chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This case was received on 23 June 2011 via a third party query tool search on the VAERS database, under reference number 420793. A 26-year-old male patient with a history of tobacco use, received a right arm injection of ACAM2000 (lot number VV04003) on 22 March 2011. On 01 April 2011, 10 days post-vaccination, he experienced an onset of chest pain which he attributed to smoking. However, after 3 days of tobacco cessation the chest pain continued, and the patient presented to the urgent care clinic on 04 April 2011. Laboratory investigations revealed elevated Troponin 1 and diffuse ST elevation on ECG. The patient was hospitalized, and the event was ongoing at the time of the report. Follow-up information was received on 26 January 2012 from the investigator. This case was determined to be a duplicate report of study case number 2011-10513. Case 2011-03775 will remain the case of reference and will be updated by adding the coded events and with information previously captured in case 2011-10513 (which will be subsequently deleted from our safety database). The following information is verbatim from case 2011-10513: This study case was received from the investigator in trial on 28 October 2011. A 26 year-old male subject with a medical history of high blood pressure was found to have an unspecified disease of the pericardium 23 days after he had received on 22 March 2011 an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I (highest recorded value not reported) and an abnormal ECG on 04 April 2011. On 18 April 2011, the subject had an abnormal echocardiogram. On 08 June 2011, the subject had a normal MRI of the heart. A lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Follow-up information was received on 22 October 2012 from the investigator. On 04 April 2011, 13 days post vaccination, the subject was diagnosed with pericarditis. The subject presented with sudden onset of chest pain for four days, which was substernal, non-radiating, sharp, constant, and increased when patient lied down and was not relieved by non-steroidal anti-inflammatory drugs (NSAID's). Subject complained of shortness of breath, nausea, and was febrile. 13 days post vaccination, the electrocardiogram (ECG) results showed diffuse ST elevation of acute pulmonary disease. 15 days post vaccination, the echocardiogram showed hyperkinesis,akinesis, IVC dilation positive, pericardial effusion, ejection fraction 64%, left ventricular function normal, and the electrocardiogram showed normal sinus rhythm, R axis deviation, ST and T were abnormality, prolonged QT and abnormal ECG. The Troponin 1 level was positive (H) with controls acceptable. Hospital admission lasted 8 days. The subject was diagnosed with persistent pericarditis and continued to by symptomatic. The subject's outcome was not recovered. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram normal, Electroencephalogram abnormal, Fall, Gaze palsy
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A patient of unknown age who on an unspecified date was vaccinated with doses of GARDASIL (lot #, doses and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed generalized seizure disorder (medically significant) with in a few months of receiving GARDASIL. Also it was reported that the patient's brother were now of a age to receive HPV vaccine. At the time of the report, the patient's outcome was not reported. Generalized seizure disorder was considered as a important medical event by the reporter. This was originally reported by a Physician. Additional information has been received from an unspecified reporter, through the vaccine adverse experience reporting system, concerning the 17 year old (now 20 year old) female patient. It was reported that the patient had a history of Gastrooesophageal reflux with several ureter repairs. On 12-DEC-2007 and on 14-DEC-2007 the patient received the first and second dose of GARDASIL respectively (dose and route were unspecified) (lot # and expiration dates unknown). On 18-APR-2008, the patient received intramuscularly, the third dose of GARDASIL (lot #: 659182/1757U). There was no illness at the time of vaccination. It was reported that on 24-JUN-2008 at 07:00 am, the patient's parents responded to loud sound on patient's room. They found her shaking/trembling with eyes rolled back in head and felling off the bed. It was reported that it lasted 2-3 minutes. On the same date, patient was taken to the emergency room for evaluation and testing and was hospitalized for two days. A magnetic resonance imaging (MRI) was performed with results of: venous anomaly; otherwise normal. Also an electrocardiogram (ECG) was performed, which showed generalized seizure, normal sinus rhythm and tracing within normal limits. Reporter stated that following that episode patient had "a number more" with similar signs and symptoms. The patient was diagnosed with seizure disorder and placed on medication. The patient's parents reported episodes of syncope between ages 11 to 12 and question absence of seizures that began 2 years prior to vaccine administration. At the time of the report, the patient had recovered from the events. Additional information is not expected. Update (25-Oct-2012): Follow up information received via office of responsible physician. Patient's weight and height added. Patient received last vaccination with GARDASIL in her right arm. