chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Neutrophil percentage decreased, Platelet count normal, Red blood cell count decreased, Red cell distribution width normal, Scan brain
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Tremor, White blood cell count increased
Clinical narrative: A serious spontaneous report of seizures questionable tonic-clonic and non-serious report of slightly irritable was received from a non-health professional concerning a 26-month-old male, subsequent to H1N1, Intranasal. The patient had heart murmur when he was born. The patient never received flu vaccine before and never experienced seizure. No concomitant medications was taken by the patient. The patient's mother had pituitary tumor and father had a history of colon CA. On the mother's side, the grandfather had intracranial tumor and spinal cancer. There was no family history of seizures. On 25-Oct-2009, the patient received first dose of H1N1, intranasal for an unknown indications. On 27-Oct-2009, the patient was laying on pillow and was shaking from his waist up, it lasted for two minutes and he was out of it. No cyanosis was there. Then patient had another short seizure with five head twitches. The child was taken to the emergency room for evaluation and testing. On 27-Oct-2009, WBC was 11.6 (high) and RBC was 4.26 (low) neutrophils was 24.9 (low) and lymphocytes was 61.2 (high); in basic metabolic panel creatinine was 0.2 (low); chest x-ray was normal; influenza serology test was negative for both A and B and the CT scan of brain without contrast noted the intracranial structures were normal. There was no hemorrhage identified. The lateral ventricles were normal in size. There was no midline displacement. The paranasal sinuses were clear and adenoid hypertrophy was noted. The patient denies any nausea, vomiting or diarrhea, fever or chills, any shortness of breath, respiratory distress or abdominal pain. The patient has had normal urine output and bowel movements. At the time of this report, the patient has had no further seizures. The child has not undergone an electroencephalogram (EEG) at the time of report, because the child was to see the neurologist first, and that appointment was scheduled for an unspecified date in mid Jan-2010. The details of physical examination are attached in the source document. The outcome of the seizures questionable tonic-clonic was resolved and for slightly irritable it was unknown. Additional information was received on 11-Nov-2009 and incorporated into the narrative. Additional information about further evaluation of progression, frequency and outcome of the event and additional scheduled investigation was included. Following additional information was received on 10-Dec-2009 and incorporated into the narrative: patient history and patient's family history, additional adverse event and lab details
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash
Clinical narrative: A non-serious spontaneous report of broke out with a rash on legs, arms and trunk area was received from a registered nurse/health professional concerning a 12-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical  history nor concomitant medications was reported for this patient. On 26-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 27-Oct-2009, the patient broke out with a rash on legs, arms and trunk area. The outcome of the event was unknown.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Burning sensation, Dizziness, Headache, Muscle fatigue, Pain
Clinical narrative: A serious spontaneous report of prolonged reaction to immunization manifested with symptoms of tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning has been received from a registered nurse concerning a 38-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history included sinusitis and bronchitis and concurrent conditions included endometriosis, gastroesophageal reflux disease, headaches and food allergies to coconut, palm kernel oil, preservation in Cool Whip. Concomitant medications included epinephrine auto injector, Trazadone HCl 50mgs HS (PO), montelukast 10mgs OD (PO), doxycycline 100mgs OD (PO), lansoprazole 30mgs OD (PO), ketorolac (PO) and triamcinolone acetonide nasal spray. On approximately 14-Oct-2009, the patient received seasonal flu injection. On 28-Oct-2009, the patient received H1N1, Intranasal for unknown indication. On 28-Oct-2009 after 30 minutes of vaccination, the patient experienced tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning. The patient was immediately provided treatment orally with two 50 mgs capsules and 25 mgs elixir of diphenhydramine and she was observed closely. On 12-Nov-2009, tongue swelling with red rings on tongue and in throat, throat tight and itchy were resolved. The dizziness was also resolved on 30-Nov-2009. The events of tremors in her hands and arms, severe muscle fatigue, frontal headaches, and generalized body aches were resolved over the two weeks of Dec-2009. The outcome for all reported events was recovered. Additional information was received on 30-Nov-2009 and incorporated into the narrative about changes in outcome of the adverse event. Additional information was received on 08-Dec-2009 and incorporated into the narrative: The outcome of events. Additional information was received on 23-Dec-2009 and incorporated into the narrative: The outcome of events.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pharyngeal erythema, Swollen tongue, Throat irritation, Throat tightness, Tongue disorder
