chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Initial report received on 15 January 2010 from a health care professional. A 54-year-old female patient had received a first intramuscular injection of H1N1 (lot number UP064AA) on 12 January 2010. Two days post-vaccination on 14 January 2010, the patient complained of feeling like her head was swimming. When asked by the pharmacist if she was dizzy, the patient stated no she felt like her head was swimming. It was not reported whether the patient required medical evaluation or treatment. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site haematoma, Pain in extremity
Clinical narrative: Initial report received from a nurse on 23 July 2010. A 58-year-old female patient, who had no concurrent illnesses, no known allergies and medical history of right breast cancer, ovarian cancer and DJD (degenerative joint disease) had received a first intramuscular left deltoid injection of H1N1 (lot number UP075AA) on 07 January 2010. One day following vaccination the patient complained of pain and limited range of motion in the left arm. She also had redness and bruising at the injection site as well. She was evaluated in the physician's office in May, June and twice in July 2010 for this complaint. Per the reporter, an MRI will be done. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: Initial case received on 07 September 2010 from a healthcare professional. An 8 year old female patient received a left deltoid intramuscular injection of H1N1 (lot number Up 063AA) on 28 January 2010. She experienced a "tick" shortly after receiving the vaccination (date not reported), which went away after 4 weeks. She was seen by a neurologist for the "tick". No further details were available from the reporter. Documents held by sender: None.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Adverse event
Clinical narrative: Adverse event NOS.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, FLU(H1N1), HEP, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Initial case was received on 13 September 2010 from a healthcare professional. A 6 month old patient received on 09 September 2010, the following vaccines: a right thigh intramuscular injection of H1N1 (lot number UP069AA); a right thigh intramuscular injection of PENTACEL (lot number C3656AA); a left thigh injection of PCV13 (lot number E63006, manufacturer Pfizer); a left thigh injection of Hep B (lot number AHBVB842AA, manufacturer not reported) and an oral dose of Rotavirus (lot number 06872, manufacturer not reported). On 10 September 2010 at 1:09 AM, the patient was taken to the emergency room (ER) experiencing vomiting and diarrhea, "that occurred through the night". The patient was treated (unspecified treatment) and released from the ER. The patient had a runny nose and cough at the time of the vaccinations. She had no pre-existing medical conditions, no concomitant medications and had not experienced any adverse events following prior vaccinations. The patient recovered from the events of vomiting and diarrhea (date not reported). Documents held by sender: None.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hyperhidrosis, Rash, Somnolence
Clinical narrative: Initial information received on 18 February 2010 from health care professional. A 56 year old male patient, who resides in a nursing home with a history of morphine allergy, paraplegia, anxiety, neurogenic bladder, ulcer, and deep vein thrombosis. Concomitant therapy included Oxycodone, BENADRYL, FLOMAX, DILAUDID, CYMBALTA, PRILOSEC, CALCIFEROL, and Propranolol. The patient experienced sleepiness with episodes of sweating one day (on 18 February 2010 at 3:30 PM) after receiving H1N1 (lot UP063AA) intramuscularly in the right deltoid on 17 February 2010 at 1:30 PM. The patient also had a rash on both arms. The patient recovered from the events. Follow-up information was received from a health care professional on 01 April 2010. The patient received no treatments other than observation within the long term care facility. He did not require evaluation from his doctor. Malaise and sweating were not present the following day and the rash lasted less than 12 hours. List of Documents held by Sender: none.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Pyrexia, Rash
Clinical narrative: Initial report received on 16 December 2009 from a health care professional. A 7 year old male patient with a history of asthma developed a fine, raised rash which started on the abdomen and spread to the arms, legs, back, and face 2 days after receiving H1N1 (lot number UP048CA) intramuscularly in the left deltoid on 12 December 2009. The patient also complained of abdominal pain and a low grade fever. On an unspecified date, the patient had a doctor's visit. Concomitant therapy included ADVAIR, ZYRTEC, and NASONEX. The patient did not recover. Additional information was received on 04 January 2010 from health care professional. The patient had no illness at the time of vaccination. The doctor's visit previously noted as unspecified was on 15 December 2009. The patient was treated with BENADRYL as needed and recovered on an unspecified date. List of Documents held by Sender: none.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Cough, Respiratory tract congestion
