chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Local swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness,. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 21 year old female patient with allergy to sulfonamides and no pertinent medical history. On 07-AUG-2006, the patient was vaccinated with the first 0.5 ml dose of (merck) VARIVAX (Lot # not reported) SQ and on 07-AUG-2006, received the second 0.5 ml dose of (merck) VARIVAX (Lot # reported as 0245F, expiration date 07-AUG-2006) SC. The medical assistant reported that o 22-APR-2013, the patient experienced negative antibody titers. The patient did not receive treatment for the adverse event. The outcome of negative antibody titers was unknown. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from pharmacist refers to a 34 year old patient (gender unknown). On an unknown date the patient inadvertently received ZOSTAVAX inj dose 1 (dose, route, site unspecified) (lot# and exp date unspecified) instead of (Merck) VARIVAX. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 8 year old female patient with no pertinent medical history and no drug reactions/allergies. On 19-MAY-2005 and 28-AUG-2008 the patient was vaccinated with two doses of VARIVAX (Merck) (dose not provided) with the respective lot numbers, lot # 0070R/expiration 07-JAN-2007 and lot # 0955X/expiration unknown. ON 23-APR-2013, the patient was found to have negative titers for varicella. The patient had sought medical attention via office visit. There were no treatment given for the adverse event. The varicella IgG blood test was performed. The outcome of the patient was found to have negative titers for varicella was reported as not recovered/ not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician regarding an unknown age and gender patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose, and route not reported). No other suspect therapies were reported. No concomitant medications were reported. The physician reported that the patient fainted after receiving one dose of GARDASIL (date not reported). The physician reported that the patient recovered and walked out of the office. No treatment information was reported. The reporter did not assess the relationship between faint and GARDASIL. Additional information is not expected.
Age: 0.66
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 34 weeks (infant) old female patient. On 09-AUG-2011 the patient was vaccinated with the third dose of oral ROTATEQ (lot number, expiration date and via not reported). There was no concomitant medication reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Redness cellulitis (L) thigh.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant reporting about unable to confirm the exact number or identities of the patients may involve more than 20 patients of unknown age and gender who on an unknown date in the last couple of months were vaccinated with an improperly stored doses of VAQTA (dose route and not number not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from a consumer reporting on her 15 year old female daughter who in July 2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The patient's mother stated that her daughter had not received doses 2 or 3 of the GARDASIL series until this time. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (Lot number and expiration date were unspecified by the reporter). On an unknown date, five days after receiving the ZOSTAVAX, the patient experienced flu like symptoms. The patient also stated that he visited an unspecified physician who prescribed TYLENOL on an unspecified date. The outcome of flu like symptoms was reported as fully recovered. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (Lot # not reported) that were exposed to 47 f for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. 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 unknown number of patients of unknown ages. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # not reported) that were exposed to 47 f for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and from the patient who reported that in October 2009, he/she was vaccinated with the first dose of GARDASIL; in November 2009, the patient was vaccinated with the second dose of GARDASIL. The nurse reported that the patient was in the facility on 24-APR-2013 for the third dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Photophobia, Pyrexia, Vomiting
Clinical narrative: At occurrence of symptoms pt. visited ER & neurologist, informed student health 4/24/13 at time of an unrelated visit. See enclosed ER report obtained with student's knowledge. The patient presents with a complaint of headache. The pain is generalized to the neck. The onset was sudden. The course has been increasing. The headache began 3 days(s) ago. The pain is characterized as: sharp. The pain severity is moderate. The headache was precipitated by: Unknown. Worse with movement. Worse with light. Associated symptoms: (-) diplopia, (-) eye pain, (-) facial pain, (+) fever, (-) nasal discharge, (-) nausea, (+) neck pain, (+) photophobia, (-) rash, (-) vertigo, (-) visual disturbance, (+) vomiting. Prior Related Problems: There are no prior related problems.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Pruritus
