chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.47
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Medication error
Clinical narrative: Child was given a Varicella vaccine on 03/08/06 Was given a 2nd Varicella vaccine by accident on  04/12/06.  Patient was fine. Notified CDC. They indicated no concern. The 2nd vaccine was only an exposure to Varicella and the 1st was to give her immunity.
Age: 3.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Acute local reaction to immunization. Pt thigh swollen after 4 mo. immunization this morning. Rt thigh swollen and red. Doctor said to give patient Tylenol for pain or fever. Pt was crying with pain.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Left upper deltoid 2 1/2 inch redness, slightly raised left upper deltoid inch redness, slightly raised itchy, fever - degree unknown- parents do not have thermometer.  Slight bluing of lips - grasping neck as if couldn't catch breath, parents gave Benadryl, no symptoms of difficult breathing.
Age: 14.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Unevaluable event
Clinical narrative: No text entered
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Dizziness, Dyspnoea, Urticaria
Clinical narrative: 03/14/2006 approximately 4:00PM patient returned to clinic with complaint of hives, shortness of breath, dizziness, anxiety.  Given 0.3mg epinephrine and oxygen.  Approximately 4:25PM transported to er via paramedics.
Age: 81.0
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: No adverse effect at all.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Bradycardia, Dehydration, Hypoxia, Nausea, Palpitations
Clinical narrative: Pt received Menactra and was sent to lab for testing glucose and lipids. suffered from syncope, bradycardia; hypoxia and was given O2 at 5L/min and sent to ER via Rescue (9-11). Pt. was dehydrated, had racing heart, palpitations and nausea. Pt. improved and discharged to home. Dx: syncope due to vasovagal 14:00. No blood drawn.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope vasovagal, Tachycardia
Clinical narrative: Pt received Menactra and was sent to lab for testing glucose and lipids. suffered from syncope, bradycardia; hypoxia and was given O2 at 5L/min and sent to ER via Rescue (9-11). Pt. was dehydrated, had racing heart, palpitations and nausea. Pt. improved and discharged to home. Dx: syncope due to vasovagal 14:00. No blood drawn.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 48 hours after vaccine given-fever, headache, pain and swelling at inj. site. 72 hours-arm still swollen. Pt feeling better. 4th day-fever and headache gone. 5th day-Pt seen by another RN who noted that an area about 4cm in diameter at inj. site that is swollen, warm and red. No streaking. Pt reports.
Age: 1.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Tic
Clinical narrative: Patient developed a tic 3 hours after vaccination.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Pain, Paraesthesia
Clinical narrative: Within 48 hours patient developed pain deltoid area with parenthesis.  Pain, weakness into deltoid.  Pain increased with abduction.  Treated with moist heat/NSAID/Physical therapy.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC
Symptoms: Crying, Heart rate increased
Clinical narrative: Approximately 15:00, mother reported baby crying frequent and crying anytime not held. Pt. was checked by doctor and states elevated pulse. Recommended taking her to ER to be checked out. Father states he will take baby to ER. Pediatrician will take baby to TMC.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Chills, fever, headache, nausea, vomiting, redness, pain/swelling at injection site.  Taken to emergency room.  Treated with IV fluids, meds by mouth.  Found also tachycardic.  Symptoms controlled.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Tachycardia, Vomiting
Clinical narrative: Chills, fever, headache, nausea, vomiting, redness, pain/swelling at injection site.  Taken to emergency room.  Treated with IV fluids, meds by mouth.  Found also tachycardic.  Symptoms controlled.
Age: 28.0
Sex: F
Vaccine: TTOX, TTOX, TTOX
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Initial report received on 3/28/2006 from a healthcare professional. A 28 year old female patient with no significant medical history, received an intramuscular injection of TET TOX ADS USP (lot number U1362BB) in the left deltoid on 3/23/2006. Twenty four hours later, she developed numbness, weakness and tingling in the entire left arm to the fingers. Three days later, she was seen by a physician and subsequently sent to the emergency room for numbness, weakness and tingling that was being felt in the left facial area, in addition to the left arm and fingers. Per the reporter, it was unknown if the patient was admitted to the hospital. At the time of the initial report, the patient had not recovered from these events.
Age: 28.0
Sex: F
Vaccine: TTOX, TTOX, TTOX
Symptoms: Paresis
Clinical narrative: Initial report received on 3/28/2006 from a healthcare professional. A 28 year old female patient with no significant medical history, received an intramuscular injection of TET TOX ADS USP (lot number U1362BB) in the left deltoid on 3/23/2006. Twenty four hours later, she developed numbness, weakness and tingling in the entire left arm to the fingers. Three days later, she was seen by a physician and subsequently sent to the emergency room for numbness, weakness and tingling that was being felt in the left facial area, in addition to the left arm and fingers. Per the reporter, it was unknown if the patient was admitted to the hospital. At the time of the initial report, the patient had not recovered from these events.