Clinical narrative: A serious spontaneous report of prolonged reaction to immunization manifested with symptoms of tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning has been received from a registered nurse concerning a 38-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history included sinusitis and bronchitis and concurrent conditions included endometriosis, gastroesophageal reflux disease, headaches and food allergies to coconut, palm kernel oil, preservation in Cool Whip. Concomitant medications included epinephrine auto injector, Trazadone HCl 50mgs HS (PO), montelukast 10mgs OD (PO), doxycycline 100mgs OD (PO), lansoprazole 30mgs OD (PO), ketorolac (PO) and triamcinolone acetonide nasal spray. On approximately 14-Oct-2009, the patient received seasonal flu injection. On 28-Oct-2009, the patient received H1N1, Intranasal for unknown indication. On 28-Oct-2009 after 30 minutes of vaccination, the patient experienced tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning. The patient was immediately provided treatment orally with two 50 mgs capsules and 25 mgs elixir of diphenhydramine and she was observed closely. On 12-Nov-2009, tongue swelling with red rings on tongue and in throat, throat tight and itchy were resolved. The dizziness was also resolved on 30-Nov-2009. The events of tremors in her hands and arms, severe muscle fatigue, frontal headaches, and generalized body aches were resolved over the two weeks of Dec-2009. The outcome for all reported events was recovered. Additional information was received on 30-Nov-2009 and incorporated into the narrative about changes in outcome of the adverse event. Additional information was received on 08-Dec-2009 and incorporated into the narrative: The outcome of events. Additional information was received on 23-Dec-2009 and incorporated into the narrative: The outcome of events.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Tremor
Clinical narrative: A serious spontaneous report of prolonged reaction to immunization manifested with symptoms of tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning has been received from a registered nurse concerning a 38-year-old female, subsequent to H1N1, Intranasal. The patient's past medical history included sinusitis and bronchitis and concurrent conditions included endometriosis, gastroesophageal reflux disease, headaches and food allergies to coconut, palm kernel oil, preservation in Cool Whip. Concomitant medications included epinephrine auto injector, Trazadone HCl 50mgs HS (PO), montelukast 10mgs OD (PO), doxycycline 100mgs OD (PO), lansoprazole 30mgs OD (PO), ketorolac (PO) and triamcinolone acetonide nasal spray. On approximately 14-Oct-2009, the patient received seasonal flu injection. On 28-Oct-2009, the patient received H1N1, Intranasal for unknown indication. On 28-Oct-2009 after 30 minutes of vaccination, the patient experienced tongue swelling with red rings on tongue and in throat, throat tight and itchy and non-serious events of tremors in upper body, dizziness, severe muscle fatigue, frontal headache, generalized body ache that felt like her muscles were burning. The patient was immediately provided treatment orally with two 50 mgs capsules and 25 mgs elixir of diphenhydramine and she was observed closely. On 12-Nov-2009, tongue swelling with red rings on tongue and in throat, throat tight and itchy were resolved. The dizziness was also resolved on 30-Nov-2009. The events of tremors in her hands and arms, severe muscle fatigue, frontal headaches, and generalized body aches were resolved over the two weeks of Dec-2009. The outcome for all reported events was recovered. Additional information was received on 30-Nov-2009 and incorporated into the narrative about changes in outcome of the adverse event. Additional information was received on 08-Dec-2009 and incorporated into the narrative: The outcome of events. Additional information was received on 23-Dec-2009 and incorporated into the narrative: The outcome of events.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of a pregnant woman received a dose of H1N1 was received from a registered nurse/health professional concerning a 33-year-old female. The patient's medical history and obstetrical history was not provided. On 15-Oct-2009, the patient received H1N1, Intranasal. On 17-Nov-2009, the patient was tested positive for pregnancy. Reporter did not know the exact date of the patient's last menstrual period or her pregnancy due date, however she estimated that the patient was seven to eight weeks pregnant at the time of report. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of the vaccine exposure during pregnancy was considered resolved.
