chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a college aged patient. The patient was vaccinated with the second dose of 0.5 ml M-M-R II (Lot# and expire date unspecified) intramuscularly on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 71 years old female patient with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot number 672932/0599AE) (dose not provided) maybe intramuscularly at her left arm on 12-JUL-2012. No other co-susects were reported. No concomitant medications were reported. On 12-JUL-2012 the patient developed "extreme pain" radiating down the left arm that was vaccinated. The vaccination may have been given intramuscularly, however the medical assistant was not sure from looking at the injection site. The patient had sought medical attention via seen in office and no treatment was given for the adverse event. The outcome of extreme pain radiating down the left arm that was vaccinated was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age vaccinated GARDASIL (lot # was unspecified. The patient was "administered the first two doses GARDASIL series on 05-JUN-2009 and 03-AUG-2009, respectively, the patient will soon receive the third dose in the GARDASIL series". No adverse effect reported. No treatment information was reported. The outcome of inappropriate schedule of vaccine is unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Activities of daily living impaired, Blister, Varicella post vaccine
Clinical narrative: Information has been received from registered nurse concerning a 6 year old male with no pertinent drug reactions who on 24-MAY-2006 was vaccinated SQ with a dose of PROQUAD (lot #652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated SQ with a dose of PROQUAD (lot#02302, expiration date unknown). There was no concomitant medication. The nurse mentioned that on on 02-MAY-2012 the patient was diagnosed with "chickenpox". The nurse mentioned that there were three cases of chickenpox at his school. The patient sought unspecified medical attention. No lab diagnostics studies were performed. No treatment was given for adverse event. The patient's chickenpox persisted. Lot number [102302] is an invalid lot number for PROQUAD (Merck). Follow-up information has been received from a registered nurse concerning a 6 year old male patient with eczema and no known drug allergies who on 24-MAY-2006 was vaccinated in left thigh with the first dose of PROQUAD (lot#652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated in left arm with the second dose of PROQUAD (lot number 666755/0230Z, expiration date unknown). It was reported that on 11-JUN-2010 the patient was vaccinated with the first dose of concomitant therapy KINRIX (lot#AC20B158AA) in the right arm. The registered nurse mentioned that on 02-MAY-2012 the patient was diagnosed with breakthrough chickenpox by doctor of medicine assessment. On 02-MAY-2012 the patient had scattered vesicular lesion on abdomen, neck, face. Patient itched. The patient had sought doctor visit. At the time of the report, the outcome was unknown. The health care professional contacted during telephone follow-up could not supply the following; patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. Additional followup information has been received from registered nurse, initial reporter, refers to the 6 year old (also reported as 7 year old) male patient with not known drug allergies and eczema who on 24-MAY-2006 was vaccinated in left thigh with the first dose of PROQUAD (lot #652328/0956R, expiration date unknown) and on 11-JUN-2010 was vaccinated in left arm with the second dose of PROQUAD (lot number 666655/0230Z, expiration date unknown). It was reported that on 11-JUN-2010 the patient was vaccinated with the first dose of concomitant therapy KINRIX (lot#AC20B158AA) in the right arm. The nurse reported that the patient's mother stated that the patient was recovered (on 07-MAY-2012) from adverse event and went back to school (it was also mentioned that the patient required emergency room visit). No further information is available.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Pain
Clinical narrative: Information has been received from a medical assistant (C.M.A.) concerning a 65 year old male patient with heart murmur, gastrooesophageal reflux disease (GERD), hyperlipidaemia, osteoarthritis, hypertension and no drug reactions or allergies who on 19-APR-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot number 672752/1786AA exp. date 08-SEP-2013, 0,5ml, IM.). It was reported that on 19-APR-2012, the patient who received a dose of PNEUMOVAX 23 developed a localized reaction of severe pain. The last time medical assistant (C.M.A.) spoke to patient was 12 hours after vaccination and at that time the patient said his symptoms were improving. Medical assistant believed that the patient had recovered by "now" (02-MAY-2012) because he has not contacted the office again. It was unknown if the patient sought medical attention (reported as "called office"). No treatment was given for the events. No lab diagnostics were performed. The patient's outcome was recovering on an approximately 19-APR-2012 (also reported as improving 12 hours after vaccination). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot # unspecified) "two years ago" on JULY 2010 and received her second dose on 09-JUL-2012. