chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.21
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Wheezing
Clinical narrative: Information has been received from an investigator (Number 045/263) as part of a business agreement, concerning a 14 month old male who entered a study. On 11-DEC-2011 (also reported as 12-DEC-2011), consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and ROTATEQ at 2 months, 4 months and 6 months of age or ROTATEQ, PENTACEL, PREVNAR 13 at 2, 4 and 6 months of age and modified process HepB vaccine at 2 and 6 months of age (study vaccine information not provided by the site). On 19-DEC-2012, the subject experienced bronchiolitis (intensity reported as 3) and on 23-DEC-2012 pneumonia (intensity reported as 3) and was hospitalized. The subject was seen in primary medical doctor (PMD) office on 19-DEC-2012 and diagnosed with ear infection, wheezing (not reported as SAE/NSAE/symptom) and bronchiolitis. On 19-DEC-2012, subject was treated with OMNICEF po for ear infection (dosing information not reported), CIPRODEX otic suspension, ear drops for ear infection (dosing information not provided) and albuterol aerosol for wheezing in office and at home and improved (dosing information not provided) (also reported as concomitant therapies). On 20-DEC-2012, subject started with high fevers 104 to 105 (unit of measurement not reported as SEA/NSAE/symptom) and was treated with TYLENOL and ibuprofen at home (dosing information not provided). On 23-DEC-2012, subject was brought to the emergency room (ER) for increase work of breathing and fevers. In the ER subject was treated with nasal cannula oxygen and ampicillin IV (dosing information not provided). Per PMD subject was in hospital for about 48 hours. On 26-DEC-2012, subject was seen in PMD office, no further information provided. At the time of reporting, subject was recovering from bronchiolitis (grade3) and pneumonia (grade3). Action taken with study therapy was not reported. At the time of reporting, the investigator did not provide a causal relationship between study vaccine therapy and bronchiolitis (grade3) and pneumonia (grade3). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever 12/27 of 102; redness at injection site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue
Clinical narrative: Extreme fatigue. Unable to sing. Lasted about six hours, then I recovered.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Approx 3 min after immunizations felt dizzy, CVR clear, breathing WNL, no color changes. HR WNL & reg. VS monitoring q 5 min, stable Oxim 100%. RR 20's. Vision felt blurry, dizziness & blurry vision increasing. Doesn't feel better seated or supine or after given water. Observed x15 min. No changes so called ambulance.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After pt received MENVEO, pt became diaphoretic & lightheaded. Pt did well after 20 min. Pt became pale, diaphoretic & dizzy after immunization. Pt told lay on table BP 96/60 HR 71 Ox 99%. Waited 20 min & BP 102/62.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age who on 19-JUL-2012 was vaccinated with the first dose of GARDASIL (Lot number, route and dose not reported) and on 27-DEC-2012 was vaccinated with the second dose of GARDASIL (Lot number, route and dose not reported). No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Cough, Malaise, Nasal congestion
Clinical narrative: 3 hrs after shot began to feel like getting a cold "under the weather" 12 hrs after nasal congestion, body aches, 24 hrs after - fever (high - did not take temp), body aches, 48 hrs after chills, body aches, 72 hrs coughing began, hurt to cough, wheezing began. Is going to MD today for follow up. Missed one wk work.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pain, Pyrexia, Wheezing
Clinical narrative: 3 hrs after shot began to feel like getting a cold "under the weather" 12 hrs after nasal congestion, body aches, 24 hrs after - fever (high - did not take temp), body aches, 48 hrs after chills, body aches, 72 hrs coughing began, hurt to cough, wheezing began. Is going to MD today for follow up. Missed one wk work.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received pneumococcal vaccine at 5:12 pm on 1/2/13 at (R) deltoid on 1/3/13 at about 8:30 pm has redness, warmth and swelling same upper arm.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: 1/31 - eve - itchy at site - hot to touch - raised area 2" x 3". 1/1/13 - remains itchy - very red, hot - no drng 3 welts have for med by 3 pm - increased headache nausea --> area has spread 6" long 4 1/2" wide. 1/2 - swelling around injection 2" round - remains very red, hot, itchy - no pain- area outside of circle - still increased warm 6" long 5" wide. 1/3/13 - same as 1/2 - increased itching - took BENADRYL last eve - no pain - area hot to touch - have been using mass & wm pks to area. 1/3 pain only if bumped or squeezed today. Still very itchy.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Nausea, Pain
Clinical narrative: 1/31 - eve - itchy at site - hot to touch - raised area 2" x 3". 1/1/13 - remains itchy - very red, hot - no drng 3 welts have for med by 3 pm - increased headache nausea --> area has spread 6" long 4 1/2" wide. 1/2 - swelling around injection 2" round - remains very red, hot, itchy - no pain- area outside of circle - still increased warm 6" long 5" wide. 1/3/13 - same as 1/2 - increased itching - took BENADRYL last eve - no pain - area hot to touch - have been using mass & wm pks to area. 1/3 pain only if bumped or squeezed today. Still very itchy.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, PNC13
Symptoms: Abdominal pain upper
