chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Electroencephalogram normal, Endotracheal intubation, Febrile convulsion, Generalised tonic-clonic seizure, Intensive care
Clinical narrative: Patient was a 4 y.o. previously healthy female with PMHx sig for ex-32 weeker twin who went to NICU and had a grade I IVH at birth. She presents as a step-down from the PICU secondary to febrile seizure after receiving MMR and Kinrix vaccines who developed aspiration pneumonia and needed to be intubated in the ER secondary to apnea, extubated 2 hours later. She had a Tmax of 39.2 at the OSH and a Tlast of 38.5 today at 04:26, but is currently afebrile at 36.6. Mom says the child received her 4 y.o. vaccines (MMR, IPV, DTAP) yesterday AM at her PMD's office, and went to daycare afterwards. She picked the child up from daycare at approx 5:45 pm, and while in the car, the pt stopped moving and was fixated to her right side. 911 was immediately called. The pt then began to have a tonic-clonic seizure that lasted >20 minutes witnessed. Per mom she did not defecate or urinate during seizure. She received 2 g of Ativan in the ER. She then became apneic and was intubated. She was then transferred to another hospital PICU. She was found to have an upper lobe aspiration PNA and was treated with Clindamycin and Ceftriaxone, Day 1/2. Blood, urine, and CSF cultures have been obtained and we will follow these results. Neurology, was consulted and a spot EEG was normal. She was discharged the following day a with normal neuro exam.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Lobar pneumonia, Neurological examination normal, Pneumonia aspiration
Clinical narrative: Patient was a 4 y.o. previously healthy female with PMHx sig for ex-32 weeker twin who went to NICU and had a grade I IVH at birth. She presents as a step-down from the PICU secondary to febrile seizure after receiving MMR and Kinrix vaccines who developed aspiration pneumonia and needed to be intubated in the ER secondary to apnea, extubated 2 hours later. She had a Tmax of 39.2 at the OSH and a Tlast of 38.5 today at 04:26, but is currently afebrile at 36.6. Mom says the child received her 4 y.o. vaccines (MMR, IPV, DTAP) yesterday AM at her PMD's office, and went to daycare afterwards. She picked the child up from daycare at approx 5:45 pm, and while in the car, the pt stopped moving and was fixated to her right side. 911 was immediately called. The pt then began to have a tonic-clonic seizure that lasted >20 minutes witnessed. Per mom she did not defecate or urinate during seizure. She received 2 g of Ativan in the ER. She then became apneic and was intubated. She was then transferred to another hospital PICU. She was found to have an upper lobe aspiration PNA and was treated with Clindamycin and Ceftriaxone, Day 1/2. Blood, urine, and CSF cultures have been obtained and we will follow these results. Neurology, was consulted and a spot EEG was normal. She was discharged the following day a with normal neuro exam.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: A 74-year-old female patient had received an intramuscular dose of FLUZONE High-Dose No preservative 2012-2013 vaccine (batch number: U4714AA, dose number was not reported) in the left deltoid on 22 August 2013. The patient had no illness at the time of vaccination and no physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. On 23 August 2013 in the morning, the patient woke up with a bruise about 2 inches in diameter at the injection site, beneath the bruise there was a red and blotchy area which was warm to touch. Corrective treatments were not reported. No laboratory investigations were performed. Corrective treatments were not reported. No laboratory investigations were performed. At the time of this report, the patient had not recovered from events. Documents held by sender: none
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Stomatitis
Clinical narrative: A 17-year-old female patient, had received an intramuscular dose of FLUZONE (lot number: UH760AC, dose number was not reported) in left deltoid on 15 January 2013. The patient had no history of medical conditions, or concomitant medications and no illness at the time of vaccination. The patient's allergies were none known. it was reported that patient was not pregnant at the time of vaccination and was administered FLUZONE at post-partum visit. On 15 January 2013, 15 minutes after vaccination, the patient experienced severe chills, fever, and sores in mouth. Corrective treatment and laboratory details were not reported. On 25 January 2013, 15 minutes after vaccination, the patient experienced severe chills, fever, and sores in mouth. Corrective treatment and laboratory details were not reported. On 25 January 2013, the patient had recovered from events. Follow-up information received from a healthcare professional on 18 April 2013: The patient's concomitant medications included prenatal vitamins. The patient had received first dose of FLUZONE on 15 January 2013 at 09:00 AM. Documents held by sender: none
