chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Abscess, Cellulitis, Erythema, Induration, Rash
Clinical narrative: Left deltoid region w/ 7x7 cm round, well circumscribed erythema.  Are defined by rash is tender & indurated.  Dx cellulitis + abscess Keflex 500 mg one tablet three times a day x 10 days.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Left deltoid region w/ 7x7 cm round, well circumscribed erythema.  Are defined by rash is tender & indurated.  Dx cellulitis + abscess Keflex 500 mg one tablet three times a day x 10 days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Broke out in a rash that evening. Rash is on the face, neck, both arms legs and abdomen. No temperature. Patient stated her Band Aid at home she had used may have had latex also used and old WYMOX pill and she scratched area of injection. No redness or swelling at site.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Malaise
Clinical narrative: 2 d Hx generalized weakness + malaise.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Rotavirus vaccine was administered first.  Then PENTACEL (IPV-DTAP-HIB) was administered IM in the right thigh, then PCV7 administered IM left thigh.  At 205am 5-1-09 mother stated child had fever of 103 degrees F.  Was advised by physician to give TYLENOL/MOTRIN every 4 hours PRN for fever or every 8 hours PRN for fever
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Left arm localized redness + swelling, hot to touch, no pain or tenderness.  Complaints of itchiness.  No fever, patient took Benadryl for allergic reaction (itchiness)  to continue Benadryl.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Throat irritation, Urticaria, Wheezing
Clinical narrative: Allergic reaction - hives - severe wheezing, breathing, throat.
Age: 2.0
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Patient was given HEP & DTAP vaccine in the (L) arm on 4/28/09, 1 day later was noted to have swelling, redness itching on the (L) deltoid area, lesion became bigger then parents sought consultation. Lesion was 8x9 induration w/redness on (L) deltoid area.
Age: 12.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient given MMR vaccine instead of MENACTRA.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: HEP A, HEP B & MMR given in (L) upper arm. Arm swollen with hive - like rash from elbow to deltoid on 2/3 of arm circumference. Cold compresses - BENADRYL cream TID.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: When pt was given MMR & VAR pt started crying.  When pt was given HEP A. pt started crying and gasping for air.  Pt also sweating.
Age: 1.4
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme - minor.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 wks after VARICELLA was given on 4-16-09 Pt developed a red swollen area located where vaccine was given.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Eyelid margin crusting, Eyelid oedema, Full blood count abnormal, Skin exfoliation
Clinical narrative: (B) eyelids swollen, puffy and red with peeling of skin and crusting.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Scab, Skin lesion
Clinical narrative: Vesicular lesion trunk with scabbing and diagnosis of herpes zoster.
Age: 4.0
Sex: F
Vaccine: DTAP
Clinical narrative: Pt developed a local rxn one day after vaccine DTAP was administered. Also papular lesion developed on chest area.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Body temperature increased, Erythema, Induration, Injection site pain
Clinical narrative: At 24-36 hours, pain, swelling at injection site. Low grade temperature 99 degree to 100 degree. Myalgias, malaise.  At 48 hours with squamous erythema, edema, induration. Maximum diameter about 10cm. Axillary pain and fullness. No palpable discrete lymphadenopathy.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Myalgia, Oedema
Clinical narrative: At 24-36 hours, pain, swelling at injection site. Low grade temperature 99 degree to 100 degree. Myalgias, malaise.  At 48 hours with squamous erythema, edema, induration. Maximum diameter about 10cm. Axillary pain and fullness. No palpable discrete lymphadenopathy.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anxiety, Hallucination
Clinical narrative: Caregiver called stating child complains of seeing snakes. Anxiety and hallucinations.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Axillary pain, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: At 48 hours, ipsilateral axillary pain, fullness. Low grade (unmeasured) fever. Local tenderness, swelling at the injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a consumer, the subject's mother, and described the occurrence of swelling in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.   Concurrent medications included CORTISONE TOPICAL, BENADRYL and Ibuprofen.  The subject had no relevant medical history or any adverse events following previous vaccinations.  On 31 March 2009 at 15:30 the subject received unspecified dose of KINRIX (.5 ml unknown, right arm).  No other vaccines were given on 31 March 2009.  