Clinical narrative: 12 a few minutes past vaccines patient complained to parent that her stomach "hurt". 400 spoke with parent-she states she is fine.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Feeling hot, Flatulence, Flushing, Headache, Influenza like illness
Clinical narrative: 12-20-12 Client took 2nd oral Typhoid pill - felt nausea, crampy, had gas, felt "hot & flushed", and had a headache. 12-22-12 Client took 3rd oral typhoid pill - felt "flu like symptoms" - worsening of above s/s - went to bed & rested x 2 days. Did not take last #4 pill. Called today to say still doesn't "feel well". Advised to seek medical care.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Malaise, Muscle spasms, Nausea
Clinical narrative: 12-20-12 Client took 2nd oral Typhoid pill - felt nausea, crampy, had gas, felt "hot & flushed", and had a headache. 12-22-12 Client took 3rd oral typhoid pill - felt "flu like symptoms" - worsening of above s/s - went to bed & rested x 2 days. Did not take last #4 pill. Called today to say still doesn't "feel well". Advised to seek medical care.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Diarrhoea, Flatulence, Influenza like illness, Nausea
Clinical narrative: 12-20-12 Client took 2nd oral Typhoid pill - felt nausea, crampy, had gas, felt "hot & flushed", and had a headache. 12-22-12 Client took 3rd oral typhoid pill - felt "flu like symptoms" - worsening of above s/s - went to bed & rested x 2 days. Did not take last #4 pill. Called today to say still doesn't "feel well". Advised to seek medical care.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated that she was having some redness & swelling at injection site. Provider looked at site & no redness noted.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) arm swelling and redness within a day of receiving pneumococcal vaccine and the swelling & redness extended as far forearm in 3 days.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Injection site pain, Malaise
Clinical narrative: Patient states soreness at site of injection, malaise, low grade temperature (less than or equal to 98.7).
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Decreased appetite, Dizziness, Hepatitis viral test negative, Incorrect route of drug administration
Clinical narrative: Patient states soreness at site of injection, malaise, low grade temperature (less than or equal to 98.7).
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling, Laboratory test normal, Mycobacterium tuberculosis complex test negative, Pyrexia
Clinical narrative: Patient states soreness at site of injection, malaise, low grade temperature (less than or equal to 98.7).
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Somnolence, X-ray normal
Clinical narrative: Patient states soreness at site of injection, malaise, low grade temperature (less than or equal to 98.7).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Received injection on 12/31/12. Spot 3 1/2 inches swollen and center red and tender to touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Received vaccine on 12/31/12. Softball size area lump & center red & warm to touch.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Erythema, Inflammation, Local swelling
Clinical narrative: Received vaccine 12/31/12 - large softball area of inflammation with inner circle raised & bright red. Cellulitis present very achy & middle area almost blister like appearance.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Received vaccine 12/31/12 - large softball area of inflammation with inner circle raised & bright red. Cellulitis present very achy & middle area almost blister like appearance.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Epistaxis, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous report as received from a 71 years old female consumer refers  herself with high blood pressure, hypothyroidism and drug reactions/allergies to sulfa and tricycle antidepressants. The patient's medical history included paradoxical reaction. The patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 10-DEC-2012. Concomitant medications included HTZ, ATENOLOL and LEVOXYL. On 13-DEC-2012 the patient experienced extreme fatigue, headache, muscle aches and mild bloody noses 2 to 3 days after immunization. She sought medical attention by calling her physician and visiting office and they did not prescribe treatment. No lab diagnostics study was performed. She reported that the symptoms had gotten less intense, but persisted. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 years old patient. On 18-DEC-2012 the patient was vaccinated with 0.5ml VARIVAX (merck) (subcutaneous, dose and lot number were not reported) instead of a dose of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with hypercholesterolemia and no known drug allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot# reported as h018088, expiration date 04-JUN-2014) on 21-DEC-2012. No other co-suspects were reported. Concomitant medications included: CRESTOR. On 23-DEC-2012 the  patient developed redness, swelling and itching in the arm surrounding the injection site, 2 days after the injection. No treatment information was reported. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of redness, swelling and itching in the arm surrounding the injection site is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age (gender unspecified). Approximately on an unknown date in 2012 (reported as few months ago), the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiration and route was not reported) which was potentially improperly stored. No concomitant medications were reported. The patients present status was unspecified. Additional information is not expected.
