chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Back of clients left upper arm was red & swollen 70mm width x 60 mm length. It was warm to touch, and hurt her. T/C was made to her Dr., but she had never been there to establish Dr - they told her to go to ER. This office gave her ice & told her to take BENADRYL (per someone before this nurse saw her) 12/15/11.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Chest pain, Chills, Headache, Hypoaesthesia, Laboratory test normal
Clinical narrative: Chills, sore throat, chest pain, vertigo, headache, neck stiffness, (L) facial numbness.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Vertigo
Clinical narrative: Chills, sore throat, chest pain, vertigo, headache, neck stiffness, (L) facial numbness.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Seizure like phenomena, Syncope, Unresponsive to stimuli
Clinical narrative: After administration of vaccine pt had vasovagal syncopal episode. Regained consciousness, few min later pt unresponsive ? seizure type movements. Pt transported to ER.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Had shingles vaccine shot on 9/5/10. Broke out in bad rash in 3 days on chest, face & underarms. Took month plus before subsiding. Have had small outbreaks on face, arms & hands recently that still continue.
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Seizure activity documented within two hours after administration of vaccine. Loaded with anti-seizure med.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Oedema peripheral, Pain in extremity, Rash erythematous
Clinical narrative: Per pt's description via email - "arm swelled & was extremely painful". Pt stated that she couldn't use the arm for 4 days. Also she states that she had a red rash from the inj. site to her elbow. All sxs resolved.
Age: 1.6
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Left thigh, red, hard, hot area - increased in size past 24 hours, painful, fever. Started on ABX TMP/SMZ.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Within one hour of administration, pt. developed redness & swelling below site 10 inches across.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: Received flu shot on 10/12/11. Soreness at injection site next day. Continues to have soreness to touch and with movement. No relief with Ibuprofen. ? nerve irritation. To reevaluate if symptoms continue.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood test normal, Body temperature increased, Fatigue, Pain
Clinical narrative: Temp >104.  Extreme fatigue and body aches x 3 days. Was taken to Urgent Care. Blood tests done--no treatment given.
Age: 7.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth over arm at and beolw injection site; Rx with Benadryl and ice.
Age: 5.0
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm swelling, itching, pain.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Tenderness
Clinical narrative: Patient states the day after flu vaccine was administered she noted on the left side, above her collar bone, at the base of her neck a small marble size not appeared.  States the it is sore to the touch and tender.  Patient calls the health department on 12/16/11 at approximatley 2:00pm and states she will be going to a doctor or an urgent care after she get's off work this evening.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Crying, Gait disturbance, Hypoaesthesia, Panic attack, Staring
Clinical narrative: Nurse administered FluMist, then proceeded to give Hepatitis A vaccine IM.  After shot patient stated the room looks funny.  Then nurse noticed patient having a blank stare and not responding to her name (approx. 20-30 seconds).  Lips normal color.  Respirations normal.  Then she responded, but had the blank stare again, lasting approx. 10 seconds.  Patient was put on cot.  Patient crying.  Mother asking patient how she was feeling.  Patient not answering but continued to cry.  Asked her if she had difficulty breathing, continued to cry.  Pulse 78, respirations normal.  Did not seem to have difficulty breathing.  Patient continued to cry, but responded to how she felt.  She stated her body felt numb.  Asked her to squeeze nurse's hands.  Both hands equal and strong.  Able to move legs.  Still stated body felt numb.  911 was called as a precaution.  No changes when ambulance arrived.  Paramedics took O2 saturation, blood pressure, pulse.  All normal. Patient continues to cry.  Paramedics assisted patient to chair.  Patient continued to cry and refused to walk out of room to car.  Paramedics put patient on cot and transported to mothers car.  Mother was given instructions on what to do:  Monitor pt at home, go to ER if conditions worsen, call HD tomorrow with update, call physician tomorrow with incident.  Mother denied any medical Hx including seizure, medications, having a recent virus.  Stated patient had Tdap last week. Pt went home.  Did not go to hospital.  Paramedics and mother felt child was having a panic attack.  PHN attempted to call family a few times, left messages, but have no call back from parent.  PHN called patient's doctor and there has been no call from parent on this child recently.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Nurse administered FluMist, then proceeded to give Hepatitis A vaccine IM.  After shot patient stated the room looks funny.  Then nurse noticed patient having a blank stare and not responding to her name (approx. 20-30 seconds).  Lips normal color.  Respirations normal.  Then she responded, but had the blank stare again, lasting approx. 10 seconds.  Patient was put on cot.  Patient crying.  Mother asking patient how she was feeling.  Patient not answering but continued to cry.  