chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Activities of daily living impaired, Bedridden, Diarrhoea, Hypokinesia
Clinical narrative: This case was reported by a physician and described the occurrence of pain radiating down arm in a 65-year-old male subject who vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included anxiety and gastroesophageal reflux disease. Concurrent  medications included PRILOSEC, WELLBUTRIN, KLONOPIN, SEROQUEL, CYANOCOBALAMIN and LEXAPRO. On 22 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in  the left arm via a 25 gauge 5/8 inch needle. Within 24 hours of FLULAVAL administration, the subject developed excruciating pain that radiated down the arm. He returned to the physician's office two days later. Two weeks later, an MRI as conducted. The MRI showed fluid collection at the injection site, but nothing else. The subject had no inflammation and good range of motion. He was treated with MEDROL DOSE PAK, antiinflammatories and PERCOCET. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. Follow-up information received via the subject on 06 November 2008 indicated that he suffered from pain in his left arm for 22 days before feeling improvement. The subject reported throbbing, achyness, inability to sleep on his sides (has to sleep on back) and inability to lift heavy things. He also reported that he was unable to close the car door with his left hand and had to use his right. He additionally reported that when he holds his left arm (which had full range of motion) up in the air, it feels better. The subject claimed that her initially reported his condition to his physician on 24 October 2008. He was prescribed DARVOCET, which he reported did not work. He then received PERCOCET which helped. He was also prescribed MEDROL DOSE PAK he took for two days and stopped because he developed stomach pains and diarrhea. He was given a mouthwash to assist with the stomach problems. A repeat MRI was negative. The subject claimed that he was bedridden for 2 weeks, which resolved and he had been unable to do anything, but that has now improved.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of pain radiating down arm in a 65-year-old male subject who vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included anxiety and gastroesophageal reflux disease. Concurrent  medications included PRILOSEC, WELLBUTRIN, KLONOPIN, SEROQUEL, CYANOCOBALAMIN and LEXAPRO. On 22 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in  the left arm via a 25 gauge 5/8 inch needle. Within 24 hours of FLULAVAL administration, the subject developed excruciating pain that radiated down the arm. He returned to the physician's office two days later. Two weeks later, an MRI as conducted. The MRI showed fluid collection at the injection site, but nothing else. The subject had no inflammation and good range of motion. He was treated with MEDROL DOSE PAK, antiinflammatories and PERCOCET. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLULAVAL. Follow-up information received via the subject on 06 November 2008 indicated that he suffered from pain in his left arm for 22 days before feeling improvement. The subject reported throbbing, achyness, inability to sleep on his sides (has to sleep on back) and inability to lift heavy things. He also reported that he was unable to close the car door with his left hand and had to use his right. He additionally reported that when he holds his left arm (which had full range of motion) up in the air, it feels better. The subject claimed that her initially reported his condition to his physician on 24 October 2008. He was prescribed DARVOCET, which he reported did not work. He then received PERCOCET which helped. He was also prescribed MEDROL DOSE PAK he took for two days and stopped because he developed stomach pains and diarrhea. He was given a mouthwash to assist with the stomach problems. A repeat MRI was negative. The subject claimed that he was bedridden for 2 weeks, which resolved and he had been unable to do anything, but that has now improved.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin discolouration, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included FEMARA, LIPITOR, LEVOXYL and Antihistamine. On 10 November 2008 at 10:00, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 10 November 2008, less that one day after vaccination with FLULAVAL, the subject experienced erythema, itching, swelling and black & blue marks on skin. The subject planned to follow-up with her physician on an unknown date. At the time of reporting the events were improved.
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Eye swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bilateral conjunctivitis in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 November 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). The FLULAVAL expiration date was reported as "2008/2009". On 11 November 2008, 1 day after vaccination with FLULAVAL, the subject experienced bilateral conjunctivitis and swollen eyes. The healthcare professional reported that a subject received FLULAVAL and woke up the following morning with swollen eyes and bilateral conjunctivitis. She was evaluated by and ophthalmologist because they thought it might be caused by allergies; however the cause could not be determined. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg rash in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL, the subject experienced leg reach and itching. Rash on ankles was also reported. The subject was treated with CORTICOSTEROIDS and ANTIHISTAMINES. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with CORTICOSTEROIDS and ANTIHISTAMINES. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A and A0757715A - A0757718A. Follow-up information was received on 09 December 2008, via healthcare who reported she was not sure if the event was related to the vaccine or not. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.
