chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified amount of patients (demographics unknown). On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medication was not reported. On unknown dates, the patients received their GARDASIL series off schedule. No adverse effect reported. This is one of two cases from the same reporter (MARRS# 1402USA008471). Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: Screaming x 4 hours and inconsolable.
Age: 58.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash around eyes.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Feeling hot, Swelling face, Urticaria
Clinical narrative: Face became hot with facial swelling; hives. (+) cough, without shortness of breath.  Advised to report to ER, (7:20 PM), at which time symptoms had already begun to subside.  Took 1 dose of Benadryl after leaving ER (10:00 PM).  Shortly after, symptoms completely dissipated.  Next day, when seen in office, no residual effect.
Age: 0.12
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 6 week old patient was given vaccinations that he was not due for. MMR, Hep A and Varicella.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Coughing, body aches, headache, mild soreness at site, fatigue, nausea, diarrhea--started few hours after receiving vaccine, and have gotten worse. Took Ibuprofen Q4hrs with no relief of aches or fever. Had to call in sick to work today. Very unusual for client, she states.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Coughing, body aches, headache, mild soreness at site, fatigue, nausea, diarrhea--started few hours after receiving vaccine, and have gotten worse. Took Ibuprofen Q4hrs with no relief of aches or fever. Had to call in sick to work today. Very unusual for client, she states.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Haematochezia, Infantile spitting up, Irritability
Clinical narrative: New onset of: Fussiness, poor feeding, mucousy diarrhea, blood in stool; frequent spitting up. Ongoing > 4 weeks.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Weight gain poor
Clinical narrative: New onset of: Fussiness, poor feeding, mucousy diarrhea, blood in stool; frequent spitting up. Ongoing > 4 weeks.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Carpal tunnel syndrome, Fatigue, Hypoaesthesia, Injection site pain
Clinical narrative: After shot while driving to work I had tingling in my fingertips.  The next day I had pain at injection sight,  Pain in my elbow.  the following day I had numbness and pain in my inection arm hand and all fingers.  Now I have numbness in every finger but pinky and pain that has been bad enough to cause me to go to emergency room.  Also, I was bone tired for the first 3-weeks after the injection.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: After shot while driving to work I had tingling in my fingertips.  The next day I had pain at injection sight,  Pain in my elbow.  the following day I had numbness and pain in my inection arm hand and all fingers.  Now I have numbness in every finger but pinky and pain that has been bad enough to cause me to go to emergency room.  Also, I was bone tired for the first 3-weeks after the injection.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site pain, Muscle twitching, Nausea
Clinical narrative: Twitching muscles at collar bone for aprox. 10 min followed by onset of fever of 102.  Arthralgias, headache, nausea, pain radiating from injection site that grew worse as day went on with most severe pain at ~26-30 hours after injection.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Twitching muscles at collar bone for aprox. 10 min followed by onset of fever of 102.  Arthralgias, headache, nausea, pain radiating from injection site that grew worse as day went on with most severe pain at ~26-30 hours after injection.
Age: 39.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: Tdap vaccine was administered after expiration date on 20OCT13. No signs or symptoms vaccine readministered.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Pruritus, Rash erythematous
Clinical narrative: Patient woke up at approximately 1 AM complaining of joint pain.  She was sent back to bed by parent.  At approximately 7 AM she again awoke, this time complaining of an itchy back.  Upon further inspection a rash was found on her trunk area (both front and back), the left side of her face and on the upper half of the front of her thighs.  Rash was most severe on back of trunk.  Rash appeared as red, raised pinpoints.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient was taking a nap, mom noticed that she woke up but was having a seizure. She did have a fever of 101.0.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: Pt was administered Tdap Vaccine on 19NOV13 that expired on 20OCT13. Pt educated vaccine readministered. Pt had no signs or symptoms.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: Pt was administered Tdap Vaccine on 19NOV13 after it expired on 20OCT13. Pt educated no signs or symptoms. Vaccine readministered.