Asked her if she had difficulty breathing, continued to cry.  Pulse 78, respirations normal.  Did not seem to have difficulty breathing.  Patient continued to cry, but responded to how she felt.  She stated her body felt numb.  Asked her to squeeze nurse's hands.  Both hands equal and strong.  Able to move legs.  Still stated body felt numb.  911 was called as a precaution.  No changes when ambulance arrived.  Paramedics took O2 saturation, blood pressure, pulse.  All normal. Patient continues to cry.  Paramedics assisted patient to chair.  Patient continued to cry and refused to walk out of room to car.  Paramedics put patient on cot and transported to mothers car.  Mother was given instructions on what to do:  Monitor pt at home, go to ER if conditions worsen, call HD tomorrow with update, call physician tomorrow with incident.  Mother denied any medical Hx including seizure, medications, having a recent virus.  Stated patient had Tdap last week. Pt went home.  Did not go to hospital.  Paramedics and mother felt child was having a panic attack.  PHN attempted to call family a few times, left messages, but have no call back from parent.  PHN called patient's doctor and there has been no call from parent on this child recently.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, pain and redness on rt. arm.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Woke up in middle of the night with extreme pain in both arms.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Developmental delay, Laboratory test abnormal, Oedema peripheral, Screaming, Skin warm
Clinical narrative: Entire arm became very hot to the touch.  Then entire arm became swollen.  Child developed hives.  Child began screaming and screamed for four hours until she fell asleep.  Woke up the next morning and spent the entire day of awake time rolling on the ground screaming.  This cycle continued for approximately three days.  Child had a developmental test the week before and tested in the normal range in all areas, child has just been tested and tested behind in 3 of the 5 areas.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Entire arm became very hot to the touch.  Then entire arm became swollen.  Child developed hives.  Child began screaming and screamed for four hours until she fell asleep.  Woke up the next morning and spent the entire day of awake time rolling on the ground screaming.  This cycle continued for approximately three days.  Child had a developmental test the week before and tested in the normal range in all areas, child has just been tested and tested behind in 3 of the 5 areas.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Dyskinesia, Feeling abnormal, Gait disturbance, Hallucination
Clinical narrative: Pain at left knee and right leg shortly after vaccine, then hand and foot pruritus, nausea with mild emesis, temp to 101, ? hallucinations and insomnia (keeps jerking up from sleep, saying he feels the bed is tilting and he is falling), feels throat swelling, walking on lateral edges of feet (?secondary to pain).
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain, Insomnia, Nausea, Pain, Pharyngeal oedema
Clinical narrative: Pain at left knee and right leg shortly after vaccine, then hand and foot pruritus, nausea with mild emesis, temp to 101, ? hallucinations and insomnia (keeps jerking up from sleep, saying he feels the bed is tilting and he is falling), feels throat swelling, walking on lateral edges of feet (?secondary to pain).
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Vomiting
Clinical narrative: Pain at left knee and right leg shortly after vaccine, then hand and foot pruritus, nausea with mild emesis, temp to 101, ? hallucinations and insomnia (keeps jerking up from sleep, saying he feels the bed is tilting and he is falling), feels throat swelling, walking on lateral edges of feet (?secondary to pain).
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting for about 6 hours. No other symptoms. No diarrhea, rash, fever, respiratory problems. Normal exam by MD. Resolved same day.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: Later in evening at home pt. noticed 1cm firm nodule at injection site.
Age: 19.0
Sex: M
Vaccine: FLU3, HEP, HEPA, MMR, PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Started with fever and had redness, swelling on left arm.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediately after receving the shot the client felt like there was an air pocket under the skin. The shot hurt more than the 1st and 2nd Hep B shots.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Redness/Swelling on Left Upper Arm. Localized reaction.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Injection site warmth
Clinical narrative: Patient reported receiving an influenza vaccine from pharmacy on 12/7/11 on her left arm.  The next morning, she started feeling pain and warmth in that upper arm.  She thought it was due to her sleeping position.  The injection site did not have inflammation.  A few days later, she believed that this reaction was from the vaccine because she thought that the injection site was up higher toward the shoulder blade than it should be.  The pain persisted for 7 days.  Now, it is resolving.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Coagulopathy, Epistaxis, Haemoptysis, Peritoneal dialysis, Platelet count decreased
Clinical narrative: Patient traveled to another country on 12/1/11.  Following day, began bleeding from his nose and coughing up blood.  Found to have low platelets and profound coagulopathy.  Subsequently has developed respiratory failure and acute renal failure requiring peritoneal dialysis.  No infectious or other etiology identified to date.
