chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Haematochezia, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Initial reported received on 31 October 2014 and follow up information received on 06 November 2014 and 08 November 2014 from an investigator participating in a trial. An 83-year-old male subject was diagnosed with Hematochezia on 30 October 2014 i.e. 20 days after the subject had received first dose of FLUZONE QUADRIVALENT (lot number, route and site of administration not reported), 10 October 2014. The event appeared after visit 1. The subject's medical history was not reported. The subject had no concomitant medications. The subject had associated symptom of severe anemia from 30 October 2014. The subject was hospitalized on 30 October 2014. The subject's wife reported that the subject experienced a possible TIA (Transient Ischemic Attack) and was seen at the emergency room . The subject's labs were done and severe anemia was diagnosed. The subject was sent to the hospital in ICU where he received 2 units of blood as a corrective measure. The subject's further diagnostic tests would be done. The subject's complementary investigations were not reported. The subject recovered from the event of Hematochezia on 04 November 2014. According to the investigator, the event was not related to the study vaccine, trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow-up information received on 13 November 2014: The subject had medical history of coronary heart disease, cardio vascular attacks, atrial fibrillation, hypertension, arthritis, enlarged prostate, alzheimer, dyslipidemia and prostate cancer. Concomitant medications were Finasteride, Pravastatin, Furosemide, NAMENDA, ARICEPT, Losartan, Famotidine, XARELTO. Carvedilol and Aspirin. Subject's wife reported a possible ischemic attack (previously reported as TIA) and was seen at the ER. Labs done, severe anemia was diagnosed and sent to the hospital, in intensive care receiving 4 units of blood (previously reported as 2 units of blood). Complementary investigations were colonoscopy which was unremarkable, CBC showed hematocrit and hemoglobin improved, echocardiogram showed ejection fraction of 30%, carotid duplex scan showed no evidence of carotid artery disease and CT scan abdomen and pelvis was unremarkable. It was reported that the subject was discontinued with XARELTO. The subject had received 4 units of blood (previously reported as 2 units of blood). The associated symptom of severe anemia was resolved on 04 November 2014 and the subject was discharged from the hospital on the same day i.e. 04 November 2014. According to the investigator, the event was not related to the concomitant medications. Follow up information received on 04 December 2014 and 09 December 2014. The subject had received first dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid region (batch number UI158AA) on 10 October 2014.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Intensive care, Transfusion, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: Initial reported received on 31 October 2014 and follow up information received on 06 November 2014 and 08 November 2014 from an investigator participating in a trial. An 83-year-old male subject was diagnosed with Hematochezia on 30 October 2014 i.e. 20 days after the subject had received first dose of FLUZONE QUADRIVALENT (lot number, route and site of administration not reported), 10 October 2014. The event appeared after visit 1. The subject's medical history was not reported. The subject had no concomitant medications. The subject had associated symptom of severe anemia from 30 October 2014. The subject was hospitalized on 30 October 2014. The subject's wife reported that the subject experienced a possible TIA (Transient Ischemic Attack) and was seen at the emergency room . The subject's labs were done and severe anemia was diagnosed. The subject was sent to the hospital in ICU where he received 2 units of blood as a corrective measure. The subject's further diagnostic tests would be done. The subject's complementary investigations were not reported. The subject recovered from the event of Hematochezia on 04 November 2014. According to the investigator, the event was not related to the study vaccine, trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow-up information received on 13 November 2014: The subject had medical history of coronary heart disease, cardio vascular attacks, atrial fibrillation, hypertension, arthritis, enlarged prostate, alzheimer, dyslipidemia and prostate cancer. Concomitant medications were Finasteride, Pravastatin, Furosemide, NAMENDA, ARICEPT, Losartan, Famotidine, XARELTO. Carvedilol and Aspirin. Subject's wife reported a possible ischemic attack (previously reported as TIA) and was seen at the ER. Labs done, severe anemia was diagnosed and sent to the hospital, in intensive care receiving 4 units of blood (previously reported as 2 units of blood). Complementary investigations were colonoscopy which was unremarkable, CBC showed hematocrit and hemoglobin improved, echocardiogram showed ejection fraction of 30%, carotid duplex scan showed no evidence of carotid artery disease and CT scan abdomen and pelvis was unremarkable. It was reported that the subject was discontinued with XARELTO. The subject had received 4 units of blood (previously reported as 2 units of blood). The associated symptom of severe anemia was resolved on 04 November 2014 and the subject was discharged from the hospital on the same day i.e. 04 November 2014. According to the investigator, the event was not related to the concomitant medications. Follow up information received on 04 December 2014 and 09 December 2014. The subject had received first dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid region (batch number UI158AA) on 10 October 2014.