chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Skin ulcer, Wound complication
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 84 years old male patient who on 17-MAY-2012, was vaccinated with a dose of ZOSTAVAX (lot number 672606/1655AA, Exp. Date: 21-JAN-2013)(dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that from the time of vaccination on 17-MAY-2012, the patient had a sore on his arm that would not heal. It was stated that the patient presented to her pharmacy the evening of 20-AUG-2012, and presented his arm for examination: The pharmacist reported that the back side of his deltoid had a scabbed area that looked like it had been picked at. She indicated that the wound appeared to be irritated from being picked at. The pharmacist stated that the patient had not reported this wound to his physician. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient did not seek medical attention. The relatedness for sore on his arm that will not heal and the wound appeared to be irritated from being picked at was unknown for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a child who on 17-AUG-2012, was vaccinated with a dose of M-M-R II (lot# 1251AA, exp 01-AUG-2013). The nurse stated that the child might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning possibly seven children who on 16-AUG-2012, were vaccinated with a dose of M-M-R II (lot# not provided). The nurse stated that the children might have been vaccinated with improperly stored M-M-R II. M-M-R II was exposed to 68 F for 9 hours and then on Wednesday last week "on 15-AUG-2012", the temperature went to 48F for 1 hour (also reported as exposed to 68 F for more than 6 hours). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Muscle twitching
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 63 year old female patient with sulfa allergy, who on 18-AUG-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX in her left arm (lot number reported as 0073AE, expiration date were not provided) (route was not provided). No other co-suspects were reported. Concomitant medications included vitamin D (unspecified) and fluticasone. The pharmacist stated that the patient developed a red, itchy rash on her left arm at the injection site after receiving ZOSTAVAX. The area of the rash was about 1 inch by 2 inches in size. The patient also told the pharmacist that her left thumb had been twitching. This started at unspecified time after she received ZOSTAVAX. The patient was given BENADRYL as treatment. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a patient's boyfriend refers to a female patient of unknown age who approximately in 2011, "about one year ago" was vaccinated subcutaneously with a dose of ZOSTAVAX 0.65 ml. No other co-suspects were reported. No concomitant medications were reported. The patient's boyfriend reported that the patient experienced shingles "about one-year" in approximately 2012, after getting ZOSTAVAX vaccination. The patient's boyfriend disconnected the call and no additional information was provided. Patient's outcome was unknown. Action taken was not applicable. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Blood test, Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with the full series of RECOMBIVAX HB doses (Lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient had a negative titer for hepatitis B antibodies. Blood test were performed (results not provided). No treatment was given for the event. The status of the patient had not changed since the titer. The relatedness for negative titer for hepatitis B antibodies was unknown unknown for RECOMBIVAX HB. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age, who on 10-AUG-2012 was vaccinated with a dose of PNEUMOVAX23 (lot # 669380/1397Z) (dose and route not reported) that expired on 04-AUG-2012. The patient was not experienced any known symptoms. No treatment information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist refers to a female patient of unknown age. In approximately July 2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed injection site reaction described as redness and rash at the injection site about 4 or 5 weeks ago in approximately July 2012. The injection site reaction and rash was reported to have developed about a day after vaccinations with ZOSTAVAX. The injection site reaction and rash was treated with cold compresses and ADVIL and resolved after an unspecified number of days. No other information was reported. Additional information has been requested. This is one of several reports from the same source.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to her 3 years old nephew who on an unspecified date. The patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that her nephew had a sensitivity to the M-M-R II vaccine at an unspecified time. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from a pharmacy's claims examiner on 09 April 2012. A female patient (age not reported) had received an injection of FLUZONE HIGH DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an adverse reaction. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer, who was also the patient, on 20 August 2012. Based upon the new information this case has been upgraded to serious. The patient was a 68-year-old female who received a dose one injection of FLUZONE HIGH-DOSE on 01 December 2011 at 7:00 PM. "Extreme pain 24/7" started on 03 December 2011 with limited movement of left arm. The patient was diagnosed with Parsonage Turner Syndrome. The patient was treated with eight different medications to stop the pain. The patient had an ultrasound, neurological tests done (results not reported) and 16 physical therapy sessions. At the time of the report, the pain was better but still present with limited use of the left arm. The patient had trouble dressing, combing hair and cannot carry handbag on left shoulder. She has moderate pain constantly. Doctors stated this may last 2-3 years or could be permanent. The patient had no past medical history, no illness at the time of vaccination and no adverse events following prior vaccinations. Concomitant medications include ZOCOR, LEVOXYL, atenolol, lisinopril and hydrochlorothiazide daily. The patient's outcome was not recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report was received from a pharmacy's claims examiner on 09 April 2012. A female patient (age not reported) had received an injection of FLUZONE HIGH DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an adverse reaction. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer, who was also the patient, on 20 August 2012. Based upon the new information this case has been upgraded to serious. The patient was a 68-year-old female who received a dose one injection of FLUZONE HIGH-DOSE on 01 December 2011 at 7:00 PM. "Extreme pain 24/7" started on 03 December 2011 with limited movement of left arm. The patient was diagnosed with Parsonage Turner Syndrome. The patient was treated with eight different medications to stop the pain. The patient had an ultrasound, neurological tests done (results not reported) and 16 physical therapy sessions. At the time of the report, the pain was better but still present with limited use of the left arm. The patient had trouble dressing, combing hair and cannot carry handbag on left shoulder. She has moderate pain constantly. Doctors stated this may last 2-3 years or could be permanent. The patient had no past medical history, no illness at the time of vaccination and no adverse events following prior vaccinations. Concomitant medications include ZOCOR, LEVOXYL, atenolol, lisinopril and hydrochlorothiazide daily. The patient's outcome was not recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site mass, Injection site pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Initial report was received from a pharmacy's claims examiner on 09 April 2012. A female patient (age not reported) had received an injection of FLUZONE HIGH DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an adverse reaction. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer, who was also the patient, on 20 August 2012. Based upon the new information this case has been upgraded to serious. The patient was a 68-year-old female who received a dose one injection of FLUZONE HIGH-DOSE on 01 December 2011 at 7:00 PM. "Extreme pain 24/7" started on 03 December 2011 with limited movement of left arm. The patient was diagnosed with Parsonage Turner Syndrome. The patient was treated with eight different medications to stop the pain. The patient had an ultrasound, neurological tests done (results not reported) and 16 physical therapy sessions. At the time of the report, the pain was better but still present with limited use of the left arm. The patient had trouble dressing, combing hair and cannot carry handbag on left shoulder. She has moderate pain constantly. Doctors stated this may last 2-3 years or could be permanent. The patient had no past medical history, no illness at the time of vaccination and no adverse events following prior vaccinations. Concomitant medications include ZOCOR, LEVOXYL, atenolol, lisinopril and hydrochlorothiazide daily. The patient's outcome was not recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Neuralgic amyotrophy, Neurological examination, Pain
Clinical narrative: Initial report was received from a pharmacy's claims examiner on 09 April 2012. A female patient (age not reported) had received an injection of FLUZONE HIGH DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an adverse reaction. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer, who was also the patient, on 20 August 2012. Based upon the new information this case has been upgraded to serious. The patient was a 68-year-old female who received a dose one injection of FLUZONE HIGH-DOSE on 01 December 2011 at 7:00 PM. "Extreme pain 24/7" started on 03 December 2011 with limited movement of left arm. The patient was diagnosed with Parsonage Turner Syndrome. The patient was treated with eight different medications to stop the pain. The patient had an ultrasound, neurological tests done (results not reported) and 16 physical therapy sessions. At the time of the report, the pain was better but still present with limited use of the left arm. The patient had trouble dressing, combing hair and cannot carry handbag on left shoulder. She has moderate pain constantly. Doctors stated this may last 2-3 years or could be permanent. The patient had no past medical history, no illness at the time of vaccination and no adverse events following prior vaccinations. Concomitant medications include ZOCOR, LEVOXYL, atenolol, lisinopril and hydrochlorothiazide daily. The patient's outcome was not recovered. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: Initial report was received from a pharmacy's claims examiner on 09 April 2012. A female patient (age not reported) had received an injection of FLUZONE HIGH DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an adverse reaction. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a consumer, who was also the patient, on 20 August 2012. Based upon the new information this case has been upgraded to serious. The patient was a 68-year-old female who received a dose one injection of FLUZONE HIGH-DOSE on 01 December 2011 at 7:00 PM. "Extreme pain 24/7" started on 03 December 2011 with limited movement of left arm. The patient was diagnosed with Parsonage Turner Syndrome. The patient was treated with eight different medications to stop the pain. The patient had an ultrasound, neurological tests done (results not reported) and 16 physical therapy sessions. At the time of the report, the pain was better but still present with limited use of the left arm. The patient had trouble dressing, combing hair and cannot carry handbag on left shoulder. She has moderate pain constantly. Doctors stated this may last 2-3 years or could be permanent. The patient had no past medical history, no illness at the time of vaccination and no adverse events following prior vaccinations. Concomitant medications include ZOCOR, LEVOXYL, atenolol, lisinopril and hydrochlorothiazide daily. The patient's outcome was not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Case number PHHY2012US067349 is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 456950) on 06 Aug 2012 and a follow up received from the quality assurance department on 23 Aug 2012: This report refers to a 17-year-old female patient. She was vaccinated with MENVEO (batch number: M10056) subcutaneously into the right arm along with GARDASIL (other manufacturer, batch number: 0476AA) intramuscularly into the left arm and with IPOL (other manufacturer and batch number: H1200) intramuscularly into the left arm on 04 Jun 2012. Within 24 hours after vaccination, she developed erythema and induration which continued to increase in size. She also developed cellulitis for which she was treated with KEFLEX. Her vital stats were stable. The final outcome of the events was reported as condition unchanged as on 06 Jun 2012. Based on the batch review report it was stated that the concerned MENVEO batch M10056 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up received from the quality assurance department on 23 Aug 2012: Updated batch review report.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Abnormal dreams, Angiogram normal, Asthenia, Blood count normal, CSF test normal
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Cataplexy, Dysarthria, Dyskinesia, Electroencephalogram abnormal, Epstein-Barr virus test negative
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Facial paresis, Faecal incontinence, Gene mutation identification test negative, Hypersomnia, Hypotonia
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Increased appetite, Muscle twitching, Narcolepsy, Neurological examination abnormal, Nightmare
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging brain normal, Periodic limb movement disorder, Protrusion tongue, Sleep study, Sleep study abnormal
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Snoring, Somnolence, Staring, Sudden onset of sleep, Thyroid function test normal
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: VIIth nerve paralysis, Weight increased
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Abnormal dreams, Asthenia, Cataplexy, Dysarthria, Electroencephalogram abnormal
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Faecal incontinence, Hypotonia, Increased appetite, Muscle twitching, Narcolepsy
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Periodic limb movement disorder, Protrusion tongue, Sleep study abnormal, Somnolence, Staring
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Suicidal ideation, Weight increased
Clinical narrative: This case was retrieved via a search of the scientific literature on 21 August 2012. It is a case report. Verbatim from the report: An 8 year-old girl developed narcolepsy with cataplexy following administration of H1N1. The girl developed sudden onset excessive daytime sleepiness about 2 months after receiving the H1N1 (dosage and route not stated). Additionally, she experienced vivid dreams and developed an increased appetite with weight gain. Subsequently, she developed an episode of sudden weakness and bowel incontinence, and was admitted. Examination revealed bilateral laxity of facial muscles with tongue protrusion. Video EEG revealed episodes of slurred speech, staring spells and facial twitching, while her periodic limb movement index was elevated. Results of a multiple sleep latency test were consistent with a diagnosis of narcolepsy with cataplexy. The girl received methylphenidate; however, due to continued sleepiness, treatment was switched to modafinil. She received fluoxetine for cataplexy; however, she developed tolerance issues with suicidal ideation, and treatment was switched to venlafaxine. She continued to experience symptoms while receiving the maximum dosage of venlafaxine and modafinil, and a trial of sodium oxybate was started (outcome not stated). Author comment: "Recent case reports of severe narcolepsy with cataplexy occurring in association with H1N1 vaccination, particularly in young children, have raised additional concerns about a possible autoimmune mechanism. The following case illustrates some typical features common to many of these patients." No further information available. The patient's outcome was not reported. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: His entire upper arm is hot and red and slightly swollen. Haven't contacted Dr yet since I have read it's a typical reaction but after reading blogs about filing one of these I figured I should since he was diagnosed on the autism spectrum..