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. The patient was vaccinated with ZOSTAVAX (lot number: 0698Z; expiration date: 28-APR-2011) on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-DEC-2012 the patient received expired ZOSTAVAX injection. No adverse event was reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received 3/4ths of a dose of ZOSTAVAX (dose and frequency unknown) subcutaneous in error on 05-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. At the time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested. Follow up information received. Reporter stated not really pertinent, the problem was mechanical rather than biological. The needle and syringe became disattached during the immunization resulting in an incomplete dose given. No problem with the vaccine, the syringe/needle combo was the problem. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 years old male patient with chronic obstructive pulmonary (COPD) who on 19-DEC-2012, was vaccinated with ZOSTAVAX (dose, route, and lot number not provided). Other co-suspects were not reported. Concomitant medications were not reported. The pharmacist reported that the patient typically takes prednisone (manufacturer unknown) 10 mg daily for his chronic obstructive pulmonary (COPD). On 19-DEC-2012, the patient experienced exacerbation of his chronic obstructive pulmonary disease (COPD). The patient sought medical attention. On the same date, following administration of ZOSTAVAX, the patient received prednisone (manufacturer unknown) 40mg once at that time. The outcome of exacerbation of his chronic obstructive pulmonary disease (COPD) was reported as not recovered. The relatedness for exacerbation of his chronic obstructive pulmonary disease (COPD) was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 months old patient (gender not reported). The patient was vaccinated with a dose of PNEUMOVAX23. Route, dose and lot number were not reported. No adverse symptoms were reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Myalgia
Clinical narrative: This spontaneous report as received from a 59 years old male patient with no drug reactions concerning himself. The patient's medical history included shingles happened in September 2012 to December 2012. The patient was vaccinated with a dose of ZOSTAVAX (1 time vaccine, subcutaneously, lot # was unknown) on 28-DEC-2012. There were no concomitant medications. On 28-DEC-2012 after 2 hours vaccination, the patient had a hard red lump at the injection site on his right arm. He also stated he had muscle pain. The patient did not seek medical attention. No treatment was given to the adverse events. No lab diagnostics were performed. The outcome of the adverse events was unknown at the time of report. The relatedness between adverse events and ZOSTAVAX was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age who at about a month ago (approximately in November 2012) was vaccinated subcutaneously (SQ) with a single dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that at about a month ago (approximately in November 2012), the patient developed redness, warmth, and pain at the injection site after administration of ZOSTAVAX "about one month ago". The symptoms resolved within 1 week (unspecified date in the 2012) without requiring medical treatment. The patient went to the pharmacy for medical attention. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Autoimmune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 3 years old female patient. The patient was 11 years old now. On an unknown date, the patient was vaccinated with 0.5 ml VARIVAX (merck) VIAL 1350U subcutaneously at 12 months of age. Lot# was unspecified. Two years later, on an unspecified date at approximately 3 years old, the patient developed immune thrombocytopenic purpura (ITP). The patient received treatment with intravenous immunoglobulins (specific products and manufacturers unspecified). The outcome of patient was unknown. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 13 months old patient. The patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number unspecified) instead of VARIVAX (Merck) on 27-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. In approximately June 2012, within the last 6 months, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned the unspecified patient had experienced cellulitis after receiving ZOSTAVAX. The nurse stated that the unspecified patient did see an unspecified doctor for treatment of the cellulitis. The nurse stated that it was within the last 6 months that the ZOSTAVAX was given and cellulitis had occurred. The nurse was unable to provide specific dates. The nurse stated that the vaccine was administered at the clinic and the nurse was not involved in any follow up. At the time of the report, the outcome of cellulitis was unknown. This is one of several reports received from same reporter (other case # 1301USA000020). 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 nurse practitioner refers to a patient of unknown age (demographics not provided). On 16-SEP-2012 the patient was vaccinated with dose 1, 0.5 ml GARDASIL, intramuscular, (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On 26-NOV-2012 patient received second dose and on 26-DEC-2012 patient received third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Injection site pain, Nuclear magnetic resonance imaging normal, Scan normal
