chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Eyes sunken, Fatigue
Clinical narrative: 12-Dec-09 MMR shot administered. 18-Dec-09 Fever (38.7C), no energy/listless, sleeping a lot, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 19-Dec-09 Fever (38.1C), no energy/listless, slept 16 hours, agitated a lot upset by small things, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 20-Dec-09 Fever (37.5C), low energy/listless, agitated a lot upset by small things, irritable, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose. Simple fall results in hard crying. She cried if she fell down without being hurt. She would normally not cry for these types of falls. She had 1 staring episode in the afternoon. She looked down and to the side. She did not respond when her name was called repeatedly. The staring episodes are what we are and were concerned about. 21-Dec-09 Fever gone, still agitated, upset by small things, cries easily over things she wouldn't normal cry about, stuffiness, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon. She ate a lot. She would eat and then want to eat again (even though she didn't actually eat much food) 20 minutes later as if she forgot she just had a snack. Congested 1 side of nose. She started adding s (plural) to all words or an a to the end of all words i.e. corna for corn, or corns. She is still doing this occasionally as of April 2010. 22-Dec-09 Cranky, congested 1 side of nose, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon, ate a lot. 23-Dec-09 More like her normal self, went to pediatrician in the morning, spent the day at the hospital, blood and urine normal, hoarse voice. 24-Dec-09 Congested 1 side of nose, gasping, otherwise OK, hoarse voice. 25-Dec-09 Congested 1 side of nose, otherwise OK. 26-Dec-09 Like her old self but with occasional gasping, morning stuffiness. 27-Dec-09 Happy again, still gasping occasionally, morning stuffiness. 28-Dec-09 Happy, normal self, still gasping occasionally, 1 staring episode about 10 seconds long at 10:30 AM.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Hypersomnia, Increased appetite, Irritability, Listless, Nasal congestion
Clinical narrative: 12-Dec-09 MMR shot administered. 18-Dec-09 Fever (38.7C), no energy/listless, sleeping a lot, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 19-Dec-09 Fever (38.1C), no energy/listless, slept 16 hours, agitated a lot upset by small things, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 20-Dec-09 Fever (37.5C), low energy/listless, agitated a lot upset by small things, irritable, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose. Simple fall results in hard crying. She cried if she fell down without being hurt. She would normally not cry for these types of falls. She had 1 staring episode in the afternoon. She looked down and to the side. She did not respond when her name was called repeatedly. The staring episodes are what we are and were concerned about. 21-Dec-09 Fever gone, still agitated, upset by small things, cries easily over things she wouldn't normal cry about, stuffiness, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon. She ate a lot. She would eat and then want to eat again (even though she didn't actually eat much food) 20 minutes later as if she forgot she just had a snack. Congested 1 side of nose. She started adding s (plural) to all words or an a to the end of all words i.e. corna for corn, or corns. She is still doing this occasionally as of April 2010. 22-Dec-09 Cranky, congested 1 side of nose, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon, ate a lot. 23-Dec-09 More like her normal self, went to pediatrician in the morning, spent the day at the hospital, blood and urine normal, hoarse voice. 24-Dec-09 Congested 1 side of nose, gasping, otherwise OK, hoarse voice. 25-Dec-09 Congested 1 side of nose, otherwise OK. 26-Dec-09 Like her old self but with occasional gasping, morning stuffiness. 27-Dec-09 Happy again, still gasping occasionally, morning stuffiness. 28-Dec-09 Happy, normal self, still gasping occasionally, 1 staring episode about 10 seconds long at 10:30 AM.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Paronychia, Pyrexia, Respiratory tract congestion, Speech disorder, Staring
Clinical narrative: 12-Dec-09 MMR shot administered. 18-Dec-09 Fever (38.7C), no energy/listless, sleeping a lot, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 19-Dec-09 Fever (38.1C), no energy/listless, slept 16 hours, agitated a lot upset by small things, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 20-Dec-09 Fever (37.5C), low energy/listless, agitated a lot upset by small things, irritable, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose. Simple fall results in hard crying. She cried if she fell down without being hurt. She would normally not cry for these types of falls. She had 1 staring episode in the afternoon. She looked down and to the side. She did not respond when her name was called repeatedly. The staring episodes are what we are and were concerned about. 21-Dec-09 Fever gone, still agitated, upset by small things, cries easily over things she wouldn't normal cry about, stuffiness, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon. She ate a lot. She would eat and then want to eat again (even though she didn't actually eat much food) 20 minutes later as if she forgot she just had a snack. Congested 1 side of nose. She started adding s (plural) to all words or an a to the end of all words i.e. corna for corn, or corns. She is still doing this occasionally as of April 2010. 22-Dec-09 Cranky, congested 1 side of nose, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon, ate a lot. 23-Dec-09 More like her normal self, went to pediatrician in the morning, spent the day at the hospital, blood and urine normal, hoarse voice. 24-Dec-09 Congested 1 side of nose, gasping, otherwise OK, hoarse voice. 25-Dec-09 Congested 1 side of nose, otherwise OK. 26-Dec-09 Like her old self but with occasional gasping, morning stuffiness. 27-Dec-09 Happy again, still gasping occasionally, morning stuffiness. 28-Dec-09 Happy, normal self, still gasping occasionally, 1 staring episode about 10 seconds long at 10:30 AM.
