chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Agitation, Body temperature increased, Crying, Decreased appetite, Erythema
Clinical narrative: 24 hours after immunization mother states pt whining, agitated, anorexia, Temp 99 degrees (A) on 7/8/13 at 9:00 pm mother gave pt 1 teasp Children's ADVIL. 7/10/13 WCC at PCP - it was noted: (1) Left arm anterior deltoid hypererythema (not endurated) measured 10cm x 9 cm (2) Left arm more distal hypererythemia with discrete in duration measured 1.5 cm x 1.5 cm.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Induration
Clinical narrative: 24 hours after immunization mother states pt whining, agitated, anorexia, Temp 99 degrees (A) on 7/8/13 at 9:00 pm mother gave pt 1 teasp Children's ADVIL. 7/10/13 WCC at PCP - it was noted: (1) Left arm anterior deltoid hypererythema (not endurated) measured 10cm x 9 cm (2) Left arm more distal hypererythemia with discrete in duration measured 1.5 cm x 1.5 cm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient presented 3 days after vaccine administration with redness, warmth, swelling and pain to (L) arm. Pt. placed on 7 day regimen of KEFLEX.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Induration, Malaise, Pyrexia, Swelling
Clinical narrative: On return from doctor's office didn't feel well 1 hr later started with fever Tmx 102 degrees. Mom gave ibuprofen and she vomited 10 min later, and has vomited twice since. No diarrhea, no rash; does have hard swelling about size of dime and tender, no increased redness/heat positive headache with "swollen temples" at 3-4 pm until went to bed; this am temples not swollen but still had mild headache. Fever lasted 24 hrs, general malaise x 3 days.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness, Vomiting
Clinical narrative: On return from doctor's office didn't feel well 1 hr later started with fever Tmx 102 degrees. Mom gave ibuprofen and she vomited 10 min later, and has vomited twice since. No diarrhea, no rash; does have hard swelling about size of dime and tender, no increased redness/heat positive headache with "swollen temples" at 3-4 pm until went to bed; this am temples not swollen but still had mild headache. Fever lasted 24 hrs, general malaise x 3 days.
Age: 24.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Disorientation, Dizziness, Incoherent
Clinical narrative: Pt received Hep B, MMR, and PPD skin test. After receiving vaccines, pt began looking through personal folder in chair. Pt states to nurse "I feel light-headed." Pt became disoriented and incoherent. Pt assisted to reclining chair her feet elevated above heart. Pt became responsive later, and oriented person, time, and place. Pt given bottle of water, cheese/peanut butter crackers, and cool compress placed to forehead/neck. Pt monitored for 25 minutes B/P 115/72 HR = 72.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 45 year-old male subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 02 April 2011. The subject had received the following other vaccines on 22 March 2011: TYPHIM VI (sanofi pasteur SA, lot number, route and site of administration not reported), Anthrax vaccine (other manufacturer; lot number, route and site of administration not reported), and Hepatitis B vaccine (other manufacturer; lot number, route and site of administration not reported). The subject experienced acute myocardial infarction (subendocardial infarction) and acute myocardial infarction (unspecified site) at 27 days post-vaccination of ACAM2000 on 29 April 2011. The Troponin I result, ECG and Echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were also not available. The subject's past medical history records were not retrievable. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 45 year-old male subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 02 April 2011. The subject had received the following other vaccines on 22 March 2011: TYPHIM VI (sanofi pasteur SA, lot number, route and site of administration not reported), Anthrax vaccine (other manufacturer; lot number, route and site of administration not reported), and Hepatitis B vaccine (other manufacturer; lot number, route and site of administration not reported). The subject experienced acute myocardial infarction (subendocardial infarction) and acute myocardial infarction (unspecified site) at 27 days post-vaccination of ACAM2000 on 29 April 2011. The Troponin I result, ECG and Echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were also not available. The subject's past medical history records were not retrievable. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL