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Initial report received from a healthcare professional on 21 November 2014. This is a linked case of 2014SA163350. A 08-year-old male patient, whose medical history and concomitant medication were not reported, received a dose of FLUZONE batch number, dose, route and site of vaccination were not reported) on an unspecified date in 2013. On unspecified date in 2013, patient had severe local reaction. In 2014, patient received 0.25 ml dose of FLUZONE quadrivalent (half dose) and had severe but manageable local reaction (swelling, redness). Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the events was reported as unknown. Follow-up information was received from the healthcare professional on 25 March 2015. The vaccine administered in 2013 was known to be quadrivalent Influenza, however it was administered at another facility and the lot number was not available to the reporter. The patient was taken to the emergency room at that time to rule out cellulitis (previous report stated that the patient was hospitalized). No additional information was known regarding this event. List of documents held by sender: none.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Upon re-evaluation of the case on 10 February 2015, the case was upgraded to serious from non-serious. Based on the follow-up information received on 19 Dec 2014, this case initially considered as serious was downgraded to non-serious. Initial unsolicited report received on 02 December 2014 from a nurse practitioner.  An 8 year-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number and site of administration not reported), on an unspecified date. Four hours post vaccination, the patient developed a large red area at the injection site. She also experienced vomiting, facial and lip swelling as well as SOB. She was taken to the ER. Concomitant therapies, corrective treatment and complementary investigations were not reported. The patient recovered from the events on an unspecified date. Document held by senders: none. Based on the follow-up information received on 19 Dec 2014 and upon medical review the case is downgrade serious to non-serious due to other medically important condition. Follow-up information received from healthcare professional on 19 Dec 2014. Patient was vaccinated at 4 PM and experienced hives at 8 PM and eye swelling, facial swelling, lip swelling, hypersensitivity to FLUZONE vaccine, SOB which required emergency doctor visit. Patient concomitantly received Flintstones vitamins and Benadryl as needed. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Skin test was positive for vaccination and formaldehyde test was performed and result awaited. Patient was treated with Benadryl, Steroid (oral) and prednisolone. Follow-up information was received from this unsolicited case on 10 February 2015 from a healthcare professional. Upon medical review of the case, the case was upgraded to serious due to seriousness criteria other: important medical event. Patch testing to formaldehyde was also negative. The reporter was unable to determine what part of the vaccine she was sensitive to based on ingredient list online and would like a more comprehensive list for evaluation. Follow-up information received for this unsolicited case on 23 March 2015 from a healthcare professional. The patient was seen on 18 November 2014 and had recovered from the events (exact date of recovery was not provided). He had received the vaccine in October (no details). Results from allergy testing came back negative for formaldehyde and for FLUVIRIN. The patient was still continuing his treatment for Flintstones multiple vitamins and Benadryl without difficulty. Documents held by sender: none. Follow-up information received from a Physician on 7-May-2015. There was no other vaccination 4 weeks prior to the vaccination date. It was reported that the patient was tested negative for FLUVIRIN so the allergen was assumed to be in FLUZONE and FLUVIRIN. The formaldehyde test was negative. She continued to take the test without difficulty. She continued to take Benadryl and multivitamins as corrective treatment without difficulty. The patient had recovered from the events on 18-Nov-2014.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Influenza, Pyrexia
Clinical narrative: Initial unsolicited case received from a consumer, who is also the patient, on 16 February 2015. Another similar event was reported for the patient's husband, captured in case number 2015SA020528. A 58-year-old female patient, with a history of asthma, egg allergy, dairy allergy, and latex allergy, received an intramuscular left deltoid injection of FLUZONE QIV, (lot number not reported) in September 2014. On 13 February 2015, i.e. 5 months post-vaccination, the patient was seen in a clinic and diagnosed with the Flu. Per the reporter, no testing was performed. The event was treated with TAMIFLU and TYLENOL, and remained ongoing. Follow-up information was received from a consumer who is the patient on 03 March 2015. The responsible physician's contact information was provided. The patient began to experience chills, fever, joint pain on 12 February 2015 in the evening. The symptoms progressed until she went to a clinic on 13 February 2015. The adverse event onset was reported as starting on 13 February 2015. Laboratory tests were not performed "due to previous night's diagnosis of her husband and symptoms." The patient was not ill at the time of vaccination and she did not have any other vaccinations within four weeks prior. She did not experience any adverse events after vaccination in the past. The patient has seasonal allergies, animal allergies and dust allergies. The patient outcome is recovered on an unreported date. Follow-up information was received on 17 March 2015 from a physician. The patient's date of recovery is uncertain. No labs were done. The patient was not seen at the facility of the reporter for this event. No further information was available at the time of this report. Documents held by sender: None. Followup information received from a Physician on 6 April 2015. It was reported that patient's concomitant medications were none at the time of vaccination and medical history includes previous vaccination with FLUZONE QIV (at least 2 doses). The batch number of the vaccination was reported as U199AB.