Age: 1.01
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Renal failure acute, Respiratory failure
Clinical narrative: Patient traveled to another country on 12/1/11.  Following day, began bleeding from his nose and coughing up blood.  Found to have low platelets and profound coagulopathy.  Subsequently has developed respiratory failure and acute renal failure requiring peritoneal dialysis.  No infectious or other etiology identified to date.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nerve injury, Pain
Clinical narrative: Patient felt soreness after shot, & can't raise arm. Patient went to see MD & they said that a nerve was hit on.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Skin discolouration, Skin warm
Clinical narrative: s/p shingles vaccine to the right shoulder, the patient developed a large area of inflammation with warmth and skin coloring changes.  He denies any fevers or pain (so no apparent infection).  This has lasted x at least 3 weeks and was noted by his wife a few weeks after his shingles shot.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: 1 inch rash on left thigh, rash on right thigh size of childs hand. Showed up on 12/15/11. Was instructed to give child BENADRYL & monitor for spreading rash, SOB, discomfort.
Age: 1.13
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme - appeared 5 days after vaccines.
Age: 1.92
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizures, fever.
Age: 0.64
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient received first Flu shot on 9/9/11 along with PEDIARIX, PCV13, Hib and ROTATEQ and had no reactions. His second Flu shot was given 10/24/11 and about 24 hours later he developed hives which lasted for about 24 hours. No intervention was needed. He has since eaten eggs without any reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching on site. Size of a baseball on 15Dec11, hard red center. Size of a softball on 16Dec11. About 1 inch width, 2 1/2 inch length.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, TDAP, YF
Symptoms: Flushing, Palmar-plantar erythrodysaesthesia syndrome, Pruritus, Sneezing, Urticaria
Clinical narrative: Patient complains of reported symptoms of itchy red palms and soles of feet & facial flushing occurring 3 times since vaccination. Episodes lasts 45 min to 1 hour. First noticed 11/27 or 12/4/11. Also complains of severe hives to thigh, abdomen, groin, & buttocks once lasting a couple of hours after exercising 1 week ago sneezing (12/9/11).
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: Vaccine Tdap & TIV influenza vaccines given 12/12/11. 12-14-11 knees, moderate joint pain bilaterally. 12-15-11 hands, bilateral swelling & joint pain/aches. 12-16-11 same s/s since 12/15/11.
Age: 48.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling
Clinical narrative: Patient developed an area of redness, swelling (6cm x 9cm), temp of 100.1 and pain at the injection site. Doctor advised applying Triamcinolone and Saran wrap to the area. Also try ice for 15 mins at a time.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: Woke up shaky, weak, diaphoretic, nauseous, dizzy/vertigo (patient NOT a diabetic). In case it was low blood sugar, patient ate apple sauce, a piece of a banana, some macaroni, and drank approximately 500mL of water. The symptoms continues with new onset fatigue. After sleeping off and on for several more hours the symptoms slowly began to resolve. Current time is 12:15 AM on 12/17/11- 8 hours after onset of symptoms and nearly 16 hours after vaccination was administered- and patient is finally able to walk appropriately, the vertigo and nausea have subsided, but the patient remains feeling sluggish.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Sluggishness, Tremor, Vertigo
Clinical narrative: Woke up shaky, weak, diaphoretic, nauseous, dizzy/vertigo (patient NOT a diabetic). In case it was low blood sugar, patient ate apple sauce, a piece of a banana, some macaroni, and drank approximately 500mL of water. The symptoms continues with new onset fatigue. After sleeping off and on for several more hours the symptoms slowly began to resolve. Current time is 12:15 AM on 12/17/11- 8 hours after onset of symptoms and nearly 16 hours after vaccination was administered- and patient is finally able to walk appropriately, the vertigo and nausea have subsided, but the patient remains feeling sluggish.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Red cheeks, hives all over body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pain, Pruritus
Clinical narrative: Redness, Itching, heat, swelling, pain, discoloration, area was very hard and swollen. Symptoms lasted approximately 10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Swelling
Clinical narrative: Redness, Itching, heat, swelling, pain, discoloration, area was very hard and swollen. Symptoms lasted approximately 10 days.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RVX
