chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Pharyngeal oedema, Shock
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 04 October 2012. A 66-year-old female patient received an intramuscular injection dose of FLUZONE HIGH-DOSE, sanofi pasteur Inc., (lot number not reported) on 25 September 2012. On the same day, 25 September 2012, the patient developed chest pains, shortness of breath, throat swelling, difficulty swallowing and hypotension with blood pressure (BP) 84/50. The patient was taken to the emergency department (ED) and treated with Prednisone and BENADRYL. The patient claims she went into shock and was hospitalized for two days and released from the hospital. The patient stated her electrocardiogram "(EKG) was ok", on date not specified. The patient denied allergies and claimed to be in good health. She denied any illness at time of vaccination and denied any other vaccinations within prior four weeks of vaccination. The patient's outcome was reported as recovered on unspecified date (and also reported as unknown). Follow-up information was received from the consumer, who was also the patient, on 16 November 2012. The patient had influenza vaccinations every year for the last six years and never had an allergic reaction. The patient never received FLUZONE HIGH-DOSE in previous years. The patient received the vaccine at 3:30 PM on 25 September 2012 and the symptoms began within three hours of vaccination. The patient was admitted to the hospital from 25 September 2012 to 27 September 2012. She was released when she was able to talk (with hoarseness), swallow and breathe. The patient had a follow-up with an internist on 02 October 2012 and an ear, nose, and throat (ENT) doctor on 05 October 2012. It was suggested that the patient wait several weeks before being prescribed swallow test and the patient opted to wait for further tests. As of the day of the report, swallowing was normal, breathing was normal and the patient had a full recovery. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Feeling hot, Headache, Pain
Clinical narrative: A 49-year-old female patient, had received an intramuscular dose of FLUZONE (lot number and dose were not reported) in right deltoid on 14 November 2012. The patient's had no illness at the time of vaccination. On 14 November 2012 i.e. 3.5 hours after vaccination, the patient had experienced symptoms of feeling hot, headache, itchy feeling at right shoulder and back. On 14 November 2012, the patient had redness at the upper extremity, soreness, and burning sensation at the right upper extremity and back, low grade temperature, localized hives at the injection site and blood pressure was 154/81. The corrective medications were not reported. The patient's outcome was recovered. Documents held by sender: no. This case is linked to case number 2013-08218 (same reporter, same patient). Follow-up information received from healthcare professional on 26 July 2013. The patient received FLUZONE from batch number: UH732AB. The patient had experienced unspecified adverse event with flu vaccine of unknown manufacturer at 41-years of age. This case is linked to case number 2013-08218 (0) (same patient, same reporter, different event).
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia
Clinical narrative: A 49-year-old female patient, had received an intramuscular dose of FLUZONE (lot number and dose were not reported) in right deltoid on 14 November 2012. The patient's had no illness at the time of vaccination. On 14 November 2012 i.e. 3.5 hours after vaccination, the patient had experienced symptoms of feeling hot, headache, itchy feeling at right shoulder and back. On 14 November 2012, the patient had redness at the upper extremity, soreness, and burning sensation at the right upper extremity and back, low grade temperature, localized hives at the injection site and blood pressure was 154/81. The corrective medications were not reported. The patient's outcome was recovered. Documents held by sender: no. This case is linked to case number 2013-08218 (same reporter, same patient). Follow-up information received from healthcare professional on 26 July 2013. The patient received FLUZONE from batch number: UH732AB. The patient had experienced unspecified adverse event with flu vaccine of unknown manufacturer at 41-years of age. This case is linked to case number 2013-08218 (0) (same patient, same reporter, different event).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 31 October 2012. Cluster of 5 patients developed the adverse event following the administration of FLUZONE HD (lot number U4492BA). Case was non-valid as individual patient identification is missing. The 5 patients, whose age, gender, medical history was not reported, had received a dose of FLUZONE HD vaccine, lot number: U4429BA intramuscularly (site of vaccination was not reported) on an unspecified date. On an unspecified date, the patients experienced stomach ailment and vomiting. The corrective treatments and laboratory investigations were not reported. The patients' outcome was unknown. List of documents held by sender: None. The follow-up information received from health care professional on 08 April 2013. Patient information provided (thus case is valid). The patient had not received any other vaccine within 4 weeks of vaccination with FLUZONE. Patient had no illness at the time of vaccination. A 76-year-old female patient had received FLUZONE vaccine on 01 October 2012 at 11:10 am. The patient had experienced vomiting and stomach discomfort on 10 October 2012 at 6.00 pm. AT the time of this report the patient had recovered from events to an unspecified date. Upon internal review, the case 2013-00640 was identified as duplicate of 2013-00579. Hence case 2013-00579 is the reference case and 2013-00640 will be deleted.