chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 21-year-old female subject who was vaccinated with FLULAVAL. Medical history included no allergies. There were no concurrent medications. On 13 October 2008 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 20008, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritis and warm to touch at injection site. The subject was treated with ibuprofen. At the time of reporting the events were unresolved. The healthcare professional considered the injection site pruritis was probably related to vaccination with FLULAVAL. An office manager reported that an adult female reported redness, itching and warm to touch in her arm following FLULAVAL injection on 13 October 2008 the subject received unspecified dose of FLULAVAL (unknown, left deltoid). On 14 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced no difficult breathing, local skin reaction with redness, induration and swelling. The subject actually got flu like symptoms one day after the injection. The subject also noted fever and myalgia with tightness in her neck. The subject's warmness to touch at injection site measured 3 centimeters by 3.5 centimeters. The flu like symptoms for three days after injection. The subject was advised she is probably allergic to thimerasol and she should not receive another flu vaccine. The healthcare professional considered the events were related to vaccination with FLULAVAL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Nervous system disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of nerve disturbance in a 64-year-old female subject who was vaccinated with FLULAVAL. A physician or other health care professional has not verified this report. The subject's medical history included reaction to preservatives. This subject had no adverse events following receipt of prior immunizations with influenza virus vaccines. The subject reported that she did not have any adverse events following receipt of previous vaccinations, but noted that she does not get vaccinations. Concurrent medications included CARDIZEM and TOPROL. No other vaccinations were administered on the date of receipt of FLULAVAL. On 14 October 2008 at 11:30 am the subject received "the one and only" dose of FLULAVAL (unknown, right arm). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced nerve disturbance described as "nerve endings felt weird", diarrhea and total exhaustion. The subject consulted a healthcare professional regarding the event. At the time of reporting the outcome of the events was resolved. The subject reported that the exhaustion is not flu-like. She could not further describe what she meant by her nerve endings feeling weird. The consumer reported that one other subject experienced adverse events following receipt of FLULAVAL. Please see case A0753992A.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Injection site erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 34-year-old female subject who was vaccinated with FLULAVAL. The reporter is the subject. A physician or other health care professional has not verified the report. The subject had no adverse events following receipt of prior immunizations (including no adverse events with prior immunizations with influenza virus vaccines) and no relevant medical history. Concurrent medications included SYNTHROID and NEURONTIN. On 14 October 2008 in the evening after 5:00 pm, the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 14 October 2008, within one hour after vaccination with FLULAVAL, the subject experienced injection site redness. On 15 October 2008, one day after vaccination with FLULAVAL, she experienced allergic reaction. On 16 October 2008, two days after vaccination with FLULAVAL, she experienced a larger area of redness. The subject was seen at a doctor's office. At the time of reporting the events were improved. Follow-up information received on 05 January 2009 indicated that the events of injection site redness, allergic reaction and area of redness began on 14 October 2008 and resolved ten days later on 23 October 2008. In the reporter's opinion, these events were possibly related to treatment with FLULAVAL.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of allergic reaction in a 62-year-old female subject who was vaccinated with FLULAVAL. Concurrent medical conditions included abdominal pain and urinary tract infection. Concurrent medications included COUMADIN, LIPITOR, ATENOLOL, XANAX and CIPRO. On 15 October 2008, the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 15 October 2008, within six to eight hours after vaccination with FLULAVAL, the subject experienced allergic reaction, extensive swelling of vaccinated limb, injection site redness and injection site tenderness.  The subject's bladder symptoms started one week prior to receiving FLULAVAL. The subject came into the physician's office on 15 October 2008 with abdominal pain and a urinary tract infection was diagnosed. There was no fever so the physician gave FLULAVAL while the subject was in the office and prescribed CIPRO for the UTI. The subject had "taken CIPRO previously for UTI with no reaction (thus CIPRO is not suspected)". The physician reported a moderately severe swelling reaction to FLULAVAL, which included redness and tenderness and is thought to be due to an allergic reaction. The physician described the swelling as "impressive". Per the subject, these events began within six to eight hours after the injection. The physician did not examine these events until the next morning, which was greater than 24 hours after the onset. The FLULAVAL injection was given in triceps muscle, "the swelling began one inch above the injection site, and extended eight to nine inches down toward elbow, the width of the swelling is three to four inches in diameter". The physician has not prescribed any treatment such as steroids, because she does not want to interfere with the immune response of FLULAVAL. The physician expects that these events will resolve without treatment. The subject reported that the events are still worsening but the physician stated, "that is to be expected as allergic reactions usually so not peak until 48 hours". The physician is question whether the subject should receive flu vaccines in the future due to these events. The physician has already submitted this report to VAERS. At the time of reporting, the events were worse. The physician considered the events were probably related to vaccination with FLULAVAL.