Clinical narrative: 4/11/13 Day of vaccine. 4/12/13 Start to itch, turn red. 4/13/13 Hurt and turned red, pain a lot. Went to immediate care start BACTRIM DS - 2 a day / cold compress.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Ongoing pruritic skin eruption - beginning evening after receiving vaccines. Pt seen in ED current eruption is less, but unabating. Pt referred today to dermatology. Parent convinced that rash is related to vaccines rec'd non 2/7/13. Prior VAERS filled 2/11/13.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bacterial test positive, Full blood count normal, Rash pruritic, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: Ongoing pruritic skin eruption - beginning evening after receiving vaccines. Pt seen in ED current eruption is less, but unabating. Pt referred today to dermatology. Parent convinced that rash is related to vaccines rec'd non 2/7/13. Prior VAERS filled 2/11/13.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 57 year old female patient with asthma, hyperlipidemia and type 2 diabetes. The patient had no drug reactions or allergies. On 26-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # J000429, expiry date was 10-APR-2014), 0.65 milliliter (ml), subcutaneous in the left arm. Concomitant therapies included calcium (unspecified), vitamin d (unspecified), cyanobalamin, Low dose aspirin, ONGLYZA, glipizide, CRESTOR, VENTOLIN (ALBUTEROL SULFATE), fluticasone propionate, ADVAIR and TYLENOL. Approximately on 27-APR-2013 (reported as 1-2 days after vaccination), the patient developed a rash on the right side of her nec (clavicle) and was diagnosed with shingles. Diagnostic test performed was none. The patient sought medical attention (office visit) and was treated with VALTREX and ZOVIRAX ointment. The outcome of the reported events was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 57 year old female patient with asthma, hyperlipidemia and type 2 diabetes. The patient had no drug reactions or allergies. On 26-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # J000429, expiry date was 10-APR-2014), 0.65 milliliter (ml), subcutaneous in the left arm. Concomitant therapies included calcium (unspecified), vitamin d (unspecified), cyanobalamin, Low dose aspirin, ONGLYZA, glipizide, CRESTOR, VENTOLIN (ALBUTEROL SULFATE), fluticasone propionate, ADVAIR and TYLENOL. Approximately on 27-APR-2013 (reported as 1-2 days after vaccination), the patient developed a rash on the right side of her nec (clavicle) and was diagnosed with shingles. Diagnostic test performed was none. The patient sought medical attention (office visit) and was treated with VALTREX and ZOVIRAX ointment. The outcome of the reported events was unknown. Additional information has been requested.
Age: 1.72
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Expired drug administered
Clinical narrative: Expired dose given to repear dose in May 2013.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Movement disorder, Nausea, Oedema peripheral, Paraesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was not pregnant. On 26-APR-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot# not provided) at an unspecified pediatrician's office. No concomitant medications. On 26-APR-2013 the patient experienced hands and feet that were numb, tingling and swelling. On the night of 30-APR-2013 the patient started experiencing nausea and vomiting and the swelling and tingling of the hands and feet have gotten worse. On the morning of 01-MAY-2013 the patient could not get out of bed. The patient sought medical attention by going to the emergency room over the weekend and then visit to this office on 29-APR-2013. The patient was given BENADRYL for treatment and follow up with an unspecified neurologist. At the time of this report the patient was not recovered. The reporter did not assess drug relationship. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was not pregnant. On 26-APR-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot# not provided) at an unspecified pediatrician's office. No concomitant medications. On 26-APR-2013 the patient experienced hands and feet that were numb, tingling and swelling. On the night of 30-APR-2013 the patient started experiencing nausea and vomiting and the swelling and tingling of the hands and feet have gotten worse. On the morning of 01-MAY-2013 the patient could not get out of bed. The patient sought medical attention by going to the emergency room over the weekend and then visit to this office on 29-APR-2013. The patient was given BENADRYL for treatment and follow up with an unspecified neurologist. At the time of this report the patient was not recovered. The reporter did not assess drug relationship. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Guillain-Barre syndrome, Neurological examination normal, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was not pregnant. On 26-APR-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot# not provided) at an unspecified pediatrician's office. No concomitant medications. On 26-APR-2013 the patient experienced hands and feet that were numb, tingling and swelling. On the night of 30-APR-2013 the patient started experiencing nausea and vomiting and the swelling and tingling of the hands and feet have gotten worse. On the morning of 01-MAY-2013 the patient could not get out of bed. The patient sought medical attention by going to the emergency room over the weekend and then visit to this office on 29-APR-2013. The patient was given BENADRYL for treatment and follow up with an unspecified neurologist. At the time of this report the patient was not recovered. The reporter did not assess drug relationship. The reporter considered the events to be significant disability or incapacity. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Movement disorder, Nausea, Oedema peripheral, Paraesthesia