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's wife) on 31 March 2015. A male patient, whose age, medical history and concomitant medication were not reported, had received a dose of Flu Vaccine (batch number, expiration date, route of administration, dose and dose cycle were not reported) in arm on 30 March 2015. On 30 March 2015, few minutes after vaccination patient's arm got very tender and painful to touch from the site of administration down to his elbow. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of event was not recovered. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 14 April 2015. A 36-year-old male patient was vaccinated with a dose of Flu Vaccine. Corrective treatments, medical history and laboratory investigations were reported as none. At the time of this report, the outcome of the events was reported as recovered on the same day of vaccination. Documents held by sender: none. Follow-up information received from a consumer on 14 April 2015. It was reported that the patient had increased pain with arm movement same day as vaccination. Concomitant medications, risk factors, medical history, relevant laboratory and diagnostic tests and treatment information reported as none. On an unknown date, the patient recovered from the event. Documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (albumin status: rHA; lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a Consumer (the patient) on 28 October 2014. A 76-year-old male patient had received an intramuscular dose of FLUZONE HD, (batch number and dose in series not reported) in left arm on 28 August 2014. The patient had no illness at the time of vaccination and had no known allergies. On 28 August 2014, same day after vaccination, the patients felt that the injection was "up high near the shoulder". By 13:00 hours, the patient had soreness at the injection site and then became very painful near top of arm and is now between elbow and shoulder. Sometimes it was sore and sometimes dull and sometimes like a knife. The patient was sent to emergency room and was evaluated by physician. Laboratory details and treatment was not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received from a Consumer (the patient) on 13 May 2015. Patient reported that he received flu shot from the pharmacy at clubhouse in his complex in August 2014 with his wife and friends and he was the only one who felt tremendous pain at his arm and was unable to lift up his arm for 3 months. Patient still felt pain and had not recovered yet. He was seen by 6 different doctors who confirmed that events were because of vaccine injected too high and doctor told it was not related to vaccine itself. Patient was still seeing his family doctor. At the time of this report, the patient was not recovered from the event. List of documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: Upon internal review the case initially captured as non-confirmed was changed to medically confirmed in follow-up. Initial unsolicited report received from a non-healthcare professional on 07 November 2014. A 50-year-old female patient, whose medical history and concomitant medication was not reported, had received intramuscularly a dose FLUZONE (batch number: UI192AA) expiry date of vaccine and cycle in series not reported, in arm on 19-Sep-2014, patient's arm swelled up from shoulder to elbow and swelling extended to breast. Corrective treatment and lab investigations were not reported. Pre-existing condition and illness at the time of vaccination was reported as none. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a physician on 3 August 2015. No new information reported. Documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Compartment syndrome, Discomfort, Muscle rigidity, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial unsolicited report received from registered nurse on 19  JANUARY 2015. A female patient of unknown age, whose medical and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UT158AB, expiry date 30 JUN 2015, route of vaccination, dose number was not reported) in deltoid right on an unspecified date. On an unspecified date after vaccination the patient had experienced acute muscle pain and weakness in the arm she had had shot in, some discomfort like a "pinched nerve", could hardly use it. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatments was not reported. It was also reported that patient visited chiropractor and about 95 percent better and able to move it. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. At the time of this report, outcome of the event was not resolved. Documents held by sender: none. Follow up report received from a healthcare professional on 19 FEBRUARY 2015. The patient had a pre-existing history of mild hypertension for which no medications were taken. The patient had no other illness at the time of vaccination and had no other medications.  It was reported that there was no adverse event following prior vaccination. It was reported that the events had resolved (98% resolved) with just some residual pain score of 3 or 4 at the time of reporting. The vaccination was accidentally given in the bursa and not in the deltoid region.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nerve injury
