chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Abasia, Bacterial infection, Cellulitis, Immune system disorder, Injection site erythema
Clinical narrative: A report was received from a healthcare professional, via another manufacturer (Ref E2006-06328) on 15/Dec/2006, concerning a 4-year-old male vaccinee. No details were provided regarding the vaccinee's concomitant medications. At the time of vaccination the vaccinee had rhinitis and increased immunoglobulin E levels. The vaccinee has a history of immunology problems and fever following vaccination. On 18/Oct/2006, the vaccinee received an influenza vaccine (brand unspecified) in his right leg and Pneumovax 23 in his left leg, exact routes and locations unknown. On 18/Oct/2006, 12 hours after vaccination, the vaccinee developed left leg pain and fever. After 24 hours the pain increased and the vaccinee refused to walk. After 48 hours, the vaccinee was seen by the physician with leg redness, fever, generalized aches and pains and  tachycardia. The vaccinee was admitted to hospital for vaccine reaction, fever, possible bacteremia and diagnosed and was treated with antibiotics. It was reported that the  tachycardia may have been due to the fever. The vaccinee recovered from the generalized aches and pains in 1- 1 1/2 weeks and made a full recovery. The physician thought that maybe the reaction was an immune reaction to the vaccine as the vaccinee has had fever in the past following vaccinations. The reporter considers left leg pain, tachycardia and fever to be an important medical event (OMIC). No further information is expected.
Age: 4.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Pain, Pyrexia, Tachycardia
Clinical narrative: A report was received from a healthcare professional, via another manufacturer (Ref E2006-06328) on 15/Dec/2006, concerning a 4-year-old male vaccinee. No details were provided regarding the vaccinee's concomitant medications. At the time of vaccination the vaccinee had rhinitis and increased immunoglobulin E levels. The vaccinee has a history of immunology problems and fever following vaccination. On 18/Oct/2006, the vaccinee received an influenza vaccine (brand unspecified) in his right leg and Pneumovax 23 in his left leg, exact routes and locations unknown. On 18/Oct/2006, 12 hours after vaccination, the vaccinee developed left leg pain and fever. After 24 hours the pain increased and the vaccinee refused to walk. After 48 hours, the vaccinee was seen by the physician with leg redness, fever, generalized aches and pains and  tachycardia. The vaccinee was admitted to hospital for vaccine reaction, fever, possible bacteremia and diagnosed and was treated with antibiotics. It was reported that the  tachycardia may have been due to the fever. The vaccinee recovered from the generalized aches and pains in 1- 1 1/2 weeks and made a full recovery. The physician thought that maybe the reaction was an immune reaction to the vaccine as the vaccinee has had fever in the past following vaccinations. The reporter considers left leg pain, tachycardia and fever to be an important medical event (OMIC). No further information is expected.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis Right deltoid at injection site noted AM of 11/3/06.
Age: 1.51
Sex: F
Vaccine: MMR, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Adolescent Tdap (Boostrix) given instead of Infant Dtap.  12/15/06 potential adverse event onset/ 0 adverse event reported. 4/24/07.
Age: 1.07
Sex: M
Vaccine: MMRV
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Mother telephoned 12/18/06 at 12N and reported child had a rash all over. On followup call  mom reports child is running a fever and acts like he doesn't feel well. Encouraged to have child evaluated by physician for acute illness vs adverse reaction.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Injection site pain, Pain, Pyrexia, Swelling
Clinical narrative: Within 8 hours of vaccine developed fever, achiness, pain at site area, large blackened area with swelling and warmness at injection site and body aches all over. Saw primary medical doctor 12/8 and was given prescription for antibiotics.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Within 1 hour of receiving Menactra developed severe arm pain and fever up to 103F. Lasted approximately 4 hours. (Fever resolved)
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Skin ulcer
Clinical narrative: Generalized Vaccinia (<50 pustule like lesions) over trunk and extremities. 12/18/06 pustular lesions resolved. Returned to work no restriction.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similiar-especially when they are removed from outer packaging.