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 81 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 24-MAY-2012 was vaccinated with a dose of PNEUMOVAX 23, 0.5ml, intramuscularly, (lot number 672394/1853AA, expiry date: 09-AUG-2013). Concomitant therapy included cephalexin, cyanocobalamin, Hydrocodone/APAP, DIOVAN, metoprolol, LIPITOR, promethazine, NAMENDA, VESICARE, alendronate sodium (manufacturer unspecified), diltiazem HCL, metformin, PLAVIX and amiodarone. It was reported that, on 24-MAY-2012, the patient developed injection site reaction after receiving a dose of PNEUMOVAX 23. The painful red swollen area spread down from the injection site area to the patient's elbow. The patient sought medical attention (saw the physician). No treatment was given for the symptoms. No laboratory studies were performed. At the time of the report, the patient's outcome was recovering. This is the first of three cases reported by the nurse. Other two reports are: WAES#1206USA00496 and WAES# 1206USA00486. The reporter requested a lot check of this vaccine due to patients having adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 years old female patient with penicillin allergy and no other pertinent medical history. The patient was vaccinated IM with ZOSTAVAX (lot# 671780/0170AE, expired date 06-MAR-2013) on 06-JUL-2012 the patient experienced pain the arm that received the injection and general body pain. No treatment information was reported. The patient had call physician for medical attention. The outcome of pain in the arm that received the injection and general body pain was reported as not recovered. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA, VARZOS
Symptoms: Accidental exposure, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 months old patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# not reported) on 05-JUL-2012. It was reported that this medical assistant noted she inadvertently administered ZOSTAVAX intramuscularly to this child. No adverse effect was reported. And whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with the first dose of GARDASIL (dose, route and indication not reported) in November 2010, the second dose of GARDASIL (dose, route and indication not reported) in May 2011, and the third dose of GARDASIL (dose, route and indication not reported) on 16-FEB-2012. No adverse effects reported. Therapy was not discontinued. It was unknown if the patient sought medical attention. Follow-up information was received from a registered nurse who stated that the 18 female student patient on 22-NOV-2010, was vaccinated intramuscularly (IM) in the left deltoid with the first dose of GARDASIL (lot#666595/0887Z, exp date 14-OCT-2012). On 20-DEC-2010, the patient was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot #666595/0887Z, exp date 14-OCT-2012). On 21-FEB-2011, the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #667944/1247Z, exp 26-FEB-2013) and on an unspecified date, the patient was vaccinated with the fourth dose of GARDASIL. The patient did not sought medical information. The nurse stated that the patient received the third dose of GARDASIL 1 month too soon for it to be effective. The patient was advised to have the fourth dose of GARDASIL; dose through Health Department based on information provided. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning  a patient who on 17-APR-2009, was vaccinated IM with 0.5 ml first dose of GARDASIL (lot # 1702X). On 19-JAN-2010, the patient was vaccinated IM with the second dose of GARDASIL (lot # 1487Y). No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 years old female patient with no pertinent medical history and no drug reactions or allergies who on 23-APR-2012 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (lot number not reported) and on 26-JUN-2012, was vaccinated with the second 0.5 ml dose of GARDASIL intramuscularly (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 29-JUN-2012, the patient developed swelling on her lips. No lab diagnostics studies were performed. No treatment was given for the experience. The patient recovered on an unspecified date. It was stated that on 29-JUN-2012, he patient was seen in the office and the physician did not feel that the reaction was due to GARDASIL. The medical assistant added that the patient did not experience any adverse effects after receiving the first dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) on 18-OCT-2010, dose 2 of GARDASIL (Lot # not reported) on 28-DEC-2011 and dose 3 of GARDASIL (Lot # not reported) on 28-FEB-2012. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a 71 year old female consumer with high blood pressure and high cholesterol and with no allergies who on 30-APR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported) in the left arm. Concomitant therapy included LIPITOR and unspecified "blood pressure medication". On 03-MAY-2012, three days later, the patient experienced bright red oval at the injection site of the left arm and "intense itch" at the site, but no rash. The consumer stated that she would call follow up with her doctor on the day of the report. At the time of reporting the consumer did not recovered. Follow up information was received from a physician refers to the 71 years old female patient with no adverse events following prior vaccinations who on 30-APR-2012, at 10:09 a.m. was vaccinated with the first dose of ZOSTAVAX subcutaneously in her left arm (lot # 672563/1649AA, Exp. Date: 21-JAN-2013) at private doctor's office/hospital. It was reported that on -07-MAY-2012 at 09:06 a.m. (previously reported as 03-MAY-2012) the patient experienced intense itch at injection site-red oval on left arm. No relevant tests and laboratory data were performed. No illness at time of vaccination. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician assistant concerning an 18 year old female patient who on an unspecified dates was vaccinated with all three doses of GARDASIL (Lot # and route were not reported). Subsequently the patient had a positive HPV test rest at unspecified time. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from a physician assistant who stated that the patient did not have an adverse reaction. The physician assistant had a question regarding whether the vaccine would show up as antibodies on an HPV test - not that the vaccine caused HPV. No further information is available.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Left arm where vaccine was given swelled and turn red around injection site > 4" diameter area per mom report. Also had pain. Mostly resolved by 7/17/12 when mom called to report.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Chest X-ray normal, Electroencephalogram, Grand mal convulsion, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Nonfebrile tonic clonic seizure 4 days after DTaP, IPV, Hep B, PNC 13.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Left arm red area 3x4 duration swollen area.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Felt Dizzy, to the point of passing out for 2 days following vaccine. No treatment sought.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Defaecation urgency, Diarrhoea, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Got very dizzy and had to sit down. I then began to start shaking and felt like I needed to use the bathroom. During the walk to the bathroom I started to sweat a great amount and fainted for about 10 seconds. After waking up I was still dizzy and sweating. I then had diarrhea. After this, I started to return to normal.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Got very dizzy and had to sit down. I then began to start shaking and felt like I needed to use the bathroom. During the walk to the bathroom I started to sweat a great amount and fainted for about 10 seconds. After waking up I was still dizzy and sweating. I then had diarrhea. After this, I started to return to normal.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient passed out in chair about 5 min after shot administered.  BP 70/48, pulse 68, respirations 12, face pale and skin clammy and cool.  Moved back to room via wheelchair and had lie on table for 10-15 minutes. Dr. checked her over, said to have her remain for few more minutes and re-do BP, when WNL can go.  Repeat BP 98/50, no longer sweaty, says feels better.  Had remain in room another 15 min to be sure. Patient released into the care of her mother.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Muscular weakness, Myalgia
Clinical narrative: Adverse event reported on 6/19/2012.  Stated had bilateral hip joint stiffness and muscle aches/weakness to bilateral legs.  On 6/19/2012 stated had been riding horses after vaccine, so not sure if symptoms were related to vaccine.  On 6/19/2012, stated symptoms getting better.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Bordetella test negative, Cough, Respiratory arrest, Retching, Vomiting
Clinical narrative: Coughing followed by gagging and vomiting. Then quit breathing. One hour later another episode of coughing and quit breathing again.
Age: 84.0
Sex: F
Vaccine: PNC
Symptoms: Injection site reaction, Local reaction, Pruritus, Rash erythematous
Clinical narrative: Moderately severe local reaction:  red rash about arm at vaccination site.  Some itching at first for a couple of days.  At 8 days, rash is dry, reddish, and fading.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Echocardiogram, Full blood count
Clinical narrative: Started with headache that never went away, on Wed. 6/20/2012 started with fever that never went away running 102-104, on Sun. 6/24 started complaining of upper left arm hurting (same arm vaccine was administered in) Tues. 6/25/2012 was admitted to Hospital with a staph infection throughout his bloodstream, on Thur. 6/28/2012 following a MRI we were notified the infection was in his left humerus, IV Ancef throughout hospital stay discharged Sat. 6/30/2012 sent home on 1000 mg 4x a day of cephalexin for 30 days. Still in treatment.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Nuclear magnetic resonance imaging, Osteomyelitis, Pyrexia
Clinical narrative: Started with headache that never went away, on Wed. 6/20/2012 started with fever that never went away running 102-104, on Sun. 6/24 started complaining of upper left arm hurting (same arm vaccine was administered in) Tues. 6/25/2012 was admitted to Hospital with a staph infection throughout his bloodstream, on Thur. 6/28/2012 following a MRI we were notified the infection was in his left humerus, IV Ancef throughout hospital stay discharged Sat. 6/30/2012 sent home on 1000 mg 4x a day of cephalexin for 30 days. Still in treatment.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Staphylococcal infection
Clinical narrative: Started with headache that never went away, on Wed. 6/20/2012 started with fever that never went away running 102-104, on Sun. 6/24 started complaining of upper left arm hurting (same arm vaccine was administered in) Tues. 6/25/2012 was admitted to Hospital with a staph infection throughout his bloodstream, on Thur. 6/28/2012 following a MRI we were notified the infection was in his left humerus, IV Ancef throughout hospital stay discharged Sat. 6/30/2012 sent home on 1000 mg 4x a day of cephalexin for 30 days. Still in treatment.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, PAIN HOT TO TOUCH.
