chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella virus test
Clinical narrative: This spontaneous report as received from a nurse refers to her sister, a 62 year old female patient. Approximately in August 2011 ("2 years ago") the patient was vaccinated with ZOSTAVAX (dose, route, indication, lot#, expiration date not reported). Approximately in August 2013 (currently) the patient had a mild case of what appeared to be shingles. The patient sought medical via physician examination and communicated with her physician. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The nurse reported improperly stored vaccines ROTATEQ (dose and lot number were not reported), which were exposed to 18.3 Celsius degrees for 86 hours and 16 minutes. Nurse did not know if any of these improperly stored vaccines were administered. Improperly stored ROTATEQ may have been administered to unspecified patients on unspecified dates. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt. states a rash occurred on his chest day after vaccination. Improving over 5 days. No other symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 03-SEP-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # G007459, expiry: 02-AUG-2013. No adverse effect reported.  Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Immediate post-injection reaction
Clinical narrative: Pt. felt dizzy immediately after flu shot was adm. and complaint of abd. pain. Was taken to school infirmary under care of school nurse.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a 26 year old female patient who on 23-AUG-2013 was vaccinated intramuscularly with 0.5 ml second dose of GARDASIL in the right arm (lot# not provided). Patient was a nursing mother. No adverse effects reported. It was unspecified whether the patient sought for medical attention. Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain, Vomiting
Clinical narrative: Patient was given an injection for the AFLURIA vaccine Lot R53107 exp 6-30-14 at 4:19pm on 9-1-13. On 9-5-13 I received a call from patient stating that after 3 hours from receiving the vaccine he felt sick and threw up. He had bad headache, body aches that lasted for 36 hours.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Headache, Neck pain, Visual impairment
Clinical narrative: Pt complaint of sore neck, blinding headache, upset stomach. Pain at back of neck. Symptoms onset 2 days after injection. Advice from doctor -> TYLENOL or ibuprofen. Warm compresses to neck. Cool compress to forehead.
Age: 0.58
Sex: M
Vaccine: FLUN4, HEPA, MMR, VARCEL, FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PCP discussed vaccine error with mom. Told s/s to monitor for. Give TYLENOL for fever. Mom told to call if fever >101.
Age: 1.13
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was administered PCV23 instead of PCV13. Provider was notified. Parent was notified. No reaction noted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a unspecified patients of unknown age and gender. The nurse reported improperly stored vaccines, GARDASIL (dose and lot number were not reported) which were exposed to 18.3 Celsius degrees for 86 hours and 16 minutes. Nurse did not know if any of these improperly stored vaccines were administered. Improperly stored GARDASIL may have been administered to unspecified patients on unspecified dates. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. On 13-AUG-2013 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # H019789, expiration 15-OCT-2013), injection, 0.5 ml, subcutaneously while pregnancy. The physician stated that her last menstrual period was 15-MAY-2013 but her estimated date of conception was 20-FEB-2013 which was determined by ultrasound and EDD of 19-FEB-2014. Initial exposure to VARIVAX (Merck) was at 13 week(s). The pregnancy outcome was outcome pending. The physician stated that the patient had no adverse effects at this time. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Fatigue, Herpes simplex, Injection site pain, Pain
Clinical narrative: Very sore at the site, body aches, fatigue for 3 days. Herpes flare up + HSV-2 outbreak.