Age: 28.0
Sex: F
Vaccine: TTOX, TTOX, TTOX
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received on 3/28/2006 from a healthcare professional. A 28 year old female patient with no significant medical history, received an intramuscular injection of TET TOX ADS USP (lot number U1362BB) in the left deltoid on 3/23/2006. Twenty four hours later, she developed numbness, weakness and tingling in the entire left arm to the fingers. Three days later, she was seen by a physician and subsequently sent to the emergency room for numbness, weakness and tingling that was being felt in the left facial area, in addition to the left arm and fingers. Per the reporter, it was unknown if the patient was admitted to the hospital. At the time of the initial report, the patient had not recovered from these events.
Age: 32.0
Sex: M
Vaccine: HEP, TD
Symptoms: Laryngospasm, Muscle contractions involuntary, Syncope
Clinical narrative: Initial report received on 3/29/2006 from a health care provider. A 31 year old male with no significant medical history, had received his first intramuscular injection of DECAVAC, lot number U1576DA, in the left deltoid, his first intra dermal injection of Tubersol 5 TU, lot number C1710AA, in the right fore arm and his first intra muscular injection of another manufactures Hepatitis B vaccine, lot number 0504R in the left deltoid on 2/23/2006 at 14:15. 180 seconds later, he experienced syncope, muscle contractions of the hands, feet and legs and laryngeal spasm. The patient had recovered at the time of this report.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood glucose increased, Erythema, Headache, Laboratory test abnormal, Pyrexia
Clinical narrative: Initial report received on 3/29/2006 from a healthcare professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel, lot number C2454AA, in the left deltoid, on 3/14/2006. That evening, she experienced a fever of 102 degrees F, headache, increased blood sugar 300, and generalized flat, red, tender, circular lesions that were forming over her old scars and over the plates in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists. The patient was seen by her primary care physician for the adverse events on three different dates, 3/19/2006, 3/20/2006 and 3/27/2006. She had a CVC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate increased, Skin ulcer, Tenderness
Clinical narrative: Initial report received on 3/29/2006 from a healthcare professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel, lot number C2454AA, in the left deltoid, on 3/14/2006. That evening, she experienced a fever of 102 degrees F, headache, increased blood sugar 300, and generalized flat, red, tender, circular lesions that were forming over her old scars and over the plates in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists. The patient was seen by her primary care physician for the adverse events on three different dates, 3/19/2006, 3/20/2006 and 3/27/2006. She had a CVC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood glucose increased, Erythema, Headache, Laboratory test abnormal, Platelet disorder
Clinical narrative: Initial report received on 3/29/2006 from a healthcare professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel, lot number C2454AA, in the left deltoid, on 3/14/2006. That evening, she experienced a fever of 102 degrees F, headache, increased blood sugar 300, and generalized flat, red, tender, circular lesions that were forming over her old scars and over the plates in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists. The patient was seen by her primary care physician for the adverse events on three different dates, 3/19/2006, 3/20/2006 and 3/27/2006. She had a CVC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Skin ulcer, Tenderness
Clinical narrative: Initial report received on 3/29/2006 from a healthcare professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel, lot number C2454AA, in the left deltoid, on 3/14/2006. That evening, she experienced a fever of 102 degrees F, headache, increased blood sugar 300, and generalized flat, red, tender, circular lesions that were forming over her old scars and over the plates in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists. The patient was seen by her primary care physician for the adverse events on three different dates, 3/19/2006, 3/20/2006 and 3/27/2006. She had a CVC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report.
