chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Nasal congestion, Pyrexia, Rash, Scab
Clinical narrative: Prevnar injection site went from 2 inches of redness at 2 pm on the 11/25 to an area about 6 inches across at 7 pm on 11/25. The area was hot to the touch, red like a sunburn, and very tight. He moved away when it was touched. The doctor saw the injury the next morning at 9:30 and measured it, 6 1/2 by 3 1/2 inches. He said it was a skin infection with surrounding the shot injection site and prescribed an antibiotic. The baby had been getting motrin for swelling and pain, and that treatment was recommended to continue. The swelling area was marked with a black marker and on the evening of the 26th, the redness and swelling did extend past the original mark about 1/2 inch. The followup appt. was for the 28th and redness and swelling had gone down considerably, but there were red spots on the baby's abdomen that the doctor could not conclude definately to be a continuation of the shot reaction or from the antibiotic, so the antibotic was changed to cleocin. As of this date, the redness and swelling is gone, but there are pinpoint size scabs on the leg, not just at the injection site, but surrounding it in 4 different places, even though there were never any scrapes to the leg. The baby also has had low fever (99-101),a persistant cough and nasal congestion ongoing since 11/30.  1/22/08 MR received from PCP.  OV 11/25/08 for c/o large, red, inflamed area on thigh where vax given 11/24/08.  Increased swelling noted. DX:  imunization reaction.Tx: abx.  F/u 11/28/08 with decreased redness, now with morbilliform rash. ? drug reaction
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Anorexia, Cellulitis, Chills, Injection site induration, Injection site rash
Clinical narrative: Large injection site reaction, with rash, hardened red area of about 6 inches x 3 inches.  101-degree fever for 3 days, followed by chills and shivering.  Overall sickness.  Slept very little, ate very little.  Possible cellulitis from injection.   (As a side note:  Patient was given 3 doses of Prevnar before 6 months of age).
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Insomnia, Pyrexia
Clinical narrative: Large injection site reaction, with rash, hardened red area of about 6 inches x 3 inches.  101-degree fever for 3 days, followed by chills and shivering.  Overall sickness.  Slept very little, ate very little.  Possible cellulitis from injection.   (As a side note:  Patient was given 3 doses of Prevnar before 6 months of age).
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Developed intussusception on 12-3-08. Barium enema reduced it.  1/6/09 Reviewed hospital medical records of 12/3-12/4/08 FINAL DX: Intussusception Records reveal patient experienced colicky abdominal pain, sleep disturbance, decreased appetite, lethargy & bloody stools.  Admitted for overnight observation & d/c to home in AM.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest pain, Dehydration, Hyperventilation, Tremor
Clinical narrative: On 6-26-08, pt presented for immunizations as follows: GARDASIL #1, Tdap #1, MENACTRA #1, and Hepatitis A #1. She was seen in the ER on 6-30-08 after experiencing chest pains, shakiness and tremors. At the time her symptoms began, she was lying on a couch, watching TV. Earlier that day, she had been working in the hot sun and symptoms were attributed to dehydration and anxiety accompanied by hyperventilation. The tremors continued in her legs and to a lesser extent in her arms intermittently for several days. She was seen at clinic on 7-01-08 due to the continued tremors. Doctor agreed with the Emergency Room physician's assessment, that the symptoms were due to dehydration, anxiety and hyperventilation. Pt returned for her second GARDASIL on 9-03-08. That evening, she experienced tremors in her legs and to a lesser extent in her arms throughout the following day. These symptoms were not reported at that time since they had not lasted as long and since the family had not connected the two episodes with the GARDASIL vaccine. When the family called to schedule her third GARDASIL vaccine, it was brought to our attention that she had a similar experience following the first two vaccines. With this information being brought to light, the third GARDASIL will not be given.  12/17/2008 ER record received for 7/1/08 with Impression Esophagitis, Tremors. Pt presented with c/o leg shaking and burning in chest. PE WNL. D/C to f/u with PCP.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Oedema peripheral, Pharmaceutical product complaint
Clinical narrative: This case was reported by a pharmacist and described the occurrence of erythema in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included ibuprofen and TYLENOL. On 3 December 2008, the subject received 3rd dose of ENGERIX B (20 mcg, unknown). On 3 December 2008, less than one day after vaccination with ENGERIX B, the subject experienced erythema, swelling and pharmaceutical product complaint. Pharmacist reported a female subject received the 3rd dose of ENGERIX B series on 03 December 2008. Vaccine was given in the outer aspect of the arm and by the evening, the inner aspect of the arm was red and swollen. By 04 December 2008, these symptoms had gotten aggressively worse so the subject went to the emergency room. At the time of call, subject was still at the hospital. The pharmacist indicated that the "healthcare facility does not want to use remaining vaccines with same lot number but return them". The pharmacist considered the events were disabling. At the time of reporting the events were worse. The pharmacist considered the events were probably related to vaccination with ENGERIX B.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Eosinophilia, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a physician and described the occurrence of pruritus body rash in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included wheezing. On 23 October 2008, the subject received a dose of FLULAVAL (unknown). On 25 October 2008, two days after vaccination with FLULAVAL, the subject experienced pruritus body rash and vesicular lesions. On 03 November 2008, eleven days after vaccination with FLULAVAL, the subject experienced eosinophil infiltration of skin. At an unspecified time after vaccination with FLULAVAL, the subject experienced wheezing. The physician stated a subject received FLULAVAL on 23 October 2008 and presented with a pruritic severe rash all over her body that was diffuse, contained vesicular lesions on 25 October 2008. She saw a dermatologist on 03 November 2008 who performed a skin biopsy and showed eosinophilic infiltrates in the rash. The subject also experienced wheezing flare-ups that correspond to flare ups of the rash. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: This case was reported by a physician and described the occurrence of pruritus body rash in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included wheezing. On 23 October 2008, the subject received a dose of FLULAVAL (unknown). On 25 October 2008, two days after vaccination with FLULAVAL, the subject experienced pruritus body rash and vesicular lesions. On 03 November 2008, eleven days after vaccination with FLULAVAL, the subject experienced eosinophil infiltration of skin. At an unspecified time after vaccination with FLULAVAL, the subject experienced wheezing. The physician stated a subject received FLULAVAL on 23 October 2008 and presented with a pruritic severe rash all over her body that was diffuse, contained vesicular lesions on 25 October 2008. She saw a dermatologist on 03 November 2008 who performed a skin biopsy and showed eosinophilic infiltrates in the rash. The subject also experienced wheezing flare-ups that correspond to flare ups of the rash. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose decreased, Convulsion, Dizziness, Flushing
Clinical narrative: This case was reported by a vaccine wholesale distributor and described the occurrence of flushing in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008, the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flushing, weakness, diaphoresis and dizziness. It was reported that the subject was placed in the supine position, given orange juice, a fruit bar and had cold compresses applied to the forehead. She was observed closely by the staff, released after 25 minutes (details of where the subject was released from was not provided). The subject was instructed to go to the emergency room if symptoms continued or worsened. At the time of reporting the outcome of the events were unspecified. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755229A. GSK case number A0755269A is a duplicate of A0753609A. All future correspondence will be submitted to A0755269A. Concurrent medications included ZOCOR, SYNTHROID, LEXAPRO and CALTRATE PLUS minerals. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 5 minutes after vaccination with FLULAVAL, the subject experienced a pre-syncope episode requiring a doctor's visit. At the time of reporting the outcome of the pre-syncope episode was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the office for 30 minutes and then released. The reporter was concerned with this particular lot number (pharmaceutical product complaint). Follow-up information was received on 03 December 2008, via healthcare professional who reported the subject has a history of diabetes, hyperlipidemia, depressive disorder, and hypothyroidism. The events occurred on 21 October 2008 and resolved the same day. Additional events of decreased blood sugar and seizure were reported. The follow-up information did not state specific details regarding the seizure experienced by the subject. Information regarding seizure symptoms were provided and stated it was witnessed, the subject had weakness in lower extremities and she did not lose consciousness. She did remember the event and was monitored in the exam room. The subject was taking LEXAPRO antidepressant which is known to reduce the seizure threshold. The reporting healthcare professional considered the events life threatening and related to vaccination with FLULAVAL.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pharmaceutical product complaint, Presyncope
Clinical narrative: This case was reported by a vaccine wholesale distributor and described the occurrence of flushing in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008, the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flushing, weakness, diaphoresis and dizziness. It was reported that the subject was placed in the supine position, given orange juice, a fruit bar and had cold compresses applied to the forehead. She was observed closely by the staff, released after 25 minutes (details of where the subject was released from was not provided). The subject was instructed to go to the emergency room if symptoms continued or worsened. At the time of reporting the outcome of the events were unspecified. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755229A. GSK case number A0755269A is a duplicate of A0753609A. All future correspondence will be submitted to A0755269A. Concurrent medications included ZOCOR, SYNTHROID, LEXAPRO and CALTRATE PLUS minerals. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 5 minutes after vaccination with FLULAVAL, the subject experienced a pre-syncope episode requiring a doctor's visit. At the time of reporting the outcome of the pre-syncope episode was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the office for 30 minutes and then released. The reporter was concerned with this particular lot number (pharmaceutical product complaint). Follow-up information was received on 03 December 2008, via healthcare professional who reported the subject has a history of diabetes, hyperlipidemia, depressive disorder, and hypothyroidism. The events occurred on 21 October 2008 and resolved the same day. Additional events of decreased blood sugar and seizure were reported. The follow-up information did not state specific details regarding the seizure experienced by the subject. Information regarding seizure symptoms were provided and stated it was witnessed, the subject had weakness in lower extremities and she did not lose consciousness. She did remember the event and was monitored in the exam room. The subject was taking LEXAPRO antidepressant which is known to reduce the seizure threshold. The reporting healthcare professional considered the events life threatening and related to vaccination with FLULAVAL.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea
Clinical narrative: Patient felt a little tighter in breathing. Worried it might be anaphylaxis. But also has anxiety problems that make breathing more difficult.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swelling at injection site, fever, nausea.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain
Clinical narrative: Throbbing, aching, (inflamed) pain 3".