Clinical narrative: Paresthesia of fingers, toes with pain - onset midnight 4/26. Seen in ED (concern for Guillain-Barre), but normal neurologic exam. Vomited next few days, then diarrhea (current). No fever. Paresthesia and pain nearly resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Paresthesia of fingers, toes with pain - onset midnight 4/26. Seen in ED (concern for Guillain-Barre), but normal neurologic exam. Vomited next few days, then diarrhea (current). No fever. Paresthesia and pain nearly resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Guillain-Barre syndrome, Neurological examination normal, Pain in extremity, Paraesthesia
Clinical narrative: Paresthesia of fingers, toes with pain - onset midnight 4/26. Seen in ED (concern for Guillain-Barre), but normal neurologic exam. Vomited next few days, then diarrhea (current). No fever. Paresthesia and pain nearly resolved.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Erythema, Leukocytosis, Liver function test abnormal
Clinical narrative: Swelling, erythema, fever to 102, leukocytosis (25,000), elevated LFT's.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Swelling, erythema, fever to 102, leukocytosis (25,000), elevated LFT's.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to her approximately 64 year old husband. The patient's concurrent condition included Chronic obstructive pulmonary disease (COPD), cardiac disease and polyneuropathy from exposure to agent orange. He was allergic to IVP contrast dye. In 2012 the patient was vaccinated with ZOSTAVAX, intramuscular in the right deltoid muscle for prophylaxis and then the patient developed pain, warmth, and a "knot" at the injection site. The patient self-treated with ibuprofen and fully recovered. No lab diagnostic studies performed. The outcome was reported as recovered/resolved. The relationship between AE and ZOSTAVAX was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Headache, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old male patient. On 22-APR-2013 the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). On 22-APR-2013, after administering GARDASIL, the patient developed a headache and tingling in the hands on the day of administration and the pain progressed to back pain over the next three days. The patient sought medical attention by visiting to physician's office. At the time of reporting, the patient's outcome was recovering. The relationship between all events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL. On an unknown date the patient suffered pain, redness and stiffness at the injection site after the administration of GARDASIL. It was not reported if the patient sought medical attention. Outcome was not reported. The reporter did not assess drug relationship. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Erythema with slight swelling right anterior thigh. Treated in ER in 5-5-13 with KEFLEX for localized allergic reaction to imm vas celluliitis. Seen in office 5-6-13 symptoms improving.
Age: 23.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Rash, Urticaria
Clinical narrative: Rashes, hives on arms and neck, none in the trunk of her body. Hives developed in the pm the day of vaccination. Advised BENADRYL. RN 5/6/2013 retrurned for Tdap; recovered no visible hives or rashes.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with a dose of improperly store PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reports that patient received first dose of GARDASIL (strength, lot#, dose/frequency, route and duration were unspecified) on 30-JUN-2012 and would received 2nd dose (strength, lot#, dose/frequency, route and duration were unspecified) today (02-MAY-2013). No adverse effect reported. At time of reporting, action taken, outcome and causality were not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients. The nurse reported that another office was improperly storing GARDASIL during the months of February 2013, March 2013 and April 2013. It was reported that there was a possibility that the vaccine was administered to an unspecified number of patients. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 80 year old male patient with penicillin allergy and type 2 diabetes. In August 2010 the patient was vaccinated with ZOSTAVAX, 1 time, subcutaneous (dosing information was not provided). On 01-MAR-2013 the patient experienced pain in his right side of his stomach area, going to his lower back. The patient had seen his physician, who advised him this was not shingles, but the patient has a follow-up visit. No treatment was given for the adverse events. The outcome of pain in his right side of his stomach area is unknown. The pain going to his lower back was reported as increased. The relatedness of the events was not reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: BCG
Symptoms: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. While an unspecified healthcare professional was administering BCG VACCINE (dose, route and site of administration and lot # not reported) some of vaccine leaked out of the syringe. The healthcare professional was wearing gloves at that time. There were concerns about the healthcare professional was inhaling the vaccine that leaked out of the syringe. No adverse events were reported. It was not reported if the patient sought medical attention. The outcome of adverse events was unknown. The relatedness between adverse events was not provided. Additional information has been requested.
