chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist (patient's mother), via a company representative, refers to a 5 year old male patient. The patient's medical history included skin issues. On an unknown date (at the age of 12-18 months) the patient was vaccinated with first dose of VARIVAX. Dosing information, route of administration and lot number were not provided. In approximately 2008 (reported as 5 years ago) the patient developed a mild case of either shingles or chickenpox. Medical attention was sought (unspecified manner). Patient was treated with ZOVIRAX. The rash was unilateral. the patient had fully recovered (date not provided). Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age who on 18-MAR-2013, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 671786/0254AE) that was expired. The vaccine expired on 08-MAR-2013. No adverse effects were reported. 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 physician assistant refers to a patient of unknown age and gender. In February 2011 and in July 2011 the patient was vaccinated with first and second doses of GARDASIL respectively (doses, route, and lot numbers not provided). The patient did not get the third dose yet, at the time of the report. NO adverse effect was reported. 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 medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 09-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA005803 MARRS 1308USA005804 MARRS 1308USA005805). This is one from several reports from the same reporter. 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 medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA004971 MARRS 1308USA005804 MARRS 1308USA005803). This is one from several reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 57 year old female patient with no pertinent medical history reported and with no drug reactions or allergies. On 07-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J000433, expiration date 10-APR-2014) (0.65 ml, subcutaneous) for "Prevent shingles". No other suspect therapies were reported. Concomitant therapies included PROTONIX, hydrochlorothiazide, LOPRESSOR and potassium. The pharmacist reported that on 09-AUG-2013 the patient called to report that she noted a red, raised area of the unspecified injection site which measured "5 inches by 2 inches". This pharmacist stated that she was going to recommend to the patient to administer oral BENADRYL and ZYRTEC to manage the symptoms. The outcome for red, raised area of the unspecified injection site was reported as not recovered. It was reported that the patient sought medical attention by calling the pharmacist. The pharmacist did not assess the causality between ZOSTAVAX and red, raised area of the unspecified injection site. 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 nurse practitioner (N.P.) refers to a patient of unknown age and gender. It was reported that on 14-AUG-2012 the patient was vaccinated with the first dose of RECOMBIVAX HB (10 Microgram, route not reported).  On 21-AUG-2012 the patient was vaccinated with the second dose of RECOMBIVAX HB (10 Microgram, route not reported). On 11-SEP-2012 the patient was vaccinated with the third dose of RECOMBIVAX HB (10 Microgram, route not reported). Concomitant therapy was not provided. No adverse effect reported. This case is related with MARRS 1308USA008540. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Urticaria
Clinical narrative: This spontaneous report was received from a 69 year old female consumer reporting on herself, a patient with thyroid cancer, breast cancer, carcinoma of the right ear and DEMEROL allergy. On 13-JUL-2013 the patient received a shot of ZOSTAVAX (dose, route and lot number were not provided) injection in the right arm for doctor recommendation. Concomitant medications were not provided. Consumer reported that on 18-JUL-2013, she developed a red, "leathery" welt on the right arm, 4 inches above the wrist after receiving ZOSTAVAX. Patient received CORTIZONE cream as treatment for the adverse event. Routine blood work was performed (results not provided). Patient did not seek medical attention. The outcome of red, "leathery" welt on the right arm was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number were not provided). Concomitant medications were not provided. It was reported that a patient was "potentially" administered RECOMBIVAX HB and had a laboratory titer that indicated that the patient was sero-negative. The outcome of patient was sero-negative was not reported. The relationship between the RECOMBIVAX HB and the event was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mass, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from an unspecified employee refers to an approximately 77 year old female patient with no pertinent medical history reported. On 25-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient submitted a rebate for ZOSTAVAX and reported an adverse event, the patient circled itching, swelling and hard lump, and wrote a message that said "I had this". Outcome for itching, swelling and hard lump was not reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (N.P.) refers to a patient of unknown age and gender. It was provided that on 14-AUG-2012 the patient was vaccinated with the first dose of VAQTA (1 mg, route not reported). On 21-AUG-2012 the patient was vaccinated with the second dose of VAQTA (1 mg, route not reported). On 11-SEP-2012 the patient was vaccinated with the third dose of VAQTA (1 mg, route not reported). Concomitant therapy included RECOMBIVAX HB. No adverse effect reported. This case is related with MARRS1308USA003437. 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 Licensed Practical Nurse refers to a patient of unknown age and gender. On 21-NOV-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot were not reported) and would receive the 2nd dose on the date of the report on 08-AUG-2013. No adverse effect was reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an 89 year old female patient with allergy to LORTAB and silk tape. No pertinent medical history was reported. On 01-JAN-2012 the patient was vaccinated with ZOSTAVAX (lot number reported as 1599AA, expiration date 13-JAN-2013) (dose and route not specified) to prevent shingles. No other suspect therapies were reported. Concomitant therapies included CITRICAL +D, PROCRIT, PRILOSEC, COUMADIN, VASOTEC, CELEXA, vitamins, LASIX, and PROSTAT. On 08-AUG-2013 the patient developed shingles after receiving ZOSTAVAX. The outcome for shingles was reported as not recovered. It was reported that the patient sought unspecified medical attention. The patient received VALTREX as treatment. No laboratory diagnostic studies were performed. The reporting nurse did not assess the causality between shingles and ZOSTAVAX. VZVIP packet was faxed. 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 Registered Nurse refers to a patient of unknown age. On an unspecified date in November 2011 and on 08-MAY-2013 the patient was vaccinated with the first and second doses of GARDASIL (lot# and expiration date not provided) (dose, route, indication not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 11-JUL-2013 the patient was vaccinated with an improperly stored dose of MMR II. The nurse reported that the vial of MMR II was exposed to 50F for 4 hours not 6 hours. This dose was administered to the patient on 11-JUL-2013 and now "supported". No adverse event and PQC involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 02-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA004971 MARRS 1308USA005803 MARRS 1308USA005805). This is one of several reports from the same reporter. 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 unspecified number of patients (age and gender unknown). He reported that GARDASIL (dose, route, indication unknown) injection 120 Y which was exposed to 22F for 3 months might have been administered to an unspecified number of patients during that period in time. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling jittery, Headache, Hyperhidrosis, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist (Pharm. D.) refers to a female patient of unknown age. The patient's concurrent condition included diabetes and high blood pressure. On an unknown date the patient was vaccinated with first dose of ZOSTAVAX (dose, route, lot#, injection site not provided). On an unspecified date the patient was vaccinated with the second dose of ZOSTAVAX (dose, route, lot#, injection site not provided). Since receiving the second dose of ZOSTAVAX she had had increased sweating, "jitteriness", and headache. The patient went to see the pharmacist. The outcome of adverse events was not recovered. The patient did not specify who administered the ZOSTAVAX and it was not administered by the pharmacist. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 18 year old (at the time of the event occurred on second occasion) female patient with no pertinent medical history and no drug reactions or allergies. On 10-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as 0555AE and December 2014 respectively, dose unspecified), intramuscularly. On 07-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiry date reported as J003727 and 07-NOV-2015 respectively, dose unspecified), intramuscularly. There were no concomitant medications. The patient experienced dizzy spells on both the occasions. The patient did not faint on either occasion. On an unknown date, the patient experienced dizzy spells after receiving the first dose of GARDASIL. On an unknown date, the patient recovered from dizzy spells. The patient experienced dizzy spells immediately after receiving the second dose of GARDASIL on 07-AUG-2013. The patient sought medical attention (call the reporting nurse). She was treated with increased fluids and salt. The patient was not recovered from dizzy spells occurred after receiving the second dose of GARDASIL. The relatedness for dizzy spells was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a health worker (nurse) refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL lot # 671463/1359AA expiration date 23-JUN-2014 (dose, route not provided). It was reported that GARDASIL underwent a temperature excursion on 18-JUN-2012. The GARDASIL was unsupported based on stability information however it was administered after excursion. There were unspecified patients that were administered both GARDASIL on an unspecified date. This is one of several cases reporting from same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Needle issue, No adverse event
Clinical narrative: This spontaneous report as received from a pregnant pharmacist who on 08-AUG-2013, had a ZOSTAVAX spilled on her pal due to needle leakage while with-drawing a dose of ZOSTAVAX from a vial (not administered). No adverse events were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that a patient was administered a first dose of VARIVAX on 15-JUL-2009. On 17-JUL-2013, patient received the first dose of ZOSTAVAX (lot number not provided) 0.5 ml subcutaneously instead of the intended VARIVAX. Concomitant medications were not provided. No adverse effect reported. No further information provided. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: This spontaneous report as received from a 78 year old male consumer reporting on himself who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that he was experiencing in approximately August 2013, skin irritation and he was going to see his health care provider to determine if this was shingles. At the time of the report, the patient's outcome was unknown. The relatedness for skin irritation and ZOSTAVAX was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender with no pertinent medical history reported. On 22-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1502AA and expiration date of 19-MAY-2013) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The reporter stated that the patient was administered PNEUMOVAX23 from an expired vial. No adverse events were reported. The medical assistant reported that other three patients were administered with PNEUMOVAX23 from an expired vial (MARRS 1308USA004971 MARRS 1308USA005804 MARRS 1308USA005805) This is one from several reports from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous report was received from a healthcare worker concern to a 28 year old female patient with asthma and had none drug reactions or allergies. On 24-JUL-2013, the patient was vaccinated with PNEUMOVAX23 lot # J001180 (exp date on 18-AUG-2014), 0.5 ml, intramuscular. Was unclear whether or not this was the patient's first dose. Concomitant therapies included albuterol. It was reported that the patient experienced soreness at the injection site "for a few days". On 31-JUL-2013, the patient reports that she developed an axillary mass on the arm which the injection was given on. The patient sought medical attention and presented at hospital Emergency Department. The reporter stated that in the emergency department notes that there were no blood work studies, no imaging, no biopsy and no culturing of the mass. The patient was prescribed KEFLEX and was not admitted to the hospital. The patient has not, at this time followed up with her physician. At the time of the report, the outcome of soreness at the injection site and axillary mass on the arm which the injection was given on was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary mass, Injection site pain
Clinical narrative: This spontaneous report was received from a healthcare worker concern to a 28 year old female patient with asthma and had none drug reactions or allergies. On 24-JUL-2013, the patient was vaccinated with PNEUMOVAX23 lot # J001180 (exp date on 18-AUG-2014), 0.5 ml, intramuscular. Was unclear whether or not this was the patient's first dose. Concomitant therapies included albuterol. It was reported that the patient experienced soreness at the injection site "for a few days". On 31-JUL-2013, the patient reports that she developed an axillary mass on the arm which the injection was given on. The patient sought medical attention and presented at hospital Emergency Department. The reporter stated that in the emergency department notes that there were no blood work studies, no imaging, no biopsy and no culturing of the mass. The patient was prescribed KEFLEX and was not admitted to the hospital. The patient has not, at this time followed up with her physician. At the time of the report, the outcome of soreness at the injection site and axillary mass on the arm which the injection was given on was unknown. Additional information has been requested.
