chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immediate post-injection reaction, Joint hyperextension, Metabolic function test normal, Muscle twitching, Partial seizures
Clinical narrative: Patient with symptoms c/w partial seizure vs. hypotonia, hyporesponsiveness.  Almost immediately after recieving her 6 mo immunizations, episode where patient with head hyperextended, arms extended to side, left lateral fixed gaze with twitch of orbital muscles, as well as hyporesponsiveness lasting approximately 3-5 minutes followed by a more somnolent state for another 5-10 minutes  10/8/09 ICD-9 Codes service dates 8/7/09 to 8/8/09: 780.32 Atypical febrile sezure poss due to vaccination, 999.0 Generalized vaccinia as complication of medical care, 112.0 Candidiasis of the mouth, E948.4 Pertussis vaccine/pertussis component causing adverse effects in therapeutic use, E849.7 Injury of poisoning occurring at/in residential institution.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Posturing, Pupil fixed, Somnolence
Clinical narrative: Patient with symptoms c/w partial seizure vs. hypotonia, hyporesponsiveness.  Almost immediately after recieving her 6 mo immunizations, episode where patient with head hyperextended, arms extended to side, left lateral fixed gaze with twitch of orbital muscles, as well as hyporesponsiveness lasting approximately 3-5 minutes followed by a more somnolent state for another 5-10 minutes  10/8/09 ICD-9 Codes service dates 8/7/09 to 8/8/09: 780.32 Atypical febrile sezure poss due to vaccination, 999.0 Generalized vaccinia as complication of medical care, 112.0 Candidiasis of the mouth, E948.4 Pertussis vaccine/pertussis component causing adverse effects in therapeutic use, E849.7 Injury of poisoning occurring at/in residential institution.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness postural
Clinical narrative: Patient rec'd 6 immunizations here in clinic. After standing waiting about 4 min. she felt dizzy, sat down, rested, wet paper towels on face and neck. Recovered well. She was dressed very warmly with scarfs on head. Foreign language, used language with her father.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: Pt rec'd 6 immunizations. Waiting for the 15 minutes with his sister. He saw her get dizzy as nurse sat her into chair, then he fainted, bumped his head on the sheetrock wall, his father partially caught him helped to floor. Not unconscious at anytime. Kept him on floor flat until recovered. Father decided he was okay. Used foreign lang line to converse.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Welps on arms, trunk, back, neck
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling at injection site, exteding 2 inch diameter.  Mild tenderness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Pt was given Zostavax to LUE on 08/06/2009 and presented to office 6 days later on 08/12/2009 w/ possible shingles lesions to RUE.  Pt presented after ~2 hrs of noticing pruritic lesions -  scattered erythematous maculopapular lesions, nontender, no drainage.  Pt denied any flu-like sxs, no f/c/s, no paresthesias to site prior to erruptions of lesion.  Pt had Herpes Zoster 20+ years ago to same location on RUE (following Right Lumpectomy w/ axillary node dissection, radiation & chemotherapy in 1996).  Pt was given prescription for Valtrex 1000mg 1 tab tid x7 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Onset of low-grade fever (100.2 orally) that night, then thigh pain the next day, then rash and swelling the day after that. I examined him 8/12/09 and noted a 6 cm round area of erythema, induration, and edema over the site of IPV vaccination, but nothing around the DTaP, MMR, and Varivax sites.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Onset of low-grade fever (100.2 orally) that night, then thigh pain the next day, then rash and swelling the day after that. I examined him 8/12/09 and noted a 6 cm round area of erythema, induration, and edema over the site of IPV vaccination, but nothing around the DTaP, MMR, and Varivax sites.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Fever of 100.0,joint pain, body aches
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Grand mal convulsion, Incontinence, Nausea
Clinical narrative: Patient was sent to the nurses station to receive a Gardasil, Menactra, and Tetanus shot.  She received all three, and was asked if she felt okay, replied yes.  She found her mom and her mom asked her again if she felt okay, again she stated yes.  They made it to the car and the patient started complaining of nausea.  As they started driving towards home, they made it about 1/2 block and the mother states that pt started seizing.  She explains that she did not pass out, but did have tonic/clonic like seizure and did become incontinent.  Mother drove the patient back to our clinic where she was seen again by ARNP.