On 31 March 2009, approximately 2 hours after vaccination with KINRIX, the subject experienced swelling, hives, redness and itching in his right arm.  The subject had not experienced any problems with prior PEDIARIX and RECOMBINANT and inactivated POLIOVIRUS vaccine combined) injections.  Medical attention was required at a physician's office.  The mother of the subject planned to continue follow-up with her son's physician on an unknown date.  On an unspecified date, the swelling on the subject's right arm improved.  On an unspecified date, the hives, redness and itching on the subject's right arm resolved.  The consumer reported that the events were clinically significant or requiring intervention. This case was reported by a consumer, the subject's mother, and described the occurrence of swelling in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Cortisone, BENADRYL, and IBUPROFEN. The subject had no relevant medical history or any adverse events following previous vaccinations. On 31 March 2009 at 15:30 the subject received unspecified dose of KINRIX (.5ml. unknown, right arm). No other vaccines were given on 31 March 2009. On 31 March 2009, approximately 2 hours after vaccination with KINRIX, the subject experienced swelling, hives, redness and itching in his right arm. The subject had not experienced any problems with prior PEDIARIX and RECOMBINANT and POLIOVIRUS vaccine combined injections. Medical attention was required at a physician's office. The mother of the subject planned to continue follow-up with her son'ts physician on an unknown date. On an unspecified date, the swelling on the subject's right arm improved. On an unspecified date, the hives, redness and itching on the subject's right arm resolved. The consumer reported that the events were clinically significant or requiring intervention. Follow up received from the physician on 03 August 2009: The subject had previously received 3 DTaP vaccinations on unknown dates. KINRIX was the 5th in the vaccinatin series. The events were reported to be a local reaction and resolved on 05 April 2009. The physician considered that the events were not serious.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). Previous and/or concurrent vaccination included (HAVRIX, GlaxoSmithKline, unknown) given on 9 April 2009; tuberculin PPD (Sanofi Pasteur MSD, unknown) given on 9 April 2009 and VARIVAX (non-gsk, Merck, unknown) given on 9 April 2009. There were no concurrent medications. On 9 April 2009 at 16:00 the subject received unspecified dose of KINRIX (.5 ml unknown, left thigh). this vaccine was reported as the 5th dose of the vaccination series. On 9 April 2009, less than one day after vaccination with KINRIX, the subject experienced injection site redness and injection site pruritis. The reporter indicated that the redness and itching were just confined to the injection site. The subject was treated with BENADRYL and ice was applied to the injection site. Medical attention was required at the doctor's office. At the time of reporting the events were unresolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema i a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). The subject's medical history included hearing loss and otitis media. Previous and/or concurrent vaccination included tuberculin PPD (Sanofi Pasteur MSD, unknown) given on 10 April 2009 and VARIVAX (non-gsk, Merck, unknown) given on 10 April 2009. There were no concurrent medications. On 10 April 2009 at 10:38 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). This vaccine was reported as the 5th dose of the vaccination series. On 12 April 2009, 2 days post vaccination with KINRIX, the subject experienced erythema and itching. Medical attention was required at the doctor's office. At the time of reporting the events were unresolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a physician via a GSK representative and described the occurrence of red spot at injection site in a 4-year-old female subject who was vaccinated with (KINRIX, GlaxoSmithKline). On 16 April 2009 the subject received 1st dose of KINRIX (0.5 ml, unknown route, unknown arm). At an unknown time later that day (16 April 2009), after vaccination with KINRIX, the subject experienced an injection site reaction with a red spot at the injection site that was warm to touch, which increased in size to approximately the size "of a half dollar". The red spot then turned brown. The spot has remained "about the same size", but has lightened in color. The time frame from the change in colors was unknown at the time of reporting. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the event was unspecified. The sales representative was told all three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780845A and A0780846A for two additional reports of swelling.
Sex: U
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the event was unspecified. The sales representative was told of three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780793A and A0780846A for the two additional reports of swelling.