Symptoms: Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: Got a fever and gave him baby Tylenol from 4:45PM and 8:45PM. He was very fuzzy until the mid of the night. His body was really hot. Next morning he was still having fever, so we fed him another bit of Tylenol on 6:45AM.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Pt. said that she had a reaction to the shot. She noticed that night that she had redness and swelling in the shot area. Also, she experienced discomfort in area. When pt. came into pharmacy the next day, I noticed that shot area was red and swollen.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction to PNEUMOVAX (redness & swelling at inj. site - 5 cm).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: (L) thigh 4x6 cm erythematous indurated lesion with expanding edges.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: On 12/7/11 mom noticed child leg seemed tender - when she checked it right leg had a red, hard lump and was warm to touch. Leg was fine yesterday (12-6-11). Seen in office 12-7-11 - Dx cellulitis & abscess - other serum reaction due to vaccination. Started on OMNICEF x 5 days & EPSOM salt soaks - recheck 12/8/11. Missed f/u appt - was looking better when last talked to mom.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site pain, Injection site warmth, Serum sickness
Clinical narrative: On 12/7/11 mom noticed child leg seemed tender - when she checked it right leg had a red, hard lump and was warm to touch. Leg was fine yesterday (12-6-11). Seen in office 12-7-11 - Dx cellulitis & abscess - other serum reaction due to vaccination. Started on OMNICEF x 5 days & EPSOM salt soaks - recheck 12/8/11. Missed f/u appt - was looking better when last talked to mom.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Lymphoedema, Oedema peripheral
Clinical narrative: (11-19-11) Patient had swelling at the arm and had to get physical therapy to reduce lymph edema. She is feeling better now. (Patient had cancer before and removed lymph node. Doctor now told her not to get immunization in the future).
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, visual
Clinical narrative: Day of immunization, pt awoke with visual hallucinations. Pt stated those things are flying all around. Lasted about 30 minutes. Pt did have a cortisone shot in the shoulder on 9/29/11. But pt has never hallucinated in the past, has never had an adverse reaction to a flu shot.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was seen about 5 days after Zoster vaccine with redness and swelling of right deltoid. Used ibuprofen, cold packs, getting progressively worse. Rx'ed BACTRIM to treat. DS 1 tab BID x 10 days.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: On 9/22, 10 days after injection, pt presents with rash approx 3 around, raised, red bumps, occasional pruritus. Pt reports rash did not occur until approximately 5 days post-injection. He has noted improvement over last 2 weeks. He did not use any creams/ointments.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site reaction, Myalgia, Pain
Clinical narrative: Was given tetanus/pertussis vaccine for possible employment. Immediately swelled and hurt. Continued pain for weeks with swelling and could see the injection site. Now have pain in the muscle that was injected and can't lift over shoulder height.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Was given tetanus/pertussis vaccine for possible employment. Immediately swelled and hurt. Continued pain for weeks with swelling and could see the injection site. Now have pain in the muscle that was injected and can't lift over shoulder height.
Age: 81.0
Sex: M
Vaccine: FLUX
Symptoms: Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Extreme discomfort in upper arm/shoulder to this date movement causes discomfort.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Pain in joints, pin and needles through-out body.  Post Flu shot Neuropathy.
Age: 0.59
Sex: F
Vaccine: DTAP, PPV
Symptoms: Urticaria
Clinical narrative: Hives on back.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever of 101 degrees and chills along with body aches. Treatment: rest, tea, not taking care of my 5 day old son.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: I experienced a large red welt (4 by 3 inches) on my arm where the injection site was.  The red welt was painful and hot to touch.  It was also swollen and raised.  It is still present (3 days following injection site).
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever nausea.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt experienced redness, swelling, fatigue, and feeling of heat at site of injection. PNEUMOVAX administered 12-15. Pt is now, on 12-18, starting to feel better. Pt's husband asked that event be reported.
Age: 2.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Flushing, Pruritus generalised, Vomiting
Clinical narrative: Vomited x1; Flushed all over, especially in the face; Vitals stable; Itchy all over initially (1st 10 minutes).
Age: 54.0
Sex: F
Vaccine: RUB
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 05-OCT-2000 was vaccinated with a dose of MERUVAX II (route and lot no. not reported). The patient was diagnosed with possible Guillain Barre Syndrome after receiving the vaccine. The date of onset of symptoms was unknown. The patient's outcome was not reported. It was unknown if the patient sought medical attention. Upon internal review Guillain Barre Syndrome was considered to be an other important medical event. Follow-up information has been received from a physician who reported that the patient did not have side effects but questioned the possibility or likelihood with this vaccine ZOSTAVAX (Merck). No further information is available.