Age: 62.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: REDNESS 2 IN DIAMETER, PAINFUL, HOT TO TOUCH.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: PAINFUL, SWELLING, REDNESS 3  1 INCH IN DIAMETER.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Decreased appetite, Diarrhoea, Insomnia, Irritability, Measles post vaccine
Clinical narrative: Child developed high fever of 103.8 and extreme irritability. Fever and irritability persisted for 6 days in addition to trouble sleeping, lack of appetite, and loose stools. Rash developed day 12 after shot and lack of appetite, difficulty sleeping, irritability, and loose stools persisted as well. Child was seen by physician day 19 after shot and was diagnosed with measles due to MMR vaccine. Today is day 19 after shot.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Child developed high fever of 103.8 and extreme irritability. Fever and irritability persisted for 6 days in addition to trouble sleeping, lack of appetite, and loose stools. Rash developed day 12 after shot and lack of appetite, difficulty sleeping, irritability, and loose stools persisted as well. Child was seen by physician day 19 after shot and was diagnosed with measles due to MMR vaccine. Today is day 19 after shot.
Age: 34.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Alopecia, Endocrine test normal, Thyroid function test normal
Clinical narrative: Alopecia onset.
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: Maternal exposure during pregnancy, Premature delivery
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of premature birth in a 18-year-old female subject who was vaccinated with DTPa (with small D & P), manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unspecified trimester. On an unspecified date, after 35 weeks of gestation, the subject gave birth to a premature live infant by unspecified method of delivery. No congenital anomaly was reported. The subject was hospitalised.
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Maternal exposure during pregnancy, Premature delivery
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of preterm birth in a neonate of unspecified gender whose mother was vaccinated with DTPa (with small D & P), manufacturer unspecified). The subject's mother medical history included delivery by cesarean section. On an unspecified date, the 22-year-old mother of the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine during unspecified trimester. On an unspecified date, after 36 weeks of gestation, the neonate was preterm born by cesarean section. No congenital anomaly was reported. The subject was hospitalised.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of a stillbirth in a 27-year-old female subject who was vaccinated with DTPa (with small D & P), manufacturer unspecified. On an unspecified date, the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at just between the 1st and the 2nd trimester (46 days prior 22 weeks of gestation). 46 days after vaccination with DTPa (with small D & P), the subject experienced stillbirth without other pregnancy complications. No congenital anomaly was reported. The subject was hospitalised.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Premature separation of placenta, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of stillbirth in a 20-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at 37 weeks of gestation. Within several hours of vaccination with DTPa (with small D + P), the subject experienced placental abruption which ended by a stillbirth. No congenital anomaly was reported. The subject was hospitalised.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of gastroschisis in a newborn of unspecified gender whose mother was vaccinated with DTPa (with small D & P), manufacturer unspecified), HPV vaccine (non-gsk). On an unspecified date, the 15-year-old mother of the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site), unspecified dose of HPV vaccine (Non-GSK) (unknown route and injection site). The mother's last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine approximately at 8 weeks of gestation. On an unspecified date, after unspecified weeks of gestation, the neonate was delivered by unspecified method. Birth defects were noted. The neonate experienced gastroschisis which was assessed as a congenital anomaly by GlaxoSmithKline. The subject was hospitalised. At the time of reporting the outcome of gastroschisis was unspecified.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. The 2 patients were vaccinated with ZOSTAVAX on JUL-2011 ("one year ago") (indication reported as "shingles"). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on JUL-2012 the 2 patients were diagnosed with shingles "one year after ZOSTAVAX was administered". They were both severe cases of the shingles and had to be admitted and treated at the hospital. At the time of the report, the patients' outcome was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: TDAP