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Neck pain, Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 06 December 2012. A 47-year-old male patient, whose medical history included allergy ro sulfa based medicinces and had no reported concomitant medications, had received an intramuscular dose of FLUZONE (lot number, dose and site of administration were not reported) on 04 December 2012 at 08:00 am. On 04 December 2012 at 06:30 pm, the patient was presented with chills, neck ache, muscle ache widespread and fever of 102.3F. It was reported that, the symptoms lasted for 24 hours. The patient had no illness at time of vaccination. Corrective treatment details were not reported. Relevant diagnostic tests/laboratory data were reported as none. The patient had recovered from the events on an unspecified date. Follow up information received from a health care professional (physician) on 03 April 2013. The reporter details were updated. The patient had no illness at the time of vaccination and had not received any other vaccinations within 4 weeks of FLUZONE administration. The patient had received FLUZONE (batch number: U4734AA, expiry date: 6/30/2013) on the left deltoid. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received on 15 July 2013 and follow-up information received on 16 July 2013 from a consumer. A female patient whose date of birth, age at the time of event, medical history and concomitant medications were not reported, had received an intramuscular 0.5 ml dose of FLUZONE SV 2012-2013 vaccine (batch number UH716AD and anatomical site of administration was not reported) on 23 October 2012. On an unspecified date, few weeks after the vaccination, the patient had experienced adverse event NOS on the arm. Corrective treatment and laboratory investigations were not reported. At the time of this report, outcome of the event was not reported. Documents held by sender: Image of reaction site.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint swelling, Peripheral swelling, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 09 October 2012. A 71-year-old male patient received a dose of FLUZONE HD (lot number U4496AA) intramuscularly in the left deltoid area on 02 October 2012. On the same day patient also received PNEUMOVAX vaccine (Lot number not reported) intramuscularly in the right deltoid area. The patient had no acutely illness at the time of vaccination, however has history of Arthritis (AAA), thyroid nodule, prostate cancer, hypercholesterol, shingles 2009, HTN, tobacco user, erectile dysfunction and is currently on medication with ASA, VIAGRA, low dose statins, OMEGA 3 and HCTZ. On 05 October 2012 i.e. 3 days after the vaccination, the patient developed low grade fever and bilateral wrist and thumb swelling. Laboratory investigations were none as per reporter. The patient received NSAIDS as corrective medication. On an unspecified date, the patient had recovered from the events. List of documents held by sender: None. Follow-up information received from a healthcare professional on 17 December 2012. The patient had no illness at the time of vaccination. Patient demographics updated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Influenza like illness, Injection site pain, Lethargy
Clinical narrative: Initial report received from a consumer (the patient) on 28 August 2013: A 68-year-old female patient had received an intramuscular second dose of FLUZONE HIGH DOSE (lot number not reported) in the left deltoid on 26 August 2013. The patients had no illness at the time of vaccination. The patient's pre-existing allergies and medical condition included hay fever, sulfa, perfumes and cosmetics allergy, allergic bronchitis, sleep apnea, thyroid and HTN (hypertension). The patient had received FLUZONE HIGH DOSE for 2 years. On 26 August 2013, the patient had soreness and redness of throat. On 27 August 2013, in the morning, the patient developed aching, myalgia, barely soreness at the injection site, flu like symptoms, lethargic, headache and body ache. On 27 August 2013, at night, the patient presented coughing and had running nose. Laboratory details were not reported and corrective medication includes Tylenol (Acetaminophen). At the time of this report, the patient had not recovered from the symptoms. Documents held by sender: none
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Oropharyngeal pain, Pain, Pharyngeal erythema, Rhinorrhoea