Age: 13.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient passed out about 5 minutes after receiving both Gardisil #3 and Hep B #2 immunizations. Came to rather quickly after cold compresses were applied to forehead and neck, and was able to walk out of clinic with mother in about 15 minutes after event.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient experienced vomitting approximately 10 mins after recieving vaccines.  Vaccines were administered at approximately 12:30 pm.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Headache, Myalgia, Neck pain
Clinical narrative: PATIENT WOKE UP LAST NIGHT, 08/11/2009, TEMP OF 104.0 C/O HEAD, NECK AND MUSCLE PAIN
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PT WAS GIVEN AN EXTRA IPV NAD TDAP BEFORE DUE
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pruritus, Pruritus
Clinical narrative: 3 days after receiving Zostavax patient came to the pharmacy with 3 shingles at the injection site and 1 shingle on her belly.  Patient said they aren't painful they just itch. Gave her Benedryl for the itch.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Nausea, Tremor, Urticaria
Clinical narrative: Pt became shaky and nauseuos within a few minutes.  She got 3 hives.  BP 125/65 pulse 93, No wheezing or trouble breathing.  25 mg of benadryl was given po.  She drank 1/2 of a can of gatorade and ate a few graham crackers.  After 25 minutes she stated she felt fine and was sent home with a script for benadryl 50 mgm to be taken every 6-8 hours. She still had the hives but there were no more.  She was advised to call EMS if any trouble breathing
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure 8-11-09 Seen in ER and air lifted to Hosp. 8/28/09 MR received for DOS 8/12-13/2009 with D/C DX:  Convulsions NEC. Neurologist dx:  Complicated Febrile Seizures with status epilepticus. Pt presented to ER after several episodes of intermittent extremity twitching which progressed to generalized tonic-clonic seizures in ED. Prior to episode had been fussy and febrile.  Conccern for respiratory compromise resulted in transfer from local hospital to current facility. Pt became responsive on arrival thus no intubation necessary.  No further tonic-clonic seizure activity however parent noted one brief episode of eyes rolled back and R shoulder twitching which lasted ~2 seconds and resolved quickly without intervention. ICD9:  780.39 10/28/09 Additional ICD9 code received: V65.40, 780.32, 345.3, 781.0.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: pt presented 2 days post vaccination for ppd reading with erythema, edema, heat and site pain.  advised cold compress for 10m on and 10m off x4 hours today.  advised ibuprofen children's dose OTC one time and prn if symptoms persist.  advised to eat prior to dosage secondary to risk of stomach upset on an empty stomach.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: The area is very red and swollen. It is also under the area. Two areas are affected. This happend the last time he got shots. It is also painful. It felt like it was very hot on the areas. NO tests were done. I do not want my child to go through this again. I want a waver so that he no longer has to go through this.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Anion gap increased, Blood glucose decreased, Body temperature decreased, Carbon dioxide abnormal
Clinical narrative: Pt c/o acute abdominal pain then syncope with decreased body temp (95). In ER, LP and bloodwork concerning for shock, no infection found. Stayed in PICU overnight then regular room. Recovered quickly with IV Cleared by GI/Genetics. 9/22/09 Medical office note received DOS 6/08 to 6/09. Hospitalized after DTaP. Reflux, stomach aches. 10/28/2009 Medical records, discharge summary and ICD9 codes received for DOS 12/21/08 (discharge date not provided on record). FINAL DX: Hypothermia, abdominal pain, chronic, vomiting, constipations. Child admitted after acute episode of abdominal pain, lethargy, vomiting and hypothermia. Temp upon admit 33c rectal. WBC increased. Blood sugar borderline hypoglycemic.  Acidotic per gases. PICU for observation then to general ward thereafter. Blood, urine and CSF cx neg.  ABX d/c due to concern for metabolic disorder. Influenza neg. Thyroid WNL. CT head neg.  Upon discharge temp WNL. Active and playful. Back to baseline. Discharged to home. Follow-up endocrine/GI.  ICD9 CODES: 991.6, 789.0, 787.03, 564. 0, 780.63, 285.9, 276. 51, 251.2, 780.65, 564.09, 276.2, 338.29, 789.05  12/21/09 DC summary and hospital records received for dates 12/21/08.  DX: hypothermia, abdominal pain, vomiting, constipation. Pt was admitted for acute episode of vomit and diaphoresis w/ temp 94-95F. Pt found to be acidotic, borderline hypoglycemic. Pt stable at dc.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Carbon dioxide decreased, Intensive care, Syncope, White blood cell count increased