Sex: U
Vaccine: DTAPIPV
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline) On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the vent was unspecified. The sales representative was told of three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780793A and A0780845A for the two additional reports of swelling.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Oedema mouth
Clinical narrative: swelling iside of cheeks.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Swelling face
Clinical narrative: swelling iside of cheeks.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Blood test, CSF oligoclonal band present, Cognitive disorder, Computerised tomogram
Clinical narrative: Received vaccination 10/30/07; returned to doctor with pain in left shoulder (same as vaccinated arm) within two months; began experiencing pain, numbness, cognitive changes 5 months later w/no previous history; admitted to hospital after symptoms worsened; diagnosed with Multiple Sclerosis in 04/2008; no history of any autoimmune disorders in family.  5/14/09 Hospital records received DOS 4/3/08 to 4/4/08. FINAL DIAGNOSIS: C2-C3 demyelinating lesion, single white matter lesion in the subcortical U fibers of the left frontal lobe Post vaccination ascending numbness feet, torso, hands.  ICD-9 Codes: 341.9 Demyelinating diseases of central nervous system unspecified. 3488.8 Condition of brain. 477.9 Allergic rhinitis cause unspecified.  Follow-up received on May 10, 2010 - Pt did not recover from the adverse events that were reported for this vaccination. Multiple sclerosis - Permanently disabled.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Laboratory test, Lumbar puncture, Multiple sclerosis, Musculoskeletal pain
Clinical narrative: Received vaccination 10/30/07; returned to doctor with pain in left shoulder (same as vaccinated arm) within two months; began experiencing pain, numbness, cognitive changes 5 months later w/no previous history; admitted to hospital after symptoms worsened; diagnosed with Multiple Sclerosis in 04/2008; no history of any autoimmune disorders in family.  5/14/09 Hospital records received DOS 4/3/08 to 4/4/08. FINAL DIAGNOSIS: C2-C3 demyelinating lesion, single white matter lesion in the subcortical U fibers of the left frontal lobe Post vaccination ascending numbness feet, torso, hands.  ICD-9 Codes: 341.9 Demyelinating diseases of central nervous system unspecified. 3488.8 Condition of brain. 477.9 Allergic rhinitis cause unspecified.  Follow-up received on May 10, 2010 - Pt did not recover from the adverse events that were reported for this vaccination. Multiple sclerosis - Permanently disabled.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination, Nuclear magnetic resonance imaging abnormal, Rhinitis allergic
Clinical narrative: Received vaccination 10/30/07; returned to doctor with pain in left shoulder (same as vaccinated arm) within two months; began experiencing pain, numbness, cognitive changes 5 months later w/no previous history; admitted to hospital after symptoms worsened; diagnosed with Multiple Sclerosis in 04/2008; no history of any autoimmune disorders in family.  5/14/09 Hospital records received DOS 4/3/08 to 4/4/08. FINAL DIAGNOSIS: C2-C3 demyelinating lesion, single white matter lesion in the subcortical U fibers of the left frontal lobe Post vaccination ascending numbness feet, torso, hands.  ICD-9 Codes: 341.9 Demyelinating diseases of central nervous system unspecified. 3488.8 Condition of brain. 477.9 Allergic rhinitis cause unspecified.  Follow-up received on May 10, 2010 - Pt did not recover from the adverse events that were reported for this vaccination. Multiple sclerosis - Permanently disabled.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Fever, ache, lethartic onset 48 hours after vaccination with guardisil
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Rash, Skin swelling, Skin warm
Clinical narrative: a week later, very tired and rash (skin raised, hot, not itchy, red) on upper left leg appeared.  Shot put in back of left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, TD
Symptoms: Rash morbilliform
Clinical narrative: Measle-like rash all over legs and arms appeared 2 days following injection. Rash lasted 8 days and continued to leave darkened spots for over 2 additional weeks.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Hypoaesthesia
Clinical narrative: Arm goes numb for approximately 30 minutes after receiving Anthrax vaccine, event has happened for the past 2 doses
Age: 2.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Ataxia, Decreased activity, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Ataxic symptoms, shaking, "bobblehead" mannerisms, "dizzy appearing" per parents starting 3 days after vaccinations.  Self-resolved by 6 days, but then developed fever, decreased activity/appetite by 8 days. "Doesn't look right" per parents.  Mildly tired-appearing but cooperative, interactive and appropriate during most recent follow-up exam (5/2/2009), slightly wide-based gait with some staggering observed; not much better at home per parents.