Sex: F
Vaccine: FLU3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Fine papular rash covering entire trunk and arms, itchy.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Eye discharge, Nasal congestion, Ocular hyperaemia, Pharyngeal oedema, Vision blurred
Clinical narrative: 3:00 pm blurred vision began. 3:30 pm swollen throat began. 4:00 pm congestion began. 5:00 pm noticed eyes were red and yellow discharge in the inner corners. Declining health through the evening. Slept 14 hours, felt better.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Glaucoma, Nausea, Ocular hyperaemia
Clinical narrative: See attached sheet.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Photosensitivity reaction, Rheumatoid factor negative, Somnolence, Uveitis
Clinical narrative: See attached sheet.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site swelling
Clinical narrative: Slightly puffy area on left thigh. Crying x 30-45 min.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: ADACEL administered 11/7/08, Pt arm redness, swelling, fever to 102 deg. 8x9 cm red, raised area of administration site on 11/10.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Blood test normal, Joint swelling, Pain
Clinical narrative: Developed swelling and pain 2 days post vaccine in (L) knee. Evaluated by PCP x-rays and blood work NEG Dx "Reactionary Arthritis" Took Tylenol for pain.
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Developed swelling and pain 2 days post vaccine in (L) knee. Evaluated by PCP x-rays and blood work NEG Dx "Reactionary Arthritis" Took Tylenol for pain.
Age: 24.0
Sex: U
Vaccine: FLUN3
Symptoms: Pruritus, Rash papular, Skin lesion, Urticaria
Clinical narrative: Developed hives to bilateral antecubes 1.5 hours after receipt first Flumist vaccine. Itching and increased hive formation noted after shower 16-24 hr post vac. Seen by Clinic MD and dx with urticaria. No other symptoms. Symptoms: Pruritus, lesions, papule.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Tremor
Clinical narrative: Patient sat down next to father after vaccines were given in the triage area. Several staff saw patient put head down and shook her head for a few seconds. Vital signs were then obtained of 10 minutes for 30 minutes. Vital signs were stable. Patient was given cold water to drink and crackers.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Rash, Swelling
Clinical narrative: Soreness on arm, swelling, rash and red bands.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Oedema, Swelling
Clinical narrative: Patient was seen on 11.21.08 and Dr noted: Patient presents for evaluation of a "reaction" that developed after receiving his PNEUMOVAX injection on Wed am. The next day he noticed rednedd and swelling of the upper arm along the lateral aspect extending downward toward elbow. There was initial redness at injection site but this area has resolved leaving only the mid and distal arm with redness and localized edema.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture, Erythema, Full blood count, Headache, Injection site cellulitis
Clinical narrative: Patient was seen on 11.17.08 and noted: lesion on upper extremity: arm, on the right for 2 days, which has been painful and red. It has been swollen, and has not been draining pus/fluid. Started Sat am after receiving PNEUMOVAX on Friday, low grade fever up to 100 degrees, vomited once, and has a headache. Patient was seen on 11.18.08 and Dr noted: this is a 17 year old female patient who comes in to the clinic in follow up after yesterday's visit. Yesterday we treated her for a cellulitis at the site of injection that had occurred on 11/14/08. The area was red, warm and swollen. I had started her on CLINDAMYCIN orally and that area had actually improved. It is much lighter red, the swelling is better and the warmth is better but overnight she has developed a new area about 2 inches below the site of injection that looks very similar and has been growing bigger. It is very red, warm and swollen as well. They had been putting compresses on the area. She has had three doses of CLINDAMYCIN. Patient was seen on 11.20.08 and Dr noted: 17 year old female here for a follow up reaction to PNEUMOVAX received 11.14.08 However, the injection site for the flu shot has remained uneventful. She was seen at ER for IV antibiotic therapy and is finally responding. She is taking CLEOCIN and DOXYCYCLINE. Patient was seen on 11.21.08 and Dr noted: resolving cellulitis. There is little to no heat or induration of distal aspect of upper arm but small amount of induration remains at injection site.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Metabolic function test, Pain
