chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A report was received from a health professional on 11/1/01 concerning a 72 year old male patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes Prostate cancer which started on an unknown date. Co-medications taken by the patient include Lupron and Pepcid. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain
Clinical narrative: A report received from a health care professional on 08Nov01 regarding a 61 year old male pt who died on 06Nov01 after receiving Fluvirin vaccine on 05November2001. Relevant medical history included right  CVA(hemiparesis), hypertension and coronary bypass surgery. The pt was taking acetylsalicylic acid, doxazosin mesilate, diltiazem hydrochloride, enalapril maleate, venlafaxine hydrochloride, isosorbide mononitrate, metoprolol tartrate, clopidogrel sulfate, lanscprazole, trazodone, glyceryl trinitrate, parecetamol and ranitidine hydrochloride. The pt was institutionalized in a nursing home and received a Fluvirin injection on 05Nov01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 06Nov01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unk.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Facial palsy
Clinical narrative: A report was received from a health professional on 11/27/01 concerning a 77 year old female patient who experienced Bell's Palsy which was considered medically significant (OMIC) 21 days after receiving the Fluvirin vaccine on 10/30/01. The patient received influenza vaccine on 11/3/98 and 11/4/00 without incidence. The patient was diagnosed with breast cancer in 1980, which is currently in remission. For the treatment of this cancer the patient has for years been taking Raloxifene Hydrochloride and Megestrol Acetate orally on a daily basis. The patient has also , for an unspecified period, been taking hydrochlorthiazide orally on a daily basis, for the treatment of hypertension. On 11/20/01, the patient experienced constriction of the mouth and difficulty swallowing. On 11/21/01, the patient was seen by a physician, was diagnosed with Bell's Palsy, and Prednisone was prescribed with some improvement. On 11/27/01, the patient was seen by her regular physician for follow up. The diagnosis of Bell's Palsy was again confirmed as the patient presented with lip drooping, however swallowing had improved. Prednisone for an additional two weeks was prescribed. The reporter was assessed the relationship of Fluvirin to the event as probable.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: A report was received from a health professional on 12/10/01 concerning an 11 year old male patient who experienced an asthma attack, resulting in hospitalization, the morning after receiving Fluvirin on 11/13/01. The patient has had asthma for an unknown duration and takes unknown concomitant asthma medication orally on an ongoing basis. It is not known whether or not the patient has been previously exposed to Fluvirin. On 11/13/01, the patient received a Fluvirin injection IM on the left deltoid muscle. On the morning of the next day (11/14/01), the patient experienced an asthma attack. He was admitted to hospital for the treatment of the asthma attack on 11/15/01. The reporter provided no information on the inpatient therapy regimen. The patient was discharged from hospital on 11/19/01 and has recovered. The reporter assessed the relationship of study medication to the event as possible, also stating that the event may have been contributed to by the patient's medical history.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebral thrombosis, Hemiparesis, Intracranial aneurysm
Clinical narrative: A report was received from a health care professional on 12/27/01 concerning a 58 year old female patient who experienced cerebral thrombosis, which led to hospitalization, within 48 hours of receiving Fluvirin on 10/18/01 or 10/19/01. The patient had a hysterectomy in 1998, has been diagnosed for years with osteoarthritis of the right knee, has had menopause diagnosed for years, and was diagnosed within the last year with glaucoma. The patient takes Conjugated Estrogens for menopause, and Fluticasone Propionate and Loratadine for allergy. The patient received a flu vaccine of unknown source on 11/5/99 without incidence. On 10/18/01 or 10/19/01, the patient received a Fluvirin vaccine on her deltoid muscle. Within 48 hours (10/20/01), the patient was diagnosed with a cerebral thrombosis and was admitted to a hospital. The patient experienced cerebral thrombosis, MCA with right hemiparesis, and aneurysm on the left carotid artery. The patient was discharged on 10/29/01 and at the time of the report was undergoing rehabilitation therapy. The reporter has stated that the patient's family doctor believed that there was a probable relationship with Fluvirin. The patient did not have a risk factor for stroke per her family physician.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: A report was received on 1/2/02 concerning a 51 year old male patient who was hospitalized for chest pain after a visit to the Emergency Room after receiving Fluvirin vaccine on 12/11/01.