Clinical narrative: Pt c/o acute abdominal pain then syncope with decreased body temp (95). In ER, LP and bloodwork concerning for shock, no infection found. Stayed in PICU overnight then regular room. Recovered quickly with IV Cleared by GI/Genetics. 9/22/09 Medical office note received DOS 6/08 to 6/09. Hospitalized after DTaP. Reflux, stomach aches. 10/28/2009 Medical records, discharge summary and ICD9 codes received for DOS 12/21/08 (discharge date not provided on record). FINAL DX: Hypothermia, abdominal pain, chronic, vomiting, constipations. Child admitted after acute episode of abdominal pain, lethargy, vomiting and hypothermia. Temp upon admit 33c rectal. WBC increased. Blood sugar borderline hypoglycemic.  Acidotic per gases. PICU for observation then to general ward thereafter. Blood, urine and CSF cx neg.  ABX d/c due to concern for metabolic disorder. Influenza neg. Thyroid WNL. CT head neg.  Upon discharge temp WNL. Active and playful. Back to baseline. Discharged to home. Follow-up endocrine/GI.  ICD9 CODES: 991.6, 789.0, 787.03, 564. 0, 780.63, 285.9, 276. 51, 251.2, 780.65, 564.09, 276.2, 338.29, 789.05  12/21/09 DC summary and hospital records received for dates 12/21/08.  DX: hypothermia, abdominal pain, vomiting, constipation. Pt was admitted for acute episode of vomit and diaphoresis w/ temp 94-95F. Pt found to be acidotic, borderline hypoglycemic. Pt stable at dc.
Age: 60.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Blister, Erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling pain at site of vaccine 8/6/09 - Seen 8/11/09 - (L) anterior thorax- diffuse erythema with vesicles.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: After receiving 4 mos. vaccines child developed hives - Mom gave 1/2 tsp BENADRYL x 1 dose hives disappeared came in for office visit on 8/12/09
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Pt's mother, called this RN at 12:15pm and stated that daughter's left arm from shoulder to elbow is red, swollen,hot to the touch and the skin looked "stretched".  Instructed her to take child to ER.  (pt uninsured.)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt had redness; Itching and warmth around MMR vaccination site.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Rash, Urticaria
Clinical narrative: Rash / Urticaria appears 2 days after completion of oral typhoid vaccine. Patient started oral vaccine or at home on 8/1/09.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Swollen injection site with vesicles, warmth redness.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Left thigh @ injection site by day 2 after administered HEP A & VARIVAX on same thigh developed redness, welt's, itching; developed into cellulitis by 1 wk out; unable to tell from what vaccine site.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Muscle rigidity, Opisthotonus, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: Varicella administered R upper arm, after a few minutes later client slumped over, non responsive, body, arms became rigid, hand fisted with some tremors, back arched backwards, client laid on floor, breathing during whole event. Emesis x1, client opened eyes and became responsive, responding to questions. Ambulance came with EMTS, client taken to Emergency Room.
Age: 1.8
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site mass, Injection site rash, Pyrexia, Rash
Clinical narrative: Rash and lump to site fever 103.4.  Rash all over left leg.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Pt received DTaP left deltoid at hosp on 8/9/09 c/o redness 3in x 3in with swelling at site of injection. Assessed by PA, local allergic reaction. Treatment cool compress and TYLENOL. Pt gave birth on 8/8/09.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Cough, Crying, Generalised erythema, Pyrexia
Clinical narrative: Very high fever and cough with lots of crying redness all over.
