chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: This case was reported by a physician and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced local reaction.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a physician and described the occurrence of a systemic reaction in a subject of unspecified age and gender who was vaccinated with Flu vaccine, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flu vaccine (unknown).  At an unspecified time after vaccination with Flu vaccine, the subject experienced a systemic reaction.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of unable to move arm in an adult female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included "oncology patient".  On 12 October 2007 the subject received 1st dose of Fluarix (.5 ml, intraarticular, left arm).  On 12 October 2007, less than one day after vaccination with Fluarix, the subject experienced severe immobilization in arm and extreme pain of the left arm.  The reporter indicated that the reaction was systemic.  The subject also experienced wrong route of administration as the pharmacist reported that the physician indicated to him that he believed that the subject was vaccinated into the intraarticular space of the shoulder.  The subject required medical attention that was not specified at the physician's office.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Fluarix.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Nasal disorder, Therapeutic response prolonged
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 75-year-old male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history included asthma, four heart attacks, high blood pressure and type II diabetes.  Concurrent medications included Advair, Metformin, Singulair, Losartan, Simvastatin, Felodipine, Metoprolol and Salbutamol sulphate (Albuterol).  On 10 October 2007 the subject received unspecified dose of Influenza vaccine (1 injection, unknown, right arm).  On 17 October 2007, 7 days after vaccination with Influenza vaccine, the subject experienced influenza and lack of efficacy.  The subject noted that he also experienced nasal symptoms.  The subject noted that no medical attention was required.  The subject reported that he was feeling better but still had nasal symptoms.  The subject consulted a healthcare professional regarding his event.  At the time of reporting the events were unresolved.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bump at injection site in an 81-year-old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis.  Previous relevant medical history included the subject always developing a bump at the injection site following influenza vaccinations.  On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown).  At an unspecified time after vaccination with Influenza vaccine, the subject experienced bump at injection site.  At the time of reporting the outcome of the event was unspecified.  In October 2007 she received Flulaval, GlaxoSmithKline for prophylaxis.  Following vaccination with Flulaval, she did not get the response she expected and is concerned because she did not exhibit an adverse event.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of eyelid in a 64-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included osteoporosis.  Concurrent medications included ibuprofen and ibandronate sodium (Boniva) taken after the Fluarix.  On 13 October 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown).  The vaccination was given between 11:00 am and 3:00 pm.  No other vaccinations were given on 13 October 2007.  Three days after vaccination with Fluarix, on 16 October 2007, the subject experienced swelling of left eyelid to the point that her left eye is nearly swollen shut.  The subject consulted with a healthcare professional regarding this event.  She was seen by her physician and was prescribed Tobradex eye ointment.  At the time of reporting the events were unresolved.  As of 24 October 2007, her eyelid was still nearly swollen shut and not improved.  The pharmacist considered the events were probably related to vaccination with Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a consumer and described the occurrence of puffiness in a female subject of unspecified age who was vaccinated with an unspecified GlaxoSmithKline influenza virus vaccine for prophylaxis.  The reporter is the subject.  The reporter was unsure whether the administered influenza virus vaccine was Fluarix or Flulaval.  A physician or other health care professional has not verified this report.  The subject reported that she had received a GSK influenza virus vaccine in 2006 and experienced "the same reaction" she experienced following administration of the GSK influenza virus vaccine in 2007, described as puffiness in her hands, shoulder, and feet.  In 2007, the subject received unspecified dose of influenza virus vaccine (unknown).  At an unspecified time following the administration of influenza virus vaccine, the subject experienced puffiness in her hands, shoulder and feet.  The subject was seen at a physician's office.  At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in the extremity in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced pain in the extremity where the vaccine was given.  At the time of reporting the event had been ongoing for two weeks following vaccine administration.  No further details were reported.
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a physician (also the subject) and described the occurrence of injection site hemorrhage in an adult male subject who was vaccinated with Fuarix, GlaxoSmithKline for prophylaxis.  On 16 October 2007, in the early afternoon, the subject (the physician) received unspecified dose of Fluarix at 0.5ml in the left arm.  On 16 October 2007, upon removal of the needle, 1/8th on an inch of blood ran down the physician's arm.  The event resolved with compression on 16 October 2007.  The physician reported that the reaction was small and it was not serious.  He did not want his information in a database.  No further information available.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  The event occurred in five different female subjects.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30-40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30 - 40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.