Sex: F
Vaccine: FLU3
Symptoms: Clumsiness, Muscular weakness, Nerve injury
Clinical narrative: A report was received from a health care professional on 10/26/01 regarding a female patient (age not reported) who experienced brachial plexitis on 10/19/01 after receiving Fluvirin vaccine on 10/16/01. Three days after vaccination in the left deltoid muscle, the patient presented with weakness and clumsiness in the left arm extending from the elbow down to the hand, diagnosed as brachial plexitis. No treatment was administered to the patient. According to a neurologist, it is thought that the patient experienced a neurological immune reaction. At the time of reporting, the patient's condition was slowly improving. The reporter has assessed the relationship of study medication to the event as unrelated. the patient has received influenza vaccine in the past years. Following internal review, on 1/21/02, this case was upgraded to serious, and following clarification on 1/25/02, the reporter's causality was amended to possible. (OMIC)
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Skin nodule
Clinical narrative: A report was received from a health professional on 1/30/02 regarding an 18 year old male patient who experienced nodules on legs and bottom of feet after receiving a Fluvirin vaccine on 11/20/01. The patient had a previous flu vaccine in 2000. On 11/20/01 the patient received a Fluvirin vaccine and on 11/27/01 the patient experienced severe pain in both legs and feet, he also started to have painful nodules on legs and bottom of feet. The patient was admitted to hospital where he remained for four days. The patient was treated with Diazepam, Prednisolone and Paracetamol. Hepatitis B and Meningitis vaccines were given approximately 2 weeks after the event. It is not known if the patient had recovered at the time of reporting the event. There was insufficient information to determine the reporter's causality assessment.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Pain, Polymyalgia rheumatica
Clinical narrative: Telephone report received on January 23, 2001, regarding adverse events possibly associated with administration of Fluvirin.  A wife reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks after receiving a Fluvirin vaccination at a local VA Clinic.  He was then prescribed "Lasix (ferosemide) for his heart, Coumadin (wafarin sodium) for his blood, Prednisone (Prednisolone) for his PMR, and Synthorid (thyroxine sodium) for his thyroid".  He had previously been on no medications and had no medical problems.  He has received flu shots in the past, without problems.  This symptoms manifested as "achiness in his hips, thighs, and calves".  He normally works out at a club three times per week, but has not yet been able to resume that activity. Follow up information received April 24th, 2001;  Physician identified as primary care provider wrote:  "I did not administer a flu shot to this patient".  No further information is expected. Additional information received on June 5, 2001, from treating Rheumatologist.  The day after receiving the flu vaccine, the patient woke up with severe pain in thighs, calves, and hips.  A few days later, joint pain began.  This patient also had fevers to 102 and lost 22 pounds.  The family doctor started him on Prednisone, Plaquenil, and NSAID's with good effect.  As of 05/21/2001, his positive RF has persisted.  Rheumatologist now believes "this patient has chronic sero+ RA".  Hand x-rays to look for pattern of erosion have been taken; results are pending at this time. (OMIC)
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Dizziness, Dyspnoea
Clinical narrative: A report was received from a health professional on 10/10/01 concerning a patient who experienced asthmatic symptoms and felt faint within 5 minutes of receiving Fluvirin. The patient has a history of allergy to latex and cats, but no known allergy to egg products. The patient began to cough and had difficulty breathing within 1 minute of the Fluvirin injection. She was given oral loratadine, but continued to have asthmatic symptoms and then began to feel faint, at which time she was given SC epinephrine hydrochloride. It took close to 24 hours for the symptoms to resolve. No reaction was seen at the site of the injection and there was no indication the vaccine may have entered a blood vessel. There was insufficient information to determine the reporter's causality assessment. Follow up information received on 2/8/02 stated that the patient was a 48 year old who had a previous flu vaccination on 10/6/99. Fluvirin was administered on 10/1/01 IM to the patient's left arm. Asthma-like symptoms developed within 5 minutes and persisted for 2-3 days, then resolved. In addition, the patient was treated with Fexofenadine hydrochloride. The reporter has indicated that he has sent the report to the regulatory authority. Following internal review on 5/7/02, this case was upgraded to serious. (OMIC)
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation
Clinical narrative: A report received from a dispensing manager on 08/20/2001, concerning a female patient of unknown age who experienced whole arm inflammation, after receiving Fluvirin last winter. On an unknown date, the patient experienced whole arm inflammation.  The patient received Fluvirin vaccination last winter and experienced an intense local reaction.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: An ASPP (Anonymised Single Patient Print) was received from the  MCS (regulatory authority) on 07/18/2001, concerning a 63 year old male patient who experienced capsulitis of the shoulder after receiving influenza vaccine October 2000.  In November 2000, the patient received the vaccination in the left arm.  The reporter did not consider the reaction to be serious. There was insufficient information to determine the reporter's causality assessment.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle disorder