Age: 2.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Gait disturbance, Posture abnormal, Pyrexia, Tremor
Clinical narrative: Ataxic symptoms, shaking, "bobblehead" mannerisms, "dizzy appearing" per parents starting 3 days after vaccinations.  Self-resolved by 6 days, but then developed fever, decreased activity/appetite by 8 days. "Doesn't look right" per parents.  Mildly tired-appearing but cooperative, interactive and appropriate during most recent follow-up exam (5/2/2009), slightly wide-based gait with some staggering observed; not much better at home per parents.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Conjunctivitis infective, Dyspnoea, Lethargy, Neck pain
Clinical narrative: WITHIN A LITTLE OVER 24 HOURS.  FIRST SIGNS, SEVERE SORE THROAT, NECK PAIN, ARM PAIN, STOMACH PAIN, A PINK EYE TYPE INFECTION. LETHARGIC.  AT FIRST THOUGHT IT WAS THE SHOTS, THEN THOUGHT MAYBE THE FLU.  NOW I GO BACK TO THE SHOTS!  I DID NOT HAVE HER SEEN FOR TREATMENT.  THIS LASTED A WEEK AND A HALF. HARD TIME BREATHING.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: WITHIN A LITTLE OVER 24 HOURS.  FIRST SIGNS, SEVERE SORE THROAT, NECK PAIN, ARM PAIN, STOMACH PAIN, A PINK EYE TYPE INFECTION. LETHARGIC.  AT FIRST THOUGHT IT WAS THE SHOTS, THEN THOUGHT MAYBE THE FLU.  NOW I GO BACK TO THE SHOTS!  I DID NOT HAVE HER SEEN FOR TREATMENT.  THIS LASTED A WEEK AND A HALF. HARD TIME BREATHING.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Mom returned to office - stated "my son passed out" - Found seat belted into passenger seat - eye opened responded by name. Asked what happened "I didn't feel good" mom stated "head fell forward" call by name then opened eyes "drove back to doctor "to get you" I feel lightheaded" - lye seat back - reclined position - color pink, freckles prominent. BP 86/52 Pulse 68 - by 1102. " I feel fine" - cool cloth behind neck - water offered food bar - encouraged to take it easy for a while - eat, drink.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Fatigue, Infection, Injection site erythema, Injection site swelling
Clinical narrative: I needed a tetanus shot for an infection, and received the tdap. I experienced a sort coughing spell within 10 hours, mild cold symptoms the next morning, a sore arm for several days, redness and swelling at the site of injection and tiredness. I received the shot 4 days ago. I suggest that tetanus shots alone be recommended by CDC for people who have allergies to other medicines and are looking for protection for the one item. Thank you.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: I needed a tetanus shot for an infection, and received the tdap. I experienced a sort coughing spell within 10 hours, mild cold symptoms the next morning, a sore arm for several days, redness and swelling at the site of injection and tiredness. I received the shot 4 days ago. I suggest that tetanus shots alone be recommended by CDC for people who have allergies to other medicines and are looking for protection for the one item. Thank you.