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: The patient received FLUMIST on 12/20/2005 and 2 days later, on 12/22/2005, developed a rash on her trunk and arms.  The rash was treated with diphenhydramine as needed, but failed to resolve.  Prior to receiving FLUMIST she had eye surgery on 12/16/2005 and took VALIUM and saline eye drops following surgery.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: MEDI-0003953 is a Non-Serious spontaneous case from a nurse in the USA of a 48 year old woman involving flu-like symptoms. The reporter causality is possible to FluMist. A 48 year old female pt received FluMist vaccination, intranasally on 12/22/2005 for influenza immunization. The pt received Trivalent Inactivated Influenza Vaccine (TIV) for the last 3 years. No other concomitant medications were reported. The night of the vaccination the pt began to feel ill. The feeling worsened over the next day. The exact symptoms were unspecified however they were described as "flu-like symptoms". No other information was provided.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: A 40 year old female who received FluMist on 01/06/2006 with family reported a stuffy nose, achiness, cough and a fever.  No history of close contact with anyone with flu or a cold.  The physician did not treat symptoms and the symptoms are ongoing.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pain
Clinical narrative: A 5 year old female who received Flumist on 01/06/2006 reported stuffy nose, achiness, and cough.  No history of close contact with anyone with flu or a cold.  Physician did not treat symptoms and still having symptoms of cold.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pain
Clinical narrative: This is a Not Serious Spontaneous case from a Pharmacist in the USA of stuffy nose, achiness, and cough. The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety surveillance accelerated reporting agreement for FluMist. An 8 year old female who received on 1/06/06 with family reported stuffy nose, achiness and cough. No history of close contact with flu or a cold. The pt's physician did not creat symptoms. The symptoms are still ongoing.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A nurse reported that a 6 year old child received expired FLUMIST vaccine on 12/16/05. No adverse event was reported. The reporter causality is not provided to FLUMIST. No other information was provided.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Cough, Medication error
Clinical narrative: A female consumer reported that she experienced irritating cough and slight tightness in the chest the next day and everyday after she received FLUMIST vaccine on 12/15/2005. She later found out that she should not have received FLUMIST due to her past medical history of asthma, although she is not sure if these symptoms are due to FLUMIST or not. The event has been considered resolved.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Migraine, Skin nodule
Clinical narrative: This is a non serious spontaneous case from a registered nurse in the USA of migraine and small nodule in nose (unlabelled, USA). The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety Surveillance Accelerated reporting agreement for FluMist. MEDI00040340 is a 40 year old male that was vaccinated with FluMist intranasally on 1/6/05. Within 1-1.5 hours of received the vaccine, he developed a migraine and a small nodule (1 millimeter) inside his right nostril. There was no aura or other migraine symptoms, and he did not take anything to treat his migraine. The nurse was not able to palpate the nodule. No treatment was prescribed for the nodule and the pt reported that the nodule had been decreasing in size. The clinical outcome of this event in unknown. Follow up - Patient's DOB and vaccine lot number provided.
Age: 35.0
Sex: M
Vaccine: FLUN3
Symptoms: Bacterial infection, Joint stiffness, Myalgia
Clinical narrative: MEDI0004267 is a Not Serious Spontaneous case from a physical therapist in the USA involving joint stiffness. The reporter causality is not provided to FluMist. On 12/8/2005, she began to complain bilateral muscle pain and joint stiffness. The pain began behind the kneecaps when going from sitting to standing. He took naproxen which relieved the pain. However, the pain returned whenever naproxen was not taken. The pt saw his primary care physician sometime at the end of 12/05, and was given naproxen. After a day of starting Naproxen, on 1/6/06, he developed soreness of the muscle, bilateral muscle pain and joint stiffness. Oxiproxin was discontinued. This event is ongoing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pain, Swelling
Clinical narrative: Patient received MMR at the right leg, developed redness, swelling, induration and pain within 8 hours of administration.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Blood amylase increased, Lymphopenia, Parotitis
Clinical narrative: Pt presented on 4/5/06 with left parotiditis, labs drawn. Pt was immun elsewhere. Pt new to our practice, HX of MMR vaccine on 6/8/05. Pt was rechecked on 4/10/2006 no parotid swelling.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Rash
Clinical narrative: Diffuse rash lasting over 36 hours. Pt given Tylenol by parents.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Chest pain, Heart rate increased, Liver disorder, Pain
Clinical narrative: Severe pain in liver after Hepatitis A vaccine and Flu shot and Pneumonia shot, all given to me at the same time, when I Have Hepatitis C, sharp stabbing pain in upper right side of my chest, below my rib cage. Rapid heart rate also.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Blood potassium increased, Hypertonia, Hypotonia, Pyrexia
Clinical narrative: At 2 months of age patient received Pediarix, Prevnar, Hib. That evening became limp, T to LOS, apneic. Did not require intubation. Hospitalized for 24 hours. At 4 months received only HIB and Prevnar. Similar reaction with perhaps TI02, same slight tonic movement. Watched overnight no sequelae. 6/26/06 Medical records received from hospital which reveal patient experienced fever & vaccine reaction as diagnosis.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vaccine positive rechallenge
Clinical narrative: At 2 months of age patient received Pediarix, Prevnar, Hib. That evening became limp, T to LOS, apneic. Did not require intubation. Hospitalized for 24 hours. At 4 months received only HIB and Prevnar. Similar reaction with perhaps TI02, same slight tonic movement. Watched overnight no sequelae. 6/26/06 Medical records received from hospital which reveal patient experienced fever & vaccine reaction as diagnosis.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Malaise, Rash
Clinical narrative: Pt called and said she had a rash on face, chest and shoulder, Thursday morning that lasted until Sunday. She went to ER on Monday because she felt sick and couldn't breath. Said she was told by ER Dr not to take another one.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Joint range of motion decreased, Shoulder pain, Skin ulcer
Clinical narrative: Pt had large 6cm in diameter lesion around site with shoulder pain and decrease ROM of right shoulder was given Benadryl and antibiotic.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Both of Pts legs were red, swollen and hot to the touch. Pts mom stated that pt may have had a reaction with last set of shots at 6 months of age.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Left arm local swelling, redness and tenderness 3x4cm by 48 hours at IM site left.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Injection site hypersensitivity, Injection site warmth
Clinical narrative: 6cm, warm, red circle surrounding vaccination site.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Woke 4-8-06 with hives on legs. Gave Benadryl, hives on legs again 4/9/06 and few on face. Relieved with Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 x 6 cm area of erythema left deltoid and 2 cm area induration left deltoid.