Clinical narrative: A report was received from a healthcare professional on 06/16/2001, concerning a 20 year old female patient who experienced motor deficiency on the left foot after receiving the Fluvirin vaccine in November 2000. In November 1999, the patient experienced motor deficiency on the left foot after receiving Vaxigrip influenza vaccine and again in November 2000 after receiving Fluvirin vaccine.  The patient recovered in May 2000 and April 2001 respectively. The reporter assessed the relationship of the Vaxigrip influenza vaccine to the event as unclassifiable. The reporter has assessed the relationship of the Fluvirin vaccine to the event as probable.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper
Clinical narrative: A report was received from a healthcare professional on 04/09/2001, concerning a 14 year old male patient who experienced mid-epigastric pain on 03/01/2001 after receiving the Fluvirin vaccine on the same day. On 03/02/2001, the patient experienced epigastric pain.  The symptoms eventually resolved on an unknown date without further complications. There was insufficient information to determine the causality assessment of the reporter. Cross reference with PJP-2001-00267 and PHP-2001-00271.
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Influenza like illness, Lethargy, Nausea, Vomiting
Clinical narrative: A report was received from a health professional on April 09, 2001 concerning several patients of unknown demography who experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain after receiving the Fluvirin vaccine on unknown dates. On unknown dates several patients experienced mild flu-like symptoms, nausea or vomiting, lethargy and mid-epigastric pain.  At the time of the report it was unknown if the patients had recovered. There was insufficient information to determine the causality assessment of the reporter.  Cross Reference with PJP2001-00267 and PJP-2001-00270.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Apnoea, Chest pain, Cyanosis, Dyspnoea
Clinical narrative: A report was received from a health professional on 9/14/01 concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 9/11/01. The patient is allergic to Sulfa drugs and metoclopramide. The patient received a dose of flu vaccine 1 year previously with no problems. On 9/11/02, the patient experienced anaphylaxis including redness/itching, difficulty breathing and chest pain 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on chest and extreme pallor of extremities, with apnea for about 30 seconds. Oxygen was administered and the patient was admitted to hospital on 9/11/01 with symptoms abating but continuing. The patient recovered on 9/13/01 and was due to be discharged from hospital on 9/14/01. The reporter has assessed the relationship of study medication to the event as possible.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoxia, Pallor, Pruritus, Urticaria
Clinical narrative: A report was received from a health professional on 9/14/01 concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 9/11/01. The patient is allergic to Sulfa drugs and metoclopramide. The patient received a dose of flu vaccine 1 year previously with no problems. On 9/11/02, the patient experienced anaphylaxis including redness/itching, difficulty breathing and chest pain 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on chest and extreme pallor of extremities, with apnea for about 30 seconds. Oxygen was administered and the patient was admitted to hospital on 9/11/01 with symptoms abating but continuing. The patient recovered on 9/13/01 and was due to be discharged from hospital on 9/14/01. The reporter has assessed the relationship of study medication to the event as possible.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A report received from a nurse on 10/02/01, concerning a 55 year old female who experienced redness and swelling at the injection site on 09/22/01 after being injected with 0.5 ml of Fluvirin at the right deltoid area on 09/21/01. The patient was treated with Tylenol and her current condition was described as better at the time of reporting. It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication to the event probable. See PJP200100298 and PJP200100299.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: A report received from a nurse on October 02, 2001, concerning a 35 year old female patient who experienced redness, itching and swelling at the injection site on September 22, 2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on September 21, 2001. The patient was treated with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assessed the relationship of study medication ot the event probable. See PJP-2002-00295 and PJP-2001-00299.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Malaise, Nausea
Clinical narrative: A report was received from a nurse on 10/02/2001, concerning a 67 year old female patient (hl) who experienced redness and swelling at the injection site and flu-like symptoms including fever, malaise and nausea on 09/22/2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on 09/21/2001. The patient was treated symptomatically with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assess the relationship of study medication to the event probable. See PJP-2001-00295 and PJP-2001-00298.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: A report was received from a nurse on 10/02/2001, concerning a 67 year old female patient (hl) who experienced redness and swelling at the injection site and flu-like symptoms including fever, malaise and nausea on 09/22/2001 after receiving an IM injection of Fluvirin 0.5ml at the right deltoid area on 09/21/2001. The patient was treated symptomatically with Tylenol and her current condition was described as better at the time of reporting.  It is unknown whether the patient has received any prior influenza vaccination. The reporter has assess the relationship of study medication to the event probable. See PJP-2001-00295 and PJP-2001-00298.