Age: 21.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of a pregnant woman got H1N1 was received from a physician concerning a 21-year-old female. The patient was 16 weeks pregnant at the time of vaccination. No medical history and concomitant medications were reported for this patient. The patient received a dose of H1N1 Intranasal on 16-Nov-2009. The pregnancy and delivery were uneventful. The patient had a one-month-old son at the time of report. The infant was fine. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of "vaccine exposure during pregnancy" was considered resolved. Additional information was received on 07-Jun-2010 and incorporated in the narrative: Pregnancy outcome. Other information received was reporter name and phone number and patient demographic details like patient name and date of birth.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Influenza like illness, Nausea
Clinical narrative: A non-serious, spontaneous report of "got H1N1 and now feeling like he has the flu" and nausea has been received from a consumer concerning an 11-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose of H1N1, Intranasal on 27-Oct-2009. On 27-Oct-2009, within an hour of receiving vaccine, began feeling like he had the flu and nausea. Neither outcome nor causality has been reported for these events.
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 to a patient with asthma was received from a registered nurse/healthcare professional concerning a 16-year-old male. The patient had a history of asthma. On 18-Nov-2009 the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Delivery, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 to a 32 week pregnant female was received from a registered nurse/health professional concerning a 27-year-old female. The patient had no relevant medical history, obstetrical history includes gravida-one and para-zero. The patient was 32 week pregnant at the time of vaccination. The estimated pregnancy due date is on 19-Dec-2009. The patient received H1N1, Intranasal on 29-Oct-2009. The patient delivered a healthy, normal little boy on 04-Dec-2009. The neonate and mother both did well on delivery and both remain healthy and well since the delivery. There was no adverse event associated with this pregnancy. Treatment was not provided. Reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. Additional information was received on 07-Dec-2009 and incorporated into the narrative: obstetrical history was added. Additional information was received on 05-Feb-2010 and incorporated into the narrative: actual EDD, EOP date and outcome of the pregnancy.
Age: 50.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Allergy to vaccine, Eyelid oedema, Fatigue, Pruritus, Scab
Clinical narrative: A serious spontaneous report of hypersensitivity reaction to H1N1 manifested with left side of face swollen, left eye swelled shut, hives fully developed and itching on face and arms has been received from a 50-year-old male patient/consumer, subsequent to H1N1, Intranasal. The patient's past medical history included pneumonia that occurred 1.5 years ago. The concomitant medication included carisoprodol which started four months ago in early Aug-2009 for treatment of back spasms. The patient received H1N1, Intranasal on 19-Nov-2009 for an unknown indication. On evening of 19-Nov-2009, the patient first experienced itching on face and arms. Next day in the morning within 12 hours of receiving the vaccine, the patient experienced left side of face swollen, left eye swelled shut and hives fully developed. The physician treated the patient with oral diphenhydramine hydrochloride one tablet every six hours. After one week, the patient told physician that due to this medication he felt too tired. Hence the therapy was stopped. The patient was also treated with prednisone for six days which was completed on 25-Nov-2009. At the time he completed that medication, the swelling on his face and eye region was approximately 99% gone. On 25-Nov-2009, the patient spoke with his physician and showed him that the hives on his face, chest and arms were still present. On 29-Nov-2009, the itching on his face and arms had resolved. The patient was diagnosed with hypersensitivity reaction to H1N1 vaccine by the physician. On 21-Dec-2009, the patient reported that he completed his second dosing of oral tapering Prednisone Dose pack for 12-days, on approximately 08-Dec-2009. At the time he completed his second dose of therapy with prednisone, the swelling on his face and eye region remained approximately 99% gone, but over the next few weeks it has completely resolved. The patient reported that the hives on his face, chest and arms were still present, they were better, but recently (unspecified date in December 2009) they were scabbing and scarring where the hives have been clearing, and that they have continued to itch. The patient has not undergone any laboratory testing and when asked if his physician was considering allergy testing, he reported that his physician has said nothing to him about having testing now or later. No additional treatment medications for the hives, scabbing, and/or itching. However the hives on his arms and chest had not resolved. Emotional support provided to the patient. The outcome of hypersensitivity reaction to H1N1 vaccine was not resolved. Additional information was received on 30-Nov-2009 and incorporated into the narrative: case typing upgrade to AESI, medical history, concomitant medication, diagnosis and outcome of events. Additional information was received on 21-Dec-2009 and incorporated into the narrative: outcome of events.