Age: 1.33
Sex: F
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper thigh erythemic 8 x 2 cm, nonfluctuant mini /// warm treatment (Orapred if swelling still there tomorrow). Benadryl, cool compresses.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Crying, Oral intake reduced
Clinical narrative: High pitch crying for at least 3 hours, inconsolable with decreased feeding. Event occurred about 24 hours after the Pediarix shot.
Age: 1.33
Sex: F
Vaccine: IPV, PNC, VARCEL
Symptoms: Antinuclear antibody positive, Aspartate aminotransferase increased, Face oedema, Prothrombin time prolonged, Purpura
Clinical narrative: Rash, 03/24/06 blanching macular, 03/27/06 mac/pap rash on trunk and legs. 4/3/06, edema eyes and nose purpuric rash.
Age: 1.33
Sex: F
Vaccine: IPV, PNC, VARCEL
Symptoms: Rash maculo-papular, Red blood cell sedimentation rate increased
Clinical narrative: Rash, 03/24/06 blanching macular, 03/27/06 mac/pap rash on trunk and legs. 4/3/06, edema eyes and nose purpuric rash.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Anorexia, Arthralgia, Dizziness, Fatigue
Clinical narrative: Patient vaccinated, injection site was SQ posterior aspect of left UA.  With 12h site swelling began with flu like symptoms with GI symptoms, abdom pain, gas, indigestion, with fever 99.1.  Progressed to anorexia, myalgia, arthralgia, malaise/fatigue, light-headedness, headaches.  The swelling was >120mm 3" below shoulder 4" above elbow on Wednesday.  Site was warm to the touch.  Patient was placed on NSAID Q6H and told to apply a warm compress for the first 24 hours and told the cold compress was ordered Q4H for 30min and continue with NSAID.  Patient check daily by provider.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Flatulence, Gastrointestinal disorder, Headache, Influenza like illness, Injection site swelling
Clinical narrative: Patient vaccinated, injection site was SQ posterior aspect of left UA.  With 12h site swelling began with flu like symptoms with GI symptoms, abdom pain, gas, indigestion, with fever 99.1.  Progressed to anorexia, myalgia, arthralgia, malaise/fatigue, light-headedness, headaches.  The swelling was >120mm 3" below shoulder 4" above elbow on Wednesday.  Site was warm to the touch.  Patient was placed on NSAID Q6H and told to apply a warm compress for the first 24 hours and told the cold compress was ordered Q4H for 30min and continue with NSAID.  Patient check daily by provider.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site warmth, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient vaccinated, injection site was SQ posterior aspect of left UA.  With 12h site swelling began with flu like symptoms with GI symptoms, abdom pain, gas, indigestion, with fever 99.1.  Progressed to anorexia, myalgia, arthralgia, malaise/fatigue, light-headedness, headaches.  The swelling was >120mm 3" below shoulder 4" above elbow on Wednesday.  Site was warm to the touch.  Patient was placed on NSAID Q6H and told to apply a warm compress for the first 24 hours and told the cold compress was ordered Q4H for 30min and continue with NSAID.  Patient check daily by provider.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Influenza like illness, Injection site inflammation, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Mild flu like reacton, local inflammation to Tdap. Febrile, stomach ache, sore throat since Tdap administered (4-11-06).
