chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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, A0753368A, A0753370A, A0753371A.
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 - A0756513A, A0756515A - 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 - A0756514A, A0756516A - 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  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 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 - A0756515A, A0756517A - A7056562A. 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 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.
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 70 linked subjects please see cases: A0756483A - A0756516A, A0756518A - 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 - A0756517A, A0756519A - 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 from 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 - A0756518A, A0756520 - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this 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 AFLUC350BA.
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 - A0756519A, A0756521A - 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 was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756520A, A0756522A - 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 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.
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 - A0756521A, A0756523A - 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 - A0756522A, A0756525A - 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 was unspecified. For the other 70 linked subjects please see cases: A0756483A - A0756523A, A0756525A - 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: 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 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. No details of the report are available and the sales representative heard the report third hand. Linked cases include: A0753365A, A0753367A, A0753368A, A0753369A and A0753371A.
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 - A0756524A, A0756526A - 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 - A0756525A, A0756527A - 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: Adverse reaction, 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 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, A0753368A, A0753369A and 0753370A.
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 - A0756526A, A0756528A - 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 - A0756527A, A0756529A - A0756526A. 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 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: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Musculoskeletal pain, Tendonitis
Clinical narrative: This case was reported by a physician and described the occurrence of shoulder pain in a 63-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In September 2008, the subject received a dose of FLUARIX (.5 ml, unknown, left arm) and within 24 hours she experienced shoulder pain and shoulder tendonitis. The reporting physician stated that the subject experienced left shoulder tendonitis and left shoulder pain within 24 hours after receiving the FLUARIX. The report indicated this was a local reaction, however it was specified as the left shoulder. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with FLUARIX. Follow-up information was received on 14 November 2008, via physician who repeated the vaccine was administered on 23 September 2008. The events occurred on 24 September 2008. On 14 October 2008, the subject was treated with a tapering dose of prednisone for 10 days. The subject returned for follow-up on 16 October 2008 and had improved. The subject was instructed to follow-up as needed and has not returned. The physician considered the events possibly related to vaccination with FLUARIX.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of nerve disturbance in a male subject aged between 70 and 79 years old who was vaccinated with influenza virus vaccine (manufacturer unspecified). The reporter is the wife of the subject. A physician or other health care professional has not verified this report. The subject's medical history included reaction to preservatives. This subject had no adverse events following receipt of prior immunizations with influenza virus vaccines and had no known adverse events following receipt of previous vaccinations. Concurrent medications included ACTONEL and AXID. On 14 October 2008 at 12:00 p.m., the subject received the "one and only" dose of Influenza virus vaccine (unknown). On 15 October 2008, 1 day after vaccination with Influenza virus vaccine, the subject experienced nerve disturbance described as "nerve endings felt weird," diarrhea and total exhaustion. The subject consulted a healthcare professional regarding the event. At the time of reporting the events were unresolved. The reporter is the subject's wife and stated that exhaustion is not flu-like. She could not further describe what she meant by nerve endings feeling weird. The subject received his flu vaccine at a clinic inside a pharmacy. She said that she does not know for sure if he received a GSK flu vaccine. The consumer reported that one other subject experienced adverse events following receipt of FLULAVAL. Please see case A0753986A.