Sex: M
Vaccine: FLU3, HEP
Symptoms: Medication error
Clinical narrative: Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similiar-especially when outer packaging is removed. Medication error.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similar -especially when removed from outer packaging. Medication error
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 59-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history included allergies and asthma. On an unspecified date before 22 August 2006, the subject received a dose of Influenza virus vaccine (lot number not provided). At an unspecified date on or before 22 August 2006, the subject experienced hive and swelling. The subject was seen at physician's office. At the time of initial reporting, 07 September 2006, the outcome of the events was not reported. Report received via manufacturer.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, the subject received a dose of Fluarix (site of injection, dose number and lot number not provided). On an unspecified date in 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced injection site swelling "the size of a baseball". At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced injection site swelling "the subject experienced injection site swelling " the size of a baseball". At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. This is in follow-up to report(s) previously submitted on 12/08/2006. Follow-up received on 16 April 2007 via a healthcare professional. She reported that the 29 year old female subject was vaccinated with FLUARIX on 28 September 2006. Two hours after the vaccination, the subject experienced a raised, red rash on arms, chest and top of her feet. The rash was hot and itchy. She was diagnosed with a photosensitive rash. She was seen on 01 October 2006 and 02 October 2006 in occupational medicine at the hospital. She was treated with ATARX, hydrocortisone cream and methylprednisone. The reporter noted that the events were improved on 10October2006 and she considered that the events were related to the use of FLUARIX.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2006, on or before 03 October 2006, the subject received a dose of Fluarix (site of injection, dose number and lot number not provided). On an unspecified date in 2006, on or before 03 October 2006 less than one year after vaccination with Fluarix, the subject experienced a rash on hands and feet. At the time of initial reporting, 03 October 2006, the event was worse. The healthcare professional considered the event was probably related to vaccination with Fluarix. Follow-up received on 16 April 2007. The nurse reported that the 46-year old female received FLUARIX (intramuscular) on 29 September 2006 in her left arm. No other concurrent medications or vaccinations were received by the subject. Two days later, on 01 October 2006, the subject experienced a 3 inch x 2 and 1/2 inch red area on her left arm that was not painful and tender. She was seen by a physician. On 06 October 2006, the events resolved. The reported considered that the events were related to FLUARIX.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a 65-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history allergy to ampicillin, allergy to Keflex, allergy to Lorabid, allergy to Percodan, bee sting allergy, bullous lung disease, Codeine allergy, lung surgery and tetracycline allergy. Concurrent medications included Esomeprazole (Nexium) and Combivent. The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events. On 25 September 2006 at 12:30 p.m., the subject received a dose of Influenza virus vaccine in the right arm. "That same evening", on 25 September 2006, at an unspecified time after vaccination with Influenza virus vaccine, the subject experienced "arm pain which radiated to the neck". The subject was seen at the physician's office. The outcome of the event was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via a representative and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On 6 October 2006 the subject received unspecified dose of Fluarix intramuscularly in the right arm. The lot number and expiration date were not known. At an unspecified time after vaccination with Fluarix, the subject experienced rash on the right arm, face and chest. The subject also reported a stinging sensation. At the time of reporting the outcome of the events was unspecified. No additional information was available.
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Cough, Nasal congestion, Wheezing
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of exacerbation of asthma symptoms in a female patient who received Advair multi dose powder inhaler for chronic obstructive pulmonary disease and asthma. Co suspect medication included influenza virus vaccine (unspecified manufacturer). Concurrent medications included Solumedrol IV, prednisone and unspecified ABX. On an unknown date, the patient started fluticasone propionate+salmeterol xinafoate (inhaled), at an unknown dosing. At an unknown time after starting fluticasone propionate+salmeterol xinafoate, the patient experienced exacerbation of asthma symptoms, cough, congestion and wheezing. This case was assessed as medically serious by manufacturer (OMIC). Treatment with fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting, the outcome of the events was unknown. The physician reported that while taking fluticasone propionate+salmeterol xinafoate, the patient's asthma symptoms of coughing, congestion, and wheezing became progressively worse. The patient received influenza vaccine (unspecified manufacturer) at the end of September 2006. At an unspecified time following receipt of influenza virus vaccine on an unspecified date on or after September 2006 and on or before 17 October 2006, the patients asthma symptoms worsened significantly. The physician discontinued fluticasone propionate+salmeterol xinafoate and continued all other medications as usual, and her asthma improved. Comment exacerbation of asthma symptoms was assessed as medically serious by manufacturer.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Nasal congestion, Pruritus
Clinical narrative: This case was reported by a consumer (also the health professional) and described the occurrence of itchy eyes in a 55-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. The subject has a history of latex allergy. No additional medical history was provided. The subject was not receiving and concurrent medications. On 19 October 2006 the subject, also the nurse, administered 50 Fluarix injections to subjects. The nurse has a medical history of latex allergy, so someone else removed the tip caps from each dose of Fluarix. After administering the injections, the nurse developed itchy eyes, a red face and cold symptoms, even though she did not touch the latex containing parts of the Fluarix. She had some improvement in symptoms by the following day. On follow-up the reporter stated that she also experienced stuffy nose and chest tightness.