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from a consumer who is also the patient daughter on 12 October 2012. An elderly female patient, whose exact age was not reported and medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination was unknown) on an unspecified date. On an unspecified date, the patient developed unspecified adverse event with "FLUZONE for over 65". Corrective medication was not reported and laboratory investigation was unknown. The patient's outcome was unknown. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: A patient whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (lot number U4490AA, route, dose and site of administration not reported) on an unspecified date. On an unspecified date, the patient experienced an adverse reaction. Laboratory details and corrective treatment were not reported. The patient's outcome was not reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Nonspecific reaction
Clinical narrative: A patient (demographics were unknown) had received a dose of FLUZONE High-dose (lot number, dose in series, route and site of administration were unknown) on an unspecified date last Fall. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination were unknown. Concomitant medications were not reported. On an unspecified date, after vaccination, the patient had a reaction (not specified). Laboratory tests and corrective treatment were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: A patient whose age, gender,medical history and concomitant medications were not reported had received a dose of FLUZONE HD vaccine (lot number, route and anatomical site of administration were not reported) on an unspecified date. Within 48 hours of vaccination, the patient developed severe dizziness. Laboratory investigations and corrective medications were not reported. The patient had seen physician who ruled out other causes and attributed it to the FLUZONE HD injection. The dizziness had lasted for 3.5 to 4 weeks. Documents held by sender: None
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: Initial report received from a consumer on 22 February 2013. An 85-year-old female patient had received an intramuscular dose of FLUZONE HD (batch number and number in series were not reported) in the left deltoid on an unspecified date in December 2012. The patient had no illness at the time of vaccination and medical history included hypertension. Concomitant medications were not reported. On 11 February 2013, the patient presented symptoms of cough, sore throat, nasal congestion and "just feeling sick" for the last 11 days. No laboratory tests were performed and corrective treatment details were not reported. At the time of this report, the patient had no recovered from the events and on 22 February 2013, it was the first day that the patient was feeling better. Documents held by sender: None. Follow up information received from a healthcare professional on 08 May 2013. The vaccination date was updated to 15 January 2013, lot number: V4491AA and expiry date: 03/27/13. The patient had not reported this adverse event previously.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Gait disturbance, Oropharyngeal pain
Clinical narrative: Initial report received from a healthcare professional on 15 February 2013. A 66-years-old female patient who had no illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition and concomitant medication were not reported, had received a dose of FLUZONE HD vaccine (Lot number: U4497AA, dose number, route and site of vaccination not reported) on 17 January 2013. Within 24 hours of vaccination, the patient had presented a sudden onset of a severe sore throat, hoarseness and stuffy nose on 20 January 2013. Corrective medications were not reported and had no laboratory tests were performed. Symptoms were lasted for three days and on an unspecified date, the patient had recovered from adverse events. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule
Clinical narrative: Initial report received from healthcare professional on 12 DECEMBER 2012. A 66-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine, batch number: U4542AA in left deltoid on 12 DECEMBER 2012. The patient has no known allergies and no illness at the time of vaccination. The patient had history of Sjogren's syndrome and Rheumatoid Arthritis for which the patient took 325 ASA (ac Acetylsalicylic acid), 800 mg "Ibuprofen" and Methotrexate. On 12 DECEMBER 2012, upon withdrawal of needle the patient had bleeding at injection site, also had "knot" at site and bruise at site. Corrective treatments and laboratory investigations were not reported. At the time of this his report, the patient had not recovered from the events. Documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Feeling abnormal
Clinical narrative: Initial report received from a non-healthcare professional (consumer) on 25 January 2013. A 54-year-old male patient, had received an intradermal dose of FLUZONE ID vaccine from Sanofi Pasteur (batch number and number in series were not reported) on the left deltoid on 11 January 2013. The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. On an unspecified date, few days after vaccination, the patient experienced pain in the joint of his left shoulder. The pain had radiated to acromioclavicular (AC) joint, collarbone, shoulder blade, neck, chest and back. The pain was severe at times. On an unspecified date, the patient felt tired and not himself. There were no laboratory tests performed and corrective treatment details were not reported. As per the reporter, the symptoms had eased a little since they began, but were still present. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Musculoskeletal pain, Neck pain