Clinical narrative: Initial report received from a healthcare professional on 15 March 2010. A 3-year old female patient received an intramuscular injection in the left thigh of H1N1 (lot number UP071AA) on 21 January 2010. Two days post-vaccination, the patient's parent reported that the patient developed a temperature of 101 to 105 (taken using an ear thermometer). The patient also had cough and congestion. The symptoms resolved in 3 days and the patient recovered. List of documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Epistaxis
Clinical narrative: Initial report was received from a health care professional on 01 February 2010. An eight-year-old  male patient who had a history of autism, received a second dose intramuscular left deltoid injection of H1N1, lot number UP040CA on 01 February 2010, and several hours after vaccination, he developed a nose bleed. The extent of bleeding was not reported, however, the patient recovered and subsequently played basketball afterwards with no problems. The event did not require a doctor's visit. The patient had no concurrent illness and he had not been taking any concomitant medications. On 24 December 2009, the patient had received a first dose of H1N1 (manufacturer and lot number not reported) with no adverse events experienced. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Full blood count normal, Pain in extremity, Red blood cell sedimentation rate normal, Sleep disorder, X-ray limb normal
Clinical narrative: Initial report received on 17 March 2010 from a health care professional. A 52 year old female patient with no medical history significant for ADD, migraines, hypertension and high cholesterol received H1N1 (lot umber UP075AA) to the right deltoid on 13 January 2010. The patient reported experiencing significant pain in deltoid since. The onset day for the pain was not reported. She stated the pain wakes her at night and that she now has trouble lifting her 90 pound dog. No additional information was provided. Follow-up information was received on 09 April 2010 from a health care professional. The date of onset of the adverse event was updated to have been 19 January 2010. Concomitant medications included ADDERRALL 20 mg BID. The patient had no illness at the time of the vaccination. On 09 March 2010 a CBC with Sed rate was within normal limits and an X-ray of the right shoulder was negative. The patient was referred to "ortho" for further evaluation of right shoulder. List of documents held by sender: None.
Age: 0.4
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Viral infection
Clinical narrative: Initial information was received on 03 February 2010 from a health care professional concerning a case of misuse. A 5 month old female patient developed a fever and a virus after she received H1N1 (lot number was unknown). The date of vaccination and event onset were unknown. Recovery status was unknown at the time of the report. List of Documents held by Sender: none.
Age: 41.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Ear infection, Increased upper airway secretion, Injected limb mobility decreased, Joint swelling, Oropharyngeal pain
Clinical narrative: This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with H1N1. The event for the second patient was captured in case number 2010-02464. Initial report received from a consumer on 26 April 2010. A 41-year-old male patient, with a medical history of a sulfonamide allergy, had received a left arm injection of H1N1 on 10 April 2010 and 2 days later, he developed a fever, phlegm, ear infection, and sore throat which persisted at the time of the report. The patient stated that he had a sore arm and was not able to lift the arm. He also complained of swollen arm joints. The patient's concomitant medications included XANAX and "merrinol". The events were reported as not recovered. Follow-up information received from a health care professional on 24 May 2010 clarified that according to the immunization program records the patient received an intramuscular H1N1, lot number UP100AA, on 30 March 2010 (previously reported by the consumer as 10 April 2010). The patient's facts were inconsistent with the truth and he had no illness at the time of vaccination. The patient did not have any cultures taken during his emergency room visit to positively diagnose his illness. The patient's information of being unable to lift his arm was inconsistent with the recent fishing stories he told while having his prescriptions filled. The patient concomitant medications included XANAX, MARINOL, OXYCONTIN, and LYRICA. Documents held by sender none.