Sex: F
Vaccine: FLU3
Symptoms: Burns second degree
Clinical narrative: This case was reported by a physician and described the occurrence of second degree burns at the injection site in an adult (50 plus years of age) female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medications were not specified.  On 9 October 2007 the subject received unspecified dose of Fluarix in an unknown arm.  Within a few days of vaccination with Fluarix, the subject developed second degree burns at the injection site.  The subject was treated with a prescribed burn cream and the event improved.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Stomach discomfort, Swelling, Visual disturbance
Clinical narrative: This case was reported by a consumer and described the occurrence of altered vision in a 65-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On 23 October 2007 at 16:00 the subject received a dose of Fluarix in the left arm.  On 23 October 2007, the same day of vaccination with Fluarix, the subject experienced left eye vision changes, swelling all over, sickness in the stomach and neck tightness.  All events resolved on 24 October 2007 with the exception of sickness in the stomach which remained unresolved at the time of reporting.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site rash in a female subject of unspecified age who was vaccinated with Fluarix for prophylaxis. A physician or other health care professional has not verified this report. On 18 October 2007, the subject received unspecified dose of Fluarix (unknown). In October 2007, on or after 18 October 2007 and on or before 20 October 2007, less than one week after vaccination with Fluarix, the subject experienced a rash in "the general area of the injection." At the time of reporting the outcome of the event was unspecified.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pityriasis rosea, Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pityriasis rosea in a 48-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included autoimmune disease for 25 years and drug allergies to erythromycin, minocycline, contrast dye, codeine, betadine and iodine.  Concurrent medications included Hydroxychloroquine sulphate (Plaquenil), Thyroxine sodium (Synthroid) and Montelukast sodium (Singulair).  On 15 October 2007 at 08:00 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm).  Fifteen minutes after vaccination with Fluarix, the subject experienced itching at the injection site.  She also experienced unspecified itching fifteen minutes after vaccination.  A couple of hours later, she experienced a rash at the injection site.  During the evening, the rash had gone down her arm and back.  One to two days after vaccination, the rash had spread to her stomach and chest.  The rash was described as being scaly and irregular.  The reporter thinks that it is pityriasis rosea.  The reporter considered that the reaction was systemic.  Medical attention was required at the physician's office.  The subject was treated with hydrocortisone (Hydrocortison) and fexofenadine hydrochloride (Allegra).  At the time of reporting the events were unresolved.  The healthcare professional considered the scaly, irregular rash, pityriasis rosacea and itching were probably related to vaccination with Fluarix.  Follow-up received on 27 November 2007 via the healthcare professional who is also the subject.  She reported that she was diagnosed with pityriasis rosacea.  She reported that the events improved.  She considered that the events were not serious and were possibly related to the use of Fluarix.  She noted that she had received Fluarix before and did not experience any adverse events following previous vaccinations.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash erythematous, Rash generalised, Rash pruritic, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject reported that she had not relevant medical history.  The subject had previously received influenza immunizations with no adverse events.  The subject had no adverse events following receipt of any previous vaccinations.  Concurrent medications included Lexapro and bupropion hydrochloride (Wellbutrin).  On 1 November 2007 at 1:00 p.m., the subject received unspecified dose of Fluarix (unknown, left arm).  On the afternoon of 2 November 2007, 1 day after vaccination with Fluarix, the subject experienced an allergic reaction.  The subject described the allergic reaction as red, swollen and itchy hives over her body from the neck down.  The subject considered the events to be disabling and to be jeopardizing or requiring intervention.  On November 3, 2007 the subject was seen by a physician and was treated with diphenhydramine hydrochloride (Benadryl) injection, and Prednisone injection.  On November 4, 2007, the hives had spread to the face.  The subject returned to the physician's office and received 2 adrenaline (Epinephrine) injections plus Benadryl and Prednisone injections.  At time of initial reporting, 5 November 2007, the subject stated that the hives on her face had resolved but she still has the hives on her body.