chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Caesarean section, Exposure during pregnancy, Live birth
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnancy before getting the vaccine. Initial exposure to GARDASIL was at 33 week (s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given a birth to female infant weighing 6 lb 2oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscularly on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result: -Rh+); glucose test on 15-AUG-2012 (negative); maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012 (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012. The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via C-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine positive, Rhesus antibodies positive, Streptococcus test negative, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnancy before getting the vaccine. Initial exposure to GARDASIL was at 33 week (s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given a birth to female infant weighing 6 lb 2oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscularly on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result: -Rh+); glucose test on 15-AUG-2012 (negative); maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012 (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012. The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via C-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Blood group O, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnancy before getting the vaccine. Initial exposure to GARDASIL was at 33 week (s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given a birth to female infant weighing 6 lb 2oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscularly on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result: -Rh+); glucose test on 15-AUG-2012 (negative); maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012 (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012. The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via C-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine, Streptococcus test negative, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnancy before getting the vaccine. Initial exposure to GARDASIL was at 33 week (s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given a birth to female infant weighing 6 lb 2oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscularly on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result: -Rh+); glucose test on 15-AUG-2012 (negative); maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012 (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012. The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via C-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 1.68
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever 102.5 with 12hr of vaccine diarrhea within 18hr of vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional concerning an unspecified number of patients of unknown age and gender. Since an unknown date between September 2012 and November 2012, patients were vaccinated with the doses of improperly stored (exposed for 123 hours at 46 Fahrenheit) VARIVAX (Merck) (lot number and expiry date reported as 670554/0672AA and 05-MAY-2013 respectively, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Mother reported raised red, indurated, warm area on (R) arm, approx 2 inches x 0.5 inches. Painful. No fever. Advised ice, ibuprofen, follow-up PRN or to ER for hives/perioral swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling of right deltoid with heat and redness. Mild to moderate discomfort. BENADRYL, TYLENOL and cool packs advised.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Received Hep B and VARIVAX vaccines on 040213. 040413 c/o redness, soreness, and swelling. Went back to HU and was told to take OTC pain reliever and apply warm compresses. 040513 c/o not better and was instructed to see PMD.
Age: 20.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: BROKE OUT IN HIVES BOTH ARMS AND STOMACH. GIVEN BENADRYL 50MG IM.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Had vaccines in office 3-22-2013 AM. Woke with raised blotchy rash on legs and buttocks. Rash was itchy. Told to give Benadryl (phone advice) qid. Hives cleared, returned next day. P Benadryl stopped. Alert. Active. Was breathing comfortably.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Mother brought child into Health Department on 3/28/13 and reported that after receiving immunizations on 8/1/12 child had a high fever and a seizure later in the day.  Mother did not report reaction to Health Department at that time. Unknown if private provider reported the event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Gait disturbance, Oedema peripheral
Clinical narrative: Swelling to both thighs, redness around both thighs, pain, difficulty walking. Promoted ER evaluation - placed child on scheduled Benadryl.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac enzymes normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: On 3/24, onset of light internal pressure in left chest area. Over next 2 days, pressure increased.  During the following 2 days, pain changed to a sharp constant pain in same area with onset of shortness of breath.  On Friday 3/29, pursued medical attention with Dr. visit and was admitted to hospital for evaluation and treatment of new-onset Atrial Fibrillation.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Echocardiogram, Electrocardiogram
Clinical narrative: On 3/24, onset of light internal pressure in left chest area. Over next 2 days, pressure increased.  During the following 2 days, pain changed to a sharp constant pain in same area with onset of shortness of breath.  On Friday 3/29, pursued medical attention with Dr. visit and was admitted to hospital for evaluation and treatment of new-onset Atrial Fibrillation.
Age: 1.53
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at site of injection.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, VARCEL
Symptoms: Areflexia, Ataxia, CSF test, Clostridium test, Electromyogram
Clinical narrative: Rapidly progressive descending paralysis with bulbar symptoms (ophthalmoplegia, facial weakness) and with hyporeflexia and truncal ataxia progressing to near-complete paralysis and areflexia.  Intubated electively on 3/15/2013 to protect airway.  Still intubated in hospital now.  See attached hospital notes (labs and consults).