Symptoms: Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 19 year-old male subject with no significant past medical history had received the following vaccines on 16 September 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax (other manufacturer; lot number, route and site of administration not reported), Hepatitis A (other manufacturer; lot number, route and site of administration not reported), and Hepatitis B (other manufacturer; lot number, route and site of administration not reported). The subject experienced encephalitis following immunization procedures at 8 days post-vaccination on 24 September 2009. The Troponin I result, ECG and Echocardiogram were not performed. Lumbar puncture and MRI of the brain, spinal cord and heart were also not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 20 year-old male subject with a past medical history of shortness of breath was found to have acute pericarditis unspecified 11 days after the subject had received the following vaccines on 08 July 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), and Anthrax I (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 05 July 2013. A 20 year-old male subject with a past medical history of shortness of breath was found to have acute pericarditis unspecified 11 days after the subject had received the following vaccines on 08 July 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), and Anthrax I (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm had swelling from deltoid/tricep (back) area down to elbow, redness, soreness, and heat were noted. Symptoms began to decrease (redness, swelling, pain) as of 7-12-13 after ice application and OTC BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Amnesia, Nervous system disorder, Psychiatric symptom, Tachycardia, Visual impairment
Clinical narrative: This spontaneous report as received from the patient's mother refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (Lot # not provided) (dose, route and frequency not reported). No other co-suspects were reported. No concomitant therapy was reported. The patient's mother reported that on an unknown date the patient experienced has been suffering "central nervous system adverse event" after vaccination with GARDASIL. The patient experienced psychiatric events, tachycardia, memory loss and vision problems. The outcome of central nervous system adverse events, vision problems, memory loss, tachycardia and psychiatric events was unknown. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling to injection site several hours after vaccine placement. Treated with MOTRIN, BENADRYL, ice packs.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old female patient, started (Merck) VARIVAX, 0.5 ml once Lot number 0331AA is an invalid not number for VARIVAX (Merck) (expired date 07-MAR-2013) (site unspecified), on 08-JUL-2013 for an unknown indication. On the same date, the patient was also vaccinated with measles virus vaccine live (unspecified) and mumps virus vaccine live (site unspecified). The patient's relevant medical history was "unremarkable". She had no relevant concomitant medications: her past drug history was unknown. On 08-JUL-2013, the patient was inadvertently vaccinated with expired product. It was unknown if there was any relevant laboratory data. As of 08-JUL-2013, the patient would not continue VARIVAX (Merck). The outcome of receiving an expired product was unknown, and it was unknown if the patient has been revaccinated. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 74 year old female patient. On 06-JUL-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # reported as H012459, expiration date 14-APR-2014) SQ. The pharmacist reported that on 07-JUL-2013, the patient developed 4 inch red area developed around the injection site that swelled into two lumps an inch deep. The pharmacist stated that the area was not a rash but an area that was swollen, red and warm. The patient did not receive treatment for the adverse events. There were no Lab/diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from an other health professional refers to a 13 month old male patient. On 01-MAY-2013 the patient was vaccinated with the first dose of VARIVAX (dose not reported, lot # H018457, expiration date: 05-OCT-2017 subcutaneously, (SQ), in right thigh (RT)). On 01-MAY-2013 the patient experienced localized redness, large area of swelling 6 x 8cm, very hard and hot and therapy with VARIVAX was not reported. This is one of several reports received from the same source (related MARRS # 1306USA008688). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare student in pharmacy refers to a patient of unknown gender and age. Medical history was not provided. On 27-JUN-2013 the patient was vaccinated with ZOSTAVAX with valid lot # 672932/0599AE and expiration date 22-JUN-2013. Concomitant medication was not provided. On 27-JUN-2013, the patient received expired dose of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Blood glucose normal, Dizziness, Fatigue, Pallor, Somnolence
Clinical narrative: 11am: HPV vaccine IM (L arm) - immediately she felt faint; dizzy, got pale and fell sleep. BP = 114/70; PR = 80. ACCUCHECK 90. 12 noon: Pt sitting up still tired; awake and felt better.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HPV4
Symptoms: Blood glucose normal, Dizziness, Fatigue, Immediate post-injection reaction, Somnolence
Clinical narrative: 11am: HPV vaccine IM (L arm) - immediately she felt faint; dizzy, got pale and fell sleep. BP = 114/70; PR = 80. ACCUCHECK 90. 12 noon: Pt sitting up still tired; awake and felt better.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old male patient. No medical history provided. On 06-JUN-2013 the patient was vaccinated with VAQTA (lot # H010437, exp date: 28-FEB-2015). No concomitant medications were reported. On 06-JUN-2013 the patient was vaccinated with improperly stored vaccine. No adverse events were reported. Additional information has been requested.