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Tremor, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A patient of unknown age who on an unspecified date was vaccinated with doses of GARDASIL (lot #, doses and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed generalized seizure disorder (medically significant) with in a few months of receiving GARDASIL. Also it was reported that the patient's brother were now of a age to receive HPV vaccine. At the time of the report, the patient's outcome was not reported. Generalized seizure disorder was considered as a important medical event by the reporter. This was originally reported by a Physician. Additional information has been received from an unspecified reporter, through the vaccine adverse experience reporting system, concerning the 17 year old (now 20 year old) female patient. It was reported that the patient had a history of Gastrooesophageal reflux with several ureter repairs. On 12-DEC-2007 and on 14-DEC-2007 the patient received the first and second dose of GARDASIL respectively (dose and route were unspecified) (lot # and expiration dates unknown). On 18-APR-2008, the patient received intramuscularly, the third dose of GARDASIL (lot #: 659182/1757U). There was no illness at the time of vaccination. It was reported that on 24-JUN-2008 at 07:00 am, the patient's parents responded to loud sound on patient's room. They found her shaking/trembling with eyes rolled back in head and felling off the bed. It was reported that it lasted 2-3 minutes. On the same date, patient was taken to the emergency room for evaluation and testing and was hospitalized for two days. A magnetic resonance imaging (MRI) was performed with results of: venous anomaly; otherwise normal. Also an electrocardiogram (ECG) was performed, which showed generalized seizure, normal sinus rhythm and tracing within normal limits. Reporter stated that following that episode patient had "a number more" with similar signs and symptoms. The patient was diagnosed with seizure disorder and placed on medication. The patient's parents reported episodes of syncope between ages 11 to 12 and question absence of seizures that began 2 years prior to vaccine administration. At the time of the report, the patient had recovered from the events. Additional information is not expected. Update (25-Oct-2012): Follow up information received via office of responsible physician. Patient's weight and height added. Patient received last vaccination with GARDASIL in her right arm. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram abnormal, Fall, Gaze palsy, Malformation venous
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A patient of unknown age who on an unspecified date was vaccinated with doses of GARDASIL (lot #, doses and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed generalized seizure disorder (medically significant) with in a few months of receiving GARDASIL. Also it was reported that the patient's brother were now of a age to receive HPV vaccine. At the time of the report, the patient's outcome was not reported. Generalized seizure disorder was considered as a important medical event by the reporter. This was originally reported by a Physician. Additional information has been received from an unspecified reporter, through the vaccine adverse experience reporting system, concerning the 17 year old (now 20 year old) female patient. It was reported that the patient had a history of Gastrooesophageal reflux with several ureter repairs. On 12-DEC-2007 and on 14-DEC-2007 the patient received the first and second dose of GARDASIL respectively (dose and route were unspecified) (lot # and expiration dates unknown). On 18-APR-2008, the patient received intramuscularly, the third dose of GARDASIL (lot #: 659182/1757U). There was no illness at the time of vaccination. It was reported that on 24-JUN-2008 at 07:00 am, the patient's parents responded to loud sound on patient's room. They found her shaking/trembling with eyes rolled back in head and felling off the bed. It was reported that it lasted 2-3 minutes. On the same date, patient was taken to the emergency room for evaluation and testing and was hospitalized for two days. A magnetic resonance imaging (MRI) was performed with results of: venous anomaly; otherwise normal. Also an electrocardiogram (ECG) was performed, which showed generalized seizure, normal sinus rhythm and tracing within normal limits. Reporter stated that following that episode patient had "a number more" with similar signs and symptoms. The patient was diagnosed with seizure disorder and placed on medication. The patient's parents reported episodes of syncope between ages 11 to 12 and question absence of seizures that began 2 years prior to vaccine administration. At the time of the report, the patient had recovered from the events. Additional information is not expected. Update (25-Oct-2012): Follow up information received via office of responsible physician. Patient's weight and height added. Patient received last vaccination with GARDASIL in her right arm. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A patient of unknown age who on an unspecified date was vaccinated with doses of GARDASIL (lot #, doses and site of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed generalized seizure disorder (medically significant) with in a few months of receiving GARDASIL. Also it was reported that the patient's brother were now of a age to receive HPV vaccine. At the time of the report, the patient's outcome was not reported. Generalized seizure disorder was considered as a important medical event by the reporter. This was originally reported by a Physician. Additional information has been received from an unspecified reporter, through the vaccine adverse experience reporting system, concerning the 17 year old (now 20 year old) female patient. It was reported that the patient had a history of Gastrooesophageal reflux with several ureter repairs. On 12-DEC-2007 and on 14-DEC-2007 the patient received the first and second dose of GARDASIL respectively (dose and route were unspecified) (lot # and expiration dates unknown). On 18-APR-2008, the patient received intramuscularly, the third dose of GARDASIL (lot #: 659182/1757U). There was no illness at the time of vaccination. It was reported that on 24-JUN-2008 at 07:00 am, the patient's parents responded to loud sound on patient's room. They found her shaking/trembling with eyes rolled back in head and felling off the bed. It was reported that it lasted 2-3 minutes. On the same date, patient was taken to the emergency room for evaluation and testing and was hospitalized for two days. A magnetic resonance imaging (MRI) was performed with results of: venous anomaly; otherwise normal. Also an electrocardiogram (ECG) was performed, which showed generalized seizure, normal sinus rhythm and tracing within normal limits. Reporter stated that following that episode patient had "a number more" with similar signs and symptoms. The patient was diagnosed with seizure disorder and placed on medication. The patient's parents reported episodes of syncope between ages 11 to 12 and question absence of seizures that began 2 years prior to vaccine administration. At the time of the report, the patient had recovered from the events. Additional information is not expected. Update (25-Oct-2012): Follow up information received via office of responsible physician. Patient's weight and height added. Patient received last vaccination with GARDASIL in her right arm. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site cellulitis, Pyrexia, Ultrasound scan, X-ray
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 years old female patient with leukemia-in remission and drug reactions/allergies to IV contrast. The patient was vaccinated with 0.5 ml PNEUMOVAX23 on 11-SEP-2012. Other suspect therapies included PROVENTIL with dosage information as (unk). Concomitant medications included SYNTHROID, PROVIGIL and interferon (unspecified). On 13-SEP-2012 the patient experienced cellulitis, 3 days after onset of therapy. The patient developed 10 by 12 cm warmth and redness at the injection site along with fever and chills. The patient went to the hospital emergency room. The patient was released after treatment clindamycin. Product lot#/Exp Date were reported as 0653AE, 10-Feb-2012. The reporter was requesting a lot check of this vaccine due to the adverse experiences. This is the first of two cases reported. The outcome of cellulitis was reported as recovered/resolved. The relatedness for cellulitis is unknown for PNEUMOVAX23 and PROVENTIL. This is one of several reports form the same source (1209USA011191). Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 years old female patient with leukemia-in remission and drug reactions/allergies to IV contrast. The patient was vaccinated with 0.5 ml PNEUMOVAX23 on 11-SEP-2012. Other suspect therapies included PROVENTIL with dosage information as (unk). Concomitant medications included SYNTHROID, PROVIGIL and interferon (unspecified). On 13-SEP-2012 the patient experienced cellulitis, 3 days after onset of therapy. The patient developed 10 by 12 cm warmth and redness at the injection site along with fever and chills. The patient went to the hospital emergency room. The patient was released after treatment clindamycin. Product lot#/Exp Date were reported as 0653AE, 10-Feb-2012. The reporter was requesting a lot check of this vaccine due to the adverse experiences. This is the first of two cases reported. The outcome of cellulitis was reported as recovered/resolved. The relatedness for cellulitis is unknown for PNEUMOVAX23 and PROVENTIL. This is one of several reports form the same source (1209USA011191). Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Chest pain, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Extreme pain in left arm body aches, fever. Blood work positive for muscle inflammation and infection. Body aches and fever were gone in about 24 hours but pain lasted 3-4 days and was quite severe.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Blood test abnormal, Infection, Myositis, Pain, Pain in extremity
Clinical narrative: Extreme pain in left arm body aches, fever. Blood work positive for muscle inflammation and infection. Body aches and fever were gone in about 24 hours but pain lasted 3-4 days and was quite severe.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Extreme pain in left arm body aches, fever. Blood work positive for muscle inflammation and infection. Body aches and fever were gone in about 24 hours but pain lasted 3-4 days and was quite severe.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eye irritation, Eye pruritus, Heart rate increased, Lacrimation increased