Clinical narrative: Patient was seen on 11.17.08 and noted: lesion on upper extremity: arm, on the right for 2 days, which has been painful and red. It has been swollen, and has not been draining pus/fluid. Started Sat am after receiving PNEUMOVAX on Friday, low grade fever up to 100 degrees, vomited once, and has a headache. Patient was seen on 11.18.08 and Dr noted: this is a 17 year old female patient who comes in to the clinic in follow up after yesterday's visit. Yesterday we treated her for a cellulitis at the site of injection that had occurred on 11/14/08. The area was red, warm and swollen. I had started her on CLINDAMYCIN orally and that area had actually improved. It is much lighter red, the swelling is better and the warmth is better but overnight she has developed a new area about 2 inches below the site of injection that looks very similar and has been growing bigger. It is very red, warm and swollen as well. They had been putting compresses on the area. She has had three doses of CLINDAMYCIN. Patient was seen on 11.20.08 and Dr noted: 17 year old female here for a follow up reaction to PNEUMOVAX received 11.14.08 However, the injection site for the flu shot has remained uneventful. She was seen at ER for IV antibiotic therapy and is finally responding. She is taking CLEOCIN and DOXYCYCLINE. Patient was seen on 11.21.08 and Dr noted: resolving cellulitis. There is little to no heat or induration of distal aspect of upper arm but small amount of induration remains at injection site.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate, Skin lesion, Swelling, Vomiting
Clinical narrative: Patient was seen on 11.17.08 and noted: lesion on upper extremity: arm, on the right for 2 days, which has been painful and red. It has been swollen, and has not been draining pus/fluid. Started Sat am after receiving PNEUMOVAX on Friday, low grade fever up to 100 degrees, vomited once, and has a headache. Patient was seen on 11.18.08 and Dr noted: this is a 17 year old female patient who comes in to the clinic in follow up after yesterday's visit. Yesterday we treated her for a cellulitis at the site of injection that had occurred on 11/14/08. The area was red, warm and swollen. I had started her on CLINDAMYCIN orally and that area had actually improved. It is much lighter red, the swelling is better and the warmth is better but overnight she has developed a new area about 2 inches below the site of injection that looks very similar and has been growing bigger. It is very red, warm and swollen as well. They had been putting compresses on the area. She has had three doses of CLINDAMYCIN. Patient was seen on 11.20.08 and Dr noted: 17 year old female here for a follow up reaction to PNEUMOVAX received 11.14.08 However, the injection site for the flu shot has remained uneventful. She was seen at ER for IV antibiotic therapy and is finally responding. She is taking CLEOCIN and DOXYCYCLINE. Patient was seen on 11.21.08 and Dr noted: resolving cellulitis. There is little to no heat or induration of distal aspect of upper arm but small amount of induration remains at injection site.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray normal, Computerised tomogram normal, Culture urine negative
Clinical narrative: Sudden onset unresponsiveness 5 hours after vaccinations with persistent abnormal mental status.  12/23/2008 MR received for DOS 12/2-4/2008 with DX:  ALTE. Pt presented after an episode of unresponsiveness and pallor. Pt's eyes rolled back and pt was clammy and "out of it".  Responsive only to pain. Still with altered mental status/LOC in ER, somewhat improved with IVF.  Admitted for sepsis w/u. Dx with GERD.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Herpes simplex serology negative, Influenza serology negative, Lumbar puncture normal, Mental status changes, Polymerase chain reaction
Clinical narrative: Sudden onset unresponsiveness 5 hours after vaccinations with persistent abnormal mental status.  12/23/2008 MR received for DOS 12/2-4/2008 with DX:  ALTE. Pt presented after an episode of unresponsiveness and pallor. Pt's eyes rolled back and pt was clammy and "out of it".  Responsive only to pain. Still with altered mental status/LOC in ER, somewhat improved with IVF.  Admitted for sepsis w/u. Dx with GERD.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Respiratory syncytial virus test, Unresponsive to stimuli
Clinical narrative: Sudden onset unresponsiveness 5 hours after vaccinations with persistent abnormal mental status.  12/23/2008 MR received for DOS 12/2-4/2008 with DX:  ALTE. Pt presented after an episode of unresponsiveness and pallor. Pt's eyes rolled back and pt was clammy and "out of it".  Responsive only to pain. Still with altered mental status/LOC in ER, somewhat improved with IVF.  Admitted for sepsis w/u. Dx with GERD.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site down to patient's Rt elbow.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Facial palsy
