chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Body temperature increased, Chills, Cough
Clinical narrative: On 2/14/11 received call from patient stating that approx 6-8 hours after receiving Hep A/Hep B vaccine, awoke from sleep w/temp of 102.9, chills, cough. Had symptoms for 4-5 days w/temp as hi as 104.4. Did not seek medical care. Pt is bipolar, injected IV Heroin on 1/30/11.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Cough, Culture throat, Ear pain, Headache
Clinical narrative: Started with slight sore throat. Had chills and fever during night.  c/o head and neck pain this a.m. along with ear pain, sore throat, nausea, and occasional cough.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pyrexia, Streptococcus test
Clinical narrative: Started with slight sore throat. Had chills and fever during night.  c/o head and neck pain this a.m. along with ear pain, sore throat, nausea, and occasional cough.
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Scab, Skin lesion
Clinical narrative: 2/2/11 noted swelling redness at injection site 2/3/11 seen in office - Ice & MOTRIN prescribed 2/7/11 seen in office - had scattered zoster like lesions. Placed off work given prescription for ZOVIRAX 2/14/11 seen in office - no new lesions - old lesions are scabbed over.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash macular
Clinical narrative: Fever & fussiness 1/3/11 - 1/6/11 extreme fussiness 1/6/11 x 24 hours rash - macular, blanchable 1/6/11 x 24 hours.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Axillary pain, Electrocardiogram normal, Pain in extremity, Sensation of heaviness, Spirometry normal
Clinical narrative: C/O left side of axillary and spreading to the left arm and leg pain and heavy feeling 1 wk after HPV vaccine. The sx lasted for couple weeks.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Pain, Sensation of heaviness
Clinical narrative: C/O left side of axillary and spreading to the left arm and leg pain and heavy feeling 1 wk after HPV vaccine. The sx lasted for couple weeks.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, Eyelid function disorder, Full blood count, Muscle twitching, Paraesthesia
Clinical narrative: Pt. described having tingling, muscle twitching, in (R) side of face, trouble closing (R) eye, blurred vision in (R) eye and tingling on his tongue.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Paraesthesia oral, Red blood cell sedimentation rate, Vision blurred
Clinical narrative: Pt. described having tingling, muscle twitching, in (R) side of face, trouble closing (R) eye, blurred vision in (R) eye and tingling on his tongue.
Age: 1.27
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Pain in extremity, Rash erythematous, Rash generalised
Clinical narrative: Redness at injection site, leg was sore, temperature was 100.1, red rash/ bumps all over face and body
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PPV, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 2 1/2 x 2 inch pink, warm area on left deltoid. No abscess.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Patient reported swelling and pain in arm. Patient came to pharmacy on 2/13 and rash was on interior of arm and was red, hot, and about 4-6 inches in diameter. Patient said that rash spread from outer to inner side of upper arm. Patient was instructed by pharmacist to take Benadryl 25mg every 6 hours and Tylenol 500mg every 6 hours.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Pallor
Clinical narrative: Patient has 2.5cm pale circle surrounding injection site -circle is not raised nor indented-merely looks as if pigment is gone. some pinkened area (about .5cm) inside pale circle
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Syncope
Clinical narrative: shortness of breath followed by syncope lasting several minutes, when patient awoke she has chest pressure and soight shortness of breath. She went to sleep and it resolved
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Local swelling, Pruritus
Clinical narrative: PATIENT CAME TO HEALTH DEPARTMENT WITH C/O THAT SHE HAD RECEIVED FLU VACCINE GIVEN AT HEALTH DEPARTMENT IN RIGHT ARM ON 12/29/2010. PATIENT STATES SHE HAD SWELLING TO INJECTION SITE ALONG WITH ITCHING AND SWELLING AND SWELLING TO RIGHT SIDE OF NECK. HAD REDNESS TO AREA WITH ITCHING. PATIENT HAS APPLIED ITCHING CREAM TO SITE, HOWEVER STILL ITCHING. NO SOB OR DISTRESS; NURSE INSTRUCTED PATIENT TO SEE PRIVATE DOCTOR.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: C-reactive protein, Erythema, Haematocrit, Haemoglobin, Mean cell haemoglobin
Clinical narrative: On the evening of vaccine mother notice increased swelling, redness and fever. On Wednesday fever was at 100.4 parent brought him into ED. They marked area and borders he was given medication, after leaving the ED mother notice redness had spread and they returned to the ED.He was given a different medication and admitted into the hospital. This information was obtained from Child's discharge summary.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Platelet count, Pyrexia, Red blood cell count