Age: 0.73
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 month old male patient. No medical history provided. On 06-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (lot # H011183 exp date: 31-JAN-2015). No concomitant medications were reported. On 06-JUN-2013 the patient was vaccinated with improperly stored vaccine. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX ("single dose"). No concomitant medications were provided. On an unknown date the patient experienced shingles. The outcome of shingles was reported as recovering. The patient sought medical attention by visiting a doctor. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Blister, Oedema peripheral, Secretion discharge
Clinical narrative: Varicella vaccine given 7/1/13. Pt called 7/2/13 evening with arm swollen. Pt went to Dr (walk-in clinic) on 7/3/13. Prescribed BACTRIM and BENADRYL (Poss. cellulitis or allergic rxn). Arm blistered and drained.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Rash, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to 3 patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. On an unknown date the 3 patients experienced large rashes in diameter, swollen and warm to touch, kind of look liked cellulites. The outcome of large rashes in diameter, swollen and warm to touch, kind of look liked cellulites was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia oral, Pruritus, Throat tightness
Clinical narrative: 7/3 eve of Inj. - numbness of lip, itching on upper right leg and testicular area, also on palms of hand, 7/5 chest and throat tightness with difficulty breathing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pharyngeal oedema, Rash, Swollen tongue
Clinical narrative: Shortness of breath, swelling of the tongue and throat, rash.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 8 day old patient with unknown gender. Relevant medical history and concomitant medication were not provided. ON 04-JUN-2013 the patient was vaccinated with RECOMBIVAX HB dose 1, 5 Microgram, intramuscular. Lot number was not provided. On 09-JUN-2013, 6 days after onset of therapy, the patient was vaccinated with RECOMBIVAX HB dose 2, 5 Microgram, intramuscular. Lot number was not provided. No adverse events were known. The reporter considered an 8 day old infant received a 2nd dose of RECOMBIVAX HB 5 mcg on 06/09/2013 to be not related to RECOMBIVAX HB. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician regarding a male patient of unknown age with atrial fibrillation and with no drug reactions or allergies. On an unknown date (reported as "on a Friday") the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies were reported. Concomitant medications included warfarin (manufacturer unknown). The patient returned to the physician's office on an unknown date (reported as "the following Tuesday") with a significant varicella-like rash. The rash was present on the patient's trunk area and both axillary and post-axillary areas on the same side. The outcome for varicella-like rash was unknown at the time of the report. The patient was prescribed with VALTREX and gabapentin to treat his symptoms. No laboratory diagnostic studies were performed. The physician did not assess the causality between ZOSTAVAX and varicella-like rash. A VZVID packet was sent. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated in error with a dose of ZOSTAVAX (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Burning sensation, Syncope
Clinical narrative: After MENACTRA client was "OK" then MMR, RN explained it would burn. Client said it did and approx 15 sec. client fainted - hanging over side of chair. Client did not report till after event but said he fainted twice when given blood.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: 7x8 cm red hot area surrounding center of DTap injection developed 48 hr post injection.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 0.18
Sex: F
Vaccine: RV1
Symptoms: Blood test abnormal, Diarrhoea, Haematochezia
Clinical narrative: Small amount of blood in stool after 2m immunization. Baby was given ROTARIX. 6 days prior to blood with loose stool.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Rash/red spots all over and spreading.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Rash erythematous, Skin plaque
Clinical narrative: Significant local reaction right upper lateral arm 10 x 10 cm erythematous plaque. 4 bullae 2 cm in length each.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Cl came down w/shingles 6/13 after receiving Zostavax 12/07.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) arm baseball size swelling, pain, erythema - after MMR and DTAP placed, resolving when seen 7/12/13.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Rash generalised
Clinical narrative: 7/13/13 1030 am (R) leg at site of injection, to ER, received Rx for BENADRYL. 7/14/13 1 am back to ER for swollen (R) leg and rash on body. Received steroid shot and BENADRYL and new Rx for steroids.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, PPV, TDAP
Symptoms: Feeling hot, Pyrexia, Rash erythematous
Clinical narrative: Clients mthr TC to this nrsg supervisor at 2:05 pm on 7/16/13 to report: "Client developed fever but she did not have a thermometer to take his temp, but he felt very hot, as well as developed pink 1/2" rash (L) arm. Mother gave client Ibuprofen with some improvement. Onset sympt at 8 pm on 7/15/13".