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Ecchymosis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm redness in a 34- year- old female subject who was vaccinated with FLULAVAL. The subject had no relevant medical history. There were no concurrent medications and the subject received no other vaccinations on the date of receipt of FLULAVAL. On 13 October 2008 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). Less than one week after vaccination with FLULAVAL, on an unspecified date in October 2008, the subject experienced arms redness, swelling arm, skin bruise on arm (ecchymosis) and arm felt warm to touch. Medical attention was required at a doctor's office. The subject was treated with KEFLEX. At the time of reporting the arms redness, swelling arm, ecchymosis were improved and the outcome of the warm to touch was unspecified. On 16 October 2008, a nurse in a clinic reported a female in their office noted that she had redness, swelling, warmness to touch in her arm following FLULAVAL injection. One of the docs in the clinic treated her with a rx of KEFLEX.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in a 37-year-old female subject who was vaccinated with FLULAVAL , pneumococcal vaccine and unspecified PNEUMOVAX. Concurrent medical conditions included chronic back pin. Concurrent medications included NSAIDS. On 13 October 2008 at 09:30, the subject received a dose of FLULAVAL (.5 ml, unknown, unknown arm) and her 1st dose of PNEUMOVAX (unknown, unknown arm). On 15 October 2008, 2 days after vaccination with FLULAVAL, and PNEUMOVAX, the subject experienced high fever, arm swollen, arms redness and hot to touch. The reporting healthcare professional stated the subject received a FLULAVAL and PNEUMOVAX vaccine on the same day and in the same arm. After two days, the subject reported high fever, and a red swollen arm that was hot to touch. She was seen at the emergency department. No other information was provided. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL and PNEUMOVAX.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 8-year-old female subject who was vaccinated with FLULAVAL. A physician or other health care professional has not verified this report. There were no concurrent medications. On 8 October 2008 the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via the mother indicated that the subject has experienced no other side effects.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 13-year-old male subject who was vaccinated with FLULAVAL. A physician or other health care professional hs not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via the mother indicated that the subject has experienced no other side effects.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of injection site soreness in a 17-year-old male who was vaccinated with FLULAVAK. A physician or other health care professional has not verified this report. There were no concurrent medications. On 8 October 2008, the subject received unspecified dose of FLULAVAL at 0.5 ml. On 8 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced injection site soreness. Administration of FLULAVAL to this subject was considered to be a drug administration error as FLULAVAL is not indicated for use in subjects under the age of 18 years. At the time of reporting, injection site soreness was resolved. Follow-up via mother indicated that the subject has experienced no other side effects.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: This case was reported by a healthcare professional (also the consumer) and described the occurrence of chest rash in a 42-year-old female subject who was vaccinated with FLULAVAL. Concurrent medications included TOPAMAX, Propranolol, PROTONIX and LIPITOR. On the morning of 2 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. Later that evening, th subject developed a rash on chest that spread to the rest of her body. The reporter/nurse stated that the rash worsened over the first three days and was unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an Unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A. Follow-up information received on 31 October 2008 indicated that the subject was an 81 year old female. The events of injection site redness and soreness began 4 days following administration of FLULAVAL and resolved 4 days later on 08 October 2008. In the reporter's opinion, the events were considered related to treatment with FLULAVAL.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concomitant medications. On 1 October 2008 the subject received a dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm. On 1 October 2008, within a few hours following vaccination with FLULAVAL, the subject experienced injection site redness. The area of redness was about 1 inch in diameter and resolved on 4 October 2008. It was also noted that the FLULAVAL was administered via the wrong route. The vaccine should have been administered intramuscularly. The healthcare professional considered that the injection site redness was possibly related to vaccination with FLULAVAL.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Rash
Clinical narrative: This case was reported by a healthcare professional that described the occurrence of injection site burning in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site burning and neck rash. At the time of reporting, the outcome of the events was unspecified. No other information was known by the reporter, and no patient specific identifiers were provided.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation
Clinical narrative: This case was reported by a healthcare professional that described the occurrence of injection site burning in four to five subjects of unspecified ages and genders who were vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date(s), the subjects received unspecified doses of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subjects experienced injection site burning. An employee reported that four to five subjects experienced burning at the injection site following FLULAVAL vaccine. At the time of reporting, the outcome of the events were unspecified. No other information was known by the reporter, and no patient specific identifiers were provided.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a physician and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2nd or 3rd, 2008 the subject received a dose of FLULAVAL in the right arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling in the right arm and heat and pain in the right arm. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pharmaceutical product complaint, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752229A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, about one week prior to this report, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. One day following vaccination with FLULAVAL, the subject experienced injection site soreness. The subject was instructed to put cold packs on the affected area. The event resolved. The reporter felt that the event was probably related to treatment with FLULAVAL.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, about one week prior to this report, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. One day following vaccination with FLULAVAL, the subject experienced injection site soreness. The subject was instructed to put cold packs on the affected area. The event resolved. The reporter felt that the event was probably related to treatment with FLULAVAL.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Hearing impaired, Immediate post-injection reaction, Inappropriate schedule of drug administration, Loss of consciousness, Visual impairment
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lost consciousness in a 15-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 4 October 2008 at 10:45 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Immediately after vaccination with FLULAVAL, the subject reported that things sounded funny and looked funny. An emergency room visit was noted. The events resolved the same day. The healthcare professional considered the events were unrelated to vaccination with FLULAVAL. This was also considered to be a case of medication error as FLULAVAL is not indicated for use in children. Follow-up information received on 19 November 2008, via healthcare professional considered the events probably related to vaccination with FLULAVAL and associated them to erroneous administration, being FLULAVAL is not indication for those under 18-years old.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of radiating pain in the arm in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Levothyroxine, Spironolactone, Desonide cream, Clindamycin lotion, LEXAPRO, AMBIEN, XANAX, FINACEA and METROGEL. On 17 November 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. After receiving FLULAVAL, the subject began to experience radiating pain in the same arm where the injection was given (the left arm). The pain reportedly radiated up and down the left arm and was not just at the injection site. The subject stated that the radiating pain started 1 to 2 days (November 2008) following FLULAVAL administration, but a specific date was not provided. The subject had described the pain as nerve-related pain. She treated herself with ibuprofen 800 mg as needed. The ibuprofen dulled the pain, but did not make it go away. At the time of reporting, the events had improved over the 2 to 3 weeks prior. The subject was still uncomfortable. The subject denied any recent change in activity level or heavy lifting that might have contributed to these events. The pharmacist considered the events were possibly related to vaccination with FLULAVAL. Follow-up information received on 05 January 2009 indicated that the events began on 19 November 2008. At the time of follow-up, the events were improved and still considered to be possibly related to treatment with FLULAVAL.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Contusion, Injection site haematoma, Migraine
Clinical narrative: This case was reported by a pharmacist and described the occurrence of increase in migraine in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included migraine. Concurrent medications included TREXIMET. On 1 December 2008 at 17:10 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 4 December 2008, 3 days after vaccination with FLULAVAL, the subject experienced increase in migraine (worsening) and bruising at the injection site. She also noted new bruising on her legs the same day. Increase in migraines and injection site bruising was improved at the time of reporting. The outcome of bruising on the legs was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 November 2008, the subject received a dose of FLULAVAL (.5 unknown, unknown). On 28 November 2008, 4 hours after vaccination with FLULAVAL, the subject experienced nausea and diarrhea. The healthcare professional reported that a female subject received a FLULAVAL vaccination on 28 November 2008 and within four hours after the vaccination, she developed nausea and diarrhea. The healthcare professional stated that she was doing better and no further adverse events were reported. The healthcare professional refused to provide any details. At the time of reporting the events were resolved.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer and described the occurrence of red rash on stomach in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy. Concurrent medications included Birth control. On 13 November 2008 at 13:00 the subject received a dose of FLULAVAL in the right arm. Five hours after vaccination with FLULAVAL, the subject experienced a red rash on the stomach and itching. The subject started treatment with BENADRYL on 19 November 2008. At the time of reporting the events were improved.