Symptoms: Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of laryngotracheomalacia in a 3-month-old subject of unspecified gender whose mother was vaccinated with DTPa (with small D + P), manufacturer unspecified) during pregnancy. On an unspecified date, the mother of the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). The mother's last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine during unspecified trimester. On an unspecified date, after unspecified weeks of gestation, the neonate was delivered by unspecified method. Birth defects were noted. The neonate experienced laryngotracheomalacia which was assessed as a congenital anomaly by GlaxoSmithKline. The subject was hospitalised. At the time of reporting the outcome of laryngotracheomalacia was unspecified.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Pre-eclampsia, Premature delivery
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of preeclampsia in a 40-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). The subject had multiple previous pregnancies. On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unspecified trimester. At an unspecified time after vaccination with DTPA, the subject experienced preeclampsia. On an unspecified date, after 36 weeks of gestation, the subject gave birth to a preterm neonate by unspecified method of delivery. No congenital anomaly was reported. The subject was hospitalised.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Crying, Emotional distress, Fatigue, Irritability, Pyrexia
Clinical narrative: It all hit my son like a ton of bricks. Out of nowhere, he started screaming and crying like I had never heard. He was absolutely inconsolable for over 30 minutes straight (and he is not a fussy child). We gave him Tylenol after 30 minutes of this and it helped calm him down a little, but he still continued to whimpered in his sleep all night long. He was fine the next morning but then spiked a fever (over 100.4)  the Tylenol brought it down a little bit. The following day he was really crabby and really tired.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Screaming
Clinical narrative: It all hit my son like a ton of bricks. Out of nowhere, he started screaming and crying like I had never heard. He was absolutely inconsolable for over 30 minutes straight (and he is not a fussy child). We gave him Tylenol after 30 minutes of this and it helped calm him down a little, but he still continued to whimpered in his sleep all night long. He was fine the next morning but then spiked a fever (over 100.4)  the Tylenol brought it down a little bit. The following day he was really crabby and really tired.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Emotional distress, Fatigue, Irritability, Pyrexia
Clinical narrative: Exactly the same reaction that his 2 months vaccinations had. It hit him like a ton of bricks. Out of nowhere he was screaming and crying and was inconsolable. He had a fever and the next day was tired and crabby.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Screaming
Clinical narrative: Exactly the same reaction that his 2 months vaccinations had. It hit him like a ton of bricks. Out of nowhere he was screaming and crying and was inconsolable. He had a fever and the next day was tired and crabby.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Fatigue, Mood altered, Pharyngitis, Pyrexia
Clinical narrative: 03/02/11 after the vaccinations he woke up really upset in the night (not typical of him at all, he's always been a really good, calm sleeper).   2 weeks after that he had to be taken to the ER for a high fever and crying a lot. They suspected something was wrong with his throat, but apparently found nothingWe went home with no answers.   10 days after that visit to the ER we were back in the ER in the middle of the night for a 106 fever that was rising and I rushed him in. He had a throat infection that had been festering for weeks.   1 day after that visit, during the night, he was SO hot that he actually woke me up from the heat (co-sleeping here). He was really upset and really tiredthe only thing I could think to do was put him in a lukewarm bath. He screamed and cried and sat there saying "momma, momma"
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Skin warm
Clinical narrative: 03/02/11 after the vaccinations he woke up really upset in the night (not typical of him at all, he's always been a really good, calm sleeper).   2 weeks after that he had to be taken to the ER for a high fever and crying a lot. They suspected something was wrong with his throat, but apparently found nothingWe went home with no answers.   10 days after that visit to the ER we were back in the ER in the middle of the night for a 106 fever that was rising and I rushed him in. He had a throat infection that had been festering for weeks.   1 day after that visit, during the night, he was SO hot that he actually woke me up from the heat (co-sleeping here). He was really upset and really tiredthe only thing I could think to do was put him in a lukewarm bath. He screamed and cried and sat there saying "momma, momma"
Age: 1.07
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Blood urine present, Cyanosis, Ear infection, Milk allergy, Pyrexia
