chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Painful, swollen lymph glands in left axilla & at site of injection swelling, redness & skin hot to touch. Approximate area on upper left arm 4 inches x 6 inches.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Pain, Somnolence
Clinical narrative: Hurt/ached from head to toes - even tips of fingers hurt. Very tired. Began feeling symptoms in eve of 9/24. Felt poorly 9/25 - went home early. Slept all day 9/25. Felt 100% better 9/26.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site pruritus, Local reaction
Clinical narrative: Within minutes following injection, pt began to complain of itching at injection site. Then developed erythema & edema. Reaction remained localized. BENADRYL administered. Symptoms subsided by following day, was able to resume normal activity.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: About 5 days after TDAP (9/10/12), pt. claims hives to back, abd., unclear if related to vaccine. Pt. still having hives.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 66 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 01-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX vial, 1 vial (lot #: H012575; Expiration date: 28-SEP-2013). Concomitant vaccination included a dose of FLUZONE. On 02-OCT-2012, the patient developed 2 inch in diameter of redness and soreness at the site of ZOSTAVAX. The patient's wife called the pharmacist to seek medical attention. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient was recovering from the events. The relatedness for 2 inch in diameter of redness and soreness at the site of ZOSTAVAX vaccination and 2 inch in diameter of redness and soreness at the site of ZOSTAVAX vaccination was unknown for ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Swollen tongue
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated intramuscularly with a 0.65 ml second dose of GARDASIL (lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient's tongue swelled up after receiving her second dose of GARDASIL on 16-OCT-2012. The patient went to the emergency room. No treatment information was reported. The outcome of tongue swelled up after receiving her second dose of GARDASIL was unknown. The relatedness for the reported event was not provided for GARDASIL. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that the office improperly stored GARDASIL. It was possible that an unspecified number of patients might have received the improperly stored GARDASIL but the nurse was not sure. No symptoms reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 17-AUG-2010. The patient received the second dose of GARDASIL on 02-SEP-2010. Another dose of GARDASIL was given on 26-OCT-2010. The office would administer a dose of GARDASIL on today 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 years old male patient. The patient was vaccinated intramuscularly in the left arm with the first 0.5 ml dose of GARDASIL on 20-DEC-2011. The second dose was administered on 08-AUG-2012 and the third dose (Lot # 0636AE, in validation, expiration date 09-JAN-2015) was given too early on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 years old female patient. The patient had no medical history or drug reactions/allergies. The patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 15-OCT-2012. Lot number H009746 (under validation), exp date 11-JAN-2015. No other co-suspects were reported. NO concomitant medications were reported. On 15-OCT-2012 the patient vomited uncontrollably starting 15 minutes after administration of her first dose of GARDASIL. No laboratory tests were performed. Treatment included ZOFRAN and patient completely recovered the same day. The relatedness for vomited uncontrollably was unknown for GARDASIL. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This spontaneous report as received from a 25 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) sometime in February 2012 and the last dose of GARDASIL (lot #, dose and route not reported) was given 2 weeks late according to the recommended schedule in August 2012. No other co-suspects were reported. Concomitant medications included: ORTHO TRI-CYCLEN LO. The patient stated that she had begun losing hair since having the vaccination. Her hair loss began approximately in June 2012 and had gotten progressively worse  through August. At the time of the report she was still losing hair. The patient explained that the hair loss had not occurred in patches, but in overall thinning. She also stated that she had developed pain in her legs to the point of needing daily massages. The patient sought unspecified medical attention, no lab diagnostic tests were performed and no treatment was given for the events. The relatedness for the events was not provided for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an Immunization Official refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient received GARDASIL that was stored improperly at 31F for 84 hours. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: This spontaneous report was received from a physician, as part of a marketing research program regarding a 14 year old female patient in approximately March 2012 (reported as spring 2012), the patient was vaccinated with a dose of GARDASIL lot number was not reported. No concomitant medications were reported. On an unknown date, the patient stated that she was hurt immediately after dosing. No treatment information was reported. The outcome of the event was reported as recovered/resolved with sequelae. The physician considered the event was related to the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient was vaccinated with dose 1 and 2 of GARDASIL on an unknown dates (dose, route, site of administration and lot # not reported). It was reported that on an unknown date, the patient received her second dose of GARDASIL 2 years after she received her first dose and the patient was HPV positive when she received her second dose. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 69 years old female patient who on 15-OCT-2012, was vaccinated subcutaneously on her right arm with a 0.65 ml dose of ZOSTAVAX (lot number H011427, Exp. Date: 12-SEP-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 17-OCT-2012, the patient called the pharmacy stating she had swollen lymph nodes under her right armpit, and a red, swollen area at the injection site of the right arm. BENADRYL was given as a treatment for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by calling to pharmacy this morning on 17-SEP-2012. The relatedness for patient had swollen lymph nodes under right armpit, swollen and red area at injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site induration