Sex: U
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 23 October 2006 the subject received unspecified dose of Fluarix. The pharmacist reported that, on 23 October 2006, less than one day after vaccination with Fluarix, "there was blood on the needle" upon withdrawal from the subject. The pharmacist noted that the nurse who injected the Fluarix "was not sure if Fluarix was injected intravenously or not". The outcome of the event was not reported. The pharmacist considered the event was probably related to vaccination with Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Medication error
Clinical narrative: This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibility 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following the medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix), for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At the unspecified time after vaccination with Fluarix, the subject experienced (1 1/2 in. diameter) area of swelling at the injection site, injection site pain, a black spot at injection site with redness around it. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination wit Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: This case was reported by a pharmacist and described the occurrence of medication errors in approximately 20 subjects and possibly 200 residents and employees at a long term care facility. Two of the subjects seen at the facility following th medication errors were female subjects of unspecified age who were vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. This subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received Fluarix at 0.5 ml, subcutaneously in an unknown deltoid. This was considered to be a medication error, as the Fluarix should have been injected intramuscularly. At an unspecified time after vaccination with Fluarix, the subject experienced injection site pain and discomfort. Tylenol was given for pain. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were probably related to vaccination with Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Skin irritation, Tongue oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza vaccine (Fluarix) for prophylaxis. On an unspecified date in October  2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. the subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Skin irritation, Tongue oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Skin irritation, Tongue oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl0. At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Skin irritation, Tongue oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seem at a physician office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Skin irritation, Tongue oedema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Myalgia, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 23-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had experienced soreness in the arm without any rash following receipt of prior immunizations of influenza virus vaccine. On 26 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 1 day after vaccination with Fluarix, the subject experienced injection site soreness, "a rash in a ring around the injection site", and body aches. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up received on 10 November 2006 indicated that on 28 October 2006 the subject was evaluated on 28 October 2006 to rule out underlying pain issues. The reporter stated that the subject experienced a "halo type rash around the site of injection,a arm pain and generalized body aches. The subject was in no distress and denied any difficulty breathing, swallowing, fever or swelling. At the time of this report, the healthcare professional considered the events were possibly related to vaccination with Fluarix.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 72-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Medical history included no allergies (no egg allergy). There were no concurrent mediations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 27 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 8 hours after vaccination with Fluarix, the subject experienced redness and rash "primarily on the trunk, arms, and legs accompanied with severe itching". The subject was seen at a physician's office on 30 October 2006. Hematological analyses from 30 October 2006 revealed a normal sedimentation rate and complete blood count. At the time of initial reporting, 30 October 2006, the itching had improved and the redness and rash were ongoing. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: A pharmacist prospectively reported the occurrence of burning sensation (rash) in a pregnant female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject's date of last menstrual period, estimated due date, or weeks of gestation at time of vaccination were not reported. On 31 October 2006 the subject received an unspecified dose of Fluarix during an unspecified trimester of pregnancy. On or after 31 October 2006 and on or before 06 November 2006, less than one week after vaccination with Fluarix, the subject experienced a rash on both of her thighs. The pharmacist reported that , "the rash was not itchy, but it did burn". The subject was treated with diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 06 November 2006, the rash had improved. The pharmacist considered the rash to possibly be related to vaccination with Fluarix. Follow-up information received on 21 November 2006 indicated that the subject was 28 years old. Her last menstrual period was on 28 August 2006. The event began on 01 November 2006 and was resolved by 06 November 2006. In the reporter's opinion, the event was considered to be related to treatment with Fluarix.