Clinical narrative: Initial report received from a consumer (the patient) on 28 August 2013: A 68-year-old female patient had received an intramuscular second dose of FLUZONE HIGH DOSE (lot number not reported) in the left deltoid on 26 August 2013. The patients had no illness at the time of vaccination. The patient's pre-existing allergies and medical condition included hay fever, sulfa, perfumes and cosmetics allergy, allergic bronchitis, sleep apnea, thyroid and HTN (hypertension). The patient had received FLUZONE HIGH DOSE for 2 years. On 26 August 2013, the patient had soreness and redness of throat. On 27 August 2013, in the morning, the patient developed aching, myalgia, barely soreness at the injection site, flu like symptoms, lethargic, headache and body ache. On 27 August 2013, at night, the patient presented coughing and had running nose. Laboratory details were not reported and corrective medication includes Tylenol (Acetaminophen). At the time of this report, the patient had not recovered from the symptoms. Documents held by sender: none
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 04 September 2013. A 77-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number: U4715AA, expiry date: 04/06/2014 and dose in series was not reported) in the right deltoid and also received an intramuscular dose of PNEUMOVAX vaccine from Merck (batch number: JOO4747 and dose in series was not reported) in the left deltoid on 03 September 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 04 September 2013, one day after vaccination, the patient developed generalized tingling due to which she woke up every hour during the night. No laboratory investigations were done and corrective treatment were not reported. On an unspecified date, the patient recovered from the event.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Middle insomnia, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 04 September 2013. A 77-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number: U4715AA, expiry date: 04/06/2014 and dose in series was not reported) in the right deltoid and also received an intramuscular dose of PNEUMOVAX vaccine from Merck (batch number: JOO4747 and dose in series was not reported) in the left deltoid on 03 September 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 04 September 2013, one day after vaccination, the patient developed generalized tingling due to which she woke up every hour during the night. No laboratory investigations were done and corrective treatment were not reported. On an unspecified date, the patient recovered from the event.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Cold sweat, Feeling cold, Feeling hot
Clinical narrative: Initial report received from a consumer on 12 November 2012. A 75-year-old female patient, whose concomitant medications were not reported, received first dose of FLUZONE HD vaccine (lot number: Unknown, route and site of vaccination was not reported) 14 September 2012. The patient had had autoimmune disease called polymyalgia rheumatic 10 years ago and she had received prednisone for the same for duration of 6 months after which it resolved. The patient also has history of subtotal parathyroid surgery. She had several flu vaccines in the past (the details not provided). On an unspecified date, 2 weeks after the vaccination, the patient developed chills, constant upper body feeling of cold and clamminess. The patient had seen many healthcare professionals, however; laboratory investigations and corrective medications were not reported. As of 12 November 2012, the patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from consumer (patient) on 19 December 2012. It was reported that the symptoms had not changed as she had a feeling of heat and feels like sweating in arms, legs and feet. The patient had done MRIs, blood tests and other tests (results not reported). The patient was seeking alternative treatments (not specified).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a consumer on 12 November 2012. A 75-year-old female patient, whose concomitant medications were not reported, received first dose of FLUZONE HD vaccine (lot number: Unknown, route and site of vaccination was not reported) 14 September 2012. The patient had had autoimmune disease called polymyalgia rheumatic 10 years ago and she had received prednisone for the same for duration of 6 months after which it resolved. The patient also has history of subtotal parathyroid surgery. She had several flu vaccines in the past (the details not provided). On an unspecified date, 2 weeks after the vaccination, the patient developed chills, constant upper body feeling of cold and clamminess. The patient had seen many healthcare professionals, however; laboratory investigations and corrective medications were not reported. As of 12 November 2012, the patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from consumer (patient) on 19 December 2012. It was reported that the symptoms had not changed as she had a feeling of heat and feels like sweating in arms, legs and feet. The patient had done MRIs, blood tests and other tests (results not reported). The patient was seeking alternative treatments (not specified).