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood pressure increased, Convulsion, Dyskinesia, Headache
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 years old female patient. The patient's medical history included vagal response to blood draw. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with the first dose GARDASIL (vaccination, site, route and strength unspecified) (Lot Number reported as 0555AE, Expire date 14-DEC-2014 waiting for verification) on 17-AUG-2012. No other co-suspects were reported. Concomitant medications included ZOLOFT, PROVENTIL HFA inhaler and clonazepam. The nurse reported that a patient had an episode of syncope and seizure following the first vaccination with GARDASIL on 17-AUG-2012. The nurse reported that about 5 minutes after vaccination while sitting down the patient threw her head back, body stiffened and became unresponsive making mouth noises, with tonic motions of the upper extremities. The patient became pale and ashen. The whole syncope / seizure event lasted about 2 minutes. The patient had a headache and stomach ache following the syncope/seizure event and her blood pressure was reported to have increased on 17-AUG-2012. The patient was treated with ice to the back of the neck and given juice and water. The outcome was reported as recovered/resolved after about 45 minutes on 17-AUG-2012 and left the office. The nurse reported the patient reported remembering everything that happened during the syncope/seizure event. The patient had sought medical attention via office visit. Upon internal review, seizure was considered to be an medically significant event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Posture abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 years old female patient. The patient's medical history included vagal response to blood draw. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with the first dose GARDASIL (vaccination, site, route and strength unspecified) (Lot Number reported as 0555AE, Expire date 14-DEC-2014 waiting for verification) on 17-AUG-2012. No other co-suspects were reported. Concomitant medications included ZOLOFT, PROVENTIL HFA inhaler and clonazepam. The nurse reported that a patient had an episode of syncope and seizure following the first vaccination with GARDASIL on 17-AUG-2012. The nurse reported that about 5 minutes after vaccination while sitting down the patient threw her head back, body stiffened and became unresponsive making mouth noises, with tonic motions of the upper extremities. The patient became pale and ashen. The whole syncope / seizure event lasted about 2 minutes. The patient had a headache and stomach ache following the syncope/seizure event and her blood pressure was reported to have increased on 17-AUG-2012. The patient was treated with ice to the back of the neck and given juice and water. The outcome was reported as recovered/resolved after about 45 minutes on 17-AUG-2012 and left the office. The nurse reported the patient reported remembering everything that happened during the syncope/seizure event. The patient had sought medical attention via office visit. Upon internal review, seizure was considered to be an medically significant event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a pharmacist (local reference # ISR-036-NOV11), for GARDASIL, a Pregnancy Registry product, concerning a female patient with condylomas who on approximately 14-NOV-2011 "less than a week ago" was vaccinated with the first dose of GARDASIL (lot number, route and dose not reported). On 21-NOV-2011, the patient had a pregnancy test that was positive. On 25-NOV-2011 the patient consulted a physician and they came to a joint decision to have an abortion. The patient indicated that she was considering an elective abortion due to exposure during pregnancy. The last menstrual period and estimated delivery date were not reported. The patient received treatment for condylomas. At the time of reporting the patient was not known whether elective abortion was already carried out. Follow up information was received confirming that the patient had an elective abortion since she did not want to take a risk. At the time of the report the patient was well. The reporter believed the patient completed vaccination schedule. Upon internal review an elective abortion was considered to be other important medical event. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Drooling, Lethargy, Periorbital oedema, Pruritus
Clinical narrative: Periorbital edema, intense itching, drooling/lethargy. Oral Pred 15mg given without improvement. EPIPEN Jr 0.15mg administered.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: 24 hours later: fiery red circle (4 in), raised circle, mild pain. 48 hours later: malaise, tiredness, dizziness, loss of appetite, headache. Rash has spread to elbow (+ do/turned to red/purple color).