Age: 1.41
Sex: F
Vaccine: HIBV, PPV
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Pyrexia, Wheezing
Clinical narrative: Fever which did not respond to Tylenol, climbed to 103.9.  Rapid heart rate, difficulty breathing, wheezing and tightness in chest.  Emergency room visit: given Tylenol and Motrin, fever eventually broke and was sent home.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Cervical dysplasia, Colposcopy normal, Exposure during pregnancy, Smear cervix abnormal, Thrombocytopenia
Clinical narrative: Initial report received from a healthcare professional on 23 October 2012. A 30-year-old pregnant female patient had received an intramuscular dose 1 of ADACEL vaccine (lot number U4421AA anatomical site of administration was not reported) on 23 October. The patient's last menstrual period date was 12 April 2012. The estimated date of delivery was 27 January 2013. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, risk factors was not reported. Concomitant medications and past medical history was not reported. Documents held by sender: None. Follow-up information was received from a healthcare professional on 02 August 2013. Based on the new information, this case has been upgraded to serious. The patient also received RhoGam (lot number, route and site not reported). The patient experienced thrombocytopenia (date not reported). The baby was large for gestational age (LGA). The patient had an ASCUS pap with negative colposcopy (date not reported). End of pregnancy date was 14 January 2013. The infant and birth outcome were normal. This was the patient's first pregnancy. Patient's outcome was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, Foetal disorder, Thrombocytopenia
Clinical narrative: Initial report received from a healthcare professional on 27 September 2012. A 23-year-old pregnant female patient; had received an intramuscular (IM), first dose of ADACEL vaccine (lot number U4421AA, and site of vaccination was not reported) on 27 September 2012. Date of last menstrual period was 01February 2012 and the estimated date of delivery was reported as 02 December 2012. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, previous pregnancy history, other medical history and concomitant medications were not reported. Follow-up information was received on 02 August 2013 from a health care professional. The patient's LMP was 16 July 2012 (previously reported as 01 February 2012). According to the reporter, any relevant illness during pregnancy/ongoing included thrombocytopenia and SUA (single umbilical artery) (dates of onset were not reported). The patient also received AFLURIA for one day (manufacturer, lot number, route site and date of vaccination not reported). According to the report, they did not experience any adverse events following vaccination. The patient had 4 pregnancies. No further information was available at the time of the report. Outcome was normal. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, Pre-eclampsia
Clinical narrative: Initial report received from a healthcare professional on 26 September 2012. A 21-year-old pregnant female patient, whose concomitant medications and medical history was not reported, had received first dose of intramuscular (IM) ADACEL (Lot number U4421AA, Expiry date of vaccine 18 January 2015, anatomical site of vaccination was not reported) on 26 September 2012. The patient had her last menstrual period on 18 February 2012 and the expected date of delivery was reported as 24 November 2012. As per reporter the patient did not experience any adverse event. The previous pregnancy history and other medical history were not reported. List of documents held by the sender: None. Follow-up information was received from a healthcare professional on 02 August 2013. Based on the new information, this case has been upgraded to serious. The patient also received AFLURIA during pregnancy (lot number, route, site and date of administration not reported). The patient experienced severe pre-eclampsia during pregnancy. End of pregnancy was 16 October 2012 with a normal birth outcome/infant. Outcome was not reported.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Placental disorder
Clinical narrative: Initial report received from a health care professional on 26 September 2012. A 28-year-old female patient whose medical history and concomitant medications were not reported, had received first dose of ADACEL vaccine (Lot number: U4421AA) (route of administration not reported) in her left deltoid region on 26 September 2012. It was reported that the patient was pregnant at the time of vaccination. The patient's date of last menstrual period was 14 January 2012 and the estimated date of delivery was reported 06 November 2012. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information was received from a healthcare professional on 02 August 2013. Based on the new information, this case has been upgraded to serious. The patient was 18-years-old. The patient experienced circumvallate placenta (date not reported). This was the patient's first pregnancy. End of pregnancy was 12 October 2012. Birth outcome and infant were both normal. Patient's outcome was not reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a 70 year old female consumer (reporting on herself). In May 2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose not reported, intramuscular route). Concomitant therapy was not reported. On an unspecified date in 2013, the patient started feeling pain on arm where shot was administered. The patient sought unspecified medica; attention and no treatment was given for adverse event. The patient got a Magnetic Resonance Imaging (MRI) on 29-JUL-2013 (waiting for results). The outcome of injection site pain was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. On 23-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) and on 30-MAY-2013 was vaccinated with the second dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapy was not reported. No adverse event reported. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Nausea