Age: 19.0
Sex: F
Vaccine: FLU3, YF
Symptoms: Abdominal pain
Clinical narrative: 6 hours after receiving YF vaccine client c/o abdominal pain and was taken to the ER by father who is a physician.  Given Lortab for pain, but no relief and returned again to ER with same c/o.  Telephone call from mother with above information and she stated that they were going to check her liver enzymes at that time.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Vertigo
Clinical narrative: By 9:15 AM he says his hands were numb and tingling and this moved up his arms.  By 9:25 AM he had returned to the health department and his arms felt very weak and he had vertigo.  He laid down and BP=120/80, P=68/min.  Gave him food and juice 10:15 AM left BP=120/72, P=68/min.  Sitting up, no vertigo.  Numbness gone, has some strength back, not normal yet.  Left with his mother to go to doctor's office.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: SLIGHT REDNESS ONE DAY AFTER ADMINISTRATION OF DTAP AND IPV. THIS HAS SINCE PROGRESS 2 DAYS LATER.
Age: 1.48
Sex: F
Vaccine: DTAP, FLU3, HEP, VARCEL
Symptoms: Abdominal pain upper, Dermatitis contact, Injection site swelling, Injection site vesicles, Irritability
Clinical narrative: 10/19/05: Mom called PCP re swelling on L leg the size of a quarter at site of vaccines had increased to double that size.  Instructed to use ice and tylenol.  10/27/05: Mom called PCP child's tummy not feeling well. 11/7/05: 2PM PCP office visit. Both of child's thighs have large blisters with welts on L thigh.  PCP states contact dermatitis inner groin due to new diaper wipes.  Instructed to stop using new diaper wipes. 11/7/05: 7:30 PM Mom called stating rash spreading to eyes, face and going down neck, child fussy.  Instructed to go to ED. 11/7/05: ED physical exam states vital signs stable. afebrile. Does not appear ill. ENT: Oropharnynx: Clear. TMs and throat clear. Neck supple. Lungs: clear.Cardiac: regular rate and rhythm. Skin: diaper area-type rash, but well peripheral to this there are also some separate and distinct-appearing urticarial plaques out on the lateral thighs. Similar urticarial plaques can be noticed on the back of the neck. No vesicles, pustules or drainage or discharge.  No petechiae, prpura.  Assessment Urticaria.  Given Benadryl x 1 in ER Resume old wipes and eliminate the new wipes. Benadryl as recommended at home.  FU with doctor.
Age: 1.48
Sex: F
Vaccine: DTAP, FLU3, HEP, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: 10/19/05: Mom called PCP re swelling on L leg the size of a quarter at site of vaccines had increased to double that size.  Instructed to use ice and tylenol.  10/27/05: Mom called PCP child's tummy not feeling well. 11/7/05: 2PM PCP office visit. Both of child's thighs have large blisters with welts on L thigh.  PCP states contact dermatitis inner groin due to new diaper wipes.  Instructed to stop using new diaper wipes. 11/7/05: 7:30 PM Mom called stating rash spreading to eyes, face and going down neck, child fussy.  Instructed to go to ED. 11/7/05: ED physical exam states vital signs stable. afebrile. Does not appear ill. ENT: Oropharnynx: Clear. TMs and throat clear. Neck supple. Lungs: clear.Cardiac: regular rate and rhythm. Skin: diaper area-type rash, but well peripheral to this there are also some separate and distinct-appearing urticarial plaques out on the lateral thighs. Similar urticarial plaques can be noticed on the back of the neck. No vesicles, pustules or drainage or discharge.  No petechiae, prpura.  Assessment Urticaria.  Given Benadryl x 1 in ER Resume old wipes and eliminate the new wipes. Benadryl as recommended at home.  FU with doctor.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and pain.
Age: 16.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Received vaccine on 04/10/2006.  On 04/11/2006, woke up with temperature 103 degrees, eye and lip edema, body aches.
Age: 1.29
Sex: M
Vaccine: HEPA, DTAP, HEPA, HIBV, MMR, PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: After 8 hours of the vaccination, symptoms were vomiting, high temperature, and diarrhea.  Episodes lasted 48 hours.  Took a week to recover.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abscess, Bacterial infection, Cellulitis, Viral infection
Clinical narrative: Received Varivax on 3/21/2006. Seen in office 4/1/06 (had broken out with chicken pox 3/31/06) for cellulitis put on clindamycin 75mg TID. Seen in office 4/2/06 referred to hospital for incision and drainage. Admitted with D of left suprapubic abscess and right flank abscess. Cultured out MRSA. IV Clindamycin. Discharged 4/5/06 on oral Clindamycin x 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Pain, Pruritus
Clinical narrative: Arm red, swollen, tender to touch, itchy.  Area involved 19cm x 21cm.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dermatitis
Clinical narrative: Dermatitis, treated with Benadryl and Calamine.
