chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Asthma, Body temperature increased, Cough, Immune system disorder, Respiration abnormal
Clinical narrative: A report has been received by VAERS via a physician concerning a 3 year old, male patient. No concomitant medication. The patient's medical history included wheezing. The patient had been receiving nasal FLUMIST started on 12-Sep-2012. The Flu Vaccine was administered to the patient by patient's ex-pediatrician on 12-Sep-2012. The patient has a wheezing history and the pediatrician was aware of the patient's history since he was treating the patient for almost 2 years. The patient was only 2 yrs 8 months old when the FLUMIST was administered. According to the reporter, after looking at FLUMIST website, it is very obvious that it is not recommended for the patient under 5 years old with wheezing history, so medication error was considered. On the morning of Thursday, 13-Sep-2012, it was noticed that he was coughing. On Thursday night the coughing was bad and the patient also had temperature about 100 deg F. On Friday, 14-Sep-2012, the cough was worse and we got an appointment with the nurse practitioner at his pediatrician's office. Upon examination, his Lungs, ears and throat were clear. They did not even think about the FLUMIST and did not remember to mention the same to the nurse. Nurse prescribed the patient with MUCINEX for cough and TYLENOL for temperature. The patient did not see any improvements all Saturday. Upon talking with some friends and neighbors on Saturday night, they realized that this might be an immune reaction due to the FLUMIST. The condition was getting worse and we rushed him to Urgent Care around 10:00AM on Sunday morning, they did mention about the FLUMIST to the pediatrician and the doctor diagnosed it as an Asthma attack and asked to start the breathing treatment immediately. They started treating him with Albuterol Sulfate through nebulizer. On Monday, 17-Sep-2012, they took him back to see his current pediatrician and she confirmed the asthma attack and the immune reaction due to FLUMIST since he has a Wheezing history. Wednesday Sep-19-2012 morning at about 8:45 AM the doctor administered Steroids orally and levalbuterol. The outcome of the event of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error was unknown. The company physician considered the events of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error to be serious, due to the serious criteria important medical event.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Respiratory tract congestion, Vaccination complication
Clinical narrative: A report has been received by VAERS via a physician concerning a 3 year old, male patient. No concomitant medication. The patient's medical history included wheezing. The patient had been receiving nasal FLUMIST started on 12-Sep-2012. The Flu Vaccine was administered to the patient by patient's ex-pediatrician on 12-Sep-2012. The patient has a wheezing history and the pediatrician was aware of the patient's history since he was treating the patient for almost 2 years. The patient was only 2 yrs 8 months old when the FLUMIST was administered. According to the reporter, after looking at FLUMIST website, it is very obvious that it is not recommended for the patient under 5 years old with wheezing history, so medication error was considered. On the morning of Thursday, 13-Sep-2012, it was noticed that he was coughing. On Thursday night the coughing was bad and the patient also had temperature about 100 deg F. On Friday, 14-Sep-2012, the cough was worse and we got an appointment with the nurse practitioner at his pediatrician's office. Upon examination, his Lungs, ears and throat were clear. They did not even think about the FLUMIST and did not remember to mention the same to the nurse. Nurse prescribed the patient with MUCINEX for cough and TYLENOL for temperature. The patient did not see any improvements all Saturday. Upon talking with some friends and neighbors on Saturday night, they realized that this might be an immune reaction due to the FLUMIST. The condition was getting worse and we rushed him to Urgent Care around 10:00AM on Sunday morning, they did mention about the FLUMIST to the pediatrician and the doctor diagnosed it as an Asthma attack and asked to start the breathing treatment immediately. They started treating him with Albuterol Sulfate through nebulizer. On Monday, 17-Sep-2012, they took him back to see his current pediatrician and she confirmed the asthma attack and the immune reaction due to FLUMIST since he has a Wheezing history. Wednesday Sep-19-2012 morning at about 8:45 AM the doctor administered Steroids orally and levalbuterol. The outcome of the event of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error was unknown. The company physician considered the events of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error to be serious, due to the serious criteria important medical event.