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A - A0759349A, A0759351A. Follow-up information received on 06 January 2009 provided no additional information concerning the reported event.
Sex: M
Vaccine: FLU3
Symptoms: Psoriasis, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a male subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759348A, A0759350A, A0759351A. Follow up information received on 06 January 2009 indicated that about one week after receiving Flulaval the subject developed a rash on his face which was later diagnosed as facial psoriasis. The events resolved and were not considered to be related to Flulaval.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tinea infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759347A, A0759349A - A059351A. Follow-up information received on 06 January 2003 indicated that about one week after receiving FLULAVAL the subject developed a rash described as 2 or 1 spots on the arms. The spots were diagnosed as ring worm and resolved an unspecified amount of time later. The events wer not ocnsidered related to treatment with FLULAVAL.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759344A, A0759348A - A059351A. Follow-up information received on 06 January 2009 indicated that the subject was 53 years of age. She received FLULAVAL in the left deltoid on 06 November 2008 and within 48 hours, on 08 November 2009, developed a rash and hives on her upper chest, neck and ears which lasted about three weeks and received by 29 November 2008. It was reported that the subject has many allergies and take an unspecified antihistamine concurrently. She treated the rash and hives with Benadryl and Claritin and was advised by her physician to stop those treatments and only continue her regular antihistamine. The subject has received previous flu shots with no reactions. In the reporter's opinion, the events were possibly related to treatment with FLULAVAL. Three weeks after the vaccination, the reporting nurse saw the subject. The subject had what looked like an intermittent rash on her upper chest. The nurse reported that the subject's employer informed the reporter that the subject was allergic to everything after this happened.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 November 2008, the subject received a dose of FLULAVAL (unknown). In November 2008, more than 48 hours after vaccination with FLULAVAL, the subject experienced rash. The healthcare professional reported a female subject experienced a rash (not at the injection site) after receiving FLULAVAL. The rash occurred more than 48 hours after receiving the vaccine. The reporting healthcare professional did not believe the rash was related to the FLULAVAL vaccination. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was not related to vaccination with FLULAVAL. The healthcare professional reported five other subjects adverse events with FLULAVAL. See cases, A0759347A - A059351A. Follow-up information received on 08 January 2009 indicated that approximately 9 days after receiving FLULAVAL, the subject developed a rash. She saw her doctor and was diagnosed with a bacterial infection that was reportedly not related to FLURAVAL. The subject has a history of many illnesses. The outcome of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. The subject was seen by a physician who diagnosed her with a secondary infection and treated her with antibiotics and TYLENOL. At the time of reporting, the events were improved. In the reporter's opinion, the events, with the exception of the secondary infection which was not specified, were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759189A.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events  were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759190A.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Pain, Pyrexia
Clinical narrative: On January 8, 2009, patient recieved intranasal life attunated influenza vaccine.  In about 3 days, he started having flu symptoms including fever, body aches and cough that lasted more than 7 days resulting in loss of work.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Bed rest, Headache, Myalgia, Nausea, Pain
Clinical narrative: LEFT SIDE UPPER BODY MUSCLE ACHES, HEADACHE, NAUSEA,PHOTOPHOBIA,PAIN 8/10.  TX: TYLENOL, PHENERGAN, BEDREST X 48 HOURS. SX'S RESOLVED IN 4 DAYS. PATIENT MISSED 2 DAYS OF WORK.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Photophobia
Clinical narrative: LEFT SIDE UPPER BODY MUSCLE ACHES, HEADACHE, NAUSEA,PHOTOPHOBIA,PAIN 8/10.  TX: TYLENOL, PHENERGAN, BEDREST X 48 HOURS. SX'S RESOLVED IN 4 DAYS. PATIENT MISSED 2 DAYS OF WORK.