Age: 1.25
Sex: M
Vaccine: HBHEPB, HEPA, IPV
Symptoms: Injection site discolouration, Rash erythematous
Clinical narrative: Rash started approximately 12 hours after immunization and increased over next 24 hours, punctate, blanching, erythema rash on chest, papules on erythematous on back, no vesicles, annular line of erythema round injection sites, no viral symptoms.
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Abscess, Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: localize swelling, redness, swelling in solid mass like an abscess. Pt had gotten Hep A and Hep B Separately prior to this w/o reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Symptoms started day after shots.  Area has grown gradually more red and swollen since injection.  Arm swollen from mid deltoid to elbow.  No pain, no fever, no warmth.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Epididymitis, Scrotal pain
Clinical narrative: Pain in left scrotum 24 hours after vaccines (see below). Diagnosed with epididymitis. Scrotum was normal on the day of the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Red arm and swollen, felt warm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Child had redness at site of immunization on left arm.  Mother noticed this and felt some hardness at site - noted 04/13/2006 at 07:00AM, by 3:45PM mother states hardness disappeared.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Electroencephalogram abnormal, Laboratory test abnormal, Muscle twitching, Pallor
Clinical narrative: Twitching of one side of the face pale and lasted for about 3 minutes according to the mother. 5/23/06 Received hospital medical records which reveal pt admitted 3/24/06 w/dx partial seizures & d/c 3/27/06.  2 episodes of left side facial twitching/drooling/staring approx 20 s/p DTP booster witnessed by PCP.  Continued to have left facial twitching despite medication.  CT & MRI were neg except for almost complete opacification of max/ethmoid air cells bilaterally.  WBC 22.6 on admit. Had been hospitalized 1 week prior to vax for high fever but all tests neg.  Referred to neurologist for f/u after d/c/ss
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Sinusitis
Clinical narrative: Twitching of one side of the face pale and lasted for about 3 minutes according to the mother. 5/23/06 Received hospital medical records which reveal pt admitted 3/24/06 w/dx partial seizures & d/c 3/27/06.  2 episodes of left side facial twitching/drooling/staring approx 20 s/p DTP booster witnessed by PCP.  Continued to have left facial twitching despite medication.  CT & MRI were neg except for almost complete opacification of max/ethmoid air cells bilaterally.  WBC 22.6 on admit. Had been hospitalized 1 week prior to vax for high fever but all tests neg.  Referred to neurologist for f/u after d/c/ss
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Difficulty in walking, Dysuria, Myelitis, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 3/2/2006 was vaccinated with a dose of Varicella virus vaccine live (lot 647533/0638R). Several days later, on 3/18/2006, the patient was hospitalized. She had approximately 3 lesions on her neck. She had difficulty urinating and difficulty walking. Her legs were extremely weak. She had a tingling sensation in her legs and abdomen. The physician believed the patient had some form of myelitis. An MRI was done on the brain and spinal cord and was normal. The patient was discharged on 3/24/2006. The patient still had some weakness on her left side. It was reported that the patient recovered on 3/24/2006. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 3/2/2006 was vaccinated with a dose of Varicella virus vaccine live (lot 647533/0638R). Several days later, on 3/18/2006, the patient was hospitalized. She had approximately 3 lesions on her neck. She had difficulty urinating and difficulty walking. Her legs were extremely weak. She had a tingling sensation in her legs and abdomen. The physician believed the patient had some form of myelitis. An MRI was done on the brain and spinal cord and was normal. The patient was discharged on 3/24/2006. The patient still had some weakness on her left side. It was reported that the patient recovered on 3/24/2006. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Anaemia, Haemoglobin decreased, Pharyngeal oedema, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old son (now 20 years old) who had an amoxicillin allergy, asthma and acne who on 6/17/2003 was vaccinated IM with a 0.5ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 644576/1013M). Concomitant therapy included albuterol sulfate (Proventil) and tetracycline. The RN reported that on 6/27/2003, her son developed a sore throat, fever and swelling of his neck. On the same day, the patient went to ER and was subsequently hospitalized. A diagnosis of tonsillitis and pharyngitis was made. On 6/28/2003, the patient was discharged from the hospital to home with an antibiotic and ibuprofen. The RN was unclear as to when her son's symptoms resolved, but noted that her son had recovered from the tonsillitis and pharyngitis. The RN also indicated that some time after vaccination, her developed low hemoglobin and was subsequently diagnosed with anemia. She felt that the anemia was not related to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Tonsillitis