Age: 1.6
Sex: F
Vaccine: MMR
Symptoms: Unresponsive to stimuli, Urine analysis, Urine analysis normal, Viral infection
Clinical narrative: 12-Dec-09 MMR shot administered. 18-Dec-09 Fever (38.7C), no energy/listless, sleeping a lot, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 19-Dec-09 Fever (38.1C), no energy/listless, slept 16 hours, agitated a lot upset by small things, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose on one side. 20-Dec-09 Fever (37.5C), low energy/listless, agitated a lot upset by small things, irritable, tired all the time, sunken eyes and either blue or grey tinge under them, not eating, stuffy nose. Simple fall results in hard crying. She cried if she fell down without being hurt. She would normally not cry for these types of falls. She had 1 staring episode in the afternoon. She looked down and to the side. She did not respond when her name was called repeatedly. The staring episodes are what we are and were concerned about. 21-Dec-09 Fever gone, still agitated, upset by small things, cries easily over things she wouldn't normal cry about, stuffiness, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon. She ate a lot. She would eat and then want to eat again (even though she didn't actually eat much food) 20 minutes later as if she forgot she just had a snack. Congested 1 side of nose. She started adding s (plural) to all words or an a to the end of all words i.e. corna for corn, or corns. She is still doing this occasionally as of April 2010. 22-Dec-09 Cranky, congested 1 side of nose, gasping, hoarse voice, 2 staring episodes one in the morning and one in the afternoon, ate a lot. 23-Dec-09 More like her normal self, went to pediatrician in the morning, spent the day at the hospital, blood and urine normal, hoarse voice. 24-Dec-09 Congested 1 side of nose, gasping, otherwise OK, hoarse voice. 25-Dec-09 Congested 1 side of nose, otherwise OK. 26-Dec-09 Like her old self but with occasional gasping, morning stuffiness. 27-Dec-09 Happy again, still gasping occasionally, morning stuffiness. 28-Dec-09 Happy, normal self, still gasping occasionally, 1 staring episode about 10 seconds long at 10:30 AM.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: CLIENT WAS VACCINATED THEN WAS WATCHING SIBLING GETTING IMMUNIZED.  MOM ASKED HIM TO STEP BACK WHILE SIBLING RECEIVED 1 OF 2 VACCINES. HEARD A THUMP.  CLIENT HAD A FAINT-LIKE EPISODE.  HEAD DID NOT HIT THE FLOOR AS HE WAS CAUGHT BETWEEN FAN AND ALL OF COUNTER.  ALMOST IMMEDIATELY CLIENT OPENED HIS EYES, ALERT TO TIME AND PLACE.  AWARE OF SURROUNDINGS.  DRANK SOME SPRITE, MOM STATED HAD NOT EATEN LUNCH.  CLIENT AMBULATED OUT WITH MOM.  ADVISED MOM TO SEEK PMD/ER EVAL IF NEEDED
Age: 0.33
Sex: M
Vaccine: 6VAX-F, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: LOOSE STOOLS STARTED THE DAY THE RTV VACCINE WAS GIVEN.  HAS HAD LOOST STOOLS 5-6/DAY X 1 WEEK SINCE. NO VOMITING.  NO FEVER.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at vaccination site (localized).