Sex: F
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional describe the occurrence of leg rash in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008  12:00 the subject received a dose of FLULAVAL at 0.5 ml. On 1 November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. The subject treated with corticosteroids and antihistamines. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A and A0757715A- A0757717A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported she was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaint was resolved. The reporter stated she was told that two females and three males had a rash. As of this report, healthcare professional had not received further information. She did stated that two subject saw their private physicians.
Sex: M
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg rash in an adult male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2008 at 12:00 the subject received a dose of FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of the subjects were females and treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757715A, A0757716A, A0757718A,  and A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported she was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. Se did state that two subjects saw their private physicians.
Sex: M
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg rash an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757715A, A0757717A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported se was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.
Sex: M
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg rash an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On November 2008, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after receiving the FLULAVAL vaccine. The subjects describes the rash as appearing as a heat rash. Two of of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known. The healthcare professional reported additional cases see: A0757694A, A0757716A, A0757719A. Follow-up information was received on 09 December 2008, via healthcare professional who reported se was not sure if the event was related to the vaccine or not. The healthcare professional stated that 01 December 2008 the complaints were resolved. The reporter stated she was told that two females and three males had a rash. As of this report, the healthcare professional had not received further information. She did state that two subjects saw their private physicians.
Sex: U
Vaccine: FLU3
Symptoms: Heat rash, Pruritus, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of leg rash in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL at 0.5 ml. On 1 November 2004, 48 hours after vaccination with FLULAVAL, the subject experienced leg rash and itching. Rash on ankles was also reported. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. The reporter stated that 6 subjects in an employee flu clinic developed a rash on their legs and ankles approximately two days after received the FLULAVAL vaccine. The subjects describe the rash as appearing as a heat rash. Two of the subjects were females and were treated by a physician with corticosteroids and antihistamines. Some of the subjects were males, but exact details were not known.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Bursitis, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shoulder bursitis in a 37-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included ADVIL. On 21 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced shoulder bursitis, inflammation of shoulder joint, shoulder pain and injection site tenderness. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Warm soaks and continued use of ADVIL was recommended. Follow-up information was received on 11 December 2008, via healthcare professional, who reported the events were unresolved. The reporting healthcare professional considered the events related to vaccination with FLULAVAL.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a physician and described the occurrence of generalized itchy rash in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 November 2008 at 14:00, the subject received unspecified dose of FLULAVAL (.5 ml, unknown). On 7 November 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced generalized itchy rash. The subject was treated with BENADRYL. The physician reported that a female subject received a FLULAVAL vaccine during her employer's flu clinic and developed generalized itching rash on her arms and trunk one hour after the injection. The subject may have taken some BENADRYL. The rash was resolving by the time the physician saw the subject in her office. No other symptoms were reported. At the time of reporting the event was improved. The physician considered the event was possibly related to vaccination with FLULAVAL.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in shoulder joint in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 October 2008 at 12:00 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme pain in the shoulder joint. The subject took ALEVE twice daily for the pain. The event was unresolved at the time of reporting.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of high fever in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (unknown). Seven hours after vaccination with FLULAVAL, the subject experienced high fever. At the time of reporting the outcome of the event was unspecified.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:15, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus and injection site redness. The healthcare professional reported that a subject received a FLULAVAL vaccination at an on job site flu clinic at 10:15. Immediately after receiving the dose, she developed redness and itching at the injection site. The subject was followed up with at 13:00 and the events had resolved. On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of local reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced an unspecified allergic reaction local reaction. At the time of reporting the outcome of the event was unspecified. The nurse reporting the event stated that out of 240 doses of FLULAVAL that she has administered, about 10 people have reported a local reaction. There were no additional details.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pharmaceutical product complaint