Clinical narrative: Initial unsolicited report received from registered nurse on 19  JANUARY 2015. A female patient of unknown age, whose medical and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UT158AB, expiry date 30 JUN 2015, route of vaccination, dose number was not reported) in deltoid right on an unspecified date. On an unspecified date after vaccination the patient had experienced acute muscle pain and weakness in the arm she had had shot in, some discomfort like a "pinched nerve", could hardly use it. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatments was not reported. It was also reported that patient visited chiropractor and about 95 percent better and able to move it. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. At the time of this report, outcome of the event was not resolved. Documents held by sender: none. Follow up report received from a healthcare professional on 19 FEBRUARY 2015. The patient had a pre-existing history of mild hypertension for which no medications were taken. The patient had no other illness at the time of vaccination and had no other medications.  It was reported that there was no adverse event following prior vaccination. It was reported that the events had resolved (98% resolved) with just some residual pain score of 3 or 4 at the time of reporting. The vaccination was accidentally given in the bursa and not in the deltoid region.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from registered nurse on 19  JANUARY 2015. A female patient of unknown age, whose medical and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UT158AB, expiry date 30 JUN 2015, route of vaccination, dose number was not reported) in deltoid right on an unspecified date. On an unspecified date after vaccination the patient had experienced acute muscle pain and weakness in the arm she had had shot in, some discomfort like a "pinched nerve", could hardly use it. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatments was not reported. It was also reported that patient visited chiropractor and about 95 percent better and able to move it. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. At the time of this report, outcome of the event was not resolved. Documents held by sender: none. Follow up report received from a healthcare professional on 19 FEBRUARY 2015. The patient had a pre-existing history of mild hypertension for which no medications were taken. The patient had no other illness at the time of vaccination and had no other medications.  It was reported that there was no adverse event following prior vaccination. It was reported that the events had resolved (98% resolved) with just some residual pain score of 3 or 4 at the time of reporting. The vaccination was accidentally given in the bursa and not in the deltoid region.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Nausea, Nervousness, Vision blurred
Clinical narrative: Initial report received from Healthcare professional on 16 October 2014. A 42-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (Batch number UI205AD, expiry ate 30 Jun 2015 and dose number was not reported) on 16 October 2014. The patient had had experienced nauseated, feels shaky, sob and blurred vision on 16 October 2014. Lab investigations and corrective treatment were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies asthma headache back issues and birth defects were not reported. At the time of this report the outcome of the event was unknown. List of documents held by sender: none. Follow up unsolicited information received from healthcare professional on 05 January 2015. The patient concomitant medications includes QVAR (unknown dose) and Albuterol HFA MDI "TT" Puff at noon. The patient had received the vaccine via intramuscular route in left deltoid region from multi-dose vial nearly 11 AM. It was reported that the vaccine was purchased with private funds. No laboratory investigations were performed. On 16 October 2014, the patient was recovered from the event. Documents held by sender: none. Addendum: 05 March 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Pyrexia, Swelling
Clinical narrative: Initial report received from a healthcare professional on 14 October 2014. This case is linked to the case 2014SA142449 same reporter and same vaccine. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch  number UI187AB and expiry date 30-JUN-2015) in the left deltoid, on 06-OCT-2014. On 06-OCT-2014, after vaccination the patient had 13 x 9 cm area that was red, swollen, and raised with some numbness in arm going down to fingertips with a fever of 100.4F. Illness at the time of vaccination, Pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient required a doctor or ER visit. Corrective treatment and Laboratory data were not reported. At the time of this report, the outcome of the adverse events was unknown. List of documents held by sender: none. Follow-up information received from a non-health care professional on 06 March 2015. Reporter information was updated. Documents held by sender: none. Follow-up information received from a nurse on 18 March 2015. A 34-year-old patient had received first dose of FLUZONE QIV on 06 October 2014 at 16:00 hours. The patient was not vaccinated with any other vaccination within 4 weeks prior to FLUZONE QIV and had no illness at the time of vaccination. The patient did not experience any adverse event following prior vaccination. On 06 October 2014 at 19:00 hours, three hours after vaccination, the patient developed fever, red, hot raised area 13cm x 9cm that lasted for 5 days. No laboratory tests were performed. Fever, redness and hot raised area lasted for 5 days and numbness resolved on an unspecified date.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Rash generalised, Rash pustular, Urticaria, Varicella
