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Administered by: Private Purchased by: Private Life Threatening? No Write-up: Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek''s sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache, blurry vision; Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall "coffee instead of coughing" "Sired instead of tired." Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7/10/2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis: Dehydration, Vasovagal syncope secondary to shot vs pain at injection site. 7/17/06 Medical records received from reporter/provider which included vax record, office note of 7/11 & neuro consult of 7/15 by MD who also saw her in the hospital on 7/11-12. Neuro report indicates the CT scan of head was WNL & that dx is syncope probably precipitated by pain of vax injection along w/dehydration (no fluid intake since evening of 7/10 until IVF given in ER). As of 7/15 patient continued to have throbbing HA when bending down & also c/o strong heart beats ocassionally. PMH: dehydration requiring hospitalization at age 3 yo. Also has hx of mild anxiety. Family hx: patient''s mother has Fuch''s disease (genetic degenertive corneal disease which her mother also had) & patient''s father has depression. There are no siblings. It was noted that she had 3 episodes of emesis following vax along w/ sustaining mild concussion when fell from exam table which was characterized by brief episode of aphasia, slurred speech & possible right facial paresis noted only by patient''s mother./ss 10/27/06 Received medical records from hospital which reveal patient seen in ER after LOC with head trauma. Noted to have slurred speech, word finding difficulty, HA & emesis x 2 which resolved after several hours. Admitted for overnight observation. Given IVF & IV Toradol. Head CT was WNL. Neurology consult done which was essentially WNL with mild generalized weakness, speech intact & mental status clear. Final dx: LOC with head trauma, vasovagal syncope. |
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Administered by: Private Purchased by: Private Life Threatening? No Write-up: Patient received Hep A in right arm. Then received HPV in left arm. C/O pain & numbness. Started walking down hall fainted and had tonic/clonic movement for 15 sec. |
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Administered by: Private Purchased by: Private Life Threatening? No Write-up: Swelling immediately after vaccine was administered, also rash. Ice pack was applied for 5 minutes and swelling decreases. Rash was still visible, but cream was applied. This is in follow-up report(s) previously submitted on 8/10/2006. Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with 0.5 ml dose of GARDASIL. Subsequently, the patient experienced painful, swelling "the size of a golf balll" at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. The patient recovered by "the next day." Additional information has been requested. |
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Administered by: Private Purchased by: Private Life Threatening? No Write-up: Dizzy, nauseated, developed axillary lymphadenopathy on side with Menactra inoculation. |
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Administered by: Other Purchased by: Unknown Life Threatening? No Write-up: Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies who "last week" on approximately 12-JUL-2006 was vaccinated with HPV vaccine rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The vaccines were administered in different arms. Subsequently, "12 hours after vaccination" the patient developed a rash throughout her whole body that lasted for two days. Unspecified medical attention was sought. The patient recovered two days after injection. Additional information has been requested. |
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Administered by: Other Purchased by: Other Life Threatening? No Write-up: Information has been received from a physician concerning an approximately 16 year old female who on 19-JUL-2006 was vaccinated with HPV rLI 6 11 16 18 VLP vaccine (yeast). It was reported that "immediately after the injection", on 19-JUL-2006, the patient experienced pain and stinging at the injection site that lasted about 2 minutes and radiated the arm. The patient also reported feeling faint following the injection and experienced swelling. It was reported that the swelling went down but the pain persisted. Unspecified medical attention was sought. Additional information has been requested. |
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Administered by: Private Purchased by: Private Life Threatening? No Write-up: Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post- ictal state. Unspecified medical attention was sought. Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 8/10/2006. Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 at 13:30 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 1/2 to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post-ictal state. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested. |
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Administered by: Other Purchased by: Other Life Threatening? No Write-up: Information has been received from a physician and registered nurse concerning a 21 year old female with no medical history of drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the left deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). Concomitant therapy included possible hormonal contraceptives (unspecified). On 27-JUL-2006 the patient experienced extreme pain at the injection site. The onset of the pain was immediate and lasted for 5 to 6 minutes and then resolved. Unspecified medical attention was sought. It was reported that the patient does not wish to continue the series of vaccinations. Additional information has been requested. |
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Administered by: Other Purchased by: Other Life Threatening? No Write-up: Information has been received from a physician concerning a 14 year old female who on 28-JUL-2006 was vaccinated with HPV rLI 3 11 16 18 VLP vaccine (yeast). Concomitant vaccination on 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The patient stated that following vaccination on 28-JUL-2006, she " experienced a great deal of pain at the injection site". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested. |
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Administered by: Unknown Purchased by: Unknown Life Threatening? No Write-up: Patient developed a fine, red rash over torso and legs with itching reported on8/22/2006. |
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