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, VARCEL
Symptoms: Endotracheal intubation, Facial paresis, Hyporeflexia, Immunoglobulin therapy, Ophthalmoplegia
Clinical narrative: Rapidly progressive descending paralysis with bulbar symptoms (ophthalmoplegia, facial weakness) and with hyporeflexia and truncal ataxia progressing to near-complete paralysis and areflexia.  Intubated electively on 3/15/2013 to protect airway.  Still intubated in hospital now.  See attached hospital notes (labs and consults).
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, VARCEL
Symptoms: Paralysis
Clinical narrative: Rapidly progressive descending paralysis with bulbar symptoms (ophthalmoplegia, facial weakness) and with hyporeflexia and truncal ataxia progressing to near-complete paralysis and areflexia.  Intubated electively on 3/15/2013 to protect airway.  Still intubated in hospital now.  See attached hospital notes (labs and consults).
Age: 0.4
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient brought into clinic on 04/05/13 with complaints of red, itchy, rash on both arms at site where vaccines were given. No treatments necessary, home care was advised.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Electromyogram, Hypoaesthesia, Lumbar puncture, Tremor
Clinical narrative: Legs and hands going numb and couldn't lift legs to walk, very shaky.
Age: 11.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Culture positive, Necrotising fasciitis, Pseudomonas test positive, Rash
Clinical narrative: Rash developed on right arm the morning after vaccinations.  Found to have probable necrotizing fasciitis.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood gases normal, Dehydration, Electroencephalogram normal
Clinical narrative: Patient initially became febrile to 38 (rectal), was seen in ED evening after vaccine administration.  Discharged home, but on 4/2/13 was found to not eat with normal vigor and be sleepier.  Proceeded to have increased sleepiness, no interest in feeding when woken up x 10 hours, when represented to ED.  In ED was found to be intermittently sleepy, continued poor feeding, hypotonic (axial, +neck lag), dehydrated.  Admitted for rehydration and observation.  CBC, Chem7, VBG all normal.  Patient mental status improved at admission (roughly midnight of 4/2/13), but in AM was found to be sleepy again, persistent hypotonia on exam.  Continued with fluctuating mental status, hypotonia.  Neuro consulted.  EEG showed nonfocal asymmetry (no seizure activity), presumably due to extra or intracranial fluid as confirmed by MRI (within limits of normal; MRI was normal).  LP attempted without success.  AST/ALT were normal.  Patient began to improve significantly at ~23:00 on 4/3/13 (~60 hours after vaccine administration) and by morning of 4/4/13 (day of discharge) was almost back to baseline - alert, interactive, feeding well, hypotonia persisted, but was improved.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Feeding disorder of infancy or early childhood, Full blood count normal, Head lag, Hypotonia, Laboratory test normal
Clinical narrative: Patient initially became febrile to 38 (rectal), was seen in ED evening after vaccine administration.  Discharged home, but on 4/2/13 was found to not eat with normal vigor and be sleepier.  Proceeded to have increased sleepiness, no interest in feeding when woken up x 10 hours, when represented to ED.  In ED was found to be intermittently sleepy, continued poor feeding, hypotonic (axial, +neck lag), dehydrated.  Admitted for rehydration and observation.  CBC, Chem7, VBG all normal.  Patient mental status improved at admission (roughly midnight of 4/2/13), but in AM was found to be sleepy again, persistent hypotonia on exam.  Continued with fluctuating mental status, hypotonia.  Neuro consulted.  EEG showed nonfocal asymmetry (no seizure activity), presumably due to extra or intracranial fluid as confirmed by MRI (within limits of normal; MRI was normal).  LP attempted without success.  AST/ALT were normal.  Patient began to improve significantly at ~23:00 on 4/3/13 (~60 hours after vaccine administration) and by morning of 4/4/13 (day of discharge) was almost back to baseline - alert, interactive, feeding well, hypotonia persisted, but was improved.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Mental status changes, Nuclear magnetic resonance imaging brain normal, Pyrexia, Somnolence