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Severe reaction; lost feeling in right hand and foot; pain (sharp) throughout body; flu like symptoms, high fever 7 days quarters 2 days hospitals.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dehydration, Nausea, Throat irritation, Vomiting
Clinical narrative: Patient received MMR, VARIVAX, DTAP, and IPV. Pt left and then returned to clinic with patient and said he felt nauseous and had an itchy throat about 5 mins after receiving vaccines. Pt was observed for an hr. Vomited twice and Dr decided to treat with BENADRYL and transport to manage patient's vomiting/dehydration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelled from elbow to shoulder - warm to touch - red.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: RECEIVED 3 SHOTS ON SAT IN AM.  NOTED ABOUT 2:30 PM SAME DATE L ARM DELTOID AREA BECOMING RED, SWELLING, HOT.  CAME INTO CLINIC TO SHOW NURSE 4/12/10 8AM.  IS VERY RED, RAISED EDEMA AREA TO UPPER L ARM. VERY WARM TO TOUCH.  SHOWED VIS INFO OF REACTIONS AND INSTRUCTED TO GIVE BENADRYL, TYLENOL OR IBUPROFEN, TRY ICE PACKS OR WARM PACKS, MASSAGE AREA, OR CAN TAKE TO DR.  WILL CHECK BY PHONE TO PARENT.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Pruritus generalised
Clinical narrative: Redness and edema at site of MCV4 with itching reported over his body.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Injection site swelling
Clinical narrative: 02/04/10 - PNEUMOVAX given in (R) deltoid - C/o onset pain at site, weakness. Area very tender to touch - no redness noted - Swelling present.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site inflammation, Irritability
Clinical narrative: Client started becoming very fussy/cranky in afternoon & it became more severe during evening & night. Morning of 4/7/10 clients upper right arm inflamed with indurated area "size of silver dollar" per mother at site of lower IM injection. By 4/8/10 inflammation & fussiness resolved. Given MOTRIN x 3 4/6/10.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised, Rash maculo-papular, Streptococcus test negative
Clinical narrative: Pt was tx for UTI on April 6th - SEPTRA BID x 5 days. Received GARDASIL vaccine on April 12th. On April 15th about 11pm pt complained of itching. Mother gave her BENADRYL. Presented to clinic AM of April 16th with raised maculopapular confluent rash generalized, was tx with ALLEGRA, Prednisone. No fever.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Ataxia, Brain injury, Demyelination, Dizziness
Clinical narrative: 2 wks. after receiving the Influenza shot started feeling dizzy, speech impaired, skin went numb, inability to walk again, involuntary hand and arm movement, eye sight became blurred and stayed blurred, fatigue, can't stand longer than 1-2 min. etc......
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dyskinesia, Dysstasia, Fatigue, Hypoaesthesia, Speech disorder
Clinical narrative: 2 wks. after receiving the Influenza shot started feeling dizzy, speech impaired, skin went numb, inability to walk again, involuntary hand and arm movement, eye sight became blurred and stayed blurred, fatigue, can't stand longer than 1-2 min. etc......
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Vision blurred
Clinical narrative: 2 wks. after receiving the Influenza shot started feeling dizzy, speech impaired, skin went numb, inability to walk again, involuntary hand and arm movement, eye sight became blurred and stayed blurred, fatigue, can't stand longer than 1-2 min. etc......
Age: 0.37
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Erythema, Irritability, Oedema peripheral, Rash generalised
Clinical narrative: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old male patient who experienced rash all over body, fussiness, red swollen feet, and loose bowel movements. At 4 months. On 07-Apr-2009, the patient experienced rash all over body, fussy, red swollen feet and loose bowel movements. The events resolved. No additional information was available at the time of this report.
Age: 0.37
Sex: M
Vaccine: PNC
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old male patient who experienced rash all over body, fussiness, red swollen feet, and loose bowel movements. At 4 months. On 07-Apr-2009, the patient experienced rash all over body, fussy, red swollen feet and loose bowel movements. The events resolved. No additional information was available at the time of this report.
Age: 0.89
Sex: M
Vaccine: PNC
Symptoms: Crying, Excessive eye blinking, Hypotonia, Inability to crawl, Irritability
Clinical narrative: Additional information was received from a healthcare professional, which medically confirmed the case and also provided medical history, laboratory results and event details resulting in an additional event.  Information regarding PREVNAR was received from a consumer and later confirmed by a healthcare professional regarding a 7-month-old patient who received a dose of PREVNAR that was not shaken prior to administration, was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The patient additionally experienced eye blinking.  At 7 months of age, the patient received the third dose on 11-Nov-2009.  On 11-Nov-2009, the patient's mother reported that her son received a dose of PREVNAR that was not shaken prior to administration and indicated the product was "crystal clear".  On the same day, the patient was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The mother expressed concern that the product was not "safe" since it was not administered according to the package insert.  On 17-Nov-2009, at a follow-up visit to the physician, the parents reported that the child was blinking his eyes.  An EEG was ordered, but as of 17-Dec-2009, had not been performed.  The patient's outcome was not reported.  See related case (s): US-WYE-H12200209 (medication error without and ae, non-expedited) and US-WYE-H12200309 (medication error without and ae, non-expedited).  No additional information was available at the time of this report.