Clinical narrative: After 1st dose - headache, nausea
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling and rash in vaccine area.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: DTaP, HIB, IPV given at WCE 8/12/13 at 1:30 pm. At 5 pm mom noticed 2" red, firm wheal at site on LT. No other s/s. Called this am, wheal decreased to 1", continues to feel well 8/14/13 redness resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 8-8-13 patient vaccinated with shingles. T/C 8-12-13 patient reports left arm, injection site, stiff, red, swollen and hot to touch, since HC not open for treatment, went to pharmacy who suggested BENADRYL which she found effective. 8/13/13 T/C reddened but better. 8-14-13 last BENADRYL yesterday - resolved.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Pallor, Pyrexia, Rash
Clinical narrative: Fever 100.2; rash is diffuse, pinpoint, blanches; pt described as irritable. Rash described as covering all over pt. Vaccine given on 08/05/2013. Treatment: ibuprofen 1.875cc every 6 hr as needed avoid other infants or anyone with bad immune system until 8/15/2013.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Skin reaction
Clinical narrative: Received first dose of Hepatitis B on 5/13/2013 and had a skin reaction lasting 3 days that she did not report. She receive 2nd dose on 7/15/2013 on had a rash lasting 1 month-requiring oral steroids.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Mobility decreased, Skin warm
Clinical narrative: Spoke with patient on 8/14/13 and she said she was fine first couple days after pneumonia shot then left arm got very hot and it burned all the way down under left breast for a week. Had to take her pain medication (SOMA) to be able to work. Could barely move her arm the whole time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: Patient had "shooting/tingling/burning" pain in the middle of the night on same exact site of vaccine administration but on opposite arm and 1 full day later. Patient also had at site swelling (injection site) but localized (not spreading).
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: Whole arm swelled excessively.  Site of injection was painful and itchy.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypotonia, Pallor, Tremor
Clinical narrative: Patient and his mom came in for his scheduled Tdap vaccination at 8:15 am.  I asked all the routine questions regarding vaccine history, reaction, etc.  He was very talkative and  said he didn't like needles.  He sat down in the chair and I administed into his R deltoid.  He sat there for about 10 seconds and then his head slumped down and he went limp for about 3 seconds.  He put his head  up and he was very pale white.  I called for the other nurse to come in and she went and got him some water.  I got two ice pack and put one on his neck and one on his forehead.  He put his head between his legs for a few minutes.  He drank two and a half bottles of water and ate a chocolate Fiber One bar.  He stated he didn't eat breakfast this morning.  He was visibly shaking a little bit and sweaty.  He was talking  the entire time, and even making jokes.  After about 1/2 hour we slowly got him up and he walked to the waiting room to sit down.  He sat there with his mom for about 10 minutes and he said he felt good enough to leave. I instructed mom to call me if there were any further problems or concerns.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: LOCALIZED LARGE AREA OF SWELLING, RED, HOT, ITCHY.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Right deltoid swollen. Patient states very, sore. No redness. Mom reports fever of 102.F, relieved with Tylenol. Full range of motion, but guarded.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Pt received her first Gardasil injection and became pre syncopal shortly thereafter.  Pt was assisted in lying down for 10-15 min, VS were stable.  She was given juice and crackers once sitting and was able to leave the department safely about 15-20 min after the injection.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: Bloody nose immediately following administration of Flumist.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Face oedema, Rash generalised
Clinical narrative: Rash starting on scalp & has spread to entire body; facial edema; joint pain.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: PATIENT HAD SYNCOPE AND PALENESS AND PASSED OUT---ALERT AFTER 10 SECONDS.  LET PATIENT REST WITH COOL CLOTH TO HEAD. PATIENT STATED DID NOT SLEEP WELL NIGHT BEFORE AND WAS TIRED.    AFTER RESTING FOR 30 MINUTES PATIENT UP AND VOICING NO COMPLAINTS--  WENT HOME WITH MOM.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Localized redness and swelling with 2-3 in diameter.  Patient didn't feel or notice until seen in mirror days later.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Temp. 101.8, headache, chills. Not reported to facility until 08/13/2013 at 4:30PM. Per patient, patient sought medical attention from own private medical doctor who prescribed Tylenol and rest.