Age: 41.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with H1N1. The event for the second patient was captured in case number 2010-02464. Initial report received from a consumer on 26 April 2010. A 41-year-old male patient, with a medical history of a sulfonamide allergy, had received a left arm injection of H1N1 on 10 April 2010 and 2 days later, he developed a fever, phlegm, ear infection, and sore throat which persisted at the time of the report. The patient stated that he had a sore arm and was not able to lift the arm. He also complained of swollen arm joints. The patient's concomitant medications included XANAX and "merrinol". The events were reported as not recovered. Follow-up information received from a health care professional on 24 May 2010 clarified that according to the immunization program records the patient received an intramuscular H1N1, lot number UP100AA, on 30 March 2010 (previously reported by the consumer as 10 April 2010). The patient's facts were inconsistent with the truth and he had no illness at the time of vaccination. The patient did not have any cultures taken during his emergency room visit to positively diagnose his illness. The patient's information of being unable to lift his arm was inconsistent with the recent fishing stories he told while having his prescriptions filled. The patient concomitant medications included XANAX, MARINOL, OXYCONTIN, and LYRICA. Documents held by sender none.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Accidental exposure, No adverse event, Skin laceration, Syringe issue
Clinical narrative: Initial case was received on 08 March 2010 from a healthcare professional who was also the patient. This is a case of misuse i.e. accidental exposure from broken syringe. The 28 year old female patient sustained a laceration on her right index finger on 18 February 2010, when the prefilled syringe "broke" of 2009 Monovalent Vaccine - No Preservative (lot number UT045BA expired 15 Feb 2010). The laceration was described as small. She could not provide dimensions, since it was healed. The patient had an allergy to penicillin ("PCN"), no other pre-existing medical conditions and no concomitant medications. She had no illnesses at the time of the laceration. No adverse event was reported. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ear infection, Increased upper airway secretion, Injected limb mobility decreased, Joint swelling, Oropharyngeal pain
Clinical narrative: This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with H1N1. The event for the second patient was captured in case number 2010-02463. Initial report received from a consumer, who was the patient's spouse, on 26 April 2010. A 38-year-old female patient, with no medical history, had received a left arm injection of H1N1 on 10 April 2010 and 1 day later, she developed a fever, phlegm, ear infection, and sore throat which persisted. The patient complained of swollen arm joints and a sore arm in which she was not able to lift the arm. The soreness still remained. The outcome was reported as not recovered. Follow-up information received from a health care professional on 24 May 2010 clarified that, according to the immunization program records, the patient received an intramuscular H1N1, lot number UP100AA, on 30 March 2010 (previously reported by the consumer as 10 April 2010). The patient's facts were inconsistent with the truth and her claim of becoming ill one day after the injection was false. Documents held by sender none.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with H1N1. The event for the second patient was captured in case number 2010-02463. Initial report received from a consumer, who was the patient's spouse, on 26 April 2010. A 38-year-old female patient, with no medical history, had received a left arm injection of H1N1 on 10 April 2010 and 1 day later, she developed a fever, phlegm, ear infection, and sore throat which persisted. The patient complained of swollen arm joints and a sore arm in which she was not able to lift the arm. The soreness still remained. The outcome was reported as not recovered. Follow-up information received from a health care professional on 24 May 2010 clarified that, according to the immunization program records, the patient received an intramuscular H1N1, lot number UP100AA, on 30 March 2010 (previously reported by the consumer as 10 April 2010). The patient's facts were inconsistent with the truth and her claim of becoming ill one day after the injection was false. Documents held by sender none.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever and headache involving a seven-year-old male subsequent to the administration of H1N1. The patient's medial history and concomitant medications were not reported. The patient received H1N1 on 09-Oct-2009. On 16-Oct-2009, the patient presented to the doctor's office with a fever of 103 and headache. The outcome of the event was not reported.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Headache
Clinical narrative: A non-serious, spontaneous report of headache has been received from a consumer concerning an adult male subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications were reported. The patient received H1N1, Intranasal on 13-Oct-2009 at 5 pm. On 13-Oct-2009 around 9 pm the patient experienced a headache lasting approximately one-half hour. The patient recovered from the event of headache on 13-Oct-2009.