Age: 50.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Scar, Swelling face, Urticaria
Clinical narrative: A serious spontaneous report of hypersensitivity reaction to H1N1 manifested with left side of face swollen, left eye swelled shut, hives fully developed and itching on face and arms has been received from a 50-year-old male patient/consumer, subsequent to H1N1, Intranasal. The patient's past medical history included pneumonia that occurred 1.5 years ago. The concomitant medication included carisoprodol which started four months ago in early Aug-2009 for treatment of back spasms. The patient received H1N1, Intranasal on 19-Nov-2009 for an unknown indication. On evening of 19-Nov-2009, the patient first experienced itching on face and arms. Next day in the morning within 12 hours of receiving the vaccine, the patient experienced left side of face swollen, left eye swelled shut and hives fully developed. The physician treated the patient with oral diphenhydramine hydrochloride one tablet every six hours. After one week, the patient told physician that due to this medication he felt too tired. Hence the therapy was stopped. The patient was also treated with prednisone for six days which was completed on 25-Nov-2009. At the time he completed that medication, the swelling on his face and eye region was approximately 99% gone. On 25-Nov-2009, the patient spoke with his physician and showed him that the hives on his face, chest and arms were still present. On 29-Nov-2009, the itching on his face and arms had resolved. The patient was diagnosed with hypersensitivity reaction to H1N1 vaccine by the physician. On 21-Dec-2009, the patient reported that he completed his second dosing of oral tapering Prednisone Dose pack for 12-days, on approximately 08-Dec-2009. At the time he completed his second dose of therapy with prednisone, the swelling on his face and eye region remained approximately 99% gone, but over the next few weeks it has completely resolved. The patient reported that the hives on his face, chest and arms were still present, they were better, but recently (unspecified date in December 2009) they were scabbing and scarring where the hives have been clearing, and that they have continued to itch. The patient has not undergone any laboratory testing and when asked if his physician was considering allergy testing, he reported that his physician has said nothing to him about having testing now or later. No additional treatment medications for the hives, scabbing, and/or itching. However the hives on his arms and chest had not resolved. Emotional support provided to the patient. The outcome of hypersensitivity reaction to H1N1 vaccine was not resolved. Additional information was received on 30-Nov-2009 and incorporated into the narrative: case typing upgrade to AESI, medical history, concomitant medication, diagnosis and outcome of events. Additional information was received on 21-Dec-2009 and incorporated into the narrative: outcome of events.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered H1N1 to six weeks pregnant woman was received from a registered nurse/health professional concerning a 32-year-old female. The patient had no known drug allergies and estimated date of delivery was 07-July-2010. On 09-Nov-2009, the six week pregnant patient received H1N1, Intranasal. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of the event vaccine exposure during pregnancy was resolved. Additional information was received on 19-Nov-2009 and incorporated into the narrative: estimated date of delivery was 07-July-2010 and no known drug allergies.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Injection site pain, Musculoskeletal chest pain
Clinical narrative: Initial case received from a consumer on 16 December 2009. A patient received H1N1 (manufacturer and lot not reported) on 06 November 2009, and 48 hours post-vaccination experienced severe pain in all of the joints. Joint pain was noted in the ankles, shoulders, elbows, and wrists, rib cage, and back. The event was ongoing at the time of the report, and was described as mild to severe despite use of TYLENOL. The vaccine was received through a military program. No additional information was reported. Additional information was received on 23 December 2009 from a consumer. The patient was a 59 year old male who received an intramuscular left deltoid injection of H1N1. On 08 November 2009, the patient also experienced pain in the rib cage and pain at the injection site. At the time of the report the patient had not recovered from the rib cage pain and the pain at the injection site. The patient had no known allergies. Follow up information was received on 08 February 2010 from a consumer. The patient did not have an illness at the time of vaccination or receive any other vaccines concomitantly or 4 weeks prior. The patient noted CELEBREX 200 mg, one per day as an other medication. It was unclear whether the medication was being taken concomitantly or as treatment. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 LAIV was given to an asthmatic child was received from a physician concerning a 5-year-old male. The patient's medical history included asthma. The concomitant medications taken by the patient was montelukast sodium daily. On 19-Nov-2009, the patient was given H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Joint dislocation