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 15 October 2012 with additional information received on 16 October 2012. A 62-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH751AB, on 11 October 2012 at 10:00 AM. Two hours post-vaccination, around 12:00 PM, the patient had swelling in her face, nose and lips, mucosa became swollen, eyes became bloodshot, had shortness of breath (SOB), she became disoriented and her throat began to close so she was transported to the emergency room (ER). The patient's body was shaking and she could see cyanosis in her fingers. Treatments included epinephrine and prednisone. The patient stayed in the ER for approximately four hours until she was stable. The patient followed up with her primary care physician on 15 October 2012. She still had a raspy voice. The patient had recovered but felt some lagging effects such as her voice is stressed, she still has mild bouts of SOB and feels lightheaded at times. The patient had no illness at the time of vaccination and no past medical history. The patient received a previous influenza vaccine a few years ago. The patient did not receive any other immunizations on the day of the FLUZONE vaccination. The patient had an allergy to onions and gets a raspy voice when she eats onions or anything that comes into contact with onions. The patient's outcome was not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling, Pharyngeal oedema, Speech disorder, Swollen tongue
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 15 October 2012 with additional information received on 16 October 2012. A 62-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH751AB, on 11 October 2012 at 10:00 AM. Two hours post-vaccination, around 12:00 PM, the patient had swelling in her face, nose and lips, mucosa became swollen, eyes became bloodshot, had shortness of breath (SOB), she became disoriented and her throat began to close so she was transported to the emergency room (ER). The patient's body was shaking and she could see cyanosis in her fingers. Treatments included epinephrine and prednisone. The patient stayed in the ER for approximately four hours until she was stable. The patient followed up with her primary care physician on 15 October 2012. She still had a raspy voice. The patient had recovered but felt some lagging effects such as her voice is stressed, she still has mild bouts of SOB and feels lightheaded at times. The patient had no illness at the time of vaccination and no past medical history. The patient received a previous influenza vaccine a few years ago. The patient did not receive any other immunizations on the day of the FLUZONE vaccination. The patient had an allergy to onions and gets a raspy voice when she eats onions or anything that comes into contact with onions. The patient's outcome was not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cyanosis, Disorientation, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 15 October 2012 with additional information received on 16 October 2012. A 62-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH751AB, on 11 October 2012 at 10:00 AM. Two hours post-vaccination, around 12:00 PM, the patient had swelling in her face, nose and lips, mucosa became swollen, eyes became bloodshot, had shortness of breath (SOB), she became disoriented and her throat began to close so she was transported to the emergency room (ER). The patient's body was shaking and she could see cyanosis in her fingers. Treatments included epinephrine and prednisone. The patient stayed in the ER for approximately four hours until she was stable. The patient followed up with her primary care physician on 15 October 2012. She still had a raspy voice. The patient had recovered but felt some lagging effects such as her voice is stressed, she still has mild bouts of SOB and feels lightheaded at times. The patient had no illness at the time of vaccination and no past medical history. The patient received a previous influenza vaccine a few years ago. The patient did not receive any other immunizations on the day of the FLUZONE vaccination. The patient had an allergy to onions and gets a raspy voice when she eats onions or anything that comes into contact with onions. The patient's outcome was not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lip swelling, Ocular hyperaemia, Oedema mucosal, Swelling face, Throat tightness
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 15 October 2012 with additional information received on 16 October 2012. A 62-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH751AB, on 11 October 2012 at 10:00 AM. Two hours post-vaccination, around 12:00 PM, the patient had swelling in her face, nose and lips, mucosa became swollen, eyes became bloodshot, had shortness of breath (SOB), she became disoriented and her throat began to close so she was transported to the emergency room (ER). The patient's body was shaking and she could see cyanosis in her fingers. Treatments included epinephrine and prednisone. The patient stayed in the ER for approximately four hours until she was stable. The patient followed up with her primary care physician on 15 October 2012. She still had a raspy voice. The patient had recovered but felt some lagging effects such as her voice is stressed, she still has mild bouts of SOB and feels lightheaded at times. The patient had no illness at the time of vaccination and no past medical history. The patient received a previous influenza vaccine a few years ago. The patient did not receive any other immunizations on the day of the FLUZONE vaccination. The patient had an allergy to onions and gets a raspy voice when she eats onions or anything that comes into contact