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Expired drug administered, Immediate post-injection reaction, Incorrect dose administered, Off label use
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 45-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to eggs and anaphylactic reaction to vaccine. On 14 December 2012 the subject received 3rd dose, 2nd dose and 1st dose of FLUARIX (.15 mL, unknown) and experienced inappropriate dose of vaccine administered and drug use for unapproved indication. On 14 December 2012, immediately after the 2nd vaccination with FLUARIX, the subject experienced lightheadedness. The subject was administered a three dose split series of 0.15 ml (from 0.5ml), the doses were administered every 20 minutes due to experiencing an anaphylactic reaction seven years ago following flu shot. The subject's job requires her to be vaccinated with flu vaccine therefore the three dose split series was administered by the physician. Right after the 2nd dose of FLUARIX the subject felt lightheaded but the series was completed 20 minutes later with the 3rd dose. After the series was completed the subject went home with EPIPEN and ZYRTEC, however, on follow up the subject did not experience any other reactions and did not need to use the EPIPEN or ZYRTEC. The reporting nurse had inquired about what to do since an expired dose of FLUARIX was administered. At the time of reporting the outcome of lightheadedness was unspecified. The healthcare professional refused to provide complete contact information. Please see A1005612B regarding the subject's anaphylactic reaction seven years ago following flu shot.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with influenza vaccine (manufacturer unspecified). On an unspecified date the subject received a dose of influenza vaccine (unknown details). At an unspecified time after vaccination with influenza vaccine, the subject experienced allergic reaction. No additional details were available at the time of reporting. At the time of reporting the outcome of the event was unspecified. After the next vaccination with influenza vaccine the event recurred. See case A1007735A for details.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of adverse reaction in a female subject aged between 30 and 39 years old who was vaccinated with influenza vaccine (manufacturer unspecified). On an unspecified date the subject received a dose of influenza vaccine (unknown details). At an unspecified time after vaccination with influenza vaccine, the subject experienced adverse reaction. The subject experienced a "reaction with flu shot (unknown brand) that occurred "couple" years ago." At the time of reporting the outcome of the event was unspecified. After the next vaccination with influenza vaccine the event recurred. See case A1008047A for details.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Patient was given the Shingles vaccine 3 weeks prior. Two weeks after the vaccine, he developed a pruritic rash across his upper torso and back. Patient was given shingles vaccine over 3 weeks ago. Within two weeks of vaccine injection, patient developed pruritic maculopapular rash across chest and upper back. Could not identify other possible causes.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 24 year old female patient. On 10-JUL-2013, the patient was accidentally vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) instead of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from pharmacist via company representative refers to a currently 3 week old female patient. In an approximately June 2013, reported as within 2 weeks of date of birth (also reported as within the past week) the patient was vaccinated with a dose of PNEUMOVAX23 (0.5 ml, once). The patient received an injection of PNEUMOVAX23 within the past two (2) weeks of date of birth. In approximately June 2013 (reported as "within the past week") the patient was kept in the hospital for an unspecified period of time after receiving the vaccine, however no adverse effect was reported. Patient sought medical attention. The action taken and the patient's outcome were not reported. The relatedness between PNEUMOVAX23 the patient's event was not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion induced, Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 32 year old female patient who on an unspecified date, was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported). Secondary suspect therapy on an unspecified date, included MMR II (lot #, dose and route not reported). The registered nurse reported that on an unspecified date, the patient found out she was pregnant after receiving VARIVAX (Merck) and MMR II. At the time of the report, the patient's last menstrual period and the estimated delivery date were unknown. No adverse effect known. Follow up information has been received from the registered nurse who reported that the patient had an elective abortion in December 2011. The registered nurse was not sure of the gestational date at termination. She also reported that there was no knowledge of any congenital anomalies in the fetus, but reported that the patient wanted to terminate the pregnancy despite reassurances of positive fetal health outcomes. Upon internal review elective abortion was considered to be a medical significant event. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Pregnancy test negative, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician assistant refers to a approximately 27 year old female patient with no drug reactions/allergies. The patient's medical history included positive ppd test for tuberculosis. On 02-OCT-2012 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number and expiry date not provided), .5 ml, subcutaneous. The patient received the first dose of VARIVAX (Merck) (lot number and expiry date not provided), .5mml, subcutaneous on 07-AUG-2012. The Concomitant therapies included in INH. The patient became pregnant with LMP of 12-Aug-2012 and EDD of 19-May-2013. The pregnancy outcome was pending. On an unknown date the patient became pregnant. On 02-OCT-2012, a pregnancy test prior to administration of VARIVAX (Merck) was negative. An ultrasound performed on 21-DEC-2012 revealed a pregnancy of 14 week gestation. Follow up information has been received from Registered Nurse on14-JUN-2013 concerning female patient who on 02-OCT-2012 was vaccinated at private medical doctor (MD) office/hospital with second dose of VARIVAX (Merck) (lot number H011724, expiry date not provided),0.5 ml and on the same date was vaccinated with the second dose of M-M-R II (0.5 ml, route not reported (lot number H012140, expiry date not provided). The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The patient became pregnant with last menstrual period (LMP) on 12-AUG-2012. Estimated date of delivery (EDD) was reported as 20-JUN-2013. The patient had 2 full term deliveries and 2 previous pregnancies. No defect, stillbirth, miscarriage in previous pregnancies. Prenatal testing included: ultrasound (unrecognizable date) with normal result ultrasound to estimate due date (reported as 21-DEC-2013) and Maternal Serum Alpha-Fetoprotein Screening (MSAFP) performed on 25-JAN-2013 (on patient request) with normal result. It was unknown if the patient experienced local reaction at vaccinated site or if the patient developed varicella or Herpes Zoster symptoms post vaccination. Additional information has been requested.
Sex: U
Vaccine: HEPAB
Symptoms: Intercepted medication error, Product contamination physical
Clinical narrative: Product: TWINRIX -Hepatitis A & B recombinant vaccine- 1mL prefilled syringe Manufacturer: GlaxoSmithKline NDC: 58160-815-52 Lot: AHABB260AB Expiration date: 11/14/14 Nurse was preparing syringe for injection and noticed a white particle floating in 1 of 10 syringes. Initially, it was thought to be undissolved portion of suspension, however after vigorous shaking, suspension was uniformly dispersed throughout & particle remained. Prior to event, product was kept refrigerated at the appropriate temperature. The identified syringe was not used, and the remaining syringe from this package were sequestered. One syringe out of package was administered to a patient prior to this event.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female with none drug reactions a history of sickle cell trait, who on 09-JAN-2012 was vaccinated SQ with a dose of VARIVAX (Merck) (dose unknown, Lot # 670559, 0864AA) while she was pregnant, (exp. 06-JUN-2013). Concomitant therapy included pregnancy vitamins (unspecified). The estimated delivery due date was 13-AUG-2012 and last menstrual period was approximately 07-NOV-2011. Pregnancy test and ultrasound were performed. No adverse effect reported. The patient sought unspecified medical attention. Follow-up information has been received from an OB/GYN physician concerning the patient with 0 number of previous pregnancy who on 09-JAN-2012 (also reported as 09-JAN-2011) was vaccinated SQ with a dose of VARIVAX (Merck) (0.5 mL, Lot # 670559/0864AA). The patient was tested for varicella antibodies before vaccination with VZV containing vaccine on 27-DEC-2011 and the result was positive. The date of last menstrual period was unspecified and the estimated delivery date was 13-AUG-2012. Ultrasound test was performed on 12-MAR-2012 for level ii sono and the result was noseval accessory. No maternal adverse event reported. Follow up information received from a physician refers to a female patient that the patient delivered a full term healthy infant at 39 weeks on 08-AUG-2012. The physician did not report the infant's weight or sex, but reported that there were no abnormalities in the delivery record. She also reported that two gestational ultrasounds done during pregnancy showed no congenital anomalies in the fetus. There was no further information reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 13-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006245 and 1306USA007793. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 12-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006245, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with second dose of GARDASIL intramuscular for prophylaxis (dosage information not provided). On an unknown date the patient experienced syncope. The patient sought medical attention by an emergency room visit on an unspecified date. The outcome of syncope is unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a Registered Nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female patient with no pertinent drug reaction/allergies and no medical history who approximately on 10-JAN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 670329/0611AA, expired date 30-JAN-2014), one shot. There was no concomitant therapy. When the patient received the dose of VARIVAX (Merck), she was pregnant for "3 weeks and 5 days". Her last menstrual period was on approximate 20-DEC-2011 and estimated delivery is on 25-SEP-2012. No adverse event was reported. No treatment was given for this event. The patient sought unspecified medical attention. Follow up information was received from the registered nurse and she did not have any pregnancy outcome information and could not find the patient's record in the medical record system. Case is lost to follow up. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On 12-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees Centigrade for 19 hours. No adverse effects were reported. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006245, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding two pediatrics patients of unknown age and gender. Pertinent medical history, drug reaction/allergies were not provided. On an unknown date, on approximately June 2013, "recently", patients received a first dose of VAQTA, (Lot number and expiration date were not provided). Co-suspect therapy and concomitant medication were not provided. On an unspecified date, a second dose of VAQTA was recently administered at a 5 month interval from the first dose. No adverse effects were reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Human chorionic gonadotropin positive, Maternal exposure before pregnancy, Nausea, Viral test negative