Clinical narrative: A non-serious spontaneous report of a pregnant woman got a dose of H1N1 was received from a registered  nurse/health professional concerning a 26-year-old female which occurred after receiving H1N1, Intranasal. The patient's medical history included hypothyroidism, prolactinoma, and irregular menses. The patient had no medical history of alcohol or substance abuse. The patient's EDD was 14-Jun-2010 and the LMP was 07-Sep-2009. The patient had taken bromocriptine, PO, in Jun-2009, and discontinued in Oct-2009 when she learned she was pregnant. Laboratory studies were drawn frequently for her hypothyroidism, and prolactinoma and all studies remained normal. The patient was in her eighth week of gestation when she was exposed to H1N1 Vaccine. The patient received H1N1, Intranasal on 16-Nov-2009. The patient delivered a baby boy on 10-Jun-2010 by a cesarean section as she wasn't progressing with dilation. The baby was born at 39-weeks gestation. The baby's weight was seven pounds and six ounces and length was 19 and half inches. The apgar scores were: at one minute-four, at five minutes-nine and at ten minutes-nine. It was unknown to the reporter why first apgar was four. Also, the baby experienced a hip dislocation at an unreported time that is resolving. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments were not applicable, and the event "vaccine exposure during pregnancy" was considered resolved. This case is linked to MEDI-0011417. Additional information was received on 03-Dec-2009 and incorporated into the narrative: Pregnancy status, obstetrical history, medical history, concomitant medications, laboratory details. Additional information was received on 13-Jul-2010 and incorporated in the narrative: outcome of pregnancy, infant information.
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Caesarean section, Drug exposure during pregnancy, Laboratory test normal, Thyroid function test normal
Clinical narrative: A non-serious spontaneous report of a pregnant woman got a dose of H1N1 was received from a registered  nurse/health professional concerning a 26-year-old female which occurred after receiving H1N1, Intranasal. The patient's medical history included hypothyroidism, prolactinoma, and irregular menses. The patient had no medical history of alcohol or substance abuse. The patient's EDD was 14-Jun-2010 and the LMP was 07-Sep-2009. The patient had taken bromocriptine, PO, in Jun-2009, and discontinued in Oct-2009 when she learned she was pregnant. Laboratory studies were drawn frequently for her hypothyroidism, and prolactinoma and all studies remained normal. The patient was in her eighth week of gestation when she was exposed to H1N1 Vaccine. The patient received H1N1, Intranasal on 16-Nov-2009. The patient delivered a baby boy on 10-Jun-2010 by a cesarean section as she wasn't progressing with dilation. The baby was born at 39-weeks gestation. The baby's weight was seven pounds and six ounces and length was 19 and half inches. The apgar scores were: at one minute-four, at five minutes-nine and at ten minutes-nine. It was unknown to the reporter why first apgar was four. Also, the baby experienced a hip dislocation at an unreported time that is resolving. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments were not applicable, and the event "vaccine exposure during pregnancy" was considered resolved. This case is linked to MEDI-0011417. Additional information was received on 03-Dec-2009 and incorporated into the narrative: Pregnancy status, obstetrical history, medical history, concomitant medications, laboratory details. Additional information was received on 13-Jul-2010 and incorporated in the narrative: outcome of pregnancy, infant information.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site swelling, Muscular weakness, Oedema peripheral, Pain in extremity
Clinical narrative: Initial case received from a health care professional on 06 November 2009. Follow-up information was received from a health care professional on 10 November 2009, which contained unlisted events. This narrative contains information from both reports. A 67-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U3212A) on 21 October 2009, and within 10 minutes of vaccination complained of swelling, pain, and numbness in her left arm. The patient's medical history included breast cancer, hyperlipidemia, and an allergy to intravenous contrast. She was seen by her physician, and noted to have inhibited left shoulder function and notable weakness in the left hand. She was treated with a MEDROL pack. The events were still ongoing at the time of the report. Follow-up information received on 07 December 2009 from a health care professional. The patient did not undergo any diagnostic tests, and received no additional