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain in a 75 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included high blood pressure. Concurrent medications included blood pressure medication. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 11 October 2006 the subject received unspecified dose of Fluarix in the left arm. On 11 October 2006, less than one day after vaccination with Fluarix, the subject experienced arm pain when she elevates her arm over her head and injection site tenderness. At the time of initial reporting, 07 November 2006, the events were worse.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site cellulitis in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix), plus a separate injection of 23-valent pneumococcal polysaccharide vaccine (Pneumovax) for prophylaxis. Medical history included cellulitis following prior receipt of concomitant administration of influenza virus vaccine and Pneumovax and sickle cell anemia. The subject received multiple unspecified concurrent medications. On 30 October 2006 at 9:00 a.m., the subject received a dose of Fluarix in the right thigh. On 30 October 2006 the subject also received a dose of Pneumovax at an unspecified site of injection. At the time of the concomitant administration of Fluarix and Pneumovax, 30 October 2006, the subject was hospitalized for sickle cell anemia. On 31 October 2006, 1 day after vaccination with Fluarix and Pneumovax, the subject experienced injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The subject's hospitalization was extended as a result of the injection site cellulitis and the pharmacist considered the event was disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with intravenous and oral clindamycin. At the time of initial reporting, 07 November 2006, the injection site cellulitis was ongoing. The pharmacist reported that she "does not know if the injection site cellulitis is due to the Fluarix or the Pneumovax".
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 51 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 07 November 2006, the subject received a dose of Fluarix in the right arm. On 07 November 2006, less than one day after vaccination with Fluarix, the subject experienced an injection site reaction described as "a 5.5 by 5.5cm circular pattern, 0.5 inch raised bump that was red, warm and painful." The subject was seen at an emergency room. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness a 33 year old female subject who was vaccinated with Fluarix for prophylaxis. On 06 November 2006 the subject received a dose of Fluarix in the left arm. On 06 November 2006, less than one day after vaccination with Fluarix, the subject experienced an injection site reaction described as " a 5.5 by 5.5 cm circular pattern, 0.5 inch raised bump that was red, warm and painful." The subject was seen at an emergency room. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site rash in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject has previous problems with the flu vaccine. It was unknown what type of problems the subject experienced or to which flu vaccine. In November 2006 the subject received an unspecified dose of Fluarix (.5 ml, unknown). In November 2006, at an unspecified time after vaccination with Fluarix, the subject experienced injection site rash and shortness of breath. The subject was seen in the emergency department. The sales representative believed that Fluarix was administered one to two days ago. He did not know if the subject was hospitalized as a result of the events was unspecified. Follow up was received from the reporting healthcare professional on 29 November 2006. The subject is a 48 year old female. On an unspecified date in November 2006, the subject received a dose of Fluarix. Approximately one to two hours later, the subject experienced injection site rash and shortness of breath. The subject was seen in an emergency department, but was not admitted to the hospital. The events resolved on an unspecified date in November 2006. The healthcare professional considered the events to possibly be related to vaccination to Fluarix and also to the preservative in Fluarix.
Sex: U
Vaccine: FLU3
Symptoms: Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix virus vaccine for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Myalgia, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Flurarix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dyspepsia
Clinical narrative: This case was reported by a consumer and described the occurrence of heartburn in a 47 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included high cholesterol, osteoporosis, and "occasional heartburn after eating a large meal." Co suspect medication included Boniva (PO 02 Nov 2006) for osteoporosis. Concurrent medications included multivitamin, aspirin, Calcium and fish oil. On 02 November 2006, the subject received her first dose of oral Boniva. Approximately two days later, on 04 November 2006, the subject experienced chest pressure. On 06 November 2006, the subject received a dose of Fluarix. On 06 November 2006, less than one day after vaccination with Fluarix and four days after the receipt of Boniva, the subject experienced heartburn and "extreme" chest pain. The subject treated the events with antacid. The heartburn and chest pain improved "approximately three hours later." Therapy with Boniva was continued. At the time of initial reporting, 10 November 2006, the subject reported that she has not had another episode of heartburn with pain, but every time she eats, she feels like food just "sits on her chest" and she has a "dull ache between her breasts."