Sex: F
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: A report received from a pharmacist on October 5, 2001, concerning a female patient who experienced severe reaction which started the previous year (2000), after receiving Fluvirin vaccine. There was insufficient information to determine the reporter's causality assessment. PJP-2001-00306 was deleted when determined to have been entered twice and to be a duplicate of this case.  This case remains the master report.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A report was received from a health professional on 10/08/01, concerning a 48 year old female patient who experienced an injection site reaction, almost immediately after receiving the Fluvirin vaccine on 10/08/01. The patient had previously received the Influenza vaccine on Oct. 2000. On 10/05/2001, the patient experienced a red raised rash approximately 4 inches by 3 inches at the site of administration, almost immediately after receiving the Fluvirin vaccine. Initially, it was tender, hot and painful, but these symptoms resolved after one day. The patient had completely recovered on 10/08/01. The reporter has assess the relationship of the study medication to the event as probable.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Influenza like illness, Medication error, Nausea
Clinical narrative: A report was received from a health care professional on 10/08/01, concerning a 46 year old female healthcare professional who experienced flu like symptoms, approximately 24 hours after she inadvertently administered the Fluvirin to a patient. On 10/03/01, the health care professional experienced flu like symptoms including fatigue and nausea, approximately 24 hours after she, accidentally sprayed her eyes with Fluvirin, during administration. The healthcare professional flushed her eyes with sterile solution immediately after the exposure. She recovered 3 days later on 10/06/01. The reporter has assessed the relationship of study medication to the event as possible.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Headache
Clinical narrative: A report was received from a health professional on 10/10/01, concerning a 64 year old male patient who experienced chest pains, dizziness and headache immediately after receiving Fluvirin vaccine on 10/05/98. The events resolved 24 hours later. There was insufficient information to determine the reporter's causality assessment.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Influenza like illness
Clinical narrative: A report was received from a consumer on 10/11/01 and a follow up from a health professional on 12/14/01, concerning a 49 year old male who experienced flu like symptoms and an injection site reaction, approximately 3 weeks after receiving the Fluvirin vaccine on 10/23/00. In November 2000, the patient experienced flu like symptoms and an inability move his arm for a few days, approximately 3 weeks after he received the Fluvirin vaccine on 10/23/00. The patient had recovered at time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received on 12/14/01 which changed the reporter's causality assessment to probable.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: A report was received from a health care professional on 10/24/01 regarding a 71 year old female patient who experienced rash on arms and chest few days after receiving Fluvirin vaccine on 10/16/01. The event was reported to be resolved. There was insufficient information to determine the reporter's causality assessment.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: A report was received from a health professional on 10/12/01, concerning a 53 year old female patient who experienced an injection site reaction after receiving Fluvirin vaccine on 10/04/01. The patient had previously received an Influenza vaccination on 11/18/99 (Batch number 60065AA). The patient received 0.5 mg IM, in the left arm on 10/04/01. The patient developed erythema with a central yellowish clearing. There was not pain or tenderness and no warmth or sign of infection. The patient was treated with warm compresses and Benadryl every 4 to 6 hours. The arm was rechecked on 10/11/01 and the skin tone was normal and the arm was getting better. At the time of the report, the patient was rescheduled in 1 week. There was insufficient information to determine the reporter's causality assessment.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error, Pain
Clinical narrative: A report was received from a health professional on 10/15/01 concerning an 88 year old female patient who received a Fluvirin overdose on 10/15/01 after an initial dose of 10/08/01. The patient experienced a sore arm after the second vaccination which resolved without sequelae on 10/16/01. There was insufficient information to determine the reporters causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose, Medication error