Clinical narrative: Initial report received from a non-healthcare professional (consumer) on 25 January 2013. A 54-year-old male patient, had received an intradermal dose of FLUZONE ID vaccine from Sanofi Pasteur (batch number and number in series were not reported) on the left deltoid on 11 January 2013. The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. On an unspecified date, few days after vaccination, the patient experienced pain in the joint of his left shoulder. The pain had radiated to acromioclavicular (AC) joint, collarbone, shoulder blade, neck, chest and back. The pain was severe at times. On an unspecified date, the patient felt tired and not himself. There were no laboratory tests performed and corrective treatment details were not reported. As per the reporter, the symptoms had eased a little since they began, but were still present. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Neck mass
Clinical narrative: Initial report received from a non-health care professional on 04 DECEMBER 2012. A 23-year-old female patient, the patient has no medical history and no concomitant vaccine. Illness at the time of vaccination , and pre-existing diagnosed allergies were none. The patient had received a dose of FLUZONE ID (dose number, lot number, route and site of vaccination not reported) on 27 NOVEMBER 2012. On 28 NOVEMBER 2012 after one day of vaccination patient presented marble size lump on neck. As of 04 DECEMBER 2012 one week later still lump on neck but decreased in size. Relevant diagnostic tests and laboratory data was not reported. At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Fatigue, Injection site pruritus, Pain
Clinical narrative: This case is linked with case # 2012-11392 (reported by same reporter for FLUZONE ID vaccine). Initial information received from a consumer4 on 22 NOVEMBER 2012. An 84-year-old male patient had received an intradermal dose of FLUZONE ID vaccine (batch number and site of vaccination were not reported) on 29 SEPTEMER 2012. The patient's medical history included COPD (Chronic Obstructive Pulmonary Disease) and had a pacemaker. Concomitant medication included COZAAR (Losartan) and ZOCOR (Simvastatin). On unspecified date, after vaccination, the patient's spot of vaccination itched and the patient was achy and fatigued. The patient was 84-year old at the time of vaccination thus the patient received the vaccination with FLUZONE ID at an inappropriate age. The laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was feeling better. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Initial report was received from a consumer on 05 NOVEMBER 2012. A male patient (date of birth: unspecified date of July 1961), whose medical history and concomitant medications were not reported, had received FLUZONE ID vaccine (lot number UT4463BA route and anatomical site of vaccine administration were not reported) on an unspecified date. On an unspecified date, after receiving FLUZONE ID vaccine, the patient experienced red induration which lasted for the last 6 weeks. It was larger in the beginning and had shrunk to about 80%. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovering. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Induration, Pruritus
Clinical narrative: The patient (demographics unknown) along with some other nurses, whose medical history and concomitant vaccinations were not reported, had received a dose of FLLUZONE ID vaccine (lot number: UT4474AA, dose number and anatomical site of administration not reported) on an unspecified date. It was reported that on an unspecified date, the patient and other nurses experienced bad itching and induration. Laboratory details and corrective treatment were not reported. As of 08 OCTOBER 2012, the outcome of the events was not reported. Documents held by sender: none.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Blister, Fatigue, Nodule, Skin warm, Wound secretion
Clinical narrative: Initial report received from a patient/consumer on 27 SEPTEMBER 2012. A 53-year-old female patient, with reported medical history of allergy to E Erythromycin and nickel, received a dose of FLUZONE intradermal (dose no. was not reported) in her deltoid region on 04 SEPTEMBER 2012 (lot number: UT4463BA). Concomitant medications were not reported. The patient reported that on 05 SEPTEMBER 2012 i.e. 01 day after receiving FLUZONE ID she developed itchy knot which was oozing clear fluid. She also felt very tired on the same day i.e. on 05 SEPTEMBER 2013. On 21 SEPTEMBER 2012 i.e. 17 days after receiving vaccine administration itchy knot have become blister in size of nickel and also nex6t day (18 September 2012) i.e. 18 days after vaccine administration the blister size of knot have become increased in size to half dollar and the blister area looked like a cluster of bumps and was still itchy and clear drainage surroundings to skin which was warm to touch. Lab investigations were none. Corrective measures were not reported. At the time of this report, the outcome of events was reported as not resolved. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Inflammation, Swelling, Yellow skin