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Generalised erythema, Injection site erythema, Retching
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot # K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the pain with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Follow up information has been received from the medical assistant on 04-AUG-2015. On 28-MAY-2015 at 10:14, the patient was vaccinated with PROQUAD (Merck) on left thigh. Concomitant therapy included KINRIX. No adverse events prior to vaccination. On 28-MAY-2015 less than 5 minutes after vaccination, the patient experienced facial skin flushing and generalized urticarial lesions of face and body, injection site where the patient was administered the vaccine swelled up into a large hive and RN (coded as runny nose). The patient was immediately given BENADRYL 2 teaspoons followed by epinephrine subcutaneously and DEPO MEDROL shot 40 mg intramuscularly. The patient fully recovered on the same day (28-MAY-2015). Upon internal review the event generalized urticarial lesions and facial skin flushing were determined to be medically significant. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot # K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the pain with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Follow up information has been received from the medical assistant on 04-AUG-2015. On 28-MAY-2015 at 10:14, the patient was vaccinated with PROQUAD (Merck) on left thigh. Concomitant therapy included KINRIX. No adverse events prior to vaccination. On 28-MAY-2015 less than 5 minutes after vaccination, the patient experienced facial skin flushing and generalized urticarial lesions of face and body, injection site where the patient was administered the vaccine swelled up into a large hive and RN (coded as runny nose). The patient was immediately given BENADRYL 2 teaspoons followed by epinephrine subcutaneously and DEPO MEDROL shot 40 mg intramuscularly. The patient fully recovered on the same day (28-MAY-2015). Upon internal review the event generalized urticarial lesions and facial skin flushing were determined to be medically significant. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Flushing, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot # K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the pain with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Follow up information has been received from the medical assistant on 04-AUG-2015. On 28-MAY-2015 at 10:14, the patient was vaccinated with PROQUAD (Merck) on left thigh. Concomitant therapy included KINRIX. No adverse events prior to vaccination. On 28-MAY-2015 less than 5 minutes after vaccination, the patient experienced facial skin flushing and generalized urticarial lesions of face and body, injection site where the patient was administered the vaccine swelled up into a large hive and RN (coded as runny nose). The patient was immediately given BENADRYL 2 teaspoons followed by epinephrine subcutaneously and DEPO MEDROL shot 40 mg intramuscularly. The patient fully recovered on the same day (28-MAY-2015). Upon internal review the event generalized urticarial lesions and facial skin flushing were determined to be medically significant. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Injection site urticaria, Pain, Retching, Rhinorrhoea, Sneezing
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot # K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the pain with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Follow up information has been received from the medical assistant on 04-AUG-2015. On 28-MAY-2015 at 10:14, the patient was vaccinated with PROQUAD (Merck) on left thigh. Concomitant therapy included KINRIX. No adverse events prior to vaccination. On 28-MAY-2015 less than 5 minutes after vaccination, the patient experienced facial skin flushing and generalized urticarial lesions of face and body, injection site where the patient was administered the vaccine swelled up into a large hive and RN (coded as runny nose). The patient was immediately given BENADRYL 2 teaspoons followed by epinephrine subcutaneously and DEPO MEDROL shot 40 mg intramuscularly. The patient fully recovered on the same day (28-MAY-2015). Upon internal review the event generalized urticarial lesions and facial skin flushing were determined to be medically significant. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot # K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the pain with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Follow up information has been received from the medical assistant on 04-AUG-2015. On 28-MAY-2015 at 10:14, the patient was vaccinated with PROQUAD (Merck) on left thigh. Concomitant therapy included KINRIX. No adverse events prior to vaccination. On 28-MAY-2015 less than 5 minutes after vaccination, the patient experienced facial skin flushing and generalized urticarial lesions of face and body, injection site where the patient was administered the vaccine swelled up into a large hive and RN (coded as runny nose). The patient was immediately given BENADRYL 2 teaspoons followed by epinephrine subcutaneously and DEPO MEDROL shot 40 mg intramuscularly. The patient fully recovered on the same day (28-MAY-2015). Upon internal review the event generalized urticarial lesions and facial skin flushing were determined to be medically significant. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Enlarged lymph node on right clavicle. Swollen biceps right side, red and tender to the touch.
Age: 1.93
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Laboratory test normal, Seizure
Clinical narrative: Reported from mother that client had a seizure. State taken to hospital and "checked out where his tests looked ok.  We are home now and he seems way better and acting more normal now".
Age: 1.69
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother reported redness and swelling at injection site, was seen by PCM and given Benadryl.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Development of linear rash on the side of trunk and onto abdomen.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: PER PATIENT: "WOKE UP AT 4:30 COULD BARELY MOVE LEFT ARM AND HAD STABBING PAIN IN LEFT SIDE. PAIN IS CONSTANT LIKE NEEDLE PRICKS BUT WHEN ARM IS LIFTED IT FEELS LIKE SOMETHING IS STABBING ME. TOOK A MUSCLE RELAXER AND IT EASES THE PAIN AND ALLOWS ME TO MOVE MY ARM AROUND."