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject reported that she had not relevant medical history.  The subject had previously received influenza immunizations with no adverse events.  The subject had no adverse events following receipt of any previous vaccinations.  Concurrent medications included Lexapro and bupropion hydrochloride (Wellbutrin).  On 1 November 2007 at 1:00 p.m., the subject received unspecified dose of Fluarix (unknown, left arm).  On the afternoon of 2 November 2007, 1 day after vaccination with Fluarix, the subject experienced an allergic reaction.  The subject described the allergic reaction as red, swollen and itchy hives over her body from the neck down.  The subject considered the events to be disabling and to be jeopardizing or requiring intervention.  On November 3, 2007 the subject was seen by a physician and was treated with diphenhydramine hydrochloride (Benadryl) injection, and Prednisone injection.  On November 4, 2007, the hives had spread to the face.  The subject returned to the physician's office and received 2 adrenaline (Epinephrine) injections plus Benadryl and Prednisone injections.  At time of initial reporting, 5 November 2007, the subject stated that the hives on her face had resolved but she still has the hives on her body.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Bursa injury, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 52-year-old female subject who was vaccinated with influenza virus vaccine (anti flu vaccine, manufacturer unspecified) for prophylaxis.  Concurrent medications included montelukast sodium (Singulair), conjugated estrogens (Premarin), mometasone furoate (Nasonex) and unknown "Zalaten".  On 25 October 2007 the subject received unspecified dose of anti flu vaccine (unknown, right arm).  On 25 October 2007, at an unknown time after the vaccination with anti flu vaccine, the subject experienced injection site reaction, injection site redness and swelling injection site.  The reporting physician stated "the person administering the vaccine may have hit the bursa" (bursa injury).  Medical attention was required at the physician's office.  At the time of reporting the events were worse.  The physician considered the events were possibly related to vaccination with anti flu vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of abnormal taste in mouth in several subjects of unspecified age and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On unspecified dates several subjects received unspecified dose of Fluarix (unknown).  At an unknown time after vaccination with Fluarix, the subjects experienced a latex taste in mouth.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Medical device complication, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate dose of vaccine administered in an adult female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 12 November 2007 at 12:00 the subject received an unspecified dose of Fluarix (unknown, left arm).  The subject experienced inappropriate dose of vaccine administered and accidental exposure as part of the dose ran down the subject's arm during the injection, and pharmaceutical product complaint.  The nurse reported that she believed that the needle may have become loose when she removed the needle cover prior to the injection causing part of the dose to leak out during the injection.  She was using a Luer-lok needle with the pre-filled syringe.  There were no clinical events reported but the nurse is concerned that the subject may not be protected with only the partial dose.  She plans to repeat the dose.  At the time of reporting the outcome of the pharmaceutical product complaint was unspecified.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash papular, Rash pruritic, Skin warm, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of welt in a 27-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject had no relevant medical history.  There were no concurrent medications.  The subject had previously received immunization with influenza virus vaccine.  The subject reported to the healthcare professional that, 3 to 4 years ago, the same rash occurred but the subject was unsure if this occurred in relation to a flu shot.  On 31 October 2007, the subject received unspecified dose of Fluarix (.5 ml, unknown, right arm).  The healthcare professional reported that this was the 1st dose of Fluarix.  On 6 November 2007, 6 days after vaccination with Fluarix, the subject experienced raised, warm, itchy raised rash that produced welts and hives on her arms, legs, behind, and knees.  This rash occurred in the night when the subject was asleep and began to resolve when she applied hydrocortisone.  However, it returned in the nighttime during sleep.  This has occurred for the past 2 nights.  The pharmacist considered the events were clinically significant (or requiring intervention).  