with onions. The patient's outcome was not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Initial report was received from a healthcare professional, who was also the patient, on 15 October 2012 with additional information received on 16 October 2012. A 62-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH751AB, on 11 October 2012 at 10:00 AM. Two hours post-vaccination, around 12:00 PM, the patient had swelling in her face, nose and lips, mucosa became swollen, eyes became bloodshot, had shortness of breath (SOB), she became disoriented and her throat began to close so she was transported to the emergency room (ER). The patient's body was shaking and she could see cyanosis in her fingers. Treatments included epinephrine and prednisone. The patient stayed in the ER for approximately four hours until she was stable. The patient followed up with her primary care physician on 15 October 2012. She still had a raspy voice. The patient had recovered but felt some lagging effects such as her voice is stressed, she still has mild bouts of SOB and feels lightheaded at times. The patient had no illness at the time of vaccination and no past medical history. The patient received a previous influenza vaccine a few years ago. The patient did not receive any other immunizations on the day of the FLUZONE vaccination. The patient had an allergy to onions and gets a raspy voice when she eats onions or anything that comes into contact with onions. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Chest pain, Headache, Pain in extremity, Photophobia
Clinical narrative: Initial report was received from a consumer on 18 October 2012. A female patient had received an injection of FLUZONE High-Dose, lot number U4499AA (date, route and site not reported). On the day of vaccination, the patient experienced a sore arm and that evening and next day experienced severe headache and tightness in chest. The symptoms lasted for one week and did not get any better so the patient was hospitalized for three days. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Headache, Pain in extremity
Clinical narrative: Initial report was received from a consumer on 18 October 2012. A female patient had received an injection of FLUZONE High-Dose, lot number U4499AA (date, route and site not reported). On the day of vaccination, the patient experienced a sore arm and that evening and next day experienced severe headache and tightness in chest. The symptoms lasted for one week and did not get any better so the patient was hospitalized for three days. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was unknown. Documents held by sender: None.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Skin warm
Clinical narrative: FAINT, LEFT ARM WARM TO TOUCH, SWOLLEN FROM SITE TO WRIST.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Injection site swelling, Oedema peripheral, Skin warm, Syncope
Clinical narrative: FAINT, LEFT ARM WARM TO TOUCH, SWOLLEN FROM SITE TO WRIST.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Asthenia, Dyspnoea, Fatigue, Infection, Injection site erythema
Clinical narrative: This consumer report (initial receipt 16-Oct-2012) concerns a 45 year old female patient with a medical history of pneumonia 6 weeks ago, mitral valve condition, anxiety, high blood pressure and pleural effusion. Concomitant medications included steroids, hydrocodone, albuterol, esomeprazole, propranolol, zolpidem, alprazolam, combination ethinylestradiol and levonorgestrel and paroxetine. There were no known drug reactions or allergies. On 12-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported). The patient also received co-suspect vaccine, PNEUMOVAX as recommended by the pulmonologist. A 0.5 mL dose injection of PNEUMOVAX was administered. On 13-Oct-2012, the day following vaccination, the patient developed a hard, raised lump along with a cluster (5 inch diameter) red rash and pain and tenderness at the insertion site. She was weak, fatigued and had difficulty breathing, "like walking a flight of stairs". The date of initial adverse event onset was 12-Oct-2012. The patient felt like when she had pneumonia. The patient was treated with diphenhydramine and acetaminophen. The patient was not recovered at the time of reporting.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: This consumer report (initial receipt 16-Oct-2012) concerns a 45 year old female patient with a medical history of pneumonia 6 weeks ago, mitral valve condition, anxiety, high blood pressure and pleural effusion. Concomitant medications included steroids, hydrocodone, albuterol, esomeprazole, propranolol, zolpidem, alprazolam, combination ethinylestradiol and levonorgestrel and paroxetine. There were no known drug reactions or allergies. On 12-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported). The patient also received co-suspect vaccine, PNEUMOVAX as recommended by the pulmonologist. A 0.5 mL dose injection of PNEUMOVAX was administered. On 13-Oct-2012, the day following vaccination, the patient developed a hard, raised lump along with a cluster (5 inch diameter) red rash and pain and tenderness at the insertion site. She was weak, fatigued and had difficulty breathing, "like walking a flight of stairs". The date of initial adverse event onset was 12-Oct-2012. The patient felt like when she had pneumonia. The patient was treated with diphenhydramine and acetaminophen. The patient was not recovered at the time of reporting.