treatments. The event is still ongoing with the arm still being extremely sore in the area where the FLUZONE vaccine was given. Follow-up information received on 04 January 2010 from a health care professional who stated that her office did not administer the vaccine, therefore she did not have any further information to provide. The reporter suggested contacting the patient. Follow-up information received on 09 February 2010 from the patient. The patient reported she was still having pain in arm as of 01 February 2010. No further information was provided in reference to other adverse events. Follow-up information received from a health care professional on 17 March 2010. It was reported that the patient has not been seen since 02 November 2009 and no updated information was available. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 administered to a pregnant women with asthma was received from a registered nurse/health professional concerning a 35-year-old female. The patient's medical history included asthma. The patient was not on any concomitant medications. No relevant obstetrical history has been reported. On 10-Nov-2009, the patient received H1N1, Intranasal for unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of reported event was resolved. Additional information was received on 18-Nov-2009 and incorporated into the narrative: The additional information was regarding date of birth of patient, medical history and concomitant medications.
Age: 50.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a 50-year-old male got a dose of H1N1 was received from a registered nurse/health professional. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 0.57
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of six month old got H1N1 LAIV dose was received from a nurse/health professional concerning a six-month-old female. The patient neither had any relevant medical history nor concomitant medications. On 14-Dec-2009, the patient received Influenza A (H1N1) 2009 MONOVALENT Vaccine Live, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 28-Dec-2009 and incorporated into the narrative: Patient's medical history, concomitant medication.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Alopecia
Clinical narrative: A non-serious spontaneous report of hair loss has been received from a nurse practitioner/healthcare professional concerning a eight-year-old male child, subsequent to H1N1, Intranasal. Relevant medical history had not been reported for this patient. The patient was on no other medications. The patient received H1N1, Intranasal on 3-Dec-2009 for an unknown indication. On 8-Dec-2003, five days after receiving H1N1 vaccine the patient was seen in the pediatrician's office with the symptoms of hair falling out. There was a triangular shape patch of hair gone from the top of the frontal part of the head. The outcome of this event was unknown.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, No reaction on previous exposure to drug, Pruritus
Clinical narrative: Initial report received on 11 December 2009 from a health care professional. A 54-year-old male patient had received a fourth dose of FLUZONE (lot number U3270GA) on 10 December 2009 at 10:00 am. The patient receives kidney dialysis; however, he declined to provide any further information regarding the circumstance surrounding indication for kidney dialysis. On 10 December 2009, the patient was seen in the office for a possible infection at the dialysis catheter site, and was prescribed KEFLEX, and he was administered the FLUZONE vaccination. The patient took the KEFLEX at 4:00 pm that day and his lips and "palms" started to itch. The patient took the second dose of KEFLEX at 21:00 pm the same day and experienced more itching. Following the third dose of KEFLEX (date and time not reported) the patient's itching worsened and he subsequently developed chest tightness. It was not reported whether the patient had received medical evaluation or treatment for the symptoms. Per the patient, he has taken KEFLEX in the past without any adverse events; and he has not experienced any adverse events with prior influenza vaccinations. At the time of this report, it was unknown if the patient had recovered. Follow-up information received on 14 January 2010 from a health care professional. Per the reporter, they have no additional information. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Initial report received on 31 December 2009 from a health care professional. This non-serious case represents one of a cluster of 4 patients who experienced adverse events after receiving H1N1 (lot number UP054AA). One of the four cases met seriousness criteria and is recorded in case number 2010-00026. Information regarding the other 2 non-serious cases are recorded in case number 2010-00023, and -00024. A 31-year-old male patient, who had no concurrent illnesses, received an intramuscular left deltoid injection of H1N1 (lot number UP054AA) on an unspecified date. It was unknown if the patient was taking any concomitant medications at the time. Less than, or equal to 15 minutes post-vaccination, the patient returned to where he received the vaccination stating he was dizzy. The patient was given Gatorade to drink and was placed in a sitting position with feet up, and there was no improvement. It was not reported whether the patient required medial evaluation or further treatment. At the time of this report, it was unknown if the patient had recovered. Follow-up information received on 06 January 2010 from a health care professional. The H1N1 was the first dose the patient had received. No doctor visit was required. Recovery status was reported as unknown. Follow-up information was received from the health care professional on 16 February 2010. The reporter was not aware of any concomitant medications or relevant medical history. The vaccine was administered at 3:45 PM, and the patient complained of dizziness at 4:00 PM, 15 minutes post-vaccination. The reporter had attempted to contact the patient via telephone, however the patient had not returned any phone calls. Outcome was unknown. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Influenza
Clinical narrative: Initial report received on 12 January 2010 from a health care professional, who is also the patient. A 39 year old female patient with no known medical history developed a sore throat, body aches, cough, nausea, and vomiting 44 days after she received H1N1 (lot UP004AA) intramuscularly in the left deltoid on 19 November 2009. On 13 October 2009 the patient received FLUVIRIN (manufacturer Novartis, lot unknown). At the time of the report, which was ten days past symptom onset, the patient's cough persisted. The patient required a doctor's visit, date was not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Cough, Nausea, Oropharyngeal pain, Pain, Vomiting
Clinical narrative: Initial report received on 12 January 2010 from a health care professional, who is also the patient. A 39 year old female patient with no known medical history developed a sore throat, body aches, cough, nausea, and vomiting 44 days after she received H1N1 (lot UP004AA) intramuscularly in the left deltoid on 19 November 2009. On 13 October 2009 the patient received FLUVIRIN (manufacturer Novartis, lot unknown). At the time of the report, which was ten days past symptom onset, the patient's cough persisted. The patient required a doctor's visit, date was not provided. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Blepharospasm, Corneal reflex decreased
Clinical narrative: Initial report was received on 29 January 2010 from a consumer, who is the patient's parent. A two-year-old female patient with a history of asthma, had received an injection of H1N1, lot number UP076AA (route and site not reported) on 15 January 2010, and 10 days later, she developed uncontrollable eye twitching and blinking. The patient had bronchitis without fever at the time of vaccination and she had not been taking any concomitant medications. During the four weeks prior to receiving H1N1, the patient had also received an injection of seasonal Influenza vaccine "approx in last year 2009 (manufacturer, lot number, route, site and specific date of administration not reported). According to the reporter, this event was reported to the patient's physician and VAERS. The patient had not experienced any other symptoms and at the time of the report, her eye twitching-blinking continued; however not as frequently. Follow-up information was received on 17 March 2010 from a healthcare physician. The patient received a right leg injection of FLUZONE (lot number U3167FA) on 22 September 2009 (Previously reported as the patient received her seasonal Influenza vaccine during the four weeks prior to receiving H1N1, "approx in last year 2009"). The patient had received the injection of H1N1, in the left leg. The patient was not seen by the physician, but the physician stated the event resolved after 10 days according to the mother. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Blepharospasm, Excessive eye blinking
Clinical narrative: Initial report was received on 29 January 2010 from a consumer, who is the patient's parent. A two-year-old female patient with a history of asthma, had received an injection of H1N1, lot number UP076AA (route and site not reported) on 15 January 2010, and 10 days later, she developed uncontrollable eye twitching and blinking. The patient had bronchitis without fever at the time of vaccination and she had not been taking any concomitant medications. During the four weeks prior to receiving H1N1, the patient had also received an injection of seasonal Influenza vaccine "approx in last year 2009 (manufacturer, lot number, route, site and specific date of administration not reported). According to the reporter, this event was reported to the patient's physician and VAERS. The patient had not experienced any other symptoms and at the time of the report, her eye twitching-blinking continued; however not as frequently. Follow-up information was received on 17 March 2010 from a healthcare physician. The patient received a right leg injection of FLUZONE (lot number U3167FA) on 22 September 2009 (Previously reported as the patient received her seasonal Influenza vaccine during the four weeks prior to receiving H1N1, "approx in last year 2009"). The patient had received the injection of H1N1, in the left leg. The patient was not seen by the physician, but the physician stated the event resolved after 10 days according to the mother. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Axillary pain, Injection site nodule, Injection site pain, Joint swelling, Musculoskeletal pain