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old son (now 20 years old) who had an amoxicillin allergy, asthma and acne who on 6/17/2003 was vaccinated IM with a 0.5ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 644576/1013M). Concomitant therapy included albuterol sulfate (Proventil) and tetracycline. The RN reported that on 6/27/2003, her son developed a sore throat, fever and swelling of his neck. On the same day, the patient went to ER and was subsequently hospitalized. A diagnosis of tonsillitis and pharyngitis was made. On 6/28/2003, the patient was discharged from the hospital to home with an antibiotic and ibuprofen. The RN was unclear as to when her son's symptoms resolved, but noted that her son had recovered from the tonsillitis and pharyngitis. The RN also indicated that some time after vaccination, her developed low hemoglobin and was subsequently diagnosed with anemia. She felt that the anemia was not related to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Chorioretinitis, Delayed delivery, Dysuria, Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a health professional concerning a 17 year old pregnant, female, with a history of 0 pregnancies and 0 live births and no known allergies, who on 9/6/2005 was vaccinated with a 0.5ml subcutaneous dose in the left deltoid of varicella virus vaccine live (lot 649741/0222R). Concomitant vaccines given on the same day included a dose of diphtheria toxoid/tetanus toxoid and a dose of hepatitis B vaccine recomb (manufacturer unknown.). Medication used during pregnancy included prenatal vitamins, daily. It was reported that the patient was at 13 1/7 weeks gestation and that her last menstrual period was 6/5/2005. There was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster symptoms post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that there were no complications during pregnancy, no infections or illnesses during pregnancy and no concurrent medical conditions. On 3/16/2006 the patient experienced the following complications during labor/delivery, dysuria although renal analysis was normal, failure to progress, which resulted in a caesarean section and chorioamnionitis, which was treated with ampicillin and Aztreonam (Azactam). On 3/13/2006 the patient delivered a male baby weighing 8 pounds and 0 ounces. There was no congential anomalies and no other complications or abnormalities. Additional information is not expected. Failure to progress was considered to be other important medical event (OMIC).
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Stridor, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 46 month old immuno compromised female with ulcerative colitis and an allergy to sulfamethoxazole + trimethoprim (Septra) who on 5/12/2003 was vaccinated SC with a dose of Varicella virus vaccine live (Lot 643532/0601M). Concomitant therapy included mercaptopurine and others. On 3/27/2006, the patient developed chickenpox and a fever, and was treated with oral acyclovir for 5 days. Subsequently, she was hospitalized and received IV acyclovir. While hospitalized, she developed stridor and received budesonide (Pulmicort). A CBC was obtained. The outcome was reported as recovered. There was no product quality complaint involved. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
Age: 1.43
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Disturbance in attention, Drug toxicity, Gastrointestinal disorder, Hypokinesia, Immune system disorder
Clinical narrative: Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received form an attorney, regarding a male patient who developed mercury poisoning, neurological injuries, neurodevelopment injuries, developmental delays, learning disabilities, social delays and social deficit, impairment of fine motor skills, gastrointestinal illness and immune system dysfunction. The patient received a dose on 7/1/1997. The patient also received a dose of Diphtheria Tetanus toxoids acellular pertussis vaccine (Acel Imune) on 7/1/1997. Relevant history was not provided. Indication for Hib Titer vaccine was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Diphtheria/Tetanus toxoids/acellular pertussis vaccine (Acel Imune), Diphtheria/ Tetanus toxoids/Pertussis vaccine absorbed/Haemophilus B conjugate (Tetramune), Engerix B (hepatitis B vaccine) and Hyprho D (immunoglobulin human anti RH), which was given to the mother of the patient during her pregnancy. Concomitant medications were not reported. On an unspecified date, the patient developed mercury poisoning (metal poisoning), neurological injuries (nervous system disorder), neurodevelopment injuries (nerve root injury), developmental delays, learning disabilities, social delays, social behavior (disturbance in social behavior), impairment of fine motor skills (psychomotor skills impaired), gastrointestinal illness (gastrointestinal disorder) and immune system dysfunction (immune system disorder). These events reportedly resulted in persistent or significant disability or incapacity. No additional information was available at the time of this report.