Age: 3.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Asthma, Cough, Drug administered to patient of inappropriate age, Immunisation reaction, Pyrexia
Clinical narrative: A report has been received by VAERS via a physician concerning a 3 year old, male patient. No concomitant medication. The patient's medical history included wheezing. The patient had been receiving nasal FLUMIST started on 12-Sep-2012. The Flu Vaccine was administered to the patient by patient's ex-pediatrician on 12-Sep-2012. The patient has a wheezing history and the pediatrician was aware of the patient's history since he was treating the patient for almost 2 years. The patient was only 2 yrs 8 months old when the FLUMIST was administered. According to the reporter, after looking at FLUMIST website, it is very obvious that it is not recommended for the patient under 5 years old with wheezing history, so medication error was considered. On the morning of Thursday, 13-Sep-2012, it was noticed that he was coughing. On Thursday night the coughing was bad and the patient also had temperature about 100 deg F. On Friday, 14-Sep-2012, the cough was worse and we got an appointment with the nurse practitioner at his pediatrician's office. Upon examination, his Lungs, ears and throat were clear. They did not even think about the FLUMIST and did not remember to mention the same to the nurse. Nurse prescribed the patient with MUCINEX for cough and TYLENOL for temperature. The patient did not see any improvements all Saturday. Upon talking with some friends and neighbors on Saturday night, they realized that this might be an immune reaction due to the FLUMIST. The condition was getting worse and we rushed him to Urgent Care around 10:00AM on Sunday morning, they did mention about the FLUMIST to the pediatrician and the doctor diagnosed it as an Asthma attack and asked to start the breathing treatment immediately. They started treating him with Albuterol Sulfate through nebulizer. On Monday, 17-Sep-2012, they took him back to see his current pediatrician and she confirmed the asthma attack and the immune reaction due to FLUMIST since he has a Wheezing history. Wednesday Sep-19-2012 morning at about 8:45 AM the doctor administered Steroids orally and levalbuterol. The outcome of the event of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error was unknown. The company physician considered the events of immune reaction due to FLUMIST, asthma attack, cough, cough was worse, fever 100 degrees F and medication error to be serious, due to the serious criteria important medical event.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Antiacetylcholine receptor antibody positive, Balance disorder, Diplopia, Dysphagia, Electromyogram abnormal
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eye movement disorder, Gait disturbance, Lumbar puncture normal, Muscular weakness, Myasthenia gravis
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Nausea, Nuclear magnetic resonance imaging spinal cord normal, Scan with contrast normal, Vision blurred, Visual impairment
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Antiacetylcholine receptor antibody positive, Computerised tomogram head, Diplopia, Dysphagia, Electromyogram
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid ptosis, Gait disturbance, Headache, Lumbar puncture, Myasthenia gravis
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Symptoms of diplopia, ptosis, altered gait, dysphagia and headache began within several days of vaccination.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, ANTH
Symptoms: Computerised tomogram abnormal, Deep vein thrombosis, Dyspnoea, Fatigue, Laboratory test normal
Clinical narrative: Information received on 06OCT2012 from a male who experienced a deep vein thrombosis (DVT) and pulmonary embolism (PE) and was hospitalized. On 06DEC2003 the subject received his sixth dose of BIOTHRAX lot FAV079; he received 6 doses of BIOTHRAX between 1999 and DEC2003. On 21FEB2004, he received his third dose of Hepatitis B vaccine. On 10MAR2004, he experienced shortness of breath with exertion. He sought treatment in the Emergency Room, and was admitted to the hospital with a PE and right lower leg DVT. At that time, laboratory testing revealed anemia and a decreased ferritin level. He was treated with heparin, LOVENOX, Aspirin, COUMADIN, iron infusions, iron supplements, and compression stockings. Subsequently, the events resolved: he continued on aspirin therapy and he resumed service with his employer. Medical correspondence dated 27JAN2010, noted that the male continued to experience intermittent swelling of the affected leg for which he wore compression stockings. In JUN2011, he experienced a second DVT in the same area of the right lower leg. His treatment at that time included enoxaparin, acetylsalicylic acid, and warfarin. Due to the second occurrence of DVT, he was been forced to leave his position in accordance with his office policy. He reports that all events have resolved. Medical history: Denies medical history or family history of clotting disorders. Concurrent medications: None. Additional adverse events noted from medical records: Barrett's esophagus, stable (2007) treated with pantoprazole; chronic low back pain (resolved with unspecified treatment); epigastric pain (resolved with reflux medication); neck mass, stable; overactive bladder and benign prostatic hypertrophy (treated with oxybutynin). Medical records available upon request.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, ANTH