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: DTaP-IPV portion of Pentacel given instead of Daptacel.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling and erythema.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception.
Age: 1.03
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Rash-2-3mm pink, blanching macular rash distributed over trunk and head. Pink irregular raised blanching patches of variable size on left upper shoulder, left trunk and left waist. Nonpruritic.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis surrounding injection site within 24 hours of receiving vaccine.
Age: 0.15
Sex: M
Vaccine: HEP
Symptoms: Dermatitis diaper, Diarrhoea, Flatulence, Irritability, Pyrexia
Clinical narrative: Child presented with diarrhea, fever, gas, vomiting, diaper rash and extreme fussy behavior within an hour of receiving vaccination. Symptoms still present 24+ hours later.
Age: 0.15
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Child presented with diarrhea, fever, gas, vomiting, diaper rash and extreme fussy behavior within an hour of receiving vaccination. Symptoms still present 24+ hours later.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 85 years old female patient with no pertinent medical history and with no drug reactions/allergies. On an unknown date the patient was vaccinated with the second dose of ZOSTAVAX dose, route of administration not provided. In April 2013 (reported as "2 months ago") the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention via speaking to the pharmacist. The outcome of adverse event was reported as recovering/resolving. The relatedness for ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Clients reports noting 1 inch line of small fluid filled blisters on Rt arm where MMR was given yesterday, also note Lt arm had 1 inch C shaped reddened area where Varicella was placed. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site swelling, Injection site warmth, Pain, Urticaria
Clinical narrative: Swelling, heat coming from injection site, painful welt.
Age: 0.42
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Diarrhoea, Vomiting
Clinical narrative: Vomitting, Diarrhea, and Crying without cause.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Dyskinesia, Muscle twitching, Pallor, Syncope
Clinical narrative: Approx 5 min after imm were administered client reports feeling "light headed", color pale. Had syncope episode on way to assisting client to lying position. Noted slight twitching or mild jerking as client became unresponsive for approx 10 seconds. Legs elavated. Color returned. BP 120/80. left in supine position for approx 15 min. Assisted to sitting position, BP remined 120/80. Ambulated out of facility per self accompanied by Mom.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx 5 min after imm were administered client reports feeling "light headed", color pale. Had syncope episode on way to assisting client to lying position. Noted slight twitching or mild jerking as client became unresponsive for approx 10 seconds. Legs elavated. Color returned. BP 120/80. left in supine position for approx 15 min. Assisted to sitting position, BP remined 120/80. Ambulated out of facility per self accompanied by Mom.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Rash vesicular, Varicella, Varicella virus test
Clinical narrative: Developed mild vesicular rash, presumed mild varicella with lymphadenopathy of the posterior auricular glands.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: Patient developed absolutely classic itchy rash consistent with chickenpox (varicella), complete with a "dewdrop on a rose petal". I was advised to submit this VAER by our infectious disease department.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: Possible seizure.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Infant cried inconsolably for 1 and 1/4 hours.  Developed indurated, tender, mildly erythematous 2 cm nodule at site of pentacel injection in right thigh.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Pt was admitted to hospital on 6/21/2013 to 6/24/2013. Pt had intussusception and no surgery was needed.
