chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Breast enlargement, Breast pain, Pain, Panic reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of breast enlargement in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Approximately 13 or 14 November 2008, the subject received a dose of Influenza vaccine (unknown, unknown arm). In November 2008, 4 days after vaccination with Influenza vaccine, the subject experienced breast enlargement, pain and panicking. The subject stated "five days ago, I had a flu vaccine shot from your company. I had no adverse events until yesterday when one breast was very achy compared to the other one. Its the same side as my shot. I did not see my gynecologist yet." The subject stated she wanted to tell her gynecologist that and she was "getting panicky". The subject reported she received the flu vaccine 13 November 2008 in the left arm and four days after her left breast had enlarged. At the time of reporting the outcome of the events were unspecified. Follow-up information received on 19 November 2008. The subject provided conflicting information. The subject then reported she received an unknown Flu vaccine on 14 November 2008 in her right arm and four days later she notice enlargement of her right breast on the same side as her flu vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site haemorrhage, Injection site rash, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hemorrhage in a female subject aged between 40 and 49 years old who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 25 November 2008, the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown).  On 25 November 2008, at the time of the vaccination with FLUARIX, the subject experienced injection site hemorrhage, intramuscular formulation administered by other route and vaccine under dose.  The healthcare professional reported the subject received a FLUARIX vaccine.  The shirt of the subject was pulled up and tight on the skin.  It is believed that the vaccine may have been given subcutaneously and not all the vaccine was received due to forced blood eruption from the site due to possible shirt acting as a tourniquet.  At the time of reporting the events were resolved.
Sex: U
Vaccine: FLU3
Symptoms: Latex allergy
Clinical narrative: This case was reported by an unknown source and described the occurrence of sensitivity to latex in an unknown number of subjects of unspecified ages and gender who were vaccinated with FLUARIX, (GlaxoSmithKline).  On unspecified dates, the subject received a dose of FLUARIX (unknown).  At unspecified times after vaccination with FLUARIX, the subject experienced sensitivity to latex.  A pharmacist reported via sales representative that he was seeing a higher incidence of reactions in subjects receiving FLUARIX compared to other Flu vaccines.  No specific number reported and no individual information provided.  At the time of reporting the outcome of the event was unspecified.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, No reaction on previous exposure to drug, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling in a 51-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included NEXIUM. On 20 October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). On 20 October 2008, within 24 hours after vaccination with FLUARIX, the subject experienced swelling and erythema. The subject received FLUARIX during a GSK employee health Flu Clinic. The subject reported that she developed redness and swelling within 24 hours after the vaccination. The subject received FLUARIX last year without any issue. On 3 November 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Follow-up information was received on 09 January 2009, via healthcare professional who reported the events resolved and were related to vaccination with FLUARIX.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Pain, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling of burning in brain in a 30-year-old female patient who received TREXIMET tablet over a period of 9 days for migraine. A physician or other health care professional has not verified this report. The patient's past medical history included tonsils removed. Concurrent medical conditions included Crohn's disease. Co-suspect medication included Flu vaccine. Concurrent medications included IMURAN and LIALDA. On 23 October 2008 the patient started Naproxen + sumatriptan succinate (oral). Same day later, on 23 October 2008, the patient experienced feeling of burning in brain and body pain. Treatment with Naproxen + sumatriptan succinate was discontinued. At the time of reporting, the event were resolved. Patient stated that she took TREXIMET on October 23, 2008 and felt like her brain was on fire (which resolved after 3 to 4 hours) and experienced body aches which resolved on October 24, 2008. Patient experienced that same symptoms after taking a TREXIMET on October 31, 2008.
Sex: U
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a subject of unspecified age and gender who was vaccinated with Influenza vaccine, (manufacturer unspecified).  On an unspecified date, the subject received a dose of Influenza vaccine (injection, unknown).  At an unspecified time after vaccination with Influenza vaccine, the subject experienced frozen shoulder.  At the time of reporting the outcome of the event was unspecified.  The orthopedist reported two other cases of frozen shoulder following influenza vaccine.  Additional cases see A0761235A and A0761289A.