Clinical narrative: 11/02/11 I had to take him to the ER after finding blood in his diaper. We cloth diaper, so I was able to tell that this was from his penis. Blood in the urine. We left with no answers. This happened three more time before November 20, 2011.  November 20, 2011 he spiked a fever of 102 that wouldn't budge no matter what I did.  November 21, 2011 we had to go to the ER in the night again as his fever reached 104 (this was just from touching his skin, he wouldn't let me put it in his mouth). It was 104.4 at the hospital. They diagnosed him with a double ear infection. He had never had an ear infection before.  December 2nd, 2011 we noticed a few weird blue/purple spells over the last week, turning up on his hands, feet, legs, mouth, and lips - just happened in the morning almost daily. No one could give us answers.  December 6th, 2011 I figured out he has a dairy allergy. A future appointment with a pediatric specialist would confirm this. I hadn't noticed this issue until after these vaccinations.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Feeling hot, Head discomfort, Syncope
Clinical narrative: Patient almost fainted; reported feeling "heavy headed" and warm. Patien't skin was clammy to the touch. Pt was instructed to lie down. He was given cold water to drink and ice pack for his head. He was able to walk and leave the pharmacy after about 40 minutes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Gave vaccination into (L) deltoid muscle. Chatted with patient for a couple minutes. Pt went to stand up (had been on exam table). Pt fainted when she stood up. I grabbed her and laid her on exam table. She opened eyes. Had her continue to lay down. Gave her apple juice and graham crackers. Recovered completely.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date, was vaccinated with a dose of VAQTA (lot# not reported). The nurse stated that the patient received the second dose of VAQTA (lot# not reported) 4 months after the first dose. No adverse effect was reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 79 years old male patient with no pertinent medical history who on 24-JUN-2012 was vaccinated with a dose of ZOSTAVAX (dose and route # not provided) (lot # 0255AE, expiration date on 14-MAR-2013). On 26-JUN-2012, the patient experienced dizziness and lightheadedness after vaccination with ZOSTAVAX. No treatment was given for the events. At the time of the report, the outcome of dizziness and lightheadedness was unknown. The patient contacted his physician. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 years old female patient. The patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route unspecified). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site reaction and a severe headache soon after receiving the ZOSTAVAX injection, injection site reaction and the headache subsided after 5 days without any specified treatment. It was reported that the patient sought to medical attention. The outcome of severe headache and injection site reaction was reported as recovered/resolved(date not provided). Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 16 years old female patient. The patient was vaccinated with, a 0.5 ml dose of GARDASIL (Lot # not reported) IM. No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 10-JUL-2012, after received an injection of GARDASIL, the patient passed out (medically significant) and fainted in the office. The patient received an unspecified treatment. At the time of the report, the patient's outcome was unknown. Upon internal review passed out was considered as an other important medical event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Rash erythematous
Clinical narrative: Developed diffuse, erythematous bumpy rash on her face with some swelling around eyes.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient broke out in hives after 36 hr of being vaccinated. He started taking BENADRYL every 6 hrs to relieve symptoms. After BENADRYL wears off hives would return and itch.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Pain in Rt arm, not relieved by PERCOCET. Occurred 12 hrs hours after injection. Swelling slightly smaller than ping pong ball size. Warm to touch. Pain & swelling at Rt arm pt.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Erythematous rash and hives all over the body.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Pain, Pyrexia
Clinical narrative: Developed fever, sore after receiving vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache - across the back. Approx began 7-12-12 - comes and goes. FIORICET takes care of it temp. but then comes back, previous history of headaches --> FIORICET 1 tab/month max.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm red, swollen at injection site, itchy, warm to touch.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling
Clinical narrative: Redness, swelling, 12 1/2 cm x 14 cm. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red area at the site of MMR immunization 40 x 30 mm.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Ped Hep A given instead of Hep A adult.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Small red, raised and warm welt at injection site noted 24 hours ago. The are remains redden, but reduced tenderness and edema. No changes in strength or range of motion left upper arm. No numbness or tingling or any other radiating symptoms from indurated injection site.