Age: 0.89
Sex: M
Vaccine: PNC
Symptoms: Physical examination normal, Wrong technique in drug usage process
Clinical narrative: Additional information was received from a healthcare professional, which medically confirmed the case and also provided medical history, laboratory results and event details resulting in an additional event.  Information regarding PREVNAR was received from a consumer and later confirmed by a healthcare professional regarding a 7-month-old patient who received a dose of PREVNAR that was not shaken prior to administration, was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The patient additionally experienced eye blinking.  At 7 months of age, the patient received the third dose on 11-Nov-2009.  On 11-Nov-2009, the patient's mother reported that her son received a dose of PREVNAR that was not shaken prior to administration and indicated the product was "crystal clear".  On the same day, the patient was fussy and crying, his head would flop over periodically and when trying to crawl, he would fall down flat.  The mother expressed concern that the product was not "safe" since it was not administered according to the package insert.  On 17-Nov-2009, at a follow-up visit to the physician, the parents reported that the child was blinking his eyes.  An EEG was ordered, but as of 17-Dec-2009, had not been performed.  The patient's outcome was not reported.  See related case (s): US-WYE-H12200209 (medication error without and ae, non-expedited) and US-WYE-H12200309 (medication error without and ae, non-expedited).  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Antibody test abnormal, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced 4 of the 7 strains drawn after PREVENAR administration showed lack of protection. The patient received the fourth dose on an unspecified date. After receiving four doses of PREVNAR, the patient had titers drawn. Results revealed that 4 of the 7 strains drawn showed lack of protection. The outcome was not specified. No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: FLU(H1N1), PNC
Symptoms: Body temperature increased, Crying, Decreased appetite, Pyrexia, Sleep disorder
Clinical narrative: Additional information provided patient demographics, product details, laboratory tests and event details. Information regarding PREVNAR was received from a healthcare professional regarding an 18-month-old male patient who experienced fever, shaky, crying, not eating all day and awake all night. The patient received the fourth dose on 16-Dec-2009. On 17-Dec-2009, the patient experienced fever progressing to 104.4 degrees Fahrenheit, was shaky, crying and not eating all day. Treatment included TYLENOL but temperature remained elevated. On 18-Dec-2009, the patient was examined by the physician at the office and the patient's ears and throat were reported as "clear". Later that day the fever abated (99.7 degrees Fahrenheit,). The patient was reported to have been awake all night and crying. A urine specimen was collected, but no results were reported. On 19-Dec-2009, the events resolved and the patient was reported as "fine" and back to his "old self". No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: FLU(H1N1), PNC
Symptoms: Tremor, Urine analysis normal
Clinical narrative: Additional information provided patient demographics, product details, laboratory tests and event details. Information regarding PREVNAR was received from a healthcare professional regarding an 18-month-old male patient who experienced fever, shaky, crying, not eating all day and awake all night. The patient received the fourth dose on 16-Dec-2009. On 17-Dec-2009, the patient experienced fever progressing to 104.4 degrees Fahrenheit, was shaky, crying and not eating all day. Treatment included TYLENOL but temperature remained elevated. On 18-Dec-2009, the patient was examined by the physician at the office and the patient's ears and throat were reported as "clear". Later that day the fever abated (99.7 degrees Fahrenheit,). The patient was reported to have been awake all night and crying. A urine specimen was collected, but no results were reported. On 19-Dec-2009, the events resolved and the patient was reported as "fine" and back to his "old self". No additional information was available at the time of this report.
Age: 1.01
Sex: M
Vaccine: PNC
Symptoms: Antibody test abnormal, Vaccination failure
Clinical narrative: Additional information provided patient demographics, dose details, medical history, and test results. The patient's lab test came back showing lack of protection (laboratory test abnormal). Outcome was unknown. Information regarding PREVNAR 7 was received from a healthcare professional regarding a 22-month-old male patient whose antibody tests came back showing lack of protection. At 12 months of age, the patient received the fourth dose on 16-Feb-2009. The patient's antibody test came back showing lack of protection on 19-Dec-2009. The event persists. No additional information was available at the time of this report.