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: This case was reported by a physician and described the occurrence of shoulder pain in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date, the subject received a dose of FLUARIX (unknown) and experienced shoulder pain and shoulder tendonitis. At the time of reporting the outcome of the events were unspecified see cases A0753545A and A073549A.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date the subject received a dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced unspecified adverse event. At the time of reporting the outcome of the event was unspecified. The sales representative received a call from another sales representative regarding a physician's assistant that was trying to report an unspecified adverse event following administration of FLUARIX.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: This case was reported by a physician (also the mother of the subject) and described the occurrence of stuttering in a 2-year-old female subject who was vaccinated with Flu vaccine (manufacture unspecified). In September 2008 the subject received unspecified dose of Flu vaccine (unknown). In September 2008, 3 to 4 days after vaccination with Flu vaccine, the subject started stuttering on and off for the past year. The reporter was not sure of the association between the stuttering and receiving flu vaccine. At the time of reporting the outcome of the event was unspecified.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Headache, Product quality issue, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of heavy breathing in a 47-year-old male patient who received ADVAIR multi dose powder inhaler for chronic obstructive pulmonary disease and flu vaccine (unspecified manufacturer). A physician or other health care professional has not verified this report. The patient's past medical history included fall off roof. Concurrent medical conditions included anxiety disorder, back pain, brain swelling, bronchitis, chronic obstructive pulmonary disease, gout, hypercholesterolemia, increased excretion of mucus, lower leg pain, meningitis, pneumonia, rhinitis, sciatic nerve pain, seizure, spinal disorder and type 2 diabetes. Co-suspect medication included Flu vaccine. Concurrent medications included COMBIVENT, PRO-AIR, SOMA, HYDROCODONE, DUONEB, ASTELIN, XANAX, GABAPENTIN, ALLOPURINOL, LIPITOR, TRICOR, COLCHICINE, LORATADINE and Diabetes medication. It was reported that the subject did not have any adverse events following previous vaccinations; however, it was also reported that the subject previously experienced diarrhea, vomiting and headache following a flu shot (unspecified manufacturer). On an unknown date, in approximately 2006 or 2007, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff (s) twice per day. On an unspecified date (the subject thinks it was in September 2008), the subject received flu vaccine (left arm). On 29 October 2008, the patient experienced heavy breathing, possible influenza, vomiting, headache, diarrhea and product complaint. On 31 October 2008, the patient took an extra dose of ADVAIR. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting, the events were improved. This caller states he forgot he took his dose of ADVAIR dose this morning (31 October 2008) and took a second dose 10-20 minutes later. He states approximately 30 minutes after taking the dose he experienced heavy breathing but he thinks he has the flu, clarified as he had a flu shot (could not provide a date but he thinks it was in September 2008) and on 29 October 2008 he started vomiting, got a headache, and had diarrhea. He attributed this to the flu vaccine. The headaches were reported as "nasty headaches". The diarrhea and vomiting resolved on 31Oct2008. The headache continues. Strongly advised caller to contact his physician, however he stated his doctor is going to tell him to go to the hospital and he has recently been there and does not want to go back. He thinks he has been taking ADVAIR for about 1.5-2 years. QA analysis results were received on 21 January 2009. QA analysis revealed that there was no lot number or sample received. Therefore, this product complaint as determined to be inconclusive.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of heavy breathing in a 47-year-old male patient who received ADVAIR multi dose powder inhaler for chronic obstructive pulmonary disease and flu vaccine (unspecified manufacturer). A physician or other health care professional has not verified this report. The patient's past medical history included fall off roof. Concurrent medical conditions included anxiety disorder, back pain, brain swelling, bronchitis, chronic obstructive pulmonary disease, gout, hypercholesterolemia, increased excretion of mucus, lower leg pain, meningitis, pneumonia, rhinitis, sciatic nerve pain, seizure, spinal disorder and type 2 diabetes. Co-suspect medication included Flu vaccine. Concurrent medications included COMBIVENT, PRO-AIR, SOMA, HYDROCODONE, DUONEB, ASTELIN, XANAX, GABAPENTIN, ALLOPURINOL, LIPITOR, TRICOR, COLCHICINE, LORATADINE and Diabetes medication. It was reported that the subject did not have any adverse events following previous vaccinations; however, it was also reported that the subject previously experienced diarrhea, vomiting and headache following a flu shot (unspecified manufacturer). On an unknown date, in approximately 2006 or 2007, the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff (s) twice per day. On an unspecified date (the subject thinks it was in September 2008), the subject received flu vaccine (left arm). On 29 October 2008, the patient experienced heavy breathing, possible influenza, vomiting, headache, diarrhea and product complaint. On 31 October 2008, the patient took an extra dose of ADVAIR. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting, the events were improved. This caller states he forgot he took his dose of ADVAIR dose this morning (31 October 2008) and took a second dose 10-20 minutes later. He states approximately 30 minutes after taking the dose he experienced heavy breathing but he thinks he has the flu, clarified as he had a flu shot (could not provide a date but he thinks it was in September 2008) and on 29 October 2008 he started vomiting, got a headache, and had diarrhea. He attributed this to the flu vaccine. The headaches were reported as "nasty headaches". The diarrhea and vomiting resolved on 31Oct2008. The headache continues. Strongly advised caller to contact his physician, however he stated his doctor is going to tell him to go to the hospital and he has recently been there and does not want to go back. He thinks he has been taking ADVAIR for about 1.5-2 years. QA analysis results were received on 21 January 2009. QA analysis revealed that there was no lot number or sample received. Therefore, this product complaint as determined to be inconclusive.