Age: 0.19
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Hard lump in leg, it is still there two weeks later.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Fear, Hallucination, Nightmare
Clinical narrative: Patient was hallucinating that there were bugs crawling on him and were around him. He was crying and scared. He kept trying to wipe them off and push them away. Had nightmares about bugs that night too.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Cytogenetic analysis, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 25 years old female patient for VARIVAX (Merck), a Pregnancy Registry product, concerning vaccine exposure during pregnancy. The patient was "5 and 1/2 weeks pregnant as of 31-OCT-2012". The patient's history of previous pregnancies and live births is not known. It has been reported that the patient has no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with VARIVAX (Merck) (dose and route not reported, lot number H006950, exp. date 16-MAR-2014) on 23-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an estimated Last menstrual period (LMP) of 22-SEP-2012 and an Estimated Date of Delivery (EDD) of 30-JUN-13. Initial exposure to VARIVAX (Merck) was estimated at 5 week(s). The patient was exposed to VARIVAX (Merck) during trimester 1. On 23-OCT-2012 the patient received VARIVAX (Merck) while pregnant. The patient experienced no adverse event. No treatment information was reported. The outcome of received VARIVAX (Merck) while pregnant was unknown. The relatedness for VARIVAX (Merck) while pregnant and no adverse event was unknown. It has been reported that the patient saw a nurse in regards to the events. This follow-up was received from a Register Nurse who reported the patient had a miscarriage in an approximately December 2012 followed by a D&C (Dilation and Curettage) procedure on 28-DEC-2012. The reporter stated that there were ultrasound, genetic tests and home pregnancy test performed (no results and dates provided). The outcome and relatedness for VARIVAX (Merck) regarding to the patient's events were not reported. Upon internal review, the patient's event of miscarriage was considered to be an other important medical event. Additional information is not expected. 15-JUL-2013. This is a correction. The 'as reported causality' for the event of drug exposure during pregnancy was updated to 'not related'.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Uterine dilation and curettage
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 25 years old female patient for VARIVAX (Merck), a Pregnancy Registry product, concerning vaccine exposure during pregnancy. The patient was "5 and 1/2 weeks pregnant as of 31-OCT-2012". The patient's history of previous pregnancies and live births is not known. It has been reported that the patient has no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with VARIVAX (Merck) (dose and route not reported, lot number H006950, exp. date 16-MAR-2014) on 23-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an estimated Last menstrual period (LMP) of 22-SEP-2012 and an Estimated Date of Delivery (EDD) of 30-JUN-13. Initial exposure to VARIVAX (Merck) was estimated at 5 week(s). The patient was exposed to VARIVAX (Merck) during trimester 1. On 23-OCT-2012 the patient received VARIVAX (Merck) while pregnant. The patient experienced no adverse event. No treatment information was reported. The outcome of received VARIVAX (Merck) while pregnant was unknown. The relatedness for VARIVAX (Merck) while pregnant and no adverse event was unknown. It has been reported that the patient saw a nurse in regards to the events. This follow-up was received from a Register Nurse who reported the patient had a miscarriage in an approximately December 2012 followed by a D&C (Dilation and Curettage) procedure on 28-DEC-2012. The reporter stated that there were ultrasound, genetic tests and home pregnancy test performed (no results and dates provided). The outcome and relatedness for VARIVAX (Merck) regarding to the patient's events were not reported. Upon internal review, the patient's event of miscarriage was considered to be an other important medical event. Additional information is not expected. 15-JUL-2013. This is a correction. The 'as reported causality' for the event of drug exposure during pregnancy was updated to 'not related'.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and low grade fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, itching, stinging, heat to touch at injection site. Right posterior upper arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Oral discomfort, Rash, Throat irritation
Clinical narrative: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR # 320872) concerning a 13 year old female patient. The patient's medical history included allergy to KEFLEX and idiopathic anaphylaxis with shellfish. On 27-MAY-2013, the patient was vaccinated with a second dose of intramuscular GARDASIL (dose and lot number were not provided). On 27-MAY-2013, 30 minutes later the patient felt faint and had a rash on the arm. Lips and throat were hot. The patient self-administered ZYRTEC. Ambulance was called and the patient was transferred to hospital, was observed and discharge. On 27-MAY-2013, the patient recovered from the adverse events. The adverse events were possible related to GARDASIL by the reporter. The original reporting source was State/Territory health department. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Hive rash = 1-2 days after vaccine administration.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Blood test, Full blood count, Local swelling, Red blood cell sedimentation rate