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2012. A 68-year-old female patient, whose medical history and concomitant vaccinations were not reported, had received a dose of FLUZONE HD (lot number U4499A) intramuscularly in deltoid (dose number not reported) on 17 SEPTEMBER 2012. On 08 OCTOBER 2012 i.e. 21 days post vaccination, the patient developed   with swelling, inflammation, yellow discoloration, general weakness and joint pain. Laboratory details and corrective treatments were not reported. The patient's outcome was unknown. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Initial information received from a healthcare professional on 05 October 2012. A 70-year-old female patient, whose medical history included none and concomitant medication were not reported, received intramuscular FLUZONE HD (Lot number U4498BA, Expiry date 16 April 2013) in right deltoid on 05 October 2012. The report stated that, the patient had arm swelling immediately post vaccination on 05 October 2012. Laboratory details and treatment were not reported. The patient did not seek medical attention for either complaint. The patient's outcome was unknown. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 25 September 2012. An 83-year-old female patient, who had allergy to penicillin, levofloxacin and sulfa with the history of hypertension, arthritis, anemia, lack of mobility in arms and asthma, had received intramuscular dose of FLUZONE HD vaccine (Lot number: U4490AA) in left deltoid on 05 September 2012. The illness at the time of vaccination was rash under right armpit. On 06 September 2012, i.e. one day post vaccination, the patient had pain at injection and lack of mobility of left arm. On 24 September 2012, the patient visited the doctor and complained of redness and swelling at injection site but now resolved, still painful at injection site. The redness and swelling at injection had resolved on unspecified date. The pain at injection site was persisting. Outcome of lack of mobility of left arm was not reported. Corrective treatment was not reported. The patient's outcome was not recovered. List of documents held by the sender: None. Follow-up information received from a healthcare professional on 23 November 2012. Illness at the time of vaccination included pain under right armpit. On an unspecified date, the patient had recovered.
Age: 26.0
Sex: F
Vaccine: JEV1
Symptoms: Dizziness, Headache, Impaired work ability, Presyncope, Somnolence
Clinical narrative: Extreme somnolence, presyncope, headache. Somnolence/dizziness was the worst symptom -- patient was unable to work for the remainder of that day and appeared to be "sleep walking" to colleagues. By 4 p.m. patient was sent home to recover.  No pain at injection site. No myalgia, no rash.  Recovery was gradual, over three to five days. Patient was able to return to work the next day but could not get very much done and left a few hours early.  Patient remained well-hydrated but did not otherwise treat symptoms.  Patient would have gone to ER, but the local ER is rural and known for being a waste of time. Patient assumed that no anaphylaxis, rash, swelling meant no life-threatening reaction, and decided to wait at home.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS AT AREA OF INJECTION; HOT TO TOUCH; ITCHING TO AREA.
Age: 1.62
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Injection site erythema, Injection site urticaria, Local reaction, Urticaria
Clinical narrative: Initial there was a local reaction (erythema) at the site of injection, underneath the arm there were hives... Over the next 7 days the hives moved from the site of injection to flank area, to stomach, to all over the body with a visit to the ER on June 14th.... Initial low grade temp on sat 6/13, and high temp of 103.7 on Sunday June 14th... While patient was in the ER his temp reached 106.3 and he was admitted overnight... Overnight he spiked another temp of 106.6.... And stayed in the hospital until Tuesday morning.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza, Myalgia, Nausea, Pyrexia
Clinical narrative: High grade fever (103), headache, muscle aches, nausea, general Flu Symptoms.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: C/o nausea, loss of appetite, vomiting x 2 sixteen to eighteen hours past immunizations.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and pain at injection site - No itching. Physician prescribed Hydroxyzine Hcl for reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Painful, redness, swelling and hot at touch.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Cellulitis, Inflammation, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient developed swelling and inflamation on 08/03/2015 and it continued to worsen. Area became painful in shoulder and Axillary area.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Vaccination complication
Clinical narrative: Patient developed swelling and inflamation on 08/03/2015 and it continued to worsen. Area became painful in shoulder and Axillary area.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling, warmth and mild pain over left upper extremity in the area of injection of pneumonia vaccine. 102 fever. Sulfamethoxazole-trimethoprim (BACTRIM DS) 800-160 mg per tablet. Prednisone (DELTASONE) 20 MG tablet. F/U if no improvement or worsening.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Injection site reaction, Insomnia, Vaccination site pain