Clinical narrative: Patient initially became febrile to 38 (rectal), was seen in ED evening after vaccine administration.  Discharged home, but on 4/2/13 was found to not eat with normal vigor and be sleepier.  Proceeded to have increased sleepiness, no interest in feeding when woken up x 10 hours, when represented to ED.  In ED was found to be intermittently sleepy, continued poor feeding, hypotonic (axial, +neck lag), dehydrated.  Admitted for rehydration and observation.  CBC, Chem7, VBG all normal.  Patient mental status improved at admission (roughly midnight of 4/2/13), but in AM was found to be sleepy again, persistent hypotonia on exam.  Continued with fluctuating mental status, hypotonia.  Neuro consulted.  EEG showed nonfocal asymmetry (no seizure activity), presumably due to extra or intracranial fluid as confirmed by MRI (within limits of normal; MRI was normal).  LP attempted without success.  AST/ALT were normal.  Patient began to improve significantly at ~23:00 on 4/3/13 (~60 hours after vaccine administration) and by morning of 4/4/13 (day of discharge) was almost back to baseline - alert, interactive, feeding well, hypotonia persisted, but was improved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Induration, Localised oedema, Pyrexia
Clinical narrative: S.Q. injection (R) deltoid. Very large area of redness, warmth, edema & hardness. Mom states child ran a fever although did not take temperature, 4/5/13 temp checked by county nurse = 97.7 oral. Child given TYLENOL, BENADRYL & cool cloths. Mom states was worried.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 30 unspecified patients. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that on an unknown date approximately 30 patients received doses of GARDASIL that were exposure to light for unspecified amounts of time since January 2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional concerning an unspecified number of patients of unknown age and gender. Since an unknown date between September 2012 and November 2012, patients were vaccinated with the doses of improperly stored (exposed for 28 hours at 30 Fahrenheit) GARDASIL (lot number and expiry date reported as 669313/0692AA and 13-AUG-2013 respectively, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient who on 03-FEB-2013 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # not provided). The nurse stated that on 19-MAR-2013, the patient received the second dose of GARDASIL (lot # not provided), IM 0.5 ml (lot # not provided). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from the Nurse practitioner, refers to an unspecified number of patients (reported as children) of unknown age and gender, with no pertinent medical history reported. On unspecified dates the patients were vaccinated with different lots of MMR II (lot number and expiration dates not reported) (dose and route not reported). The Nurse stated that a facility had MMR II that had multiple above temperature excursions with different lots of MMR II. The nurse reported that an unspecified number of children were vaccinated with these vaccines. No adverse effects were reported at that time. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a 74 year old female consumer reporting on herself. No drug reactions/allergies were reported. On 14-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 25-MAR-2013, the patient was placed on therapy with DULERA (dose not reported) inhales, twice a day for pulmonary arterial hypertension. Concomitant therapy names were not reported. On 25-MAR-2013, the patient got hives on scalp and around the edge of her face when she started using DULERA. Action taken with DULERA was unknown. The outcome of hives on her scalp and around the edge of her face was unknown. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Runny nose began very soon after my 2 year 2 weeks old daughter received the Nasal Flu Spray. It is still an ongoing problem along with wheezing as of today, nearly 6 months later.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Anti-thyroid antibody positive, Autoimmune disorder, Eyelid oedema, Laboratory test abnormal, Rash generalised
Clinical narrative: Swelling eyelids and rashes on body started occurring on a daily basis after vaccination. Thyroid antibodies detected and autoimmune thyroid disease diagnosed. Later on autoimmune urticaria finally diagnosed too.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Thyroid disorder, Urticaria
Clinical narrative: Swelling eyelids and rashes on body started occurring on a daily basis after vaccination. Thyroid antibodies detected and autoimmune thyroid disease diagnosed. Later on autoimmune urticaria finally diagnosed too.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Haemorrhage, Palpitations, Swelling face, Throat irritation
Clinical narrative: Started with scratchy throat, then approx 6:30 pm had swelling, heart pounding, could feel pounding in hands, face swollen, then vomiting, then diarrhea, then bleeding.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Started with scratchy throat, then approx 6:30 pm had swelling, heart pounding, could feel pounding in hands, face swollen, then vomiting, then diarrhea, then bleeding.
