chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Gingival disorder, Musculoskeletal chest pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in rib cage in a 79-year-old female subject who was vaccinated with Flu vaccine, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included bone spur of neck and hip surgery.  Concurrent medical conditions included arthritis, fibromyalgia and hypertension.  Concurrent medications included SYNTHROID, POTASSIUM, VOLTAREN, VASOTEC, Glucosamine, Multivitamin, Vitamin B, NIACIN, Stool softener, Lortab, Vitamin D, Baby aspirin, COQ-10 and Red yeast rice.  In 2006 the subject received a dose of flu vaccine (unknown manufacturer).  That night following flu vaccination the subject felt achy.  In the morning, the event resolved.  On 24 October 2008 at 14:30, the subject received flu vaccine (unknown GlaxoSmithKline brand). Less than one day after vaccination with Flu vaccine, 4 hours after vaccination with flu vaccine, the subject experienced pain in rib cage, painful feeling, shoulder pain and neck pain.  At the time of reporting the events were unresolved.  Follow-up information was received on 24 November 2008 via consumer who reported she had physical therapy on the same day as her Flu vaccine, and her physician believed the physical therapy might be partially responsible for her symptoms.  She also visits her dentist every three months, on her Thursday visit the dentist mentioned her gums were softer than they were at her last visit.
Age: 8.0
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an unspecified adverse event in a 8-year-old subject of unspecified 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.  The outcome of the event was not reported and no additional details regarding the event were provided.  This was also considered to be a maladministration.  FLUARIX is not indicated for use in children.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Oedema peripheral, Reaction to preservatives
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject thought to be aged between 60 and 69 years old who was vaccinated with influenza virus vaccine (flu vaccine, manufacturer unspecified). Concurrent medical conditions included iodine allergy. Previous vaccination included influenza virus vaccine given in 1999 (Wyeth vaccine), 2002 (Aventis vaccine), 2003 (Evans vaccine) and 2004 (Aventis vaccine). On an unspecified date the subject received a dose of flu vaccine (unknown). At an unspecified time after vaccination with this flu vaccine, the subject experienced swelling from the elbow to the shoulder. The swelling lasted for 3 weeks and then resolved. According to the subject, these events occurred on one or more occasions in the past following flu vaccination. The physician told the reporting nurse that he believed the events were due to the subject being allergic to the preservative in the flu vaccine. At the time of reporting the events were resolved. On 08 November 2006 the subject received flu vaccine (supposedly a GlaxoSmithKline vaccine) and experienced no reactions. On 19 June 2007, the subject received PNEUMOVAX and reacted such that the injection site got huge and red. The events were treated with ice at the injection site and they resolved after several days. According to information received, this event would have taken place after the reported reaction to flu vaccine documented in this case. Information received documented the following: The subject recorded a historical reaction of swelling for 3 weeks on her flu vaccine screening form completed 08 November 2006. Thus, the above reported swelling reaction had to have occurred sometime prior to 08 November 2006. Later that same day, 08 November 2006, despite a known history of previous reactions as recorded above, the subject was given and unknown brand of what was believed by the nurse to be a GlaxoSmithKline flu vaccine. No reactions to this vaccine were documented. No further information is available concerning this case.