Clinical narrative: Burning left side of face (Hot) (shot given (L) arm) Resolved 1 hr. History of Bell's Palsy 2/08 no treatment needed. No other neuralogia signs/symptoms.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Diagnostic procedure, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain became severe approximately 2 hours after influenza vaccination, with inability to raise arm; active range of motion severely compromised, passive range of motion moderately compromised. Mild chronic pain; moderate to severe night pain. Consistent with adhesive capsulitis. Tx: Naproxen 500 mg bid, steroid injection at shoulder, daily physical therapy.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray
Clinical narrative: Shoulder pain became severe approximately 2 hours after influenza vaccination, with inability to raise arm; active range of motion severely compromised, passive range of motion moderately compromised. Mild chronic pain; moderate to severe night pain. Consistent with adhesive capsulitis. Tx: Naproxen 500 mg bid, steroid injection at shoulder, daily physical therapy.
Age: 17.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Nausea, Palpitations
Clinical narrative: nausea & increased racing heartbeat
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Full blood count normal, Grand mal convulsion, Laboratory test normal
Clinical narrative: My son received the Flumist vaccine on November 7th at 4:30pm.  On November 8th at approximately 2:30 am, he had a grand mal seizure.  He was not ill at the time and was afebrile.  We went to the ER, and his labs and CAT scan were normal.  The next week he had an MRI and EEG, both of which were also normal.  He has not had another seizure since.  He has no past history of seizures.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: My son received the Flumist vaccine on November 7th at 4:30pm.  On November 8th at approximately 2:30 am, he had a grand mal seizure.  He was not ill at the time and was afebrile.  We went to the ER, and his labs and CAT scan were normal.  The next week he had an MRI and EEG, both of which were also normal.  He has not had another seizure since.  He has no past history of seizures.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Nausea, Oedema peripheral
Clinical narrative: I experienced dizziness, nausea, and headache about an hour after my third Gardasil injection.  My left arm was sore and swollen.  I had all these symptoms, but much less severe after the first and second injections.  I contacted my doctor's office after the third and they instructed me to come in if I felt it were an emergency or take OTC medication for the pain and swelling and see if the symptoms resided.  I took 600 mg of ibuprofen which helped mildly with the pain. The dizziness and nausea were gone within 24 hours.  My arm continued to be sore to the touch and difficult to move for about 14 days post injection; longer than I have ever experienced after a vaccination.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: I experienced dizziness, nausea, and headache about an hour after my third Gardasil injection.  My left arm was sore and swollen.  I had all these symptoms, but much less severe after the first and second injections.  I contacted my doctor's office after the third and they instructed me to come in if I felt it were an emergency or take OTC medication for the pain and swelling and see if the symptoms resided.  I took 600 mg of ibuprofen which helped mildly with the pain. The dizziness and nausea were gone within 24 hours.  My arm continued to be sore to the touch and difficult to move for about 14 days post injection; longer than I have ever experienced after a vaccination.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza like illness, Injection site pain, Pain
Clinical narrative: Symptoms resembling influenza: chills, fever, aches and pains in arms and body.  Arm unusually sore at the vaccination site on the day of injection and couple of days after injection on 10/21/08.  Flu-like symptoms again on 12/1/2008 that are still in progress with severe chills, fever, aches, pains, coughing, sneezing, running nose, etc.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Symptoms resembling influenza: chills, fever, aches and pains in arms and body.  Arm unusually sore at the vaccination site on the day of injection and couple of days after injection on 10/21/08.  Flu-like symptoms again on 12/1/2008 that are still in progress with severe chills, fever, aches, pains, coughing, sneezing, running nose, etc.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Received zostrvax 0.5 ml@1230pm.  Presented to clinic 45 min. later with itchy skin on throat Injection of .5ml benadryl given.  NOTE:  Pt received anesthesia for mole excision on back prior to presenting to immunizations for zostrix.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mole excision, Pruritus, Throat irritation
Clinical narrative: Received zostrvax 0.5 ml@1230pm.  Presented to clinic 45 min. later with itchy skin on throat Injection of .5ml benadryl given.  NOTE:  Pt received anesthesia for mole excision on back prior to presenting to immunizations for zostrix.