Age: 18.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: This case was reported by a consumer and described the occurrence of Guillain Barre Syndrome in an 18-year-old male subject 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). At an unspecified time after vaccination with Flu vaccine, the subject experienced Guillain Barre Syndrome. The subject was hospitalised. At the time of reporting the outcome of the Guillain Barre Syndrome was unspecified. The consumer reported that she knew of a male subject that received a flu vaccine (unknown manufacturer) years ago and was diagnosed with Guillain-Barre Syndrome. The consumer reported (or it was reported) that this event occurred approximately seven years ago and the subject was 18. The consumer reported that the subject was placed in intensive care unit in the hospital. The consumer did not want to provide any additional information and did not want any further contact. This was one of two cases reported by this consumer; see case A0811647A for additional report of a subject experiencing Guillain Barre Syndrome after receiving a flu shot vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of frozen shoulder in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). On an unspecified date, the subject received a dose of Influenza vaccine (injection, unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced frozen shoulder. At the time of reporting the outcome of the event was unspecified. The orthopedist reported two other cases of frozen shoulder following influenza vaccine. Additional cases see A0761235A and A0761286A.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Palpitations
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included asthma, dystonia and laryngospasm. In November 2006 the subject received unspecified dose of FLUARIX (unknown). Two hours after vaccination with FLUARIX, the subject experienced nausea, sweating and heart palpitation. The subject reported experiencing sweating, nausea and heart palpitations two hours after receiving the flu vaccine in November 2006. The subject experienced these symptoms intermittently for three to four days. At the time of reporting the events were resolved.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of acute trouble breathing in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 November 2008 the subject received unspecified dose of FLUARIX (unknown). On 24 November 2008, less than one day after vaccination with FLUARIX, the subject experienced acute trouble breathing also described as "acute breathing". At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: This case was reported by a consumer and described the occurrence of Guillain Barre Syndrome in a male subject of 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). At an unspecified time after vaccination with Flu vaccine, the subject experienced Guillain Barre Syndrome. The subject was hospitalised. At the time of reporting the outcome of the Guillain Barre Syndrome was unspecified. The consumer reported that she knew of a male subject that received a flu vaccine (unknown manufacturer) an unspecified number of years ago and was diagnosed with Guillain Barre syndrome. The consumer reported that the subject was placed in intensive care unit in the hospital. The consumer did not want to provide any additional information and did not want any further contact. This was one of two cases reported by this consumer; see case A0811643A, for an additional report of a subject experiencing Guillain Barre Syndrome after receiving a flu shot vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Grip strength decreased, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle pain in a female subject of unspecified age (30's - 40's) who was vaccinated with Flu vaccine (manufacturer unspecified0. Concurrent medical conditions included lymphoma. The subject was reportedly undergoing chemotherapy on a protocol called ABVD and was receiving multiple unspecified concurrent medications. On 12 November 2008 the subject received unspecified dose of Flu vaccine (unknown). On 13 November 2008, 1 day after vaccination with Flu vaccine, the subject developed pain in her arm. Muscle pain was reported with onset of 13 November 2008. Pain progressed to her shoulders and neck. Leg pain was also documented. The subject reported that she was experiencing weakness and as a result was unable to open jars. She had shortness of breath on climbing stairs. Additionally, she reported that it hurt to lift her arms above her head. At the time of reporting, muscle pain was unresolved and the outcome of the other events was unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle pain in a female subject of unspecified age (30's - 40's) who was vaccinated with Flu vaccine (manufacturer unspecified0. Concurrent medical conditions included lymphoma. The subject was reportedly undergoing chemotherapy on a protocol called ABVD and was receiving multiple unspecified concurrent medications. On 12 November 2008 the subject received unspecified dose of Flu vaccine (unknown). On 13 November 2008, 1 day after vaccination with Flu vaccine, the subject developed pain in her arm. Muscle pain was reported with onset of 13 November 2008. Pain progressed to her shoulders and neck. Leg pain was also documented. The subject reported that she was experiencing weakness and as a result was unable to open jars. She had shortness of breath on climbing stairs. Additionally, she reported that it hurt to lift her arms above her head. At the time of reporting, muscle pain was unresolved and the outcome of the other events was unspecified.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hives over whole body in a 78-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). Concurrent medical condition included arthritis, high cholesterol and an unspecified respiratory disorder. Concurrent medications included ADVAIR and VYTORIN. On the evening of 12 September 2008, the subject received the 1st dose of Flu vaccine (.5 ml, unknown) at a local hospital. On 12 September 2008, less than one day after vaccination with Flu vaccine, the subject experienced hives over her whole body and severe itching. The subject was treated with triamcinolone cream. The subject had previously received flu vaccinations with no prior adverse events. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were improved. The pharmacist considered the events were probably related to vaccination with Flu vaccine.