Age: 12.0
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 patient of unknown age. The healthcare worker reported that the patient received the first dose of GARDASIL (lot# unspecified) on 23-AUG-2012 the second dose of GARDASIL (lot# unspecified) on 25-FEB-2013 and the third dose of GARDASIL (lot# unspecified) on 30-APR-2013. No adverse event reported. The outcome of the patient was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with a dose of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pain in extremity, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 79 year old female patient. The patient had no pertinent medical history and no drug allergy. On approximately 17-APR-2013 the patient was vaccinated with ZOSTAVAX for shingles prevention. Lot # was unspecified. Concomitant therapies included TOPROL XL TABLETS, ADVIL, SYNTHROID, metoprolol, amlodipine, estrogens, PREMARIN and vitamin D. The physician reported that on 01-MAY-2013 the patient experienced a "sudden onset of right-sided pain down her leg and a zoster-like lesion over the area where ZOSTAVAX was administered about two weeks ago". Physician reported that the patient had been diagnosed by her primary physician. He stated that the patient was currently being treated for Herpes Zoster with VALTREX. Outcome of event was reported as not recovered. The patient came to doctor's office to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a child of unknown age. On 24-JUL-2012 the patient was vaccinated with the second dose of oral ROTATEQ (lot number was unknown, expired date 21-JUL-2012) (dose, route and injection site were not reported). The patient was not experiencing any known symptoms. The outcome was unknown. The action taken and causality were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient who on 29-APR-2013 was vaccinated with a dose of PROQUAD (dose, route and lot# not reported). No adverse symptoms reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Acne, Constipation, Disturbance in attention, Feeling abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient with no pertinent medical history, allergic to cats and allergic to pollens, who wasn't pregnant at the time of the report. On 07-MAY-2010 the patient was vaccinated with GARDASIL, (dose route and site of administration was not reported). Lot number: 1337Y, exp. date 29-JUN-2012 is an invalid lot number for GARDASIL. Patient's concomitant therapy included "oral contraceptive". In April 2012 (one year ago) the patient experienced difficulty concentrating, constipation, bloating, acne and mental fogginess. No lab diagnostics studies were performed. There was no treatment provided. The outcome was reported as not recovered. The patient sought medical attention: she saw the physician. The relatedness between adverse events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date "6 days ago" (on 26-APR-2013) the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). Other suspect therapies included MEDROL. At the time of report the patient had been prescribed a MEDROL dose pack for unspecified symptoms. The outcome was unknown. The action taken and causality was not provided at the time of report. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Chest discomfort, Cough, Fatigue
Clinical narrative: This spontaneous report was received from a 66-year-old male patient. Current conditions included high blood pressure (reported as manufacturer and dosage unspecified), high cholesterol and allergy to sulfur drug. On 02-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date not reported), subcutaneously. Other suspect therapies included PNEUMOVAX 23 (manufacturer unspecified) on the same date. Since 09-APR2013 (reported as since that time) the patient had been tired and had lack of energy. The patient stated that he was experiencing chest pressure and coughing on an unknown date in April 2013 (reported as now experiencing). The outcome of the reported events were unknown. No treatment was rendered for the events. It was unspecified whether laboratory diagnostic tests were performed. The patient sought medical attention by contacting the physician via telephone. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Redness, swelling, pain from shoulder to elbow. Pt given 6 day prednisone.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Blood test, Burning sensation, Chest X-ray, Computerised tomogram
Clinical narrative: On 3/26/13 I got a cortisone injection for my finger. On 4/2/13 I went to pharmacy for shingles shot. I had itching, burning, red rash and lump under skin. On 4/5/13 I awoke with what I thought was a heart attack. Blood pressure 200/1110, trouble breathing, heart racing, blood sugar - 200+ and a headache, within 4-5 hrs in E.R. readings went back to normal. No diagnosis given. No one advised me that I might have trouble with cortisone and shingles shot.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Electrocardiogram, Headache, Palpitations, Pruritus
