chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer (the patient) on 22 OCTOBER 2014. A 75-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number and dose in series not reported) in right deltoid on 20  OCTOBER 2014. The patient was feeling tired on the day of vaccination from over activity and pre-existing physician diagnosed allergies, birth defects and medical conditions incudes allergy to shellfish, seasonal rhinitis for which patient received ZYRTEC and cough due to acid reflux. The patient's concomitant medications were not reported. The patient had been receiving yearly flu shot.  On 02 OCTOBER 2014, same day after vaccination, the patient developed weakness, dizziness, low grade fever of 99.6-100.6 degree Celsius. The patient slept the entire day and also experienced soreness at the injection site. IT was reported that the reaction was due to a week immune system but the patient states that she does not have a week immune system. Patient did not seek physician evaluation and treatment. Complimentary investigations were not reported. On 22 OCTOBER 2014, the patient had recovered from the symptoms. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 21 OCTOBER 2014.  A 59 year old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose  of FLUZONE QIV (batch number U5008BA and expiry date not reported) in the left deltoid on 21-OCT-2014. On 21-OCT-2014, two hours after vaccination, the patient called the pharmacy to report that she had red, itchy and swollen left deltoid.  Pharmacist advised her to take BENADRYL. The patient had no illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were none reported. Corrective treatment was not reported and laboratory data were reported as none. At the time of this report the outcome of the adverse events was unknown. List of documents held by sender: none. Follow-up received from a healthcare professional on 27 JANUARY 2015 and 30 JANUARY 2015. It was reported that patient had received dose 1 of vaccine. No relevant laboratory or diagnostic tests were needed and no treatment information was available. The patient recovered after few days on an unspecified date.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain, Rash, Skin warm
Clinical narrative: Initial report received from a consumer on 20 OCTOBER 2014. A 62 year old female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose FLUZONE QIV (batch number and expiry date was not reported) in the left deltoid on 16-OCT-2014. On 17-OCT-2014, one day after vaccination the patient's redness, warmth and swollen area 2 inches below the injection site. There was a rash on back and "tummy". She went to the orthopedic doctor who saw the rash. She is going to her personal doctor today. The patient has pain when she moves the arm. Symptoms eased some, but have not become worse. Pain is still present 3 weeks after vaccination. The patient's illness at the time of vaccination, pre-existing allergies, birth defects and medical conditions was unknown. Corrective treatment and laboratory data were not reported. At the time of this report the patient was not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Initial report received from a non-healthcare professional on 13 OCTOBER 2014. Case is linked to 2014SA129883. A female patient (age not reported), whose concomitant medication were not reported, had received a dose INFLUENZA (batch number, cycle in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, patient experienced cold like symptoms (felt sick). Corrective treatment and laboratory investigations were not reported. Patient previous medication was reported as BETASERON (2009-2009), AVONEX (2009-2009), COPAXONE (2011-2011) and AVONEX (2011-2014). At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30 July 2015. A female patient had received a dose of FLUZONE HD (batch number: U5044BA, expiry date: 24 May 2015, dose, dose in series were not reported) intramuscularly in left deltoid in October 2014. Medical history and concomitant medications were not reported. Illness at the time of vaccination and the patients pre-existing physician diagnosed allergies, birth defects, medical conditions reported as not provided. In October 2014, after vaccination, the patient had developed pain in the left arm, arm was sore and she had difficulty with ROM. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 06-MAY-2015.  A female patient (age not provided), whose medical history and concomitant medications were not reported had received a dose of INFLUENZA (dose details, batch number, route of administration and site of administration were not reported) on an unspecified date in the year 2015.  On an unspecified date in the year 2015 after vaccination, the patient had developed flu twice. Laboratory investigations and corrective treatments were not provided. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 23 January 2015. A 50-years-old female patient, whose concomitant medications were not reported, had received a first dose of ADACEL (batch number U4870BA, expiry date 3-OCT-2016 and route of vaccination was not reported) in the right deltoid on 07 Nov 2014. The patient had received eleventh dose of FLUZONE (batch number, expiry date and route of vaccination were not reported) in the right deltoid on an unknown date within four weeks prior to ADACEL dose. The patient had allergies to Apples, Cherries and penicillin (PCN). On 10 Nov 2014 i.e. 3 days post vaccination the patient had a palpable lump at the injection site, pain in arm and she hurts to use the arm at times. The patient had no illness at time of vaccination. The patient does not have any birth defects and relevant medical conditions. The patient does not have any laboratory data and corrective treatment was not reported. At the time of this report withink one week the patient was recovered from the event palpable lump at the injection site and the evens pain in arm and still hurts to use the arm was not recovered. The patient required ER visit. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Initial unsolicited report received from healthcare professional on 12 DEC 2014. A 70-year-old female patient, whose medical history and concomitant medications were not reported, and received an intramuscular dose of FLUZONE HD (lot number: U5063BA, expiry: 06 JUN 2015) in the left deltoid on 15 OCT 2014. It was reported that on 16 DEC 2014, the patient experienced generalized numbness of the right side back part of her body intermittently. Lab details and corrective treatments were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Swollen tongue