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 - A0756543A, A0756545A - 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: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified) given on an unspecified date in 2002 (same date of flu vaccine administration). In 2002 the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced rash. At the time of reporting the outcome of the event was unspecified.
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 - A0756544A, A0756546A - 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 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: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling at the injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included degenerative arthritis and multiple sclerosis. Concurrent medications included Gabapentin, Glucosamine, Baclofen, Arthrotec, COPAXONE and PROVIGIL. On 31 October 2008 the subject received a dose of FLUARIX at 1.0 ml in the left arm. On 1 November 2008, 1 day after vaccination with FLUARIX, the subject developed a swollen red area on her left upper arm about the size of a small lemon. The area was tender to touch and she put ice on it and used NSAIDs. Within two to three weeks it was better, but her left arm did continue to hurt. Three weeks prior to reporting, the pain began to intensify. The subject experienced tremendous aching pain in the lateral part of her upper arm, neck and shoulder, radiating down her arm. She wakes up at night due to the pain. The reporter stated that the subject holds her arm on her upper abdomen because it hurts for her arm to hang down. The subject stopped climbing stairs and cannot pick up her child due to the pain, but she still continues to work. She sought medical attention on the day of reporting and the following was noted: The injection site area was mildly swollen, the subjects reflexes and strength were normal, but when a little pressure was put on the arm, the subject resisted. There was no numbness or tingling. Deep touch was normal and deep tendon reflexes were normal. The reporter suspected that the injection may have been given too deep in the muscle and therefore, performed an ultrasound that was found to be normal. It was specifically noted that the events of swelling, redness, tenderness and pain were worse at the time of reporting and probably related to treatment with FLUARIX. The outcomes and relationships of the other events to FLUARIX were not specifically stated. Follow-up information was received on 23 January 2009: The diagnosis was reported as arm pain at injection site. Onset date of earliest sign or symptoms was 31 October 2008. Outcome of the events was reported as unresolved and worse. The reporter considered the events were possibly related to FLUARIX. Ultrasound of the left upper arm was negative for hematoma. A biopsy was not performed. The subject did not use alcohol or tobacco. The subject has received flu shots "yearly".