Age: 1.03
Sex: M
Vaccine: PNC
Symptoms: Antibody test, Viral titre decreased
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 20-month-old male patient who experienced low PREVNAR titer levels for Serotypes 4, 9 and 23. The patient received the fourth dose on 08-May-2009. After testing on 08-Jan-2010 for immunogenicity, it was revealed that the patient had low PREVNAR titer levels for Serotypes 4, 9 and 23. The outcome is unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Dyspnoea, Pyrexia, Rash
Clinical narrative: Information regarding PREVNAR 7 was received from a consumer regarding a 6-month-old male patient who experienced fever, breathing issues and rash. The patient received a dose on 12-Feb-2010. The patient experienced fever, breathing issues and rash on 12-Feb-2010. No additional information was available at the time of this report.
Age: 0.41
Sex: F
Vaccine: PNC
Symptoms: Injection site induration
Clinical narrative: Additional information provided medical history, test results and patient demographics. Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who experienced hard area at the injection site. At 4 months of age, the patient received the second dose on 19-Jan-2009. The patient experienced hard area at the injection site on 23-Jan-2009. The patient recovered. See related case(s): US-WYE-H09136009 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Body temperature increased, Irritability, Pyrexia, Urinary tract infection
Clinical narrative: Information regarding PREVENAR was received from a healthcare professional regarding a 10-week-old female patient who experienced UTI and a little fussy. At 10 weeks of age, the patient received a dose on 19-Jun-2009. The patient experienced a UTI in 2009 and a little fussy on 20-Jun-2009. The irritability and urinary tract infection persisted. It was reported that the infant had been otherwise healthy. The reporter noted that the UTI caused the fever. No additional information was available at the time of this report.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC
Symptoms: Pyrexia, Rash papular, Swelling
Clinical narrative: Additional information included PREVNAR lot number, outcome, recovery date and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female patient who experienced wide spread rash described as red, raised and pimple like on trunk and face and fever. At 12 months of age, the patient received the fourth dose on 22-Jun-2009. The patient also received the first dose of HAVRIX (Smith Kline Beecham) on 22-Jun-2009. On 23-Jun-2009 within 24 hours after being administered the vaccine, the patient experienced wide spread rash described as red, raised and pimple like on trunk and face and fever of 104 deg. F. Treatment included MOTRIN and TYLENOL for the fever. The patient has recovered. No additional information was available at the time of this report.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Diarrhoea
Clinical narrative: Additional information provided updated test results. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced diarrhea. At 2 months of age, the patient received a dose on 06-Nov-2009. The patient also received a dose of Hepatitis B vaccine (manufacturer unknown) and a dose of PENTACEL (Aventis-Pasteur) on 06-Nov-2009. The patient experienced diarrhea on 07-Nov-2009. The patient recovered (2009). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Pain
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced stinging.  The patient received a dose on an unspecified date.  The reporter noted that PREVNAR hurts more than other vaccines.  The outcome was not specified.  The reporter was unable to specify the number of patients who experienced this event.  Additional reports will be generated when identifying information is provided.  No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area of redness with swelling 1 cm X 1 cm RUT where Pentacel was given.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of redness with local temp increased 3 cm x 2 cm R upper arm where MENACTRA was given.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea, Fibrin D dimer normal, Rash, Urine analysis normal
Clinical narrative: 22 Sept 2009 received reg nasal flu. About 6 hrs later developed rash and breathing problems. Seen in ER that night. Inhaler and observation.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Culture stool, Haematochezia, Occult blood positive, Rotavirus infection, Rotavirus test positive
Clinical narrative: Blood in stool, persistent > 10 days, rotavirus antigen positive in stool.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Local red and swelling with blistering at injection.
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Arthralgia, Diarrhoea, Headache, Malaise, Myalgia
Clinical narrative: Telephone call fr. pt. 48 hrs after vaccination arm swelled, 72 hrs after had diarrhoea, nausea myalgia, arthralgias, headache and malaise.  Swelling has gone down but arm still sore.  Night sweats, joint hurts, finger hurts, night sweat.
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Nausea, Night sweats, Oedema peripheral, Pain in extremity
Clinical narrative: Telephone call fr. pt. 48 hrs after vaccination arm swelled, 72 hrs after had diarrhoea, nausea myalgia, arthralgias, headache and malaise.  Swelling has gone down but arm still sore.  Night sweats, joint hurts, finger hurts, night sweat.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling and tenderness to right deltoid area. Applied warm packs.  Took 600 mg Ibuprofen on 4/24/10 and 200 mg Ibuprofen on 4/25/10.