Clinical narrative: On the evening of vaccine mother notice increased swelling, redness and fever. On Wednesday fever was at 100.4 parent brought him into ED. They marked area and borders he was given medication, after leaving the ED mother notice redness had spread and they returned to the ED.He was given a different medication and admitted into the hospital. This information was obtained from Child's discharge summary.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Red cell distribution width, Swelling, White blood cell count
Clinical narrative: On the evening of vaccine mother notice increased swelling, redness and fever. On Wednesday fever was at 100.4 parent brought him into ED. They marked area and borders he was given medication, after leaving the ED mother notice redness had spread and they returned to the ED.He was given a different medication and admitted into the hospital. This information was obtained from Child's discharge summary.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Laboratory test normal, Oedema peripheral, Platelet count decreased
Clinical narrative: ARM SORE SWOLLEN AND RED FROM UPPER ARM DOWN TO ELOW WITH OUT CROSS OF JOINT
Age: 1.29
Sex: M
Vaccine: HIBV, MMR
Symptoms: Dysstasia, Gait disturbance
Clinical narrative: When child woke up from nap, he would not stand or walk on right leg.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Back pain, Erythema, Haemoglobin normal, Laboratory test normal
Clinical narrative: One day after receiving vaccine, 2-1-11, whole upper arm was red & swollen & painful. Also reported back and abdominal pains & diffuse aches all over. Lasted 2wks. felt better 2-13-11.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: One day after receiving vaccine, 2-1-11, whole upper arm was red & swollen & painful. Also reported back and abdominal pains & diffuse aches all over. Lasted 2wks. felt better 2-13-11.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Eye pruritus, Eye swelling, Headache, Ocular hyperaemia, Urticaria
Clinical narrative: Approximately 5 hours after injection eyes became very swollen and itchy - took a CLARITIN. By morning, eyes were even more swollen, very red and (R) eyelid had a large hive on it. Moderately severe headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient complained of some lightheadedness following vaccine administration. Had her wait 10 more minutes. Patient then stated that lightheadedness did not get worse and was somewhat better. She elected to leave. I called her about 2 hrs later - still a little lightheaded. She will contact MD. I also notified MD.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Laboratory test normal, Pruritus, Rash, Rash papular
Clinical narrative: Severely itchy papular/eczematous skin eruption. Tx with Systemic steroids and antihistamines.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Severely itchy papular/eczematous skin eruption. Tx with Systemic steroids and antihistamines.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Pt states the vaccinated arm is stiff and she still cannot fully raise her arm.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site swelling
Clinical narrative: PEDIARIX (DTAP-IPV-HBV) and ACTHIB given. Left thigh swollen (PEDIARIX) and left deltoid swollen (HIB). PREVNAR 13 not given this date. Twin administered PEDIARIX HIB PCV13 with no adverse effects same date and time.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia, Sleep paralysis, Toothache
Clinical narrative: W/i 1 mo of vaccine started experiencing periodic chills, migratory myalgia dental pain & sleep paralysis. Episodes last several hours and are occurring every 1-3 days.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Approximately 5 min after vaccination, mother noted redness at area surrounding site of injection area (RVL) developed approx. 1/2 inch hive. MD notified ordered BENADRYL PO. Stayed in office under observation.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability, Pyrexia
Clinical narrative: Had PENTACEL, Rotavirus, PREVNAR - Hep. B 12-2-10 that night had 102 temperature fussy lasted 2 days. Next set of (no Hep. B) shots done 12.2.11. Fever 104 - very fussy next day - came to office - Inj. sites looked fine.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dizziness, Face oedema, Headache
Clinical narrative: (L) facial edema x 30 min, 30 min after injection 40 after injection -> HA, dizzy, nausea.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: (L) facial edema x 30 min, 30 min after injection 40 after injection -> HA, dizzy, nausea.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia facial, Nausea, Pyrexia, Vision blurred
Clinical narrative: (L) facial edema x 30 min, 30 min after injection 40 after injection -> HA, dizzy, nausea.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound scan, Unevaluable event