Clinical narrative: A report was received from a health professional on 10/12/01 concerning a patient of unknown demography who had received an overdose of Fluvirin on 10/12/01. On 10/12/01the patient was have a number of vaccinations and was inadvertently given 2 doses of Fluvirin within a time frame of a few minutes. There were no Adverse Events reported at the time of reporting.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular
Clinical narrative: A report was received from a health care professional on 10/26/01 regarding a 80 year old female patient who developed a rash 24 hours following the administration of Fluvirin vaccine (batch E4254BB) on 12/01/94. Rash was described as red, pitted, lumpy over arm and chest. The patient was treated with cortisone cream administered by the casualty department. The event resolved approximately 6 days later. There was insufficient information to determine the  reporter's causality assessment.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Influenza like illness
Clinical narrative: A report was received from a health professional on 10/17/01, concerning a 70 year old female patient who experienced mild flu like symptoms and a hot and red arm, 1 hour after receiving the Fluvirin vaccine on 10/10/01. The patient experienced a similar reaction last year but it is unknown if it was due to Fluvirin. The patient recovered on 10/16/01. There was insufficient information to determine the causality assessment of the reporter.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Urticaria
Clinical narrative: A report was received from a health care professional on 16 October 2001 regarding a 42 year old female patient who experienced an injection site reaction on 12 October 2001 after receiving fluvirin vaccine (batch E04861KA) on 11 October 2001. The patient received the flu vaccine the year before without a problem. Twenty four hours following the vaccination, the patient developed a 5-10 mm wheal and peripheral blisters. No treatment was undertaken and the wheal and blisters resolved on their own 3 days later. There was insufficient information to determine the reporter's causality assessment.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a health professional on 10/18/2001, concerning a 76 year old male patient who experienced an overdose, after inadvertently receiving the Fluvirin vaccine on 10/08/2001 and again on 10/18/2001. On 10/18/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 10 days after the first vaccination. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: A report was received from a health professional on 10/09/2001 concerning a patient who was inadvertently given last season's Fluvirin vaccine. There was no adverse event reported. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a distributor on 10/12/2001, concerning 2 elderly patients who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart, on an unknown date. On an unknown date, 2 elderly patients experienced an overdose after inadvertently receiving 2 doses of the Fluvirin vaccine 2 days apart. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment of the reporter.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a health professional on 10/17/2001 concerning a 74 year old male who experienced an overdose of Fluvirin on 10/17/2001. The patient received a Fluvirin vaccination on 10/12/2001, then again on 10/17/2001 in error. There were no adverse events reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling, Syncope
Clinical narrative: A report was received from a consumer's wife on October 19, 2001 regarding an elderly male patient who experienced syncope and swollen and inflamed joints after receiving Inactivated Influenza vaccine in 1986 and 1987. The patient was vaccinated in 1986 and experienced syncope and collapsed approximately 48 hours later.  The patient was vaccinated in 1987 after which he experienced swollen and inflamed joints which lasted 5 weeks.  The patient has recovered from both incidents.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gout, Insomnia, Joint swelling, Oedema peripheral
Clinical narrative: A report was received from a health professional on 10/30/01 concerning a 53 year old female patient who experienced swelling of the elbow and wrist and subsequently experienced swelling of the knee, 3 and 6 days respectively after receiving the Fluvirin vaccine on 10/17/01. On 10/20/01, the patient experienced swelling of the left elbow and wrist 3 days after receiving the Fluvirin vaccine in the left deltoid muscle. The swelling spread to the hands whereby the patient was unable to put her ring on. On 10/23/01, the patient noticed swelling and pain in the right knee and had difficulty sleeping, going up and down stairs and putting pants on as a result of the swelling in the knee. The patient tested negative for gout, lupus and rheumatoid arthritis. At the time of report, the patient was still recovering. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid arthritis, Swelling, Systemic lupus erythematosus