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 37 year old female with anaemia and no drug reactions/allergies who on 06-JAN-2012 was vaccinated with VARIVAX (Merck) (Lot#: 670656/0783AA, Exp Date: 24-MAY-2013, route not reported). Concomitant therapy included iron and vitamin D. The physician was reporting that the patient became pregnant after receiving the dose of VARIVAX (Merck). The patient complained of pregnancy symptoms such as dizziness and nausea which happened "several weeks ago". The patient sought unspecified medical attention and the patient's pregnancy had been confirmed by urine pregnancy test. Her Last Menstrual Period (LMP) was on 30-DEC-2011. Expected date of delivery was 05-OCT-2012. Follow up information was received from the physician concerning the female patient who on 06-JAN-2012 was vaccinated with a dose of 0.5 mL VARIVAX (Merck) (Lot#: 670656/0783AA). The patient was tested for varicella antibodies before vaccination with VZV containing vaccine on 24-OCT-2011 with a negative result. The patient's Last Menstrual Period (LMP) was on 30-DEC-2011. Expected date of delivery was 03-OCT-2012 (also calculated as 05-OCT-2012). The patient had 2 previous pregnancies with 2 full-term deliveries. No birth defects occurred in any previous live births. No miscarriage or stillbirth occurred in any previous pregnancy. No local reaction happened at vaccination site. No varicella (chickenpox) symptoms happened post vaccination. No herpes zoster (shingles) symptoms happened post vaccination. Follow-up information was received from the healthcare worker on 10-JUL-2013. Healthcare worker reported that the patient never returned to their office for care. The office did not have any information on the patient's pregnancy outcome or where the patient went for prenatal care. Case was lost to follow-up. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to a patient of unknown age and gender. On 05-JUL-2013 the patient was vaccinated with an improperly stored dose of PROQUAD (lot # J002933, expiration date 12-SEP-2014 and route not reported). The nurse reported that PROQUAD was stored at 20 Fahrenheit (F) for 144 hours. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. In approximately June 2013 (about a month ago) the patient was vaccinated with the second dose of GARDASIL (lot # unspecified) for prophylaxis. On an unknown date the patient experienced unspecified joint pain after vaccination. The physician reported that the patient would not receive the third dose of GARDASIL. The outcome of unspecified joint pain was unknown. Unspecified laboratory tests were performed. The patient had sought medical attention via calling the physician. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a  patient of unknown age and gender. On 07-JUN-2013 the patient was vaccinated with a dose of GARDASIL (lot # H021608, exp. date 13-AUG-2013) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1C for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1306USA007793, 1307USA006245, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. On 11-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees Centigrade for 19 hours. No adverse effects were reported. This is one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Edema, erythema, low grade fever (left arm) - injection site.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse practitioner for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 07-OCT-2011 was vaccinated with the first dose of VARIVAX (Merck) and on 07-NOV-2011 was vaccinated with the second dose of VARIVAX (Merck) (Lot numbers, doses and routes not reported). There was no concomitant medication. The nurse practitioner reported that the patient was administered with VARIVAX (Merck) while she was pregnant. Her last menstrual period (LMP) was on 13-OCT-2011 and her expected delivery date (EDD) was 19-JUL-2012. No lab diagnostics studies were performed. No adverse effects were reported. Follow up information was received from a Certified Registered Nurse Practitioner (CRNP) refers to the patient that the delivered a healthy baby girl full term at 39 weeks (14-JUL-2012) and the infant had no congential anomalies. The infant weight was unknown at the time of the report but was told that all was good with the child. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Pt's LMP 11/5/12 had to Tdap 11/15/12. Pt was early pregnant baby now has hypoplastic Lt heart.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from registered nurse (R.N.) for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 16 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 10-JAN-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 670249/0461AA (dose and route not reported), exp. date 31-MAR-2013. There was no concomitant medication. Registered nurse reported that on 10-JAN-2012, the patient who was pregnant received a dose of VARIVAX (Merck). Lab test included urine pregnancy test. LMP was 14-DEC-2011 and EDD is 19-SEP-2012. No adverse effect reported. Follow up information has been received from the registered nurse who reported that the patient never returned to the clinic for any care and had no information regarding her prenatal care or pregnancy outcome. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Inflammation
Clinical narrative: 11x12 cm round red inflammed area.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness
Clinical narrative: Approx. 5 mins after vaccination in (L) arm, pt felt (R) hand weakness that lasted 1 hr, then resolved. Also experienced 5 mins of (L) hand weakness during episode. Now resolved with no lingering effects.