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling hot, Vomiting
Clinical narrative: Woke with vomiting.  Has vomited 4 times this morning. Feels warm.  Mom did not take temperature.
Age: 57.0
Sex: F
Vaccine: HEP, TD
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting began 7/31/15 - 8/3/15.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electrocardiogram, Syncope, Unresponsive to stimuli
Clinical narrative: Patient had a syncopal episode in the passageway outside of treatment room about 1-2 minutes after receiving vaccinations. Patient was helped to the ground by mother of patient who shouted for a corpsman. Corpsman was unable to rouse patient by tapping/shaking shoulders but patient was aroused after he performed a sternal rub. Patient was unresponsive for approximately 10 seconds. Patient's BP was taken on scene and reported as 78/50 and heart rate was 60. Code was called and patient was escorted to emergency room.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Gait disturbance, Muscular weakness, Myalgia
Clinical narrative: Extreme joint and muscle pain over entire body. Weakness particularly in neck and legs, difficulty walking, loss of appetite.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular, Rash pustular
Clinical narrative: Maculopapular and pustular rash started on trunk.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site mass, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: MOTHER REPORTED 8-7-15 THAT CHILD DEVELOPED A APPROX QUARTER-SIZED SWOLLEN, HARD, RED "LUMP" UNDER VACCINE SITE TO (L) LEG.  REPORTED WAS WARM TO THE TOUCH.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Fever, loss of arm mobility requiring physical therapy, severe pain - ongoing.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dysphagia, Dyspnoea, Injection site swelling, Rash
Clinical narrative: Swelling right deltoid, facial rash, difficulty breathing/swallowing 24 hours after administration.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: INDURATION AND REDNESS AT INJECTION SITE.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Reports approx 8pm 8-5-15 that her (L) arm was red and swollen approx 2 inches in diameter from injection site of tetanus shot.  On 8-6-15 at 11 pm, she reports becoming nauseous & vomiting x 3 this AM (8-7-15) at approx 7:30.  Patient is unsure if nausea & vomiting if related to immunization or possibly food poisoning.  Reports taking Dramamine this morning for nausea and plans to continue use for nausea.  Advised to apply cold compress to site and Ibuprofen or other NSAID for swelling to area.  May also use Benadryl if needed.  Reports no fever or drainage from injection site.  Advised uncertain if nausea/vomiting related to vaccine, however, to monitor for fever for this as well and to insure hydration.  If she feels she is becoming dehydrated to seek medical intervention at MD or ER.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Malaise, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 30 November 2012. A 73-year-old male patient, whose date of birth, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of administration were not reported) on an unspecified date. This patient is a doctor. On an unspecified date, the patient presented fever, malaise and dehydration. Corrective treatment and laboratory investigations were not reported. The patient outcome was not reported. Documents held by sender: none.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 20 November 2012. An 84-year old male patient, who was allergic to PCN (Penicillin), illness at the time of vaccination was none and whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD vaccine, batch number: U4491AA on left deltoid on 11 October 2012. On an unspecified date, after receiving FLUZONE HD vaccine, the patient experienced bruising from the left deltoid to the bicep, almost to the elbow and soreness to the same area. The patient had no difficulty with movement of the arm. Laboratory investigations were none and corrective treatment was not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Initial report received from a healthcare professional who is the patient on 01 November 2012. A 72-year-old female patient, with a history of back pain from herniated disc and illness at the time of vaccination was reported as none, had received a dose of FLUZONE HD vaccine in left deltoid (Lot number, dose number and route of vaccination were not reported) on 26 October 2012. On 26 October 2012, after receiving the vaccine, the patient presented swelling, redness, pain and tender to touch area around the injection site. The patient also experienced muscle aches in the left arm, headache, and irritability. As of 01 November 2012, some of the symptoms have subsided such as redness and swelling but other events were not recovered. Laboratory details were none and corrective treatment was not reported. The patient's outcome was not recovered. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Initial report received from a healthcare professional who is the patient on 01 November 2012. A 72-year-old female patient, with a history of back pain from herniated disc and illness at the time of vaccination was reported as none, had received a dose of FLUZONE HD vaccine in left deltoid (Lot number, dose number and route of vaccination were not reported) on 26 October 2012. On 26 October 2012, after receiving the vaccine, the patient presented swelling, redness, pain and tender to touch area around the injection site. The patient also experienced muscle aches in the left arm, headache, and irritability. As of 01 November 2012, some of the symptoms have subsided such as redness and swelling but other events were not recovered. Laboratory details were none and corrective treatment was not reported. The patient's outcome was not recovered. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: A 71-year old female patient had received an intramuscular dose of FLUZONE (lot number: U4524AA, site of vaccination was not reported) on 27 October 2012. The patient's medical history included anxiety, depression, knee pain and allergy to sulfa. Illness at the time of vaccination was none. The patient had received FLUZONE HD on an unspecified date in 2011. The patient's concomitant medications included Naprosyn (naproxen), Cymbalta (Duloxetine), Exforge (amlodipine and Valsartan), Ativan (lorazepam) and Tramadol. It was reported that on 28 October 2012, 1 day after vaccination, the patient presented 4x4 inch area of bruising with minor swelling at injection site. No medical intervention. Laboratory details and treatment information were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Dysgeusia, Ocular hyperaemia
Clinical narrative: A 68-year old female patient, who had no illness at the time of vaccination, allergies included Prednisone and concomitant medication were not reported, had received an intramuscular dose of FLUZONE HD (lot number: U4498BA) on left arm on 22 October 2012. On 22 October 2012, within an hour of vaccination, the patient experienced metallic taste in mouth which lasted about an hour. Later on same day, the patient presented discomfort in throat. The patient was observed at the pharmacy. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Follow up information received fro a healthcare professional on 25 January 2013. On 22 October 2012 approximately at 7-8 PM that evening, the patient's eyes turned red. The patient's concomitant medication included Lorazepam 0.5 mg tablets. On an unspecified date the following day, all symptoms were resolved. Documents  held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: A female patient (age not reported) whose medical history or concomitant medications was unknown had received an intramuscular dose of FLUZONE HD vaccine (lot number and site of administration not reported) on 17 October 2012. On 18 October 2012, i.e. one day post vaccination, the patient experienced violent tremors that were shaking the bed. The lab investigations and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender:  none.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dry eye, Eye irritation, Feeling abnormal
Clinical narrative: Initial report received from a healthcare professional (veterinarian) on 17 October 2012. The male patient (date of birth: 31 December 1943), whose medical history and concomitant medications were not reported, had received FLUZONE HD (batch number, route and site of administration were not reported) and a few weeks ago at 3:00 M on an unspecified date. On an unspecified date, after receiving FLUZONE HD vaccine, by 5:30 PM the patient started began to "fee funny", his eyes felt dry and irritated and began to feel unwell. Approximately one hour later the patient developed joint pain, muscle aches, felt cold and had to chills. The patient did not take his temperature and was not certain if he had a fever. The patient did not require medical treatment or intervention for his symptoms and was not seen by physician. The laboratory investigations were not reported. By 4:30 AM the following day, the outcome was recovered. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Malaise, Myalgia
Clinical narrative: Initial report received from a healthcare professional (veterinarian) on 17 October 2012. The male patient (date of birth: 31 December 1943), whose medical history and concomitant medications were not reported, had received FLUZONE HD (batch number, route and site of administration were not reported) and a few weeks ago at 3:00 M on an unspecified date. On an unspecified date, after receiving FLUZONE HD vaccine, by 5:30 PM the patient started began to "fee funny", his eyes felt dry and irritated and began to feel unwell. Approximately one hour later the patient developed joint pain, muscle aches, felt cold and had to chills. The patient did not take his temperature and was not certain if he had a fever. The patient did not require medical treatment or intervention for his symptoms and was not seen by physician. The laboratory investigations were not reported. By 4:30 AM the following day, the outcome was recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 16 October 2012. The female patient, over the age of 65 years) initials, date of birth were not reported) whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. After receiving FLUZONE HD vaccine, the patient had swelling of entire arm. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: none