Clinical narrative: Based on information received on 06-April-2015 the case is now medically confirmed. Initial unsolicited report received from Consumer on 16 December 2014. A 61-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Batch number, expiry date, route, site of vaccination and dose number was not reported) in morning on 22 October 2014. On 22 October 2014, the patient had experienced swelling under tongue, fever and chills in afternoon. Laboratory investigations and corrective treatment were not reported. On 23 October 2014 the swelling under tongue, fever and chills was resolved. At the time of this report, the outcome of the event was resolved. List of documents held by sender: none. Follow-up information received from a physician on 6 April 2015. No additional information to provide. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: Initial report received from a non-healthcare professional on 5 NOVEMBER 2014. A 54-years-old female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of FLUZONE QIV, (batch number, expiry date, dose number, route and site of vaccination were not reported), on 09-OCT-2014. It was reported that three week after vaccination the patient had elevated liver enzymes, AST and ALT. Illness at the time of vaccination was none. Pre-existing physician diagnosed allergies and birth defects were unknown. Corrective treatment and laboratory data were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Flushing, Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 05 NOVEMBER 2014. A 66-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE QIV, batch number - UI205AB and expire date - 30 JUNE 2015, intramuscularly in left deltoid on 04 NOVEMBER 2014. The patient had no illness at time of vaccination and was sensitive to vaccines, took BENADRYL prior to administration. On 05 NOVEMBER 2014, one day after vaccination, the patient experienced erythema at the left deltoid, her skin is flushed in the upper torso to her face, neck and face are reddened and it is moving down to her arms and temperature was 99.4 F.  Patient required ER/doctor visit. Laboratory investigation and corrective treatment was not reported. At the time of this report the patient was not recovered from event. Document held by sender: none. Follow-up information received from a health care professional on 30 JAN 2015. Patient's vaccination within 4 weeks prior was reported as none. At the time of this report, the outcome of the events was reported as recovered on an unspecified date. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Initial unsolicited report received from healthcare professional (patient) on 03 NOVEMBER 2014. This case is linked to case 2014SA033390 (same patient). A female patient, whose medical history and concomitant mediations were not reported, had received a dose of INFLUENZA (batch number, dose number and route of administration were not reported) in arm on 10 OCTOBER 2014. The patient received FLUZONE (batch number UH909AA intramuscularly in left deltoid) on 1 OCTOBER 2013 previously and experienced soreness at the injection site and left upper arm muscle spasm which was extended upward to her shoulder and down to her elbow. It was reported that on an unspecified date, after receiving influenza vaccine, the patient experienced soreness with muscle tightness. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from a health care professional on 22 JUNE 2015. It was reported that, patient's symptoms got better and after the amend attempt to work out with weights or other equipment activities, patient's muscle pain was back and it was hard to know if it was still affected by the vaccine the pain seems extreme from the activity. At the time of report, patient was recovering from event sore with muscle tightness (in initial report it was unknown). No new additional information reported. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Skin irritation, Urticaria
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 29 OCTOBER 2014. A 13-year-old female patient, whose medical history and concomitant medication were not reported, had received a dose of INFLUENZA, (batch number, expiry date of vaccine, cycle in series, route and site of vaccination was not reported, on 25 OCT 2014. On 26 OCT 2014, patient experienced skin irritation. On 27 OCT 2014, she had hives on her body. On 28 OCT 2014, patient's condition got worse. Corrective treatment was reported as BENADRYL cream and liquid BENADRYL . Laboratory investigations were not reported. 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 Consumer on 13 JANUARY 2015: The responsible physician address was updated. The patient born on 23 MAY 2001 visited the physician who advised to continue on liquid BENADRYL and follow with visit if symptoms do not disappear. The patient was administered fifth dose of influenza vaccine (manufacturer Sanofi Pasteur) and presented with adverse events on 27 OCTOBER 2014 at 07:30 hours. The patient had no illness at the time of vaccination and did not receive any concomitant medications. The patient did not have any adverse event following prior vaccination. On 31 OCTOBER 2014, all skin irritation had disappeared and the patient outcome was recovered. Follow-up information received from a Consumer on 11 FEBRUARY 2015. It was reported that patient received intramuscularly a dose of INFLUENZA QUADRIVALENT, batch no. UI207AA in left deltoid. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a Consumer on 19-JAN-2015. A male patient (age was not reported), whose medical history and concomitant medications were not reported had received a dose of FLUZONE (dose details, batch number, route and site of administration was not reported) on 18-SEP-2014. On 18-SEP-2014, the patient experienced soreness, redness and hot to touch area at injection site. It was reported that over next 2 days he also had "stomach symptoms", weakness and continued muscle soreness of arm. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient recovered from the events of stomach symptoms and weakness on an unspecified date and continued to have left arm pain and limited use of arm due to pain. The patient required ER or doctor visit. Documents held by sender: none.  Follow up information received from a consumer on 23 FEBRUARY 2015: Patient reported that in spite of his warning to pharmacist that he injection was being injected in patient's upper right arm too high, the pharmacist went ahead and did so, the needle going into reach the shoulder joint, and or pieces of connective tissue. It was immediately painful and remained so to the day of reporting, six months later the arm was till hurting daily in that area and its motion was limited. Pharmacy is to blame. At the time of report patient had not recovered from the event "arm hurts daily in that area" and "it's motion is limiting". List of Documents held by sender: none. Follow-up information received from a non-healthcare professional (consumer) on 30 APRIL 2015. It was reported that wrong injection technique of the pharmacist caused adverse events (muscle soreness of arm, mobility decreased, soreness, redness, hot to touch area at injection site) to the patient.
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Mobility decreased, Myalgia, Pain in extremity, Wrong technique in product usage process
Clinical narrative: Initial unsolicited report received from a Consumer on 19-JAN-2015. A male patient (age was not reported), whose medical history and concomitant medications were not reported had received a dose of FLUZONE (dose details, batch number, route and site of administration was not reported) on 18-SEP-2014. On 18-SEP-2014, the patient experienced soreness, redness and hot to touch area at injection site. It was reported that over next 2 days he also had "stomach symptoms", weakness and continued muscle soreness of arm. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient recovered from the events of stomach symptoms and weakness on an unspecified date and continued to have left arm pain and limited use of arm due to pain. The patient required ER or doctor visit. Documents held by sender: none.  Follow up information received from a consumer on 23 FEBRUARY 2015: Patient reported that in spite of his warning to pharmacist that he injection was being injected in patient's upper right arm too high, the pharmacist went ahead and did so, the needle going into reach the shoulder joint, and or pieces of connective tissue. It was immediately painful and remained so to the day of reporting, six months later the arm was till hurting daily in that area and its motion was limited. Pharmacy is to blame. At the time of report patient had not recovered from the event "arm hurts daily in that area" and "it's motion is limiting". List of Documents held by sender: none. Follow-up information received from a non-healthcare professional (consumer) on 30 APRIL 2015. It was reported that wrong injection technique of the pharmacist caused adverse events (muscle soreness of arm, mobility decreased, soreness, redness, hot to touch area at injection site) to the patient.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Initial unsolicited report received from other company via physician on 21 JANUARY 2015. A patient whose age, gender, medical history and  concomitant medications were not reported, had received a dose of INFLUENZA (batch, route of administration and site of administration were not reported) on an unknown date. On an unspecified date after vaccination, the patient could not breathe. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Skin warm
Clinical narrative: Initial unsolicited report received from a health care professional via other company on 21 JANUARY 2015. An unknown patient (age and gender not reported), whose medical history and concomitant medications were not reported had received a dose of INFLUENZA (batch number, route and site of administration not reported) on an unspecified date. It was reported that on an unspecified date after the vaccination the patient had experienced difficulty in breathing and felt warm. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was recovered on an unspecified date. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Initial report received from healthcare professional on 17 SEPTEMBER 2014. A 33-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number was unknown, dose number, route and anatomical site of administration were not reported) on 15 SEPTEMBER 2014. It was reported that on 15 SEPTEMBER 2014, on the same day after receiving FLUZONE QIV vaccine, the patient experienced fever up to 102 degree Fahrenheit then dizziness, nausea and feeling of Sinus pressure. The patient's corrective treatments and laboratory investigations were not reported. On an unspecified date the events fever, nausea and dizziness were recovered but feeling of sinus pressure was not recovered. Documents held by sender. none. Follow-up information received from healthcare professional on 3 NOVEMBER 2014. Patient's demographics updated. It was reported that, the patient received intramuscular dose of FLUZONE QIV (batch number: UI158AB) in right deltoid. It was reported that, the outcome was not recovered. Follow-up information received from a healthcare professional on 22 DECEMBER 2014: No new information was available.