Age: 36.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Myalgia, Oedema peripheral, Rash
Clinical narrative: R deltoid injection 5/1/09 yellow fever vaccine.  Noted arthralgias, myalgias, swollen hands and fingers and bilateral lower leg red rash. Specific manufacturer and Lot # not known to provider completing this form.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Full blood count, HIV test, Rash pustular
Clinical narrative: Papulo-pustular rash extending from L shoulder near vaccination site, across back and upper chest, few lesions on thighs  5/28/09 ED records received DOS 5/3/09. FINAL DIAGNOSIS: Rash - possible smallpox reaction. Post vaccination presented with rash on hips, chest, arms.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Blood glucose normal, Dizziness, Muscular weakness
Clinical narrative: This case was initially received as part of cluster of nine patients on 21 May 2008. Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children. This case contains information regarding one of the nine patients in the clusters (VARES number 312829). A 12-year-old male patient, with a history of headaches, received an injection of DECAVAC (lot number 020788A) on 19 May 2008, site of administration was reported as "right forearm". Following vaccination, the subject complained of dizziness and leg weakness. Blood glucose was 103. He was taken to the emergency department, and treated with Benadryl. The event was considered to be resolved. The reporter in the case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01710, 2008-01711, 2008-01712, 2008-01713, 2008-01714, and 2008-01715, and 2008-01716.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Dizziness, Feeling hot, Headache
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center for Biologics and Evaluation Research (CBER).  Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children.  This case contains information regarding one of the nine patients in the cluster (VAERS number 312832).  A 12-year-old male patient received an injection of DECAVAC (lot number U2078BA) on 19 May 2008; site of administration was reported as "right forearm".  Following vaccination, the subject complained of dizziness, headache, weakness and feeling hot.  He was taken to the emergency department, and treated with BENADRYL.  The event was considered to be resolved.  The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01711, 2008-01712, 2008-01713, 2008-01714, 2008-01715, and 2008-01716.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Abdominal discomfort, Chills, Dizziness
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center for Biologics and Evaluation Research (CBER).  Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children.  This case contains information regarding one of the nine patients in the cluster (VAERS number 312833).  A 12-year-old female patient received an injection of DECAVAC (lot number U159BB) on 19 May 2008; site of administration was reported as "right forearm".  Following vaccination, the subject complained of dizziness, chills, and upset stomach.  She was taken to the emergency department, and treated with BENADRYL.  The event was considered to be resolved.  The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01710, 2008-01712, 2008-01713, 2008-01714, 2008-01715, and 2008-01716.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Crying
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center for Biologics and Evaluation Research (CBER).  Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children.  This case contains information regarding one of the nine patients in the cluster (VAERS number 313157).  A 12-year-old female patient received an injection of DECAVAC (lot number U159BB) on 19 May 2008; site of administration was reported as "right forearm".  Approximately 15 minutes after vaccination, the subject experienced crying.  The event was considered to be resolved.  Follow up information received on 03 July 2008 from the health professional.  The patient received an intramuscular right deltoid injection of DECAVAC (lot number U159BB) on 19 May 2008.  The patient recovered on 19 May 2008.  The reporter in this case also reported in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01711, 2008-01713, 2008-01714, 2008-01715, and 2008-01716.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dizziness, Feeling hot, Pallor
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center for Biologics and Evaluation Research (CBER).  Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children.  This case contains information regarding one of the nine patients in the cluster (VAERS number 313158).  A 12-year-old female patient received an injection of DECAVAC (lot number U1959BB) on 19 May 2008; site of administration was reported as "right forearm".  Approximately 30 minutes after vaccination, the subject became pale and very warm with chills, and felt faint.  The event lasted 30 minutes, and then resolved.  Follow up information was received on 03 July 2008.  A 12-year-old female patient received an intramuscular injection of DECAVAC (lot number U159BB) on 19 May 2008; site of administration was reported as "right forearm".  The patient's recovery date was on 19 May 2008.  The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01710, 2008-01711, 2008-01712, 2008-01714, 2008-01715, and 2008-01716.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Fall, Feeling hot, Mydriasis, Unresponsive to stimuli