Clinical narrative: Initial report received from a consumer on 24 September 2012. An 83-year-old male patient had medical history of hypertension and glaucoma, had received second dose of FLUZONE HD vaccine on left arm (route and lot not reported) on 22 September 2012. The patient had current medications with amlodipine, sodium bicarb, pilocarpine, ALPHAGAN and latanoprost. It was stated that the patient after receiving FLUZONE HD he was unable to sleep from 10 pm to 01 am and feeling of "not being able to get comfortable- tossing and turning". The patient did not feel similar feeling with the previous FLUZONE HD vaccine in the past. The patient also experienced minor tenderness at vaccination site on an unspecified date, but did not have redness and also he was not bothered about this event. Lab investigations were not reported. As corrective measure he administered acetaminophen 500mg and was then able to fall asleep within 01 hour. The patient's outcome was recovered next morning and has had no residual effects since that time. Documents held by sender: none. Follow-up information received from a healthcare professional on 07 December 2012. The patient received FLUZONE HD vaccine intramuscularly. The patient's son received FLUZONE ID vaccine on 19 September 2011 and experienced burning sensation at injection site at same day (Information retrieved from the linked son case 2011-08899). This case is no longer linked with 2012-11766. This case is linked with case number 2011-08889 (case of patient's son). Follow up information received from a healthcare professional (patient's daughter) on 06 August 2013: Patient's first name was updated. On 22 September 2012, the patient experienced vaccination site tenderness.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 19 September 2012. Two patients of unspecified demographics, whose concomitant medications and medical history was not reported, has received second dose of FLUZONE HD vaccine (Lot number: UH489AC or UH457AA, route, anatomical site of vaccination were not reported) on unspecified date last year. The two patient's had unspecified reactions and refused to go for next dose of FLUZONE HIGH DOSE. It was reported that no more description was available. The outcome of the events and corrective treatment was not reported. List of documents held by the sender none.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Initial report received from a health care professional on 19 September 2012. Two female patients (date of birth not reported) had received a dose of FLUZONE HD vaccine (dose no. not reported) on an unspecified date (lot number: not reported). It was stated that after administration of vaccine they experienced flu like symptoms. At the time of report laboratory investigations and corrective measures were not reported. At the time of this report, the patient's outcome was not reported. Documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Pain in extremity, Walking aid user
Clinical narrative: Initial report received from non-health care professional on 20 September 2012. A 82-years-old female patient, whose concomitant medications included TYLENOL and concurrent conditions included: Arthritis, Kidney problems and Knee replacements, had received intramuscular FLUZONE HD (Lot number was unavailable) on left deltoid 12 September 2012. The same day i.e. on 12 September 2012, the patient had pain in both arms up to shoulders and problems with her knees and had to use walker to get around. It was reported that the patient was self-medicating with extra strength of TYLENOL. Corrective treatment was not reported. Outcome of the events was reported as "unknown". List of documents held by sender none. Follow-up information was received from a healthcare professional on 19 November 2012. The patient was treated with intramuscular DEPO-MEDROL and tramadol for knee pain and pain in both arms on unspecified date.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Initial information received from a healthcare professional on 20 September 2012. A 67-years-old female patient whose medical history included restless leg syndrome and concomitant medications were not reported had received a dose of FLUZONE HD vaccine (Batch Lot number: U4499AA, route of administration not reported) in left deltoid on 19 September 2012. The reporter stated that, the patient experienced "Charley horses" in both legs on 19 September 2012 (the day of vaccination) and also on the next day of vaccination. Laboratory details were none and corrective treatment was not reported. As of 20 September 2012, the patient had not recovered from the event. Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Oropharyngeal pain, Rash, Respiratory tract congestion, Urticaria
Clinical narrative: Initial report received from a healthcare professional on 9 SEPTEMBER 2012. A 73-year-old male patient, received a dose of FLUZONE HD (lot number: U4489AA) intramuscularly in the left deltoid area on 07 SEPTEMBER 2012. The patient had no illness at the time of vaccination. The patient had cold symptoms three weeks prior vaccination. Concomitant medications were not reported. The patient was receiving yearly flu shots since an unknown duration. On 09 SEPTEMBER 2012, the patient experienced sore throat and congestion. Also he developed hives in the back and lower arms. Laboratory investigations were not reported. As per patient there was no physician intervention. The patient self-treated with BENADRY. On an unspecified date the patient had recovered from the events. List of documents held by sender: none. Follow-up information received from consumer on 17 DECEMBER 2012. The patient continued to take generic BENADRYL and rash lasted for 2 more days. As per reporter it was an allergic reaction. No further treatment was needed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear pain, Oropharyngeal pain, Pyrexia, Sinus headache