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Asthenia, Dyspnoea, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: This consumer report (initial receipt 16-Oct-2012) concerns a 45 year old female patient with a medical history of pneumonia 6 weeks ago, mitral valve condition, anxiety, high blood pressure and pleural effusion. Concomitant medications included steroids, hydrocodone, albuterol, esomeprazole, propranolol, zolpidem, alprazolam, combination ethinylestradiol and levonorgestrel and paroxetine. There were no known drug reactions or allergies. On 12-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported). The patient also received co-suspect vaccine, PNEUMOVAX as recommended by the pulmonologist. A 0.5 mL dose injection of PNEUMOVAX was administered. On 13-Oct-2012, the day following vaccination, the patient developed a hard, raised lump along with a cluster (5 inch diameter) red rash and pain and tenderness at the insertion site. She was weak, fatigued and had difficulty breathing, "like walking a flight of stairs". The date of initial adverse event onset was 12-Oct-2012. The patient felt like when she had pneumonia. The patient was treated with diphenhydramine and acetaminophen. The patient was not recovered at the time of reporting.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site mass, Injection site pain, Injection site rash
Clinical narrative: This consumer report (initial receipt 16-Oct-2012) concerns a 45 year old female patient with a medical history of pneumonia 6 weeks ago, mitral valve condition, anxiety, high blood pressure and pleural effusion. Concomitant medications included steroids, hydrocodone, albuterol, esomeprazole, propranolol, zolpidem, alprazolam, combination ethinylestradiol and levonorgestrel and paroxetine. There were no known drug reactions or allergies. On 12-Oct-2012, the patient received flu vaccine (manufacturer unspecified, batch number not reported). The patient also received co-suspect vaccine, PNEUMOVAX as recommended by the pulmonologist. A 0.5 mL dose injection of PNEUMOVAX was administered. On 13-Oct-2012, the day following vaccination, the patient developed a hard, raised lump along with a cluster (5 inch diameter) red rash and pain and tenderness at the insertion site. She was weak, fatigued and had difficulty breathing, "like walking a flight of stairs". The date of initial adverse event onset was 12-Oct-2012. The patient felt like when she had pneumonia. The patient was treated with diphenhydramine and acetaminophen. The patient was not recovered at the time of reporting.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot number reported as H009826, expiration date 11-FEB-2014) on 09-OCT-2012. No other co-suspects were administered. No concomitant medications were administered. On 11-OCT-2012 the patient developed cellulitis infection. No lab diagnostic studies were performed. The patient sought medical attention by contacting pharmacist. The patient was treated with KEFLEX. The outcome of cellulitis infection was reported as recovering/resolving. The relatedness for cellulitis infection was unknown for PNEUMOVAX 23. The reporting pharmacist was requesting a lot check on this product. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot number reported as H009826, expiration date 11-FEB-2014) on 09-OCT-2012. No other co-suspects were administered. No concomitant medications were administered. On 11-OCT-2012 the patient developed cellulitis infection. No lab diagnostic studies were performed. The patient sought medical attention by contacting pharmacist. The patient was treated with KEFLEX. The outcome of cellulitis infection was reported as recovering/resolving. The relatedness for cellulitis infection was unknown for PNEUMOVAX 23. The reporting pharmacist was requesting a lot check on this product. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Blood pressure increased, Endotracheal intubation, Eosinophil percentage increased, Muscular weakness
Clinical narrative: 10/14/2012 Several weeks of non productive cough, generalized weakness, along with paresthesia in her lower limbs. Her weakness progressed to the point which she had difficulty ambulating and was unable to do her daily chores without assistance. On admission on 10/14/2012 she continued to have progressive weakness which progressed to respiratory failure.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neutrophil percentage increased, Paraesthesia, Paralysis, Plasmapheresis
Clinical narrative: 10/14/2012 Several weeks of non productive cough, generalized weakness, along with paresthesia in her lower limbs. Her weakness progressed to the point which she had difficulty ambulating and was unable to do her daily chores without assistance. On admission on 10/14/2012 she continued to have progressive weakness which progressed to respiratory failure.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, CSF test normal, Computerised tomogram head normal, Cough
Clinical narrative: 10/14/2012 Several weeks of non productive cough, generalized weakness, along with paresthesia in her lower limbs. Her weakness progressed to the point which she had difficulty ambulating and was unable to do her daily chores without assistance. On admission on 10/14/2012 she continued to have progressive weakness which progressed to respiratory failure.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Gait disturbance, Paraesthesia, Respiratory failure, West Nile virus test negative