Age: 30.0
Sex: M
Vaccine: HPV4, TDAP, YF
Symptoms: Expired drug administered
Clinical narrative: Patient was administered a vaccine of Tdap. Expiration 10/20/2013 and was administered on 11/19/2013.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after receiving MMR, varicella, Dtap, in combination vaccines in clinic, patient developed hives on face and back. Pt received BENADRYL and ORAPRED and monitored for 1 1/2 hours - hives resolved completely.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: 1 day after PNEUMOVAX (R) arm, developed pain and swelling (R) arm with redness.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9 AM 2/14/14 Mother called HD. Mother stated child had imm 2 day ago. Left arm now red, hot to touch and size of tennis ball. Advised to call pediatrician.
Age: 1.25
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Abnormal behaviour, Blood glucose decreased, Feeling abnormal, Malaise, Staring
Clinical narrative: This child came in for a well visit on 12/19/2013 and after his exam was given immunizations, PREVNAR, Hep A and Flu at about 10:00 AM. Mom called during lunch hour to report that she had driven to another city and back (about 30 minutes away) with child in car seat in back. When she got home he was sleeping and did not wake up when she took him out of the car. She was then able to wake him but he was dazed and not responding to her. She had already called 911 and paramedics were at the house when Nurse spoke with her. Paramedics reported his vital signs were good. We advised her to have his blood sugar checked and bring him to the emergency department for evaluation. Blood sugar was 68 per EMT at home. He did become more alert after given some juice and was observed and discharged from Emergency Department. There was no fever. Patient was seen in our office on 12/23/2013 for an illness and mom reported no further abnormal behavior. Mom called back on 01/08/2014 and stated more episodes of unusual behavior-staring and not responding to her. The episodes last several minutes and between episodes, behavior is normal with no regression. We are in the process of referring him to a Pediatric Neurologist for further evaluation.
Age: 1.25
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: This child came in for a well visit on 12/19/2013 and after his exam was given immunizations, PREVNAR, Hep A and Flu at about 10:00 AM. Mom called during lunch hour to report that she had driven to another city and back (about 30 minutes away) with child in car seat in back. When she got home he was sleeping and did not wake up when she took him out of the car. She was then able to wake him but he was dazed and not responding to her. She had already called 911 and paramedics were at the house when Nurse spoke with her. Paramedics reported his vital signs were good. We advised her to have his blood sugar checked and bring him to the emergency department for evaluation. Blood sugar was 68 per EMT at home. He did become more alert after given some juice and was observed and discharged from Emergency Department. There was no fever. Patient was seen in our office on 12/23/2013 for an illness and mom reported no further abnormal behavior. Mom called back on 01/08/2014 and stated more episodes of unusual behavior-staring and not responding to her. The episodes last several minutes and between episodes, behavior is normal with no regression. We are in the process of referring him to a Pediatric Neurologist for further evaluation.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: Child developed rash RLE approximately 38 days post vaccines including VARIVAX - seen by pediatric dermatologist and lab testing confirmed varicella. Unable to reach parents for completion of form, client new to current pediatrician.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Rash papular
Clinical narrative: Child developed rash RLE approximately 38 days post vaccines including VARIVAX - seen by pediatric dermatologist and lab testing confirmed varicella. Unable to reach parents for completion of form, client new to current pediatrician.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Full blood count normal, HIV test negative, Injection site induration, Injection site plaque, Injection site reaction
Clinical narrative: Child developed rash RLE approximately 38 days post vaccines including VARIVAX - seen by pediatric dermatologist and lab testing confirmed varicella. Unable to reach parents for completion of form, client new to current pediatrician.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash papular, Varicella virus test positive
Clinical narrative: Child developed rash RLE approximately 38 days post vaccines including VARIVAX - seen by pediatric dermatologist and lab testing confirmed varicella. Unable to reach parents for completion of form, client new to current pediatrician.
