chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: his case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756549A, A0756551A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA 320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756550A, A0756552A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Oedema peripheral, Rash generalised, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash-whole body in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). Immediately after vaccination with FLUARIX, the subject experienced rash-whole body, swelling all over body, swelling-feet and rash neck area. The pharmacist reported that the subject, an employee of the hospital, had immediate systemic reactions after receiving the FLUARIX vaccine. The subject reported a severe reaction with a rash on the neck and body immediately after receiving the vaccine. The subject also reported swelling in the feet and all over the body. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist, see cases A0809614A and A0809777A for the other reports.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756551A, A0756553A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756552A, A0756554A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756553A, A0756555A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756554A, A0756556A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756555A, A0756557A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Local reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of local reaction in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included allergies and asthma. Concurrent medications included SINGULAIR, ADVAIR and NASONEX. On 24 September 2009 at mid-afternoon, the subject received 1st dose of FLUARIX (right arm), and experienced intramuscular formulation administered by other route. On 25 September 2009, 24 hours after vaccination with FLUARIX, the subject experienced a local reaction. The consumer reported that the subject, her husband, was given a GSK flu vaccine intradermally, but was uncertain if it was FLUARIX or FLULAVAL at his physician's office. The consumer stated that the physician's office only reported that it was a GSK vaccine. The consumer reported that she was informed by the physician's office that the vaccine was administered intradermally due to there being a vaccine shortage. The subject experienced a big local reaction 24 hours after receiving the vaccine. The consumer reported that the physician's office stated that this was normal. At the time of reporting the local reaction were improved. At the time of reporting the events were improved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756556A, A0756558A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases:  A0756483A - A0756557A, A0756559A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) :  AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) :  AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Off label use, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline).  On 22 September 2009 the subject received a dose of FLUARIX (unknown, unknown arm) and drug use for unapproved indication.  On 23 September 2009, one day after vaccination with FLUARIX, the subject experienced fever.  FLUARIX was administered to a 4-year old subject on 22 September 2009.  On 23 September 2009, she experienced a mild fever.  At the time of reporting the outcome of the fever was unspecified.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Decreased appetite, Dysphonia, Fungal infection
Clinical narrative: This case was reported by a consumer and described the occurrence of no appetite in a 83-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) and ADAIR multi dose powder inhaler for asthma, chronic obstructive pulmonary disease and bronchial disorder. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and chronic obstructive pulmonary disease. Concurrent medications included ADVAIR. In 2007 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) at night. On 14 September 2009, the subject received unspecified dose of Flu vaccine (injection, left arm). On an unspecified date, she experienced no appetite, ran a slight or low grade fever, weak, and laid around for a week and half, didn't feel well, and fungus in her throat were unknown. On 14 September 2009, the subject received a flu shot. On an unspecified date, she experienced no appetite, ran a slight or low-grade fever, weak, and lay around for a week and a half. The subject went to her physician and he prescribed Levaquin. On 18-SEP-2009, patient experienced throat burning after taking one dose from a new ADVAIR diskus 100/50. She rinsed her mouth with plain Listerine and after a few hours it was okay. On 19-SEP-2009, she didn't feel well, her voice was shot, and she could hardly talk. On 21-SEP-2009, she went to her physician. He prescribed Nystatin for fungus in her throat. She is still experiencing the voice shot and can hardly talk when she gets tired. The subject could not clarify if the symptoms she was experiencing (no appetite, ran a slight or low-grade fever, weak and layed around) were do to the flu shot or as a result of using ADVAIR. She has also been using ADVAIR diskus 250/50 in the morning since 2008, but she did not relate the above issues to use of the higher strength. Quality assurance results received on 9 November 2009 revealed the product complaint to be inconclusive as the complaint was received without sample.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pyrexia, Throat irritation