Age: 43.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site joint movement impairment, Injection site pain, Pain
Clinical narrative: Burning sensation at injection site with loss of mobility in right shoulder.  Mobility returned in @48 hours.  Pain and range of motion remains.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Swelling
Clinical narrative: Redness and swelling; small nodule when injection occurred.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Fatigue, Pallor, Somnolence
Clinical narrative: After administration of Gardasil #2 and Menactra the patient went to the waiting room.  She became pale and dizzy and was brought back to an exam room and lay down supine.  Her Heart rate was 55 and her blood pressure was 106/64 with an O2 Sat of 98% room air.  She was able to talk the entire time.  She complained of feeling tired and wanted to go to sleep.  She did not fall asleep, and there was no loss of conciousness.  Her heart rate increased to the 70's over time.  Her pallor resolve over about 10 minute and she had decreased clamminess. At about 10 minutes she started to feel better, and was asked to stay for observation for an additional 1/2 hour.  Her repeat BP was 110/62 and her heart rate was in the 80s.  In retrospect mom reported that after Gardasil #1 she had tingling at the injection site while at school (hours after administration.)
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Screaming
Clinical narrative: Patient screamed almost non stop for 3 days.  She only didn't cry when she was nursing and/or sleeping after each set of vaccines.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Glassy eyes, Pallor, Pruritus, Throat tightness, Urticaria
Clinical narrative: Full-body hives; tightening of the throat, paleness, glassy eyes, itching.  Was given 25 mg of Benadryl every 6 hours, and was prescribed Prednisolone 1.5 tsp, twice daily for 5 days.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Dizziness, Ear pain, Facial pain
Clinical narrative: Severe dizziness, site pain and redness, nausea, vomiting. Numbness, weakness and pain in all extremeties and face (cheeks, lips, tongue). Chronic sleepiness (have slept 60 out of 72 hours over the past three days). My arms are so weak that it feels as if there are no bones in my arms. Headache, ear ache and deep chest cough.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Glossodynia, Headache, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Severe dizziness, site pain and redness, nausea, vomiting. Numbness, weakness and pain in all extremeties and face (cheeks, lips, tongue). Chronic sleepiness (have slept 60 out of 72 hours over the past three days). My arms are so weak that it feels as if there are no bones in my arms. Headache, ear ache and deep chest cough.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Lip pain, Muscular weakness, Nausea, Pain in extremity, Somnolence
Clinical narrative: Severe dizziness, site pain and redness, nausea, vomiting. Numbness, weakness and pain in all extremeties and face (cheeks, lips, tongue). Chronic sleepiness (have slept 60 out of 72 hours over the past three days). My arms are so weak that it feels as if there are no bones in my arms. Headache, ear ache and deep chest cough.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Severe dizziness, site pain and redness, nausea, vomiting. Numbness, weakness and pain in all extremeties and face (cheeks, lips, tongue). Chronic sleepiness (have slept 60 out of 72 hours over the past three days). My arms are so weak that it feels as if there are no bones in my arms. Headache, ear ache and deep chest cough.
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 26-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # 672476/1605AA, expiry date 13-JAN-2013) (subcutaneous, 0.65 ml). Pharmacist reported that this was an expired dose. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 67 year old male patient with diabetes and shingles attacks since 1965. The patient's medical history included high blood pressure and high cholesterol. The patient had no drug reactions or allergies. On 11-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot # 0564AE, expiration date unspecified) (dose not reported) subcutaneous. Concomitant therapies included JANUVIA, glyburide (manufacturer unspecified), AMLODIPINE, Ramipril (manufacturer unspecified), metformin (manufacturer unspecified), CRESTOR, thyroid (manufacturer unspecified), ATROVENT, alprazolam (manufacturer unspecified) and hydrocodone (manufacturer unspecified). The physician reported that the patient experienced an increase in shingles frequency since the patient was administered ZOSTAVAX. The physician reported that the patient got shingles once a year since 1965. The physician also reported that the patient had a shingles attack in the beginning of February of 2013 (date unspecified) and again in 01-APR-2013 (two attacks) since the patient was vaccinated with ZOSTAVAX. The physician described the recent shingles attacks as similar to the shingles attacks the patient has been getting since 1965, with the exception of the frequency. The patient sought medical attention and was treated with VALTREX. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-APR-2013 the patient was vaccinated with M-M-R II (lot # 0447AA, expiration date 28-MAR-2013) (route and dose unspecified). On 02-APR-2013 the patient was inadvertently administered M-M-R II that had expired on 28-MAR-2013. No adverse effects reported. Additiona information is not expected.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 30 year old male IV drug user patient who on 03-AUG-1992 was vaccinated with the first dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose and route were not reported). On 08-SEP-1992, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). On 30-MAR-1993, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). The medical assistant reported that a patient had a negative anti-HBs titer (less than 5) after receiving the primary three dose series of Hepatitis B vaccine (manufacturer unknown). The primary vaccination series was administered at another unspecified clinicians office. No adverse event reported other than the negative anti-HBs titer. On 01-DEC-2012, an unspecified titer test was performed (results not provided). Also it was reported that the patient was administered a dose of RECOMBIVAX HB on 02-APR-2013. The patient sought unspecified medical attention by an office visit. At the time of the report, the patient's outcome was not provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-APR-2013, the patient was vaccinated with ZOSTAVAX (lot # 0257AE, expiration date 15-MAR-2013) (0.65 ml, subcutaneously). No adverse effect was reported. The outcome of the event was reported as unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye pain, Ocular discomfort
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old male patient with no drug reactions or allergies. On 11-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route not reported). On 16-MAR-2013, the patient experienced discomfort in the corner his right eye. He stated that his vision was not affected. On 17-MAR-2013, he noticed that his eye was inflamed. He stated that he has experienced a very dull, achy sensation in his right eye. The patient sought medical attention and received treatment with TOBRADEX. The outcome of the patient events was reported as recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 23 year old female patient who on 05-OCT-2012, was vaccinated intramuscular with 0.5 ml of GARDASIL (lot # H011350) dose 1. 28-JAN-2013, was vaccinated with GARDASIL (dose, lot # and route not provided) dose 2. No concomitant medications were reported. No adverse events reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). ZOSTAVAX was exposed to temperature up to 24F for 67 days (1608 hours) and it was determined not viable. Improperly stored ZOSTAVAX had been administered to the patient. No adverse effects reported. This is one of several reports received from the same source (same reporter link: 1303USA011844 and 1304USA002221). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Atrial fibrillation, Cardiac pacemaker insertion, Heart rate increased, Laboratory test
Clinical narrative: Heart rate went to 170 went to ER was admitted over night.  Heart rate was converted back to normal.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Numbness and tingling in toes of right foot; over next six days spread throughout body; saw PCP on 1/31/11, 2/1/11, 2/4/11. Admitted to hospital and diagnosed with Guillain Barre Syndrome 2/5/11.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The reporter stated that on an unknown date, unspecified number of patients may have vaccinated with unspecified number of doses of PNEUMOVAX23 (lot number, expiry date and route unspecified) that was exposed to 9 degrees Celsius (C) for 63 hours. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 17-year-old patient, gender unspecified. On 29-MAR-2013, the patient was inadvertently vaccinated with 0.5 milliliter PROQUAD (lot# and expiration date not reported) subcutaneously. No adverse effects reported. No further information provided. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chondropathy, Joint fluid drainage, Musculoskeletal pain
Clinical narrative: Informed of event 3/28/2013. Cartilage problems in back of shoulder, sore shoulder. She has seen family doctor and orthopedic doctor. She had some physical therapy and some fluid drained from shoulder area.
Age: 17.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Dysarthria, Eyelid ptosis, Gait disturbance, Joint range of motion decreased, Mobility decreased
Clinical narrative: High fever, droopy (eyes both) and left cheek, slur in speech, unstable in walking, neck and shoulder and arm (left) very warm to the touch and unable to move. Pain level was high. (Documentation by parent) and called in on 4-6-2013) advise nurse.