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Aortic valve disease, Arthritis, Deafness neurosensory, Essential hypertension
Clinical narrative: Based on additional information received on 12-NOV-2014 and 17-NOV-2014 from health care professional, this case is considered as medically confirmed. Initial report received from a non-healthcare professional on 20 OCTOBER 2014. An elderly male patient, concomitant medications were not reported, had received a dose of INFLUENZA (batch number, lot number, expiry date and route of vaccination was not reported) in to the arm, on an unspecified date two weeks ago. The patient had received flu shot two years ago and two months later got the flu. The patient did not have any testing to determine the strain and was treated with TAMIFLU. The patient had arthritis in the shoulder (pointed to his left shoulder).  It was reported that the patient had received the flu vaccine "two weeks ago" administered it too high "right into the joint". The patient could not move his arm and has been going to physician therapy for it. Corrective treatment and laboratory data were not reported. At the time of this report the outcome of the adverse event was unknown. Follow-up information received from the healthcare professional on 12 NOV 2014 and 17 NOV 2014. The patient had previously received FLUZONE 2012-2013 to SEP 2012, FLUZONE 2013-2014 on 18 SEP 2013, FLUZONE QUADRIVALENT 2014-2015 on 26 SEP 2014, PNEUMOVAX23 DEC 2003, ZOSTAVAX in OCT 2009 and TETANUS-DIPTHERIA TOXOID, ADULT (TD) in APR 2006. HPI was not improved with the use of NAPROXEN. On 1 MAR 2013, the patient had problems with allergic rhinitis, cause unspecified. Aortic value disorder, esophageal reflux, impaired fasting glucose, other and unspecified hyperlipidemia, other psoriasis, sensorineural hearing loss, bilateral and unspecified essential hypertension. The patient had allergies to CEFZIL. The patient had received following corrective treatments. On 3 JAN 2013, UROXATRAL 10 mg tablet, extended release capsule orally and aspirin 81 mg tablet orally. On 6 JUNE 2014, received MECLIZINE 25 mg table 1 orally, on 14 MARCH 2014 the patient had received FLONASE 50 mg per inch spray NAS, 3 refills; VERELAN PM 300 mg/24 hours capsules, extended release orally, LIPITOR 80 mg table orally; NEXIUM 20 mg delayed release capsule orally; NAPROSYN 500 mg tablets 1 tablet orally on 1 JULY 2014. The patient had stomach "upset" after PM dose of NAPROXEN. The vital signs of the patient are as follows: Weight 208.0 lb; body temperature 98.6 degrees F, Blood pressure 128/60 lying down. The patient had received Mobic SIG 15 mg tablet 1 orally. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Gastrooesophageal reflux disease, Hyperlipidaemia, Impaired fasting glucose, Incorrect route of drug administration, Injected limb mobility decreased
Clinical narrative: Based on additional information received on 12-NOV-2014 and 17-NOV-2014 from health care professional, this case is considered as medically confirmed. Initial report received from a non-healthcare professional on 20 OCTOBER 2014. An elderly male patient, concomitant medications were not reported, had received a dose of INFLUENZA (batch number, lot number, expiry date and route of vaccination was not reported) in to the arm, on an unspecified date two weeks ago. The patient had received flu shot two years ago and two months later got the flu. The patient did not have any testing to determine the strain and was treated with TAMIFLU. The patient had arthritis in the shoulder (pointed to his left shoulder).  It was reported that the patient had received the flu vaccine "two weeks ago" administered it too high "right into the joint". The patient could not move his arm and has been going to physician therapy for it. Corrective treatment and laboratory data were not reported. At the time of this report the outcome of the adverse event was unknown. Follow-up information received from the healthcare professional on 12 NOV 2014 and 17 NOV 2014. The patient had previously received FLUZONE 2012-2013 to SEP 2012, FLUZONE 2013-2014 on 18 SEP 2013, FLUZONE QUADRIVALENT 2014-2015 on 26 SEP 2014, PNEUMOVAX23 DEC 2003, ZOSTAVAX in OCT 2009 and TETANUS-DIPTHERIA TOXOID, ADULT (TD) in APR 2006. HPI was not improved with the use of NAPROXEN. On 1 MAR 2013, the patient had problems with allergic rhinitis, cause unspecified. Aortic value disorder, esophageal reflux, impaired fasting glucose, other and unspecified hyperlipidemia, other psoriasis, sensorineural hearing loss, bilateral and unspecified essential hypertension. The patient had allergies to CEFZIL. The patient had received following corrective treatments. On 3 JAN 2013, UROXATRAL 10 mg tablet, extended release capsule orally and aspirin 81 mg tablet orally. On 6 JUNE 2014, received MECLIZINE 25 mg table 1 orally, on 14 MARCH 2014 the patient had received FLONASE 50 mg per inch spray NAS, 3 refills; VERELAN PM 300 mg/24 hours capsules, extended release orally, LIPITOR 80 mg table orally; NEXIUM 20 mg delayed release capsule orally; NAPROSYN 500 mg tablets 1 tablet orally on 1 JULY 2014. The patient had stomach "upset" after PM dose of NAPROXEN. The vital signs of the patient are as follows: Weight 208.0 lb; body temperature 98.6 degrees F, Blood pressure 128/60 lying down. The patient had received Mobic SIG 15 mg tablet 1 orally. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Psoriasis, Rhinitis allergic