Clinical narrative: Patient at office 4/5/2013 for booster of Tetanus. Td administered to left deltoid IM. Given vaccine due to allergy to pertussis. Pt. seen at ER 4/8/2013 due to arm pain and swelling. Pt. also seen at office blood work done on 4/08/2013.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Full blood count abnormal, Haemoglobin normal, Petechiae, Platelet count decreased, Platelet morphology abnormal
Clinical narrative: Started having petechiae on 7/2/13. Brought in for evaluation on 7/5/13 had platelet count of 2,000.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Pt pregnant at time of vaccinations 7/08 unknown to PCP. 7/16 mom came to tell PCP of pregnancy.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old male patient. On an unknown date the patient was vaccinated with 3 vaccination on one day: Hib (manufacturer unknown), Hep A (manufacturer unknown) and PREVNAR 13. The description of the adverse event was: 24 hours after vaccination the patient developed hives on his trunk, face and legs. The outcome of hives on his trunk, face and legs is unknown. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. On 01-JUL-2013 the patient was vaccinated with the first dose of ROTATEQ (Lot# and dose not reported) oral. No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date in June 2012 (reported as approximately one year ago) the patient was vaccinated with second dose of GARDASIL (dose, lot number and route of administration were not reported). On 18-JUN-2013 the patient was in the office to receive her 3rd 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 was received from a licensed practical nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On 02-JUL-2007, the patient was vaccinated with the first dose of GARDASIL  (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not reported. The licensed practical nurse stated that on 19-JUN-2013, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 11-JUL-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot# unspecified, expiry: 20-MAR-2013), 0.65 ml, subcutaneously. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTP, FLUX, HPV4
Symptoms: Fall, Scratch, Syncope
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a 13 year old female patient with no known drug reactions/allergies. On an unknown date the patient was vaccinated with GARDASIL lot # H017698 dose 2 (site and dose not specified). The patient had not eaten before being administered the vaccine. Concomitant  therapies included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (manufacturer unknown), influenza virus vaccine (manufacturer unknown) and tuberculin purified protein derivative (PPD). On 28-JUN-2013 the patient fainted after receiving GARDASIL. After falling, the patient developed a little scratch on her face or head area. The patient was given oxygen, elevated her legs and provided a sugar popcicle. No lab diagnostic tests were performed. The event occurred during an office visit. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB. Lot number 1520Z. Dose, route and frequency were not provided. On 14-JUN-2013, the patient was vaccinated with RECOMBIVAX which expired on 04-MAY-2013. The patient did not experience an adverse event. The outcome of vaccinated on 14-JUN-2013 with RECOMBIVAX which expired on 04-MAY-2013 and no adverse event was unknown. The reporter considered vaccinated on 14-JUN-2013 with RECOMBIVAX which expired on 04-MAY-2013 and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, C-reactive protein, Diplegia, Dyspnoea, Facial pain
Clinical narrative: Case number PHHY2013US056693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486919) website on 05 Jun 2013 with the follow-up received from Quality Assurance Department (reference number: 234094) on 11 Jul 2013. This report refers to a 48 year-old female patient. Her medical history included aortic valve disease bicuspid and her concomitant medications included verapamil. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in the right arm on 02 Oct 2012. Two weeks after vaccination, she experienced pain and tingling at knees which progressed to arm and face. She visited emergency department. It was reported that she was hospitalized twice on 22 Oct 2012 for three days and on 3 Dec 2012 for three days. It was reported that she also experienced breathing difficulty but was not ever intubated. She also experienced paralysis in arms. Lab tests such as magnetic resonance imaging (MRI), lumbar puncture, sedimentation rate and C-reactive protein (CRP) were performed, but the results were not reported. The final outcome was reported as condition unchanged. The causality was not reported. Based on the batch review report received from the QA department on 11 Jul 2013, it was concluded that the concerned FLUVIRIN (batch number: 1204521) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow-up received from the Quality Assurance Department on 11 Jul 2013: Updated batch review report.