Clinical narrative: Went to ER see attached papers.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline), (non-gsk) PNEUMOVAX. Concurrent medical conditions included arthralgia - lower back and fibromyalgia. Concurrent medications included Vitamin D, Metoprolol, MOBIC, Stool softener, LASIX and Herbal bowel stabiliser. On 13 October 2009 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm), and 2nd dose of PNEUMOVAX (unknown, right deltoid). On 13 October 2009, less than one day after vaccination with FLULAVAL and PNEUMOVAX, the subject experienced headache, chills, immobility left arm, left arm pain, felt achy all over, and on 14 October 2009, the subject experienced redness and hot to touch. On 16 October 2009, the headache, chills, immobility left arm, left arm pain, and felt achy all over were resolved. On 19 October 2009, redness and hot to touch were resolved. The healthcare professional considered headache, chills, immobility left arm, and left arm pain were probably related to vaccination with FLULAVAL and PNEUMOVAX. It was unknown if felt achy all over, redness and hot to touch were related to vaccination with FLULAVAL and PNEUMOVAX. The nurse from the physician's office reported the subject received FLULAVAL in her left arm and PNEUMOVAX in her right arm on 13 October 2009 in the clinic. On 13 October 2009 the subject experienced headache, chills, pain in her left arm, and could not move her left arm that evening. The subject stated that she felt achy all over. The next day (14 October 2009) the subject reported she had redness from her shoulder to her elbow on her left arm, and the area was hot to touch. On 16 October 2009, the subject contacted the physician's office to report the reaction, and was seen the same day. During the visit on 16 October 2009, the subject's headache and achiness had gone; and her range of motion in her left arm had returned. The subject still had a red band about two to two and a half inches in the anticubital area, but no redness at the injection site. The red band remained hot to touch. The subject called the physician's office on 19 October 2009 and reported that all reactions had resolved. The nurse reported that the physician requested her chart be flagged for the reaction, and did not want the subject to have another flu shot. The nurse reported that the physician thought PNEUMOVAX could be co-suspect. The nurse reported the subject stated PNEUMOVAX was given in her left arm, but the chart stated the PNEUMOVAX was given in the right. Follow up information was received on 13 November 2009 via the reporting nurse. The nurse reported neither the subject's medical history/concurrent illness, lack of efficacy, erroneous administration nor suspected transmission of an infectious agent could have been associated with the subject's events.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline), (non-gsk) PNEUMOVAX. Concurrent medical conditions included arthralgia - lower back and fibromyalgia. Concurrent medications included Vitamin D, Metoprolol, MOBIC, Stool softener, LASIX and Herbal bowel stabiliser. On 13 October 2009 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm), and 2nd dose of PNEUMOVAX (unknown, right deltoid). On 13 October 2009, less than one day after vaccination with FLULAVAL and PNEUMOVAX, the subject experienced headache, chills, immobility left arm, left arm pain, felt achy all over, and on 14 October 2009, the subject experienced redness and hot to touch. On 16 October 2009, the headache, chills, immobility left arm, left arm pain, and felt achy all over were resolved. On 19 October 2009, redness and hot to touch were resolved. The healthcare professional considered headache, chills, immobility left arm, and left arm pain were probably related to vaccination with FLULAVAL and PNEUMOVAX. It was unknown if felt achy all over, redness and hot to touch were related to vaccination with FLULAVAL and PNEUMOVAX. The nurse from the physician's office reported the subject received FLULAVAL in her left arm and PNEUMOVAX in her right arm on 13 October 2009 in the clinic. On 13 October 2009 the subject experienced headache, chills, pain in her left arm, and could not move her left arm that evening. The subject stated that she felt achy all over. The next day (14 October 2009) the subject reported she had redness from her shoulder to her elbow on her left arm, and the area was hot to touch. On 16 October 2009, the subject contacted the physician's office to report the reaction, and was seen the same day. During the visit on 16 October 2009, the subject's headache and achiness had gone; and her range of motion in her left arm had returned. The subject still had a red band about two to two and a half inches in the anticubital area, but no redness at the injection site. The red band remained hot to touch. The subject called the physician's office on 19 October 2009 and reported that all reactions had resolved. The nurse reported that the physician requested her chart be flagged for the reaction, and did not want the subject to have another flu shot. The nurse reported that the physician thought PNEUMOVAX could be co-suspect. The nurse reported the subject stated PNEUMOVAX was given in her left arm, but the chart stated the PNEUMOVAX was given in the right. Follow up information was received on 13 November 2009 via the reporting nurse. The nurse reported neither the subject's medical history/concurrent illness, lack of efficacy, erroneous administration nor suspected transmission of an infectious agent could have been associated with the subject's events.