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Reflex test normal
Clinical narrative: This case was reported by a physician and described the occurrence of swelling at the injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included degenerative arthritis and multiple sclerosis. Concurrent medications included Gabapentin, Glucosamine, Baclofen, Arthrotec, COPAXONE and PROVIGIL. On 31 October 2008 the subject received a dose of FLUARIX at 1.0 ml in the left arm. On 1 November 2008, 1 day after vaccination with FLUARIX, the subject developed a swollen red area on her left upper arm about the size of a small lemon. The area was tender to touch and she put ice on it and used NSAIDs. Within two to three weeks it was better, but her left arm did continue to hurt. Three weeks prior to reporting, the pain began to intensify. The subject experienced tremendous aching pain in the lateral part of her upper arm, neck and shoulder, radiating down her arm. She wakes up at night due to the pain. The reporter stated that the subject holds her arm on her upper abdomen because it hurts for her arm to hang down. The subject stopped climbing stairs and cannot pick up her child due to the pain, but she still continues to work. She sought medical attention on the day of reporting and the following was noted: The injection site area was mildly swollen, the subjects reflexes and strength were normal, but when a little pressure was put on the arm, the subject resisted. There was no numbness or tingling. Deep touch was normal and deep tendon reflexes were normal. The reporter suspected that the injection may have been given too deep in the muscle and therefore, performed an ultrasound that was found to be normal. It was specifically noted that the events of swelling, redness, tenderness and pain were worse at the time of reporting and probably related to treatment with FLUARIX. The outcomes and relationships of the other events to FLUARIX were not specifically stated. Follow-up information was received on 23 January 2009: The diagnosis was reported as arm pain at injection site. Onset date of earliest sign or symptoms was 31 October 2008. Outcome of the events was reported as unresolved and worse. The reporter considered the events were possibly related to FLUARIX. Ultrasound of the left upper arm was negative for hematoma. A biopsy was not performed. The subject did not use alcohol or tobacco. The subject has received flu shots "yearly".
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Ultrasound scan normal
Clinical narrative: This case was reported by a physician and described the occurrence of swelling at the injection site in a 42-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included degenerative arthritis and multiple sclerosis. Concurrent medications included Gabapentin, Glucosamine, Baclofen, Arthrotec, COPAXONE and PROVIGIL. On 31 October 2008 the subject received a dose of FLUARIX at 1.0 ml in the left arm. On 1 November 2008, 1 day after vaccination with FLUARIX, the subject developed a swollen red area on her left upper arm about the size of a small lemon. The area was tender to touch and she put ice on it and used NSAIDs. Within two to three weeks it was better, but her left arm did continue to hurt. Three weeks prior to reporting, the pain began to intensify. The subject experienced tremendous aching pain in the lateral part of her upper arm, neck and shoulder, radiating down her arm. She wakes up at night due to the pain. The reporter stated that the subject holds her arm on her upper abdomen because it hurts for her arm to hang down. The subject stopped climbing stairs and cannot pick up her child due to the pain, but she still continues to work. She sought medical attention on the day of reporting and the following was noted: The injection site area was mildly swollen, the subjects reflexes and strength were normal, but when a little pressure was put on the arm, the subject resisted. There was no numbness or tingling. Deep touch was normal and deep tendon reflexes were normal. The reporter suspected that the injection may have been given too deep in the muscle and therefore, performed an ultrasound that was found to be normal. It was specifically noted that the events of swelling, redness, tenderness and pain were worse at the time of reporting and probably related to treatment with FLUARIX. The outcomes and relationships of the other events to FLUARIX were not specifically stated. Follow-up information was received on 23 January 2009: The diagnosis was reported as arm pain at injection site. Onset date of earliest sign or symptoms was 31 October 2008. Outcome of the events was reported as unresolved and worse. The reporter considered the events were possibly related to FLUARIX. Ultrasound of the left upper arm was negative for hematoma. A biopsy was not performed. The subject did not use alcohol or tobacco. The subject has received flu shots "yearly".
Sex: F
Vaccine: FLUX
Symptoms: Sensory disturbance, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of abnormal sensations arms in an adult female subject 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). At an unspecified time after vaccination with Flu vaccine, the subject experienced abnormal sensations arms. The subject reported that everytime she gets a flu shot, she can feel it go down her arm. At the time of reporting the outcome of the event was unspecified.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Tuberculin test negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of tinnitus-bilateral in a 63-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject had not previously received any flu shots. The subject's medical history included breast cancer. In 1975, the subject declined Td (tetanus and diphtheria vaccine) due to known reaction. "PPD" in August 2007 and was negative on 14 October 2008. Concurrent medications included FOSAMAX, PAXIL, FEMARA and XANAX. On 16 October 2008 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm). On 17 October 2008, 24 hours after vaccination with FLUARIX, the subject experienced tinnitus-bilateral. The physician's assistant reported that the subject developed the tinnitus greater in the left ear than the right ear and it was more annoying at night when things are quiet. At the time of reporting the events was unresolved. Follow-up information received on 13 February 2009 indicated that the event was still unresolved as of 27 January 2009. In the reporter's opinion, the event was possibly related to treatment with FLUARIX.