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: Patient reported that on June 10 it was red and very irritated and itchy.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Syncope
Clinical narrative: Syncope following immunization - while leaving immunization room; became awake while laying down Pt. on exam table with legs elevated.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Pt. feels like blackingout, seizures ~ 1 min. Pt was placed on flat position. EMS was called. Pt. wa staken to ED.
Age: 70.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Abdominal discomfort, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: A shingles symptom with large area red rash at the left side of my body with a lot of small and big poxes, pain, fever, stomach upset after three days later since 8/7/13.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: 1 day after vaccine was administered patient started to feel fatigue and stiff neck 2 days after vaccine started to feel nauseous and mild dizziness. Treat with Meclizine 25 mg for the dizziness.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Gianotti-Crosti syndrome
Clinical narrative: Gianotti Crosti.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Borrelia test, CSF myelin basic protein, CSF test, Cryptococcus test
Clinical narrative: Numbness feet to knees and paresthesias back of thighs.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal test, HIV test, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Numbness feet to knees and paresthesias back of thighs.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Numbness feet to knees and paresthesias back of thighs.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound Doppler, Vitamin D
Clinical narrative: Numbness feet to knees and paresthesias back of thighs.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Burning sensation, Pain, Pyrexia, Rash erythematous
Clinical narrative: Red rash with blisters on left side of head/lower jaw/neck upper to hairline. Lesions spread then became crusted and over 3 week period have dried to a dark scab. Lesions did not itch but were very exqusitely painful and she said had a deep burning sensation especially if were touched. She ran low grade fever early on. She was seen by a physician and was given antivirals orally, steroid injection and did use a compounded cream for pain. OTC ADVIL in large quantities.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Tenderness
Clinical narrative: Red rash with blisters on left side of head/lower jaw/neck upper to hairline. Lesions spread then became crusted and over 3 week period have dried to a dark scab. Lesions did not itch but were very exqusitely painful and she said had a deep burning sensation especially if were touched. She ran low grade fever early on. She was seen by a physician and was given antivirals orally, steroid injection and did use a compounded cream for pain. OTC ADVIL in large quantities.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Disorientation, Extremity contracture, Hyperhidrosis, Loss of consciousness, Mydriasis
Clinical narrative: Eyes dilated, loss consciousness for 20 sec. opened eyes then lost consciousness again for 10 sec, arms drew towards chest as if having seizure and some shaking. Unaware of her location when became conscious again. Diaphoretic and nauseated.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Nausea, Tremor
Clinical narrative: Eyes dilated, loss consciousness for 20 sec. opened eyes then lost consciousness again for 10 sec, arms drew towards chest as if having seizure and some shaking. Unaware of her location when became conscious again. Diaphoretic and nauseated.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Blindness, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 31 year old female consumer (reporting on herself), with unspecified digestion problems and none drug reaction allergies. On 05-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). There was no concomitant therapy. On 05-AUG-2013, 5 min after onset of therapy, the patient experienced loss of memory, loss of vision, numbness, tingling, vomiting and pain. The patient went to the emergency room and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The outcome of loss of memory, loss of vision, numbness, tingling, vomiting and pain was reported as not recovered. Upon internal review the loss of vision was considered an other important medical event. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a 31 year old female consumer (reporting on herself), with unspecified digestion problems and none drug reaction allergies. On 05-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). There was no concomitant therapy. On 05-AUG-2013, 5 min after onset of therapy, the patient experienced loss of memory, loss of vision, numbness, tingling, vomiting and pain. The patient went to the emergency room and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. The outcome of loss of memory, loss of vision, numbness, tingling, vomiting and pain was reported as not recovered. Upon internal review the loss of vision was considered an other important medical event. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Diarrhoea, Influenza like illness, Nausea, Vomiting
Clinical narrative: Pt sts she started feeling "FLUISH" at 2 pm-followed by several bouts of N/V/D - unrelieved with PHENERGAN supp-went to ER-tx'd with IV fluids and meds.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Slight varicella-like lesions noted in few places. There are approximately 6 lesions.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Syncope. Following Gardasil dose 1, anaphoretic, paller and weakness.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red itchy 50 cent size area at site of vaccine injection.