Age: 23.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Injection site rash
Clinical narrative: Rash appeared around injection site within 48 hours of administration. Triamcinolone 0.1% cream prescribed. Rash cleared up within 30 days of initial vaccination.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Convulsion, Diarrhoea
Clinical narrative: 2/5/14 - Shots given in the office PM 2/6/14 - Convulsions at home, went to ER and temp of > 104.5 degrees F around PM 2/10/14 - F/U in the office. T 101.7 F, (+) diarrhea.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted after shot. Monitor in office for 20 minutes.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Extreme edema in arm to wrist and down leg. MD prescribed BENADRYL. Patient advised pharmacist of reaction 02/13/14 at noon.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Nausea, Pyrexia
Clinical narrative: Nausea, fever 100.5 degrees F, swollen arm.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test, Dizziness, Electromyogram, Fatigue, Hypoaesthesia
Clinical narrative: Dizziness, extreme fatigue/lethargy, muscle numbness and muscle fasiculations.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Muscle contractions involuntary, Nuclear magnetic resonance imaging
Clinical narrative: Dizziness, extreme fatigue/lethargy, muscle numbness and muscle fasiculations.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash occurred after varicella injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injection site. Soreness at inject site. Swelling and itching at injection site size of palm of hand.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left anterior/medial thigh with large area of erythema and warmth it measures 11.5 cm in diameter by 14 cm in length at greatest dimensions. Non tender, but itching.
Age: 1.24
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erosion, Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: Four inch wheal and flared area bilateral thighs. Indurated, excoriated, non tender at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient received FLUVIRIN IM right arm 11/18/13. Reported tingling in wrist (right) immediately. Experiencing tingling, pain the length of right arm, right scapular pain, underarm soreness. No rash, redness or fever.
Age: 25.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: After flu shot was given, patient said he felt dizzy then fell off the chair unconscious. Patient was responsive after about 1 min. 911 team came and did further assessment. The emergency response team said he was ok and no further treatment was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-FEB-2014 the patient was vaccinated with ROTATEQ (dose, strength and route were not reported) dose 1. Co-suspect and concomitant therapies were not reported. The medical assistant reported that on 04-FEB-2014, the patient received a dose 1 of ROTATEQ (that was improperly stored). No adverse effects reported. These case is linked to MARRS # 1402USA005231 by the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Noticed large area of erythema around injection site 24 hrs after given. Eval in clinic 48 hours after injection revealed 6 x 8 cm rea of erythema and induration around injection site.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen area, 4" x 3", warm to the touch at the injection site. Headache - relieved by ibuprofen. Symptoms persist to current date although greatly improved - a "pea-sized" area and although headache persists ibuprofen not needed.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: After receiving vaccine patient experienced a severe headache, insomnia and extreme fatigue that would not go away x 24 hours. H/A and fatigue continued x 1 week.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 04-FEB-2014 the patient was vaccinated with the third dose of oral ROTATEQ (dose, strength, and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that on 04-FEB-2014, the patient received the third dose of oral ROTATEQ that was improperly stored. No adverse effects reported. These case is linked to MARRS # 1402USA003353 by the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 74 year old female patient with sulfa allergy. The patient's medical history included chickenpox as a child. On 21-JAN-2009 the patient was vaccinated with ZOSTAVAX (lot # 663639/1707X, expiration date 26-MAY-2010) (dose and route were not reported) for vaccination. There were not concomitant medications. The nurse practitioner reported that, on 14-FEB-2014, patient developed shingles following vaccination with ZOSTAVAX. The nurse practitioner described the shingles as a maculopapular rash on the right flank, which was the patient's first case of shingles. No lab diagnostics studies were performed. Patient received FAMVIR as treatment for the adverse event. Patient sought medical attention: contacted nurse practitioner. The outcome of shingles was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Decreased immune responsiveness