Symptoms: Oedema peripheral, Pulmonary embolism
Clinical narrative: Information received on 06OCT2012 from a male who experienced a deep vein thrombosis (DVT) and pulmonary embolism (PE) and was hospitalized. On 06DEC2003 the subject received his sixth dose of BIOTHRAX lot FAV079; he received 6 doses of BIOTHRAX between 1999 and DEC2003. On 21FEB2004, he received his third dose of Hepatitis B vaccine. On 10MAR2004, he experienced shortness of breath with exertion. He sought treatment in the Emergency Room, and was admitted to the hospital with a PE and right lower leg DVT. At that time, laboratory testing revealed anemia and a decreased ferritin level. He was treated with heparin, LOVENOX, Aspirin, COUMADIN, iron infusions, iron supplements, and compression stockings. Subsequently, the events resolved: he continued on aspirin therapy and he resumed service with his employer. Medical correspondence dated 27JAN2010, noted that the male continued to experience intermittent swelling of the affected leg for which he wore compression stockings. In JUN2011, he experienced a second DVT in the same area of the right lower leg. His treatment at that time included enoxaparin, acetylsalicylic acid, and warfarin. Due to the second occurrence of DVT, he was been forced to leave his position in accordance with his office policy. He reports that all events have resolved. Medical history: Denies medical history or family history of clotting disorders. Concurrent medications: None. Additional adverse events noted from medical records: Barrett's esophagus, stable (2007) treated with pantoprazole; chronic low back pain (resolved with unspecified treatment); epigastric pain (resolved with reflux medication); neck mass, stable; overactive bladder and benign prostatic hypertrophy (treated with oxybutynin). Medical records available upon request.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, ANTH
Symptoms: Abdominal pain upper, Anaemia, Back pain, Barrett's oesophagus, Benign prostatic hyperplasia
Clinical narrative: Information received on 06OCT2012 from a male who experienced a deep vein thrombosis (DVT) and pulmonary embolism (PE) and was hospitalized. On 06DEC2003 the subject received his sixth dose of BIOTHRAX lot FAV079; he received 6 doses of BIOTHRAX between 1999 and DEC2003. On 21FEB2004, he received his third dose of Hepatitis B vaccine. On 10MAR2004, he experienced shortness of breath with exertion. He sought treatment in the Emergency Room, and was admitted to the hospital with a PE and right lower leg DVT. At that time, laboratory testing revealed anemia and a decreased ferritin level. He was treated with heparin, LOVENOX, Aspirin, COUMADIN, iron infusions, iron supplements, and compression stockings. Subsequently, the events resolved: he continued on aspirin therapy and he resumed service with his employer. Medical correspondence dated 27JAN2010, noted that the male continued to experience intermittent swelling of the affected leg for which he wore compression stockings. In JUN2011, he experienced a second DVT in the same area of the right lower leg. His treatment at that time included enoxaparin, acetylsalicylic acid, and warfarin. Due to the second occurrence of DVT, he was been forced to leave his position in accordance with his office policy. He reports that all events have resolved. Medical history: Denies medical history or family history of clotting disorders. Concurrent medications: None. Additional adverse events noted from medical records: Barrett's esophagus, stable (2007) treated with pantoprazole; chronic low back pain (resolved with unspecified treatment); epigastric pain (resolved with reflux medication); neck mass, stable; overactive bladder and benign prostatic hypertrophy (treated with oxybutynin). Medical records available upon request.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, ANTH
Symptoms: Deep vein thrombosis, Dyspnoea exertional, Hypertonic bladder, Neck mass, Oedema peripheral
Clinical narrative: Information received on 06OCT2012 from a male who experienced a deep vein thrombosis (DVT) and pulmonary embolism (PE) and was hospitalized. On 06DEC2003 the subject received his sixth dose of BIOTHRAX lot FAV079; he received 6 doses of BIOTHRAX between 1999 and DEC2003. On 21FEB2004, he received his third dose of Hepatitis B vaccine. On 10MAR2004, he experienced shortness of breath with exertion. He sought treatment in the Emergency Room, and was admitted to the hospital with a PE and right lower leg DVT. At that time, laboratory testing revealed anemia and a decreased ferritin level. He was treated with heparin, LOVENOX, Aspirin, COUMADIN, iron infusions, iron supplements, and compression stockings. Subsequently, the events resolved: he continued on aspirin therapy and he resumed service with his employer. Medical correspondence dated 27JAN2010, noted that the male continued to experience intermittent swelling of the affected leg for which he wore compression stockings. In JUN2011, he experienced a second DVT in the same area of the right lower leg. His treatment at that time included enoxaparin, acetylsalicylic acid, and warfarin. Due to the second occurrence of DVT, he was been forced to leave his position in accordance with his office policy. He reports that all events have resolved. Medical history: Denies medical history or family history of clotting disorders. Concurrent medications: None. Additional adverse events noted from medical records: Barrett's esophagus, stable (2007) treated with pantoprazole; chronic low back pain (resolved with unspecified treatment); epigastric pain (resolved with reflux medication); neck mass, stable; overactive bladder and benign prostatic hypertrophy (treated with oxybutynin). Medical records available upon request.