Age: 37.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 39.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal discomfort, Headache, Pain, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of headache, sneezing, achy, stomach wasn't feeling right and sniffles has been received from a consumer/wife concerning her 39-year-old husband, subsequent to H1N1, Intranasal. The patient had no medical history and no concomitant medications was taken by the patient. The patient received intranasal H1N1 at 5:15pm on 15-Oct-2009. Approximately two hours after the patient received intranasal H1N1 he experienced a headache and sneezing. The next morning he experienced a headache, sniffles and sneezing. He was achy and his "stomach wasn't feeling right". The events of headache and sneezing were resolved on 16-Oct-2009 and the events of achy, stomach wasn't feeling right and sniffles were resolved on 17-Oct-2009. Additional information was received on 17-Dec-2009 and incorporated into the narrative: patient's age, medical history and concomitant medications, outcome and date of the outcome.
Age: 81.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Arthralgia, Erythema, Muscle spasms, Pyrexia
Clinical narrative: Initial case was received on 14 July 2010 from a healthcare professional. An 81 year old male patient received on 02 July 2010 an injection of  H1N1 (lot number UP102AA). On 13 July 2010 he experienced a fever of 100.6, joint pain and cramps (not specified). The patient had an allergy to Cox 2 inhibitors. No pre-existing medical conditions or concomitant medications were reported. The outcome of the events was unknown. Follow-up information was received 14 July 2010 from a health care professional. The patient's fever subsided and he had no further abdominal cramps. His symptom of joint pain decreased; however he began to experience a severe spasm behind the knee area which was also pink. The patient had a history unspecified knee surgery two years prior, and the pink area was reported to be to the right of the old incision. The patient was referred to their health care provided for evaluation. No additional information was reported. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious spontaneous report of "accidentally gave" H1N1 to a 72-year-old male was received from a registered nurse. Relevant medical history and concomitant medications were not reported. On 16-Oct-2009, the patient received H1N1. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Age: 57.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious, spontaneous report of H1N1 administered to a 57 year old has been received from a registered nurse concerning a 57-year-old female patient. The patient's medical history and concomitant medications was not reported. The patient received H1N1 on 16-OCT-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Overdose, Vaccination error
Clinical narrative: A non-serious spontaneous report of "granddaughter received H1N1 two times within four hours" has been received from a consumer concerning a 45-month-old female, subsequent to H1N1. Neither relevant medical history nor concomitant medications have been reported for this patient. On 14-Oct-2009, the patient received H1N1 two times within four hours. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 53.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of "gave H1N1 mist to our doctor and he is over 50" has been received from a medical assistant concerning a 53-year-old male patient, subsequent to H1N1. The patient's medical history and concomitant medications were not reported. On 12-Oct-2009, H1N1 was given to the patient. Per the reporter, the patient had "no problems" and no treatment was administered. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious report of H1N1 administration to an individual over 49 years old was received from a physician concerning an over 49-year-old adult unknown gender. The patient's medical history was not reported. On 16-Oct-2009, H1N1 was administered to an individual over 49 years. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 30.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 Mist went into the patient's eye was received from a registered nurse concerning a 30-year-old male. The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. During administration of the first half of the dose some of the vaccine went onto the patient's glasses and some got in his eye. The second half of the dose " was administered to the other nostril appropriately." There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Age: 1.34
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a 16-month-old was received from a health professional in a physician's office concerning a 16-month-old male, subsequent to H1N1, Intranasal. The child had no medical history and had not received any concomitant medications. On 15-Oct-2009, a nurse inadvertently administered H1N1, Intranasal to a 16-month-old. The reporter stated that the child had no problems post the receipt of the H1N1 vaccine, no signs or symptoms ever developed, and at the time of this call the child remained well and healthy. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: information regarding patient's medical history and concomitant medications was reported.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, Fatigue
Clinical narrative: A non-serious spontaneous report of administration of H1N1 vaccine into one nostril and tiredness was received from a patient parent concerning a 3.5 year old male subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 14-Oct-2009, the patient received H1N1. During administration of H1N1, the whole dose was administered into one nostril. According to the reporter, the patient seemed fine; however he was a bit tired at the time of reporting. The outcome of the event was not reported. Rechallenge is not applicable because re-administration of this product was not reported.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Swelling