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008. Follow-up information was received from a health professional via CBER on 23 May 2008, which provided patient identifiers for each of the nine children. This case contains information regarding one of the nine patients in the clusters (VARES number 313159).  A 12-year-old male patient received an injection of DECAVAC (lot number U2078BA) on 19 May 2008; site of administration was reported as "right forearm". Approximately 30 minutes after vaccination, he fell to the ground and was unresponsive "for a short time", and had dilated pupils. According to the reporter, the patient was in a dark room at the time. He felt warm, and oxygen was administered. The event subsequently resolved. Follow up information was received from the health professional on 03 July 2008. A 12-year-old male patient received a right deltoid intramuscular injection of DECAVAC (lot number U1959BB) on 19 May 2008. The patient recovered on May 2008. The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01710, 2008-01710, 2008-01711, 2008-01713, 2008-01715, and 2008-01716.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Pallor
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center for Biological and Evaluation Research. Follow-up information was  received from a health professional via the center on23 May 2008, which provided patient identifiers for each of the nine children. This case contains information regarding one of the nine patients in the cluster (VAERS number 313160). A 12-year-old male patient, received an injection of DECAVAC (lot number U159BB); site of administration was reported as "right forearm". Following vaccination, he became pale, felt faint, and fell to his knees. The event subsequently resolved. Follow up information was received on 03 July 2008 from a health care professional. A 12-year-old male patient received a right deltoid intramuscular injection of DECAVAC (lot number U159BB) on 19 May 2008. Within a half hour of injection, the patient became pale, felt faint, and fell to his knees. The patient recovered on 19 May 2008. The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01710, 2008-01711, 2008-01712, 2008-01713, 2008-01714, and 2008-01716.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Hyperventilation
Clinical narrative: This case was initially received as part of a cluster of nine patients on 21 May 2008 from the Center. Follow-up information was received from a health professional via the Center on 23 May 2008, which provided patient identifiers for each of the nine children. This case contains information regarding one of the nine patients in the cluster (VAERS number 313161). A 12-year-old male patient received an injection of DECAVAC (lot number U159BB); site of administration was reported as "right forearm". Approximately 15 to 30 minutes following vaccination, he hyperventilated, later stating that he was "fine". The event was considered to be resolved. Follow up information was received on 03 July 2008. A 12-year-old male patient received a right deltoid intramuscular injection of DECAVAC (lot number U159BB). The patient recovered on 19 May 2008. Per the reporter "no problem from the immunization". The reporter in this case also reported adverse reactions for eight other patients, captured in 2008-01697, 2008-01709, 2008-01710, 2008-01711, 2008-01712, 2008-01713, 2008-01714, and 2008-01715.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Blood creatine phosphokinase normal, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Initial report was received 21 August 2008 from a health care professional. A 44-year-old female patient with a history of anxiety disorder, had received a left deltoid injection of DECAVAC, lot number U2294BA on 06 August 2008, and that same day following vaccination, experienced nausea, dizziness, decreased appetite, fatigue, headache and subjective fevers "since 06 August 2008". The patient had a hand laceration at the time of vaccination. The patient received corrective treatment wit CAMPAZINE for the nausea. Laboratory test included CK and ESR with normal results. Per the reporter, the seriousness criteria on the VAERS form was entered as "none of the above - work compensation follow-up visit". At the time of the report, the patient's recovery status was not reported. Follow-up information received on 24 November 2008 from the original reporter who is a physician. Per the reporter, the DECAVAC vaccine was administered intramuscularly. The reporter does not know the recovery status of the patient, as the patient went elsewhere for follow-up. No other contact information was provided for follow-up. Documents held by sender: None The reporter for this case is the same as for case numbers 2008-02681 and 2008-02683.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Initial report was received 21 August 2008 from a health care professional. A 44-year-old female patient with a history of anxiety disorder, had received a left deltoid injection of DECAVAC, lot number U2294BA on 06 August 2008, and that same day following vaccination, experienced nausea, dizziness, decreased appetite, fatigue, headache and subjective fevers "since 06 August 2008". The patient had a hand laceration at the time of vaccination. The patient received corrective treatment wit CAMPAZINE for the nausea. Laboratory test included CK and ESR with normal results. Per the reporter, the seriousness criteria on the VAERS form was entered as "none of the above - work compensation follow-up visit". At the time of the report, the patient's recovery status was not reported. Follow-up information received on 24 November 2008 from the original reporter who is a physician. Per the reporter, the DECAVAC vaccine was administered intramuscularly. The reporter does not know the recovery status of the patient, as the patient went elsewhere for follow-up. No other contact information was provided for follow-up. Documents held by sender: None The reporter for this case is the same as for case numbers 2008-02681 and 2008-02683.