Age: 23.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Acute tonsillitis, Dysphagia, Pruritus generalised, Pyrexia, Rash
Clinical narrative: Pt developed maculopapular rash associated with generalized itchiness without respiratory involvement after receiving anthrax and flumist 18 Nov 08. On 20 Nov 08, pt was also seen in ship's medical with complaint of fever and diff of swallowing, dx with acute tonsilitis and was given azithromycin and tylenol for fever. Pt developed the rash 8 hours after medication were given and 2 days after shot/mist were given.
Age: 23.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Rash maculo-papular
Clinical narrative: Pt developed maculopapular rash associated with generalized itchiness without respiratory involvement after receiving anthrax and flumist 18 Nov 08. On 20 Nov 08, pt was also seen in ship's medical with complaint of fever and diff of swallowing, dx with acute tonsilitis and was given azithromycin and tylenol for fever. Pt developed the rash 8 hours after medication were given and 2 days after shot/mist were given.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Lip swelling, Pruritus, Rash maculo-papular
Clinical narrative: Pt developed generalized maculopapular rash and pruritus after the second dose of anthrax, no respiratory involvement. Pt had mild lip swelling after the first dose of anthrax but also received smallpox and flumist 2 weeks before the 2nd dose.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Crying, Depression, Electrocardiogram normal, Headache
Clinical narrative: Information has been received from a consumer concerning his 26 year old girlfriend with an occasional migraine, who was vaccinated with the complete series of GARDASIL. Concomitant therapy included hormonal contraceptives. Beginning either after the first or second vaccination, she began to experience headaches, depression, nausea, physical pain, crying, migraines, vomiting, and had became "a shell person". The patient was hospitalized overnight for a spinal tap. At one time she was going to the emergency room 3 times a week. She has had a battery of medical tests that included a MRI, an EKG and a spinal tap which all came back normal. The reporter stated that the GARDASIL had ruined her life, her career and his relationship with her. The patient has been treated with many unspecified medications. The patient present status is not recovered. The patient sought medical attention. Ruined her life, her career and relationship were considered to be disabling. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Lumbar puncture normal, Migraine, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a consumer concerning his 26 year old girlfriend with an occasional migraine, who was vaccinated with the complete series of GARDASIL. Concomitant therapy included hormonal contraceptives. Beginning either after the first or second vaccination, she began to experience headaches, depression, nausea, physical pain, crying, migraines, vomiting, and had became "a shell person". The patient was hospitalized overnight for a spinal tap. At one time she was going to the emergency room 3 times a week. She has had a battery of medical tests that included a MRI, an EKG and a spinal tap which all came back normal. The reporter stated that the GARDASIL had ruined her life, her career and his relationship with her. The patient has been treated with many unspecified medications. The patient present status is not recovered. The patient sought medical attention. Ruined her life, her career and relationship were considered to be disabling. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Personality change, Quality of life decreased, Vomiting
Clinical narrative: Information has been received from a consumer concerning his 26 year old girlfriend with an occasional migraine, who was vaccinated with the complete series of GARDASIL. Concomitant therapy included hormonal contraceptives. Beginning either after the first or second vaccination, she began to experience headaches, depression, nausea, physical pain, crying, migraines, vomiting, and had became "a shell person". The patient was hospitalized overnight for a spinal tap. At one time she was going to the emergency room 3 times a week. She has had a battery of medical tests that included a MRI, an EKG and a spinal tap which all came back normal. The reporter stated that the GARDASIL had ruined her life, her career and his relationship with her. The patient has been treated with many unspecified medications. The patient present status is not recovered. The patient sought medical attention. Ruined her life, her career and relationship were considered to be disabling. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness & swelling at site of injection with a pimple-like raised area at the actual injection site.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling at site, date given 11-04-08. Calls 11-7-8 with report pain at site, warmth, swelling and red approx size of fist X 2 days. Pt. advised her to use ice with heat and TYLENOL PRN, per RN Pt to call in 4 hr before office closes with report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: PT had influenza injection in deltoid.  C/o deep muscle pain to wrist X 2-3 weeks.   Took OTC ALLEVE sporadically.  Concerned re: nerve damage or staph infection pending.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry mouth, Lip swelling, Throat irritation
Clinical narrative: 12/1/08 5pm patient states cough, some swelling under tongue and chills. 12/2/08 Patient called office complaining of mouth dry, lips puffy, throat scratchy. No swallowing or breathing difficulty. Injection site without redness or swelling, afebrile.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Food allergy, Immediate post-injection reaction, Lip swelling
Clinical narrative: Lip swelling within 15 minutes of injection. Immediately went to ED. Treated with BENADRYL, Cortisone injection. Was able to leave ED 3 hours later. Full recovery.