Clinical narrative: Initial report received from an investigator on 08 march 2010 under the reference number FUF14. A 64 year-old female subject with a history of occasional heart palpitations, hyperlipidemia, urinary incontinence, sciatica, back pain, dry skin, depression, seasonal allergy to penicillin, spinal stenosis, dysthymia, skin tag, sleep apnea, osteopenia, and hypertension developed cellulitis of the left ankle secondary to a cat bite 36 days after receiving a second injection of H1N1 (7.5 ug HA, lot number UD12414) on 28 August 2009. The first dose was administered on 06 August 2009. On 29 September 2009 the subject was bitten by her cat on her left ankle. As a result, the subject developed swelling, redness, and pain. She went to an urgent care center on 02 October 2009 and was given tetracycline and keflex without improvement. On 03 October 2009 she was admitted to the hospital. An incision and drainage were performed. She was given fentanyl during the procedure and CIPRO and clindamycin at a later time. She was discharged on 04 October 2009. The subject continued participation in the study and recovered from the event. According to the investigator, the event of cellulitis was not related to the study product. Follow-up information was received from the investigator on 23 March2010. The event began on 29 September 2009 was considered to be fully recovered on 04 October 2009. The subject was taking CELEXA 20 mg per os since 2006. No additional information was reported. Follow-up information was received from the investigator on 26 March 2010. The event was updated to "Cellulitis left lower extremity secondary to a cat bite"; redness, swelling, and pain were added as symptoms, beginning 29 September 2009 and resolving 04 October 2009. Study vaccine was administered intramuscularly in the right deltoid. Treatment medications tetracycline and keflex were started on an unknown date. Fentanyl 500mcg was taken x1 on 03 October 2009; ciprofloxacin 500mg was taken 03 October 2009 - 12 October 2009; clindamycin 300mg was taken 03 October 2009 through 12 October 2009.In addition, the patient also received ZOFRAN 4mg x1 on 03 October 2009 and PERCOCET 1 tab on 03 October 2009. The outcome was updated from "recovered; to "recovered with sequelae". Follow-up information received from the investigator on 31 March 2010. The subject had received additional treatment for the serious adverse event of bacitracin topical (Start date 03 October 2009, stop date unknown). The dose for fentanyl treatment was 50mcg times one dose (not 500mcg as previously reported). The stop date of 04 October 2009 was removed by the investigator from the symptoms of redness and swelling as the subject was evaluated by her primary care physician on 07 October 2009 for follow-up and the wound was healing, but was still swollen and red. At that time, the subject was still taking antibiotics. Per investigator, the subject has not followed-up with them since that time. Recovery status remains "recovered with sequelae." This study was unblinded on 25 October 2009. Documents held by sender: None
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 Mist squirted in eye was received from a registered nurse concerning a child (age and gender not provided). The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. During administration, part of the dose of H1N1 mist squirted in the eye of the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a 32-year-old female. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a 44-month-old male. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a four-year-old female. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 18.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious report of "we gave a partial (1/2) of H1N1 to 5" was received from a physician concerning an 18-year-old male. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A spontaneous, non-serious report of H1N1 (intranasal) sprayed into eyes was received from a nurse concerning a six-year-old female patient. While receiving the vaccine on 21-Oct-2009, the patient jumped during administration and the vaccine sprayed into her eyes. There was no adverse event associated with the medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 12.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash pruritic, Urticaria
Clinical narrative: A non-serious spontaneous report of itchy rash and hives rash on trunk, arms and legs has been received from a registered nurse concerning a 12-years-old male, subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not provided. On 19-Oct-2009, the patient received H1N1. Within hours of vaccination, the patient developed an itchy rash and hives on his trunk, arms, and legs. The events have improved.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of a 52-year-old received H1N1 Mist was received from a registered nurse concerning a healthy 52-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Medical device complication, Skin laceration
Clinical narrative: A non-serious spontaneous report of a nurse cutting her finger on the syringe while administering H1N1, Intranasal has been received from a pharmacist concerning an adult female. Medical history and concomitant medications were not provided. On 21-Oct-2009, the nurse administered H1N1, Intranasal. During administration of the vaccine to a patient, the nurse cut her finger on the syringe. The outcome of the event is unknown.