Clinical narrative: Initial report received from healthcare professional on 29 October 2014. A female patient, whose date of birth, age at the time of event and concomitant medications were not reported, had received a dose of FLUZONE ID (batch number UT4993BA, intradermal, dose number and anatomical site of administration were not reported) having expiry date 6 May 2015 on 15 October 2014 in the AM. It was reported that, the patient has no illness at the time of vaccination and has no known allergies. The patient did not receive any other vaccination within four weeks of FLUZONE ID vaccination. It was reported that, the patient has no illness at the time of vaccination and has no known allergies. The patient did not receive any other vaccination within four weeks of FLUZONE ID vaccination. It was reported that on 15 October 2014, on the same day at evening after receiving FLUZONE ID vaccine, the patient had temperature of 102.8 with a full body rash which looked like hives and others looked similar to pustules. As per reporter, it was chicken pox. The patient had temperatures of 102 for almost 2 days. It was reported that, the patient required ER/doctor visit. The patient received BENADRYL and TYLENOL as a corrective treatment for fever and laboratory investigations were unknown. On an unspecified date, the outcome was recovered. Documents held by sender: none. Follow-up information received from a Nurse on 26 January 2015. The patient's date of birth was 11 July 1967 and age at the time of the event was 47 years. The patient had not received any other vaccinations 4 weeks prior to FLUZONE ID administration. The patient had received NASONEX 2 sprays in Arm. The patient had seasonal allergies and no illness at the time of vaccination. It was reported that the rash and hives were spreaded similar to chicken pox.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 28 October 2014. A 37 year old female patient had received a second dose of FLUZONE, (batch number UI200AB, intramuscularly in left deltoid) on 07 October 2014 at 14:30 hours. The patient had no illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 07 October 2014 at 20 hours; after vaccination, the patient presented with sore arm and the arm was warm. The patient could not move arm and the pain was so bad radiating down arm. Three weeks later, the pain radiated to left neck area. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a health care professional on 17 March 2015. It was reported that pain continues in the deltoid area, now has full range of motion most of the time (approximately 80 percent). No primary care evaluation, even though primary care provider contacted by patient. No laboratory of physical therapy treatments were prescribed. No current corrective treatments ordered. Original vaccination occurred at employee influenza vaccination clinic and not at primary care provider. When weather or season changers deltoid region becomes sorer. More recently, less difficulty with gym activities but some arm activities still limited. At the time of the report, the outcome of the event was unknown.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Neuralgia
Clinical narrative: Initial report received from Healthcare professional on 23 October 2014. A 73-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in to the left deltoid on 07 October 2014. The patient can't lift her left arm beyond the level of her shoulder; nerve pain on the left side of her chest wall on 08 October 2014. The patient required emergency room or visited doctor. Lab investigation and corrective treatment were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies, birth defects were reported as none. At the time of this report the outcome of the event was not resolved. List of documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Heart rate increased, Rash macular
Clinical narrative: Initial report received from a healthcare professional on 04 November 2014. A 30-year-old female patient had received dose of FLUZONE QIV (batch number UI205AC, Expire date 30 June 2015), intramuscularly in left deltoid on 03 November 2014. The patient's medical history includes eustachian tube disorder and concomitant medication was not reported. On 03 November 2014 twenty minutes after vaccination, the patient had experienced flushed, blotchy face, rapid pulse. Laboratory investigation was not reported. On 03 November 2014 the patient was treated with 50 mg BENADRYL intramuscularly. Several minutes later i.e. on 03 November 2014 the patient was recovered from event and able to return to work. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Initial report received from a healthcare professional on 01 November 2014. A 79-year-old female patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, (batch number: U5063BA and Exp. date: 06-JUN-2015) cycle in series and site of vaccination not reported on 29-Oct-2014. On an unspecified date, patient can't lift her arm. Illness at the time of vaccination was not reported. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Skin discolouration