Age: 56.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain
Clinical narrative: Muscle pain (L) deltoid - Started  1 1/2 days after injection still very painful 4/26/10 even with MOTRIN use. Pt using MOTRIN 3 tabs q 6 hours - provider suggested 4 tabs q 8 hours - No redness - No swelling - Pt states she has used cold pack.
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Inflammation, redness and warm to touch to RD  25mg diphenhydramine given IM
Age: 7.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Alopecia, Alopecia areata, Fungal test negative, Thyroid function test normal
Clinical narrative: I noticed a bald spot on the top of patient's head.  Within days I noticed more balding spots and thinning.  I took her to her pediatrician who referred me to a dermatologist who referred me to our current Pediatric Dermatologist Specialist.  Patient has used/ is using 2 different medications on her scalp and received injection in her scalp on April 23, 2010.  She has lost about 35% of her hair.  It falls out every day by the handfuls.  She has been diagnosed with alopecia areata.  It was caused by the H1N1 shot.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: Redness and swelling at injection site, mild fever of 99, fatigue, nausea, diarrhea, chills, body aches and sore joints.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Redness and swelling at injection site, mild fever of 99, fatigue, nausea, diarrhea, chills, body aches and sore joints.
Age: 0.76
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: Patient suffered febrile seizure at home.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: C/o Shoulder pain. Pt. re-ckd on 4-23-10 - (Got vaccine on 4-21-10) Given pain Rx and advised warm compress. Pt. and OTR were present on 4-23-10.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Oedema peripheral
Clinical narrative: Pt. had hand red and swollen. Also pt felt dizzy after the 48 hrs of the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Induration
Clinical narrative: 8x9 cm red warm indurated patch on (L) thigh - not painful - no treatment.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray, Death, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea 4/24/10. Fever 4/25/10.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, RV1
Symptoms: Intussusception
Clinical narrative: Infant was admitted to hospital with intussusception on 4/24/10.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Within 24 hrs. of MENACTRA vaccine, pt developed fever (102 degrees), joint pain, fatigue, anorexia. Took ibuprofen 400 mg to reduce fever. Pt. telephoned clinic 4/8/10 to report reaction - fever absent, joint pain and fatigue continue.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Large local reaction on R ant. thigh, Tx 11 1/2 cm. some? warmth to touch, some pain, but no bruising.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Swelling, ecchymosis at site of vaccination - Upper left arm - (deltoid).
Age: 1.27
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pruritus, Rash generalised, Viral rash
Clinical narrative: Seen in office on 4/26/10, patient had rash.  Started on 4/23 & spread all over body.  Temperature 100 on 4/23 & 4/24 & itching & pulling on ear.  Dx: Viral Exanthem & MMR rash.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swollen, warm to touch one day after receiving PENTACEL , ENGERIX-B - same leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 15 cm by 6cm burns on top on rt arm swollen & red from DTaP.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Client reported to his health care provider this AM (4/26) with a shingles like rash described as a cluster of vesicles under left axilla and at left nipple area with a linear vesicular rash on left side of back.  Pt also c/o pain.  Per PA-C.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Client reported to his health care provider this AM (4/26) with a shingles like rash described as a cluster of vesicles under left axilla and at left nipple area with a linear vesicular rash on left side of back.  Pt also c/o pain.  Per PA-C.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Myalgia, Pain, Paraesthesia
Clinical narrative: The above patient petted puppies on April 2 and one puppy diagnosed with rabies, patient received her rabies injections April 18. She obtained a prescription for the additional RABAVERT vaccines from our clinic and took the order to the health department where she picked up the vaccine. On April 21 she received her second injection here, the next day she called and reported muscle and body aches, but was advised to continue with the next vaccination. Dose 3 and Dose 4 were scheduled to be given on a Sunday the patient was given an order and the vaccines (on ice and told to immediately return to refrigeration as soon as possible) to be given at an outpatient clinic. On April 25, she was given dose 3, she called us this morning complaining of muscle and joint pain and left sided tingling down leg to her toes. I was told by the Health Department, that it would be in the best interest of the patient to contact Novartis and Sanofi-Pasteur the manufacturers of the rabies vaccines. I did contact each of them and was told that the muscle and joint pain as well as the tingling were side effects and the degree of the severity differs in each individual. I was also told that the injections should not be discontinued due to this individual's symptoms, because the benefits would certainly outway the potential of risk of rabies. The patient will notified of these findings.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Fever, myalgia, diffuse joint pain
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Flank pain, Injection site pain, Nausea
Clinical narrative: Pain at the injection site (more so than the first two shots in the series), nausea daily since shot was administered and pain in her side.