Clinical narrative: Initial case received 15 January 2010 from a healthcare professional. A 48 year old female patient received a right deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3224BB) on 14 January 2010. On 15 January 2010 the patient was seen by a nurse due to a large bump at the right deltoid (approximately the size of a golf ball). She had shoulder and axillary pain. There was swelling from the axillary area, down the arm to the wrist. She could lift her arm, but it caused pain in the shoulder. The patient had a medical history of hypertension. Concomitant medications included NORVASC and HTCZ. She had no illnesses at the time of the vaccination. At the time of the report the patient had not recovered. Follow up information was received on 12 February 2010 from a health care professional. The patient was started on methylprednisone 4 mg dose pack for 6 days on 16 January 2010. The patient recovered as a result. Based upon new information received, this case meets seriousness criteria and has been upgraded to serious. Follow-up information was received 21 April 2010 from a health care professional who provided additional contact information. No additional information was provided at the time of the report. Follow-up information was received 25 August 2010 from a health care professional who provided patient contact information. According to the reporter, they were unable to provide additional information. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral
Clinical narrative: Initial case received 15 January 2010 from a healthcare professional. A 48 year old female patient received a right deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3224BB) on 14 January 2010. On 15 January 2010 the patient was seen by a nurse due to a large bump at the right deltoid (approximately the size of a golf ball). She had shoulder and axillary pain. There was swelling from the axillary area, down the arm to the wrist. She could lift her arm, but it caused pain in the shoulder. The patient had a medical history of hypertension. Concomitant medications included NORVASC and HTCZ. She had no illnesses at the time of the vaccination. At the time of the report the patient had not recovered. Follow up information was received on 12 February 2010 from a health care professional. The patient was started on methylprednisone 4 mg dose pack for 6 days on 16 January 2010. The patient recovered as a result. Based upon new information received, this case meets seriousness criteria and has been upgraded to serious. Follow-up information was received 21 April 2010 from a health care professional who provided additional contact information. No additional information was provided at the time of the report. Follow-up information was received 25 August 2010 from a health care professional who provided patient contact information. According to the reporter, they were unable to provide additional information. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Axillary pain, Extensive swelling of vaccinated limb, Injection site mass, Musculoskeletal pain, Pain
Clinical narrative: Initial case received 15 January 2010 from a healthcare professional. A 48 year old female patient received a right deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3224BB) on 14 January 2010. On 15 January 2010 the patient was seen by a nurse due to a large bump at the right deltoid (approximately the size of a golf ball). She had shoulder and axillary pain. There was swelling from the axillary area, down the arm to the wrist. She could lift her arm, but it caused pain in the shoulder. The patient had a medical history of hypertension. Concomitant medications included NORVASC and HTCZ. She had no illnesses at the time of the vaccination. At the time of the report the patient had not recovered. Follow up information was received on 12 February 2010 from a health care professional. The patient was started on methylprednisone 4 mg dose pack for 6 days on 16 January 2010. The patient recovered as a result. Based upon new information received, this case meets seriousness criteria and has been upgraded to serious. Follow-up information was received 21 April 2010 from a health care professional who provided additional contact information. No additional information was provided at the time of the report. Follow-up information was received 25 August 2010 from a health care professional who provided patient contact information. According to the reporter, they were unable to provide additional information. Documents held by sender: None.