Clinical narrative: This case was reported by a consumer and described the occurrence of no appetite in a 83-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) and ADAIR multi dose powder inhaler for asthma, chronic obstructive pulmonary disease and bronchial disorder. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma and chronic obstructive pulmonary disease. Concurrent medications included ADVAIR. In 2007 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) at night. On 14 September 2009, the subject received unspecified dose of Flu vaccine (injection, left arm). On an unspecified date, she experienced no appetite, ran a slight or low grade fever, weak, and laid around for a week and half, didn't feel well, and fungus in her throat were unknown. On 14 September 2009, the subject received a flu shot. On an unspecified date, she experienced no appetite, ran a slight or low-grade fever, weak, and lay around for a week and a half. The subject went to her physician and he prescribed Levaquin. On 18-SEP-2009, patient experienced throat burning after taking one dose from a new ADVAIR diskus 100/50. She rinsed her mouth with plain Listerine and after a few hours it was okay. On 19-SEP-2009, she didn't feel well, her voice was shot, and she could hardly talk. On 21-SEP-2009, she went to her physician. He prescribed Nystatin for fungus in her throat. She is still experiencing the voice shot and can hardly talk when she gets tired. The subject could not clarify if the symptoms she was experiencing (no appetite, ran a slight or low-grade fever, weak and layed around) were do to the flu shot or as a result of using ADVAIR. She has also been using ADVAIR diskus 250/50 in the morning since 2008, but she did not relate the above issues to use of the higher strength. Quality assurance results received on 9 November 2009 revealed the product complaint to be inconclusive as the complaint was received without sample.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Anaphylactic reaction, Rash, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of systemic itching rash in a 21-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included LEXAPRO, Birth control and Hyosycamine. On 21 September 2009, between 1:00pm and 3:00pm, the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 02 October 2009, 11 days after vaccination with FLUARIX, the subject experienced systemic itching rash. The nurse practitioner reported that the subject developed an itchy rash that started at her feet and had spread over her body. At the time of reporting the systemic itching rash was unresolved. The healthcare professional considered the event was probably related to vaccination with FLUARIX. Follow up information was received on 27 October 2009 via the nurse practitioner. The healthcare provider diagnosed the subject with Exanthema, and reported that systemic itching rash and Exanthema were associated with the subject having an allergy to vaccination. A biopsy was not performed. The subject had received FLUARIX in 2007 and 2008 without any adverse events following vaccinations. At the time of reporting the systemic itching rash systemic itching rash, exanthema and allergy to vaccine were resolved.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Off label use, Swelling face, Urticaria
Clinical narrative: This case was reported by a physician (subject's mother) and descried the occurrence of the hives in a 10-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On 30 October 2008 in the afternoon, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm), and experienced drug use for unapproved indication. On 30 October 2008, 30 minutes after vaccination with FLUARIX, the subject experienced hives, swelling of face, lip swelling, and swelling of eyes. On 1 November 2008, hives, swelling of face, lip swelling, swelling of eyes and drug use for unapproved indication were resolved. The physician considered the hives, swelling of face, lip swelling, swelling of eyes and drug use for unapproved indication were probably related to vaccination with FLUARIX. The physician reported that her daughter had received FLUARI at a local fire station on 30 October 2008 and 30 minutes after administration she had hives, swelling of face, swelling of lips, and swelling of eyes. The physician treated her daughter with medications and monitored her after the events. The physician was also concerned that her daughter who way 10 years old had received FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of muscle aches (post treatment) in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included knee surgery. Concurrent medications included diabetes medication. In October 2009 the subject received unspecified dose of FLUARIX (unknown). In October 2009, 3 weeks after vaccination with FLUARIX, the subject experienced muscle aches (post treatment) and body pain. At the time of reporting the outcome of the muscle aches (post treatment) and body pain were unspecified. The pharmacy intern reported that the subject came into the pharmacy to inquire about a recent flu vaccine. The pharmacy intern reported that she did not know the subject's initials or any personal information, and was unaware where or who administered the vaccine.