Age: 4.0
Sex: M
Vaccine: YF
Symptoms: Convulsion
Clinical narrative: My son had a seizure the day after (11/11/08) he had the yellow fever vaccine (11/10/08).  It was during nap time at school.  He was rushed to the emergency room.  He also had another seizure in his sleep on 12/14/08.  He was then referred to a pediatric neurologist who has scheduled him for a sleep deprived EEG on 2/5/09.  2/3/09 Received ER medical records & peds neuro consult records. ER records of 11/11/2008: FINAL DX: seizure Records reveal patient had seizure while in school when he cried out & then started shaking all over followed by sleepiness & confusion.  Peds Neuro consult of 1/22/2009: FINAL DX: partial seizure Records reveal patient traveled out of county x 1 mo.  Had witnessed nocturnal convulsive seizure lasting approx 2 min on 12/12/08.  Referred for EEG.
Age: 0.5
Sex: M
Vaccine: DTAP, RVX
Symptoms: Diarrhoea, Hypersomnia, Hypophagia, Malaise, Vomiting
Clinical narrative: Patient received the vaccine on 1/30/09.  The next day, 1/31/09, he vomited twice.  He also didn't eat very much that day, prompting me to think he didn't feel well.  He slept much more than usual on 1/31/09.  On 2/01/09, he had diarrhea and vomited a little and still wasn't eating as much as usual.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient devleoped herpes zoster on the left side of the body, where vaccine was administered.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blister, Herpes zoster, Injection site erythema, Neuralgia
Clinical narrative: Patient devleoped herpes zoster on the left side of the body, where vaccine was administered.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient devleoped herpes zoster on the left side of the body, where vaccine was administered.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Blood test, CSF protein increased, Computerised tomogram normal, Confusional state
Clinical narrative: February 2008 first shot experienced headaches, dizziness, back pain, soreness at injection site (still feels pain in arm today). April 2008 after second infection in addition to above symptoms, confustion, lethargic, gagging, nausea, vomiting, massive warts on the bottom of feet, mood swings, altered personality, shaking. In May 2008 was brought to the hospital had a MRI and cat-scan both normal. The doctor said she was experiencing headaches. In June 2008 she woke up with a headache and vomiting, collasped into a grand-mal seizure. Tranferred to a hosptal. Went through every test possible and came home for a few days. Went into another grand-mal seizure that lasted about three hours, had to be intabated again and transported to the hospital again where they did another MRI, EEG, Spinal Tap and more and more blood tests. Her protein level in her Spinal Tap was very high (159). We are still dealing with a very ill child. On Christmas day she had a seizure and back to hospital which is two and a half hours away from where we live. She takes 14 pills a day with really no answers to why she is ill. Her immune system is confused, confusing her brain. Her life has changed dramatically as she is unable to do the things a healthy 17 year old should be able to do.  2/17/09 Neuro consult dated 1/2/09 received with dx: probable Hashimoto's Encephalopathy.  Report reveals pt had 2 prolonged seizures in summer 2008 with behavioral and mood changes.  Dx with Hashimoto's Encephalopathy and tx with steroids x 3 mon which were tapered off. On 12/25/09 pt woke feeling nauseous and gagging, tremoulous, and feeling sick.  Felt like face "was pulling off".  Unable to yell or move. Found by parents seizing ~ 10 minutes.  Diastat administered. Transferred to hospital. Post-ictal then later combative and agitative. Pt reports being tired and achey since 11/08.  Neuro exam WNL.   3/19/09 Additional records received from 7/23/08, 8/26/08 and 2/20/09 Neuro consults as well as rheum consult 2/20/20009 as well. Pt hospitalized in June 2008 and July 2, 2008 for prolonged seizure in status epilepticus which required intubation and ICU time. Pt had prodrome beginning 2/2008 which consisted of H/A, personality changes and deterioration in school performance. Seen in 8/2008 for increased shakiness, twitching of extremities and unusual posturing with walking. Tx with Ativan for anxiety. W/U (-). Seen in f/u 7/23/08 and 8/26/08. Still with decreased energy, weakness and H/A. Recent weight loss of 15-20lbs 2' to decreased appetite. PE (+) for brisk reflexes.  Improving on steroids. DX:  Presumed Hashimoto's encephalopathy.  Rheum consult 2/20/09. DX not suggestive of Lupus. No further dx noted.