Clinical narrative: On 3/26/13 I got a cortisone injection for my finger. On 4/2/13 I went to pharmacy for shingles shot. I had itching, burning, red rash and lump under skin. On 4/5/13 I awoke with what I thought was a heart attack. Blood pressure 200/1110, trouble breathing, heart racing, blood sugar - 200+ and a headache, within 4-5 hrs in E.R. readings went back to normal. No diagnosis given. No one advised me that I might have trouble with cortisone and shingles shot.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: On 3/26/13 I got a cortisone injection for my finger. On 4/2/13 I went to pharmacy for shingles shot. I had itching, burning, red rash and lump under skin. On 4/5/13 I awoke with what I thought was a heart attack. Blood pressure 200/1110, trouble breathing, heart racing, blood sugar - 200+ and a headache, within 4-5 hrs in E.R. readings went back to normal. No diagnosis given. No one advised me that I might have trouble with cortisone and shingles shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4-18-13 noticed red raised area on right upper arm. Area warm and tender. Childrens Ibuprofen given per weight recommendations. Vomiting and diarrhea episodes started 4-18-13 night. 7 1/2 cm wide 8 cm long.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: 4-18-13 noticed red raised area on right upper arm. Area warm and tender. Childrens Ibuprofen given per weight recommendations. Vomiting and diarrhea episodes started 4-18-13 night. 7 1/2 cm wide 8 cm long.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an 18 year old male patient with no drug reactions or allergies. The current condition of the patient included needle phobia in which he experiences nausea or passes out or has a reaction every time he sees a needle. On 01-MAY-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in the left arm. Concomitant therapy included MENACTRA (lot number, expiry date, dose and route unspecified) injected at the same office visit on 01-MAY-2013 with GARDASIL. On 01-MAY-2013, the patient passed out for five seconds after receiving his first dose of GARDASIL. The patient was still in the physician office when he passed out, and he revived a few seconds later. The patient was given a piece of unspecified candy and unspecified juice to drink. He was retained in the physician office for an unspecified amount of time for monitoring after he passed out. No lab tests were performed. The patient appeared to be fully recovered after reviving and left the office on 01-MAY-2013. The relatedness for the event was unknown for GARDASIL. Upon internal review the event, passed out was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Full blood count normal, Ileus, Metabolic function test normal
Clinical narrative: Vomiting started with in several hours of receiving the vaccine, had a 4 oz. weight loss which lead to a work-up for vomiting and weight loss to rule-out pyloric stenosis and intussusception. Pt. did have a documented ileus on abdominal x-ray developed diarrhea 2 days later.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Ultrasound abdomen normal, Vomiting, Weight decreased, X-ray abnormal
Clinical narrative: Vomiting started with in several hours of receiving the vaccine, had a 4 oz. weight loss which lead to a work-up for vomiting and weight loss to rule-out pyloric stenosis and intussusception. Pt. did have a documented ileus on abdominal x-ray developed diarrhea 2 days later.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swelling, pain, warmth around shot site on back of right arm where SQ VARIVAX was given.
Age: 1.27
Sex: F
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Mom reported at 18 M WCC on 4/23/13 7 days after receiving MMR developed hives within 7 more days had resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient called pharmacy 5/2/13 to state she had a red strip that appeared to be an allergy around the injection site, about 2 inches in length. No other adverse reactions reported.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Blood urine present, Cystitis haemorrhagic, Dysuria, Hypersensitivity, Rash
Clinical narrative: About 3 weeks after shot I began to have difficult urination. Vaccine given 8-28-12 on 9-28-12 I went to hospital. Diagnosis given "hemorrhagic cystitis." Had rash on right arm off and on from Sept through Jan 2013. Have had slight allergy to chocolate for many years. This allergy increased severely and has not abated.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Urine analysis abnormal
Clinical narrative: About 3 weeks after shot I began to have difficult urination. Vaccine given 8-28-12 on 9-28-12 I went to hospital. Diagnosis given "hemorrhagic cystitis." Had rash on right arm off and on from Sept through Jan 2013. Have had slight allergy to chocolate for many years. This allergy increased severely and has not abated.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Two days after receiving shot pt reported the injection site was swollen, red, warm painful. Recommended pt take Ibuprofen and use a cold pack and see MD to follow up.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Pain in extremity
Clinical narrative: Ache, pain in joints. Redness at injection site. Bilateral toe pain.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Severe redness at site 9 cm x 12 cm raised in some areas. Itchy.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Injection site swelling, Pain in extremity
Clinical narrative: Arm sore, injection site swollen and chills.