Clinical narrative: Initial report received from a consumer on 17 SEPTEMBER 2012. A 70-year-old female patient received FLUZONE HD intramuscularly in the right arm (batch number: U4496AA) on 12 SEPTEMBER 2012. Medical history included environmental allergies, many antibiotics, Diabetic, Hx triple by pass 2007, Lt breast lumpectomy 2011, Staph infection for 11 months 2011. Concomitant medications not reported. On 12 SEPTEMBER 2011, within short time after vaccination the patient developed sore throat, sinus and ear pain. Later that night the patient had 102 degree Celsius fever and cough. Treatment included Tylenol and saline solution. Lab investigations were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Initial report received from a health care professional on 18 MARCH 2013. An 87-year old female patient, had received a dose of FLUZONE (lot number: UH712AA, expiry date: 06/30/2013, dose number and route of administration was not reported) in left deltoid on 22 AUGUST 2012. The patient had no illness at the time of vaccination and concomitant medications were not reported. The patient's previous medical history includes Thyroid disorder and heart disease. ON 22 AUGUST 2012, the patient developed tenderness and redness at the site but not unusual  to her. The patient has persistent muscle soreness, like a "tight band around the arm" and difficulty in picking up things. Corrective treatment and laboratory details were not reported. As of 18 MARCH 2013, the patient had not recovered from the events. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from a non-healthcare professional on 12 JUN 2013. This case was received by Sanofi Pasteur Inc, Insurance Claims Division. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE High Dose (lot number, dose number, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, after vaccination the patient had experienced adverse reaction (not specified). Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of event was not reported. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Initial report from a non-healthcare professional on 19 NOVEMBER 2012. A 69-year-old female patient, who had no known allergies and had no illness at the time of vaccination and medical history, had received a dose of FLUZONE HD intramuscularly (lot number: unknown, anatomical site of administration was not reported) on 16 NOVEMBER 2012. On 16 November 2012, after 4  hours of vaccination, the patient had vomiting, nausea, diarrhea, chills and upset stomach. The symptoms lasted for 4 hours and then the patient felt better. Corrective treatments and laboratory investigations were not reported. The patient had recovered on an unspecified date. Follow up information received from the non-healthcare professional on 10 MAY 2013. The patient's date of birth was reported as 22 OCTOBER 1943. The patient had received FLUZONE HIGH DOSE No Preservative 2012-2013 (batch number U4524AA, expiry date: 21 APRIL 2013) in the left deltoid.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Migraine, Musculoskeletal stiffness
Clinical narrative: Initial information received from a consumer who is also the patient on 25 OCTOBER 2012. An 85-year-old male patient with the history migraines, hay fever and heart condition and concomitant medications was not reported, had received a dose of FLUZONE HD (lot number U4530AA) intramuscularly in the left deltoid on 20 OCTOBER 2012. On OCTOBER 2012, shortly after vaccination, the patient began having migraine. It was reported that he had migraine every day since the vaccine. Previously he would get it only once a month. The patient also complained of stiffness in his neck. The  laboratory investigations were none. The patient was prescribed pain reliever. At the time of this report, the patient's outcome was not recovered. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Incorrect dose administered, Malaise, Pain, Pain in extremity
Clinical narrative: Initial report received from a consumer on 16 OCTOBER 2012. A 55-year-old female patient had received an intramuscular dose of FLUZONE HD in the right arm region on 12 OCTOBER 2012 (lot no not reported). The patient had no illness at the time of vaccination, however she had medical history of Tetracycline allergies, Valium rash, fast heart rate and history of Mitral Value prolapse. The patient had no reported concomitant medications. It was stated that on 12 OCTOBER 2012 the patient requested for FLUZONE std. vaccine but was administered FLUZONE HD and she immediately had a sore arm and tingling in her legs. She also experienced headache in the evening. On the same day i.e. on 12 OCTOBER 2012 she had body ache and general malaise. Lab details were not reported. As corrective measure she received Ibuprofen. Outcome of the events was reported as not resolved at the time of report. List of documents  held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Initial report received from a consumer on 16 OCTOBER 2012. A 55-year-old female patient had received an intramuscular dose of