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 1 of 7 (see case IDs A0885268A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010 indicated that the subject was 54 years old at the time of events. FLULAVAL was administered intramuscularly in the left deltoid. The onset of the events was the day of vaccination, 04 October 2010. The events resolved on an unspecified date.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of guillain barre syndrome in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 5 October 2010 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm).  On 11 October 2010, 6 days after vaccination with FLULAVAL, the subject experienced guillain barre syndrome.  The subject was hospitalised on 11 October 2010.  He was discharged to rehab on 17 October 2010 and at the time of reporting was still undergoing rehab.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was possibly related to vaccination with FLULAVAL.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of guillain barre syndrome in a 67-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 5 October 2010 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm).  On 11 October 2010, 6 days after vaccination with FLULAVAL, the subject experienced guillain barre syndrome.  The subject was hospitalised on 11 October 2010.  He was discharged to rehab on 17 October 2010 and at the time of reporting was still undergoing rehab.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was possibly related to vaccination with FLULAVAL.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced possible allergic reaction. At the time of the report no other information was available. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 08 December 2010. It was reported that the female subject was 93 years old at the time of event. Onset of possible allergic reaction was 27 September 2010. The event was unresolved at the time of follow-up and not considered to be serious.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Depressed level of consciousness, Postictal state, Reflexes abnormal, Stereotypy
Clinical narrative: Initial report was received on 02 December 2010 from a health care professional. A two month-old infant patient with no reported past medical history, had received PENTACEL (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a "reaction to the pertussis part" of the vaccine. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 09 February 2011 provided the original VAERS form. The patient had no medical history, took no concomitant medications, had no illness at the time of vaccination and had no adverse event following prior vaccinations. The female patient received on 23 November 2010 at 8:40 AM a left thigh intramuscular injection (dose 1) of PENTACEL, sanofi pasteur Ltd. lot number C3793AA, a right thigh intramuscular injection (dose 1) of PREVNAR 13, Wyeth lot number 914513 and dose 1 of oral (PO) ROTATEQ, Merck lot number 05262. Early in the evening at 7:00 PM on 23 November 2010, the patient had an episode that resembled repetitive mono reflexes followed by 30-40 minutes when she was not really alert or responding normally. The patient was felt to have a post vaccine seizure with a postictal period. The patient subsequently was back to normal and had no repeat episodes since. The outcome was reported as recovered. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Initial report was received on 02 December 2010 from a health care professional. A two month-old infant patient with no reported past medical history, had received PENTACEL (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a "reaction to the pertussis part" of the vaccine. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 09 February 2011 provided the original VAERS form. The patient had no medical history, took no concomitant medications, had no illness at the time of vaccination and had no adverse event following prior vaccinations. The female patient received on 23 November 2010 at 8:40 AM a left thigh intramuscular injection (dose 1) of PENTACEL, sanofi pasteur Ltd. lot number C3793AA, a right thigh intramuscular injection (dose 1) of PREVNAR 13, Wyeth lot number 914513 and dose 1 of oral (PO) ROTATEQ, Merck lot number 05262. Early in the evening at 7:00 PM on 23 November 2010, the patient had an episode that resembled repetitive mono reflexes followed by 30-40 minutes when she was not really alert or responding normally. The patient was felt to have a post vaccine seizure with a postictal period. The patient subsequently was back to normal and had no repeat episodes since. The outcome was reported as recovered. Documents held by sender: none.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Localized swelling at varicella vaccine inj site measured by physician today as 7 x 5cm. Tx with Hydroxyzine HCL tablet 25 mg 3 times daily.
Age: 9.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test negative, Lymphadenopathy, Pyrexia, Rash, Tonsillar hypertrophy
Clinical narrative: 8 days after receiving MMR, varicella & Hep A, clients' guardian reported client had a rash on his fingers, fever, and swollen glands in his neck. Guardian took him to Dr. He was tested for influenza- Neg. Guardian states "tonsils were swollen".