Clinical narrative: This spontaneous report as received from a 39 year old female consumer who was a other health professional regarding herself. Patient reported that when she was younger she received one dose of VARIVAX (Merck) (lot #, dose, route of administration not reported). No concomitant therapy was reported. Recently she found that she does not have immunity to VARIVAX (Merck). So, her healthcare provider recommended that she be vaccinated again with VARIVAX (Merck). She got vaccinated again with VARIVAX (Merck) on 07-FEB-2014. The patient sought medical attention. The outcome of event was unknown. The causality of the event with suspect VARIVAX (Merck) was unknown. This case is linked with 1402USA006201 via same patient link. This case is related with 1402USA006289 via same reporter link. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever (100 degrees F). Clear liquids and OTC pain/fever reliever.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Vaccine administered in left deltoid on Jan 27, 2014. That night patient states that her arm started to hurt, became red, hot and hard. Next day went to the ER and was treated for cellulitis of her left arm with antibiotics. After starting antibiotics arm healed completely and has no concerns at this time.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Genital rash, Measles antibody negative, Mumps antibody test positive, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 37 year old female patient. Patient's concurrent conditions included Kidney stones. The patient's medical history included unspecified broken arm (on unspecified date) and measles titer resulted low. The patient received a Measles shot on 15-DEC-1990 and Rubella shot on 05-MAR-1997. On 05-FEB-2014, the patient was vaccinated with MMR II, albumin status HSA, 0.5 ml, subcutaneous (lot # J006995, expiration date: 14-JUN-2015). On an unspecified date in February 2014 (also reported as "5-6 days ago") the patient experienced rash on her chest that was "blistery" and itchy". The reporter stated that the rash spread to the patient "back and arms and down to her genitals". On 15-FEB-2014 (also reported as "two days ago"), the patient was treated with VALTREX (manufacturer unknown). The reporter also reported that prior to receiving the MMR II, the patient had a titer drawn on 03-FEB-2014. She stated that the patient's measles titer results was "low" but that the patient was immune to mumps. No drug reactions and allergies were reported. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 37 year old female patient. Patient's concurrent conditions included Kidney stones. The patient's medical history included unspecified broken arm (on unspecified date) and measles titer resulted low. The patient received a Measles shot on 15-DEC-1990 and Rubella shot on 05-MAR-1997. On 05-FEB-2014, the patient was vaccinated with MMR II, albumin status HSA, 0.5 ml, subcutaneous (lot # J006995, expiration date: 14-JUN-2015). On an unspecified date in February 2014 (also reported as "5-6 days ago") the patient experienced rash on her chest that was "blistery" and itchy". The reporter stated that the rash spread to the patient "back and arms and down to her genitals". On 15-FEB-2014 (also reported as "two days ago"), the patient was treated with VALTREX (manufacturer unknown). The reporter also reported that prior to receiving the MMR II, the patient had a titer drawn on 03-FEB-2014. She stated that the patient's measles titer results was "low" but that the patient was immune to mumps. No drug reactions and allergies were reported. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Later that afternoon swelling, redness and pain noted at injection site.  Area 2.5cm x 5cm (marked with pen), by 12:00 PM next day 2/19/2014 redness and warmth spread to 5cm x 7.5cm.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site occurred after injection. As of 2/19/14, there is still some redness, a slightly raised area and occasional itching at the injection site.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Immediate post-injection reaction, Local swelling
Clinical narrative: Immediate swelling of throat, face, hands. Numbness in arms and legs. Dizziness and fatigue.
Age: 19.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Immediate swelling of throat, face, hands. Numbness in arms and legs. Dizziness and fatigue.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood test, Chest X-ray, Dyspnoea, Rash generalised, Swelling face
Clinical narrative: Rash and hives to left and right arms, neck, back, trunk, and inner thighs. Swelling in face and then had trouble breathing. Went to ER, received steroids and put in hospital (1) day observation.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Rash and hives to left and right arms, neck, back, trunk, and inner thighs. Swelling in face and then had trouble breathing. Went to ER, received steroids and put in hospital (1) day observation.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt reports that he suffered no adverse effects.