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, ANTH
Symptoms: Pulmonary embolism, Serum ferritin decreased
Clinical narrative: Information received on 06OCT2012 from a male who experienced a deep vein thrombosis (DVT) and pulmonary embolism (PE) and was hospitalized. On 06DEC2003 the subject received his sixth dose of BIOTHRAX lot FAV079; he received 6 doses of BIOTHRAX between 1999 and DEC2003. On 21FEB2004, he received his third dose of Hepatitis B vaccine. On 10MAR2004, he experienced shortness of breath with exertion. He sought treatment in the Emergency Room, and was admitted to the hospital with a PE and right lower leg DVT. At that time, laboratory testing revealed anemia and a decreased ferritin level. He was treated with heparin, LOVENOX, Aspirin, COUMADIN, iron infusions, iron supplements, and compression stockings. Subsequently, the events resolved: he continued on aspirin therapy and he resumed service with his employer. Medical correspondence dated 27JAN2010, noted that the male continued to experience intermittent swelling of the affected leg for which he wore compression stockings. In JUN2011, he experienced a second DVT in the same area of the right lower leg. His treatment at that time included enoxaparin, acetylsalicylic acid, and warfarin. Due to the second occurrence of DVT, he was been forced to leave his position in accordance with his office policy. He reports that all events have resolved. Medical history: Denies medical history or family history of clotting disorders. Concurrent medications: None. Additional adverse events noted from medical records: Barrett's esophagus, stable (2007) treated with pantoprazole; chronic low back pain (resolved with unspecified treatment); epigastric pain (resolved with reflux medication); neck mass, stable; overactive bladder and benign prostatic hypertrophy (treated with oxybutynin). Medical records available upon request.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Case number PHEH2012US019667 is an initial spontaneous report received from a nurse on 28 Sep 2012 and combined follow up information received from a nurse and from a healthcare professional on 10 Oct 2012 and 17 Oct 2012 respectively. This case refers to an adult female patient (previously reported as multiple patients on 28 Sep 2012). Her medical history included allergy to penicillin and sulfa drugs. She vaccinated with FLUVIRIN (batch number: 12262P) at a dose of 0.5ml intramuscularly in her left arm on 25 Sep 2012. On an unknown date after vaccination she developed cellulitis at the injection site in left arm. The outcome was reported as completely recovered on an unspecified date. A quality investigation was requested for this batch of FLUVIRIN with reference number 186104 and 186107). No other information was available. Follow up information received from the nurse on 28 Sep 2012: update on number of patients and the events experienced by them (redness and induration at the injection site, previously reported as cutaneous reactions). Combined follow up information received from a nurse on 10 Oct 2012 and from a healthcare professional on 17 Oct 2012: Patient details identified, medical history, event and its outcome were updated.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Case number PHEH2012US019667 is an initial spontaneous report received from a nurse on 28 Sep 2012 and combined follow up information received from a nurse and from a healthcare professional on 10 Oct 2012 and 17 Oct 2012 respectively. This case refers to an adult female patient (previously reported as multiple patients on 28 Sep 2012). Her medical history included allergy to penicillin and sulfa drugs. She vaccinated with FLUVIRIN (batch number: 12262P) at a dose of 0.5ml intramuscularly in her left arm on 25 Sep 2012. On an unknown date after vaccination she developed cellulitis at the injection site in left arm. The outcome was reported as completely recovered on an unspecified date. A quality investigation was requested for this batch of FLUVIRIN with reference number 186104 and 186107). No other information was available. Follow up information received from the nurse on 28 Sep 2012: update on number of patients and the events experienced by them (redness and induration at the injection site, previously reported as cutaneous reactions). Combined follow up information received from a nurse on 10 Oct 2012 and from a healthcare professional on 17 Oct 2012: Patient details identified, medical history, event and its outcome were updated.