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: This case was reported by a physician and described the occurrence of shoulder pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date, the subject received a dose of FLUARIX (unknown) and experienced shoulder pain and shoulder tendonitis. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Drug administration error, Nonspecific reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nonspecific reaction in an adult female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced a nonspecific reaction. At the time of reporting the outcome of the event was unspecified. It was reported that due to this reaction in the past, the subject has had health care providers divide subsequent flu vaccine doses and give as two half doses in an effort to prevent a reaction. This was considered to be a drug administration error. No further adverse events were reported.
Sex: M
Vaccine: FLU3
Symptoms: Injection site extravasation
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site leaking in a male subject of unspecified age who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 21 October 2008, the subject received a dose of FLUARIX (intramuscular, unknown arm) and experienced injection site leaking.  Pharmacist stated that a nurse gave a male subject FLUARIX and after the intramuscular injection, "some of the mediation bubbled out of his arm".  The pharmacist stated the medication came because the subject did not have "very much muscle mass".  No other information was provided.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 10 November 2008 via pharmacist who reported that she had no additional information to provide.  She contacted us to state she will not be providing any additional information.
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX. On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 21 October 2008, the events of rash and itching were resolved. The healthcare professional considered these events unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked cases include: A0753760A, A0753770A, A0753771A. Follow-up information received on 07 November 2008 indicated that the events actually began on 08 October 2008. One day following vaccination with FLUARIX. The events resolved and were not considered to be related to treatment with FLUARIX.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 37-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 20 October 2008 the subject received a dose of FLUARIX (.5 ml, unknown, right arm).  On 20 October 2008, less than one day after vaccination with FLUARIX, the subject experienced injection site soreness.  The subject reported she experienced soreness at the injection site after receiving FLUARIX.  She stated the soreness resolved about 6 to 7 hours later, before she went to bed.  She stated she had also been lifting some items between receiving the FLUARIX vaccine and the time the soreness resolved.  On 20 October 2008, the event was resolved.  The healthcare professional considered the event was probably related to vaccination with FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling in the feet in an adult female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  There were no concurrent medications.  On 31 October 2008, at 09:00, the subject received a dose of FLUARIX at 0.5 ml.  On 31 October 2008, at 17:00 (8 hours after FLUARIX administration), the subject experienced swelling in the feet and hives on the trunk.  The subject was seen by an internal physician at the hospital and was treated with unknown medications.  The events resolved.  The pharmacist considered the events possibly related to vaccination with FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever blisters in the mouth in an adult female subject who was vaccinated with FLUARIX. There were no concurrent medications. On 01 November 2008 the subject received a dose of FLUARIX at 0.5 ml. On 01 November 2008, less than one day after vaccination with FLUARIX, the subject developed fever blisters in her mouth. The event resolved. The pharmacist considered the events unrelated to vaccination with FLUARIX.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Incorrect dose administered, Pain in extremity, Wrong drug administered
Clinical narrative: This case reported by a healthcare professional and described the occurrence of sore arm in a 40-year-old female subject who was vaccinated with FLUARIX. On 16 October 2008 the subject received a dose of FLUARIX (unknown). On 16 October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced sore arm. The event resolved. Later, on 28 October 2008, the subject went in to receive another vaccine and inadvertently received a 2nd dose of FLUARIX. This was considered to be a maladministration (asymptomatic/extra dose given). No adverse events were reported. Follow-up information was received on 01 December 2008, via healthcare professional who reported the subject's event was due to erroneous administration. The subject was given a second dose of FLUARIX (intramuscular) 12 days after a single seasonal dose of received. The subject had a sore arm after the first dose on 16 October 2008 and fatigue 24 hours after the second dose was given on 28 September 2008.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of induration in a 30-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 22 October 2008 the subject received a dose of FLUARIX at 0.5 ml in the left arm. One day later, on 23 October 2008, a 2 cm by 2 cm area of induration was reported. Additionally, at an unspecified amount of time following administration of FLUARIX, the subject developed arm redness and swelling. The redness was unresolved at the time of reporting and the outcome of induration and swelling were unknown. The subject was treated with warm compresses and was advised to apply warm compresses 4 times daily for the next few days. Follow-up information was received on 12 December 2008, via healthcare professional, who reported the events resolved on an unknown date. The reporting healthcare professional considered the events related to vaccination with FLUARIX.