Clinical narrative: Initial report received from healthcare professional on 07 Nov 2014. An 81-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, dose, dose number, route and site of vaccination not reported) on 07 Nov 2014. It was reported that on 07 Nov 2014, the patient developed dark or black line and a knot 8-10 inches from her elbow to her hand. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspepsia, Injection site pain
Clinical narrative: Initial report received from consumer on 03 Nov 2014. An 81-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number: UI188AA, expiry: 30 Jun 2015, dose, dose number not reported) in right deltoid, on 21 Oct 2014 at 16:00 hours. The patient had previously vaccinated with flu shots every year, however she developed extreme intense indigestion after flu shot, five years back. It was reported that on 21 Oct 2014, three hours after vaccination at 19:00 hours, the patient had extreme intense indigestion that lasted about 3 hours. The patient also developed soreness and achiness in right shoulder. Lab details and corrective treatments were not reported. The outcome of event was reported as resolved. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Joint swelling, Muscular weakness
Clinical narrative: Based on additional information received on 12 March 2015, the case became medically confirmed. Initial unsolicited report received from Consumer on 14 November 2014. A 65-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Batch number U4995AA, expiry date, route of vaccination and dose number was not reported) in the left deltoid on 13 October 2014. On 14 October 2014, the patient had experienced swollen hands, swollen right knee, intermittent dizziness and terrible pain at around 02:30 AM. The patient had no laboratory investigations and corrective were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included allergies to methotrexate, REMICADE, tetracycline, METAMUCIL, and rheumatoid arthritis. At the time of this report, the outcome of the event was resolving. List of documents held by sender: none. Follow-up information received from a physician on 12 March 2015. Patient had received first dose of 0.5 ml of FLUZONE HD (expiry date: 18 March 2015) on 13 November 2014 at 11:30 hrs (which was previously reported as 13 October 2014) intramuscularly in left arm. Concomitant medications included PLAQUENIL 200 mg, SYNTHROID 25 mcg and REMICADE monthly. The patient had no illness at the time of vaccination. The patient's pre-existing physician-diagnosed allergies, birth defects, medical condition included rheumatoid arthritis, hypothyroidism and osteoporosis. Patient experienced swollen right knee, intermittent dizziness and terrible pain on 14 November 2014 instead of 14 October 2014 which was previously reported. In addition to above events, the patient also experienced swelling in hands, joint pain, muscle pain, muscle weakness, chills and fever on the same day at 2:00 hrs. On an unspecified date, the patient recovered from all the events. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Based on additional information received on 12 March 2015, the case became medically confirmed. Initial unsolicited report received from Consumer on 14 November 2014. A 65-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Batch number U4995AA, expiry date, route of vaccination and dose number was not reported) in the left deltoid on 13 October 2014. On 14 October 2014, the patient had experienced swollen hands, swollen right knee, intermittent dizziness and terrible pain at around 02:30 AM. The patient had no laboratory investigations and corrective were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included allergies to methotrexate, REMICADE, tetracycline, METAMUCIL, and rheumatoid arthritis. At the time of this report, the outcome of the event was resolving. List of documents held by sender: none. Follow-up information received from a physician on 12 March 2015. Patient had received first dose of 0.5 ml of FLUZONE HD (expiry date: 18 March 2015) on 13 November 2014 at 11:30 hrs (which was previously reported as 13 October 2014) intramuscularly in left arm. Concomitant medications included PLAQUENIL 200 mg, SYNTHROID 25 mcg and REMICADE monthly. The patient had no illness at the time of vaccination. The patient's pre-existing physician-diagnosed allergies, birth defects, medical condition included rheumatoid arthritis, hypothyroidism and osteoporosis. Patient experienced swollen right knee, intermittent dizziness and terrible pain on 14 November 2014 instead of 14 October 2014 which was previously reported. In addition to above events, the patient also experienced swelling in hands, joint pain, muscle pain, muscle weakness, chills and fever on the same day at 2:00 hrs. On an unspecified date, the patient recovered from all the events. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Fatigue, Malaise, Nausea
Clinical narrative: Initial report received from Consumer via other company on 29 October 2014. A female patient, whose age, medical history and concomitant medications was not reported, had received a dose of FLUZONE batch number, dose, dose in series, route and site of administration was not reported on an unknown date. On unknown date, after vaccination the patient experienced malaise, fatigue, nausea and clamminess. Patient's corrective treatment and laboratory investigation was not reported. At the time of this report the outcome of event was not reported. Documents held by sender: None. Follow up information received from physician on 20 January 2015. It was reported that the patient had not received the vaccine at the reported medical centre the vaccine was administered elsewhere.