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a product complaint in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included PNEUMOVAX 23 (Merck) given on 28 October 2008. On 28 October 2008 the subject received a dose of FLULAVAL at 0.5 ml. Following administration of FLULAVAL, the pharmacist noted that there was a small piece of foreign matter in the vaccine vial. It was estimated that perhaps 5 subjects may have been injected with FLULAVAL from this vial. This was considered to be a product complaint. The pharmacist was not aware of any adverse events following this occurrence. The pharmacist did not have any specific information regarding the subjects involved. The pharmacist called back on 29 October 2008 to report that it was noted that a piece of the vial stopper was missing from the rim and that was the particulate that was floating in the vaccine solution. He was fairly certain that this was the particulate, but still has the vial for testing if necessary.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash maculo-papular
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. At the time of reporting, the outcome of the events was not known. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash maculo-papular
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The outcome of the events was unknown at the time of reporting. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Erythema, Immediate post-injection reaction, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 at 12:01 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 1 October 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus. Over the next two weeks, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The subject treated herself with BENADRYL. the events were ongoing, but improved at the time of reporting. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 05 January 2009, via healthcare professional who reported the subject had received her shot on 01 October 2008. On 02 October 2008, she started itching. The rash started on 02 October 2008, but later in the day. The symptoms were very acute , one night the subject almost went to the emergency room. The subject was "trying to stick it out to see if it would run its course but it got too bad that I had to go to my doctor. I was red all over and itching like mad." The subject's primary care physician started the subject on ATARAX. Per subject rash and itching persisted. The subject was referred to an allergist. The subject reported to the healthcare professional on 19 December 2008, that she had been seeing a dermatologist who prescribed Triamcinolone Acetonide Ointment 0.1% twice daily, which has helped with pruritus; "itched for 57 days and two days later I stopped itching". "Rash is gradually disappearing, but I still have a little". The subject also stated that on 17 December the she had seen an allergist, "they did 96 patch test on me, they said I was allergic to glutaraldehyde (glutaral - test score 45), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5)." Plan is to eventually wean off Triamcinolone ointment from twice daily to once daily to no ointment at all. The subject is planning to follow-up with allergist and dermatologist in January.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 at 12:01 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 1 October 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus. Over the next two weeks, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The subject treated herself with BENADRYL. the events were ongoing, but improved at the time of reporting. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 05 January 2009, via healthcare professional who reported the subject had received her shot on 01 October 2008. On 02 October 2008, she started itching. The rash started on 02 October 2008, but later in the day. The symptoms were very acute , one night the subject almost went to the emergency room. The subject was "trying to stick it out to see if it would run its course but it got too bad that I had to go to my doctor. I was red all over and itching like mad." The subject's primary care physician started the subject on ATARAX. Per subject rash and itching persisted. The subject was referred to an allergist. The subject reported to the healthcare professional on 19 December 2008, that she had been seeing a dermatologist who prescribed Triamcinolone Acetonide Ointment 0.1% twice daily, which has helped with pruritus; "itched for 57 days and two days later I stopped itching". "Rash is gradually disappearing, but I still have a little". The subject also stated that on 17 December the she had seen an allergist, "they did 96 patch test on me, they said I was allergic to glutaraldehyde (glutaral - test score 45), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5)." Plan is to eventually wean off Triamcinolone ointment from twice daily to once daily to no ointment at all. The subject is planning to follow-up with allergist and dermatologist in January.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 69-year-old female subject who was vaccinated with FLULAVAL. Concurrent medical conditions included hypertension and psoriasis. Concurrent medications include Raptiva and Crinoretic. On 24 September 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. Within 1 week after vaccination with FLULAVAL, the subject developed itching and redness in her left arm. The itching and redness spread to her right arm, and then to her back, chest, stomach and legs. She saw a dermatologist and had a biopsy to determine if the rash was caused by a bacteria, virus or fungus and was told the biopsy was negative for all three and that she had hives. The subject was treated with hydroxyzine, Xyzal, Fexofenadine and three unknown creams. At the time of reporting the outcome of the events was unspecified with the exception of hives which was reportedly unresolved. In the reporter's opinion, the hives were possibly related to treatment with FLULAVAL.