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Chills, Erythema, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 75-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included carotid endarterectomy, carotid stenosis, cholesterol, hypertension and irritable bowel syndrome. Concurrent medications included Diavan, Atenolol, LIPITOR, Aspirin and CO Q 10. On an unspecified date in 2008 and on an unspecified date in September 2009 he subject received a dose of Influenza vaccine (unknown). On an unspecified date in March 2009, the subject started generic product Isradipine (oral, manufacturer unknown) at 5 mg daily and discounted on an unspecified date in October 2009. On 17 October 2009, the subject started DYNACIRC CR, (oral) at 5 mg daily. In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced fever and chills. On an unspecified date in 2009, after vaccination with Influenza vaccine, the subject experienced "felt terrible with generalized feeling bad". At an unknown time after starting generic Isradipine, in March 2009, the subject experienced lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension. On 17 October 2009, within 24 hours of starting DYNACIRC CR, the subject experienced a "flutter type" headache with redness of her face and neck. Treatment with generic Isradipine was discontinued in October 2009, while therapy with DYNACIRC CR continued. At the time of reporting, the fever, chills, feel terrible, headache, red skin on face and neck,  lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension were resolved. She had a flu shot this year, about six weeks ago. She felt terrible with generalized feeling bad for about 24 hours then it went away. Last year was her first time for getting the flu shot. She got fever and chills for 24 hours then all went away. Caller reports that she takes DYNACIRC for her blood pressure. Back in the spring of this year, around March, she took generic for DYNACIRC because she was unable to get the brand product. While on the generic she reports lack of effect, anxiousness, palpitations, felt stressed out, tense, nervous, uptight feeling and hyped started on the name brand CR product. She reports that she initially had a flutter type headache, with redness of her face and neck within an hour of taking the product. These issues have since resolved and her blood pressure has lowered.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nervousness, Palpitations, Pharyngeal oedema, Psychomotor hyperactivity
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 75-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included carotid endarterectomy, carotid stenosis, cholesterol, hypertension and irritable bowel syndrome. Concurrent medications included Diavan, Atenolol, LIPITOR, Aspirin and CO Q 10. On an unspecified date in 2008 and on an unspecified date in September 2009 he subject received a dose of Influenza vaccine (unknown). On an unspecified date in March 2009, the subject started generic product Isradipine (oral, manufacturer unknown) at 5 mg daily and discounted on an unspecified date in October 2009. On 17 October 2009, the subject started DYNACIRC CR, (oral) at 5 mg daily. In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced fever and chills. On an unspecified date in 2009, after vaccination with Influenza vaccine, the subject experienced "felt terrible with generalized feeling bad". At an unknown time after starting generic Isradipine, in March 2009, the subject experienced lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension. On 17 October 2009, within 24 hours of starting DYNACIRC CR, the subject experienced a "flutter type" headache with redness of her face and neck. Treatment with generic Isradipine was discontinued in October 2009, while therapy with DYNACIRC CR continued. At the time of reporting, the fever, chills, feel terrible, headache, red skin on face and neck,  lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension were resolved. She had a flu shot this year, about six weeks ago. She felt terrible with generalized feeling bad for about 24 hours then it went away. Last year was her first time for getting the flu shot. She got fever and chills for 24 hours then all went away. Caller reports that she takes DYNACIRC for her blood pressure. Back in the spring of this year, around March, she took generic for DYNACIRC because she was unable to get the brand product. While on the generic she reports lack of effect, anxiousness, palpitations, felt stressed out, tense, nervous, uptight feeling and hyped started on the name brand CR product. She reports that she initially had a flutter type headache, with redness of her face and neck within an hour of taking the product. These issues have since resolved and her blood pressure has lowered.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Stress, Swollen tongue, Tension
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 75-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included carotid endarterectomy, carotid stenosis, cholesterol, hypertension and irritable bowel syndrome. Concurrent medications included Diavan, Atenolol, LIPITOR, Aspirin and CO Q 10. On an unspecified date in 2008 and on an unspecified date in September 2009 he subject received a dose of Influenza vaccine (unknown). On an unspecified date in March 2009, the subject started generic product Isradipine (oral, manufacturer unknown) at 5 mg daily and discounted on an unspecified date in October 2009. On 17 October 2009, the subject started DYNACIRC CR, (oral) at 5 mg daily. In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced fever and chills. On an unspecified date in 2009, after vaccination with Influenza vaccine, the subject experienced "felt terrible with generalized feeling bad". At an unknown time after starting generic Isradipine, in March 2009, the subject experienced lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension. On 17 October 2009, within 24 hours of