Age: 1.43
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Mental retardation severity unspecified, Nervous system disorder, Social avoidant behaviour, Unintended pregnancy
Clinical narrative: Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received form an attorney, regarding a male patient who developed mercury poisoning, neurological injuries, neurodevelopment injuries, developmental delays, learning disabilities, social delays and social deficit, impairment of fine motor skills, gastrointestinal illness and immune system dysfunction. The patient received a dose on 7/1/1997. The patient also received a dose of Diphtheria Tetanus toxoids acellular pertussis vaccine (Acel Imune) on 7/1/1997. Relevant history was not provided. Indication for Hib Titer vaccine was immunisation. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Diphtheria/Tetanus toxoids/acellular pertussis vaccine (Acel Imune), Diphtheria/ Tetanus toxoids/Pertussis vaccine absorbed/Haemophilus B conjugate (Tetramune), Engerix B (hepatitis B vaccine) and Hyprho D (immunoglobulin human anti RH), which was given to the mother of the patient during her pregnancy. Concomitant medications were not reported. On an unspecified date, the patient developed mercury poisoning (metal poisoning), neurological injuries (nervous system disorder), neurodevelopment injuries (nerve root injury), developmental delays, learning disabilities, social delays, social behavior (disturbance in social behavior), impairment of fine motor skills (psychomotor skills impaired), gastrointestinal illness (gastrointestinal disorder) and immune system dysfunction (immune system disorder). These events reportedly resulted in persistent or significant disability or incapacity. No additional information was available at the time of this report.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cellulitis
Clinical narrative: Local progression to Cellulitis
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning 3-4 infants who in 2006 were vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. The physician reported that in 2006, the infants developed a fever after vaccination. Unspecified medical attention was sought. Subsequently, the fevers resolved. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old female (born at 37.4 weeks gestation at 2396 grams) with a history of a NICU admission (3 days) at the time of birth due to a right pneumothorax (unspecified cause) and a normal MRI of the lumbar spine done for a sacral dimple who on 3/14/06 was vaccinated, PO, with the first 2.0 mL dose of ROTETEQ  (lot 0145F). Concomitant vaccinations administered on that same day include a dose of PEDIARIX and PEDVAX HB and a dose of PREVNAR. There was no other concomitant therapy at the time of vaccination. The RN reported that on 3/15/06, the patient's mother called the office reporting her daughter had a bloody stool as she had blood in her diaper. The patient's mother indicated that she did not test the stools with guiac paper for blood. No other symptoms were reported. The RN indicated she had spoken with the patient's mother several times since 3/15/06 and the child did not have any other occurrences of blood in her stool. At the time of this report, the patient was noted to be well and was considered to be recovered. Additional information has been requested. Information has been received from a registered nurse (RN) concerning an 8-week-old female (born 37.4 weeks gestation at 2396 grams) a with a history of a NICU admission (3 days) at the time of birth due to a right pneumothorax (unspecified cause) and a normal MRI of the lumbar spine done for a sacral dimple who, at her 2-month check-up, on 14-MAR-2006, at approximately 1200, was vaccinated, PO, with the first 2.0 mL dose of ROTATEQ (Lot #652964/0145F). Concomitant vaccinations administered on that same day included a dose of PEDIARIX a dose of PREVNAR. Ther was no illness or other concomitant therapy at the time of vaccination. The RN reported the patient's mother called the physician's office indicating that on 15-MAR-2006, at about 0955, her daughter had a bloody stool as she had a small amount of blood in the stool in her diaper. The patient's mother indicated that she did not test the stools with guiac paper for blood. No other symptoms were reported and no laboratory/diagnostic tests were performed. The patient did not require an Emergency Room or doctor visit. The patient was not hospitalized. The mother was advised to monitor her daughter and report any abnormal pain or vomiting. The patient's mother indicated that her daughter's nex stool was normal. As of 16-MAR-2006, the patient was noted to be well and was considered to be recovered. The RN indicated that she has spoken with the patient's mother several times since 15-MAR-2006 and the child did not have any other occurrences of blood in her stool. No further information is available.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Respiratory syncytial virus infection, Viral infection
Clinical narrative: Information has been received from a receptionist in a physician's office concerning a child (age noted to be between 6-12 weeks) who in March 2006, was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. The physician reported that in march 2006, the day after vaccination, the patient developed diarrhea which lasted 12 days. Unspecified medical attention was sought. The child was tested for rotavirus and the results were positive. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Patient had febrile seizure within 24 hours of mmr being given.
Age: 4.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Patient had febrile seizure within 24 hours of mmr being given.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Blood pressure increased, Injection site induration, Injection site mass, Injection site rash, Injection site warmth
Clinical narrative: Pt received vaccinations on 07 April - one in each deltoid.  Pt received Hepatitis B and Anthrax, and documentation was done, but given by someone else (name unknown)  Pt reported warmth in left deltoid for several days, with onset of rash and knot in vaccine adminstration location on 13 April.  Rash grew progressively larger and pt reported on evening of 13 April.  Recorded BP and temperature as being elevated, and referred pt to clinic the next day.  PT has been taking Tylenol for elevated temperature, and seen here in clinic today (14 April).  Vital signs are stable and pt is afebrile.  Rash is approximately 9 cm in diameter with area of induration in the center.