Age: 69.0
Sex: M
Vaccine: HEP, HEPA, VARZOS
Symptoms: Chills, Condition aggravated, Diarrhoea, Facial pain, Foreign travel
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that a 69 year old male with, sleep apnea, restless leg syndrome, hypertension and trigeminal neuralgia a history of craniotomy (2004) and previous illness reported as none who on 21-APR-2008 was vaccinated with first dose of ZOSTAVAX (Merck) (lot # 659268/0158X) intramuscularly into the right arm; secondary suspect vaccination given on the same date on 21-APR-2008 included second dose of RECOMBIVAX HB (manufacturer unknown) (lot number AHAVB236, route intramuscular into left arm) and second dose of dose of VAQTA (manufacturer unknown) (lot number AHBVB520, route intramuscular into left arm). It was reported that the patient had a history of trigeminal neuralgia having had shin surgery in 2004. For four years, the patient was pain-free. On 22-APR-2008, the patient had a shingles shot: by 01-MAY-2008, the patient's trigeminal neuralgia was back, this time with a vengeance. Since shingles was a nerve disease and the vaccine was live, the patient was exploring whether there was a relation between this two events. On 19-AUG-2008, the hospital medical records from 02-JUL-2008 to 03-JUL-2008 were reviewed. The final diagnosis was right trigeminal neuralgia. The records revealed that the patient experienced recent severe worsening of sharp right facial pain with occasional right tongue numbness. The patient had a foreign travel approximately 6 weeks prior and had a presyncopal episode preceded by viral illness with fevers, chills and significant diarrhea. The patient completely recovered. The patient was admitted for percutanous balloon compression of right trigeminal nerve. The patient did well postoperatively and was discharged to home with numbness across right distribution of trigeminal nerve without sharp pain as preoperative. The patient had no difficulty swallowing and temporal and masseter muscles were intact. It was noted that the patient had visited two neurosurgeons. The events were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 659268/0158X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was originally reported by a consumer. The VAERS ID number is 318106. No further information is available.
Age: 69.0
Sex: M
Vaccine: HEP, HEPA, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia oral, Presyncope, Pyrexia, Surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that a 69 year old male with, sleep apnea, restless leg syndrome, hypertension and trigeminal neuralgia a history of craniotomy (2004) and previous illness reported as none who on 21-APR-2008 was vaccinated with first dose of ZOSTAVAX (Merck) (lot # 659268/0158X) intramuscularly into the right arm; secondary suspect vaccination given on the same date on 21-APR-2008 included second dose of RECOMBIVAX HB (manufacturer unknown) (lot number AHAVB236, route intramuscular into left arm) and second dose of dose of VAQTA (manufacturer unknown) (lot number AHBVB520, route intramuscular into left arm). It was reported that the patient had a history of trigeminal neuralgia having had shin surgery in 2004. For four years, the patient was pain-free. On 22-APR-2008, the patient had a shingles shot: by 01-MAY-2008, the patient's trigeminal neuralgia was back, this time with a vengeance. Since shingles was a nerve disease and the vaccine was live, the patient was exploring whether there was a relation between this two events. On 19-AUG-2008, the hospital medical records from 02-JUL-2008 to 03-JUL-2008 were reviewed. The final diagnosis was right trigeminal neuralgia. The records revealed that the patient experienced recent severe worsening of sharp right facial pain with occasional right tongue numbness. The patient had a foreign travel approximately 6 weeks prior and had a presyncopal episode preceded by viral illness with fevers, chills and significant diarrhea. The patient completely recovered. The patient was admitted for percutanous balloon compression of right trigeminal nerve. The patient did well postoperatively and was discharged to home with numbness across right distribution of trigeminal nerve without sharp pain as preoperative. The patient had no difficulty swallowing and temporal and masseter muscles were intact. It was noted that the patient had visited two neurosurgeons. The events were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 659268/0158X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was originally reported by a consumer. The VAERS ID number is 318106. No further information is available.