Age: 9.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Raised area of induration and redness, urticaria at site of vaccine administration noted next morning with pain.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administered DTAP instead of Tdap.  No side effects.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Received Tdap vaccine, 24 hours later had vomiting every 10 minutes for 6 hours. Since then without problems except slight soreness to arm. Missed 1 day of work.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Nausea, Rash, Stomach discomfort
Clinical narrative: 11/17/08- Received Tdap (+) BACTRIM (1st time) and developed headache, fatigue, nausea, upset stomach, rash. 11/24/08- BACTRIM discontinued. 11/25/08- Returned to clinic- received Prednisone and Hydroxyzine. Symptoms resolved in 24 hours.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye pruritus, Eye swelling, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Red swollen eyes 4 hrs after shot. Also have a slight fever and sore throat. Eyes have a yellow discharge and are itchy.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Red swollen eyes 4 hrs after shot. Also have a slight fever and sore throat. Eyes have a yellow discharge and are itchy.
Age: 3.0
Sex: M
Vaccine: FLUN3, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Area edema, red, warm.
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Varicella
Clinical narrative: We received call from Buford Care that patient had been seen in their office with diagnosis of chicken pox on 11/26/08.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Gait disturbance, Tenderness
Clinical narrative: Client received Menactra and HPV4 vaccines during day on 9-22-08.  Client states that by 9:00 pm on 9-22-08, her entire body was very sore.  Client states it was painful to walk.  Client did not seek medical attention but client's mother did call an after hours health access phone line.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt. accidentally given a MENACTRA instead of an MMR on 12/5/08, error discovered on 12/8/08. Called mom. Pt. doing well. No treatment needed.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Very tender erythematus, 5x6 cm area at injection site. 100 degree temperature 48 hours later.
Age: 9.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site warmth
Clinical narrative: Patient returned to clinic 12/6/2008 with complain of redness of right arm. Erythema, extended about 7cm in annular pattern at site of vaccine injection. Warm to touch.
Age: 1.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Varicella
Clinical narrative: Child was vac. on 07/30/08. Has developed case of chickenpox. (noticed 12/1/08 by mom)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 24 hrs after DTaP/ MMR II, developed redness, swelling and induration around site, about 10 cm around. Started on PO bachrim for presumed cellultis. 0 improvement in 24 deg --> evaluated by Pedid in ED all meds d/c'ed.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site pain, Injection site swelling, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 19 year old female, who in February 2008, was vaccinated with the first dose of (dose and duration not reported). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient experienced an indentation at the injection site, it appeared that there was soft tissue or subcutaneous fat missing in an area of a centimeter and a half, and there was a little bit of swelling below that area. The patient indicated that the indentation was getting bigger and the indentation was painful at times. At the time of the report, the patient was not recovered. The patient sought medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a Licensed Practical Nurse concerning a 20 year old female with allergies and sinusitis who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 660393/0067X) IM into the left arm. Concomitant therapy included DESOGEN. 3 weeks prior to 14-OCT-2008, on 23-SEP-2008, the patient developed a dimple or indent of the skin on the left arm. There is slight pain with pressure at the injection site. The patient was seen in the office on 14-OCT-2008. The dimple had increased in size. At the time of the report the patient had not recovered. Follow-up information was received from the Licensed Practical Nurse which reported that the patient has a nickel allergy and mild asthma. It was reported that in 2002 the patient had a tetanus booster (manufacturer unknown). On 21-NOV-2008, the patient went to the doctor's office complaining of dimpling of the left deltoid. The patient had no illness at the time of vaccination. A few weeks after vaccination, the patient had noted dimpling and pain at the injection site, she had no redness or sloughing in the skin, the patient had no fever and she believed the lesion was increasing in size and wanted to have this evaluated by an specialist. Patient weight: 134, blood pressure: 124/68 and temperature 97.8 F. Medical examination showed a stable appearing dimpling size 2.5 cm horizontally and 1 cm vertically. It appeared that there was lots of subcutaneous tissue. There was no evidence of secondary infection or sensory deficits at the site. The physician reported that dimpling and pain of left deltoid likely secondary to GARDASIL. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with the first dose of GARDASIL vaccine. Concomitant therapy included antibiotic (unspecified). The physician reported that about 1 day after the patient received the shot of GARDASIL vaccine, she experienced a rash over most of her body. The patient sought medical attention from the physician. Additional information has been requested