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Musculoskeletal stiffness
Clinical narrative: stiff neck, difficulty swallowing.She took benadryl at her home
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site swelling, Screaming
Clinical narrative: Mother states that infant started crying once home and lasted for 4 hours.  Infant quieted to sleep for approx. 20 minutes and then awoke again and screamed for additional 2 hours.  Right thigh was reddened/swollen and hard.  All symptoms were gone and baby was "back to normal" by the next day.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: HIVE AROUND INJECTION SITE APPROXIMATELY 4CM X 4 CM LESS THAN 20 MINUTES AFTER IMMUNIZATION ADMINISTERED.  HIVES CONTINUED APPEARING OVER FACE, ARMS AND UPPER BACK. PHYSICIAN WAS PRESENT, BENADRYL WAS ADMINISTERED AND CHILD WAS SENT TO THE ER.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Dermatillomania, Flat affect, Gastroenteritis viral, Hypophagia, Lethargy
Clinical narrative: Our family caught a stomach virus in which the pt. didn't recover like the rest of us.  She would not eat or drink and was lethargic.  What worried me was she was complaining her feet hurt, she was picking at her face for no reason and she was emotionally detached from the family.  What started as a stomach virus on Sunday 3/15/2009 became a potential reaction to the MMR shot she received on 3/11/2009.  Everyone recovered from the virus within 3 days but she did not.  It seems to me a bit more than a coincidence she had this vaccine and 10 days later she is in the ER because of foot pain and a weird habit of picking at her face.  She also had not passed urine for 24 hours.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Urinary tract infection, Urine output decreased
Clinical narrative: Our family caught a stomach virus in which the pt. didn't recover like the rest of us.  She would not eat or drink and was lethargic.  What worried me was she was complaining her feet hurt, she was picking at her face for no reason and she was emotionally detached from the family.  What started as a stomach virus on Sunday 3/15/2009 became a potential reaction to the MMR shot she received on 3/11/2009.  Everyone recovered from the virus within 3 days but she did not.  It seems to me a bit more than a coincidence she had this vaccine and 10 days later she is in the ER because of foot pain and a weird habit of picking at her face.  She also had not passed urine for 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: reaction of a defined red circular area around the injection site.  involved whole thigh, no fever, or warmth to touch.  slowly resolving.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid function disorder
Clinical narrative: Initial report received on 03 February 2011 from a company representative who had received the report from a nurse who had received the original report from a health care professional. A 40 year-old male patient had received a dose of FLUZONE SV 2010-2011 (lot number U3651AA) during a flu clinic that took place at his place of employment on 01 November 2010. Since the vaccination, the patient has experienced difficulty with opening his eye, and has since been hospitalized. The hospital linked the patient's eye problem to the flu vaccination. The patient has not recovered. No further information was provided. Documents held by sender: None.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Pain
Clinical narrative: Inconsolable crying reported by mom who also felt child seemed to be in some pain. Had been given a fever reducer about 1 1/2 hours before crying began.
Sex: F
Vaccine: DTP
Symptoms: Adverse reaction, Pertussis, Respiratory arrest
Clinical narrative: Initial report was received 05 February 2011 via a company sponsored web site from a consumer, who is the patient's parent.  A female patient (age and date of birth not reported), had received a second dose of DTP (manufacturer name, lot number, route, site and date of administration not reported) and an unspecified amount of time later, she developed a "bad reaction".  In the middle of the night the patient stopped breathing.  The reporter stated, "somehow I woke up to hear her not breathing.  I picked her up and blew in her face to get her to breath again".  The reporter had the patient sleep on her chest the remainder of the night to make sure the patient would be alright.  It was further noted that the patient has to take antibiotics during outbreaks of whooping.  The reporter noted that this event occurred over 22 years ago, and the patient was now a healthy adult.  No additional information was provided at the time of the report.  Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: On 2/11/11 pt had swollen thighs, warm to touch, redden area, rash, & pain.
Sex: F
Vaccine: FLU3
Symptoms: Rhesus antibodies positive
Clinical narrative: Initial report was received from a health care professional on 09 February 2011. An unidentified female patient with a history of being Rh negative had received FLUZONE (lot number, route, site and exact date of administration not reported) "in December" and an unspecified amount of time later "in February" was "retested and was found to be Rh positive. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt came in for an OV, complaining of a lump with redness at injection site, pt was Rx'ed ABX.