Age: 55.0
Sex: F
Vaccine: DTP
Symptoms: Arthralgia, Balance disorder, Blood pressure immeasurable, Decreased appetite, Discomfort
Clinical narrative: When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
Age: 55.0
Sex: F
Vaccine: DTP
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Heart rate increased
Clinical narrative: When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
Age: 55.0
Sex: F
Vaccine: DTP
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Joint stiffness, Lymphadenopathy
Clinical narrative: When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
Age: 55.0
Sex: F
Vaccine: DTP
Symptoms: Nausea, Pain, Pallor, Pyrexia, Respiratory rate increased
Clinical narrative: When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
Age: 55.0
Sex: F
Vaccine: DTP
Symptoms: Skin discolouration, Tremor, Vomiting
Clinical narrative: When given vaccine, shot hurt significantly, and noticed discomfort in raising right arm within 2 hours of getting vaccine.  Slept well night of 2-17-14, but woke up with a bad headache which is atypical.  Took Tylenol.  Went to work, where I sat in a meeting from 8:00 a.m. to 12:45.  Felt very tired, fatigued, and joints hurt and were stiff.  Left to return to school that I am employed at (it was an inservice day).  Did not feel hungry, but since had eaten all day ate cottage cheese, berries, raw carrots, gluten free crackers.  Head ache had returned, and started to become nauseated.  By 2:00 pm feeling very bad:  nauseated, shaking because I was so cold, lymph nodes in neck swollen, joints ached, and very tired.  Co-worker concerned so went and got school nurse.  School nurse came to room around 2:25 pm.  Tried to take BP and couldn't get reading.  I then vomited 4 times (it is very unusual for me to vomit or to run fevers.....typical body temperature around 96 or 97).  Nurse took BP again and got 70/40.  Felt very shaky, looked pale and gray, and not steady on feet.  My son came and got me and took me back to Urgent Care where I had been on 2-17-14 and gotten the vaccine.  Confirmed that I had been given the Tdap.  Blood pressure had risen to 129/59.  Heart rate high for me (resting is typically 60).  It was measured at 79.  Also rate of breathing greatly accelerated, however O2 SATS at 100%.  Blood sugar tested and was at 129.  Due to how busy the clinic was it would of been 1 1/2 to 2 hours before I could of been seen by doctor.  Also told that if it was a vaccine reaction there wasn't anything they could do.  Did not feel I could sit that long due to how bad I felt, so my husband took me home.  Spent entire night in bed, running 100 degree fever.  Did not get sick again, but ate nothing but black tea.  Slept through the night and awoke with headache and body aches, but temp. down to 98.7.  Took bath and Tylenol and went to work at 8:30.  Still feel achy but markedly improved from 2-18-2014.  Injection sight slightly swollen and sensitive to touch, but not overly sore.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Decreased appetite, Mobility decreased, Pyrexia
Clinical narrative: Fever, chills, weakness.  Lasted 3 days (bad enough to not get out of bed or eat).