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Myalgia, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of arm soreness in a 8 year old male subject who was inadvertently vaccinated with Fluarix for prophylaxis. Previous history of arm soreness with other influenza vaccinations. On 07 November 2006 the subject received Fluarix .5 ml and experienced a sore arm and inadvertently vaccination with Fluarix. Fluarix is recommended for immunizing individuals 18 years and older. Further information was not known.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after vaccination with Fluarix the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a pharmacist and describe the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic and allergy to penicillin. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after the vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a 23 year old male subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic and allergy to pencilling. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 18 October 2006, the subject received unspecified dose of Fluarix. On 19 October 2006, one day after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room and was treated with Benadryl. The events resolved on an unspecified date. On 20 November 2006, the subject again experienced hives. The outcome of the second episode of hives was not reported. The pharmacist considered the events to not be related to vaccination with Fluarix.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of chills in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 1 November 2006 the subject received 1st dose of FLUARIX at 0.5 ml. On 2 November 2006, in the morning, the subject experienced chills, vomiting, fever up to 104 degrees and diarrhea. The events were improved by 5 November 2006.  Follow-up infromation was receivved on 30 December 2006. The subject's concurrent conditions included tobacco use of 1/2 pack per day. The subject was 50 years of age at the time of the events. The events resolved on 05 November 2006. The reporter copnsidered that the events were not related to vaccination with FLUARIX.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Pain, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 32 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. The subject's medical history included allergy to gentamycin, allergy to phenergan, penicillin allergy, rocephin allergy, sulfa allergy and vancomycin allergy. The subject reported that she is "not allergic to latex." There were no concurrent medications. The subject had received influenza virus vaccine in previous years and had experienced "the flu." On 13 November 2006 the subject received unspecified dose of Fluarix in the left arm. On 13 November 2006, 2 hours after vaccination with Fluarix, the subject experienced an allergic reaction described as rash, itching and erythema on the lower body extremities and hives. "That evening," on 13 November 2006, the subject experienced flu like symptoms, aches, and head and spine pain. The subject was seen by a physician. The subject was treated with Benadryl. At the time of initial reporting, 22 November 2006, the events were improved. The vaccination course with Fluarix was discontinued. Follow-up received on 03 January 2007 from the healthcare professional (who is also the subject) noted that she considered the events to be related to the use of Fluarix because "it contains gentamicin."
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Reaction to preservatives, Urticaria, Urticaria, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 32 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. The subject's medical history included allergy to gentamycin, allergy to phenergan, penicillin allergy, rocephin allergy, sulfa allergy and vancomycin allergy. The subject reported that she is "not allergic to latex." There were no concurrent medications. The subject had received influenza virus vaccine in previous years and had experienced "the flu." On 13 November 2006 the subject received unspecified dose of Fluarix in the left arm. On 13 November 2006, 2 hours after vaccination with Fluarix, the subject experienced an allergic reaction described as rash, itching and erythema on the lower body extremities and hives. "That evening," on 13 November 2006, the subject experienced flu like symptoms, aches, and head and spine pain. The subject was seen by a physician. The subject was treated with Benadryl. At the time of initial reporting, 22 November 2006, the events were improved. The vaccination course with Fluarix was discontinued. Follow-up received on 03 January 2007 from the healthcare professional (who is also the subject) noted that she considered the events to be related to the use of Fluarix because "it contains gentamicin."