Age: 19.0
Sex: F
Vaccine: TYP, YF
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Chills, Feeling cold, Pyrexia, Rash, Vomiting
Clinical narrative: Vomitting, cold chills, (per patient mother lasted 90 mins) rash on chest (very mild). Fever <101.5.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dysuria, Full blood count, Headache, Pain, Pyrexia
Clinical narrative: Received vaccines on 8/7/13 at 3 PM. That evening developed headache, fever (101.4) and body aches. dysuria x 2. Tx: Supportive cares at home.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Received vaccines on 8/7/13 at 3 PM. That evening developed headache, fever (101.4) and body aches. dysuria x 2. Tx: Supportive cares at home.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour
Clinical narrative: Mom states child was "out of it" until bedtime, (stoned). Fine the next morning.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Lip swelling, Oedema peripheral, Rash, Rash papular
Clinical narrative: Diffuse red papular rash on arms, legs followed by swollen lips, feet and hands and more widespread rash.  Administered Benadryl and steroids.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: 3-1/2 BY 3-1/2 AREA THAT WAS WARM TO TOUCH WITH REDNESS AND HARD AS A ROCK. ARM SORE DAY PRIOR YET SYMPTOMS STARTED ON THE 10TH.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: RED SWOLLEN ARM.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema, Rash
Clinical narrative: Edema and Rash - Both mostly resolved. No SOB.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Syncope, nauseous. Patient laid out for 15 minutes, felt better with juice and ice pack.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Feeling hot, Joint effusion, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Injection was given up at the top of my left shoulder.  Felt pain and an unusual feeling in shoulder.  Next day pain and a band of heat around my bicep that lasted for a month and a half. Pain is constant, I have limited ROM. Tried NSAIDS, have had an MRI, 2 cotisone shots, PT, and now have been told I need a shoulder scope in order to fix my shoulder. I had no problems with this shoulder prior to the injection.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis, X-ray abnormal
Clinical narrative: Injection was given up at the top of my left shoulder.  Felt pain and an unusual feeling in shoulder.  Next day pain and a band of heat around my bicep that lasted for a month and a half. Pain is constant, I have limited ROM. Tried NSAIDS, have had an MRI, 2 cotisone shots, PT, and now have been told I need a shoulder scope in order to fix my shoulder. I had no problems with this shoulder prior to the injection.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint swelling, Oedema peripheral
Clinical narrative: Numbness of right arm, swelling fingers and wrist (arm feels asleep).
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Patient had a vasovagal episode immediately after the shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) leg is red, swollen and warm to the touch. TX: Monitor reaction. If worsens will treat with antibiotics.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed redness at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Rash papular, Rash vesicular, Urticaria
Clinical narrative: Patient broke out in a generalized non erythematous papular rash over face, trunk, extremities. Few looked vesicular, few wheal like lesions.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood culture negative, Chest pain, Computerised tomogram thorax normal, Echocardiogram normal, Haematuria
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Headache, Injection site erythema, Lethargy, Pain, Troponin increased
Clinical narrative: Chest pain 11 days post SPV with elevated troponins. He denied problems with previous immunizations and noted around day 7 the onset of a headache, and overall not feeling well. His SPV site was red and swollen. On 14 Jun he developed the onset of chest pain center of chest that felt like he was being crushed by a 15 lb weight. He rated this pain # 3. He was evaluated at the clinic and was given antibiotics for his red arm and to report to ED if chest pain worsened. Later that evening, his pain worsened to #5, he had slight radiation to left side and his neck, he reported SOB when climbing stairs and he was diaphoretic. He denied n/v and denied problems with position changes. He never had pain like this before. He went to the local emergency dept where they did some tests and because there were abnormalities he was transferred to a Medical Center where he was admitted and discharged on 18 Jun. Pain started easing on Sat morning and currently he reports that he occasionally gets pain described as very mild just left of sternum. Currently pain will only last approx. 5 sec, feels like it is muscular and will ease on its own. The highest level it reached since discharge has been #3. He only reports SOB when he climbs the stairs and reports that overall he is feeling much better.