Sex: F
Vaccine: FLUX
Symptoms: Reaction to previous exposure to any vaccine, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject thought to be aged between 60 and 69 years old who was vaccinated with influenza virus vaccine (flu vaccine, manufacturer unspecified). Concurrent medical conditions included iodine allergy. Previous vaccination included influenza virus vaccine given in 1999 (Wyeth vaccine), 2002 (Aventis vaccine), 2003 (Evans vaccine) and 2004 (Aventis vaccine). On an unspecified date the subject received a dose of flu vaccine (unknown). At an unspecified time after vaccination with this flu vaccine, the subject experienced swelling from the elbow to the shoulder. The swelling lasted for 3 weeks and then resolved. According to the subject, these events occurred on one or more occasions in the past following flu vaccination. The physician told the reporting nurse that he believed the events were due to the subject being allergic to the preservative in the flu vaccine. At the time of reporting the events were resolved. On 08 November 2006 the subject received flu vaccine (supposedly a GlaxoSmithKline vaccine) and experienced no reactions. On 19 June 2007, the subject received PNEUMOVAX and reacted such that the injection site got huge and red. The events were treated with ice at the injection site and they resolved after several days. According to information received, this event would have taken place after the reported reaction to flu vaccine documented in this case. Information received documented the following: The subject recorded a historical reaction of swelling for 3 weeks on her flu vaccine screening form completed 08 November 2006. Thus, the above reported swelling reaction had to have occurred sometime prior to 08 November 2006. Later that same day, 08 November 2006, despite a known history of previous reactions as recorded above, the subject was given and unknown brand of what was believed by the nurse to be a GlaxoSmithKline flu vaccine. No reactions to this vaccine were documented. No further information is available concerning this case.
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: A0756484A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in 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.
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). 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, A0753769A and A0753771A.
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). 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, A0753769A and A0753770A. Follow-up information received on 07 November 2008 indicated that the events actually began on 08 October 2008. One day following administration of FLUARIX. The events resolved.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 52-year-old female subject who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included hot flash. Concurrent medical conditions included high blood pressure. Previous and/or concurrent vaccination included pneumonia vaccine, unspecified ;manufacturer unspecified;unknown;unknown given on 15 October 2008. Concurrent medications included Lisinopril and ESTRADIOL. On an unspecified date, the subject received a dose of Flu vaccine (unknown, unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced injection site redness and injection site tenderness. On 15 October 2008 at 10:00, the subject received a dose of Flu vaccine (unknown, left thigh). On 15 October 2008, 6 hours after vaccination with Flu vaccine, the subject experienced injection site redness, swelling injection site, injection site pain and vaccine administered at inappropriate site. The subject reported she received a Flu vaccine (brand unknown) in her upper leg and is experiencing redness, pain, and swelling at injection site. She reported the redness has spread to both sides of her leg about three inches. She stated in the past she has experienced mild redness and tenderness at the injection site when she has received a Flu vaccine (brand unknown) but it goes away. At the time of reporting, the events were unresolved.
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a female subject who unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). One week after vaccination with Flu vaccine, the subject experienced shingles. The subject was treated with VALTREX. At the time of reporting the outcome of the event was unspecified. The subject questioned if this would alter her positive response to the flu vaccine and if she needed another flu shot.
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, A0756485A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in 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, A0756484, A0756486A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in 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.
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 - A0756485A, A0756487A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in 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 - A0756486A, A0756488A - 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 reaction, Product quality issue, Rash erythematous
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 - A0756487, A0756489 - A0756562A. The CRC provided lot number AFLUA3208A to 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 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 (FLUA320 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 FLUA350B. 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 - A0756488A, A0756490A - 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 reaction, Product quality issue, Rash erythematous
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 79 linked subjects please see cases: A0756483A - A0756489A, A0756491A - A0756562A. The CR provided lot number AFLUA3208A to QA regarding this product complaint, while the report received 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.
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 - A0756490A, A0756492A - 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): 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 - A0756491A, A0756493A - A0756562A.  The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in 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.
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 - A0756491A, A0756494A - 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 - A0756493A, A0756495A - 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.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Product quality issue, Rash erythematous
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 - A0756494A, A0756496A - 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 FULARIX, 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 79 linked subjects please see cases: A0756483A - A0756495A, A0756497A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received 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 (ALFUA320AA 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 - A0756496A, A0756498A - 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 received (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 - A0756497A, A0756499A - 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 reaction, Product quality issue, Rash erythematous
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 - A0756498A, A075600 - 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 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 (FLUA320 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 FLUA350B. 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 reaction, Product quality issue, Rash erythematous
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 - A0756499A, A0756501A - 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 reaction, Product quality issue, Rash erythematous
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 - A0756500A, A0756502A - 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 - A0756528A, A0756530A - 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.