Age: 53.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test normal, Cardiac stress test normal, Chest pain, Rash
Clinical narrative: 7/5/13 Seen in clinic for rash/given BENADRYL. 6/25/13 Hospitalized for 2 days with chest pain on (L) side and radiating into (L) arm. Had 2 day Cardiolyte Stress tests - negative. Developed rash. Questioning whether the prodrome to chicken pox was the instigating factor to his left sided chest pain.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Administered 4 PM reaction 8 PM. Went to ER.
Age: 19.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Dyspnoea, Flushing, Pruritus, Rash, Skin lesion
Clinical narrative: C/o of dyspnea, flushing, pruritus, lesion to the face and upper chest and rash. 20 mins after vaccines and receiving Bicillin. RECEIVED BENADRYL 25 MG. AND EPI .03 Subq OG EPI.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Hypersensitivity, Swelling face
Clinical narrative: Parents brought child to ER with concern of facial swelling/allergic reaction. ER notes state: 'Well child check. I am not seeing any obvious sign of allergic reaction or respiratory distress and child appears to be well hydrated.' Review of systems noted on record were all normal except for temp of 99.3.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sore, red and a little swollen at injection site. Ice 10-15 minutes 3-4 times daily, Motrin, HC cream.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Red dots to trunk A/P.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Induration, Mass, Pruritus, Swelling
Clinical narrative: PT stated she felt hard lump the evening following her injection.  Pt states she saw swelling and redness along with itching the day after, and subsequently reported to the immunizations clinc. Denies any other symptoms.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Haematoma, Headache, Immediate post-injection reaction, Injection site discomfort
Clinical narrative: Immediate discomfort at injection site. The following day Pt developed a low fever of 99.1 and began experiencing headaches. Pt has a hematoma from 1 inch below her left shoulder continuing halfway to her elbow. Pt states the day after her left arm was bruised and swollen.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Immediate discomfort at injection site. The following day Pt developed a low fever of 99.1 and began experiencing headaches. Pt has a hematoma from 1 inch below her left shoulder continuing halfway to her elbow. Pt states the day after her left arm was bruised and swollen.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right thigh with 10 mm area of erythema-non tender.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right thigh-15 mm area of erythema-non vesicular.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Feeding disorder of infancy or early childhood, Infantile spitting up, Irritability, Pyrexia, Screaming
Clinical narrative: Baby never really stopped screaming and fussing after vaccines. About 4pm same day a low grade fever set in. The next day and for the following week she would hardly eat and when she actually did eat, about 1/3 came back up. This lasted for a little over a week. Treated with Tylenol, called office and they said it sounded like typical reaction and wouldn't last.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: 5cm. round red area R arm itchy induration. 15 X 10 cm. area with red, warm induration which includes a 4X4 cm. area of vesicles at the injection site.