Age: 0.6
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash macular, Streptococcus test negative, Urticaria
Clinical narrative: Initial report received from a health care professional on 04 December 2014. A 07-months-old female patient, had received a first dose of FLUZONE QIV vaccine (lot number: U5064AB, expiry date- 30 Jun 2015, route not reported) in right thigh on 03 December 2014. The patient had no illness at the time of vaccination. The patient did not receive any other vaccinations within 4 weeks of vaccinations of FLUZONE QIV. The patient had no pre-existing physician diagnosed allergies, birth defects and medical conditions. On 03 December 2014 i.e. same day after vaccination patient had developed welts on her back and a red face. It was reported that patient mother called to the answering service and spoke with the physician and physician advised to give BENADRYL and the patient was being brought in this arm for evaluation of possible allergic reaction. Corrective treatment was not reported. No laboratory details. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow Up information received from a Nurse on 26-Jan-2015. A dose of FLUZONE QIV vaccine was given in the right anterior lateral thigh on 03-Dec-2014 at 16:00 hours. The patient did not experience any respiratory and feeding problems. On 03-Dec-2014, at 18:00 hours, the patient developed welts on her back (small erythema macular rash on trunk, face). Laboratory investigations included Rapid strep. test and strep culture. It was reported that the all the results were negative as on 04-Dec-2014. Corrective treatment included "BENADRYL oral". An allergies was to be consulted and the medication "ATARAX 2 mg/kg/day divided every 6 hour" was reported. At the time of this report, the patient had recovered from the event of red face on an unspecified date and the event welts on her back (small erythema macular rash on trunk, face) persisted upto 04-Dec-2014.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test positive, Chest X-ray normal, Computerised tomogram, Productive cough, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a consumer on 03 August 2015. A 65-year-old male patient, had received a dose of FLUZONE HD (batch number was unknown, route and site of administration were not reported) on 09 October 2014. Patient had no illness at the time of vaccination. Patient had a history of PCN (penicillin allergy), history of thyroid disease and CABG (Coronary artery bypass grafting) 2007. Patient took Metformin, Levothyroxine, ASA (Aspirin), Krill Oil, and Glyperide previously. On 10 October 2014, next day after vaccination, the patient developed nasal drip and post nasal drip, described as "large amounts, gushing, makes me gag", severe congestion, drainage from my nose and coughing up phlegm to the point of throwing up. Laboratory investigations included CXR was negative (chest x-ray), CT of nose was performed, skin prick allergy testing was positive for oak pollen and dust mites and blood allergy test was negative. Patient received po ABX (Antibiotics), nasal steroid spray (oral and nasal spray), nasal wash (Saline nasal rinses) and MUCINEX as corrective treatments. Patient required ER Doctor Visit. Patient stated that he has seen primary physician allergist, phone no known, Pulmonologist, 2 other physicians at respective facilities due to symptoms which have continued from next day of vaccination (10 October 2014). At the time of this report, the patient was not recovered from the events nasal drip, post nasal drip, gushing and gagging and outcome of the events severe congestion, drainage from my nose and coughing up phlegm to the point of throwing up were not reported. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Retching, Rhinorrhoea, Upper-airway cough syndrome, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 03 August 2015. A 65-year-old male patient, had received a dose of FLUZONE HD (batch number was unknown, route and site of administration were not reported) on 09 October 2014. Patient had no illness at the time of vaccination. Patient had a history of PCN (penicillin allergy), history of thyroid disease and CABG (Coronary artery bypass grafting) 2007. Patient took Metformin, Levothyroxine, ASA (Aspirin), Krill Oil, and Glyperide previously. On 10 October 2014, next day after vaccination, the patient developed nasal drip and post nasal drip, described as "large amounts, gushing, makes me gag", severe congestion, drainage from