Age: 29.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Rash erythematous, Rash generalised, Swollen tongue, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 08 October 2012. A 19-year-old male patient received an intramuscular dose of FLUZONE SV, sanofi pasteur Inc., lot number UH721AD), (site not reported) on 02 October 2012. On the same day, 02 October 2012, two hours after vaccination, he developed hives. The next day, 03 October 2012, the patient stated he "broke out from head to toe with hives". The patient stated he saw his own healthcare professional and was treated with steroids and medication (unspecified). The patient stated he continued to experience hives and also had experienced an episode in which he had tongue swelling (on an unspecified date) for which he went to the hospital emergency room (ER) where he was treated with intravenous (IV) fluids. The patient stated he continued to have hives. No laboratory or diagnostic testing were reported. The patient's past medical history or illness at time of vaccination were not reported. The report stated the patient had "several" influenza vaccines in the past. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Activities of daily living impaired, Swollen tongue, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 08 October 2012. A 19-year-old male patient received an intramuscular dose of FLUZONE SV, sanofi pasteur Inc., lot number UH721AD), (site not reported) on 02 October 2012. On the same day, 02 October 2012, two hours after vaccination, he developed hives. The next day, 03 October 2012, the patient stated he "broke out from head to toe with hives". The patient stated he saw his own healthcare professional and was treated with steroids and medication (unspecified). The patient stated he continued to experience hives and also had experienced an episode in which he had tongue swelling (on an unspecified date) for which he went to the hospital emergency room (ER) where he was treated with intravenous (IV) fluids. The patient stated he continued to have hives. No laboratory or diagnostic testing were reported. The patient's past medical history or illness at time of vaccination were not reported. The report stated the patient had "several" influenza vaccines in the past. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 08 October 2012. A 19-year-old male patient received an intramuscular dose of FLUZONE SV, sanofi pasteur Inc., lot number UH721AD), (site not reported) on 02 October 2012. On the same day, 02 October 2012, two hours after vaccination, he developed hives. The next day, 03 October 2012, the patient stated he "broke out from head to toe with hives". The patient stated he saw his own healthcare professional and was treated with steroids and medication (unspecified). The patient stated he continued to experience hives and also had experienced an episode in which he had tongue swelling (on an unspecified date) for which he went to the hospital emergency room (ER) where he was treated with intravenous (IV) fluids. The patient stated he continued to have hives. No laboratory or diagnostic testing were reported. The patient's past medical history or illness at time of vaccination were not reported. The report stated the patient had "several" influenza vaccines in the past. The patient's outcome was reported as not recovered. Documents held by sender: None.
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age with no drug reactions/allergies. The patient's medical history included rotator cuff injury to both shoulders going back 30 years. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot # reported as H010515, exp 13-FEB-2014, route and dose not reported) on 10-OCT-2012. No other co-suspects were reported. There was no concomitant medication. The patient went to the reporter's clinic on 11-OCT-2012s, a day after he received PNEUMOVAX23 and complained that he could not lift his arm. The nurse practitioner reported that her colleague examined the injection site area and there were no visible reactions such as swelling or redness. The patient went to see his primary care physician and received hydrocodone. The patient would follow up with his physician on 15-OCT-2012. The outcome of the event was not reported. The relationship between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age with no drug reactions/allergies. The patient's medical history included rotator cuff injury to both shoulders going back 30 years. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot # reported as H010515, exp 13-FEB-2014, route and dose not reported) on 10-OCT-2012. No other co-suspects were reported. There was no concomitant medication. The patient went to the reporter's clinic on 11-OCT-2012s, a day after he received PNEUMOVAX23 and complained that he could not lift his arm. The nurse practitioner reported that her colleague examined the injection site area and there were no visible reactions such as swelling or redness. The patient went to see his primary care physician and received hydrocodone. The patient would follow up with his physician on 15-OCT-2012. The outcome of the event was not reported. The relationship between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chest pain, Hyperventilation