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Small red, raised and warm welt at injection site noted 24 hours ago. The are remains redden, but reduced tenderness and edema. No changes in strength or range of motion left upper arm. No numbness or tingling or any other radiating symptoms from indurated injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male with no pertinent medical history and no drug reactions/allergies who on 24-APR-2012 was vaccinated with a single 0.65 mL dose of ZOSTAVAX (Merck) (lot# not reported) via intramuscular injection. The patient reported receiving doses of unspecified tetanus and hepatitis A virus vaccines (manufacturer unknown) on Friday, 20-APR-2012. On 24-APR-2012, in the pharmacy, the patient flinched during the injection and reported the injection hurt. No treatment was given for adverse event. On the same day, the patient recovered from reported adverse event. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 21-MAR-2012 and 15-MAY-2012 the patient was vaccinated with the first and second dose of GARDASIL (lot # 1560 AA, exp. date: 15-AUG-2014). On 11-JUL-2012, the patient was vaccinated with the third dose of GARDASIL (lot # 1860AA, exp. date: 30-SEP-2014) a few days earlier than recommended minimal dosing interval. If the patient sought medical attention was unknown. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacy technician concerning an unspecified patient of unknown age. The patient was vaccinated with a dose of expired ZOSTAVAX (lot number was unknown, dose, injection site and route were not reported) which was 3 to 4 months expired when given on an unspecified date. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Aggression, Blood test, Hair texture abnormal, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter 4 years old female patient with penicillin allergy. The patient was vaccinated with VAQTA on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that, while on VAQTA, on 14-JUN-2005, the patient's hair became dry. The patient did not eat fish or tomatoes because they will give her headaches. The patient started pulling her hair out. The patient behaved aggressively. The patient was seen by several physicians. No treatment was given to the patient. The patient had done unspecified skin and blood tests. At the time of the report, the patient was not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Skin test, Trichotillomania
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter 4 years old female patient with penicillin allergy. The patient was vaccinated with VAQTA on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that, while on VAQTA, on 14-JUN-2005, the patient's hair became dry. The patient did not eat fish or tomatoes because they will give her headaches. The patient started pulling her hair out. The patient behaved aggressively. The patient was seen by several physicians. No treatment was given to the patient. The patient had done unspecified skin and blood tests. At the time of the report, the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Nausea
Clinical narrative: Information has been received from a female consumer who was vaccinated SC with a 0.5 ml dose of ZOSTAVAX on 22-JUN-2012. On 23-JUN-2012 the patient experienced atypical herpes zoster after receiving ZOSTAVAX. The patient had been nauseous and fatigued, but attributed those reactions to the acyclovir (strength and manufacture unspecified) medication her physician put her on after discovering the atypical herpes zoster. It was unknown if the patient sought medical attention. At the time of report, the patient was not recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 27-SEP-2011. On 12-JUL-2012 the patient received another dose of GARDASIL which was expired on 27-APR-2012. No adverse event reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Scab
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 years old female patient with codeine allergy and no pertinent medical history. The patient was subcutaneously vaccinated with ZOSTAVAX on 14-APR-2011 (lot# and dose were unspecified). No concomitant medications were reported. On 30-JUN-2012, the patient broke out in case of shingles on her forehead and was experiencing bumps on her head, mouth and right ear. She had pain off and on and had a rash which was beginning to crust over on her forehead. The patient went to the doctor, and subsequently the ophthalmologist and received treatment for the shingles outbreak, The treatment included valacyclovir three times a day, hydrocortisone 1%, neo-poly-dex for eye. The outcome of shingles was reported as recovering/resolving. No lab diagnostic study was performed. No additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated subcutaneously with an expired dose of ZOSTAVAX (Lot# 669746/0356AA, expired date 09-JUN-2012, dose not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was not known if the patient sought for medical attention. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Epidural injection
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date approximately in June 2012, "one to two weeks ago". No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient needed "an epidural" for an unspecified reason. It was unspecified if the patient had sought medical attention. The outcome of the adverse event was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was SQ vaccinated with a 0.5 ml dose of VARIVAX which was exposed to temperature cannot be supported on 03-JUL-2012. It was unknown if the patient sought medical attention. No adverse effects reported. Additional information has been requested.