starting DYNACIRC CR, the subject experienced a "flutter type" headache with redness of her face and neck. Treatment with generic Isradipine was discontinued in October 2009, while therapy with DYNACIRC CR continued. At the time of reporting, the fever, chills, feel terrible, headache, red skin on face and neck,  lack of effect, anxiety, palpitation, stressed out, hyped up, general bad feeling, uptight feeling, nervousness and tension were resolved. She had a flu shot this year, about six weeks ago. She felt terrible with generalized feeling bad for about 24 hours then it went away. Last year was her first time for getting the flu shot. She got fever and chills for 24 hours then all went away. Caller reports that she takes DYNACIRC for her blood pressure. Back in the spring of this year, around March, she took generic for DYNACIRC because she was unable to get the brand product. While on the generic she reports lack of effect, anxiousness, palpitations, felt stressed out, tense, nervous, uptight feeling and hyped started on the name brand CR product. She reports that she initially had a flutter type headache, with redness of her face and neck within an hour of taking the product. These issues have since resolved and her blood pressure has lowered.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site warmth, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 42-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  Concurrent medical conditions included allergy to macrolides and sulfa allergy.  On 21 October 2009 in the afternoon, the subject received unspecified dose of FLUARIX (subcutaneous, left arm).  On 21 October 2009, at an unspecified time after vaccination with FLUARIX, the subject experienced injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route.  At the time of reporting injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route were unresolved.  The pharmacist considered injection site redness, injection site warmth, wrong vaccine administered and intramuscular formulation administered by other route were probably related to vaccination with FLUARIX.  The pharmacist reported that the subject was supposed to receive a tuberculosis shot, but instead the subject received FLUARIX via subcutaneous as opposed to intramuscular.  The subject experienced redness and warmth at the injection site.  No further information was provided.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Tendonitis
Clinical narrative: This case was reported by a physician and described the occurrence of shoulder pain in a 57-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  Previous medical conditions included rotator cuff surgery on the left shoulder.  On an unspecified day in September 2009 the subject received a dose of FLUARIX (.5 cc, unknown, right arm).  On an unspecified day in September 2009, at an unspecified time after vaccination with FLUARIX, the subject experienced (right) shoulder pain.  The lot number was reported as FLUA458BA.  Relevant test results included magnetic resonance imaging (MRI) which noted tendonitis of right shoulder.  The physician considered the (right) shoulder pain was possibly related to vaccination with FLUARIX.  The physician was reporting on an employee subject that received the flu vaccine about a month ago.  The subject has had pain in her right shoulder (deltoid area) that has not resolved.  The physician reported that he believed the subject stated she had had pain in her right deltoid/shoulder before receiving the shot.  At the time of reporting the (right) shoulder pain was unresolved.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Malaise, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling sick in a 42-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included womb removed and splenectomy.  On 15 October 2007 between 10:00 and 11:10, the subject received 1st dose of Flu shot (unknown, left arm).  On 15 October 2007 between 12:00 and 13:00, within 1 hour after vaccination with Flu shot, the subject experienced feeling sick.  On 15 October 2007, less than one day after vaccination with Flu shot, the subject experienced anxiety, left leg pain, tingling (left leg) and muscle pain.  The subject reported side effects that she had experienced since having the flu shot (GSK brand unknown) on 15 October 2007.  At the time of reporting the events were unresolved.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a 54-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergic reaction to msg and milk allergy. Concurrent medications included CARDIZEM, INSPRA, AVODART, CRESTOR, TRICOR, LOVAZA and NEXIUM. The subject had previously received influenza vaccinations and had experienced slight fatigue. Outcome of the slight fatigue was unspecified. On 17 November 2009 at 15:30, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). In the morning on 18 November 2009, unspecified hours after vaccination with FLUARIX, the subject experienced fatigue, myalgia and arthralgia. At the time of reporting the events were improved. The healthcare professional considered fatigue and myalgia were probably related to vaccination with FLUARIX. The healthcare professional arthralgia was possibly related to vaccination with FLUARIX.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a consumer via an other manufacturer and described the occurrence of difficulty breathing in a 67-year-old female subject who was vaccinated with Influenza vaccine, (manufacturer unspecified). Co-suspect medication included Fentanyl patch. On 5 November 2009, the subject received unspecified dose of Influenza vaccine (unknown) and also started Fentanyl at 25 mcg every three days. On 5 November 2009, less than one day after vaccination with Influenza vaccine and starting Fentanyl, the subject experienced difficulty breathing, nausea, weakness and sweating. The report stated the subject experienced difficulty breathing, nausea, weakness and sweating on 05 November 2009, the same day she started Fentanyl. The events resolved after approximately 24 hours; the subject stated she "is just fine now". Therapy with Fentanyl patch continued. On an unspecified date in November, the difficulty breathing, nausea, weakness and sweating were resolved.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Oedema peripheral, Swelling face, Urticaria