Sex: F
Vaccine: HPV4
Symptoms: Muscle disorder
Clinical narrative: This spontaneous report refers to a female patient of unknown age. Medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL (dose and lot number not provided). Concomitant medication was not provided. On an unknown date the patient was diagnosed with myoglobinopathy, shortly after having received the third dose of GARDASIL. After first calling the physician, patient went to a hospital where the diagnosis was made. It was unspecified whether or not the patient was hospitalized. The outcome of myoglobinopathy is unknown. The reporter did not suspect GARDASIL as causative, he believed that the patient's "intense exercise" the day after receiving the third GARDASIL dose might have contributed to the myoglobinopathy. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: The injection site on her left arm had developed a dollar coin size that is itchy with red bumps and felt hot.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a 63 year old male consumer reporting on himself with Multiple sclerosis (MS) and anxiety disorders. On 29-DEC-2010 the patient was vaccinated with ZOSTAVAX (Lot # not reported) subcutaneous. No other co suspects were reported. Concomitant therapies included COPASCON 20 mg, ZANEXIN, FEXORIL, FLOMAX and LEXAPRO. The patient reported that on 04-JUL-2013 he experienced shingles after receiving the vaccine. The patient stated that the shingles were on high right side (front and back), from leg to lower spine region. The patient reported that he had numbness in the same areas, along with shingles. The patient reported that the shingles never got the rash on the skin surface. The patient did not seek medical attention. Treatment was not given for the events. Labs diagnostics were not performed. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a patient of 22 years old (current age) who had a positive PAP smear for HPV, on preventative exam, after patient had received first dose of GARDASIL (route, dose, frequency unspecified) (lot # and exp date unknown) in 2009. Concomitant therapy included unspecified birth control pills. Physician believed patient completed GARDASIL vaccination series. Patient has not had sexual contact. The patient did not seek medical attention and no treatment was given to the patient. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacist refers to a 68 year old patient. No medical history or drug reactions/allergies were reported. The pharmacist reported that on 29-AUG-2013, a nurse administered the enrite volume of a multi-dose vial of PNEUMOVAX23 (Lot # not provided), the patient received 5 doses of PNEUMOVAX23, 2.5 ml, intramuscularly. It was unknown to which area of the patient's body, the 5 doses were administered. The pharmacist reported that she was not aware of any adverse effects at this time. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to a 55 year old male patient. No medical history or drug reactions/allergies were reported. On 27-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001697; exp. date: 06-MAY-2014), 0.65 ml, subcutaneous in the left arm for shingles prevention. On 29-AUG-2013, the patient experienced a red blotch over the injection site. The patient did not seek medical attention. At the time of the report, the outcome of red blotch over the injection site was unknown. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Drug administered at inappropriate site, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. 01-JUL-2008 and 07-AUG-2013, the patient was vaccinated with dose 1 and dose 2 of M-M-R II (lot#, expiry not reported) 0.5 ml, intramuscularly. On 15-AUG-2013, the patient was vaccinated with dose 3 of M-M-R II (lot#, expiry not reported)0.5 ml, intramuscularly about a week after second dose was administered. The nurse also reported that all three doses of M-M-R II were administered intramuscularly. No adverse effect reported. Follow up report as received from the other health professional refers to a 12 month old male patient (now 6 year and 2 month) with no known allergies. On 07-AUG-2013 the patient was vaccinated with M-M-R II (lot # H013041, exp date: 17-JUL-2014) dose 2, 0.5 ml, subcutaneous in the left leg. On 15-AUG-2013 9:40 AM the patient was vaccinated with M-M-R II (lot # H018945, exp date: 18-OCT-2014) dose 3, 0.5 ml, subcutaneous in the left leg. Concomitant therapies included INFANRIX (lot #25LP9) and IPOL (lot #H1354). The patient didn't require emergency room/doctor visit. Additional information is not expected.
Age: 1.8
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Chills, Cold sweat, Gait disturbance, Peripheral coldness
Clinical narrative: This spontaneous report as received from the Mother of the Patient refers to her approximately 20 month old daughter with Ear infection. On 26-AUG-2013 the patient was vaccinated with M-M-R II (lot # H01582, expiration 24-AUG-2014), (dose unspecified), injection. Other suspect therapies included VARIVAX (Merck) and HIB vaccine (unspecified carrier) (manufacturer unknown). Concomitant therapies included amoxicillin. The Mother reported that since received the vaccine, the daughter's behavior had changed. In August 2013 she expressed that the child seemed "intoxicated", scratched her head, walked on her toes and occasionally stumbled. When slept, the child seemed to be perspiring but was cool to the touch with chills. The reporter specified that there were two vaccination sites, one in the arm and one in the leg, however, she was uncertain as to which site received which vaccine. The child had been seen by an unspecified Urgent Care facility as well as by her regular doctor. No treatment was given. At the time of report, the events outcomes were unknown. Additional information has been requested.