Age: 1.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt in at 0900 on 2-14-11. I gave her a PCV13 and PENTACEL. Later that evening mother calls to report child fever of 102.4.
Age: 0.88
Sex: M
Vaccine: FLU3, IPV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 6 days after receiving flu shot. Had concurrent otitis media.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion missed, Abortion spontaneous, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with high risk papilloma viral infection diagnosed on 16-AUG-2010 and no drug reactions or allergies who was vaccinated IM with the first, second and third 0.5ml dose of GARDASIL (lot# not reported) on 29-MAR-2010, 02-JUN-2010 and 23-SEP-2010 respectively.  Concomitant therapy included prenatal vitamins (unspecified).  It was reported that the patient was administered her third dose of GARDASIL on 23-SEP-2010 and was subsequently determined to be pregnant on 13-OCT-2010.  A pregnancy test in the office on 23-SEP-2010 was negative but a urine pregnancy test in the office on 13-OCT-2010 was positive.  Her last menstrual period was 31-AUG-2010 and her estimated delivery date was 07-JUN-2011.  A prenatal ultrasound would be scheduled for next week.  No problems reported.  The patient sought medical attention.  Follow up information received indicating the patient had ultrasound on 09-NOV-2010 which showed 8 weeks and 2 days pregnancy, early dating.  The patient had irregular menses.  The patient's last menstrual period was 31-AUG-2010, estimated delivery date was 19-JUN-2011.  The patient had no previous pregnancies.  Follow-up information was received from a outcome pregnancy questionnaire which reported that the patient had prenatal vitamins daily from 21-OCT-2010 to 01-DEC-2010 for pregnancy.  The patient had IUFD (intra uterine fetal demise) and on 01-DEC-2010 sonogram showed missed abortion at approximately 9.5 weeks (also reported on 06-DEC-2010, at 12 weeks and 1 day).  Upon internal review, spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Papilloma viral infection, Ultrasound antenatal screen, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with high risk papilloma viral infection diagnosed on 16-AUG-2010 and no drug reactions or allergies who was vaccinated IM with the first, second and third 0.5ml dose of GARDASIL (lot# not reported) on 29-MAR-2010, 02-JUN-2010 and 23-SEP-2010 respectively.  Concomitant therapy included prenatal vitamins (unspecified).  It was reported that the patient was administered her third dose of GARDASIL on 23-SEP-2010 and was subsequently determined to be pregnant on 13-OCT-2010.  A pregnancy test in the office on 23-SEP-2010 was negative but a urine pregnancy test in the office on 13-OCT-2010 was positive.  Her last menstrual period was 31-AUG-2010 and her estimated delivery date was 07-JUN-2011.  A prenatal ultrasound would be scheduled for next week.  No problems reported.  The patient sought medical attention.  Follow up information received indicating the patient had ultrasound on 09-NOV-2010 which showed 8 weeks and 2 days pregnancy, early dating.  The patient had irregular menses.  The patient's last menstrual period was 31-AUG-2010, estimated delivery date was 19-JUN-2011.  The patient had no previous pregnancies.  Follow-up information was received from a outcome pregnancy questionnaire which reported that the patient had prenatal vitamins daily from 21-OCT-2010 to 01-DEC-2010 for pregnancy.  The patient had IUFD (intra uterine fetal demise) and on 01-DEC-2010 sonogram showed missed abortion at approximately 9.5 weeks (also reported on 06-DEC-2010, at 12 weeks and 1 day).  Upon internal review, spontaneous abortion was considered to be an other important medical event.  Additional information is not expected.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Culture stool positive, Culture urine, Dehydration, Metabolic function test, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 month old female with no drug reactions/allergies or pertinent medical history who on 18-SEP-2008, 19-NOV-2008 and 21-JAN-2009 was vaccinated PO with the first and second and third dose of ROTATEQ, 2 ml, respectively ( lot #: dose one 661054/0966X, dose two 661582/0595X, dose three 661395/0926X).  Concomitant therapy included PENTACEL and PREVNAR given with each dose of ROTATEQ.  On 03-FEB-2011 the patient experienced vomiting, fever and dehydration and had been hospitalized.  Stool culture was positive rotavirus.  Urine culture and Comprehensive Metabolic Panel (CMP) were also done, results not provided.  The patient had been diagnosed with rotavirus.  At the time of the report, the patient's dehydration and rotavirus persisted.  Additional information has been requested.  The patient was hospitalized in Medical Center.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 month old female with no drug reactions/allergies or pertinent medical history who on 18-SEP-2008, 19-NOV-2008 and 21-JAN-2009 was vaccinated PO with the first and second and third dose of ROTATEQ, 2 ml, respectively ( lot #: dose one 661054/0966X, dose two 661582/0595X, dose three 661395/0926X).  Concomitant therapy included PENTACEL and PREVNAR given with each dose of ROTATEQ.  On 03-FEB-2011 the patient experienced vomiting, fever and dehydration and had been hospitalized.  Stool culture was positive rotavirus.  Urine culture and Comprehensive Metabolic Panel (CMP) were also done, results not provided.  The patient had been diagnosed with rotavirus.  At the time of the report, the patient's dehydration and rotavirus persisted.  Additional information has been requested.  The patient was hospitalized in Medical Center.