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Pain
Clinical narrative: Achy, fatigue, diarrhea x 2 days.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Lump to left upper arm around 0.5 mm round.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm on movement. Has not gone away.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Myalgia
Clinical narrative: Localized muscle soreness and pain in area around injection site that has not gone away after 5 months.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Cardiac pacemaker evaluation, Chills, Dyspnoea, Pyrexia
Clinical narrative: Fever, chills and shortness of breath on 02/07, 4 hours after receiving Fluzone High Dose 2013-14 PFS.  Arrhythmia triggered and corrected by pacemaker on 02/08/2014 at 12:30 PM.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV, TD
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea/Vomiting.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Aarm started hurting and I had trouble lifting it.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain when moving her hand (soreness).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient describes arm pain at injection site requiring doctor visit.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain at injection site requiring office visit.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site nodule, Injection site rash
Clinical narrative: Initially had a hard knot at the site now with a rash.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea x 1 day. Starting 12 hours after vaccines.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Dr says the injection site "has always remained itchy" since 1st put in (12/14/13). No lump at site. Topically a little rashy. But the itch is more the irritation. Wants to know when it will stop being itchy.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt. called w/ redness, swelling 4-5 days out and resolved after 8-9 days.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Nervousness
Clinical narrative: Patient is an employee who was administered her 3rd Hep B injection. Injection was tolerated well. About 10 minutes after injection she reported feeling very shaky in her.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: (L) deltoid with 5 x 6 cm erythema, induration and mild pain. No fever.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The night of vacc. admin. patient's arm (Left) started to become red, swollen and warm at site of vacc. Measured 4 inches x 3 inches and was red and indurated. Told to apply cold compress and take Motrin.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant and a physician refers to a patient of unknown age. The patient had no pertinent medical history and no known allergies. ON 17-FEB-2014 the patient was vaccinated with a dose of ROTATEQ (dose, lot # not reported), oral. No concomitant medications. On 17-FEB-2014, patient proceeded to "vomit" the dose up along with breast milk at the office visit. No treatment was given for the event. The outcome of the event was unknown. It was unknown if the patient sought medical attention. The reporter did not provide causality assessment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug allergies or reactions were not reported. On 12-SEP-2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # was not reported). Late on 10-FEB-2014, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (lot # was not reported). Concomitant medication was not reported. No adverse effects reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Raised red blister around injection site, area hot to touch, and painful per patient.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cellulitis, Injection site streaking, Injection site vesicles, Local swelling, Lymphangitis
Clinical narrative: This spontaneous report was received from an medical assistant refers to a 24 year old female patient. No pertinent medical history, drug reactions or allergies were reported. On 11-FEB-2014 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (Invalid lot number reported as J00999, with expiration date: 04-DEC-2015) in the right arm. Concomitant therapies included SPRINTEC. Dose 1 of GARDASIL was administered on an unspecified date. The patient did not have any reaction with dose 1. On 12-FEB-2014, (reported as the following day) the patient experienced blistering and swelling of her right forearm (disability). The swelling had moved up her arm and towards the back of her arm, she was unable to move her arm (disability). A physician saw the patient on 13-FEB-2014 and sent the patient to the emergency room. It was also reported that no treatment was given for adverse event, but sent the patient to emergency room. No lab diagnostic studies were performed. The patient had sought medical attention. It was reported that there was no PQC involved. The reporter had requested for a lot check. The outcome of the events were reported as not recovered. The causality of the event was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from an medical assistant refers to a 24 year old female patient. No pertinent medical history, drug reactions or allergies were reported. On 11-FEB-2014 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (Invalid lot number reported as J00999, with expiration date: 04-DEC-2015) in the right arm. Concomitant therapies included SPRINTEC. Dose 1 of GARDASIL was administered on an unspecified date. The patient did not have any reaction with dose 1. On 12-FEB-2014, (reported as the following day) the patient experienced blistering and swelling of her right forearm (disability). The swelling had moved up her arm and towards the back of her arm, she was unable to move her arm (disability). A physician saw the patient on 13-FEB-2014 and sent the patient to the emergency room. It was also reported that no treatment was given for adverse event, but sent the patient to emergency room. No lab diagnostic studies were performed. The patient had sought medical attention. It was reported that there was no PQC involved. The reporter had requested for a lot check. The outcome of the events were reported as not recovered. The causality of the event was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blister, Injected limb mobility decreased, Local swelling