Age: 1.6
Sex: U
Vaccine: MMRV
Symptoms: Crying, Injection site swelling, Irritability, Pyrexia, Screaming
Clinical narrative: Information has been received from a nurse concerning an approximately 19 month old patient who in September 2010, was vaccinated with a dose of PROQUAD (Merck) (Lot# unknown). In approximately September 2010, the patient experienced swelling at injection site, fever, vomiting, crying, screaming and fussiness. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. The nurse said that the office no longer gave the first dose of PROQUAD (Merck) in the younger patients, they only gave it to 4-6 year old patients now. this is one of several reports from the same source. Additional information is not expected.
Age: 1.6
Sex: U
Vaccine: MMRV
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning an approximately 19 month old patient who in September 2010, was vaccinated with a dose of PROQUAD (Merck) (Lot# unknown). In approximately September 2010, the patient experienced swelling at injection site, fever, vomiting, crying, screaming and fussiness. At the time of the report, the patient had recovered. It was unknown if the patient sought medical attention. The nurse said that the office no longer gave the first dose of PROQUAD (Merck) in the younger patients, they only gave it to 4-6 year old patients now. this is one of several reports from the same source. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Arthralgia, Arthritis, C-reactive protein normal, Erythema, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with MMR II SC. The physician stated that his patient "had received a swollen foot and joint pain" 10 days after receiving the MMR II (Lot#/Exp. Date: unspecified) (Dosage/Frequency: unspecified). Therapy with MMR II was discontinued. At the time of the report the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician concerning a 4 year old female patient with no pertinent medical history, and past drug history of a dose of MMR II and a dose of VARIVAX (Merck) when she was one year old. On 17-AUG-2010 at 16:00, the patient received the second dose of PROQUAD (Merck) (Lot # reported as 0177V), SQ, in the right arm. The patient also received a dose of PREVNAR 13, IM, given in the right arm, and a dose of KINRIX, IM, given in left arm. The physician reported that on 17-AUG-2010 at 18:00, the patient complained of foot pain. The following three nights the patient awoke, complaining of foot and ankle pain without diagnostic of trauma. On 29-AUG-2010, ankles were noticing swollen, red, and warm. The patient went to E.R. visit on 30-AUG-2010 and was performed the following lab tests: C reactive protein, Anti Streptolysin (ASO), Erythrocyte sedimentation rate (ESR), all within normal limits. The symptoms improved on 21-AUG-2010 with resolution of arthralgias and arthritis on around 03-SEP-2010. When the symptoms occurred he came across literature articles on post-rubella arthritis. He also reported that he had found some articles which further stated that the arthritis reaction rarely occurred in children. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Joint swelling, Joint warmth, Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with MMR II SC. The physician stated that his patient "had received a swollen foot and joint pain" 10 days after receiving the MMR II (Lot#/Exp. Date: unspecified) (Dosage/Frequency: unspecified). Therapy with MMR II was discontinued. At the time of the report the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician concerning a 4 year old female patient with no pertinent medical history, and past drug history of a dose of MMR II and a dose of VARIVAX (Merck) when she was one year old. On 17-AUG-2010 at 16:00, the patient received the second dose of PROQUAD (Merck) (Lot # reported as 0177V), SQ, in the right arm. The patient also received a dose of PREVNAR 13, IM, given in the right arm, and a dose of KINRIX, IM, given in left arm. The physician reported that on 17-AUG-2010 at 18:00, the patient complained of foot pain. The following three nights the patient awoke, complaining of foot and ankle pain without diagnostic of trauma. On 29-AUG-2010, ankles were noticing swollen, red, and warm. The patient went to E.R. visit on 30-AUG-2010 and was performed the following lab tests: C reactive protein, Anti Streptolysin (ASO), Erythrocyte sedimentation rate (ESR), all within normal limits. The symptoms improved on 21-AUG-2010 with resolution of arthralgias and arthritis on around 03-SEP-2010. When the symptoms occurred he came across literature articles on post-rubella arthritis. He also reported that he had found some articles which further stated that the arthritis reaction rarely occurred in children. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Streptococcus test negative