At the time of reporting the events were unresolved. Follow-up received on 25 February 2008 via the healthcare professional who was alos the subject. On 06 November 2007, six days after vaccination with FLUARIX, the subject experienced a welt, raised rash and itching as previously reported. Two days later, on 08 NOvember 2007, the symptoms resolved. This healthcare professional considered that the events were not serious and possibly related to the use of FLUARIX. She also considered that she could have reacted to other sources besides the flu vacicne, such as laundry detergent.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a 37-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  The subject had no relevant medical history.  There were no concurrent medications.  The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events.  On 6 November 2007 at 7:45 a.m., the subject received unspecified dose of Fluarix (unknown, left arm).  The healthcare professional reported that the vaccine was administered into the bone which was the incorrect route of administration.  On 6 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm pain.  At the time of reporting the outcome of the arm pain was unspecified.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Incorrect dose administered, Incorrect route of drug administration, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of forearm erythema in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent vaccination included Fluarix, GlaxoSmithKline, correct dosage administered on 2 November 2007.  Concurrent medications included Tuberculin (tuberculosis skin test).  On 2 November 2007 at 09:00 the subject inadvertently received a dose of Fluarix at 0.1 ml, subcutaneously in an unknown forearm.  The subject was supposed to have received a Tuberculin skin test and the nurse noted that she inadvertently administered an incorrect dose of Fluarix via the wrong route of administration instead.  That same day, on 2 November 2007, the nurse repeated the Tuberculin skin test appropriately in the other forearm and also administered a correct dose of 0.5 ml Fluarix in an unknown deltoid.  On 3 November 2007, 24 hours after vaccination with Fluarix, the subject experienced mild forearm erythema and slight swelling where the Fluarix was administered subcutaneously.  At the time of reporting, the events were improving with a mild pink area and decreased swelling by 5 November 2007.  The healthcare professional considered the forearm swelling and redness were probably related to vaccination with Fluarix.  Follow-up information was received on 29 November 2007.  The healthcare professional reported she inadvertently administered 0.1 ml of Fluarix as a Tuberculin skin test (PPD).  The healthcare professional stated, "no PPD was placed ever in either forearm".  The full dose 0.5 ml of Fluarix was then administered to the left deltoid.  On 05 November 2007, the subject reported her forearm was a "mild shade of pink and the swelling was very minimal".  The subject was concerned about receiving more than 0.5 ml of Fluarix and if she would experience an adverse reaction.  The healthcare professional explained to the subject she was experiencing symptoms that were expected from the vaccine administered in the wrong location.  As of 22 November 2007, no further complaints were noted by the subject.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crankiness in a 3-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix GlaxoSmithKline) for prophylaxis. There were no concurrent medications. The subject had no relevant medical history. The subject had no adverse events following the receipt with any prior immunizations. On 2 November 2007 the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of vaccination with Fluarix, the subject experienced vaccination error, decried as "adult" by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. The healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness had improved but the subject was still cranky.
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crankiness in a 5-year-old subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 2 November the subject received unspecicifed dose of Fluarix (unknown, left thigh). As a result of the vaccination with Fluarix, the subject experienced vaccination error, described as "adult" by the healthcare professional. On 2 November 2007, less than one day after vaccination with Fluarix, the subject experienced crankiness. Th healthcare professional reported on 7 November 2007 that the subject was unusually cranky since receiving the Fluarix on Friday (2 November 2007) and that the crankiness has improved but the subject wad still cranky.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On a unspecified date the subject received unspecified dose of Fluarix (unknown). One and a half weeks later after vaccination with Fluarix, the subject experienced influenza and lack of efficacy. At the time of reporting the events were resolved.