Age: 20.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm swelled to a baseball size knot that was red, hot and itchy. Went to ER.  Diagnosed as cellulitis and received antibiotics.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Herpes zoster in a person previously vaccinated with herpes zoster vaccine.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella virus test
Clinical narrative: Labs indicated a <0.9 Varicella IgG and was provided a Varicella Vaccination on 7/3/2013. He was housed with someone who also had a <0.9 Varicella IgG and was provided a Varicella Vaccination on 7/3/2013. Both patients were vaccinated with the same Merck Varivax Lot#H021386 Expiration date 30NOV14 and both developed Varicella within 7 days of the vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle mass, Pruritus, Skin warm
Clinical narrative: Itching, redness, warm to touch and hard lump in the muscle tissue.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Immediate post-injection reaction, Infantile spitting up
Clinical narrative: The patient showed several signs of a dairy allergy immediately following his second DTaP vaccine (Brand used was Sanofi Pasteur).  His first bowel movement following his second DTaP vaccine was drastically different than normal.  He had been exclusively breastfed, and up until this day his bowel movements were completely normal.  Immediately following the vaccine, he had diarrhea that was green, had mucous in it, and smelled extremely bad.  Normal breastfeed bowel movements are yellow-ish, don't have much of a smell and don't have a mucous consistency to them.  Before this DTaP vaccine, his skin was completely clear of any eczema, rash, or redness.  Immediately following this injection, his skin broke out in a red, bumpy rash.  His face was the portion of his skin that was the most red and bumpy.  The rest of his body was covered in these small bumps, but weren't as red as his face. Each time he would nurse, his face would get more red.  He also began spitting up an excessive amount following this vaccine.  He spit up before hand, but after the second DTaP vaccine, his spit up increased in frequency and volume.  His spitting up would continue from one feeding to the next (three hours lapsed between daytime feedings).  After two weeks of these symptoms showing no signs of dissipating, I consulted patient's physician and he suggested taking dairy products out of my diet to see if he had a dairy allergy. I stopped eating all dairy products and after about a month, I saw cessation of all of the above listed symptoms in patient.  I re-introduced dairy into my diet to see if the symptoms would return, and they did immediately.  After discontinuing dairy products again in my diet, his symptoms again stopped.  He has not had any blood work done to test for a dairy allergy, but I believe it has been confirmed from this trial and error of removing and reintroducing dairy into my diet.  My suspicion is that the casamino acid in the Sanofi Pasteur DTaP vaccine is what caused his dairy allergy.  There is no history of dairy allergies in his immediate or extended family.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Milk allergy, Rash erythematous, Rash generalised
Clinical narrative: The patient showed several signs of a dairy allergy immediately following his second DTaP vaccine (Brand used was Sanofi Pasteur).  His first bowel movement following his second DTaP vaccine was drastically different than normal.  He had been exclusively breastfed, and up until this day his bowel movements were completely normal.  Immediately following the vaccine, he had diarrhea that was green, had mucous in it, and smelled extremely bad.  Normal breastfeed bowel movements are yellow-ish, don't have much of a smell and don't have a mucous consistency to them.  Before this DTaP vaccine, his skin was completely clear of any eczema, rash, or redness.  Immediately following this injection, his skin broke out in a red, bumpy rash.  His face was the portion of his skin that was the most red and bumpy.  The rest of his body was covered in these small bumps, but weren't as red as his face. Each time he would nurse, his face would get more red.  He also began spitting up an excessive amount following this vaccine.  He spit up before hand, but after the second DTaP vaccine, his spit up increased in frequency and volume.  His spitting up would continue from one feeding to the next (three hours lapsed between daytime feedings).  After two weeks of these symptoms showing no signs of dissipating, I consulted patient's physician and he suggested taking dairy products out of my diet to see if he had a dairy allergy. I stopped eating all dairy products and after about a month, I saw cessation of all of the above listed symptoms in patient.  I re-introduced dairy into my diet to see if the symptoms would return, and they did immediately.  After discontinuing dairy products again in my diet, his symptoms again stopped.  He has not had any blood work done to test for a dairy allergy, but I believe it has been confirmed from this trial and error of removing and reintroducing dairy into my diet.  My suspicion is that the casamino acid in the Sanofi Pasteur DTaP vaccine is what caused his dairy allergy.  There is no history of dairy allergies in his immediate or extended family.
Age: 36.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Sweaty, dizzy, dry heaves, tired, experienced nausea, site tenderness, swollen and redness about golf ball size and warm to the touch.
Age: 36.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Nausea, Retching
Clinical narrative: Sweaty, dizzy, dry heaves, tired, experienced nausea, site tenderness, swollen and redness about golf ball size and warm to the touch.