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dyspnoea, Injection site pain, Pain, Pyrexia
Clinical narrative: RECD VACCINES MID AFTERNOON 11-12-08. STATES THAT IN THE NIGHT SHE BEGAN HAVING FEVER,CHILLS & PAIN @ INJECTION SITES. ALSO STATES SHE ACHED ALL OVER.ALSO INDICATED SHE HAD LABORED BREATHING. TOOK ASPIRIN FOR FEVER & PAIN.wAS SEEN BY ONE OF THE ACHD PRACTITIONERS.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Pain, Swelling
Clinical narrative: Hard swelling and soreness at injection site (left deltoid), persisting for 6 weeks.  Pain increases in upper left arm and shoulder after physical activity.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Palpitations, Pyrexia
Clinical narrative: 1.Minor pain around area shot was administered.2. Two days of racing heart.3. Two weeks of fever and cough. I have not had a reaction like this any time before.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Erythema, Inflammation, Local reaction, Rash pruritic, Skin warm
Clinical narrative: LOCAL RED, WARM AND INFLAMMED REACTION ON LEFT ARM, SHOULDER AREA.  ITCHY RASH ALSO ON SHOULDER AREA.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Convulsion, Muscle contracture, Syncope
Clinical narrative: Syncope with seizure activity and bilat forearm contractures (normal respiratory rate) after smallpox vaccination.  Also had anthrax and typhoid vaccinations before given smallpox vaccine.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Back pain
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with right knee, hip and back pain. Vaccination took place 3/13/08. According to the physician, the relationship to reatment is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request. 12/15/05-records received-C/O right knee, hip and back pain on 3/13/08-Hospitalized 7/15-7/25/08.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash
Clinical narrative: red, raised rash over torso and face over 4-5 days, benadryl given by primary care physician
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Rash macular
Clinical narrative: SPLOTCHES, COUGH DIFFICULTY BREATHING  PATIENT WAS TREATED WITH 0.3cc OF EPINEPHRINE (LDIM), PER DR'S ORDER.
Age: 54.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Activities of daily living impaired, Weight decreased
Clinical narrative: A week after getting two vaccination one vaccination was for Pneumonia the second was for Tetanus. Patient lost the use of her right foot and leg. Within the next 4 days she lost the use of her right leg. This has now moved in to her arms. She is unable to feed herself. She has to be taken to the bathroom and set on the commode. After she has finished using the toilet she has to be cleaned up by me because she can't clean herself. I have to carry her to the shower and bathe her while in the shower. Then I have to dry her and get her dressed. Then I take her back to her chair where she stays. She has lost about 13 pounds since she got the shots. 12/17/08-records received-for DOS 10/14-10/17/08-DC DX Right leg weakness, myopathy, neuropathy. Likely post-vaccination syndrome. In May received vaccine subsequently had progressive weakness involving right leg, had a fall due to leg weakness. Idiopathic lumbosacral plexitis.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: New onset of seizures within 24 hours of vaccine administration. Child has never had seizures prior to this.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Erythema, Pruritus
Clinical narrative: itching, anxious feeling, redness on hands and arms
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site oedema, Oedema peripheral, Pruritus
Clinical narrative: Injections given 12/3/08 at 12n, mom noticed that he was scratching his left arm as soon as he left the clinic.  Due to history of ezcema, mom didn't pay attention to his arm.  when they were out at yogurt place on 12/5/08 at 4p looked at arm, swollen and felt warm to touch.  edema below site of injection, mid upper arm to elbow.  no signs of infection.  plan cool compresses and oral bendryl
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives approximately 3 days after the immunization was given.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye swelling
Clinical narrative: Father of patient states, about one hour after receiving the Flumist, patient's eyes became puffy and swollen. This lasted for three to four hours, then eyes returned to normal state.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Intensive care, Syncope
Clinical narrative: 2-3 hours after receiving vaccination he experienced a syncopal episode and became diaphoretic and weak.  Drove self to local ED and was admitted to ICU for cardiac work-up.  Unsure results of evaluation. 12/10/08 MR received for DOS 11/6-7/2008 with D/C DX:  Presyncope-unclear etiology.  Pt presented after an episode of light-headedness. W/U (-).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 24 hours after injection soreness at site and red erythema Left deltoid 6 inches in diameter
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold
Clinical narrative: - Patient got the chills and was unable to get warm. Tried to put on jacket and turn on heater (12/3/08). Was relieved later without any treatment.