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 71 years old female patient with penicillin allergy. The patient's medical history included breast cancer in 2002. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011427, expiration date 12-SEP-2013) SQ in the left arm on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 11-OCT-2012, immediately after withdrawing the needle, the patient developed a hardened bubble at the injection site. The bubble enlarged but subsequently stabilized. The injection site bled for a short time then resolved. On 12-OCT-2012, the pharmacist called the patient, the bubble had resolved and there was a quarter sized blue area at the injection site and the patient was recovering. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX on 19-SEP-2012. (Lot number was not reported, Expiration date 26-JUL-2012). Concomitant medications were not reported. The reporter stated that the patient received ZOSTAVAX on 19-SEP-2012 that had expired on 26-JUL-2012. The patient did not experience any known symptoms. No treatment information was reported. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 03-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX vial, 1 vial (Lot #: H012575: Expiration Date: 28-SEP-2013). Concomitant medications included: FLUZONE. In October 2012, the patient developed 2 inches of redness and soreness at the site of ZOSTAVAX. The patient sought medical attention by calling the pharmacist. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, in October 2012, the patient's outcome of 2 inches of redness and soreness at the site of vaccination was reported as recovered/resolved. The relatedness for 2 inches of redness and soreness at the site of ZOSTAVAX vaccination was unknown for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 62 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX (once, lot number not provided) on approximately 08-OCT-2012, a week ago. No other co-suspects were reported. No concomitant medications were reported. The following day, on 09-OCT-2012 the patient came back to the office because the injection site was red and hot. The next day, on 10-OCT-2012 the patient came back again because the reaction area was larger and there was a white spot in the middle, which the doctor thought could be an infection. The doctor also stated that there were vesicles and that it could be rash. Antibiotics and steroids were given as treatment for adverse event. Adverse event improved after stopping therapy. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report as received from a 74 year old female consumer reporting on herself with no drug reactions or allergies. The patient's medical history included mini stroke. The patient was vaccinated with ZOSTAVAX in September 2012 (dose, route and lot # not provided). No other co-suspects were reported. Concomitant medications included folic acid, fexofenadine hydrochloride, ALLEGRA-D, NEXIUM, CELEBREX, alprazolam, chloroquine, furosemide (manufacturer unknown), sertraline hydrochloride, naproxen, verapamil, tramadol hydrochloride, phytonadione, omega-3 marine triglycerides, calcium (unspecified), iron (unspecified), CENTRUM SILVER. The consumer stated that in September 2012 about a week after receiving ZOSTAVAX she developed shingles. The patient stated that her physician was not available so she was diagnosed by clinic. After that her physician was made aware. She reported that it was a mild case but was directed to call by an unspecified pharmacist. Unspecified cream was given as a treatment. A blood work was performed (no results provided). The outcome of shingles was reported as recovering. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 62 years old female patient with hypertension and no drug reactions/allergies who on 13-OCT-2012, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# H012650, exp date 27-FEB-2014). Concomitantly, the patient had been vaccinated on 06-OCT-2012 with a dose of influenza virus vaccine (unknown) given in the same arm. It was reported that on 14-OCT-2012, the patient returned to the pharmacy complaining of soreness at injection site along with swelling around surrounding area. The pharmacist checked the patient's blood pressure which was "fine". The pharmacist stated that this morning "on 15-OCT-2012" the patient had a little bit of soreness and swelling went down. Compressions did help. The patient was treated with TYLENOL. At the time of the report, the patient's soreness was recovering. The patient recovered from swelling around surrounding area. The relatedness for soreness at injection site and swelling around surrounding area was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 years old female patient (age at the time of reporting). On an unknown date, the patient was vaccinated with ZOSTAVAX. The dose, route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed a huge water blister the size of a lemon, at the injection site. No treatment information was reported. The outcome of huge water blister the size of a