Age: 61.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a 61-year-old female given H1N1 Mist was received from a registered nurse concerning a 61-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Age: 1.62
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A spontaneous, non-serious event of inadvertently gave H1N1, Intranasal to a 19-month-old patient was received from a registered nurse. There was no adverse event associated with this medication error; therefore, treatment and reporter/company causality assessments are not applicable, and the event is considered resolved.
Age: 0.58
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious spontaneous report of administration to seven-month-old was received from a registered nurse concerning a seven-month-old female patient who received H1N1. The patient's medical history included chronic constipation and concomitant medications included polyethylene glycol. The patient was given one capful OD in an 8-ounce bottle of juice, PO for the treatment of the patient's constipation. Since beginning this medication, no further bouts of constipation have occurred for this patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 10-Nov-2009 and incorporated into the narrative: which includes reporter information, patient's gender, patient's medical history, concomitant medication and its doses.
Age: 19.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of body aches, fever, sore throat, and vomiting has been received from a nurse practitioner concerning a 19-year-old female subsequent to H1N1. The patient's medical history and concomitant medications were not provided. The patient received H1N1 (date not provided). On 22-Oct-2009, the patient experienced "reactogenic effects including fever, body aches, sore throat and vomiting from the administration of the H1N1 Mist vaccine". The reporter indicated "some of the reactogenic effects continue". The outcome of each event was not provided.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: A non-serious spontaneous report of nausea, diarrhea, and abdominal pain has been received from a consumer/husband concerning his 38-year-old wife, subsequent to H1N1. The patient's medical history and concomitant medications were not provided. On 24-Oct-2009, the patient received H1N1. Several hours after the patient received the vaccine, she experienced nausea, diarrhea and abdominal pain which lasted for four hours. The events resolved.