Age: 69.0
Sex: M
Vaccine: HEP, HEPA, VARZOS
Symptoms: Trigeminal neuralgia, Viral infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that a 69 year old male with, sleep apnea, restless leg syndrome, hypertension and trigeminal neuralgia a history of craniotomy (2004) and previous illness reported as none who on 21-APR-2008 was vaccinated with first dose of ZOSTAVAX (Merck) (lot # 659268/0158X) intramuscularly into the right arm; secondary suspect vaccination given on the same date on 21-APR-2008 included second dose of RECOMBIVAX HB (manufacturer unknown) (lot number AHAVB236, route intramuscular into left arm) and second dose of dose of VAQTA (manufacturer unknown) (lot number AHBVB520, route intramuscular into left arm). It was reported that the patient had a history of trigeminal neuralgia having had shin surgery in 2004. For four years, the patient was pain-free. On 22-APR-2008, the patient had a shingles shot: by 01-MAY-2008, the patient's trigeminal neuralgia was back, this time with a vengeance. Since shingles was a nerve disease and the vaccine was live, the patient was exploring whether there was a relation between this two events. On 19-AUG-2008, the hospital medical records from 02-JUL-2008 to 03-JUL-2008 were reviewed. The final diagnosis was right trigeminal neuralgia. The records revealed that the patient experienced recent severe worsening of sharp right facial pain with occasional right tongue numbness. The patient had a foreign travel approximately 6 weeks prior and had a presyncopal episode preceded by viral illness with fevers, chills and significant diarrhea. The patient completely recovered. The patient was admitted for percutanous balloon compression of right trigeminal nerve. The patient did well postoperatively and was discharged to home with numbness across right distribution of trigeminal nerve without sharp pain as preoperative. The patient had no difficulty swallowing and temporal and masseter muscles were intact. It was noted that the patient had visited two neurosurgeons. The events were considered to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number 659268/0158X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was originally reported by a consumer. The VAERS ID number is 318106. No further information is available.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired dose of vaccine administered was received from a physician concerning a five-year-old female.  No medical history or concomitant medications were reported.  The patient received FLUMIST vaccine on 05-Feb-2008.  The FLUMIST vaccine administered had an expiration date of 31-Dec-2007.  Follow-up call to the reporter after four weeks on 04-Mar-2008 confirmed that the patient did not experience any adverse events after receiving expired FLUMIST vaccine.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional information received on 04-Mar-2008  :  reporter confirmed patient did not experience adverse events.  Additional information received on 21-Nov-2008 :  patient's date of birth and lot number.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Heart rate normal, Nausea, Oxygen saturation normal, Vomiting
Clinical narrative: A non-serious spontaneous report of dizziness, nausea, and emesis has been received from a nurse concerning a 12-year-old male, subsequent to FLUMIST.  No relevant medical and/or drug history information has been reported for this patient.  Concomitant vaccines included Hepatitis A, MENACTRA, and Tdap, which were all given on the same day as FLUMIST.  The patient received FLUMIST on 13-Oct-2008.  After receiving the vaccines followed by a lead test, the patient complained of being dizzy, lightheaded, nauseated and  he vomited once.  The patient was placed in a lying position, with his feet elevated, and given cold water to drink. The patient's blood pressure was "fine".  Thirty to 45 minutes later, the events resolved and the patient left the clinic with his mother.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL, FLUN3, MNQ, TDAP, VARCEL, FLUN3, HEPA, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: A non-serious spontaneous report of dizziness, nausea, and emesis has been received from a nurse concerning a 12-year-old male, subsequent to FLUMIST.  No relevant medical and/or drug history information has been reported for this patient.  Concomitant vaccines included Hepatitis A, MENACTRA, and Tdap, which were all given on the same day as FLUMIST.  The patient received FLUMIST on 13-Oct-2008.  After receiving the vaccines followed by a lead test, the patient complained of being dizzy, lightheaded, nauseated and  he vomited once.  The patient was placed in a lying position, with his feet elevated, and given cold water to drink. The patient's blood pressure was "fine".  Thirty to 45 minutes later, the events resolved and the patient left the clinic with his mother.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Nausea, Pregnancy test positive, Pyrexia