Age: 1.37
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Gave flu serum for 3 years and older. I believe .25 dose was givien.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: immunization sites red and swollen, taken to local Dr. office.  PA is following up with allergy testing. Since all 3 sites reacted the same he feels it may be a reaction to the metal of the needle possibly nickel
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Coeliac disease, Irritable bowel syndrome, Pyrexia, Ultrasound scan normal
Clinical narrative: Initial report received on 16 Dec 2010: This patient (centre number 08, patient number 080013) was enrolled in study V72_29.  Study medication was commenced on 21 Oct 2010 at 16:45 hrs and on 21 Nov 2010 at 11:16 hrs.  On 13 Dec 2010, the patient presented with abdominal pain, vomiting and feeling feverish.  The patient was hospitalized on 15 Dec 2010.  The patient received treatment with morphine.  The ultra sound scan of the patient was performed.  At the time of reporting, the patient's condition was persisting.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow-up received prior to circulation of the initial on 21 Dec 2010: The investigator did not provide any final diagnosis.  The ultrasound scan of the patient was normal.  At the time of reporting the patients condition was improving.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow up received on 21 Jan 2011: The patient had similar previous episodes prior to enrollment in the study although none required hospital admission.  The onset date of vomiting and feeling feverish was 15 Dec 2010.  The pain persisted and the general practitioner (GP) was called for a home visit who diagnosed irritable bowel syndrome due to gluten intolerance.  No diagnosis was given on discharge from hospital but there was a possible diagnosis of endometriosis.  Treatment was with Oramorph and codeine.  The patient completely recovered from vomiting and feeling feverish by 16 Dec 2010.  The abdominal pain continued niggling and completely resolved by 18 Jan 2011.  In the absence of investigator's causality assessment, agency has processed the event 'irritable bowel syndrome due to gluten intolerance' as suspected for reporting purposes.  Follow up received on 01 Feb 2011: The investigator confirmed that the onset date of the irritable bowel syndrome due to gluten intolerance was 17 Jan 2011.  The investigator also stated that the provisional diagnosis of irritable bowel syndrome due to gluten intolerance was made on 17 Jan 2011 (after the study vaccination) but the symptoms proceeded the study vaccination.  At the time of this report, the irritable bowel syndrome due to gluten intolerance was improving.  The investigator assessed the irritable bowel syndrome and gluten intolerance as non serious events and not suspected to be related to the study vaccine.  The investigator stated that endometriosis was not a confirmed diagnosis but was assessed to be non serious and not suspected to be related to the study vaccine.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial report received on 16 Dec 2010: This patient (centre number 08, patient number 080013) was enrolled in study V72_29.  Study medication was commenced on 21 Oct 2010 at 16:45 hrs and on 21 Nov 2010 at 11:16 hrs.  On 13 Dec 2010, the patient presented with abdominal pain, vomiting and feeling feverish.  The patient was hospitalized on 15 Dec 2010.  The patient received treatment with morphine.  The ultra sound scan of the patient was performed.  At the time of reporting, the patient's condition was persisting.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow-up received prior to circulation of the initial on 21 Dec 2010: The investigator did not provide any final diagnosis.  The ultrasound scan of the patient was normal.  At the time of reporting the patients condition was improving.  The investigator did not suspect a relationship between the event and the study vaccine.  Follow up received on 21 Jan 2011: The patient had similar previous episodes prior to enrollment in the study although none required hospital admission.  The onset date of vomiting and feeling feverish was 15 Dec 2010.  The pain persisted and the general practitioner (GP) was called for a home visit who diagnosed irritable bowel syndrome due to gluten intolerance.  No diagnosis was given on discharge from hospital but there was a possible diagnosis of endometriosis.  Treatment was with Oramorph and codeine.  The patient completely recovered from vomiting and feeling feverish by 16 Dec 2010.  