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Local swelling, Malaise, Pain, Rash erythematous
Clinical narrative: 24 hours later: fiery red circle (4 in), raised circle, mild pain. 48 hours later: malaise, tiredness, dizziness, loss of appetite, headache. Rash has spread to elbow (+ do/turned to red/purple color).
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test, Malaise, Pain, Rash
Clinical narrative: 24 hours later: fiery red circle (4 in), raised circle, mild pain. 48 hours later: malaise, tiredness, dizziness, loss of appetite, headache. Rash has spread to elbow (+ do/turned to red/purple color).
Age: 4.0
Sex: F
Vaccine: FLUN3, MMRV
Symptoms: Abdominal pain, Diarrhoea, Pyrexia
Clinical narrative: 8/27 Complained abdominal pain AM and PM  8/28 Watery diarrhea starting 2 AM Fever 100 F 8 AM, ibuprofen given
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling, Upper extremity mass
Clinical narrative: Red, warm to the touch, swollen, lump in arm. Area of reaction is larger than injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Woke up with severe pain at sight of injection. No noticable adverse reaction at sight of injection.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Pt. received DTAP vaccine 8-27-12. Came in today with large red rash, warm to touch (swollen) near injection site.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Initial report was received from a health care professional through the local affiliate on 21 August 2012 under local reference number BR2012-427. A female patient (age not reported) had received an injection of INFLUENZA VACCINE (manufacturer, lot number, route and site not reported) on 16 May 2012 and an unspecified amount of time later presented influenza A/H1N1 that was confirmed with laboratory tests performed on 16 July 2012. Universal detection of swine-origin influenza A and specific detection of influenza pandemic strain A/H1N1 were positive except for Influenza A seasonal. No additional information was provided. The patient's outcome was unknown. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Gave Zostavax instead of Varciella vaccine to a 12 year old. Patient also received Influenza, HPV, TDAP, MCV4 that day. Mother only signed one of the consent forms of the three she filled out. 0.5mL IM Zostavax in the right deltoid.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, No adverse event
Clinical narrative: Gave Zostavax instead of Varciella vaccine to a 12 year old. Patient also received Influenza, HPV, TDAP, MCV4 that day. Mother only signed one of the consent forms of the three she filled out. 0.5mL IM Zostavax in the right deltoid.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Pallor, Urticaria
Clinical narrative: Hives over most of the body, dizziness, weakness, pale.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Erythema & pain at site of injection which developed in 6 hours, fever of 101.6, severe mylagia & arthralgia, headache.  Most severe symptoms lasted 24 hours. Myalgia & arthralgia still present after 36 hours. Treated with Aleve & ice to injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Erythema & pain at site of injection which developed in 6 hours, fever of 101.6, severe mylagia & arthralgia, headache.  Most severe symptoms lasted 24 hours. Myalgia & arthralgia still present after 36 hours. Treated with Aleve & ice to injection site.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Swelling in right arm (arm in which MCV was administered). Right arm soreness. Applied ice.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Local swelling, Oedema peripheral
Clinical narrative: See urgent care record attached. * Mom declines all additional doses of MENVEO. D/T severe reaction. Swelling to (L) arm, got shots done the 15th. Began with local swelling right after shot. Swelling around arm & down to elbow.