Clinical narrative: I had a mild amount of discomfort, as expected, following the injection. The next day, I had quite a bit of aching and soreness at the injection site which seemed similar to previous flu shots I have received. This pain has not gone away since the injection date and has gotten worse.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Called by school nurse that he had broken out in raised, red, itchy rash behind ears- spread to back & chest. Also c/o headache 8 days post vaccination with MMR.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Syncope
Clinical narrative: This spontaneous report as received from a consumer refers to her 16 years old female daughter with tetracycline allergy. The patient had no pertinent medical history. The patient was vaccinated with the first dose of GARDASIL (lot # unspecified) on 27-DEC-2012. No other co-suspects were reported. There were no concomitant medications. On 28-DEC-2012 the patient fainted and was taken to the emergency room of hospital. She was found to be fine and was not admitted. No treatment information was given. Chest X-ray, blood work and electrocardiogram were performed. The outcome of fainted was reported as recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who administered vaccines refers to a patient of unknown age. On 31-DEC-2012, the patient was administered a dose of GARDASIL (lot # reported as H013977; expired date; 15-MAR-2015) intramuscularly that was exposed to an unsupported temperature excursion (58 degrees Fahrenheit for 106 hours). It was not specified if this was the first, second, or third dose of GARDASIL this patient had been administered. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Feeling hot, Flatulence, Flushing, Headache, Influenza like illness
Clinical narrative: Patient felt flu-like symptoms after 2nd dosage. Nausea, gassy, soft stools.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Malaise, Muscle spasms, Nausea
Clinical narrative: Patient felt flu-like symptoms after 2nd dosage. Nausea, gassy, soft stools.
Age: 59.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Diarrhoea, Flatulence, Influenza like illness, Nausea
Clinical narrative: Patient felt flu-like symptoms after 2nd dosage. Nausea, gassy, soft stools.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Itching, rash on hands, abdomen pt given BENADRYL capsules and hydrocortisone 1% crm.
Age: 1.1
Sex: M
Vaccine: MMR, PNC10, VARCEL
Symptoms: Febrile convulsion, Flushing, Posture abnormal, Pyrexia, Unresponsive to stimuli
Clinical narrative: My son had begun to run fever earlier in the day.  Around 6:30 pm that evening, I had placed him in his high chair. A few moments later I noticed his head was turned to the side and his face looked very flushed.  Also, his eyes were open but he was unresponsive to me.  I immediately called 911.  He remained in this state a few minutes.  By the time the ambulance arrived he was better.  We took him to the emergency room and doctor diagnosed episode as a febrile seizure.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eyelid margin crusting, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Eyes: red, irritated, watering, stuck shut in the morning. Still a problem & it has been 3 1/2 days.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Pain
Clinical narrative: Lower body aches, burning leg nerves.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash & shingles.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Complication of pregnancy, Maternal exposure during pregnancy
Clinical narrative: A report had been received from a health professional concerning a female patient of age 36 years. The patient's concomitant medication included ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin B NOS, vitamin D NOS. The patient reported her last menstruation on 20-Aug-2012, and the patient was administered nasal FLUMIST on 14-Sep-2012, when she was pregnant. It was reported, that FLUMIST was administered to 3 pregnant patients. It was reported that the patient experienced complications during the current pregnancy however, no additional details were provided. The patient had two previous pregnancies excluding the current one. Live birth and normal delivery were reported in previous pregnancies. Action taken with FLUMIST, were unknown. The company physician assessed the event of complications during the current pregnancy to be serious with the serious criteria of important medical event and the event of FLUMIST was administered to 3 pregnant patients to be non serious. Corrected report on 20-Nov-2012: The event of administration to 3 pregnant patients has become a KUR term, therefore the case has been updated accordingly. Summary of follow up information received by AstraZeneca/Medimmune on 18-Dec-2012: Patient's initial, date of birth added. FLUMIST start date updated, concomitant medication added. New event of patient experienced complications during the pregnancy was added. Trimester exposed added. Patient's last menstruation date, pregnancy due date updated. Number of previous pregnancy added as 2. PSUR comment added. Narrative updated. Follow-up information received by AstraZeneca 20-Dec-2012 from health professional upgraded this case to globally expeditable: Serious criteria changed for the event of patient experienced complications during the pregnancy.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Rash, Wheezing