Age: 1.06
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Started as small spots Sunday May 5th on his face, spread to his trunk arms and legs by Monday May 6th accompanied by 103 fever and severe itching.
Age: 68.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 6x9 cm red, warm induration on L deltoid area.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHING, WARM, PAIN TO THE BONE, HIVE.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: REDNESS, SWELLING, ITCHING, WARM, PAIN TO THE BONE, HIVE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Injury, Pain in extremity, Walking aid user
Clinical narrative: Middle of the night, patient woke up with sudden bilateral pain from knees to end of toes (burning sensation).  Sudden sharp pain in right knee.  No recent injury or any other attributable cause.   After this sudden onset, patient needed to use a cane to walk for 1+ weeks.  Tramadol was prescribed after this incident and patient still taking it due to lingering pain issues. Also attending rehab since the injury.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Patient awoke in the middle of the night with severe chills and fever, pain in arms, shoulders, legs, feet.  Fever and chills subsided by next morning, but patient unable to move, or even lift head off of pillow in the morning.  Severe pain persisted for 1 week, gradually resolving over the next week until pain only noticeable in right leg.
Age: 27.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Injection site pain, Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Patient presented on 5-6-13 with swelling and pain in right arm. The area of the injection was warm to touch. Patient noticed arm was hurting after someone else touched the area on 5-5-13. There was no pain or swelling in left arm.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Immediate post-injection reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Onset time is listed as when noticed. Son complained of pain with movement immediately after injection to upper arm. Site had severe swelling and was very warm to the touch.
Age: 46.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Planted 0.1ml Inactivated Polio from multidose vial in left forearm, instead of PPD. (PPD planted correctly in right forearm when error noted, several minutes later.) Site looked slightly red within 30 minutes and at 48 hours later still reddened, but not indurated but "not as bad" as the previous day.
Age: 1.57
Sex: M
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: Pain 5/10 at site and enlarged, tender axillary nodes.  Accompanied by mild swelling and erythema of the site and flu-like symptoms.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Lymphadenopathy
Clinical narrative: Pain 5/10 at site and enlarged, tender axillary nodes.  Accompanied by mild swelling and erythema of the site and flu-like symptoms.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Injection site erythema, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Patients mother contacted the office on 05/02/2013 AM with patient's symptoms which included; low grade fever, swelling and redness at vaccination site (RT), nausea, vomiting, loss of appetite started end of day after date of vaccination 04/30/2013.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Vomiting
Clinical narrative: Patients mother contacted the office on 05/02/2013 AM with patient's symptoms which included; low grade fever, swelling and redness at vaccination site (RT), nausea, vomiting, loss of appetite started end of day after date of vaccination 04/30/2013.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Extreme pain in all of left arm all the way thru left hand, major pain at injection site, was unable to move my left arm in excess of 4 days.  Severe rash around injection sight into the armpit, sweats for 5 days and a fever that reached 102.7.  Excessive swelling in my left arm mostly in the muscle near the injection.  Followup visit was made with administering doctor to confirm all side effects/illnesses.  Medication, prescribed to counteract effects.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Extreme pain in all of left arm all the way thru left hand, major pain at injection site, was unable to move my left arm in excess of 4 days.  Severe rash around injection sight into the armpit, sweats for 5 days and a fever that reached 102.7.  Excessive swelling in my left arm mostly in the muscle near the injection.  Followup visit was made with administering doctor to confirm all side effects/illnesses.  Medication, prescribed to counteract effects.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Episode of syncope with second HPV vaccine today. It is unknown if the patient had and episode with first dose. Patient is alert, responsive 2 minutes after episode.  BP 108/78 with pulse rate of 68 bpm.  Patient stayed in office for 45 minutes after episode with no further signs or symptoms of syncope. Mother picked up patient at 12:15 pm to drive pt home. Patient advised not to seek third dose of HPV.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Heart rate increased, Insomnia, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: Fussy, irritable, high fever (103.9), unable to sleep, rapid breathing (50 breaths per minute) rapid heart rate (160 bpm).