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of influenza in 74-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Unknown (Unspecified medications). On 3 October 2007, the subject received unspecified dose of Fluarix (.5 ml, subcutaneous, unknown). The reporting physician believed the subject's dose of Fluarix was "inadvertenly administered subcutaneously rather than intramuscularly and thus was not effective". At an unspecified time after vaccination with Fluarix, the subject experienced two occurrences of influenza and lack of efficacy. The subject did not require any treatment. At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling unwell in a adult subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. The subject was the reporter's physician. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced feeling unwell. At the time of reporting the outcome of the event was unspecified.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Headache, Pain, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bad taste in a 41-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 7 November 2007 at 16:45 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm). Approximately 5 minutes after vaccination with Fluarix, the subject experienced bad taste, pain, vomiting and headache. On 10 November 2007, the events were resolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.  Follow-up information received on 13 December 2007 indicated that the subject felt that the events were related to treatment with FLUARIX, the health care professional did not. The events resolved.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Pain, Pharyngolaryngeal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of flu like symptoms in a 54-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 6 November 2007 at 15:30 the subject received unspecified dose of Fluarix (unknown, right arm). On 7 November 2007, 1 day after vaccination with Fluarix, the subject experienced flu like symptoms, chills, congestion (nos), fever, sore throat, pain and headache. The patient required medical attention at her physician's office. At the time of reporting the events were improved.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a consumer and described the occurrence of flu like symptoms in a 54-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 6 November 2007 at 15:30 the subject received unspecified dose of Fluarix (unknown, right arm). On 7 November 2007, 1 day after vaccination with Fluarix, the subject experienced flu like symptoms, chills, congestion (nos), fever, sore throat, pain and headache. The patient required medical attention at her physician's office. At the time of reporting the events were improved.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Feeling abnormal, Head discomfort, Nausea, Oropharyngeal pain
Clinical narrative: This case was reported by a healthcare professional (also the subject and consumer) and described the occurrence of a 49-year-old female subject feeling strange following vaccination with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On November 2007 it was reported that the subject received unspecified dose of Fluarix and approximately one to two hours following vaccination reported feeling strange with waves of nausea, scratchy throat and heavy headedness which continued three hours after the injection and had not resolved at the time of reporting at 15:00 hours. On 7 November 2007, at 09:00 hours, the subject reported that her ears were burning and she had nausea all night long. Her throat remained sore and scratchy. At the time of reporting the events were unresolved. Follow-up received on 10 January 2008 via the nurse. SHe reported that on 08 November 2007 she experienced strange feeling, nausea, scatchy throat, heavy  headedness. Oora burning and sore throat. The events resolved on 13 November 2007. The reporter noted that the events were not serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: This case was reported by a healthcare professional (also the subject and consumer) and described the occurrence of a 49-year-old female subject feeling strange following vaccination with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On November 2007 it was reported that the subject received unspecified dose of Fluarix and approximately one to two hours following vaccination reported feeling strange with waves of nausea, scratchy throat and heavy headedness which continued three hours after the injection and had not resolved at the time of reporting at 15:00 hours. On 7 November 2007, at 09:00 hours, the subject reported that her ears were burning and she had nausea all night long. Her throat remained sore and scratchy. At the time of reporting the events were unresolved. Follow-up received on 10 January 2008 via the nurse. SHe reported that on 08 November 2007 she experienced strange feeling, nausea, scatchy throat, heavy  headedness. Oora burning and sore throat. The events resolved on 13 November 2007. The reporter noted that the events were not serious.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes and hypertension. Concurrent medications included Diabetes medication and Antihypertensive (Hypertension med). On 13 October 2007 at 13:15 the subject received unspecified dose of Fluarix (.5 ml, unknown). On 14 October 2007, 1 day after vaccination with Fluarix, the subject experienced tiredness. on 14 October 2007, the event was resolved.