lemon, at the injection site was unknown. The relatedness for huge water blister the size of a lemon, at the injection site was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on an unknown date, was vaccinated with ZOSTAVAX (dose, route and lot number not reported) instead of his first dose of VARIVAX (Merck). No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. The route and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date a couple of days after vaccination, the patient came back to pharmacy with redness on the arm and some warmth to the touch. The patient did not seek medical attention. No treatment information was reported. The outcome of redness on the arm and some warmth to the touch was reported as recovering/resolving. The relatedness for redness on the arm and some warmth to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of age in her 50's. There was medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 28-OCT-2011, second dose on 29-NOV-2011 and the third dose on 27-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician's office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case was linked to case # 1210USA006250 and # 1210USA006251 (due to the same reporter link). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age who on 15-OCT-2012 was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. It was reported that the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number unknown) on 05-SEP-2012, which had expired on 31-AUG-2012. No concomitant medications were reported. No adverse effect was reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a 59 year old female consumer regarding herself. The patient had no pertinent medical history. The patient had drug reactions or allergies to doxycycline that had caused a rash and ANAPROX that had caused severe stomach pains on unknown dates. On 02-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number unspecified). Concomitant medication included HYZAAR. The patient experienced cold sores on four separate occasions. Approximately on 15-JUL-2012 ('in mid July 2012'), the patient experienced 1st cold sore and she recovered in 10 days (on an unknown date in 2012). On an unknown date in 2012, she experienced 2nd cold sore and she recovered in 10 days (approximately in 25-JUL-2012). Approximately in August 2012, she experienced 3rd cold sore and she recovered in 10 days (approximately in August 2012). On an unknown date in 2012, she experienced 4th cold sore and she recovered in 10 days (on an unknown date in 2012). She sought medical attention (she had called to physician's office). The patient took valacyclovir hydrochloride (reported as valcyclovir) as a treatment at each time of the cold sore occurrence. There were no laboratory studies performed. The relatedness for cold sores was unknown for ZOSTAVAX. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Pallor
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67-year-old male patient. On 19-SEP-2012 the patient was vaccinated with dose 1, 0.65 milliliters (ml) ZOSTAVAX (lot # 0564AE, expiration date 21-MAR-2013) subcutaneously. No concomitant medications were reported. The reporting pharmacist stated that the patient's wife called on 20-SEP-2012 and reported that the patient was complaining of "being weak, not feeling well and was pale". Treatment information was unspecified by the reporter. Outcome of the reported events was unknown. No further information was provided. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of age in his 50's. No medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 28-DEC-2011, second dose on 01-FEB-2012 and the third dose on 28-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, on an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician's office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case is linked to # 1209USA005863 and # 1210USA006250. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of age in her 50's. There was no medical history and no known drug reactions or allergies was reported. The patient was vaccinated with a dose of 1 ml of RECOMBIVAX HB (lot number reported as 1106AA and expiry date unspecified) given intramuscularly with first dose on 19-OCT-2011, second dose on 18-NOV-2011 and the third dose on 18-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in 2012, the patient experienced negative hepatitis B surface antibody titers. No treatment was given. The patient sought medical attention and visited the physician's office. The outcome of negative hepatitis B surface antibody titers was not recovered at the time of report. The relatedness for the event was unknown for RECOMBIVAX HB. The patient was in the process of repeating the 3 dose series of RECOMBIVAX HB. The case is linked to # 1209USA005863 and # 1210USA006251 (Due to same reporter link). Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 83 years old female patient with atrial fibrillation, GERD, iron deficiency and allergy to DARVOCET, who on 02-OCT-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) at local pharmacy. No other co-suspects were reported. Concomitant medications included INDERAL, trazodone hydrochloride, PRILOSEC, cyanocobalamin and VERAMYST. On 02-OCT-2012, one hour after receiving ZOSTAVAX, patient experienced hives starting in abdomen and then 3 hours after receiving ZOSTAVAX the hives were "all over". ALLEGRA was given as a treatment. Patient was seen in the office where doctor diagnosed hives and diffuse urticaria. No laboratory diagnostic studies were performed. The outcome of hives all over/diffuse urticaria was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 25 year old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated subcutaneously with dose 1 MMR II (lot # and dose not reported) as a child on 01-MAR-1989 and was vaccinated subcutaneously with dose 2 MMR II (lot # 1579AA; exp date 