Clinical narrative: This case was reported by a sales representative and described the occurrence of hives in a 78-year-old female subject who was vaccinated with seasonal trivalent influenza vaccine Dresden (manufacturer unspecified).  A physician or other health care professional has not verified this report.  On 30 December 2009 the subject received 1st dose of influenza HA vaccine (unknown).  On 3 January 2010, 4 days after vaccination with influenza HA vaccine, the subject experienced hives, neck swelling, swelling of face and hand swelling.  The subject was treated with cortisone and antihistamine.  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Neurological symptom, Paraesthesia
Clinical narrative: This case was reported by a physician and described the occurrence of paresthesia in extremities in a female subject of unspecified age who was vaccinated with Seasonal Influenza vaccine, (manufacturer unspecified), pandemic vaccine H1N1 (non-gsk).  Concurrent medical conditions included under active thyroid.  Concurrent medications included SYNTHROID, birth control and unknown medication.  On an unspecified date in 2008 and on an unspecified date in November 2009 the subject received unspecified dose of Seasonal Influenza vaccine (unknown), on an unspecified date in December 2009 the subject received unspecified dose of Pandemic vaccine H1N1 (non-GSK) (unknown).  In 2008, at an unspecified time after vaccination with Seasonal Influenza vaccine the subject experienced paresthesia in extremities.  It was reported that in 2008, the subject received an unknown seasonal flu vaccine and experienced paresthesia symptoms in all four extremities for a short period of time and resolved.  On an unspecified date in 2009, less than one year after vaccination with Seasonal Influenza vaccine and approximately 2 weeks after vaccination with Pandemic vaccine H1N1 (non-GSK), the subject experienced paresthesia in extremities, fatigue, neurological symptom and weakness.  A neurologist reported the subject received a seasonal influenza vaccine (unknown manufacturer) in November 2009 and one month later in December 2009 received Pandemic H1N1 influenza vaccine (other manufacturer).  The subject developed paresthesia in all extremities a couple of weeks following administration.  Upon examination they had intact strength.  As of this report, the subject had experienced 60-70 percent improvement in paresthesia.  The physician did not have all the detail because the vaccines were not administered in his office.  At the time of reporting the paresthesia in extremities, fatigue and weakness were unresolved; neurological symptom had improved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site stinging in a 40-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 14 October 2008 at 11:30, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). On 14 October 2008, immediately after vaccination with FLUARIX, the subject experienced injection site stinging, injection site pruritus and intramuscular formulation administered by other route. The healthcare professional reported that she was vaccinated with FLUARIX via deep subcutaneous injection. She also reported some tissue stinging "that comes and goes" and some itching. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event, Hypersensitivity
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction. At the time of reporting the outcome of the event was unspecified. The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 subjects developing adverse events after receiving the FLUARIX vaccination. No details of the report are available and the sales representative heard the report third hand. Linked cases include: A0753367A, A0753368A, A0753369A, A0753370A and A0753371A.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction. At the time of reporting the outcome of the events was unspecified. The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 suspects developing adverse events after receiving the FLUARIX vaccination. No details of the report are available and the sales representative heard the report third hand. Linked cases include: A0753365A, A0753368A, A0753369A, A0753370A and A0753371A.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event, Hypersensitivity
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced an unspecified adverse event described as a sensitivity reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative stated that she was at a large convention on 30 September 2008 and was approached by a physician that reported his hospital had suspended administration of FLUARIX due to 6 subjects developing adverse events after receiving the FLUARIX vaccination.  No details of the report are available and the sales representative heard the report third hand.  Linked cases include:  A0753365A, A0753367A, A0753369A, A0753370A and A0753371A.