Age: 85.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: Initial report received on 07 May 2013 from an investigation participating in a study. A 86-year-old female subject was diagnosed with Bell's Palsy on 02 MAY 2013, i.e. 193 days after receiving the first dose of study vaccine (FLUZONE High Dose or FLUZONE) on 21 October 2012 (site and route of administration were not reported). The subject had medical history of bilateral cataracts, mild sinus problems, bilateral dry eyes, thyroid diease, blood clot near pituitary gland, hyperlipidemia, anemia, cholelithiasis, left inguinal hernia, osteoarthritis bilateral hands and right knee, pain bilateral knees, TIA, overactive bladder, Bjorgren's syndrome and polyclonal gammopathy. On the evening of 02 MAY 2013, the subject noticed that the left side of her face started sagging and she couldn't close her left eyelid. Subject went to the ER on 03 MAY 2013 and was diagnosed with Bell's Palsy. The event of Bell's palsy was other important medical event. The subject's complementary investigations were not reported. As per subject report, subject started on steroid and Prozac. The outcome of event Bell's palsy along with the symptom of left side of face sagging and unable to close left eyelid was not reported. According to the investigator, the event was not related to the study vaccine or trial procedures. The serious adverse event did not lead to the termination of the subject form the study.  List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: HEPA, JEV1
Symptoms: Headache, Meningitis viral, Musculoskeletal stiffness, Neck pain
Clinical narrative: Approximately 2 hours after the JE (Ixiaro) vaccine patient developed a headache. The headache became "pretty severe" and lasted about 2 weeks in all. She also developed neck pain and stiffness. She says she isn't sure if the neck pain and stiffness may have been from her holding her neck stiff because the headache was bad. She saw her PCP and was evaluated in his office. PCP thought there was a chance at one point that she had a "mild case" of viral meningitis but was not concerned enough about this to send her to ER or for evaluation/LP for this. She went to physical therapy for her neck stiffness. She states she is mostly recovered at this point and headache and neck pain and stiffness are pretty much gone.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dry mouth, Pain, Throat tightness
Clinical narrative: I had severe chills, felt as if I was in tube of ice water, I ached all over, mouth very dry, tightness in my throat. I had a horrible night.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Client received Hepatitis A, Menactra, and Tdap vaccine.  Within one minute of administering the vaccine, client got very light headed and turned white.  He asked for some water, I gave him a bottle of water.  He was sweaty and cold. His dad was there to help.  We kept telling him to take deep breaths and he was.  He stated he felt like he was going to throw up, and he did.  Once he threw up, he felt much better.  He stayed seated for about 10 minutes and color returned to his face.  He waited in our office for about another 20 minutes and stated he felt fine.  He left with his father.  Of note: a very similar incident happened with his older brother when he received a vaccine here about 2 years ago.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Vomiting
Clinical narrative: Client received Hepatitis A, Menactra, and Tdap vaccine.  Within one minute of administering the vaccine, client got very light headed and turned white.  He asked for some water, I gave him a bottle of water.  He was sweaty and cold. His dad was there to help.  We kept telling him to take deep breaths and he was.  He stated he felt like he was going to throw up, and he did.  Once he threw up, he felt much better.  He stayed seated for about 10 minutes and color returned to his face.  He waited in our office for about another 20 minutes and stated he felt fine.  He left with his father.  Of note: a very similar incident happened with his older brother when he received a vaccine here about 2 years ago.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Apnoeic attack, Blood culture, CSF culture, Chest X-ray abnormal, Culture urine
Clinical narrative: Patient was a 4 y.o. previously healthy female with PMHx sig for ex-32 weeker twin who went to NICU and had a grade I IVH at birth. She presents as a step-down from the PICU secondary to febrile seizure after receiving MMR and Kinrix vaccines who developed aspiration pneumonia and needed to be intubated in the ER secondary to apnea, extubated 2 hours later. She had a Tmax of 39.2 at the OSH and a Tlast of 38.5 today at 04:26, but is currently afebrile at 36.6. Mom says the child received her 4 y.o. vaccines (MMR, IPV, DTAP) yesterday AM at her PMD's office, and went to daycare afterwards. She picked the child up from daycare at approx 5:45 pm, and while in the car, the pt stopped moving and was fixated to her right side. 911 was immediately called. The pt then began to have a tonic-clonic seizure that lasted >20 minutes witnessed. Per mom she did not defecate or urinate during seizure. She received 2 g of Ativan in the ER. She then became apneic and was intubated. She was then transferred to another hospital PICU. She was found to have an upper lobe aspiration PNA and was treated with Clindamycin and Ceftriaxone, Day 1/2. Blood, urine, and CSF cultures have been obtained and we will follow these results. Neurology, was consulted and a spot EEG was normal. She was discharged the following day a with normal neuro exam.