Age: 31.0
Sex: F
Vaccine: HEPATYP, JEV1, PPV, TYP
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: Fever-Temp 101- 103 degrees, swelling in upper rt arm with tenderness -pain rated 8 on scale 1-10. States she can not lift arm due to pain.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Pyrexia, Screaming
Clinical narrative: Would not stop screaming, fever of 100.4.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Local reaction, Oedema peripheral
Clinical narrative: Patient expereinced significant swelling of entireupper arm.  Initial visit to clinic MD believed it was infection.  Pt returned to clinic next day, and her primary care provider deemed it a localized allergic/adverse reaction. Received cephalexin, methylprednisolone, and loratadine.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Local swelling, Swelling face, Throat tightness
Clinical narrative: Face and neck swelling, tightness in throat and chest, trouble breathing.  Lasted until the hospital gave him an epinephrine shot.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Face and neck swelling, tightness in throat and chest, trouble breathing.  Lasted until the hospital gave him an epinephrine shot.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: 35 weeks pregnant.  Water broke while in bed sleeping.  Son was born premature on 11/11/2011.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and mild swelling around vaccination administration site persisting approximately one week after vaccine was administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 27-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot # not provided)(dose not provided). No other co suspects were reported. No concomitant therapy was reported. On 27-JUN-2013 when the patient received ZOSTAVAX and she had a red, itchy rash that resembled a gardening type of rash. The nurse stated the rash became more painful 2 days after the patient received ZOSTAVAX and the patient was then diagnosed to have shingles. The patient sought medical attention at office visit. The outcome of the patient was then diagnosed to have shingles, the rash became more painful, itchy rash and she had a red was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No known drug allergies were reported. The patient had never had chicken pox. On 27-JUN-2013 at 10:00 am, the patient was vaccinated with ZOSTAVAX (lot # H020683, exp. date 15-FEB-2013), 0.65 ml, subcutaneous. Concomitant medications included unspecified antihypertensive medication. On 27-JUN-2013, "around 08:00 pm" the patient began vomiting and "vomited all night until the morning". The pharmacist reported that the patient was "very weak". The pharmacist advised the patient to drink GATORADE and replenish her fluids and electrolytes so that patient did not get dehydrated. The outcome of events was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Initial information has been received from a physician concerning a baby patient of unknown age, unknown gender, unspecified pertinent medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with ROTATEQ, oral (duration, dose, frequency were not reported). No other co-suspect medications were reported. No concomitant medications were reported. It was reported that on an unknown date, after administering ROTATEQ to the "baby", the "baby" regurgitated. Treatment was not reported. The patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer reporting on himself, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that on an unknown date, he developed shingles after receiving ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Splenic haematoma, Vomiting
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a male patient of unknown age with no pertinent medical history reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies were reported. Concomitant medications included fish oil (dosage and manufacturer unspecified). On an unknown date the patient developed an hematoma on the spleen, high fever and vomiting after receiving the GARDASIL shot. The patient was hospitalized and the hospital was monitoring the patient but no treatment was being given (length of stay unspecified). The outcome for hematoma on the spleen, high fever and vomiting was unknown at the time of the report. The reporter did not assess the causality between hematoma on the spleen, high fever and vomiting and GARDASIL. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Splenic haematoma, Vomiting
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a male patient of unknown age with no pertinent medical history reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies were reported. Concomitant medications included fish oil (dosage and manufacturer unspecified). On an unknown date the patient developed an hematoma on the spleen, high fever and vomiting after receiving the GARDASIL shot. The patient was hospitalized and the hospital was monitoring the patient but no treatment was being given (length of stay unspecified). The outcome of hematoma on the spleen, high fever and vomiting was unknown at the time of the report. The reporter did not assess the causality between hematoma on the spleen, high fever and vomiting and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist. The pharmacist reported that an unknown number of doses of RECOMBIVAX HB, that were improperly stored at 15 degrees F for 21 hours, the doses may have been administered. Additional information is not expected.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that a 19 year old patient (gender not provided) was administered a pediatric dose of VAQTA, 0.5 ml, intramuscular (lot # not reported) on 03-JUN-2013. No adverse effect reported. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 73 year old female patient. On 05-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # H017759, (exp. date 04-JUL-2014) 0.5 ml, (route reported as injection). On 07-JUN-2013, the patient returned to the office with extreme swelling, pain, tenderness at the injection site. The swelling was said to measure 4 and a quarter by 12 and a quarter inches in diameter and spread toward the elbow. On an unknown date in June 2013 the patient experienced limited arm mobility. The patient was treated with ROCEPHIN and other unspecified antibiotics for two days. The patient improved after antibiotics, but limited arm mobility continued for several days. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source (related MARRS # 1307USA001665). Additional information has been requested.