my nose and coughing up phlegm to the point of throwing up. Laboratory investigations included CXR was negative (chest x-ray), CT of nose was performed, skin prick allergy testing was positive for oak pollen and dust mites and blood allergy test was negative. Patient received po ABX (Antibiotics), nasal steroid spray (oral and nasal spray), nasal wash (Saline nasal rinses) and MUCINEX as corrective treatments. Patient required ER Doctor Visit. Patient stated that he has seen primary physician allergist, phone no known, Pulmonologist, 2 other physicians at respective facilities due to symptoms which have continued from next day of vaccination (10 October 2014). At the time of this report, the patient was not recovered from the events nasal drip, post nasal drip, gushing and gagging and outcome of the events severe congestion, drainage from my nose and coughing up phlegm to the point of throwing up were not reported. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site scab, Wound
Clinical narrative: Initial unsolicited report received from a physician on 20 August 2015. A 63-year-old female patient, whose concomitant medications were not reported, had received an intradermal dose of FLUZONE ID and an intramuscular dose of PNEUMOVAX (manufacturer Merck) (batch number, dose and site of administration site of administration were not reported for both vaccines) on 9 October 2014. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. On 9 October 2014, same day after vaccination, the patient experienced an injection site reaction and a scab formed at the injection site which fell off and there was a wound. Patient was seen by a MD for wound care. The patient required emergency room or physician visit. Laboratory investigations and corrective treatments were not reported. On an unspecified date the patient was recovered from the vaccination site scab and injection site reaction and wound took 2-3 months to heal. Documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Initial unsolicited report received from a Nurse on 30-DEC-2014. A 46-year-old female patient had received a dose of FLUZONE QIV via intramuscular route in the right arm (batch number was unknown, dose details not reported) on an unspecified date. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On an unspecified date after vaccination, the patient experienced soreness at the injection site especially when patient sleeps on it and occasionally could not lift her right arm over her head. Patient had received a MOTRIN as a corrective treatment. Laboratory investigations were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information received from health care professional on 10 February 2015. Patient had received third dose of FLUZONE QIV (batch number: UI190AA) at 16:30 pm on 19-Nov-2014. On 19-Nov-2014, patient occasionally cannot lift her right arm over her head and had soreness at the injection site. Vaccination within 4 weeks prior vaccine was reported as none. At the time of this report, the event outcome was unknown. Documents held by sender: none. Follow-up information received from health care professional on 24 February 2015. It was reported that the patient received FLUZONE QIV. No additional information provided.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a Nurse on 30-DEC-2014. A 46-year-old female patient had received a dose of FLUZONE QIV via intramuscular route in the right arm (batch number was unknown, dose details not reported) on an unspecified date. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On an unspecified date after vaccination, the patient experienced soreness at the injection site especially when patient sleeps on it and occasionally could not lift her right arm over her head. Patient had received a MOTRIN as a corrective treatment. Laboratory investigations were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information received from health care professional on 10 February 2015. Patient had received third dose of FLUZONE QIV (batch number: UI190AA) at 16:30 pm on 19-Nov-2014. On 19-Nov-2014, patient occasionally cannot lift her right arm over her head and had soreness at the injection site. Vaccination within 4 weeks prior vaccine was reported as none. At the time of this report, the event outcome was unknown. Documents held by sender: none. Follow-up information received from health care professional on 24 February 2015. It was reported that the patient received FLUZONE QIV. No additional information provided.