Age: 22.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous event of "a woman received H1N1 Mist and then was pregnant" was received from a nurse, concerning a 22-year-old female patient. The patient history included one full term delivery. The concomitant medications includes norethindrone tablets once daily. The patient was five weeks pregnant at the time of vaccination. On 21-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 23-Oct-2009, the patient found out that she was pregnant. Her last menstrual period was on 02-Sep-2009. The patient terminated the pregnancy in Oct-2009. There was no adverse event associated with this vaccine exposure during pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of the event "vaccine exposure during pregnancy" was considered as resolved. Additional information was received on 03-Aug-2010 and incorporated into the narrative: Pregnancy outcome.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: A non-serious spontaneous report of colds and low grade fever has been received from a consumer concerning an adult female subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Oct-2009, the patient received a single dose of H1N1. On 17-Oct-2009, the patient experienced a low grade fever and colds (on and off). The events of low grade fever and colds resolved.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Lymphadenitis, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of swelling/inflammation of a superficial cervical lymph node, colds, sore throat, and low grade fever has been received from a consumer concerning an adult male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Oct-2009, the patient received a single dose of H1N1. On 17-Oct-2009, the patient experienced a low grade fever and colds (off and on) and a sore throat. On 23-Oct-2009 the patient started to have swelling/inflammation of a superficial lymph node on the right side of the neck and below his right ear. The low grade fever, colds and sore throat were ongoing and the outcome of the swelling/inflammation of a superficial lymph node was not reported.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1), FLUX
Symptoms: Headache, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of temperature of 102.3, lethargy, headache and sore throat has been received from a physician concerning a six-year-old male, subsequent to H1N1. The patient's medical history includes mild asthma which is well controlled. The patient uses albuterol inhaler as a rescue medication for his asthma but has not needed to use it in over a year. The patient received H1N1 on 22-Oct-2009 along with a seasonal flu shot. During the night of 22-Oct-2009 the patient woke with a temperature of 101.2, lethargy, headache and sore throat. By 3 PM the following day the child had a fever of 102.3, all his other symptoms resolved. The event of fever is ongoing while the events of lethargy, headache and sore throat all resolved on 23-Oct-2009.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration of H1N1 to a 52-year-old has been received from a consumer concerning a 52-year-old patient. The patient's medical history and concomitant medications were not provided. The patient received H1N1 on 22-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, Ocular hyperaemia
Clinical narrative: A non-serious spontaneous report of "nurse got H1N1 in my eye" and " it is a little red" has been received from a consumer concerning a 41-year-old female, subsequent to H1N1, intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Oct-2009, the patient received H1N1. The patient reported that a nurse got H1N1 vaccine in the patient's eye. Her eye was a little red but not painful. The patient washed her eye with normal saline. The outcome for the reported adverse event was not reported.
Age: 37.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Ankle fracture, Cast application, Fall, Joint dislocation, Joint dislocation reduction
Clinical narrative: Initial report received from an investigator on 15 March 2010 under the reference number FUF14. A 37-year-old male subject was hospitalized for broken left ankle 175 days after receiving a second dose of H1N1 (lot number UD12414, 7.5 mcg HA, Group 1) on 27 August 2009. The first dose of study product was received on 06 August 2009. The subject fell off his roof and sustained broken left ankle on 18 February 2010 and underwent surgery (type unknown) the same day without placement of ankle in cast. He was given Hydrocodone 10/325 prn for pain and released from the hospital the following day. Hydrocodone was stopped 23 days after onset. Per the investigator, medical records are pending. The subject has not recovered. The serious adverse event did not lead to study termination for the subject. According to the investigator, the event was not related to the study vaccine. Follow-up information was received 27 March 2010 from the investigator. The subject had no relevant medical history; he fell off a roof. He was hospitalized from 18 February 2010 until 19 February 2010. At the time of the report, medical records were pending, and the surgery type, diagnostic test results and treatments received were unknown. Follow-up information received from the investigator on 31 March 2010. The investigator received medical records and amended the diagnosis from "broken left ankle" to "left ankle fracture and dislocation." Start date was 18 February 2010 (no change from previous reporting). The subject underwent open reduction and internal fixation of the left ankle fracture/dislocation on day one of hospitalization (18 February 2010). While hospitalized, the subject received cefazolin, zolpidem, and 9% sodium "cloride". The subject was discharged on day two of hospitalization with a fracture boot. The investigator has spoken to the subject, and his ankle is still healing. Recovery status is still not recovered. Unblinding information was received on 25 October 2009. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Open reduction of fracture, Surgery
Clinical narrative: Initial report received from an investigator on 15 March 2010 under the reference number FUF14. A 37-year-old male subject was hospitalized for broken left ankle 175 days after receiving a second dose of H1N1 (lot number UD12414, 7.5 mcg HA, Group 1) on 27 August 2009. The first dose of study product was received on 06 August 2009. The subject fell off his roof and sustained broken left ankle on 18 February 2010 and underwent surgery (type unknown) the same day without placement of ankle in cast. He was given Hydrocodone 10/325 prn for pain and released from the hospital the following day. Hydrocodone was stopped 23 days after onset. Per the investigator, medical records are pending. The subject has not recovered. The serious adverse event did not lead to study termination for the subject. According to the investigator, the event was not related to the study vaccine. Follow-up information was received 27 March 2010 from the investigator. The subject had no relevant medical history; he fell off a roof. He was hospitalized from 18 February 2010 until 19 February 2010. At the time of the report, medical records were pending, and the surgery type, diagnostic test results and treatments received were unknown. Follow-up information received from the investigator on 31 March 2010. The investigator received medical records and amended the diagnosis from "broken left ankle" to "left ankle fracture and dislocation." Start date was 18 February 2010 (no change from previous reporting). The subject underwent open reduction and internal fixation of the left ankle fracture/dislocation on day one of hospitalization (18 February 2010). While hospitalized, the subject received cefazolin, zolpidem, and 9% sodium "cloride". The subject was discharged on day two of hospitalization with a fracture boot. The investigator has spoken to the subject, and his ankle is still healing. Recovery status is still not recovered. Unblinding information was received on 25 October 2009. Documents held by sender: None.