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with MMR II SC. The physician stated that his patient "had received a swollen foot and joint pain" 10 days after receiving the MMR II (Lot#/Exp. Date: unspecified) (Dosage/Frequency: unspecified). Therapy with MMR II was discontinued. At the time of the report the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician concerning a 4 year old female patient with no pertinent medical history, and past drug history of a dose of MMR II and a dose of VARIVAX (Merck) when she was one year old. On 17-AUG-2010 at 16:00, the patient received the second dose of PROQUAD (Merck) (Lot # reported as 0177V), SQ, in the right arm. The patient also received a dose of PREVNAR 13, IM, given in the right arm, and a dose of KINRIX, IM, given in left arm. The physician reported that on 17-AUG-2010 at 18:00, the patient complained of foot pain. The following three nights the patient awoke, complaining of foot and ankle pain without diagnostic of trauma. On 29-AUG-2010, ankles were noticing swollen, red, and warm. The patient went to E.R. visit on 30-AUG-2010 and was performed the following lab tests: C reactive protein, Anti Streptolysin (ASO), Erythrocyte sedimentation rate (ESR), all within normal limits. The symptoms improved on 21-AUG-2010 with resolution of arthralgias and arthritis on around 03-SEP-2010. When the symptoms occurred he came across literature articles on post-rubella arthritis. He also reported that he had found some articles which further stated that the arthritis reaction rarely occurred in children. Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, MMRV
Symptoms: Full blood count normal, Metabolic function test normal, Pallor, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with no drug allergies and a history of eczema who on 29-JUN-2011 was vaccinated IM with a 0.5 ml dose of PROQUAD (Merck) (lot # 666370/0194Z, expired date 15-JUL-2011). There was no concomitant medication. On 05-JUL-2011 the patient developed rash after receiving PROQUAD (Merck). Patient's entire body was covered with diffused, papular rash. Patient also presented low grade fever and runny nose. No treatment was given for adverse events. Patient had complete blood cell count (CBC) and Comprehensive Metabolic Panel (CMP) with no results provided. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Information received from medical records concerning a 13 month (previously reported as 12 month) old male which confirmed that the patient was vaccinated SQ with the dose of PROQUAD (Merck) on 29-JUN-2011. The patient was also vaccinated with an IM HAVRIX within four weeks of received the PROQUAD (Merck) (exact date not specified). On 12-JUL-2011 (previously reported as 05-JUL-2011) the patient experienced diffuse papular rash on his body with coalesce and blanching on trunk, arms, legs, cheeks, sparing his forehead; low grade fever and runny nose. A Complete Blood Count and Comprehensive Metabolic Panel were drawn on 12-JUL-2011 with normal results with the exception of: basophils at 0.14, lymphocytes at 79% and serum glutamic oxaloacetic transaminase (SGOT) of 44 U/L. It was reported that the patient recovered (no date provided). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, MMRV
Symptoms: Rash papular, Rhinorrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with no drug allergies and a history of eczema who on 29-JUN-2011 was vaccinated IM with a 0.5 ml dose of PROQUAD (Merck) (lot # 666370/0194Z, expired date 15-JUL-2011). There was no concomitant medication. On 05-JUL-2011 the patient developed rash after receiving PROQUAD (Merck). Patient's entire body was covered with diffused, papular rash. Patient also presented low grade fever and runny nose. No treatment was given for adverse events. Patient had complete blood cell count (CBC) and Comprehensive Metabolic Panel (CMP) with no results provided. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Information received from medical records concerning a 13 month (previously reported as 12 month) old male which confirmed that the patient was vaccinated SQ with the dose of PROQUAD (Merck) on 29-JUN-2011. The patient was also vaccinated with an IM HAVRIX within four weeks of received the PROQUAD (Merck) (exact date not specified). On 12-JUL-2011 (previously reported as 05-JUL-2011) the patient experienced diffuse papular rash on his body with coalesce and blanching on trunk, arms, legs, cheeks, sparing his forehead; low grade fever and runny nose. A Complete Blood Count and Comprehensive Metabolic Panel were drawn on 12-JUL-2011 with normal results with the exception of: basophils at 0.14, lymphocytes at 79% and serum glutamic oxaloacetic transaminase (SGOT) of 44 U/L. It was reported that the patient recovered (no date provided). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, MMRV
Symptoms: Aspartate aminotransferase normal, Basophil count decreased, Full blood count, Lymphocyte count increased, Metabolic function test