Clinical narrative: A report was received from a health professional on 10/30/01 concerning a 53 year old female patient who experienced swelling of the elbow and wrist and subsequently experienced swelling of the knee, 3 and 6 days respectively after receiving the Fluvirin vaccine on 10/17/01. On 10/20/01, the patient experienced swelling of the left elbow and wrist 3 days after receiving the Fluvirin vaccine in the left deltoid muscle. The swelling spread to the hands whereby the patient was unable to put her ring on. On 10/23/01, the patient noticed swelling and pain in the right knee and had difficulty sleeping, going up and down stairs and putting pants on as a result of the swelling in the knee. The patient tested negative for gout, lupus and rheumatoid arthritis. At the time of report, the patient was still recovering. The reporter has assessed the relationship of the study medication to the event as possible. (OMIC)
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lethargy, Listless
Clinical narrative: A report was received from a health professional on October 22, 2001 concerning a 40 year old male patient who experienced lethargy and headache after receiving Fluvirin in October 2000. 20 minutes after the vaccination the patient complained of a "tight ring around head" and having a "cotton wool head".  The patient had also been feeling lethargic and listless, especially after exercise.  The patient had not recovered at the time of reporting. There was insufficient information to assess the reporter's causality.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Chills, Cold sweat, Dizziness, Mydriasis
Clinical narrative: A report was received from a health professional on 30 October 2001, concerning a 78 year old male patient who experienced chills, a light head, dilated pupils, raised blood pressure and raised pulse, 45 minutes after receiving an Influenza vaccine on 17 October 2001. On 17 October 2001, the patient experienced a cold clamy feeling, a distant feeling, a lump in throat, dilated pupils, and a raised blood pressure and pulse, 45 minutes after receiving an Influenza vaccine.  The patient recovered 2 hours later. There was insufficient information to determine the reporter's causality assessment.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Overdose
Clinical narrative: A report was received from a health professional on 22Oct01 concerning an 89 year old female pt who experienced an overdose after receiving a second dose of Fluvirin on 15Oct01. The pt received Fluvirin on 28Sept01 and received a second dose on 15Oct01. There were no adverse events reported. There was insufficient information to determine the reporter's causality assessment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: A report was received from a health professional on 10/29/02 and a follow up on 04/02/02. A second follow up was received on 05/21/02 concerning a 51 year old female patient, who experienced flu like symptoms the evening following a Fluvirin vaccine on 10/24/01. The patient had been vaccinated in the pas with no side effects. The hospital where she received the vaccine did not refrigerate the vaccine as recommended in the SPC, but stored it at room temperature instead. The patient recovered approximately a week after receiving the vaccination. There was insufficient information to determine the reporter's causality assessment.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a health care professional on 10/30/2001 and a follow up was received on 11/26/2001, concerning a 73 year old female patient who experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 11 days apart, on 10/19/2001 and 10/30/2001. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 11 days after the first vaccination on 10/19/2001. No adverse effects were reported at time of report. There was insufficient information to determine the causality assessment of the reporter.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a health professional on 10/30/2001, concerning an 80 year old female patient experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 19 days apart. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 19 days after the first vaccination on 10/11/2001. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment  of the reporter.