Age: 17.0
Sex: M
Vaccine: HPVX, MEN
Symptoms: Pain, Pyrexia, Skin warm, VIIth nerve paralysis
Clinical narrative: High fever, droopy (eyes both) and left cheek, slur in speech, unstable in walking, neck and shoulder and arm (left) very warm to the touch and unable to move. Pain level was high. (Documentation by parent) and called in on 4-6-2013) advise nurse.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This medically confirmed report received on 08-Feb-2013 concerns a 21-year-old male patient, who had a medical history of ulcerative colitis. Concomitant medications included prednisolone, azathioprine, mesalamine and dicyclomine. He had no drug reactions / allergies. On 27-Nov-2012 the patient received AFLURIA (batch number: P58507) injection intramuscularly at a dose of 0.5 mL once for vaccination. A couple of days after receiving AFLURIA, the patient developed sore arm for several months since the vaccination. He saw the pharmacist and was treated with TYLENOL. No lab diagnostic studies were performed. The adverse event was not improved. The outcome was not recovered. Case correction (22-Mar-2013) : Merck confirmed time to onset, upgraded to serious.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This medically confirmed report received on 08-Feb-2013 concerns a 21-year-old male patient, who had a medical history of ulcerative colitis. Concomitant medications included prednisolone, azathioprine, mesalamine and dicyclomine. He had no drug reactions / allergies. On 27-Nov-2012 the patient received AFLURIA (batch number: P58507) injection intramuscularly at a dose of 0.5 mL once for vaccination. A couple of days after receiving AFLURIA, the patient developed sore arm for several months since the vaccination. He saw the pharmacist and was treated with TYLENOL. No lab diagnostic studies were performed. The adverse event was not improved. The outcome was not recovered. Case correction (22-Mar-2013) : Merck confirmed time to onset, upgraded to serious.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This medically confirmed report received on 08-Feb-2013 concerns a 66-year-old female patient, who had no pertinent medical history, concomitant medication or drug reaction / allergies. On 27-Nov-2012 the patient received AFLURIA (batch number: P58507) injection intramuscularly at a dose of 0.5 mL once. A couple of days after receiving AFLURIA, the patient developed sore arm for several months since after the vaccination. She saw the pharmacist and was treated with TYLENOL. No lab diagnostic studies were performed. The outcome was not reported. Case correction (22-Mar-2013): Merck confirmed the time of onset, upgraded to serious.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This medically confirmed report received on 08-Feb-2013 concerns a 66-year-old female patient, who had no pertinent medical history, concomitant medication or drug reaction / allergies. On 27-Nov-2012 the patient received AFLURIA (batch number: P58507) injection intramuscularly at a dose of 0.5 mL once. A couple of days after receiving AFLURIA, the patient developed sore arm for several months since after the vaccination. She saw the pharmacist and was treated with TYLENOL. No lab diagnostic studies were performed. The outcome was not reported. Case correction (22-Mar-2013): Merck confirmed the time of onset, upgraded to serious.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Abdominal distension, Choking sensation, Computerised tomogram abdomen abnormal, Death, Dyspnoea
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Ear infection, Gastrectomy, Gastric perforation, Gastrointestinal gangrene, General physical health deterioration
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Guillain-Barre syndrome, Haemodialysis, Mechanical ventilation, Plasmapheresis, Post procedural complication
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Pyrexia, Renal failure, Respiratory failure, Surgery, Upper gastrointestinal haemorrhage
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Arthralgia, Asthenia, Death, Ear pain, Headache
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: YF, YF
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Initial report received on 25 March 2013 from a consumer, who is also the patient's daughter. A 75-year-old male patient with a sulfa allergy received an injection of Yellow Fever vaccine, Sanofi Pasteur lot number UH588AA, on 06 March 2013 or 08 March 2013 (Expiration date 05 October 2014, route and site not reported). Patient received vaccination at unknown Infectious Diseases Specialist. One week post vaccination, the patient experienced hurting in the knees, weakness, headache, ear ache, throat ache, and low grade fever. The patient was seen by his healthcare provider and was started on antibiotics. The patient then went to the emergency room for symptoms. The patient died on 21 March 2013 and stated no autopsy to be done. No other information was provided. The patient's outcome was fatal. Documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Blood electrolytes, Fall, Full blood count, Headache
Clinical narrative: (IV immunoglobulin given). Diagnosis post-vaccination viral syndrome R/O Guillain Barre syndrome. Flu-like symptoms & neck pain; headaches; loss of ability to support myself & loss of ability to walk: loss of ability to protect airway - visited emergency dept at hospital 2-11-13, then hospitalized at hospital 2-14-13 to 2-21-13. Required intensive unit care, monitoring multiple systems, IV meds, lab, MRI of head.