12-OCT-2013) (dose not reported) on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and ENGERIX-B. The nurse practitioner reported that the patient performed a "home pregnancy test" on 21-SEP-2012 and a confirmatory home pregnancy test on either 22-SEP-2012 or 23-SEP-2012 and these tests noted she was pregnant. Her LMP was on 18-AUG-2012, the EDD was 25-MAY-2013. The patient went into the office of the reporting nurse and no treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 16-OCT-2012, the patient was vaccinated with an expired dose of PNEUMOVAX 23 INJ, (dose and route were not provided) (lot number 669579/0595AA, expiration date 30-AUG-2012). No symptoms reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 44 years old female patient who on 28-AUG-2012, was vaccinated subcutaneously with the first 0.5 ml dose of M-M-R II (lot number 1117AA, Exp. Date: 12-JUL-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 04-OCT-2012, the patient failed to seroconvert and showed no titers against to rubella when was tested on the same day. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient failed to seroconvert and showed no titers against rubella was unknown for M-M-R II. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age who on 05-OCT-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 70 years old female patient with diabetes under control and no known allergies, who on 02-OCT-2012, was vaccinated subcutaneously on her left arm with a 0.65 ml dose of ZOSTAVAX (lot number 0468AE, Exp. Date: 04-APR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist that on 14-OCT-2012, the patient came into the pharmacy with was appeared to be shingles. The patient was seen by her doctor and shingles were confirmed on an unknown date, in October 2012. The patient was treated with a unspecified antiviral and was giving a unspecified steroid shot. At the time of the report, the patient was improving. The relatedness for patient was diagnosed with shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age who on 01-OCT-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age who on 28-SEP-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age who on 27-SEP-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a newborn infant. The patient was vaccinated intramuscularly with dose 1 and 2, 0.5 ml RECOMBIVAX HB (lot# not reported) on 16-OCT-2012. The doses were given a few hours apart. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers his aunt of unknown age, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "as of the last several weeks of month" on an unknown date, his aunt developed shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient had developed shingles was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 4 patients of unknown ages who at "varying" dates, on an unknown date, were vaccinated with a dose of ZOSTAVAX (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "as of the last several weeks of month" on an unknown date, the patients developed shingles. No treatment information was reported. At the time of the report, the patients' outcome was unknown. It was reported that an unspecified number of those 4 patients did see the physician for a follow up visit. The relatedness for 4 patient had developed shingles was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to two patients of unknown age. The patients were vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # H013399; exp date 13-OCT-2012) on 13-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 13-OCT-2012 the patients developed arthralgia, fatigue and pain at the injection site after receiving PNEUMOVAX 23. The patients sought unspecified medical attention and were given unspecified antibiotics and antihistamines as treatment. The outcome of arthralgia, fatigue and pain at the injection site was unknown. The relatedness for the reported events was not provided for PNEUMOVAX 23. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Nurse concerning to a 5 years old child male patient who was vaccinated with a 2 and final dose of VARIVAX (Merck) (dose, route and lot # not provided) "injection" in "late" August 2012 approximately on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that in the end of September 2012, approximately on 30-SEP-2012, the patient developed "chickenpox" about 3 to 4 weeks later" after being administered the vaccine. The nurse also stated that the patient went to unspecified "urgent care" facility for an unspecified duration and was diagnosed with the chickenpox there. The patient saw the physician a couple of days later and he confirmed the diagnosis. At the time of the report, the patient's chickenpox had improved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with ZOSTAVAX on 12-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient received only a partial dose of ZOSTAVAX due to a syringe malfunction. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Doctor of pharmacy concerning a patient of unknown age and gender. On 18-SEP-2012, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23, intramuscularly. Lot number and expiry date was reported as 669579/0595AA and 31-AUG-2012 respectively. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Soreness, inability to use or raise arm, swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Soreness, inability to use or raise arm, swelling.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Erythema, Inflammation, Pharyngeal oedema, Urticaria
Clinical narrative: Anaphylaxis. Hives, throat closed. Epi pen administered. Transported to hospital via ambulance.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Throat tightness, Urticaria
Clinical narrative: Anaphylaxis. Hives, throat closed. Epi pen administered. Transported to hospital via ambulance.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Itching, hives, redness at injection site.