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Muscular weakness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Initial report was received 21 August 2008 from a health care professional.  A 12-year-old female patient with no known medical history, had received a left deltoid injection of DECAVAC, lot number U2294BA on 13 August 2008 and within 24 hours, she became dizzy, and developed fever, nausea, lower extremity weakness and pain in her legs.  Corrective treatments were not reported.  At the time of the report, the patient had not yet fully recovered from the event.  Follow-up information received on 07 October 2008 from the original reporter who is a physician in the USA.  The reporter reviewed the case and provided no additional information.  Follow-up information received 10 November 2008 from a health care professional who confirmed the route of administration for DECAVAC had been intramuscular.  The reporter reviewed the case and provided no additional information at the time of the report.  The reporter for this case is the same as for case number 2008-02681 and 2008-02682.  Documents held by sender:  None
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Blood pressure increased, Blood test abnormal, Constipation, Crying
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Drooling, Electrocardiogram, Electroencephalogram, Head banging, Hemiparesis
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Hepatic enzyme increased, Hepatomegaly, Hypertension, Intensive care, Lumbar puncture normal
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Motor dysfunction, Nuclear magnetic resonance imaging, Pyrexia, Rash, Renal disorder
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Streptococcal identification test positive, Trichotillomania, Ultrasound scan, Varicella post vaccine
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: Vaccine associated Varicella. 05/11/10 Follow up: Encephalopathy, hemiparesis, weakened right arm with spasms, learning to walk and talk again. Receiving P/T and O/T.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Bacterial DNA test, Bronchial obstruction, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Please refer to report already submitted
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Heart valve incompetence, Pulmonary embolism, Right ventricular dysfunction, X-ray
Clinical narrative: Please refer to report already submitted
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Chest pain, Cough, Factor V Leiden mutation, Pain in extremity, Pulmonary embolism
Clinical narrative: Please refer to report already submitted
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, FLU3, HPV4
Symptoms: Factor V Leiden mutation, Haematocrit, Unevaluable event
Clinical narrative: Please refer to report already submitted
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Diabetes mellitus, Psoriasis, Rectal haemorrhage, Visual impairment
Clinical narrative: Diabetes, Vision, Blood restal, psoriasis  6/8/09 Received medical records from 7/20/2006-6/4/2009. Records reveal patient experienced: exacerbation of psoriasis, low back pain, dislipidemia, hypercholesterolemia, overweight, adjustment disorder w/depression & anxiety, insomnia, sleep apnea, recurrent ventral hernia repairs, GERD, intermittent tinnitis, allergic rhinitis, HAs, sinusitis, plantar fasciitis, intermittent shoulder hip throat pain, elevated FBS.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a TV news report and the patient's father concerning his 16 year old daughter who in March 2008, was vaccinated with GARDASIL. The patient's father reported that in March 2008 just after the vaccination, he received a phone call in which he was informed that his daughter had a seizure and was on her way to the ER. The patient's father stated that although the doctors were not connecting seizures with the vaccine, he thought it was too much of a coincidence that the vaccination was involved at the same time, closely related with the only seizure his daughter has had in her life. The patient's father felt that the GARDASIL had absolutely something to do with the seizure. It as reported that the patient survived and is healthy today. Upon internal review, seizure was considered an important medical event. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUX, HEPA, MMR, RV5
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her son, an 11 year old male who was born prematurely and was diagnosed with cerebral palsy, who on an unspecified date was vaccinated with a dose of MMR II (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), VAQTA (unspecified) (manufacturer unknown) and ROTATEQ (unspecified). It was reported that the patient were given a lot of vaccines for his age that included the MMR II. The patient's mother reported that the patient was diagnosed with autism later after receiving the MMR II. The patient sought an unspecified medical attention. At the time of reporting, the patient's outcome was Not Recovered/Not Resolved. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Convulsion, Electrocardiogram, Nuclear magnetic resonance imaging, Positron emission tomogram