Clinical narrative: Cough, wheeze & rash. Cephalexin 500 mg BID, Diphenhydramine 25 mg PRN.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Dysphonia, Dyspnoea, Eye discharge
Clinical narrative: LOSS OF APPETITE, FATIGUE, CONTINUOUS COUGH, WHEEZING, FELT LIKE THROAT WAS CLOSING UP, HOARSENESS, SORENESS, RED ITCHY EYES, EYES WERE DISCHARGING (ALMOST LOOKED LIKE EGG WHITE DISCHARGE-VERY THICK) HARD TIME BREATHING.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Fatigue, Headache, Ocular hyperaemia, Pain
Clinical narrative: LOSS OF APPETITE, FATIGUE, CONTINUOUS COUGH, WHEEZING, FELT LIKE THROAT WAS CLOSING UP, HOARSENESS, SORENESS, RED ITCHY EYES, EYES WERE DISCHARGING (ALMOST LOOKED LIKE EGG WHITE DISCHARGE-VERY THICK) HARD TIME BREATHING.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Wheezing
Clinical narrative: LOSS OF APPETITE, FATIGUE, CONTINUOUS COUGH, WHEEZING, FELT LIKE THROAT WAS CLOSING UP, HOARSENESS, SORENESS, RED ITCHY EYES, EYES WERE DISCHARGING (ALMOST LOOKED LIKE EGG WHITE DISCHARGE-VERY THICK) HARD TIME BREATHING.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Depression, Hyperhidrosis, Laboratory test abnormal, Methylenetetrahydrofolate reductase deficiency
Clinical narrative: Patient got hyperhidrosis of the hands and feet after the vaccine and also depression, neither of which she had had before. We asked for just the tetanus vaccine, but was administered DTaP.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Five hours after receiving the seasonal flu shot Afluria, I had a fever (99.7) and aches all over. I also woke up with a headache.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Grand mal convulsion, Somnolence
Clinical narrative: Child was well, became suddenly sleepy, then experienced generalized tonic-clonic seizure x1-2 minutes. In ED Temp 38.9-->39.8.  No other symptoms, and appeared well.  Diagnosed febrile seizure.  No further evaluation or sequelae.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I received the flu vaccine.  My arm was red, swollen, warm to the touch and itchy only on the injection site.  It remained this way for 4-5 days.  However, my arm is still a little itchy and it has now been 7 days since vaccination.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Still complaining of arm pain, particularly when doing range of motion.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself who on 17-SEP-2011 was vaccinated with the first dose of GARDASIL (dose and route not reported) and on 05-DEC-2011 was vaccinated with the second dose of GARDASIL (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient missed the third dose of GARDASIL. No adverse effect was reported. Patient's outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Flushing
Clinical narrative: 1:30 pm pt complaint of feeling flushed, redness of skin, neck, upper arms, & upper back. Pt observed/monitored for 30 minutes until resolved.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Influenza.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Balance disorder, Hypoglycaemia, Lethargy
Clinical narrative: Hypoglycemia following swimming. Lethargy, unbalanced. Given sugary snack and felt better.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthropathy, Muscle tightness, Pain in extremity
Clinical narrative: Acute bilateral elbow, wrist, & finger pain, hands get tight, feels like has knots in her muscles, feels like she's putting cold metal inside her joints. Put on methylprednisolone pak 4 mg oral tablets (Qty 21) for 7 days.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 2 year old received 0.5 ml dose of Seasonal Influenza TIV.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 months old patient (gender unknown) who on 20-DEC-2012, was inadvertently administered a 0.5 ml dose of MMR II subcutaneously (anatomical location and lot number not provided) and a 0.5 ml dose of PROQUAD (Merck) subcutaneously (anatomical location and lot number not provided). Concomitant medications were not reported. No adverse effect reported. Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Feeling hot, Headache, Nausea
Clinical narrative: Patient stated that Sunday 12/16/12 he had a headache, felt nausea, & felt warm & thought he was going to pass out at 10 am.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Burning sensation, Injection site pain, Pain in extremity