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 09-Oct-2012) concerns a 58-year-old female patient, who had a pertinent medical history of diabetes, hypertension, hypercholesterolemia and thyroidectomy. She had allergy to 'mycins'. On 05-Oct-2012 the patient was received a flu shot (manufacturer, brand name and batch number were not provided). On the same day the patient also received PNEUMOVAX 23 (batch number was not provided) injection intramuscularly. On 06-Oct-2012 the patient experienced a light burning sensation in the upper part of her chest that would come and go. Last night, 08-Oct-2012, she experienced a constant burning sensation in the upper part of her chest, described further as a dull ache. She found herself taking deep breaths, although not short of breath. No lab diagnostic study was performed. The patient did not seek medical attention or receive any treatment for the events. The event outcome was not recovered.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chest pain, Hyperventilation, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 09-Oct-2012) concerns a 58-year-old female patient, who had a pertinent medical history of diabetes, hypertension, hypercholesterolemia and thyroidectomy. She had allergy to 'mycins'. On 05-Oct-2012 the patient was received a flu shot (manufacturer, brand name and batch number were not provided). On the same day the patient also received PNEUMOVAX 23 (batch number was not provided) injection intramuscularly. On 06-Oct-2012 the patient experienced a light burning sensation in the upper part of her chest that would come and go. Last night, 08-Oct-2012, she experienced a constant burning sensation in the upper part of her chest, described further as a dull ache. She found herself taking deep breaths, although not short of breath. No lab diagnostic study was performed. The patient did not seek medical attention or receive any treatment for the events. The event outcome was not recovered.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Feeling hot, Oedema peripheral, Pain, Swelling
Clinical narrative: Right arm swollen up in the shoulder and into the armpit, red, hot to the touch and very painful.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Axillary pain, Erythema, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Right arm swollen up in the shoulder and into the armpit, red, hot to the touch and very painful.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Right arm swollen up in the shoulder and into the armpit, red, hot to the touch and very painful.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Aggression, Blood test normal, Computerised tomogram normal, Dyskinesia, Impulsive behaviour
Clinical narrative: Spontaneous verbal outbursts, tics complex Tourette's Syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Obsessive-compulsive disorder, Posture abnormal, Throat irritation, Tic, Tourette's disorder
Clinical narrative: Spontaneous verbal outbursts, tics complex Tourette's Syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Speech disorder, Tic, Tourette's disorder
Clinical narrative: Spontaneous verbal outbursts, tics complex Tourette's Syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Blood test, Computerised tomogram normal, Dyskinesia, Muscle twitching
Clinical narrative: Spontaneous verbal outbursts, tics complex Tourette's Syndrome.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Petit mal epilepsy, Rash generalised, Secondary transmission, Tic, Varicella
Clinical narrative: Spontaneous verbal outbursts, tics complex Tourette's Syndrome.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lethargy, Muscular weakness, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: 2 days following shot, I had a sore throat, lethargy and general aches and pains. That subsided within 1 day and by 10-3-12, I had soreness/swelling and stiffness present in both hands. The pain is moderate (scale 3 out of 10). The joint pain is mostly present in my hands but will be transient in my left knee and all my toes bilaterally. The pain in my hands has subsided a bit but comes and goes throughout the day. I have persistent feeling of swollen hands and residual weakness, more prominent in my left hand.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: 2 days following shot, I had a sore throat, lethargy and general aches and pains. That subsided within 1 day and by 10-3-12, I had soreness/swelling and stiffness present in both hands. The pain is moderate (scale 3 out of 10). The joint pain is mostly present in my hands but will be transient in my left knee and all my toes bilaterally. The pain in my hands has subsided a bit but comes and goes throughout the day. I have persistent feeling of swollen hands and residual weakness, more prominent in my left hand.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Headache, nausea, 101 fever, malaise.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient who is a physician without drug reactions or allergies. The patient had no pertinent medical history. The patient was vaccinated with the first dose of PNEUMOVAX23 (lot number, injection site and route were not known) (0.5 ml) 15 years ago, in 1997. No other co-suspects were reported. There was no concomitant medication. On 11-OCT-2012 the patient experienced developed severe throbbing and inability to raise his right arm after administration of his second dose of PNEUMOVAX23 (lot number reported as H009826 expired date 11-FEB-2014) (0.5 ml, intramuscular, right arm) on 11-OCT-2012. The patient called the pharmacy for medical attention within 3 hours of administration of the PNEUMOVAX23 to report the symptoms. There was no treatment given for adverse event and no laboratory diagnostics studies performed. The patient was reported as not recovered at the time of report. The reporter considered that patient unable to lift his right arm to be significant disability or incapacity. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Clostridium test, Inflammation, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes under left arm were painful and inflamed when I woke up the morning after I received the shot.  The lymph nodes by my collar bone were painful and inflamed when I woke up the second morning after the shot.  