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of diffuse itching in a 77-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included latex allergy and sore throat. On 20 October 2008, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm) and was prescribed Amoxicillin for her sore throat. On 22 October 2008, 2 days after vaccination with FLULAVAL, the subject experienced diffuse itching. The physician reported that the subject came into the urgent care practice complaining of a sore throat. The physician prescribed Amoxicillin 875 mg, twice daily and FLULAVAL was given as a preventative. Two days after receiving FLULAVAL and the amoxicillin was started, the subject developed itching. The itching was diffuse and not just at the FLULAVAL injection site. The physician did not know whether the itching was due to the FLULAVAL or the Amoxicillin. The subject does have a history of latex allergy, but the physician reported he "was told FLULAVAL does not contain latex". The physician did discontinue the amoxicillin on 22 October 2008 and there was a mild improvement in the itching, but the itching had not resolved. No treatment has been required. At the time of reporting, the event was improved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by an allergy physician and described the occurrence of rash-pruritic in a 68-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2008, the subject received a dose of FLULAVAL (unknown). On 17 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced rash-pruritic. The subject was treated with steroid cream. The subject was received FLULAVAL dose at another office on 16 October 2008. On 17 October 2008, the developed a generalized rash all over. She has been using a steroid cream and the rash is getting better but it is still very pruritic. At the time of reporting the event was improved. Follow-up information was received on 15 December 2008, via healthcare professional, who reported the events resolved on an unknown date. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 29-year-old female subject who was vaccinated with FLULAVAL. On 14 October 2008 at 16:30, the subject received a dose of FLULAVAL (.5ml, unknown, right arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site and injection site redness. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritis in a 68-year-old female subject who was vaccinated with FLULAVAL. On 13 October 2008, the subject received unspecified dose of FLULAVAL (.5ml, unknown, left arm). On 13 October 2008, within minutes of vaccination with FLULAVAL, the subject experienced injection site pruritis and injection site redness; 30 minutes later, she experienced a lump at injection site and injection site pain. The subject was treated with BENADRYL and antibiotics for five days. The subject has not reported any further problems. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Ear discomfort, Laryngitis
Clinical narrative: This case was reported by a consumer and described the occurrence of ears clogged in a 58-year-old female subject who was vaccinated with FLULAVAL. A physician or other healthcare professional has not verified this report. Concurrent medical conditions included asthma and food allergy. Concurrent medications included NEXIUM, ADVAIR and CARDIZEM. On 16  October 2008 at 13:30 the subject received unspecified dose of FLULAVAL at 0.5ml in the left arm. On 16 October 2008, 2 hours after vaccination with FLULAVAL, the subject's ears began clogging. She took BENADRYL. Then the roof of her mouth, which is usually smooth, puckered. The subject also began to experience laryngitis on 16 October 2008. The subject began to recognize that she may be having an allergic reaction. At 20:00 the subject took another BENADRYL and went to the emergency room. In the emergency room she received a PREDNISONE burst and prescribed oral PREDNISONE, PEPCID and BENADRYL. The consumer stated that these medications only temporarily relieve the symptoms. At the time of reporting the outcome of the events was unspecified.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Myalgia, Nausea, Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of low temperature in a 20-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included acne and depression. The subject had no adverse events following receipt of previous immunizations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included LEXAPRO, RETIN A and BENADRYL. The subject received no other immunizations on the date of receipt of FLULAVAL. On 19 October 2008 at 9:00 am, the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 October 2008 at 6:00 pm, 9 hours after vaccination with FLULAVAL, the subject experienced low temperature, chills, muscle pain, rash, nausea, vomiting and itching. At the time of reporting the events were improved. The physician considered the events were possible related to vaccination with FLULAVAL. The physician reported that the subject is his daughter that is a nursing student. The physician reported that his daughter's temperature was as low as 95.0 degrees Fahrenheit.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of low temperature in a 20-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included acne and depression. The subject had no adverse events following receipt of previous immunizations. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included LEXAPRO, RETIN A and BENADRYL. The subject received no other immunizations on the date of receipt of FLULAVAL. On 19 October 2008 at 9:00 am, the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 October 2008 at 6:00 pm, 9 hours after vaccination with FLULAVAL, the subject experienced low temperature, chills, muscle pain, rash, nausea, vomiting and itching. At the time of reporting the events were improved. The physician considered the events were possible related to vaccination with FLULAVAL. The physician reported that the subject is his daughter that is a nursing student. The physician reported that his daughter's temperature was as low as 95.0 degrees Fahrenheit.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of incorrect storage of drug in a 52-year-old male subject who was vaccinated with FLULAVAL. The reporter is the subject. The subject received no other vaccines on the date of receipt of FLULAVAL. There were no concurrent medication. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time following the receipt of INFLUEZA vaccine (unknown), the subject experienced a sore arm. The outcome of the sore arm was not reported. On 19 October 2008 at 1:00 pm, the subject received 1st dose of FLULAVAL (.5ml, unknown, left arm), and experienced incorrect storage of drug. The physician reported that, on 19 October 2008, the subject was administered FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. The physician reported that one other subject received FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. Please see case A0754351A.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction, Injection site discolouration, Pharmaceutical product complaint