Sex: U
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of taste abnormality in an unknown number of subjects of unspecified ages and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Since approximately two weeks prior to this report, when the hospital's clinics started administering Fluarix.  A small number of subjects received an unspecified dose of Fluarix (.5 ml, unknown) and at an unspecified time after the vaccination, the subjects experienced latex taste in their mouths (taste abnormality).  No other adverse events were reported.  The reporter could not isolate any cases to one particular clinic and has not identified these reports to be a specific lot number.  At the time of reporting, the outcome of the event was unspecified.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Bursa injury, Incorrect route of drug administration, Inflammation, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bursa injury in a 31-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On the morning of 7 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) that was mistakenly administered into the bursa and in the top of the shoulder rather than intramuscularly.  On 7 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced bursa injury and intramuscular formulation administered by other route.  The subject required medical attention at the doctors office and was treated with a Medrol dose pack (Medrol Pak) and ibuprofen.  At the time of reporting the events were unresolved.  The pharmacist considered the events were possibly related to vaccination with Fluarix. Follow-up received on 25 January 2008 via the pharmacist. He reported that on 08 November 2007, the subject experienced a partial tear and inflammation of the rotator cuff tendon from the misplacement of the injection and secondary axillary lymphadenopathy. He also confirmed that on 08 November 2007, the subject experienced a bursa injury and intramuscular formulation administered by another route. He noted that the MRI indicated administration likely occurred into the infraspinatus tendon/bursa and local inflammation of tendon along with partial tear likely at injection site. The subject was treated with a MEDROL 4 mg dosepack and referred to physical therapy. He noted that the partial tear and inflammation of the rotation cuff tendon and bursa injury improved and he considered that these events were not related to the use of FLUARIX. He reported that the secondary axillary lymphadenopathy resolved on 07 January 2008 and he considered that it was possibly related on the use of FLUARIX. He considered that the events were not serious. The reporter indicated that the events could have been associated with the erroneous administration based on the result of the MRI.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bursa injury in a 31-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  On the morning of 7 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) that was mistakenly administered into the bursa and in the top of the shoulder rather than intramuscularly.  On 7 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced bursa injury and intramuscular formulation administered by other route.  The subject required medical attention at the doctors office and was treated with a Medrol dose pack (Medrol Pak) and ibuprofen.  At the time of reporting the events were unresolved.  The pharmacist considered the events were possibly related to vaccination with Fluarix. Follow-up received on 25 January 2008 via the pharmacist. He reported that on 08 November 2007, the subject experienced a partial tear and inflammation of the rotator cuff tendon from the misplacement of the injection and secondary axillary lymphadenopathy. He also confirmed that on 08 November 2007, the subject experienced a bursa injury and intramuscular formulation administered by another route. He noted that the MRI indicated administration likely occurred into the infraspinatus tendon/bursa and local inflammation of tendon along with partial tear likely at injection site. The subject was treated with a MEDROL 4 mg dosepack and referred to physical therapy. He noted that the partial tear and inflammation of the rotation cuff tendon and bursa injury improved and he considered that these events were not related to the use of FLUARIX. He reported that the secondary axillary lymphadenopathy resolved on 07 January 2008 and he considered that it was possibly related on the use of FLUARIX. He considered that the events were not serious. The reporter indicated that the events could have been associated with the erroneous administration based on the result of the MRI.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 13 November 2007 at 10:59 the subject received a dose of Fluarix at 0.5 ml in the right arm. On 14 November, 1 day after vaccination with Fluarix, the subject developed a 8 x 6 cm area of redness at the injection site. No treatment was required. At the time of reporting the events was unresolved. Follow-up received on 11 December 2007 via the nurse. The nurse reported that the subject had a history of hypertension. It was noted that the subject had no previous reaction to influenza vaccinations. It was reported that the injection site redness resolved on 19 November 2007. The nurse considered that the injection site redness was related to the injection site redness was related to the use of FLUARIX. She also considered that the events were not related to the use of FLUARIX. She also considered that the events were not serious.
Age: 0.87
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Incorrect drug dosage form administered, Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade fever in a 10-month-old male subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included healthy baby.  No concurrent medications.  The subject had experienced no adverse events following previous vaccinations.  On 27 November 2007 the subject received unspecified dose of Fluarix (.5 unknown) and experienced a vaccination error.  On 29 November 2007, 2 days after vaccination with Fluarix, the subject experienced low grade fever, diarrhea and runny nose.  No other vaccinations were given on 27 November 2007.  Medical attention was not required.  At the time of reporting the runny nose had improved and the fever and diarrhea were unresolved. Follow-up information was received on 17 December 2007, via healthcare professional, who reported the subject received the wrong dose and wrong drug. One day later on 28 November 2007, the subject experienced the previously reported events that resolved 04 December 2007. The healthcare professional considered the events related to erroneous administration. The reporter was "positive the baby was given to much and not the correct dose".