I went to my PCP on Monday, October 8, 2012.  he gave me a course of antibiotics (Augmentin) and I was told to return to see him on October 15.  I did so and the swelling had gone down but was not completely gone.  To this day the glands are still a little swollen and painful.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: Lymph nodes under left arm were painful and inflamed when I woke up the morning after I received the shot.  The lymph nodes by my collar bone were painful and inflamed when I woke up the second morning after the shot.  I went to my PCP on Monday, October 8, 2012.  he gave me a course of antibiotics (Augmentin) and I was told to return to see him on October 15.  I did so and the swelling had gone down but was not completely gone.  To this day the glands are still a little swollen and painful.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Henoch-Schonlein purpura, Joint range of motion decreased, Joint swelling, Rash erythematous
Clinical narrative: He was diagnosed with HSP at 4:30pm the day after the vaccine.  His elbow joint was swollen and immovable.  He also had the classic red dots on his butt and lower extremities.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: He was diagnosed with HSP at 4:30pm the day after the vaccine.  His elbow joint was swollen and immovable.  He also had the classic red dots on his butt and lower extremities.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Gait disturbance, Pruritus, Pyrexia, Rash erythematous, Swelling
Clinical narrative: Red spots growing bigger, swelling, fever, itching and hard to walk.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Headache, Pain, Pruritus, Pyrexia
Clinical narrative: Itching, rash, burning, large whelp, high fever, hurting all over, headache.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Itching, rash, burning, large whelp, high fever, hurting all over, headache.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Aarm reddened and warm to touch about 3 inches below and to left of injection site.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Croup infectious, Nausea, Pain
Clinical narrative: Fever, chills, aching, nausea, vomiting, wheezing, constant croupy cough persistent for 3 days, symptoms still present.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Fever, chills, aching, nausea, vomiting, wheezing, constant croupy cough persistent for 3 days, symptoms still present.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swollen area around injection site. Redness, Pain, very warm to the touch.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Dizziness, feeling abnormal.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Right arm swelling. Pain and redness at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm red, hot, swollen down to elbow.
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Crying, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of mouth open breathing in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm) and experienced mouth open breathing, injection site redness, injection site pruritus, injection site pain, hot all over, watery eyes, anxiety and crying. A discrepancy existed in the administration record and the incident report from the reporter as to the site of injection versus the site of the adverse events. "The vaccine was administered at a Flu clinic at a local business. Patient had itching and pain in her left upper arm with a large area of redness. She complained of feeling hot all over. She was breathing through her mouth, but there was no wheezing or shortness of breath. Her eyes were slightly watery. The patient was anxious and crying." Based on the report it was unclear which arm the events and injection occurred. The reporter indicated that the injection site was right arm and the adverse events at the injection site occurred in the "LUA" (left upper arm). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE and BENADRYL. The subject was encouraged by the flu clinic to "call her doctor or go to ER if symptoms persisted." The subject contacted her physician, but it was unknown if she visited the office. The "practice called the (subject) this morning (11 October 2012) and (the subject) report(ed) improvement but not 100 percent."
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Lacrimation increased, Mouth breathing
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of mouth open breathing in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm) and experienced mouth open breathing, injection site redness, injection site pruritus, injection site pain, hot all over, watery eyes, anxiety and crying. A discrepancy existed in the administration record and the incident report from the reporter as to the site of injection versus the site of the adverse events. "The vaccine was administered at a Flu clinic at a local business. Patient had itching and pain in her left upper arm with a large area of redness. She complained of feeling hot all over. She was breathing through her mouth, but there was no wheezing or shortness of breath. Her eyes were slightly watery. The patient was anxious and crying." Based on the report it was unclear which arm the events and injection occurred. The reporter indicated that the injection site was right arm and the adverse events at the injection site occurred in the "LUA" (left upper arm). The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with EPINEPHRINE and BENADRYL. The subject was encouraged by the flu clinic to "call her doctor or go to ER if symptoms persisted." The subject contacted her physician, but it was unknown if she visited the office. The "practice called the (subject) this morning (11 October 2012) and (the subject) report(ed) improvement but not 100 percent."