Age: 11.0
Sex: F
Vaccine: HPVX, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at the time of injection (greater than injections at other sites given at that time), redness and swelling started the next day just below the site and extended distally to the lower aspect of the deltoid by the time she was seen on 10/20 in ER.  Ice applied at home, no medications used.  Other sites of injection without reaction.  HPV first injection for patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Oedema peripheral
Clinical narrative: Patient reported a localized redness and swelling over a large area of her arm that remained unresolved for 2-3 weeks after vaccination. She also reported back pain that began the day following her vaccination and has continued thru the present time.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Computerised tomogram, Eyelid oedema, Incisional drainage, Periorbital cellulitis, Scan with contrast
Clinical narrative: Swelling of right eyelid 10/7/12, swelling continued through 10/8/12, antibiotics administered to no relief, admitted to hospital 10/09/2012 diagnosed with periorbital cellulited, I&D right eyelid performed 10/10/2012.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Swelling, itching, redness at injection site.  Continued reaction over next 4 days: headache, neck pain, lower leg pain, increased redness, swelling, hardness at injection site about 2.5 inches in diameter. Swelling not significantly raised. Leg pain in right leg painful enough to interrupt sleep Friday night. Fatigue since Thursday morning.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Middle insomnia, Neck pain, Pain in extremity
Clinical narrative: Swelling, itching, redness at injection site.  Continued reaction over next 4 days: headache, neck pain, lower leg pain, increased redness, swelling, hardness at injection site about 2.5 inches in diameter. Swelling not significantly raised. Leg pain in right leg painful enough to interrupt sleep Friday night. Fatigue since Thursday morning.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, itching, redness at injection site.  Continued reaction over next 4 days: headache, neck pain, lower leg pain, increased redness, swelling, hardness at injection site about 2.5 inches in diameter. Swelling not significantly raised. Leg pain in right leg painful enough to interrupt sleep Friday night. Fatigue since Thursday morning.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Got hot red swollen and painful.  Took Aleve.  Went to Dr two days later and was prescribed antibiotics (Keflex) and symptoms resolved.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disorientation, Dizziness, Fall, Malaise
Clinical narrative: Patient got very dizzy and disoriented and fell into bathtub.  Could not get out without assistance because he could not think straight.  This resolved after a few hours.  He felt very weak and ill for a week.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Thinking abnormal
Clinical narrative: Patient got very dizzy and disoriented and fell into bathtub.  Could not get out without assistance because he could not think straight.  This resolved after a few hours.  He felt very weak and ill for a week.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Electrocardiogram, Flushing
Clinical narrative: Throat felt like it was closing up, face/upper body extremely flushed, itchiness on left forearm with small hives, uncontrollable shaking, difficulty breathing, numbness & tingling in face, left arm, and both legs.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus, Throat tightness, Tremor
Clinical narrative: Throat felt like it was closing up, face/upper body extremely flushed, itchiness on left forearm with small hives, uncontrollable shaking, difficulty breathing, numbness & tingling in face, left arm, and both legs.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Throat felt like it was closing up, face/upper body extremely flushed, itchiness on left forearm with small hives, uncontrollable shaking, difficulty breathing, numbness & tingling in face, left arm, and both legs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Red, hot and sore to touch the area. The area is about the size of a silver dollar.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Tongue ulceration
Clinical narrative: Ulcer on the tip of my tongue.  I am not prone to ulcers tried many solutions and finally took lysine for two days and it went away.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Feeling hot, Flushing
Clinical narrative: Coughing, head/face hot and flushed, body very warm, but simultaneously with chills, aches and fatigue.  Gave Tylenol and liquids to drink.  Symptoms lasted approximately 36-48 hours.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Skin warm
Clinical narrative: Coughing, head/face hot and flushed, body very warm, but simultaneously with chills, aches and fatigue.  Gave Tylenol and liquids to drink.  Symptoms lasted approximately 36-48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Purulent discharge, Rash
Clinical narrative: Patient received ZOSTAVAX (6/21/12. (Thur.). Following week on Wed., she noticed rash on right buttock. Her dermatologist said it was herpes rash. Patient said it was a rough patch and didn't have it in another place. It took about week for rash to go away (Pusy at first, but no pain).