Clinical narrative: A spontaneous non-serious report of administration to pregnant female, fever and stomach ache has been received from a nurse concerning a 14 year old female patient subsequent to FLUMIST. Medical history included psychiatric disorder. Concomitant medications included psychiatric medications (no specific medications provided), Tdap, MCV and HPV vaccines. On 05-Dec-2008, the patient received FLUMIST. The school nurse administered FLUMIST concomitantly with Tdap, MCV and HPV vaccinations. The patient reported to the nurse that her last menstrual period was less that one month prior to receiving the vaccinations. On 10-Dec-2008, the patient presented to the emergency room (ER) with fever and a stomach ache. Laboratory tests included a urine pregnancy test which was positive. The patient was to visit an obstetrician on 22-Dec-2008; she plans to maintain the pregnancy. After returning to school, the patient was transferred to a different school. At the time of the report, the outcome for the events of administered to a pregnant female, fever and stomach ache was unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Vomiting
Clinical narrative: A spontaneous non-serious report of administration to pregnant female, fever and stomach ache has been received from a nurse concerning a 14 year old female patient subsequent to FLUMIST. Medical history included psychiatric disorder. Concomitant medications included psychiatric medications (no specific medications provided), Tdap, MCV and HPV vaccines. On 05-Dec-2008, the patient received FLUMIST. The school nurse administered FLUMIST concomitantly with Tdap, MCV and HPV vaccinations. The patient reported to the nurse that her last menstrual period was less that one month prior to receiving the vaccinations. On 10-Dec-2008, the patient presented to the emergency room (ER) with fever and a stomach ache. Laboratory tests included a urine pregnancy test which was positive. The patient was to visit an obstetrician on 22-Dec-2008; she plans to maintain the pregnancy. After returning to school, the patient was transferred to a different school. At the time of the report, the outcome for the events of administered to a pregnant female, fever and stomach ache was unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Pregnancy test positive, Pyrexia
Clinical narrative: A spontaneous non-serious report of administration to pregnant female, fever and stomach ache has been received from a nurse concerning a 14 year old female patient subsequent to FLUMIST. Medical history included psychiatric disorder. Concomitant medications included psychiatric medications (no specific medications provided), Tdap, MCV and HPV vaccines. On 05-Dec-2008, the patient received FLUMIST. The school nurse administered FLUMIST concomitantly with Tdap, MCV and HPV vaccinations. The patient reported to the nurse that her last menstrual period was less that one month prior to receiving the vaccinations. On 10-Dec-2008, the patient presented to the emergency room (ER) with fever and a stomach ache. Laboratory tests included a urine pregnancy test which was positive. The patient was to visit an obstetrician on 22-Dec-2008; she plans to maintain the pregnancy. After returning to school, the patient was transferred to a different school. At the time of the report, the outcome for the events of administered to a pregnant female, fever and stomach ache was unknown.
Age: 5.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired vaccine used (expired drug administered). A non-serious, spontaneous report of administration of expired product was received from a nurse. There was no adverse event associated with this medication error; therefore treatment and reporter / sponsor causality assessment are not applicable and the event is considered resolved. Based on the results of the investigation the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: Product complaint investigation results.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Arthralgia, Histone antibody positive, Immediate post-injection reaction, Joint swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Rash, Screaming, Systemic lupus erythematosus, Urine analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Antinuclear antibody, Arthralgia, DNA antibody, Histone antibody positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Joint swelling, Musculoskeletal pain, Rash generalised, Screaming
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Systemic lupus erythematosus, Urine analysis, X-ray limb
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with no known pertinent medical history and no known preexisting illness and with periodic swelling of lip and eye was vaccinated with the third dose of GARDASIL (Lot # 660612/0229X) intramuscularly on 29-DEC-2008. There were no concomitant medications. Immediately following vaccine, the patient began to complain of mild symptoms (shoulder and wrist hurts and spots on her legs). On 05-JAN-2009, she came home from school with pain in both of her ankles but after resting and an ADVIL, she felt ok to go to school. She came home from school on 06-JAN-2009 screaming of pain her ankles were so swollen, we had a lot of trouble getting her boots off. She could not walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent the patient to hospital. She had a lot of test included blood work of DNA, ANA, complement levels, urine analysis, and X-rays of ankles. Later did histone tests which indicated strong positive for drug induced lupus. Intravenous steroids and antibiotics were prescribed. They later diagnosed her with lupus. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 350284.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Anaphylactic reaction, Lip swelling, Nasal congestion, Pruritus, Throat tightness