Clinical narrative: Information has been received from an 83 year old male with no pertinent medical history or no allergy who on 31-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663637/1705X). Concomitant therapy included terazosin hydrochloride. On 03-APR-2009 the patient experienced seizure after receiving ZOSTAVAX (Merck). Prior to the seizure he was in great health. He stated, "I skied until I was 82 years old". He was examined on 03-APR-2009 at hospital and was released that same day. He was prescribed gabapentin. On 03-APR-2009, the patient recovered from seizure. Electrocardiogram, magnetic resonance imaging and positron emission tomography were performed with unknown results. The patient also sought medical attention via telephone. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested. A seizure that occurred 2 1/2 days after the vaccination. I had never experienced a seizure before. Follow-up: Still under care of Neurologist who handled after the seizure. Still on medication after 5/5/10 office visit.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging, Positron emission tomogram normal
Clinical narrative: Information has been received from an 83 year old male with no pertinent medical history or no allergy who on 31-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663637/1705X). Concomitant therapy included terazosin hydrochloride. On 03-APR-2009 the patient experienced seizure after receiving ZOSTAVAX (Merck). Prior to the seizure he was in great health. He stated, "I skied until I was 82 years old". He was examined on 03-APR-2009 at hospital and was released that same day. He was prescribed gabapentin. On 03-APR-2009, the patient recovered from seizure. Electrocardiogram, magnetic resonance imaging and positron emission tomography were performed with unknown results. The patient also sought medical attention via telephone. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested. A seizure that occurred 2 1/2 days after the vaccination. I had never experienced a seizure before. Follow-up: Still under care of Neurologist who handled after the seizure. Still on medication after 5/5/10 office visit.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Nuclear magnetic resonance imaging, Positron emission tomogram normal
Clinical narrative: Information has been received from an 83 year old male with no pertinent medical history or no allergy who on 31-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663637/1705X). Concomitant therapy included terazosin hydrochloride. On 03-APR-2009 the patient experienced seizure after receiving ZOSTAVAX (Merck). Prior to the seizure he was in great health. He stated, "I skied until I was 82 years old". He was examined on 03-APR-2009 at hospital and was released that same day. He was prescribed gabapentin. On 03-APR-2009, the patient recovered from seizure. Electrocardiogram, magnetic resonance imaging and positron emission tomography were performed with unknown results. The patient also sought medical attention via telephone. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested. A seizure that occurred 2 1/2 days after the vaccination. I had never experienced a seizure before. Follow-up: Still under care of Neurologist who handled after the seizure. Still on medication after 5/5/10 office visit.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no medical history or drug allergy who on 13-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 660076/1850U, SQ, 0.5ml) and initially experienced no adverse event. On 24-MAR-2009 the patient was vaccinated with MMR II in the opposite arm. On the same day, the injection site area of the arm which VARIVAX (Merck) was administered to developed swelling. The patient was told to treat the area with antihistamines, ice packs, and hydrocortisone cream. The patient had no lab diagnostics studies performed. At the time of the report the patient was not recovered. The patient sought medical attention- office visit. Additional information has been received on 24-APR-2009 from a registered nurse who reported that the patient received second dose of VARIVAX (Merck) (Lot # not reported) 0.5 ml, subcutaneously on 22-APR-2009. On 23-APR-2009 the patient was experiencing difficulty breathing and was brought to the emergency room. While at the emergency room the patient experienced a systemic reaction and "coded". Upon internal review, systemic reaction and "coded" was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the GARDASIL, concerning a 17 year old female patient with a history of pelvic inflammatory disease who on 19-Mar-2009 was vaccinated with a dose of GARDASIL (lot# not specified). It was reported that 2 weeks ago the patient was being treated for pelvic inflammatory disease, and that time was given an urine hCG test which was negative. On 19-Mar-2009 the patient was given vaccines (not specified) and afterward was also given another urine hCG pregnancy test which was positive. LMP was not provided. The nurse indicated that the patient has an office visit on 23-Mar-2009 for counseling. The patient will not receive prenatal care there since this is a pediatric office. The nurse will provide whatever health care professional contact information for the patient's prenatal care that she obtains. Follow up information has been received from a health professional and a registered nurse concerning a 17 year old female with oligomenorrhoea and a history of pelvic inflammatory disease who on 19-Mar-2009 was vaccinated with third dose of GARDASIL (dose and route not reported, lot number 661531 / 1311X). The registered nurse reported that the patient's mother had called the clinic on 26-Mar-2009 to report that her daughter had an appointment on 30-Mar-2009. In a subsequent phone call to the clinic on 22-Apr-2009, the mother reported that the pregnancy had been electively terminated. Upon internal review, pregnancy had been electively terminated was determined to be an other important medical event. Additional information has been requested.