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A report was received from a health professional on 10/31/2001, concerning a female patient of unknown demography who was inadvertently administered the Fluvirin vaccine whi1st 23 weeks pregnant, on an unknown date. On unknown date, the patient received the Fluvirin vaccine whi1st 23 weeks pregnant. No further information was given. There was insufficient information to determine the reporter's causality assessment.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: A report was recieved from a health professional on 11/02/2001, concerning a 55 year old female patient who developed an intolerance to eggs, after receiving the Fluvirin vaccine on an unknown date in 1999 and 2000. On an unknown date in 1999, the patient developed an intolerance to eggs, after receiving the Fluvirin vaccine. The patient experienced a similar reaction after receiving the Fluvirin on an unknown date in 2000. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vision blurred
Clinical narrative: A report was received from a health professional on 11/02/2001, concerning a 29 year old female patient who experienced a headache and blurred vision, 1 day after receiving a Fluvirin vaccine on 10/21/2001. On 11/01/2001 , the patient experienced a temporal headache on the right side and blurring of vision in the left eye, 1 day after receiving a Fluvirin vaccine. The patient had previous vaccinations without adverse reactions. At the time of report, the patient had not recovered. There was insufficient information to determine the reporter's causality assessment.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: A report was received from a health professional on 05 Nov 2001, concerning a 62-year-old female patient who experienced swollen and tender lymph nodes, 1 day after receiving the Fluvirin vaccine on 02 Nov 2001.  On 03 Nov 2001, the patient ( a registered nurse and an infection control practitioner ) experienced swollen lymph nodes and tenderness under the right arm that spread to the right chest area, 1 day after receiving the Fluvirin vaccine in the right deltoid muscle.  The patient experienced a similar reaction 2 years previously, following an Influenza vaccination (brand unknown).  At time of report, the patient had not recovered.  There was insufficient informaton to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Accidental overdose
Clinical narrative: A report was received from a health professional on 03 Apr 2001, concerning 5 patients of unknown demography, who received an overdose of Fluvirin vaccine or Pru-immune-23, on an unknown date.  On an unknown date, the patient inadvertently received a double dose of the Fluvirin vaccine and Pru-immune-23.  No adverse event was reported.  There was insufficient information to determine the reporter's, causality assesment.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A report was received from a health professional on 29 October 2001 regarding a female patient over 65 year old who experienced an injection site reaction after receiving Fluvirin vaccine in 2000.  The patient had previsously received Fluvirin with no ill effects.  The patien developped 4 cm area of red swelling around the site of injections.  The event was reported to be resolved.  There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a Health professional regarding a patient who was accidently given last years flu vaccine in error.  There were no adverse events reported.  There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health professional regarding 20 patients who had inadvertently received only half doses of Fluvirin. There were no adverse events reported. There was insufficient information to determine the reporter's causality assessment.
Age: 0.82
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a healthcare professional on 13Nov01 regarding a 1 month old girl who accidentally received Fluvirin 0.5ml instead of hep B. There were no adverse events reported. No specific treatment other than supportive care was provided. There was insufficient information to determine the reporters causality assessment.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Vaccine positive rechallenge
Clinical narrative: A report was received from a health professional on 16Nov01, concerning a 6 year old male pt who experienced an injection site reaction which was considered to be serious as medical intervention was required, several hours after receiving the Fluvirin vaccine on 15Nov01. Relevant medical history include eczema, and seasonal  and food allergies. The pt was received concomitant medication Montelukast sodium for over 6 months. On 15Nov01, the pt developed a local erythematous, edematous, itchy and red reaction at the injection site (approx 13cm by 13cm in area), several hours after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Cetirizine Hydrochloride, oral Prednisolone and topical Corticosteroids. The pt experienced a similar reaction last year after receiving the influenza vaccine (brand unk). At time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as probable. A follow up report was received on 13Dec01: The reporter described the events as oedema, erythema and pruritus from which the pt recovered on 16Nov01. The pt had experienced a similar reaction last year on 01Nov00. The pt additionally had a medical history of RAD and insect bites. He also was taking budenoside and salbutamol as concomitant medication. The events were not considered to be serious as per telephone conversation 17Dec01.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Unintended pregnancy