The abdominal pain continued niggling and completely resolved by 18 Jan 2011.  In the absence of investigator's causality assessment, agency has processed the event 'irritable bowel syndrome due to gluten intolerance' as suspected for reporting purposes.  Follow up received on 01 Feb 2011: The investigator confirmed that the onset date of the irritable bowel syndrome due to gluten intolerance was 17 Jan 2011.  The investigator also stated that the provisional diagnosis of irritable bowel syndrome due to gluten intolerance was made on 17 Jan 2011 (after the study vaccination) but the symptoms proceeded the study vaccination.  At the time of this report, the irritable bowel syndrome due to gluten intolerance was improving.  The investigator assessed the irritable bowel syndrome and gluten intolerance as non serious events and not suspected to be related to the study vaccine.  The investigator stated that endometriosis was not a confirmed diagnosis but was assessed to be non serious and not suspected to be related to the study vaccine.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: General hip, shoulder joint pain 2 days after injection. Pain in (R) hand (soreness) that started about same time but increased in symptoms (pain when drying hands, shaking of another's hand, using hand to dry off body). Occasionally tingling, throbbing in (R) hand, wrist, elbow, shoulder.
Age: 0.27
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria, Wheezing
Clinical narrative: Rec'd first set of age appropr vaccines within 5 min after admin of Imm. develop migratory urticaria & wheezing in lungs - SpO2 100% - nebulized Albuterol treatment - pt to ED 1930 - exam unremarkable.
Age: 14.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Feeling hot, Syncope
Clinical narrative: Felt hot, fainted, fainted for about 5 seconds
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Grand mal convulsion, Haemoglobin decreased, Laboratory test normal, Monocyte percentage increased, Streptococcus test negative
Clinical narrative: Tonic generalized seizure lasting about 15 seconds
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Tonic convulsion, White blood cell count normal
Clinical narrative: Tonic generalized seizure lasting about 15 seconds
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Computerised tomogram head, Endotracheal intubation, Fall, Head injury, Intensive care
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Skull fracture, Subdural haematoma, Syncope
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Bladder catheterisation, Blood potassium abnormal, Brain midline shift, Bruxism, Computerised tomogram abnormal
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Computerised tomogram head, Convulsion, Endotracheal intubation, Fall, Gaze palsy
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Head injury, Hypokalaemia, Intensive care, Skull fracture, Subdural haematoma
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 22.0
Sex: F
Vaccine: DTAP, HPV4, DTAP, HPVX, DTAP, HPV4
Symptoms: Subdural haemorrhage, Syncope, Tonic clonic movements, Unresponsive to stimuli, White blood cell count increased
Clinical narrative: Syncopal episode, 5-10 minutes after vaccine administration.  Fell to ground from standing position, hit head.  Skull fracture, subdural hematoma.  Required intubation, ICU admission.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: "h1n1/seasonal flu vaccine"   I have pain in my left shoulder at the sight of the vaccine injection. It radiates down my arm - my ring finger and little finger on my left hand are somewhat numb. My left shoulder's range of motion is severely limited. A stabbing pain occurs when this limited range of motion is exceeded. It feels like the needle broke off the syringe and is in my arm... though I know this is not the case.  There has been no fever, redness or discoloration at the site of the injection.  Bathing, dressing and daily activity is very limited with my left arm. Sleeping with this injury is very difficult because my arm aches in almost any position when in bed. Heavy lifting and any other type of physical activity or exercise is greatly impaired.  The pain in the muscle at the site of the injection has increased over time.  I've been taking Advil on a daily basis but it does practically nothing for my discomfort.  To date, no sign of recuperation. Clinic - procedure and diagnosis codes:  Influenza Vaccination-V04.81 Vaccine Injection-90471 Flu Vaccine-With Preservative 90658