Clinical narrative: Case number PHEH2012US025644 is an initial spontaneous report received from a medical assistant on 28 Dec 2012. This report refers to a 74-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206101) intramuscularly on 03 Oct 2012. Two days later on 05 Oct 2012, she began to experience left arm and shoulder pain. She explained pain as a burning sensation that radiates away from the injection site and that her bones in the area are also painful. At the date of reporting, the events are ongoing. Reporter stated that she was refused to a physician for follow-up but she was refusing to go because the patient insists that her pain is due to the vaccine. The seriousness and causality of the events was not reported.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, VARCEL
Symptoms: Blood culture, Chills, Convulsion, Hepatic enzyme, Urine analysis
Clinical narrative: Urine, blood cultures, liver enzymes. ER with generalized seizure activity. 5 minutes interval. Reported chills in evening. Temp 103.6 (R) HR 33.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hypoaesthesia, Injection site anaesthesia, Injection site reaction, Insomnia
Clinical narrative: Tingling and numbness at injection site and spreads to other parts of the body at different times.  Chills and nervousness.  Difficulty sleeping.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Nervousness, Paraesthesia
Clinical narrative: Tingling and numbness at injection site and spreads to other parts of the body at different times.  Chills and nervousness.  Difficulty sleeping.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother reports minor swelling and redness on Rt arm at injection site that extends to elbow. No treatment. Suggested low dose NSAID and cold compress.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Crying, Decreased appetite, Erythema, Fatigue
Clinical narrative: By 9:50, at injection site:  pain, swelling. By 12:00 PM:  location 4-5 inches surrounding injection site:  increased pain, increased swelling, itching, muscle harder/firmer, redness.  Above symptoms continue throughout the first and second day with following additional symptoms: patient tired, sleepy, crying, chilled, decreased appetite.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site pain, Injection site swelling, Pruritus, Somnolence
Clinical narrative: By 9:50, at injection site:  pain, swelling. By 12:00 PM:  location 4-5 inches surrounding injection site:  increased pain, increased swelling, itching, muscle harder/firmer, redness.  Above symptoms continue throughout the first and second day with following additional symptoms: patient tired, sleepy, crying, chilled, decreased appetite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Contusion, Cough, Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: 4 yo female was given 4 yr shots and flu vaccine on 28 Dec 2012 the following AM patient had rash and redness over the right thigh area at the injection sites. Rash was small bumps and itchy about a quarter size. Rash spread to inner thigh area but resolved in the prior areas as it did. Mother describe local reaction as red, bruised, and welted up and started as a size of a quarter then increase in size as big as her palm of her hand.  No difficulty breathing, no wheezing. Patient still complaints of itchiness on her legs. Patient has continued to have cough and congestion for several weeks now. Pt had fever of 101 on 01/03/2013 but no fevers prior to this. Patient with small non red bumps on back now felt. But not similar to rash around the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Injection site rash, Local reaction, Pruritus, Pyrexia, Rash
Clinical narrative: 4 yo female was given 4 yr shots and flu vaccine on 28 Dec 2012 the following AM patient had rash and redness over the right thigh area at the injection sites. Rash was small bumps and itchy about a quarter size. Rash spread to inner thigh area but resolved in the prior areas as it did. Mother describe local reaction as red, bruised, and welted up and started as a size of a quarter then increase in size as big as her palm of her hand.  No difficulty breathing, no wheezing. Patient still complaints of itchiness on her legs. Patient has continued to have cough and congestion for several weeks now. Pt had fever of 101 on 01/03/2013 but no fevers prior to this. Patient with small non red bumps on back now felt. But not similar to rash around the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Respiratory tract congestion, Urticaria
Clinical narrative: 4 yo female was given 4 yr shots and flu vaccine on 28 Dec 2012 the following AM patient had rash and redness over the right thigh area at the injection sites. Rash was small bumps and itchy about a quarter size. Rash spread to inner thigh area but resolved in the prior areas as it did. Mother describe local reaction as red, bruised, and welted up and started as a size of a quarter then increase in size as big as her palm of her hand.  No difficulty breathing, no wheezing. Patient still complaints of itchiness on her legs. Patient has continued to have cough and congestion for several weeks now. Pt had fever of 101 on 01/03/2013 but no fevers prior to this. Patient with small non red bumps on back now felt. But not similar to rash around the injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Body temperature increased, Chest discomfort, Chest pain, Chills