Clinical narrative: Information has been received from a pharmacist concerning her 6 year old son with no known drug allergies who on 10-DEC-2003 was vaccinated with the first dose of VARIVAX (Merck). On 30-JUL-2007 the patient was vaccinated with the second first dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2007 the patient experienced an allergic reaction 15 minutes after administration of her second dose of VARIVAX (Merck). Initially he started sneezing and then 10 to 20 minutes later his hands, feet, and back became itchy. He developed hives on his back and his nose was stuffed up. He was unable to breath through his nose. His face was flushed and then hives appeared on his cheeks and face. He was given BENADRYL. About 5 to 10 minutes later he vomited. His breathing became labored. EPINEPHRINE was administered. He remained at the physician's office for an additional 2.5 hours. By the time he left the office his symptoms had resolved. Allergic reaction, sneezing, hands, feet and back became itchy, hives on back, cheeks and face, nose was stuffed up, face was flushed, vomited and breathing became labored were considered to be an other important medical event by the pharmacist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning her 6 year old son with no known drug allergies who on 10-DEC-2003 was vaccinated with the first dose of VARIVAX (Merck). On 30-JUL-2007 the patient was vaccinated with the second first dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2007 the patient experienced an allergic reaction 15 minutes after administration of her second dose of VARIVAX (Merck). Initially he started sneezing and then 10 to 20 minutes later his hands, feet, and back became itchy. He developed hives on his back and his nose was stuffed up. He was unable to breath through his nose. His face was flushed and then hives appeared on his cheeks and face. He was given BENADRYL. About 5 to 10 minutes later he vomited. His breathing became labored. EPINEPHRINE was administered. He remained at the physician's office for an additional 2.5 hours. By the time he left the office his symptoms had resolved. Allergic reaction, sneezing, hands, feet and back became itchy, hives on back, cheeks and face, nose was stuffed up, face was flushed, vomited and breathing became labored were considered to be an other important medical event by the pharmacist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Flushing, Hypersensitivity, Nasal congestion, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning her 6 year old son with no known drug allergies who on 10-DEC-2003 was vaccinated with the first dose of VARIVAX (Merck). On 30-JUL-2007 the patient was vaccinated with the second first dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2007 the patient experienced an allergic reaction 15 minutes after administration of her second dose of VARIVAX (Merck). Initially he started sneezing and then 10 to 20 minutes later his hands, feet, and back became itchy. He developed hives on his back and his nose was stuffed up. He was unable to breath through his nose. His face was flushed and then hives appeared on his cheeks and face. He was given BENADRYL. About 5 to 10 minutes later he vomited. His breathing became labored. EPINEPHRINE was administered. He remained at the physician's office for an additional 2.5 hours. By the time he left the office his symptoms had resolved. Allergic reaction, sneezing, hands, feet and back became itchy, hives on back, cheeks and face, nose was stuffed up, face was flushed, vomited and breathing became labored were considered to be an other important medical event by the pharmacist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning her 6 year old son with no known drug allergies who on 10-DEC-2003 was vaccinated with the first dose of VARIVAX (Merck). On 30-JUL-2007 the patient was vaccinated with the second first dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2007 the patient experienced an allergic reaction 15 minutes after administration of her second dose of VARIVAX (Merck). Initially he started sneezing and then 10 to 20 minutes later his hands, feet, and back became itchy. He developed hives on his back and his nose was stuffed up. He was unable to breath through his nose. His face was flushed and then hives appeared on his cheeks and face. He was given BENADRYL. About 5 to 10 minutes later he vomited. His breathing became labored. EPINEPHRINE was administered. He remained at the physician's office for an additional 2.5 hours. By the time he left the office his symptoms had resolved. Allergic reaction, sneezing, hands, feet and back became itchy, hives on back, cheeks and face, nose was stuffed up, face was flushed, vomited and breathing became labored were considered to be an other important medical event by the pharmacist. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a nurse and the patient's mother concerning a 24 year old female with migraine & depression, no known drug allergies (NKDA) and a history of seizure due to an overdose of WELLBUTRIN which was only one incident couple years ago. Concomitant therapy included LOESTRIN 1/20 and WELLBUTRIN. On 29-JUN-2009 the patient was vaccinated with the first dose of GARDASIL (LOT #658556/1060U). On 30-JUL-2009 she had a seizure. The outcome of the patient was recovered. She sought medical attention and was taken to ER but was not admitted. Upon internal review, seizure was determined to be an other important medical event. No further information is available.