FLUZONE HD in the right arm region on 12 OCTOBER 2012 (lot no not reported). The patient had no illness at the time of vaccination, however she had medical history of Tetracycline allergies, Valium rash, fast heart rate and history of Mitral Value prolapse. The patient had no reported concomitant medications. It was stated that on 12 OCTOBER 2012 the patient requested for FLUZONE std. vaccine but was administered FLUZONE HD and she immediately had a sore arm and tingling in her legs. She also experienced headache in the evening. On the same day i.e. on 12 OCTOBER 2012 she had body ache and general malaise. Lab details were not reported. As corrective measure she received Ibuprofen. Outcome of the events was reported as not resolved at the time of report. List of documents  held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case is linked with case 2012-10121 adverse event developed following the administration of FLUZONE HD (Lot number not provided) case reported by same reporter. Initial report received from a consumer who is also the patient daughter on 12 October 2012. An elderly male patient, whose exact age was not reported and medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination was unknown) on an unspecified date. On an unspecified date, the patient developed unspecified adverse event with "FLUZONE for over 65". Corrective medication was not reported and laboratory investigation was unknown. The patient's outcome was unknown.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site joint effusion, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Initial information received from a consumer who is also the patient on 04 October 2012. An 81-year-old female patient, whose medical history and concomitant medication were not reported, had received intramuscular dose 2 FLUZONE HD (Lot number unknown) in left deltoid on 01 October 2012. On 01 October 2012 in evening, the patient experienced redness and itching at injection site after the vaccination. Next day she had red, rash, itching, swollen area from elbow to shoulder of left arm on which she had received her vaccination. Red, rash and itching were better and only swelling of elbow, like "fluid around elbow" was there. Laboratory details were not reported. Corrective treatment included "BENADRYL". The patient's outcome was not recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Nodule, Pain in extremity, Pruritus
Clinical narrative: Initial report received from a consumer on 16 September 2012. A male patient, whose age, medical history and concomitant medications were not reported, received dose of FLUZONE HIGH DOSE vaccine on an unspecified date (lot number, route of administration and site of administration were not reported). Patient's granddaughter reported that on an unspecified date that the patient had received Flu high dose vaccine and developed arm pain, a knot and itching. The corrective treatments and laboratory investigations were not reported. The outcome of the events was reported as unknown at the time of report. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vertigo
Clinical narrative: She developed vertigo and nausea and vomiting 3 days ago. Skin warm raised and red arond injection site and down arm.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: She developed vertigo and nausea and vomiting 3 days ago. Skin warm raised and red arond injection site and down arm.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blister, Contusion, Injection site bruising, Injection site rash, Injection site vesicles
Clinical narrative: Father called on 7/30/15 and reported that on 7/21/15, patient developed bruise with blister in the middle of bruise at injection site on left leg.  Said took to MD who gave them Benadryl and told to give Aveno baths.  Also using Aveno lotion.  Father said patient now has additional "bumps" that started as a bruise and with a blister developing two days later.  Father said there are 2 on right leg, 1 on back of left leg, and one on right arm between elbow and wrist.  Father states patient has not had fever and does not appear to have itching. Spoke with father again 7/31/15 who called pediatrician to report changes since patient evaluation with onset of symptoms and said was told to continue with Benadryl.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Father called on 7/30/15 and reported that on 7/21/15, patient developed bruise with blister in the middle of bruise at injection site on left leg.  Said took to MD who gave them Benadryl and told to give Aveno baths.  Also using Aveno lotion.  Father said patient now has additional "bumps" that started as a bruise and with a blister developing two days later.  Father said there are 2 on right leg, 1 on back of left leg, and one on right arm between elbow and wrist.  Father states patient has not had fever and does not appear to have itching. Spoke with father again 7/31/15 who called pediatrician to report changes since patient evaluation with onset of symptoms and said was told to continue with Benadryl.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Rash generalised
Clinical narrative: A rash began on his arms and traveled to the entire body. No hives or blisters. No other symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Rash with hive on it at injection site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature decreased, Cold sweat, Dehydration, Dizziness