Clinical narrative: Woke up chills, temp 101, headache, nausea, went to work took ASA at 11:00 AM started "chest burning" cough stated taking inhalers Proair 5:00 PM starting to get hoarse voice got home still chest burning and tightness  took Advair inhaler went to bed 12/2/20012 6:00 AM woke still cough, hoarse headache went to work {ICU NURSE} arrived at 6:45 started coughing very hoarse now difficulty breathing especially exhaling rushed to Emergency room on arrival at 6:55 AM given DuoNeb, Benadryl IV, Pepcid IV, dexamethasone IV breathing improved still hoarse then 15 mins later had acute shortness of breath again and stridorous placed on 100% oxygen and given epinephrine sq breathing improved dramatically off oxygen breathing not burning but remained hoarse adm to hospital over night getting steroids and Benadryl of note I HAVE NEVER HAD AN ASTHMA ATTACK IN MY LIFE I have reactive airways last had used inhaler about one year ago. Discharged on Epi Pen.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Cough, Dysphonia, Dyspnoea, Headache
Clinical narrative: Woke up chills, temp 101, headache, nausea, went to work took ASA at 11:00 AM started "chest burning" cough stated taking inhalers Proair 5:00 PM starting to get hoarse voice got home still chest burning and tightness  took Advair inhaler went to bed 12/2/20012 6:00 AM woke still cough, hoarse headache went to work {ICU NURSE} arrived at 6:45 started coughing very hoarse now difficulty breathing especially exhaling rushed to Emergency room on arrival at 6:55 AM given DuoNeb, Benadryl IV, Pepcid IV, dexamethasone IV breathing improved still hoarse then 15 mins later had acute shortness of breath again and stridorous placed on 100% oxygen and given epinephrine sq breathing improved dramatically off oxygen breathing not burning but remained hoarse adm to hospital over night getting steroids and Benadryl of note I HAVE NEVER HAD AN ASTHMA ATTACK IN MY LIFE I have reactive airways last had used inhaler about one year ago. Discharged on Epi Pen.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Stridor
Clinical narrative: Woke up chills, temp 101, headache, nausea, went to work took ASA at 11:00 AM started "chest burning" cough stated taking inhalers Proair 5:00 PM starting to get hoarse voice got home still chest burning and tightness  took Advair inhaler went to bed 12/2/20012 6:00 AM woke still cough, hoarse headache went to work {ICU NURSE} arrived at 6:45 started coughing very hoarse now difficulty breathing especially exhaling rushed to Emergency room on arrival at 6:55 AM given DuoNeb, Benadryl IV, Pepcid IV, dexamethasone IV breathing improved still hoarse then 15 mins later had acute shortness of breath again and stridorous placed on 100% oxygen and given epinephrine sq breathing improved dramatically off oxygen breathing not burning but remained hoarse adm to hospital over night getting steroids and Benadryl of note I HAVE NEVER HAD AN ASTHMA ATTACK IN MY LIFE I have reactive airways last had used inhaler about one year ago. Discharged on Epi Pen.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Stated noted 30mm redness at left posterior arm.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 10/20/2012: Woke up with tingling in my hands and feet. 10/22/2012: Severe tingling and numbness in hands and feet with soreness in back and neck. 10/24/2012: Severe pain in legs which led to trouble walking. 10/25/2012: Pain in legs, neck and back with trouble walking. Doctor told me to take 2 Aleve twice a day for pain for a week. 10/27/2012: Numbness in feet and hands with severe pain in legs. Left side of face started to slowly paralyze at 9:00AM. 10/28/2012: Numbness and Tingling in hands and feet. Pain in legs and total left side of face was paralyzed. 10/29/2012: Numbness and Tingling in hands and feet with severe pain in legs. Total face was paralyzed as of 8:00AM. Emergency Room visit diagnosed it as Guillain Barre Syndome and admitted me to hospital. 10/31/2012: First Plasmapheresis treatment administered. 11/1/2012: Second Plasmapheresis Treatment administered. 11/2/2012: Third Plasmapheresis Treatment administered. 11/5/2012: Fourth Plasmapheresis Treatment administered. 11/7/2012: Fifth Plasmapheresis Treatment administered. During the 12 days in the hospital I received 5 plasmapheresis treatments with physical and occupational therapy sessions.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture abnormal, Neck pain, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: 10/20/2012: Woke up with tingling in my hands and feet. 10/22/2012: Severe tingling and numbness in hands and feet with soreness in back and neck. 10/24/2012: Severe pain in legs which led to trouble walking. 10/25/2012: Pain in legs, neck and back with trouble walking. Doctor told me to take 2 Aleve twice a day for pain for a week. 10/27/2012: Numbness in feet and hands with severe pain in legs. Left side of face started to slowly paralyze at 9:00AM. 10/28/2012: Numbness and Tingling in hands and feet. Pain in legs and total left side of face was paralyzed. 