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Swelling
Clinical narrative: Patient arms were numb, and he started to experience swelling throughout his body.
Age: 1.18
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: POSITIVE FOR CHICKEN POX.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule
Clinical narrative: After injection approx 10 min, large hard knot appeared on arm, no discoloration, no pain, warm to touch, no drainage. Pt. denied N.V, fever/chills, SOB. Pt. inst. to use cool packs at site, elevate arm, take TYLENOL. Go to E.R. if symptoms worsen.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Skin infection
Clinical narrative: Superficial skin infection still visible 27 days post injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pallor
Clinical narrative: 4-16-13: Red area (L) upper thigh (IPV, VARIVAX) 4-17-13 increased size red area, tender, warm to touch 6 cm x 6 cm. Positive blanches. Treated w/Abx for possible cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Joint injury, Lip swelling, Pallor, Syncope
Clinical narrative: B/P 124/70 P 63 4/30/13 230pm. 240pm syncope, fainting outside clinic. Fall/shaking to ground per mother. Carried into clinic pt room by other person. Pale, alert, laying down exam table. Noted (L) upper lip swelling, (L) elbow scrape. Seen by Dr. 247pm B/P 124/70 P 63. Observed, cleaned, sent home.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Tremor
Clinical narrative: B/P 124/70 P 63 4/30/13 230pm. 240pm syncope, fainting outside clinic. Fall/shaking to ground per mother. Carried into clinic pt room by other person. Pale, alert, laying down exam table. Noted (L) upper lip swelling, (L) elbow scrape. Seen by Dr. 247pm B/P 124/70 P 63. Observed, cleaned, sent home.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Crying
Clinical narrative: Excessive crying for greater than 6 hours.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on chin and face toward ear (R).
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Body temperature increased, Irritability
Clinical narrative: Pt woke this A.M. fussy and temp of 102.8 rectally, then temp went down to 101.0 rectally after giving juice. Pt without any other problems per mom.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Redness, swelling dx w/ cellulitis given KEFLEX and BACTRIM for tx.
Age: 1.38
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Mom noticed increased redness and blisters at injection site (L and R) thighs.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered
Clinical narrative: ZOSTAVAX was administered. Exp on box 3/7/14, after administration, noticed that real exp 3/13.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: ZOSTAVAX was administered. Exp on box 3/7/14, after administration, noticed that real exp 3/13.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt was given varicella inj. on 4/30/13 in (L) arm SQ. Pt RTC on 5/1/13 c/o pain, redness at inj. site - lemon size red area noted with warm to touch at inj. site. Instructed to apply ice to area, use TYLENOL/MOTRIN PRN. Report to ER/MD with further concerns or if worsens at all.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Vaccination complication
Clinical narrative: Adverse reaction to chicken pox (Varicella) vaccine. Chicken pox like rash.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None.  Pt should have received hepatitis B vaccine instead she received Gardasil.
Age: 74.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Erythema, Injection site erythema, Joint swelling, Local swelling
Clinical narrative: Moderate swelling of entire left shoulder deltoid muscle, red stripe leading from shot site toward lymph node, pain in armpit. Pain and swelling lasted four days in total.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Patient was instructed by her immunologist (followed for allergies and asthma) to have a Pneumovax vaccine (23 valent pneumococcal vaccine) due to low antibody levels against pneumococcus. Mom brought in patient to the clinic and vaccine given. Was encouraged to massage and move arm around after vaccine administration. 30 minutes after vaccine administration, patient started to complain local injection pain and warm. Once when patient and family returned home, patient took Tylenol for the pain. The next morning, patient woke up with localized swelling approx 10 cm around the injection area on left deltoid, redness, warmth and tightness to muscle with pain and decreased ROM. No fevers, no swelling outside of area mentioned above. Patient with out prior vaccine reactions. No other skin lesions. no difficulty breathing, no vomiting.