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site mass, Injection site nodule, Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a 70 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included femoral venous bypass graft, lichen nitidus, ovarian cancer and rheumatoid arthritis. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications include Extra strength Tylenol, Tiazac, Diavan, Synthroid, Nexium, Plavix. On 07 November 2006 the subject received a dose of Fluarix in the left deltoid. On 07 November 2006, less than one day after vaccination with Fluarix, the subject experienced injection site inflammation and a lump injection site. On an unspecified date after 07 November 2006 and on or before 28 November 2006, the subject experienced injection site rash and injections site papule. The subject did not have pain or itching at the injection site. The subject was seen at a physician's office. At the time of initial reporting, 28 November 2006, the events were ongoing.  Follow-up was received from the healthcare professional on 11 December 2006.  The events had improved on 07 December 2006.  The healthcare professional considered the events to be related to vaccination with FLUARIX.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site erythema, Injection site swelling, Skin discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling at the injection site in a 63 year old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline). Concurrent medications included MVI, Tylenol, Cenestin, Diovan, Felodipine, Synthroid, Nexium, Hydrochlorothiazide, Anacin, Requip, Enablex and Lipitor.  Medical history included non-smoker, non-drinker, sleep problems, estrogen therapy, hypertension, thyroid disorder, gastric disorder, fluid retention, headache, parkinsinonism, spasms, and elevated cholesterol.  On 13 November 2006 the subject received 1st dose of FLUARIX at 0.5 ml, intramuscularly in the right deltoid. On 20 November 2006, 7 days after vaccination with FLUARIX, the subject experienced swelling at the injection site and injection site redness. At the time of follow-up reporting, 11 December 2006, the events had imorpved and the healthcare professional reported that, "the swelling has decreased but remains slightly pink."
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of unspecified adverse reaction in a male subject of unspecified age who was vaccinated with Fluarix for prophylaxis. On an unspecified date in November 2006, the subject received unspecified dose of Fluarix (unknown). On an unspecified date, in November 2006, but prior to 28 November 2006, after vaccination with Fluarix, the subject experienced unspecified adverse reaction. At the time of reporting, the nurse practitioner stated the subject received the Fluarix approximately one month ago and was complaining of several adverse events (unspecified). The nurse practitioner was to see the subject the next day and was to call back with further details of the adverse events. At the time of reporting the outcome of the event was unspecified.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of joint pain in adult male subject who was vaccinated with Fluarix for prophylaxis. On 02 November 2006 the subject received unspecified dose of Fluarix. On 04 November 2006, 2 days after vaccination with Fluarix, the subject experienced joint pain, muscle pain, painful skin, respiratory congestion, fever, headache and chest pain. The events were ongoing as of 15 November 2006, but the pharmacist was unsure if the events persisted at the time of initial reporting, 30 November 2006.  Follow-up information received on 02 January 2007 indicated that the events were improved and in the reporter's opinion, the events were not related to treatment with FLUARIX.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a pharmacist and described the occurrence of joint pain in adult male subject who was vaccinated with Fluarix for prophylaxis. On 02 November 2006 the subject received unspecified dose of Fluarix. On 04 November 2006, 2 days after vaccination with Fluarix, the subject experienced joint pain, muscle pain, painful skin, respiratory congestion, fever, headache and chest pain. The events were ongoing as of 15 November 2006, but the pharmacist was unsure if the events persisted at the time of initial reporting, 30 November 2006.  Follow-up information received on 02 January 2007 indicated that the events were improved and in the reporter's opinion, the events were not related to treatment with FLUARIX.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Rash
Clinical narrative: Rash, edema of arm, erythema
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Patient experiencing upper extremity pain (not local reaction) after 3rd Engerix-B immunization
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Erythema induratum, Feeling hot, Oedema, Pruritus
Clinical narrative: Client with large localized reaction, upper deltoid area. Left arm edematous, tight, warm to touch, complained of itching, minimal erythema, increased 6"circumscribed area. Advised by Health Department physician to apply ice, cold compress, Benadryl every 4-6 hours when needed for itching. Follow up if worsens.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: Severe Muscle weakness developed within 12 hours.  Lack of appetite, very lethargic, high grade fever (103.8, taken in ear) present 20 hours after administration of shot.  On recommendation from nurse at clinic, Subject given aspirin and fever was reduced through out the night.  31 hours after vaccine, Subject's temp was close to normal.