Clinical narrative: Based on additional information received on 12-NOV-2014 and 17-NOV-2014 from health care professional, this case is considered as medically confirmed. Initial report received from a non-healthcare professional on 20 OCTOBER 2014. An elderly male patient, concomitant medications were not reported, had received a dose of INFLUENZA (batch number, lot number, expiry date and route of vaccination was not reported) in to the arm, on an unspecified date two weeks ago. The patient had received flu shot two years ago and two months later got the flu. The patient did not have any testing to determine the strain and was treated with TAMIFLU. The patient had arthritis in the shoulder (pointed to his left shoulder).  It was reported that the patient had received the flu vaccine "two weeks ago" administered it too high "right into the joint". The patient could not move his arm and has been going to physician therapy for it. Corrective treatment and laboratory data were not reported. At the time of this report the outcome of the adverse event was unknown. Follow-up information received from the healthcare professional on 12 NOV 2014 and 17 NOV 2014. The patient had previously received FLUZONE 2012-2013 to SEP 2012, FLUZONE 2013-2014 on 18 SEP 2013, FLUZONE QUADRIVALENT 2014-2015 on 26 SEP 2014, PNEUMOVAX23 DEC 2003, ZOSTAVAX in OCT 2009 and TETANUS-DIPTHERIA TOXOID, ADULT (TD) in APR 2006. HPI was not improved with the use of NAPROXEN. On 1 MAR 2013, the patient had problems with allergic rhinitis, cause unspecified. Aortic value disorder, esophageal reflux, impaired fasting glucose, other and unspecified hyperlipidemia, other psoriasis, sensorineural hearing loss, bilateral and unspecified essential hypertension. The patient had allergies to CEFZIL. The patient had received following corrective treatments. On 3 JAN 2013, UROXATRAL 10 mg tablet, extended release capsule orally and aspirin 81 mg tablet orally. On 6 JUNE 2014, received MECLIZINE 25 mg table 1 orally, on 14 MARCH 2014 the patient had received FLONASE 50 mg per inch spray NAS, 3 refills; VERELAN PM 300 mg/24 hours capsules, extended release orally, LIPITOR 80 mg table orally; NEXIUM 20 mg delayed release capsule orally; NAPROSYN 500 mg tablets 1 tablet orally on 1 JULY 2014. The patient had stomach "upset" after PM dose of NAPROXEN. The vital signs of the patient are as follows: Weight 208.0 lb; body temperature 98.6 degrees F, Blood pressure 128/60 lying down. The patient had received Mobic SIG 15 mg tablet 1 orally. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Based on additional information received on 23 MARCH 2015, this case is considered as medically confirmed. Initial report received from a Consumer on 20 OCTOBER 2014. A 48-year-old female patient, whose medical history included allergic to sulfa and phentanyl, and concomitant medication ere not reported, had received a dose of FLUZONE (batch number: UT4993BA (site and dose in series not reported) on 17 OCTOBER 2014. The patient had experienced burning in her legs from the thigh to the mid calves, redness and swelling at the injection site, felt achey, pain in her legs from the thigh to the mid calves and rash has spread to about 5 inches long and 3-4 inches, the swelling was larger than a half dollar after vaccination in the evening on 17 OCTOBER 2014. The patient visited the emergency room. It was also reported that the patient had no illness at the time of vaccination. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the events was not resolved. List of documents held by sender: none. Follow-up information received from physician on 23 MARCH 2015: It was reported that, patient had received FLUZONE via subcutaneous route into left arm. Patient's relevant diagnostic tests/laboratory data was none reported. At the time of this report, the outcome of the events was reported as recovered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Based on additional information received on 23 MARCH 2015, this case is considered as medically confirmed. Initial report received from a Consumer on 20 OCTOBER 2014. A 48-year-old female patient, whose medical history included allergic to sulfa and phentanyl, and concomitant medication ere not reported, had received a dose of FLUZONE (batch number: UT4993BA (site and dose in series not reported) on 17 OCTOBER 2014. The patient had experienced burning in her legs from the thigh to the mid calves, redness and swelling at the injection site, felt achey, pain in her legs from the thigh to the mid calves and rash has spread to about 5 inches long and 3-4 inches, the swelling was larger than a half dollar after vaccination in the evening on 17 OCTOBER 2014. The patient visited the emergency room. It was also reported that the patient had no illness at the time of vaccination. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the events was not resolved. List of documents held by sender: none. Follow-up information received from physician on 23 MARCH 2015: It was reported that, patient had received FLUZONE via subcutaneous route into left arm. Patient's relevant diagnostic tests/laboratory data was none reported. At the time of this report, the outcome of the events was reported as recovered.
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 11 SEPTEMBER 2015. This case involves a 25 patients (age and gender not reported) who was vaccinated with a (dose not reprioted) intramuscular (dose series not reported) dose of HEPATITIS B (batch number UT443AB, expiry date 30 JUNE 2016, site of administration was not reported) on an unspecified date "multiple". Medical history was not reported. Patient had no other vaccination within four weeks of vaccinations. On an unspecified date, few second "immediately" following the vaccination patients had black dot at the injection site. It was also reported that, patients had no bleeding while doing the injection. BD safety needle with a 25 gauge 1 inch needed was  used for vaccination. Patient had no laboratory investigation done and corrective treatment was not reported. On an unspecified date, patient had recovered. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 10 SEP 2015. This case involved a 74 years old female patient, who was vaccinated with an intramuscular first dose of FLUZONE HD in the left deltoid (batch number, expiry date, and dose details were not provided) on 08-SEP-2015. There was no known allergy at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions included mitral valve infarction. Concomitant medications included "pentapril melate" and "amlodiire besylate". On 08-SEP-2015, in the evening, same day post-vaccination, the patient's eyes were itching and she developed hives on the arms and back. She was seen by a physician on 10-SEP-2015 and would be referred to an allergist. It was reported that the patient never  had flu vaccine before. Laboratory investigations were not reported. The patient required ER/doctor visit. The patient had not yet recovered from the above mentioned events. List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Malaise, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (medical assistant) on 8 SEPTEMBER 2015. This case involves a 13 years old male patient who was vaccinated with a first dose of FLUZONE QIV (batch number UI431AB, expiry date: 30 JUNE 2016) in left deltoid on 1 SEPTEMBER 2015. Illness at time of vaccination, birth defects and medical conditions were reported as none. The patient was allergic to "peanuts tree nuts bananas", and history of egg allergy as an infant. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 1 SEPTEMBER 2015, one hour following the vaccination, the patient began to feel ill and at 11 PM at same night the patient also had chills, body aches, scratchy throat, runny nose, and low grade fever up to 100.5 Fahrenheit. Laboratory investigations were reported as none. The physician advised to treat patient symptomatically with over the counter medications. On 3 SEPTEMBER 2015 AM, 3 days (reported as Symptoms lasted about 24 hours  after onset the patient was recovered from the events. It was reported that, the Allergist felt the illness was coincidental not allergy or vaccine related. List of documents  held by sender: none.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (medical assistant) on 8 SEPTEMBER 2015. This case involves a 13 years old male patient who was vaccinated with a first dose of FLUZONE QIV (batch number UI431AB, expiry date: 30 JUNE 2016) in left deltoid on 1 SEPTEMBER 2015. Illness at time of vaccination, birth defects and medical conditions were reported as none. The patient was allergic to "peanuts tree nuts bananas", and history of egg allergy as an infant. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 1 SEPTEMBER 2015, one hour following the vaccination, the patient began to feel ill and at 11 PM at same night the patient also had chills, body aches, scratchy throat, runny nose, and low grade fever up to 100.5 Fahrenheit. Laboratory investigations were reported as none. The physician advised to treat patient symptomatically with over the counter medications. On 3 SEPTEMBER 2015 AM, 3 days (reported as Symptoms lasted about 24 hours  after onset the patient was recovered from the events. It was reported that, the Allergist felt the illness was coincidental not allergy or vaccine related. List of documents  held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office manager) on 08 SEPTEMBER 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA QUADRIVALENT (batch number, dose, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced a lot of stiffness and her bones ached. It was reported that at the time of report, the patient was on antibiotics for another condition. Lab data and corrective treatments were not provided. The patient recovered from the events about two days after the onset. List of documents held by sender: none.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 4 September 2015. This case involves a female patient [age not reported] who was vaccinated with an intramuscular first dose of H1N1 (dose, batch number, expiry date and site of administration were not reported), on an unspecified date in 2009. Illness at time of vaccination was unknown and preexisting physician diagnosed allergies included allergy to Amoxicillin. Concomitant medications was not reported. On an unspecified date in 2009, post vaccination, the patient experienced shortness of breath and swelling of the injection site. Laboratory data and corrective treatment was not reported. On an unspecified date, the patient recovered from the above mentioned events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 05 September 2015. This case involves a 67-year-old female patient who was vaccinated with first dose of FLUZONE HD (batch number: UI428AB, expiry date: 19 March 2016) via intramuscular route in right deltoid on 03 September 2015. Reporter denied any illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 05 September 2015, two days post vaccination, the patient developed redness at injection site, lump at site, warmth and red ring around injection site. Laboratory data and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Initial unsolicited report received from a health care professional on 7 August 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, dose, route of administration and site of administration were not reported) on an unspecified date. On an unspecified date, 2-10 days after vaccination, the patient experienced shingles last year. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Hypertension
Clinical narrative: Initial unsolicited report received from a consumer on 04 September 2015. This case involves a 75-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, route of administration not reported) in the left deltoid on 01 September 2015. Illness at time of vaccination was reported as none. Patient had Sulfa and dye allergy, other medical history and concomitant medications were not reported. On 02 September 2015, one day after vaccination, the patient experienced high blood pressure of 20 points higher, shortness of breath and headache. It was reported that the patient received FLUZONE HD vaccine few times before (date was not specified). Lab data and corrective treatment were not reprovided. It was reported that patient felt better and "the events had resolved" (There is a discrepancy in the outcome of structured field and narrative of source document). List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site haemorrhage, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 2 September 2015. This case involves a 73 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number, dose, dose in series were not reported) via unspecified route in left deltoid on 1 September 2015. Pre-existing physician diagnosed allergies and concomitant medications were unknown. Illness at time of vaccination was reported as none. On 1 September 2015 (within 2 hours) after vaccination the patient returned to pharmacy with pain and bleeding at injection site and also had pain in shoulders and upper back. The patient was advised to seek treatment from an emergency room or urgent care at that time. Lab data and corrective treatments were unknown. The outcome of the events were unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from a pharmacist on 01 September 2015. This case involves a patient (age and gender not reported) who was vaccinated with a high dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient experienced potential problem with high dose of FLUZONE. Laboratory investigation and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Tachycardia