Clinical narrative: 10/14/2012 Several weeks of non productive cough, generalized weakness, along with paresthesia in her lower limbs. Her weakness progressed to the point which she had difficulty ambulating and was unable to do her daily chores without assistance. On admission on 10/14/2012 she continued to have progressive weakness which progressed to respiratory failure.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood immunoglobulin M decreased, Borrelia test negative, Eosinophil count increased, Mechanical ventilation, Monocyte count increased
Clinical narrative: On 10/15/2012 - around midnight when patient trying to go to the bathroom, she noticed some numbness in her both lower extremities particularly the left leg. Again around 4 am she woke up to go to the bathroom when her lower extremity felt significantly numb. Her left leg felt weak as well. She also noticed some tingling involving the tips of her fingers. Admitted on 10/15/2012. Symptoms progressively got worse and on 10/19/2012 developed respiratory failure.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Monocytosis, Neutrophil count increased, Paraesthesia, Plasmapheresis, Protein total decreased
Clinical narrative: On 10/15/2012 - around midnight when patient trying to go to the bathroom, she noticed some numbness in her both lower extremities particularly the left leg. Again around 4 am she woke up to go to the bathroom when her lower extremity felt significantly numb. Her left leg felt weak as well. She also noticed some tingling involving the tips of her fingers. Admitted on 10/15/2012. Symptoms progressively got worse and on 10/19/2012 developed respiratory failure.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Respiratory muscle weakness, White blood cell count increased
Clinical narrative: On 10/15/2012 - around midnight when patient trying to go to the bathroom, she noticed some numbness in her both lower extremities particularly the left leg. Again around 4 am she woke up to go to the bathroom when her lower extremity felt significantly numb. Her left leg felt weak as well. She also noticed some tingling involving the tips of her fingers. Admitted on 10/15/2012. Symptoms progressively got worse and on 10/19/2012 developed respiratory failure.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: On 10/15/2012 - around midnight when patient trying to go to the bathroom, she noticed some numbness in her both lower extremities particularly the left leg. Again around 4 am she woke up to go to the bathroom when her lower extremity felt significantly numb. Her left leg felt weak as well. She also noticed some tingling involving the tips of her fingers. Admitted on 10/15/2012. Symptoms progressively got worse and on 10/19/2012 developed respiratory failure.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Respiratory failure
Clinical narrative: On 10/15/2012 - around midnight when patient trying to go to the bathroom, she noticed some numbness in her both lower extremities particularly the left leg. Again around 4 am she woke up to go to the bathroom when her lower extremity felt significantly numb. Her left leg felt weak as well. She also noticed some tingling involving the tips of her fingers. Admitted on 10/15/2012. Symptoms progressively got worse and on 10/19/2012 developed respiratory failure.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (reported lot number H012575) in the right arm on 17-OCT-2012. Route was not reported. No other co-suspects were reported. Concomitant medications included: AFLURIA (reported lot number 07349211A), administered on the same day in the left arm. On 17-OCT-2012 the patient developed a half dollar size knot at injection site and a baseball size red spot around injection site. The patient was advised to take BENADRYL and to apply a cold compress. The outcome the events was unknown. The relatedness for the events was not reported for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (reported lot number H012575) in the right arm on 17-OCT-2012. Route was not reported. No other co-suspects were reported. Concomitant medications included: AFLURIA (reported lot number 07349211A), administered on the same day in the left arm. On 17-OCT-2012 the patient developed a half dollar size knot at injection site and a baseball size red spot around injection site. The patient was advised to take BENADRYL and to apply a cold compress. The outcome the events was unknown. The relatedness for the events was not reported for ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Inflammation, Middle insomnia, Pruritus, Rash erythematous, Sleep talking
Clinical narrative: Patient woke up talking in his sleep and saying his feet itched.  He had large, red, inflamed bumps all over the tops of each foot and the itching was enough to wake him up.  Took him to Emergency Room for review and evaluation.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Drug administered at inappropriate site, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Shot was given very high in my arm and hurt worse than any previous shot given. After shot my shoulder hurt and ached, and has continued to hurt. It has been almost 4 weeks and I have pain and aching through my neck and shoulder and down my arm. Feels like the pain is in my bone.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Shot was given very high in my arm and hurt worse than any previous shot given. After shot my shoulder hurt and ached, and has continued to hurt. It has been almost 4 weeks and I have pain and aching through my neck and shoulder and down my arm. Feels like the pain is in my bone.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Crying, Irritability, Rash