Clinical narrative: This was reported by a healthcare professional via a inside sales representative and described the occurrence of black spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On an unspecified date the subject received unspecified dose of FLULAVAL at 0.5ml. At an unspecified time after vaccination with FLULAVAL, the subject developed a black spot about the size of a half dollar at the injection site. This was also considered to be a product complaint as the reporter expressed concern with the quality of the FLULAVAL administered. At the time of reporting the outcome of the black spot was unspecified. This was second call regarding this sort of adverse event from this inside sales representative that spoke with this facility. Previous events were filed with a QA report number of UV20080143. The facility called this inside sales representative stating that she had not been contacted regarding the first QA. She decided to use the product on another subject and they contacted her stating they had a half dollar size black spot at the injection site. The facility was concerned with the quality of the FLULAVAL. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0752233A. Follow- up information received on 07 November 2008, via healthcare professional who reported the 54-year-old male subject experienced an additional adverse reaction was reported, details not provided. The events occurred on 22 October 2008 and resolved on 26 October 2008. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 65-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included cholesterol, hypertension, and allergy to BIAXIN. Concurrent medications included TOPROL, LIPITOR and Aspirin (Baby ASA). On 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 2008, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritis and warmness to touch at injection site. At the time of reporting the events were unresolved. The healthcare professional considered the injection site pruritis and warmness to touch at injection site were probably related to vaccination with FLULAVAL. An office manager reports that an adult female reported redness, itching and warm to touch in her arm following FLULAVAL injection on Oct 14th.  The office manager reported that one other subject experienced adverse events following administration of FLULAVAL. Please see case A0754164A.  Follow-up information was reported on 10 November 2008, via healthcare professional who reported the subject on 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, left deltoid). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced redness measuring 8 centimeters by 4.5 centimeters (very large), red and indurated skin local reaction; the subject had no bronchospasm. The subject has had flu vaccines for years and never had a reaction before. The subject was advised to use cortisone cream at injection site and BENADRYL two 5mg, once daily for itching and two ADVIL three times daily for inflammation. On 31 October 2008, the events were resolved. The subject was advised "thimerasol from flu vaccine". The healthcare professional considered the events were related to vaccination with FLULAVAL.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 65-year-old female subject who was vaccinated with FLULAVAL. The subject's medical history included cholesterol, hypertension, and allergy to BIAXIN. Concurrent medications included TOPROL, LIPITOR and Aspirin (Baby ASA). On 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 2008, less than one week after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritis and warmness to touch at injection site. At the time of reporting the events were unresolved. The healthcare professional considered the injection site pruritis and warmness to touch at injection site were probably related to vaccination with FLULAVAL. An office manager reports that an adult female reported redness, itching and warm to touch in her arm following FLULAVAL injection on Oct 14th.  The office manager reported that one other subject experienced adverse events following administration of FLULAVAL. Please see case A0754164A.  Follow-up information was reported on 10 November 2008, via healthcare professional who reported the subject on 14 October 2008 the subject received unspecified dose of FLULAVAL (unknown, left deltoid). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced redness measuring 8 centimeters by 4.5 centimeters (very large), red and indurated skin local reaction; the subject had no bronchospasm. The subject has had flu vaccines for years and never had a reaction before. The subject was advised to use cortisone cream at injection site and BENADRYL two 5mg, once daily for itching and two ADVIL three times daily for inflammation. On 31 October 2008, the events were resolved. The subject was advised "thimerasol from flu vaccine". The healthcare professional considered the events were related to vaccination with FLULAVAL.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Influenza like illness, Injection site erythema, Injection site pruritus
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: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Local reaction, Muscle tightness, Myalgia, Pyrexia
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.