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with no drug allergies and a history of eczema who on 29-JUN-2011 was vaccinated IM with a 0.5 ml dose of PROQUAD (Merck) (lot # 666370/0194Z, expired date 15-JUL-2011). There was no concomitant medication. On 05-JUL-2011 the patient developed rash after receiving PROQUAD (Merck). Patient's entire body was covered with diffused, papular rash. Patient also presented low grade fever and runny nose. No treatment was given for adverse events. Patient had complete blood cell count (CBC) and Comprehensive Metabolic Panel (CMP) with no results provided. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Information received from medical records concerning a 13 month (previously reported as 12 month) old male which confirmed that the patient was vaccinated SQ with the dose of PROQUAD (Merck) on 29-JUN-2011. The patient was also vaccinated with an IM HAVRIX within four weeks of received the PROQUAD (Merck) (exact date not specified). On 12-JUL-2011 (previously reported as 05-JUL-2011) the patient experienced diffuse papular rash on his body with coalesce and blanching on trunk, arms, legs, cheeks, sparing his forehead; low grade fever and runny nose. A Complete Blood Count and Comprehensive Metabolic Panel were drawn on 12-JUL-2011 with normal results with the exception of: basophils at 0.14, lymphocytes at 79% and serum glutamic oxaloacetic transaminase (SGOT) of 44 U/L. It was reported that the patient recovered (no date provided). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, MMRV
Symptoms: Pallor, Pyrexia, Rash generalised, Rash papular, Rhinorrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with no drug allergies and a history of eczema who on 29-JUN-2011 was vaccinated IM with a 0.5 ml dose of PROQUAD (Merck) (lot # 666370/0194Z, expired date 15-JUL-2011). There was no concomitant medication. On 05-JUL-2011 the patient developed rash after receiving PROQUAD (Merck). Patient's entire body was covered with diffused, papular rash. Patient also presented low grade fever and runny nose. No treatment was given for adverse events. Patient had complete blood cell count (CBC) and Comprehensive Metabolic Panel (CMP) with no results provided. Patient sought medical attention by office visiting. At the time of reporting, patient's outcome was unknown. Information received from medical records concerning a 13 month (previously reported as 12 month) old male which confirmed that the patient was vaccinated SQ with the dose of PROQUAD (Merck) on 29-JUN-2011. The patient was also vaccinated with an IM HAVRIX within four weeks of received the PROQUAD (Merck) (exact date not specified). On 12-JUL-2011 (previously reported as 05-JUL-2011) the patient experienced diffuse papular rash on his body with coalesce and blanching on trunk, arms, legs, cheeks, sparing his forehead; low grade fever and runny nose. A Complete Blood Count and Comprehensive Metabolic Panel were drawn on 12-JUL-2011 with normal results with the exception of: basophils at 0.14, lymphocytes at 79% and serum glutamic oxaloacetic transaminase (SGOT) of 44 U/L. It was reported that the patient recovered (no date provided). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse and a physician (through a completed questionnaire), concerning a 5 year old male patient with asthma and no known allergies who on 03-MAY-2011 was vaccinated with PROQUAD (Merck) (lot number 666885/0283Z) in the left thigh. Concomitant therapy included DAPTACEL administered on 03-MAY-2011, montelukast sodium (MSD), PROVENTIL and FLOVENT. On 03-MAY-2011 at the injection site the patient developed "red, raised rash, painful with blisters". On 04-May-2011 the patient developed chickenpox; more than 5 lesions (exact number unknown) and circular around injection site. The patient presented a maximum temperature of 100.7. It was reported that the patient had no recent exposure to chickenpox or shingles. The patient called the physician and was started on prednisone and either CLARITIN or ZYRTEC". On 05-MAY-2011, the patient recovered from red, raised rash, painful with blisters at the injection site. At the time of the report the patient's chickenpox status was unknown. The patient's blisters scab over. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 07-MAY-2011. The sample was taken from a scab (results pending). Additional information has been received and the PCR analysis revealed the sample was inadequate to process. Additional information has been received which stated that on 07-MAY-2011 a small scab from left thigh was taken, on 12-May-2011 the specimen arrived to the lab and a VZV amplification could not be done. A beta-globin DNA was also not amplified. The final PCR specimen result was inadequate specimen. Follow-up information has been received from a physician concerning the 5 year old male student with "none" illness at time of vaccination, who on 04-MAY-2011 (previously reported as 03-MAY-2011) at 14:10, was vaccinated with the first dose of PROQUAD (lot # 666885/0283Z) in the left leg. The same day, the patient received the sixth dose of DAPTACEL (Lot# C3358AA) in the right leg and the fifth dose of IPOL (lot # D0674-1) in the left leg. On 04-MAY-2011, the patient developed a 8 x 5.5 cm area of erythema and induration with tiny vesicles in center. Subsequently, the patient recovered from 8 x 5.5 cm area of erythema and induration with tiny vesicles in center on an unspecified date. The patient did not seek medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Beta globulin, Blister, Body temperature increased, Erythema, Induration