Age: 1.8
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pruritus, Toe walking
Clinical narrative: This spontaneous report as received from the Mother of the Patient refers to her approximately 20 month old daughter with Ear infection. On 26-AUG-2013 the patient was vaccinated with M-M-R II (lot # H01582, expiration 24-AUG-2014), (dose unspecified), injection. Other suspect therapies included VARIVAX (Merck) and HIB vaccine (unspecified carrier) (manufacturer unknown). Concomitant therapies included amoxicillin. The Mother reported that since received the vaccine, the daughter's behavior had changed. In August 2013 she expressed that the child seemed "intoxicated", scratched her head, walked on her toes and occasionally stumbled. When slept, the child seemed to be perspiring but was cool to the touch with chills. The reporter specified that there were two vaccination sites, one in the arm and one in the leg, however, she was uncertain as to which site received which vaccine. The child had been seen by an unspecified Urgent Care facility as well as by her regular doctor. No treatment was given. At the time of report, the events outcomes were unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Constipation, Exposure during pregnancy, Pregnancy test urine
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 27 year old female patient. There were no pertinent medical history or drug reactions or allergies. Approximately on 11-JUL-2013, the patient who was approximately in 9 weeks gestation period was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was unknown). Concomitant therapies included vitamins (PRENATAL). The patient was found to be pregnant with Estimated Delivery Date of 04-MAY-2014. Date of conception was approximately on 13-JUL-2013 and last menstrual period was on 29-JUN-2013. On 11-JUL-2013, the patient experienced constipation after vaccination. There was no treatment taken for the event. The medical assistant stated that the patient was moved to the there clinic not long ago. On 29-AUG-2013, urine pregnancy test was performed. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a health professional concerning an 18 year old female patient for a VARIVAX (Merck), a Pregnancy Registry product. The patient has a history of no previous pregnancies and 0 live births. On 22-JAN-2013, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, lot # reported as H017133, route not provided. The patient became pregnant with LMP estimated on 17-SEP-2012 and EDD of 24-JUN-2013 (method of confirmation not reported). Initial exposure to VARIVAX (Merck) was at 18 weeks. Laboratory tests included ultrasound on 16-NOV-2012 (reason: "dating"; result unknown) and varicella antibody test on 15-JAN-2013 (negative). Additional information was received regarding lot # H017133 for VARIVAX (Merck) which has been verified as valid lot number. Additional information was received from the nurse. Reporter details were updated. The nurse reported that the VARIVAX (Merck) was administered by the pediatric department of her facility. She did not know who the provider was at the pediatric department. Follow up information as received from a Certified Nurse-Midwife refers to the 18 year old female patient with no previous pregnancy. The patient became pregnant with LMP of 23-SEP-2012 (previous reported 17-SEP-2012) and EDD of 30-JUN-2013. On 15-JAN-2013 the patient was tested for varicella antibodies and the results showed negative. On 22-JAN-2013 the patient was vaccinated with VARIVAX (Merck) (lot number H017133). It was unknown if there were any local reaction at vaccination site, and if there were any varicella symptoms/Herpes zosters symptoms post vaccination. The patient did ultrasound test on 25-MAR-2013, 29-APR-2013 and 31-MAY-2013 due to varicella exposure and the result revealed choroid plexus cyst. Patient did not performed amniocentesis and Maternal Serum Alpha-Fetoprotein (MSAFP). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient with no known allergies. On 14-AUG-2013 the patient was vaccinated with a dose of PROQUAD (Merck), (lot # H020140 07-MAY-2014), subcutaneous. On 15-AUG-2013, the patient experienced local reactions, large, swollen, red areas, about size of an egg, on the thigh, after receiving PROQUAD (Merck). On 15-AUG-2013 the patient was seen in the office. The outcome of events was unknown. The relatedness between the events and PROQUAD (Merck) was not reported. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Constipation, Dry mouth, Intestinal obstruction
Clinical narrative: Pt started oral Typhoid on 17th - completed all 4 pills developed very dry mouth and slt constipation after 2 pills. Continues with bowel blockage receiving Tx at hospital.
Age: 8.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Hepatic encephalopathy, Liver transplant
Clinical narrative: A report has been received from a physician concerning a 10 years old, male patient. The patient's relevant medical history or concomitant medications were not reported. In Dec-2012 the patient received nasal FLUMIST (intranasal). The patient developed acute hepatic failure which required a liver transplant. The action taken with FLUMIST and the outcome of acute hepatic failure was unknown. The reporter assessed the event of acute hepatic failure to be serious due to medical importance and hospitalization. The reporting doctor stated that the other doctor at the hospital where the patient was treated attributed the hepatic failure to the vaccine.