Age: 64.0
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Blood test, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever (101), nausea, severe shivers, fatigue.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Biopsy artery abnormal, Computerised tomogram head normal, Dizziness, Dyspnoea
Clinical narrative: Pt. reports fever, severe headaches, eyes sore, draining ears, SOB, back pain, "knots" under skin.  States she had CAT scan of head due to severe headaches to r/o tumor - no tumor.  Had biopsy of "knot" on side of head that was Dx as keratosis.  States she has remained dizzy and still has severe headaches.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Headache, Hyperkeratosis, Otorrhoea, Pyrexia
Clinical narrative: Pt. reports fever, severe headaches, eyes sore, draining ears, SOB, back pain, "knots" under skin.  States she had CAT scan of head due to severe headaches to r/o tumor - no tumor.  Had biopsy of "knot" on side of head that was Dx as keratosis.  States she has remained dizzy and still has severe headaches.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Skin mass
Clinical narrative: Pt. reports fever, severe headaches, eyes sore, draining ears, SOB, back pain, "knots" under skin.  States she had CAT scan of head due to severe headaches to r/o tumor - no tumor.  Had biopsy of "knot" on side of head that was Dx as keratosis.  States she has remained dizzy and still has severe headaches.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: MOM STATED THAT CHILD'S ARM STARTED WITH A RED/WARM AREA THAT CONTINUED TO GET BIGGER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood pressure increased, Dissociation, Dizziness
Clinical narrative: Feeling very weak unable to do normal errands, lightheaded, felt a little spacey/ detached, pulse rate sometimes elevated to 110 just sitting in a chair.  Blood pressure elevated. Took aspirin to thin my blood, and just rested. Symptoms gradually decreased over next 3 days to just occasional waves of weakness.  Now I'm fine again - a week after the shot.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Heart rate increased
Clinical narrative: Feeling very weak unable to do normal errands, lightheaded, felt a little spacey/ detached, pulse rate sometimes elevated to 110 just sitting in a chair.  Blood pressure elevated. Took aspirin to thin my blood, and just rested. Symptoms gradually decreased over next 3 days to just occasional waves of weakness.  Now I'm fine again - a week after the shot.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac monitoring, Chills, Dizziness, Dysstasia, Feeling cold
Clinical narrative: Patient felt very dizzy, complained of blurred vision and "seeing spots". Patient stated she felt like she couldn't stand and felt like vomiting when offered food or liquids. EMT's were onsite and took her BP which was normal both sitting and orthostatic. EMT's stated she had tachycardia which subsided within a few minutes. Patient was tearful and seemed nervous. Patient said she had chills and felt freezing, I oberved she was warm to touch (within normal limits). She stated that she had not eaten all morning but had drank a coffee. She was offered water and a granola bar - patient refused saying it made her want to "vomit". She was then taken by EMS to a local hospital because she was not feeling any better. Her vital signs remained normal. The hospital treated her for an "allergic reaction" and she was given Benadryl, Pepcid, and prednisone. She returned to work at 1:30 PM and is doing fine.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Malaise, Nausea, Nervousness, Pregnancy test urine
Clinical narrative: Patient felt very dizzy, complained of blurred vision and "seeing spots". Patient stated she felt like she couldn't stand and felt like vomiting when offered food or liquids. EMT's were onsite and took her BP which was normal both sitting and orthostatic. EMT's stated she had tachycardia which subsided within a few minutes. Patient was tearful and seemed nervous. Patient said she had chills and felt freezing, I oberved she was warm to touch (within normal limits). She stated that she had not eaten all morning but had drank a coffee. She was offered water and a granola bar - patient refused saying it made her want to "vomit". She was then taken by EMS to a local hospital because she was not feeling any better. Her vital signs remained normal. The hospital treated her for an "allergic reaction" and she was given Benadryl, Pepcid, and prednisone. She returned to work at 1:30 PM and is doing fine.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Tachycardia, Tearfulness, Vision blurred, Visual impairment
Clinical narrative: Patient felt very dizzy, complained of blurred vision and "seeing spots". Patient stated she felt like she couldn't stand and felt like vomiting when offered food or liquids. EMT's were onsite and took her BP which was normal both sitting and orthostatic. EMT's stated she had tachycardia which subsided within a few minutes. Patient was tearful and seemed nervous. Patient said she had chills and felt freezing, I oberved she was warm to touch (within normal limits). She stated that she had not eaten all morning but had drank a coffee. She was offered water and a granola bar - patient refused saying it made her want to "vomit". She was then taken by EMS to a local hospital because she was not feeling any better. Her vital signs remained normal. The hospital treated her for an "allergic reaction" and she was given Benadryl, Pepcid, and prednisone. She returned to work at 1:30 PM and is doing fine.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Hives, itching all over body. The hives / rash outbreaks are still occurring from 09-12-2012 to date 10-18-2012.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy complaining that arm soreness has lasted 3 weeks after receiving her flu vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Reports headache, nausea, sweating, dizziness, lightheadedness.
Age: 73.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pain, swelling and redness of site and upper arm.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Rash vesicular
Clinical narrative: Small, fluid filled blisters on arms, chest, abdomen, waist, behind ears, and smaller blisters on inner thighs. Patient states blisters resemble "Chicken Pox".
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Headache, Nausea
Clinical narrative: Hot/cold spells, nausea headache. Headache persists on and off, varying in intensity/duration.