Age: 59.0
Sex: M
Vaccine: FLUX, TYP
Symptoms: Pain, Salivary gland enlargement
Clinical narrative: This case was reported by a physician and described the occurrence of submandibular gland swelling in a 59-year-old male subject who received flu vaccine (Dresden), MALARONE tablet over a period of 2 weeks for malaria and typhoid and typhus vaccine. The subject has no relevant medical history and no concurrent medications were reported. On or about 16 January 2009 the subject received an unspecified flu vaccine (manufacturer unknown), MALARONE (GlaxoSmithKline) and typhoid and typhus vaccines (both from unknown manufacturers). On 31 January 2009, the subject experienced swelling of the right submandibular salivary glands. Pain was also reported. Treatment with MALARONE was discontinued. At the time of reporting, the events were unresolved.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 63-year-old male subject who was vaccinated with Influenza 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 Influenza vaccine. At an unspecified time after vaccination with Influenza vaccine, the subject experienced influenza and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood test normal, Body temperature increased, Chest discomfort, Erythema
Clinical narrative: This case was reported by a sales representative and described the occurrence of fever in a 48-year-old female subject (the reporter's sister) who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included mastectomy. Concurrent medical conditions included breast cancer and breast implant. There were no concurrent medications. On 6 February 2009 at 09:00 the subject received unspecified dose of FLUARIX in the left arm. Six hours after FLUARIX injection, the subject developed fever, swelling and redness. Severe muscle pain began at an unknown time and was described as getting worse. Also reported were swollen lymph nodes under her arms and around her back, severe headache, neck pain, fatigue, chest tightness and heaviness and she was not able to get out of bed for three days. The subject contacted the clinic 24 hours after experiencing the events and was told to see her oncologist. During a follow-up visit to the clinic on an unspecified date, she had a Strep test and bloodwork which were negative. A nasal swab for flu was also negative. On the morning of reporting, the subject reported a fever of 102.1 degrees. The subject contacted her husband and was waiting to be taken to the emergency room. At the time of reporting the outcome of the events was unspecified.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza serology negative, Lymphadenopathy, Myalgia
Clinical narrative: This case was reported by a sales representative and described the occurrence of fever in a 48-year-old female subject (the reporter's sister) who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included mastectomy. Concurrent medical conditions included breast cancer and breast implant. There were no concurrent medications. On 6 February 2009 at 09:00 the subject received unspecified dose of FLUARIX in the left arm. Six hours after FLUARIX injection, the subject developed fever, swelling and redness. Severe muscle pain began at an unknown time and was described as getting worse. Also reported were swollen lymph nodes under her arms and around her back, severe headache, neck pain, fatigue, chest tightness and heaviness and she was not able to get out of bed for three days. The subject contacted the clinic 24 hours after experiencing the events and was told to see her oncologist. During a follow-up visit to the clinic on an unspecified date, she had a Strep test and bloodwork which were negative. A nasal swab for flu was also negative. On the morning of reporting, the subject reported a fever of 102.1 degrees. The subject contacted her husband and was waiting to be taken to the emergency room. At the time of reporting the outcome of the events was unspecified.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pyrexia, Streptococcus test negative, Swelling
Clinical narrative: This case was reported by a sales representative and described the occurrence of fever in a 48-year-old female subject (the reporter's sister) who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included mastectomy. Concurrent medical conditions included breast cancer and breast implant. There were no concurrent medications. On 6 February 2009 at 09:00 the subject received unspecified dose of FLUARIX in the left arm. Six hours after FLUARIX injection, the subject developed fever, swelling and redness. Severe muscle pain began at an unknown time and was described as getting worse. Also reported were swollen lymph nodes under her arms and around her back, severe headache, neck pain, fatigue, chest tightness and heaviness and she was not able to get out of bed for three days. The subject contacted the clinic 24 hours after experiencing the events and was told to see her oncologist. During a follow-up visit to the clinic on an unspecified date, she had a Strep test and bloodwork which were negative. A nasal swab for flu was also negative. On the morning of reporting, the subject reported a fever of 102.1 degrees. The subject contacted her husband and was waiting to be taken to the emergency room. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin discolouration, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of skin discoloration in an adult female subject who was vaccinated with Flu vaccine, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 21 October 2008 the subject received unspecified dose of Flu vaccine (unknown).  The reporter, who was also the subject, could not confirm which GlaxoSmithKline flu vaccine she was given, but she provided a partial lot number reported as "UL2757AA".  At an unspecified time after vaccination with Flu vaccine, the subject experienced skin discoloration, leg rash and swelling.  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 11 September 2009, the subject received a dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site, injection site pain, headache, pain and leg calf muscle cramp.  The consumer reported she received FLUARIX vaccination on 11 September 2009.  "Aside from the expected redness, swelling and injection site pain, I've also experienced a sever headache and a terribly painful muscle cramp in my left lower calf muscle.  The calf cramp was so intense that I could actually feel the muscle tighten up and release.  It happened several times, one after the other, lasting a total of approximately 15 minutes.  On a scale of 1-10, with 10 being the most pain, I would rate it a 10."  At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 11 September 2009, the subject received a dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced injection site redness, swelling injection site, injection site pain, headache, pain and leg calf muscle cramp.  The consumer reported she received FLUARIX vaccination on 11 September 2009.  "Aside from the expected redness, swelling and injection site pain, I've also experienced a sever headache and a terribly painful muscle cramp in my left lower calf muscle.  The calf cramp was so intense that I could actually feel the muscle tighten up and release.  It happened several times, one after the other, lasting a total of approximately 15 minutes.  On a scale of 1-10, with 10 being the most pain, I would rate it a 10."  At the time of reporting the outcome of the events were unspecified.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 38-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  On an unspecified date, the subject received a dose of FLUARIX (unknown, unknown arm).  Twelve hours after vaccination with FLUARIX, the subject experienced headache and slight temperature.  The subject who in also a nurse, experienced headaches and a temperature of 101 degrees 12 hours post vaccination with FLUARIX.  The events resolved approximately 24 hours later.  The subject stated "this had occurred four or five times over the past 10 years.  She stated due to this experienced there have been years where she has skipped getting the flu shot, however, when she gets the injection again, she experienced the same events.  She is unsure if the flu vaccine she has always received is FLUARIX".  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Haematoma, Injection site swelling, Oedema peripheral
Clinical narrative: This case was reported by a physician and described the occurrence of arm swelling in a 60-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). The subject's medical history included diabetes. On 16 September 2009, the subject received a dose of Influenza vaccine (unknown, right arm). On 16 September 2009, 8 hours after vaccination with Influenza vaccine, the subject experienced arm swelling. The physician reported a subject received a flu vaccine (unsure of specific flu vaccine, but was positive it was a GSK vaccine) on 16 September 2009. Within approximately eight hours of receiving the vaccine, the subject developed a severe local reaction, clarified as swelling at the injection site that has worsened into swelling over a larger portion of the arm including the deltoid and shoulder area. At this time, the subject has been into the office to see the physician on 17 September 2009. The physician feels the event is worsening and is most probably caused by the vaccine received. The physician does not plan to administer any further flu vaccines to this subject in the future. At the time of reporting the event was worse. The physician considered the event was probably related to vaccination with Influenza vaccine. Follow up information was received on 16 November 2009 via the reporting physician. The physician determined that the subject had a factor deficiency (acquired factor X deficiency) totally unrelated to the influenza vaccine. The subject developed a large hematoma from the vaccine because of the factor deficiency and not due to the influenza vaccine.
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 - A0756545A, A0756547A - 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 - A0756546A, A0756548A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Product quality issue
Clinical narrative: This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756547A, A0756549A - 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 - A0756548A, A0756550A - 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.