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Paraesthesia, Paraesthesia oral, Pruritus generalised, Rash
Clinical narrative: C/O tingling of head, lips, extremities, flushing of face, and ears. Rash on back and arms. Itching all over body and nose. EPI-PEN administered (L) thigh at 1432 - BP 160/90 Pulse 121 Resp. 25.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Sensation of heaviness, Tenderness
Clinical narrative: Pt. received PNEUMOVAX on 9-4-12. She stated she had pain immediately upon insertion of needle and felt like "something was hit". The pain and severe heaviness continues x 1 week and continues today as a slight tenderness when she lifts her arm.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site inflammation, Injection site nodule, Injection site streaking, Injection site swelling
Clinical narrative: Injection site reaction - swelling streak that is inflamed. A knot has formed.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Fever, aches, chills, tremor. All described as severe or high. Lasted for several hours and resolved overnight.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site haemorrhage
Clinical narrative: Nicked patient's vein during injection, which caused bleeding. Blood squirt when withdrawing syringe. Bleeding stopped with pressure. Follow up call with patient morning of 10/19/12. Patient fine, arm bruised.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma, Oedema peripheral, Pruritus
Clinical narrative: 48 hours after administration, pt. experienced itching, swelling of (R) arm up to elbow area, and bruising at admin. site. Only used BENADRYL cream on arm. Recommended BENADRYL tabs but pt. purch. CLARITIN.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Mobility decreased, Sleep disorder
Clinical narrative: Severe headache, can't lift an arm, sleep disturbance.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Injury, Presyncope
Clinical narrative: Vasovagal episode after vaccines with physical injury.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chest discomfort, Dyspnoea
Clinical narrative: Patient was administered FLUVIRIN and PNEUMOVAX. After 5 min. patient began complaining of trouble breathing and chest pressure. Also complained of pain in the knees. One dose of Epi was administered (EPI PEN). Improvement after 3-5 min. Patient was taken to ER by paramedics.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation, Skin lesion, Urticaria
Clinical narrative: Patient called this AM (1125 A.M.) to report 2 "quarter sized" skin areas of irritation that appear hives or lesion-like. Referred to urgent care & MD & told to take BENADRYL too.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Swelling face
Clinical narrative: Lips and lower face started tingling then swelling - (no difficulty breathing - no injection site reaction) - occurred approx. 30 min. after injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Vaccine administered 10/15/12. Patient appeared at pharmacy 10/18/12 to ask about redness at injection site and stiff neck. I advised patient to seek medical attention. 10/19/12 Called patient for follow-up. Dr. prescribed AUGMENTIN and CLARITIN.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: 3 days after vaccination, patient presented w/ a hardened red area at site of administration. Both hands are swollen and sweaty. Also developed chills and headache w/o a fever (afebrile).
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Oedema peripheral
Clinical narrative: 3 days after vaccination, patient presented w/ a hardened red area at site of administration. Both hands are swollen and sweaty. Also developed chills and headache w/o a fever (afebrile).
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report was received from a consumer refers to a 15 or 16 years old female patient. On an unknown date in 2007, the patient was vaccinated with HPV vaccine (Manufacturer unknown). No concomitant medications were reported. On an unknown date in 2007, the patient experienced swelling of arm in one arm. No treatment information was reported. The outcome of the event was reported as recovering. The reporter considered the event was related to HPV vaccine (Manufacturer unknown). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, lot number was not reported. No concomitant medications were reported. On an unknown date, the patient after getting GARDASIL had a positive pap smear. Treatment information was not reported. Additional information has been requested.