Clinical narrative: This spontaneous report was received from an medical assistant refers to a 24 year old female patient. No pertinent medical history, drug reactions or allergies were reported. On 11-FEB-2014 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (Invalid lot number reported as J00999, with expiration date: 04-DEC-2015) in the right arm. Concomitant therapies included SPRINTEC. Dose 1 of GARDASIL was administered on an unspecified date. The patient did not have any reaction with dose 1. On 12-FEB-2014, (reported as the following day) the patient experienced blistering and swelling of her right forearm (disability). The swelling had moved up her arm and towards the back of her arm, she was unable to move her arm (disability). A physician saw the patient on 13-FEB-2014 and sent the patient to the emergency room. It was also reported that no treatment was given for adverse event, but sent the patient to emergency room. No lab diagnostic studies were performed. The patient had sought medical attention. It was reported that there was no PQC involved. The reporter had requested for a lot check. The outcome of the events were reported as not recovered. The causality of the event was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Menorrhagia, Oligomenorrhoea
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to an approximately 15 year old female patient. The pertinent medical history and drug allergies were none. On 15-FEB-2014, the patient was vaccinated with a dose of 0.5 ml GARDASIL (lot # J008423, expiry date 21-JAN-2016) intramuscular. The concomitant medications were none. The patient was found to be pregnant with Last Menstrual Period of 18-SEP-2013 and Estimated Date of Delivery of 25-JUN-2014. On 15-FEB-2014, the healthcare worker reported that the patient was five months pregnant received a dose of GARDASIL. On 15-FEB-2014, the patient was seen in the office for vaginal bleeding which started on an unknown date. On 15-FEB-2014, the patient had haemoglobin drawn and it was 8.7. The patient was schedule for follow up visit on 18-FEB-2014. There was no treatment rendered for the event. The patient sought medical attention. The outcome of vaginal bleeding was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, Haemoglobin decreased, Vaginal haemorrhage
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to an approximately 15 year old female patient. The pertinent medical history and drug allergies were none. On 15-FEB-2014, the patient was vaccinated with a dose of 0.5 ml GARDASIL (lot # J008423, expiry date 21-JAN-2016) intramuscular. The concomitant medications were none. The patient was found to be pregnant with Last Menstrual Period of 18-SEP-2013 and Estimated Date of Delivery of 25-JUN-2014. On 15-FEB-2014, the healthcare worker reported that the patient was five months pregnant received a dose of GARDASIL. On 15-FEB-2014, the patient was seen in the office for vaginal bleeding which started on an unknown date. On 15-FEB-2014, the patient had haemoglobin drawn and it was 8.7. The patient was schedule for follow up visit on 18-FEB-2014. There was no treatment rendered for the event. The patient sought medical attention. The outcome of vaginal bleeding was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker refers to an approximately 15 year old female patient. The pertinent medical history and drug allergies were none. On 15-FEB-2014, the patient was vaccinated with a dose of 0.5 ml GARDASIL (lot # J008423, expiry date 21-JAN-2016) intramuscular. The concomitant medications were none. The patient was found to be pregnant with Last Menstrual Period of 18-SEP-2013 and Estimated Date of Delivery of 25-JUN-2014. On 15-FEB-2014, the healthcare worker reported that the patient was five months pregnant received a dose of GARDASIL. On 15-FEB-2014, the patient was seen in the office for vaginal bleeding which started on an unknown date. On 15-FEB-2014, the patient had haemoglobin drawn and it was 8.7. The patient was schedule for follow up visit on 18-FEB-2014. There was no treatment rendered for the event. The patient sought medical attention. The outcome of vaginal bleeding was unknown. Additional information has been requested.
Age: 1.65
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Immediate post-injection reaction, Pyrexia
Clinical narrative: Immediately tired following vaccination, later on in evening child developed fever, still has fever next morning.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with pre-existing allergy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date was not reported). No concomitant medication was reported. As reported, now (unknown date) patient needed steroid shot for a pre-existing allergy (medically significant). The outcome of the event was unknown. Upon internal review the event allergy was considered medically significant. Additional information has been requested.