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Muscular weakness, Myalgia, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of exacerbation of pain in muscles in a 14-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included leg weakness and sore muscle. Subject participated in baseball, basketball and weight training. Concurrent medications included cold and sinus medication. On 19 November 2007 at 19:42 the subject inadvertently received unspecified dose of Fluarix (.5 ml, unknown, right arm) and experienced a vaccination error. He was supposed to receive an influenza vaccine that was approved for  14 year old subjects. At an unspecified time after vaccination with Fluarix, on or before 30 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. At the time of reporting the exacerbation of pain in muscles and muscle weakness aggravated were unresolved. The healthcare professional considered that the exacerbation of pain in muscles and muscle weakness aggravated were possibly related to vaccination with Fluarix. Follow-up received on 09 January 2008 via the healthcare professional. She reported that two days following vaccination with FLUARIX (intramuscular), on 21 November 2007, the subject experienced exacerbation of pain in muscles and muscle weakness aggravated. It was also reported that the events had improved by 10 December 2007. In the relevant medical history section of the adverse event form, it was noted that leg weakness and sore muscle started on 21 November 2007 and resolved on 10 December 2007. The reporter considered that the events were not serious and possibly related to the use of FLUARIX. The healthcare professional also considered that the events could have been associated with the subject's participation in weight training, baseball and basketball practices.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with Fluarix. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix vaccine, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 13 December 2007 via a healthcare professional who reported that the subject was a 70-year-old male who was vaccinated with FLULAVAL (Glaxosmithkline) on 29 October 2007. The subjects's medical history included adult onset diabetes mellitus, gastroesophageal reflux disease and smoking. On 29 October 2007 the subject received a dose of FLULAVAL. On the same day that the subject was vaccinated with FLULAVAL, the subject experienced extensive swelling of the vaccinated limb, pitting edema, injection site redness, hotness at injection site, and fatigue. The healthcare professional described the swelling as "edema" +3 from shoulder to elbow. As of 02 November 2007, the reporter stated that the events had resolved on their own. The reporting healthcare professional considered the events to be related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Oedema
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with Fluarix. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix vaccine, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 13 December 2007 via a healthcare professional who reported that the subject was a 70-year-old male who was vaccinated with FLULAVAL (Glaxosmithkline) on 29 October 2007. The subjects's medical history included adult onset diabetes mellitus, gastroesophageal reflux disease and smoking. On 29 October 2007 the subject received a dose of FLULAVAL. On the same day that the subject was vaccinated with FLULAVAL, the subject experienced extensive swelling of the vaccinated limb, pitting edema, injection site redness, hotness at injection site, and fatigue. The healthcare professional described the swelling as "edema" +3 from shoulder to elbow. As of 02 November 2007, the reporter stated that the events had resolved on their own. The reporting healthcare professional considered the events to be related to vaccination with FLULAVAL.
Age: 0.33
Sex: F
Vaccine: DPP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Cough, Crying, Erythema, Irritability, Nasopharyngitis
Clinical narrative: After the injection, the baby had a fever and her body temperature reached 38. She also suffered from cold, snot fluid, cough and these symptoms lasted for nearly two weeks. On Nov 29, we found much redness on her face and after that the redness covers her whole body for 2 weeks. The baby was very fussy and kept crying day and night, sometimes she kept crying for more than one hour. Her situation is very severe and we visited the doctor on Dec 10. The redness was still on her body and she still suffered from snot fluid and cough.
Age: 0.33
Sex: F
Vaccine: DPP, HEP, HIBV, OPV, PPV, RVX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: After the injection, the baby had a fever and her body temperature reached 38. She also suffered from cold, snot fluid, cough and these symptoms lasted for nearly two weeks. On Nov 29, we found much redness on her face and after that the redness covers her whole body for 2 weeks. The baby was very fussy and kept crying day and night, sometimes she kept crying for more than one hour. Her situation is very severe and we visited the doctor on Dec 10. The redness was still on her body and she still suffered from snot fluid and cough.
Age: 1.0
Sex: F
Vaccine: FLU3, HBHEPB, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to 103.7, eight days after MMR, varicella, Comvax, influenza vaccines