Age: 0.38
Sex: M
Vaccine: RV5
Symptoms: Hypersensitivity, Rash, Swelling
Clinical narrative: Mother states a couple hours after I administered Rotateq at 11:30 am patient broke out in a raised rash on chest and face. Mother took him to emergency room and was told by ER doctor that it was some type of allergic reaction not sure from Rotateq. Instructed to give Benadryl. No other symptoms. Patient had received Rotarix on 02/02/2010. I talked to mom on 04/22/2010 and she said it was improved by evening and today it was much improved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscular weakness, Pruritus, Tenderness
Clinical narrative: Patient became aware that arm was tender, itchy and reddened about 2 1/2 inches diameter.  Patient applied hydrocortisone cream and warm washcloth.  She also took Ibuprofen 200 mg every 4-6 hours starting 4/24/10 at 1:00 pm till 4/26/10 morning.  Patient also stated slight weakness in left arm started 4/25 AM and continued till 4/26 at around 12N. Patient states tenderness, itching gone and less redness by 4/26 AM.
Age: 0.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Mom brought child to clinic on 4/21/10 with mult. red papules; appeared to be chicken pox. Addendum to report #E - 43216 outbreak started 4/17/10 (one day after vaccine administered) pt seen 4/28/10 and MD diagnosed chicken pox (resolved).
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood potassium increased, Electrocardiogram abnormal, Electroencephalogram normal, Faecal incontinence, Grand mal convulsion
Clinical narrative: Pt became pale, lay himself down, then passed out with tonic-clonic seizure activity c stool incontinence.  Adverse event lasted less than a minute.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt became pale, lay himself down, then passed out with tonic-clonic seizure activity c stool incontinence.  Adverse event lasted less than a minute.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, induration 2"x 2 1/2" to injection site. Pt. reports site is painful to touch.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling to size of golf ball w/ redness to diameter of orange at vaccine site
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Dyskinesia, Electroencephalogram, Laboratory test, Muscle contracture
Clinical narrative: PATIENT OBSERVED DOING A UNUSUAL MOVEMENT WHILE IN A SITTING POSITION. PT IS ABLE TO SIT ON HER OWN. FATHER OBSERVED FOR THE FIRST TIME THE MOVEMENT. PT IS SITTING AND SHE CONTRACTS AND MOVES HER SHOULDERS FORWARD AND HER HEAD DUCKS DOWN. PT IS NOT SHAKING. PARENTS DESCRIBE THE MOVEMENT AS A CONTRACTION. THE MOVEMENT IS BECOMING MORE FREQUENT. PT HAS HAD MORE THAN A DOZEN OF THESE MOVEMENTS IN THE LAST 20 MIN. She does not seem to be bothered by it.  Symptoms only occur while sitting; not with laying down or while being carried.  An episode was recorded on video.
Sex: M
Vaccine: PNC
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Information regarding PREVNAR 7 was received from a healthcare professional regarding a 3-year-old male patient who experienced pneumococcal bacteremic pneumonia. The patient received a dose on an unspecified date. The patient experienced pneumococcal bacteremic pneumonia on 30-Nov-2009. The patient was hospitalized and treated with unspecified IV antibiotics. The patient recovered. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Pneumococcal infection
Clinical narrative: Information regarding PREVNAR was received from a consumer, who reported a friend's child, a female patient had received a full PREVNAR schedule and still got a pneumococcal illness. The patient received the fourth dose on an unspecified date. The patient received a "full PREVNAR schedule" (dates not specified) and "still got a pneumococcal illness" on an unspecified date. The patient's outcome was unknown. No further information was available at the time of this report.
Age: 0.8
Sex: F
Vaccine: IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: "None stated".
Sex: M
Vaccine: PNC
Symptoms: Pneumococcal infection
Clinical narrative: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a male patient who experienced frequent pneumococcal infections. The patient received the fourth dose in 2007. The patient experienced frequent pneumococcal infections. Outcome was unknown. No additional information was available at the time of this report.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Blood immunoglobulin E, Eosinophil count increased, Full blood count, Hypoaesthesia, Malaise
Clinical narrative: Tremors and numbness noted after Tdap after being bitten by a domesticated dog a day before in community. C/O fever and feeling sick for almost a month now.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Tremors and numbness noted after Tdap after being bitten by a domesticated dog a day before in community. C/O fever and feeling sick for almost a month now.