Age: 1.08
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Wheezing
Clinical narrative: A non-serious spontaneous report of administered to 13-month-old, fever of 102 and wheezing has been received from a respiratory therapy technician/father concerning his 13-month-old daughter, subsequent to H1H1, Intranasal. The patient had no past medical history or concomitant medications. The patient received H1N1, Intranasal on 21-Oct-2009 for an unknown indication. On 24-Oct-2009, the patient experienced fever of 102 and wheezing which resolved within 24 hours of their onset. These symptoms were mild. The patient was treated with albuterol inhaler on the day of the symptoms. Medical attention was not sought. The outcome of events was resolved. Additional information was received on 11-Nov-2009: information on patient's medical history, concomitant medications, adverse event information and outcome of the events.
Age: 67.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of "I am 67 years old and I received H1N1 mist," muscle aches and runny nose has been received from a consumer concerning herself, subsequent to H1N1. The patient's past medical history and concomitant medications were not reported. On 25-Oct-2009 the patient received H1N1. On the same day after her vaccination, the patient stated that "she is 67 years of age and she received the H1N1 mist" at the County Health Department. She also experienced muscle aches and a runny nose that lasted for two days after vaccination. The adverse events resolved.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of "he got H1N1 and got fever and body aches" has been received from a nurse concerning an eight-year-old male, subsequent to H1N1, intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, intranasal on 23-Oct-2009 for unknown indication. Three days after receiving H1N1, intranasal, the patient developed fever and body aches. Treatment for the events was not provided. The outcome for the reported adverse events is ongoing.
Age: 0.51
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough
Clinical narrative: A non-serious spontaneous report of "we gave H1N1 vaccine to a six-month-old child" and cough has been received from a physician concerning a six-month-old male, subsequent to H1N1, Intranasal. The patient's past medical history included feeding problem as a newborn, whereby feedings took approximately one-hour each which had resolved. The patient had not taken any concomitant medication. On 26-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. The patient had a cough for the past week. The patient had good reflex tone, lungs were clear bilaterally to auscultation; there was no respiratory distress, rectal temperature was 98.2, thus no necessary medical intervention was required. The outcome was unknown. Additional information was received on 12-Nov-2009 and incorporated into the narrative: cough has been added as new event term. The medical history has been added and new information incorporated into event description.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough
Clinical narrative: A non-serious spontaneous report of cough has been received from a consumer, patient's mother, concerning a four-year-old female subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal, nasally on 22-Oct-2009. On 23-Oct-2009, the patient experienced cough. The outcome of the event was unknown.
Age: 5.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious report of "child received two doses" was received from a registered nurse concerning a five-year-old patient of unknown sex. The patient's medical history was not reported. On 27-Oct-2009, the patient received two doses of H1N1 within hours. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.