Clinical narrative: Information has been received from a registered nurse and a physician (through a completed questionnaire), concerning a 5 year old male patient with asthma and no known allergies who on 03-MAY-2011 was vaccinated with PROQUAD (Merck) (lot number 666885/0283Z) in the left thigh. Concomitant therapy included DAPTACEL administered on 03-MAY-2011, montelukast sodium (MSD), PROVENTIL and FLOVENT. On 03-MAY-2011 at the injection site the patient developed "red, raised rash, painful with blisters". On 04-May-2011 the patient developed chickenpox; more than 5 lesions (exact number unknown) and circular around injection site. The patient presented a maximum temperature of 100.7. It was reported that the patient had no recent exposure to chickenpox or shingles. The patient called the physician and was started on prednisone and either CLARITIN or ZYRTEC". On 05-MAY-2011, the patient recovered from red, raised rash, painful with blisters at the injection site. At the time of the report the patient's chickenpox status was unknown. The patient's blisters scab over. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 07-MAY-2011. The sample was taken from a scab (results pending). Additional information has been received and the PCR analysis revealed the sample was inadequate to process. Additional information has been received which stated that on 07-MAY-2011 a small scab from left thigh was taken, on 12-May-2011 the specimen arrived to the lab and a VZV amplification could not be done. A beta-globin DNA was also not amplified. The final PCR specimen result was inadequate specimen. Follow-up information has been received from a physician concerning the 5 year old male student with "none" illness at time of vaccination, who on 04-MAY-2011 (previously reported as 03-MAY-2011) at 14:10, was vaccinated with the first dose of PROQUAD (lot # 666885/0283Z) in the left leg. The same day, the patient received the sixth dose of DAPTACEL (Lot# C3358AA) in the right leg and the fifth dose of IPOL (lot # D0674-1) in the left leg. On 04-MAY-2011, the patient developed a 8 x 5.5 cm area of erythema and induration with tiny vesicles in center. Subsequently, the patient recovered from 8 x 5.5 cm area of erythema and induration with tiny vesicles in center on an unspecified date. The patient did not seek medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Injection site pain, Injection site reaction, Injection site scab, Injection site vesicles, Polymerase chain reaction
Clinical narrative: Information has been received from a registered nurse and a physician (through a completed questionnaire), concerning a 5 year old male patient with asthma and no known allergies who on 03-MAY-2011 was vaccinated with PROQUAD (Merck) (lot number 666885/0283Z) in the left thigh. Concomitant therapy included DAPTACEL administered on 03-MAY-2011, montelukast sodium (MSD), PROVENTIL and FLOVENT. On 03-MAY-2011 at the injection site the patient developed "red, raised rash, painful with blisters". On 04-May-2011 the patient developed chickenpox; more than 5 lesions (exact number unknown) and circular around injection site. The patient presented a maximum temperature of 100.7. It was reported that the patient had no recent exposure to chickenpox or shingles. The patient called the physician and was started on prednisone and either CLARITIN or ZYRTEC". On 05-MAY-2011, the patient recovered from red, raised rash, painful with blisters at the injection site. At the time of the report the patient's chickenpox status was unknown. The patient's blisters scab over. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 07-MAY-2011. The sample was taken from a scab (results pending). Additional information has been received and the PCR analysis revealed the sample was inadequate to process. Additional information has been received which stated that on 07-MAY-2011 a small scab from left thigh was taken, on 12-May-2011 the specimen arrived to the lab and a VZV amplification could not be done. A beta-globin DNA was also not amplified. The final PCR specimen result was inadequate specimen. Follow-up information has been received from a physician concerning the 5 year old male student with "none" illness at time of vaccination, who on 04-MAY-2011 (previously reported as 03-MAY-2011) at 14:10, was vaccinated with the first dose of PROQUAD (lot # 666885/0283Z) in the left leg. The same day, the patient received the sixth dose of DAPTACEL (Lot# C3358AA) in the right leg and the fifth dose of IPOL (lot # D0674-1) in the left leg. On 04-MAY-2011, the patient developed a 8 x 5.5 cm area of erythema and induration with tiny vesicles in center. Subsequently, the patient recovered from 8 x 5.5 cm area of erythema and induration with tiny vesicles in center on an unspecified date. The patient did not seek medical attention. Additional information has been requested.