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a male patient who experienced fever and seizure. The patient received vaccine. The patient experienced fever and seizure after receiving PREVNAR on an unknown date. The child additionally received other immunisations on the same day. The outcome was not specified. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13
Symptoms: Blister, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Varicella vaccine 4-16-10 then developed fever + rash started 4-21-10, crops of red bumps, fluid-filled vesicles, pruritic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL, DTAPIPV, MMR, PNC13
Symptoms: Blister, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Varicella vaccine 4-16-10 then developed fever + rash started 4-21-10, crops of red bumps, fluid-filled vesicles, pruritic.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red spots on legs, where shots were given.  Pt's mom called to report symptoms on 4-23-10 at 1:46 PM.  Pt told to give MOTRIN and BENADRYL and draw line around area that is red.  Per Dr.
Age: 1.03
Sex: F
Vaccine: DTP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Incorrect route of drug administration, Irritability
Clinical narrative: Additional information provided patient demographics, lot number, additional suspect vaccines, event details and laboratory data. Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female who received PREVNAR that was administered orally and was fussy. The patient received a dose on 02-Mar-2009. Additional suspect vaccines included Dpt, Haemophilus Influenzae B, M-M-R II, Varicella Virus Vaccine, Live and Hepatitis B Vaccine. On 02-Mar-2009, the patient received PREVNAR that was administered orally. The patient's grandmother reported the child was fussy, but since she had received "5 other shots", they did not associate the fussiness with the PREVNAR. The outcome was unknown. On follow-up the physician noted that no adverse event had occurred. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Decreased immune responsiveness, Seroconversion test negative
Clinical narrative: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 2-year-old male patient who received a dose on an unspecified date and failed to seroconvert with PREVENAR. On an unspecified date, the reporter noted that the patient failed to seroconvert with PREVENAR (decreased immune responsiveness). The patient was evaluated by the physician in the office. The patient's outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Blister, Latex allergy, Skin exfoliation
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 7 was received from a healthcare professional regarding a patient who experienced blisters and skin peeling on legs, knees and back of neck diagnosed as a latex allergy. The patient received a dose of an unspecified date. The patient experienced blisters and skin peeling on legs, knees and back of neck which was diagnosed as a latex allergy. Outcome was unknown. It has been determined that US-WYE-H0883109, is a duplicate report of US-WYE-H08805109. Therefore, the reports are being consolidate into US-WYE-H08805109, which will remain the official case of record. No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Erythema, Irritability, Oedema peripheral, Rash generalised
Clinical narrative: Follow-up information was received that provided source information patient information, vaccination information, concomitant vaccines, additional events and outcome. Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced rash all over body, fussiness, red swollen feet, and loose bowel movements. The patient received the first dose on 20-Jan-2009. The patient also received a dose of PENTACEL (Aventis-Pasteur), a dose of ROTATEQ (Merck & Co Inc)  and a dose of Hepatitis B Vaccine (manufacturer unknown) on 20-Jan-2009. On 25-Jan-2009, the patient developed rash all over body, red swollen feet and loose bowel movements and was fussy. The patient recovered. No additional information was available at at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Dermatitis exfoliative, Rash
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced exfoliative dermatitis. At 2 months of age, the patient received the first dose on 18-Feb-2009. The patient also received a dose of TRIPEDIA (Connaught Medical Research Laboratories), a dose of ACT-HIB (Aventis), a dose of IPOL (Aventis-Pasteur), a dose of Hepatitis B Vaccine (manufacturer unknown) and a dose of ROTATEQ (Merck & Co Inc) on 18-Feb-2009. The patient experienced a rash on her legs on 27-Feb-2009. She was diagnosed with exfoliative dermatitis by a dermatologist. The child recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Incorrect storage of drug
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR that had been improperly stored. The patient received a dose on an unspecified date. The patient received PREVNAR that had been improperly stored in 2009. No adverse event was reported. The outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced low titer levels. The patient received a dose on an unspecified date. The patient experienced low titer levels (antibody test abnormal). Lab results were not provided by the time of this report. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin G abnormal, Seroconversion test negative, Viral titre decreased
Clinical narrative: Follow-up information provided patient demographics, medical history, product details, concomitant therapy, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 30-month-old male patient who experienced low titer levels. The patient received the fourth dose on 24-Sep-2007. The patient also received the fourth dose of Hib (manufacturer unknown) on 24-Sep-2007. The patient experienced low titer levels on 01-Apr-2009. The patient was reported to have recovered. No additional information was available at the time of this report. See related case(s): US-WYE-H09094309 (adverse event, expedited); US-WYE-H09220109 (adverse event, non-expedited); and US-WYE-H09220209 (adverse event, non-expedited).