10/29/2012: Numbness and Tingling in hands and feet with severe pain in legs. Total face was paralyzed as of 8:00AM. Emergency Room visit diagnosed it as Guillain Barre Syndome and admitted me to hospital. 10/31/2012: First Plasmapheresis treatment administered. 11/1/2012: Second Plasmapheresis Treatment administered. 11/2/2012: Third Plasmapheresis Treatment administered. 11/5/2012: Fourth Plasmapheresis Treatment administered. 11/7/2012: Fifth Plasmapheresis Treatment administered. During the 12 days in the hospital I received 5 plasmapheresis treatments with physical and occupational therapy sessions.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plasmapheresis, VIIth nerve paralysis
Clinical narrative: 10/20/2012: Woke up with tingling in my hands and feet. 10/22/2012: Severe tingling and numbness in hands and feet with soreness in back and neck. 10/24/2012: Severe pain in legs which led to trouble walking. 10/25/2012: Pain in legs, neck and back with trouble walking. Doctor told me to take 2 Aleve twice a day for pain for a week. 10/27/2012: Numbness in feet and hands with severe pain in legs. Left side of face started to slowly paralyze at 9:00AM. 10/28/2012: Numbness and Tingling in hands and feet. Pain in legs and total left side of face was paralyzed. 10/29/2012: Numbness and Tingling in hands and feet with severe pain in legs. Total face was paralyzed as of 8:00AM. Emergency Room visit diagnosed it as Guillain Barre Syndome and admitted me to hospital. 10/31/2012: First Plasmapheresis treatment administered. 11/1/2012: Second Plasmapheresis Treatment administered. 11/2/2012: Third Plasmapheresis Treatment administered. 11/5/2012: Fourth Plasmapheresis Treatment administered. 11/7/2012: Fifth Plasmapheresis Treatment administered. During the 12 days in the hospital I received 5 plasmapheresis treatments with physical and occupational therapy sessions.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Abnormal dreams, Confusional state, Dizziness, Hyperhidrosis, Skin warm
Clinical narrative: She was watching a movie and gradually became dizzy, sweats, and was warm.  She was also very confused.  I didn't take her temp to confirm she had a fever.  She fought bad dreams after that until about 4am.  She has had BAD dreams and confusion 4 of the last 6 nights after that. (continuing)
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: Started as a dull ache at the shot sight in my right shoulder. The pain worsened over the next 3 hours until I could hardly move my arm. On a scale of 1-10, the pain was an 8. It hurt so that I could hardly sleep.  The pain subsided the next evening enough for me to sleep.  Was pain free within 48 hours.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Crying, Discomfort, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: My son started getting very uncomfortable and crying very hard so I checked his leg where the Pentacel shot was given and it was turning red and seemed a bit swollen. I gave my son children's Tylenol like Dr. suggested to relieve any pain. A minute later the redness spread down his leg, and his leg swelled up more. Then the redness reached his foot and all down the other leg and foot that was not vaccinated. At that point his vaccinated leg, and both feet were swollen, and so red it looked like a bad sunburn, all up and down both feet and both legs, followed with my son screaming and crying. This lasted about ten minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Oedema peripheral, Screaming
Clinical narrative: My son started getting very uncomfortable and crying very hard so I checked his leg where the Pentacel shot was given and it was turning red and seemed a bit swollen. I gave my son children's Tylenol like Dr. suggested to relieve any pain. A minute later the redness spread down his leg, and his leg swelled up more. Then the redness reached his foot and all down the other leg and foot that was not vaccinated. At that point his vaccinated leg, and both feet were swollen, and so red it looked like a bad sunburn, all up and down both feet and both legs, followed with my son screaming and crying. This lasted about ten minutes.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Electrocardiogram normal, Laboratory test normal, Pallor, Pregnancy test urine negative
Clinical narrative: Patient received HPV, then went down to lab for blood work.  After blood work she went to waiting room were she had an episode of  syncope followed by brief tonic clonic movements which were witnessed by her parent.   Nurses were called to evaluate and she was pale and unresponsive but was breathing.  Mom stated that pt had history of syncope after medical procedures including ear piercing and blood draws. Patient was given NS 1L IV bolus. EKG was done and was normal. Stat Chem 7 was normal.  Urine pregnancy test was negative. Patient was observed for two hours.  At the end of this time she was awake, alert and cooperative.  VS were stable. Patient was sent home with parent with instructions to return if any further syncope.