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Case number PHHY2013US056693, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486919) website on 05 Jun 2013 with the follow-up received from Quality Assurance Department (reference number: 234094) on 11 Jul 2013. This report refers to a 48 year-old female patient. Her medical history included aortic valve disease bicuspid and her concomitant medications included verapamil. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in the right arm on 02 Oct 2012. Two weeks after vaccination, she experienced pain and tingling at knees which progressed to arm and face. She visited emergency department. It was reported that she was hospitalized twice on 22 Oct 2012 for three days and on 3 Dec 2012 for three days. It was reported that she also experienced breathing difficulty but was not ever intubated. She also experienced paralysis in arms. Lab tests such as magnetic resonance imaging (MRI), lumbar puncture, sedimentation rate and C-reactive protein (CRP) were performed, but the results were not reported. The final outcome was reported as condition unchanged. The causality was not reported. Based on the batch review report received from the QA department on 11 Jul 2013, it was concluded that the concerned FLUVIRIN (batch number: 1204521) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow-up received from the Quality Assurance Department on 11 Jul 2013: Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Head discomfort, Laboratory test normal, Musculoskeletal stiffness, Pain
Clinical narrative: Case number PHHY2013US056737 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 487747) web site on 05 Jun 2013, and with a follow up report received from QA department (QA reference number: 234080) on 11 Jul 2013. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included adsorbed tetanus toxoid on an unspecified date. She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into right arm on 05 Jan 2013. On 07 Jan 2013, 48 hours after vaccination, she experienced heavy/stiff feeling at the base of the skull and throbbing jaw pain. She went to emergency room on unspecified date. It was reported that the symptoms subsided after 3 to 4 weeks, but returned and persisted till date of reporting. She also had large hematoma on arm which continued for 3 to 4 weeks. There was no fever. Diagnostic lab tests were done and meningitis was ruled out. The outcome of the events was reported as condition unchanged. The causality was not reported. Based on the batch review report received from the QA department on 11 Jul 2013, it was concluded that this product FLUVIRIN batch number 1206801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 11 Jul 2013. Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in jaw
Clinical narrative: Case number PHHY2013US056737 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 487747) web site on 05 Jun 2013, and with a follow up report received from QA department (QA reference number: 234080) on 11 Jul 2013. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included adsorbed tetanus toxoid on an unspecified date. She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into right arm on 05 Jan 2013. On 07 Jan 2013, 48 hours after vaccination, she experienced heavy/stiff feeling at the base of the skull and throbbing jaw pain. She went to emergency room on unspecified date. It was reported that the symptoms subsided after 3 to 4 weeks, but returned and persisted till date of reporting. She also had large hematoma on arm which continued for 3 to 4 weeks. There was no fever. Diagnostic lab tests were done and meningitis was ruled out. The outcome of the events was reported as condition unchanged. The causality was not reported. Based on the batch review report received from the QA department on 11 Jul 2013, it was concluded that this product FLUVIRIN batch number 1206801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 11 Jul 2013. Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Laboratory test normal, Musculoskeletal stiffness, Pain in jaw, Sensation of heaviness
Clinical narrative: Case number PHHY2013US056737 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 487747) web site on 05 Jun 2013, and with a follow up report received from QA department (QA reference number: 234080) on 11 Jul 2013. This report refers to a 64-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included adsorbed tetanus toxoid on an unspecified date. She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into right arm on 05 Jan 2013. On 07 Jan 2013, 48 hours after vaccination, she experienced heavy/stiff feeling at the base of the skull and throbbing jaw pain. She went to emergency room on unspecified date. It was reported that the symptoms subsided after 3 to 4 weeks, but returned and persisted till date of reporting. She also had large hematoma on arm which continued for 3 to 4 weeks. There was no fever. Diagnostic lab tests were done and meningitis was ruled out. The outcome of the events was reported as condition unchanged. The causality was not reported. Based on the batch review report received from the QA department on 11 Jul 2013, it was concluded that this product FLUVIRIN batch number 1206801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 11 Jul 2013. Updated batch review report.