Age: 8.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Acute hepatic failure, Liver transplant, Vaccination complication
Clinical narrative: A report has been received from a physician concerning a 10 years old, male patient. The patient's relevant medical history or concomitant medications were not reported. In Dec-2012 the patient received nasal FLUMIST (intranasal). The patient developed acute hepatic failure which required a liver transplant. The action taken with FLUMIST and the outcome of acute hepatic failure was unknown. The reporter assessed the event of acute hepatic failure to be serious due to medical importance and hospitalization. The reporting doctor stated that the other doctor at the hospital where the patient was treated attributed the hepatic failure to the vaccine.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arteriogram coronary normal, Chest pain, Computerised tomogram abdomen normal, Computerised tomogram thorax abnormal, Echocardiogram abnormal
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Mitral valve incompetence, Mitral valve prolapse, Nuclear magnetic resonance imaging thoracic normal, Pericardial effusion
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin increased
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Brain natriuretic peptide normal, C-reactive protein normal
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac imaging procedure, Chest X-ray normal, Chest pain, Complement factor C3 increased, Complement factor C4
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Complement factor normal, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram normal, Ejection fraction decreased
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, Hepatitis B virus test, Lipids normal, Metabolic function test
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 19.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging normal, Pericardial effusion, Red blood cell sedimentation rate normal, Troponin I increased
Clinical narrative: (VAERS filed by facility - Case 6202 - prob myocarditis). 19 y/o M who awoke around 0500 with squeezing pain over center of chest (not substernal). Pain intensity increased to 9-10/10 as day progressed. Described as sharp, squeezing pain. Worse with pressure/palpation on sternum and chest, but pain was not reproducable. No change in CP with change in positions or deep breaths. Chest pain decreased after ASA and SL nitroglycerin. No palpitations. +/- SOB difficult to breathe d/t pain. No p. edema. No radiation. No diaphoresis. No n/v. Admitted to hospital on 27 AUG and discharged on 31 AUG. At time of discharged, he was asymptomatic and his CE's had returned to normal.
Age: 0.22
Sex: F
Vaccine: HEP
Symptoms: Crying, Hyperhidrosis, Irritability, Muscle twitching, Peripheral coldness
Clinical narrative: Persistent crying/fussing (has not stopped yet), sweating and then cool to touch, twitching head and leg, vomiting, this is still happening. We will be calling doctor in the morning.
Age: 0.22
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Persistent crying/fussing (has not stopped yet), sweating and then cool to touch, twitching head and leg, vomiting, this is still happening. We will be calling doctor in the morning.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Redness, rash looking, itchy, hives.  At 2:00 am rubbed Benadryl lotion over back, arms, stomach and chest.  Took Benadryl tablet at 9:00am and continue to put Benadryl gel lotion on body.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Pt was diagnosed pregnant 09/03/2013.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Skin infection
Clinical narrative: Skin infection; patient took Keflex 500mg (Antibiotic).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Wrong technique in drug usage process
Clinical narrative: Pt was given MENVEO and the powder was diluted with the wrong liquid.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, redness, and warmth at site of pneumococcal vaccine injection.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Injection site pain, Muscle spasms, Musculoskeletal pain, Nausea
Clinical narrative: Severe burning at inj site x 3 hours; cramping pain in neck and shoulders x 1 hour; debilitating headache x 1 1/2 hrs followed by nausea and vomiting. Fever on/off x nearly 2 weeks.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: Severe burning at inj site x 3 hours; cramping pain in neck and shoulders x 1 hour; debilitating headache x 1 1/2 hrs followed by nausea and vomiting. Fever on/off x nearly 2 weeks.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash, Urticaria
Clinical narrative: 3 yo who developed rash and hives around mouth and nose few hours after administration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, White blood cell count increased
Clinical narrative: Red area in location of vaccination the day after. Progressively worsened to red bump (raised) larger requiring visit to urgent care 2 days later after vaccination.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 16 week old female patient. On 03-SEP-2013, the 16 week old patient was vaccinated with a first dose of ROTATEQ (Lot number and expiry date were not reported) 2 milliliter (ml), orally. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date were reported as 671553/1138AA and 27-APR-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Asthma, Chills, Condition aggravated