Clinical narrative: Child spiked temperature of 103. The temperature lasted for 3 days off and on, and on the 3rd day she came down with a rash all over her torso and face. She has been extremely fussy and crying a lot.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Oedema peripheral, Syncope, Vomiting
Clinical narrative: Patient reported swelling of arm 10-20 minutes after administration. While at home, patient became nauseous, fainted & began vomiting. She called EMS who took her to hospital. She reported hospital did not treat her for allergic reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Bronchial irritation, Heart rate increased, Injection site erythema, Injection site rash
Clinical narrative: On 9-20-2012 at about 5:20pm, I received a ZOSTAVAX (shingles) vaccine at pharmacy by the pharmacist. Within 5 minutes, I felt like my heart was beating fast and I felt my bronchial tubes get tickly (asthma like). Also I had a rash at site of shot. The next day it was big as a fist. I still have a red mark and I had to go to the doctor on 9-25-12 for persistent rash (red mark) and asthma symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Heart rate increased, Pyrexia, Throat irritation
Clinical narrative: On 9-20-2012 at about 5:20pm, I received a ZOSTAVAX (shingles) vaccine at pharmacy by the pharmacist. Within 5 minutes, I felt like my heart was beating fast and I felt my bronchial tubes get tickly (asthma like). Also I had a rash at site of shot. The next day it was big as a fist. I still have a red mark and I had to go to the doctor on 9-25-12 for persistent rash (red mark) and asthma symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: On 9-20-2012 at about 5:20pm, I received a ZOSTAVAX (shingles) vaccine at pharmacy by the pharmacist. Within 5 minutes, I felt like my heart was beating fast and I felt my bronchial tubes get tickly (asthma like). Also I had a rash at site of shot. The next day it was big as a fist. I still have a red mark and I had to go to the doctor on 9-25-12 for persistent rash (red mark) and asthma symptoms.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness. Nausea.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical history of recent massive heart attack and narcolepsy. He had no known drug allergy. He was taking 'a lot of medications' (type unspecified). On 11-Oct-2012 the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL intramuscularly. On the day of vaccination, the patient did not complain of any symptoms and went home without any adverse events. On 13-Oct-2012 the patient was found dead. The cause of death was still being investigated. According to the pharmacist (reporter), the patient had many health problems including a recent massive heart attack (date unspecified).
Age: 0.53
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Electroencephalogram normal, Musculoskeletal stiffness
Clinical narrative: Pt. returned to office approximately 1 1/2 hr after receiving adtp & hib vaccine due to stiffening and flexing motion to body - especially in arms & neck that started 45 minutes after vaccine given.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a female patient, who had allergy to sulfa antibiotics. On an unknown date the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) and had trouble breathing. The event outcome was not reported. On 18-Oct-2012 the pharmacist considered event to be serious as it was life-threatening and resulted in significant disability or incapacity.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Feeling cold, Headache, Hot flush
Clinical narrative: I woke up next day w/ splitting headache, aches & pains all over my body, dizzy & weak with hot & cold flashes. This lasted 6 days. Dr said take 2 TYLENOL every 4 hrs until you feel better. I was weak & dizzy for 2 weeks after that, but finally got to feeling better. It left me so weak.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: I woke up next day w/ splitting headache, aches & pains all over my body, dizzy & weak with hot & cold flashes. This lasted 6 days. Dr said take 2 TYLENOL every 4 hrs until you feel better. I was weak & dizzy for 2 weeks after that, but finally got to feeling better. It left me so weak.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Culture throat positive, Fatigue, Laboratory test
Clinical narrative: Initial case received from a consumer on 18 October 2012. A 12 year old male patient was administered an intramuscular injection of ADACEL on 24 August 2011, lot number not reported. The patient's medical history and concomitant medications were not reported. Several months later on an unspecified date in September 2012, the patient began having an excessive cough. The patient was assessed by a physician on an unknown date and a throat culture was performed. The culture results were positive for pertussis. Laboratory tests performed and the tests results were not specified. The patient was prescribed antibiotics on an unknown date. Details of treatment were not reported. The patient outcome is not yet recovered at the time of the report and the patient is reported as still coughing and is often tired. No further details were available at the time of this report. Documents held by sender: None.