Clinical narrative: Extreme dizziness, vomiting, hallucinations, body aches and pains, extremely low body temperature (93.5F), headache, severe dehydration, inability to sit or stand under own power, racing heart, cold sweats.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hallucination, Headache, Pain, Palpitations, Vomiting
Clinical narrative: Extreme dizziness, vomiting, hallucinations, body aches and pains, extremely low body temperature (93.5F), headache, severe dehydration, inability to sit or stand under own power, racing heart, cold sweats.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had redness and swelling on right arm, the site of injection of MMRV 9 cm by 8.1 cm on 8/7/15 @1545.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red warm swelling.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red soreness. Swelling 08/07/2015 when went to doctor.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Wheezing. Sudden onset, lasting approximately 20 minutes.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Erythematous welt, about 3 cm in diameter reported.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Middle insomnia, Pain in extremity, Pruritus, Rash generalised
Clinical narrative: I woke up from a dead sleep in the middle of the night itching the palms of my hands vigorously.  Rash present over my whole body.  My hands hurt and itch.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine product.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine product given.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient has all over body rash.  No difficulty breathing no swollen lips.. just all over body itchy rash. I advised patient to call his doctor to report this and advised patient to take Benadryl to relieve the rash.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site discolouration, Injection site vesicles, Skin lesion
Clinical narrative: Initial report received from a healthcare professional on 12 December 2012. A 66-year-old female patient, had received an intramuscular dose of FLUZONE vaccine (lot number: UH734AA) on the right deltoid on 10 December 2012. The patient's pre-existing allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. The patient had no illness at the time of vaccination. The patient had received many doses of FLUZONE vaccine previously on unspecified dates. On 11 December 2012, the patient experienced bolus eruption on right deltoid (4x4mm) debrided with hypopigmentation. The patient had also developed bulla sep (1x1mm) which was intact. There was no erythema and tenderness. Laboratory data was not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None. Follow-up information received from a healthcare professional on 08 April 2013: The reporter states that the roof of the larger lesion had ruptured and peeled away resulting in an area of hypopigmentation. No additional tests were done. The roof of the larger lesion had been ruptured and peeled away had not recovered.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial misuse report received from healthcare professional on 13 November 2012. A 44-year-old male patient, whose has hypertension as concurrent illness and concomitant medication was none and has, had received a dose of FLUZONE (batch number: UH734AB) intradermal on left deltoid on 09 November 2012. It was reported that on 09 November 2012, after receiving FLUZONE ID, the patient experienced redness; swelling, itching and warmth at injection site immediately post administration of the vaccine and received BENADRYL as a corrective treatment. It was reported that the patient received FLUZONE intradermal, thus the patient received vaccine by inappropriate route. As per reporter, the patient's symptoms were resolving. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature, Influenza, Mobility decreased, Musculoskeletal stiffness, Poor quality sleep
Clinical narrative: Initial report received from a consumer who is also the patient on 18 December 2012. A 78-year-old male patient, had received an intramuscular dose of FLUZONE (Lot number, dose in series, side and site of administration were not reported) on 10 October 2012. Patient had environmental allergies and no illness at time of vaccination. Concomitant medications and medical history were not reported. About 2.5 weeks after vaccination, the patient had come down to flu, coughing up mucus and his body produced a tremendous amount of mucus. Patient could not sleep well, the muscle in his shoulder tightened and he could not lift the arm up. It was reported that, the patient was running a temperature and had not measured it. It was reported that patient was improving. Corrective treatment were not reported. No laboratory investigations were done. On an unspecified date, the patient outcome was recovered. Documents held by sender: None. Follow up information received from a healthcare professional on 09 May 2013. This case is linked to case number 2013-06242 for same patient. The FLUZONE lot number was UH719AB and site of administration was deltoid right. The patient had not return to office with complaint of reaction until all problems were resolved. The patient had flu vaccine previously with no report of reaction in 2009, 2010 and "documented in 2006, patient reported that the flu vaccine always made him sick and had not taken one for 10 years".