Clinical narrative: This spontaneous report as received from a physician (it was also reported the primary reporter was the patient's mother) refers to a 17 year old female patient with asthma. The patient had no drug reactions or allergies. On 29-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported). Concomitant therapies included XOPENEX Inhaler (dosage unspecified). On 29-JUL-2013 developed a fever of 104 and joint pains and chills and weakness and asthma attacks and then broke out in hives. She went to the emergency room for a few hours for medical attention and was treated (treatment unspecified) and the hives went away. A week later (on 05-AUG-2013) the hives returned and the mother gave the patient BENADRYL and the hives subsided. A few days later (approximately in August 2013) they came back again and the patient still had hives. The patient did not plan to continue with the series. Treatment BENADRYL was given for adverse events. There was no lab diagnostics study performed. Therapy with GARDASIL was discontinued. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pyrexia, Urticaria
Clinical narrative: This spontaneous report as received from a physician (it was also reported the primary reporter was the patient's mother) refers to a 17 year old female patient with asthma. The patient had no drug reactions or allergies. On 29-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported). Concomitant therapies included XOPENEX Inhaler (dosage unspecified). On 29-JUL-2013 developed a fever of 104 and joint pains and chills and weakness and asthma attacks and then broke out in hives. She went to the emergency room for a few hours for medical attention and was treated (treatment unspecified) and the hives went away. A week later (on 05-AUG-2013) the hives returned and the mother gave the patient BENADRYL and the hives subsided. A few days later (approximately in August 2013) they came back again and the patient still had hives. The patient did not plan to continue with the series. Treatment BENADRYL was given for adverse events. There was no lab diagnostics study performed. Therapy with GARDASIL was discontinued. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL, HEPA, IPV, MEN, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 19 year old female patient with no drug reactions or allergies. On 07-AUG-2013, the pregnant patient was vaccinated with the first dose of VARIVAX (Merck) (lot # J003218 and expiry date 15-MAR-2013, dose and route unspecified) and first dose of M-M-R II (lot # H014646 and expiry date 03-AUG-2014, dose and route unspecified). There were no concomitant medications. Patient was 9 weeks gestation. Last menstrual period of the patient was estimated to be 28-JUN-2013 and estimated date of delivery (EDD) was found to be 04-APR-2014. The pregnancy outcome was pending. It was reported that the pregnancy was normal to date. The patient sought medical attention (seen in clinic). No treatment was given. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL, HEPA, IPV, MEN, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Diagnosed as pregnant on August 29th-LMP 06/26/13- EDC 04/04/14.
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. On 09-MAY-2013 the patient was vaccinated with a dose of expired ZOSTAVAX (lot # 0168AE, expiration date 06-MAR-2013, 0.65 ml, subcutaneously, indication not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a female patient of unknown age. Approximately on AUG-2013(reported as last week), the patient was vaccinated with a dose of GARDASIL,(lot number, expiry date and route was not reported). On an unknown date in AUG-2013, the patient experienced allergic reaction with swelling. The patient was treated with BENADRYL. The outcome of allergic reaction with swelling was reported as recovered. The patient sought medical attention (office contact). Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Vaccines For Children (VFC) consultant refers to numerous unspecified patients of unknown ages and gender. The VFC consulted reported that PEDVAXHIB and GARDASIL may have been administered after going through unsupported temperature excursions on 05-MAR-2013 and 06-MAR-2013. There was no adverse effect reported. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. On 04-SEP-2013, 6 month old patient was accidentally vaccinated with VAQTA, 0.5 ml, intramuscular instead of RECOMBIVAX. No adverse effect reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Odynophagia, Pyrexia
Clinical narrative: This spontaneous report as received from an other health professional refers to a 9 year old female patient. On 30-APR-2013 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly. On 12-JUL-2013, 73 days after vaccination the second dose of GARDASIL, the patient experienced pain on swallowing and fever. The outcome of pain on swallowing and fever is unknown. Action taken with GARDASIL due to pain on swallowing and fever was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from an unknown age male pharmacist refers to himself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). And when the patient received ZOSTAVAX, it hurt. The patient did not seek medical attention. The outcome of the event was unknown. This is one of the report from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a other health professional refers to a 11 year old female patient. On 14-MAY-2013 the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly. On 15-AUG-2013, 93 days after vaccination the second dose of GARDASIL, the patient experienced headache and rhinorrhea. The outcome of rhinorrhea and headache were unknown. Action taken with GARDASIL due to events were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Injury associated with device, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist (who is the female patient) of unknown age regarding herself. On 04-SEP-2013, the patient who is pregnant was inadvertently exposed to ZOSTAVAX, (lot number, expiry date and route was not reported) via a needle stick on her finger as she was preparing to administer the vaccine. The LMP and EDD were not known. No adverse effects were reported. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from Physician Assistant refers to a 79 year old male patient. Information on medical history was not reported. Approximately in August 2010, reported as approximately 3 years ago, the patient was vaccinated with ZOSTAVAX (lot # not reported) 65ml, subcutaneously, (exact date, frequency not reported). On 23-AUG-2013 the patient come into the physician assistant's office presenting with severe case of shingles on his hands and face. The onset of the shingles was not reported. No treatment was given for the event. The patient sought medical attention by coming to physician's assistant's office. The outcome of severe case of shingles on his hands and face was reported as not recovered/not resolved. The reporter did not access the relationship between the shingles and ZOSTAVAX. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test, Blood gases, Blood grouping, Blood lactic acid, Blood magnesium
Clinical narrative: Sudden cardiac death. Received CPR for 2 hours. Transvenous pacemaker placement.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac pacemaker insertion, Full blood count, Metabolic function test, Resuscitation, Sudden cardiac death
Clinical narrative: Sudden cardiac death. Received CPR for 2 hours. Transvenous pacemaker placement.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Feels like a burning sensation and area is red and tender/warm to touch and feels thickened underneath skin - started 9/4/13 when noticed area - only treated 9/5/13 with Triamcinolone. She has warmth to touch at site, erythemas, and tenderness burning.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin hypertrophy, Skin warm, Tenderness
Clinical narrative: Feels like a burning sensation and area is red and tender/warm to touch and feels thickened underneath skin - started 9/4/13 when noticed area - only treated 9/5/13 with Triamcinolone. She has warmth to touch at site, erythemas, and tenderness burning.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Cardiac discomfort, Cardiac enzymes increased
Clinical narrative: At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cardiomegaly, Chest discomfort, Chest pain, Chills, Disease prodromal stage
Clinical narrative: At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Headache
Clinical narrative: At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Left ventricular dysfunction, Malaise, Myocarditis, Nipple pain, Pain
Clinical narrative: At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: At time of event in 2006, 26 y/o M who received his primary smallpox and anthrax vaccines on 24 APR 2006. Around 3 MAY, he developed a prodromal syndrome with chills, headache, and body aches. On 6 MAY 2006, he awoke with mild pain (2/10) over his left nipple area. As the day progressed, his chest pain spread to the entire left side of his chest, and increased in pain intensity to 5-6/10. His pain was described as nonradiating. nonexertional, dull "pressure around heart". There was no change in his chest pain with changes in position or deep breaths. He denied any shortness of breath, but reported his chest felt "tight". No accompanying symptoms were reported in his records. Patient was initially evaluated at the ER where he had ECG changes and elevated cardiac enzymes. He was admitted to hospital x 1 day before being transferred to another hospital. He was placed on limited duty, and was prescribed lisinopril 5 mg daily. Patient continued Cardiology follow up at hospital, until he was discharged from employment. He denies any recurrence of chest pain since initial episode.
Sex: M
Vaccine: MEN
Symptoms: Abasia, Loss of consciousness, Syncope, Visual impairment
Clinical narrative: Initial report received from a healthcare provider (nurse) on 27 August 2013. A male patient, was vaccinated with an unspecified meningococcal vaccine, manufacturer not reported on an unreported date. The batch number, route and site of administration were not reported. On an unreported date the patient felt like he was losing his vision, was unable to walk, passed out and then fainted. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The patient outcome was not reported. Further details were not available at the time of this report. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL (lot numbers not reported) on 21 January 2011, 01 April 2011, 06 June 2011, and on 25 April 2012. The subject developed a cough on 29 July 2013, approximately 15 months after the last dose, and a paroxysmal cough without a whoop on 03 August 2013. The subject also developed cold like symptoms on 29 July 2013. Laboratory testing included positive PCR on 01 August 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 01 August 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 12 August 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.