Clinical narrative: Initial unsolicited report received from a nurse on 26 August 2015. This case involves a male (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number unknown, expiration date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified date. The patient had medical history of Postural orthostatic tachycardia (POTS) syndrome, asthma, migraines, developmental disorders and food allergies. There were no vaccinations within four weeks of vaccination with FLUZONE and no illness at time of vaccination. On an unspecified date in past, the patient has received many doses of FLUZONE vaccine. It was reported that with the last few flu shots her son received he had tachycardia and dizziness starting 24 hours after the vaccination and lasting for a week or more before resolving spontaneously. The patient did not perform any laboratory investigation. Corrective treatment was not reported. On an unspecified date, the patient recovered from the events. List of documents held by sender: none. Follow up report received from a nurse on 17 September 2015. This case involve 12 years old male patient who received intramuscular dose 12 of FLUZONE (batch number UI231AA) in left arm on 15 November 2015.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 August 2015. A 76-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE HD (batch number: UI428AA, expiration date: 18 March 2016, dose and dose number were not reported) intramuscularly in left arm on 17 August 2015. The patient's medical history includes allergic to sulfa, cipro, celestone and gabapentin and also Hypothyroidism. The patient did not have illness at time of vaccination. On 17 August 2015, same day post vaccination, the patient developed pain in injection area and area was the size of a deck of cards which was fading at the time of report. Next day morning, on 18 August 2015 the size of a deck of cards which was fading at the time of report. Next day morning, on 18 August 2015 the patient had injection area redness, and the area on left arm between the injection site and her elbow was black and blue in color. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Antibody test negative, Blood immunoglobulin G
Clinical narrative: Initial unsolicited report received from the literature on 9 August 2015. The following is verbatim from the article: Background: Mechanisms underlying poor Ab responses to vaccines in well controlled HIV infected patients are not fully understood. In this study we have examined the role of a novel subset, the peripheral T follicular helper cells (pTFH) in Ab production. Methods: The study was conducted in cryopreserved cells of 16 HIV infected, ART-treated individuals and 8 healthy donors (HD) who had been given a single dose of H1N1/09 influenza vaccine in 2009. Only 8 of the 16 patients and all HD had a flu-Ab response at 4 weeks post vaccination. Vaccine responder (VR) and non-responder (VNR) patients were equivalent in mean age, viral load, CD4 and CD8 T band B cells. B (CD20 plus) and TFH (CD3 plus CD4 plus CD45RA- CXCR5 plus) cells were purified by cell sorting on a FACS ARIA and co-cultured. IgG levels in culture supernatants were determined by ELISA. B and T cell phenotypic analysis was performed by multicolor flow cytometry. Differences between groups were analyzed by Student t-test or the 2-sample Wilcoxon rank-sum (Mann-Whitney) test. Results: Frequency of pTFH was equivalent in HIV positive patients and HD before vaccination. pTFH cells underwent significant expansion at week 4 compared to baseline in VR patients (p equal to 0.003) and HD (p equal to 0.001) with increased frequency of Ki67plus cells. In VR, H1N1-specific IgG production was evident in CD4 plus CXCR5 plus /B cell co -cultures but not in CD3 plus CXCR5-/ B cell co-cultures [HIV positive n equal to 3; p equal to 0.043] and [HD n equal to 3; p equal to 0.014], concurrently with increase in frequencies of plasmablasts. These changes were not seen in vaccine non responders. Conclusion: pTFH cells promote antigen-specific Ab production by B cells in vitro. Although their relationship to lymph node germinal center TFH has not been clarified, analysis of pTFH function represents a novel and easily accessible surrogate marker for vaccine responsiveness in stable HIV infected patients with equivalent CD4 T cells. This case involves an eight patients (age and gender not reported) those were vaccinated with a dose of INFLUENZA vaccine (batch number, dose route and site of administration was not reported) on an unspecified date in 2009. All patients had a medical history of HIV infection. Concomitant medications were not reported. On an unspecified date, following the vaccination, patients were not showing Ab (antibody) response. Relevant laboratory test results included antibody test (immunoglobulin G) negative and IgG levels in culture supernatants were determined by ELISA. Corrective treatments were not reported. Outcome of event was unknown. Documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L012475, exp. date on 10-JUL-2016, (strength, route of administration and dose were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.