Clinical narrative: A report was received from a health professional on 07Nov01, concerning a 32 year old female pt, who was administered the Fluvirin vaccine on 06Nov01 whilst 7 weeks pregnant. The pt experienced nausea and dizziness in the evening on 06Nov01. The pt had a pregnancy test 2 weeks previously which tested positive. Per the pt, her obstetrician said she was 7 weeks pregnant. The pt experienced nausea and dizziness in the evening of 06Nov01. At the time of the report the pt had recovered. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: A report was received from a health professional on 08Nov01, concerning a 48 year old female pt who experienced muscle spasms and wrist pain, 1 day after receiving the Fluvirin vaccine on 25Oct01. On 25Oct01, the pt experienced muscle spasms bilaterally in the arms and legs and wrist pain, 1 day receiving the Fluvirin vaccine. The pt was not treated at the time of event. At time of report, the symptoms had decreased but the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as not known.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Peripheral coldness
Clinical narrative: A report was received from a health professional on 12Nov01 concerning a 21 year old female pt who experienced cyanosis of the left hand fingers 3,4 and 5 after receiving Fluvirin (batch E02101HA) on 09Nov01. The pt left hand fingers (3,4 and 5) turned blue and were cool touch. She was able to detect sensation. The event was increasing and decreasing in intensity and was ongoing at the time of reporting. There was insufficient information to determine the reporter's causality assessment.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Thermal burn
Clinical narrative: A report was received from a health professional on 12Nov01 concerning a 5 year old female pt who experienced an injection site reaction 2 days after receiving Fluvirin on 25Oct01. The pt had previously received an influenza vaccine (brand unspecified) in Nov 2000 without any adverse sequelae. The pt is a near drowning victim who is now medically compromised receiving 29 medications on an as needed basis (list unavailable by the reporter at the time of the call). On 25Oct the pt received Fluvirin 0.5ml IM. the pt did not received any concomitant vaccines. After 48 hours, a 5x9cm reddened are with 15-20 white dots developed at the site of injection. Twenty four hours later, the area developed into 2 dime-sized blisters. The physician diagnosed the reaction as a chemical burn. The pt is currently being treated with silver sulfadiazine and oral cephalin. The reporter assessed the relationship to the injection site reaction as probable.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: A report was received from a health professional on 19Nov01, concerning a female pt who experienced total body hives, 7 days after receiving the Fluvirin vaccine on 09Nov01. Comedication taken by the pt included a Nicotine patch and Bupropion hydrochloride. On 16Nov01, the pt developed total body hives, 7 days after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Prednisolone and Loratadine. The pt had previous influenza vaccinations (brand unspecified) with no adverse effects. The pt had not recovered at time of report. The reporter has assessed the relationship of the study medication to the event as possible.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: A report was received from a health professional on 20Nov01, concerning a 58 year old female pt who experienced a maculopapular rash, 1 day after receiving the Fluvirin vaccine on 16Nov01. On 17Nov01, the pt developed a maculopapular rash and pruritus on her abdomen, 1 day after receiving the Fluvirin vaccine. On 20Nov01, the pt was seen at the reporter's clinic for treatment of the rash, which had expanded from the abdomen to the breast and pubic area. The pt did not have a fever or any signs or symptoms of infection. The pt received previous influenza vaccinations in 1999 (Flushield brand), 1998, and 1997 without incident. At the time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as unclassifiable.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: A report was received from a health professional on 11/16/2001 concerning a 50 year old male patient who experienced persistent lightheadedness 5 days after receiving Fluvirin on 11/07/2001. On 11/12/2001 the patient developed lightheadedness that had persisted since onset. The patient did not have a fever or exhibit any flu-like symptoms. The patient's blood pressure and pulse were normal and a neurological exam was normal. The patient was not receiving treatment for lightheadedness at the time of the report. The reporter's causality assessment was recorded as possible.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: A report was received from a health professional on 11/13/2001, concerning a 69 year old male, who experienced an injection site reaction, 3 - 4 days after receiving the Fluviron vaccine on 11/06/2001. On 11/09/2001, the patient experienced severe pain at the injection site, approximately 3 - 4 days after receiving the Fluvirin vaccine in the deltoid portion of his left arm. There were no signs of infection of inflammation including redness and tenderness at the injection site. The patient had received previous influenza vaccinations (brand unspecified) without incidence. The patient did not receive any treatment for the pain. At time of report, the pain had continued for 3 days but was improving. The reporter has assessed the relationship of the study medication to the event as probable.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Dysphonia, Stridor, Wheezing
Clinical narrative: An anonymous single patient print was received from the MCA on 11/26/01, regarding a 4 year old male patient who experienced wheeze, stridor and loss of voice on 10/16/01 after receiving Fluvirin vaccine (batch 760169) on the same day. The patient's medical history included asthma and the patient was receiving Prednisolone, ipratropium and budesonide. The events resolved on the same day. Therapeutic measures included dexamethasone po and salbutamol nebulizer. There was insufficient information to determine the reporter's causality assessment.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia
Clinical narrative: A report was received from a health professional on 11/20/2001, concerning an 18 year old female patient who experienced fever 38.5 C and pronounced asthenia, 3 days after receiving Fluvirin on 11/11/01. The patient recovered after treatment on 11/15/01. the reporter has assessed the relationship of the study medication to the event as possible.