chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Consciousness fluctuating, Dizziness, Feeling abnormal, Tremor
Clinical narrative: Around 3 hours after the shot I started shaking all over. Got light headed, weak and woozy. Started going in and out of consciousness. Had to call my husband to help me get to a chair. Then he helped me get to bed so I could lay down all the while passing out. Once got laying down, things eased up unless I tried to get up again. The next day my head felt very out of it and my eyes would get blacked out for just seconds. On the second day after shot, I started feeling back to myself.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Visual impairment
Clinical narrative: Around 3 hours after the shot I started shaking all over. Got light headed, weak and woozy. Started going in and out of consciousness. Had to call my husband to help me get to a chair. Then he helped me get to bed so I could lay down all the while passing out. Once got laying down, things eased up unless I tried to get up again. The next day my head felt very out of it and my eyes would get blacked out for just seconds. On the second day after shot, I started feeling back to myself.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme shoulder pain and lack of ability to rotate shoulder. Flu shot was given very high up on the arm near shoulder. Physical therapy and cortisone shots to no avail. Told tear in rotator. Considered surgery and set a date for it, but needed to cancel. 11 months after pain began, I woke up one day and it was gone. The reason I am writing this now, is that no one believed that the flu shot caused my problems. I read a story this week in the newspaper which mirrored all my problems. So I am reporting this because I do not want to see people suffer because shots are being administered improperly.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Facial Droop Right Side of Face Diagnosed on 10/26/2015 with Bell's Palsy Right side of face.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Haematoma, Injection site haemorrhage, Mobility decreased, Muscle twitching
Clinical narrative: Bleeding at injection sight.  Pain began the next day and increased with each subsequent day.  Pain makes arm hard to raise and move especially at work and during getting dressed and undressed.  Also having muscle twitching in legs.  Pain and coldness in arm caused me to seek medical advise from my physician on 10/28.   His diagnosis was Hematoma.  If pain does not abate will seek second opinion.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Bleeding at injection sight.  Pain began the next day and increased with each subsequent day.  Pain makes arm hard to raise and move especially at work and during getting dressed and undressed.  Also having muscle twitching in legs.  Pain and coldness in arm caused me to seek medical advise from my physician on 10/28.   His diagnosis was Hematoma.  If pain does not abate will seek second opinion.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Neck pain, Vertigo, Vomiting
Clinical narrative: Vertigo, vomiting, headache, neck/shoulder pain.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: Patient reported to my immunizations department at Clinic and stated that she had a reaction to a vaccine that she received two days ago.  Pt stated that she had received two immunizations on 27 Oct 2015, one immunization in each arm, and states that she believes it was the TDAP vaccine which is causing the reaction. Pt states that she felt febrile last night has Urticaria swelling and erythema at the site of the injection. Pt denies any other symptoms.  I reported the patients symptoms to the medical department at our clinic where she is being seen by a provider.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pyrexia
Clinical narrative: I was home after getting my influenza vaccine that morning. I had increased joint pain throughout my body with low grade temp. 100.8-101. I have continued to have joint pain ever since. Severity varies day to day but never gone. Referred to Occupational Medicine Provider and was referred to Primary Care Provider.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram abnormal, Dyskinesia, Dysphagia, Influenza like illness, Injection site swelling
Clinical narrative: Felt flu like symptoms next day. Progressed with localized arm swelling where received shot, then trouble swallowing. Saw PCP who then prescribed abx. 10/25/2015 could not close mouth on one side. 10/26/2015 facial drooping to opposite side of arm where received shot. Went to ED that day CT scan was done and noted sinus inflammation and diagnosed as Bell's Palsy. Went to PCP next day and diagnosed Bell's palsy and stated from flu shot. Prescribed meds.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Sinusitis, VIIth nerve paralysis
Clinical narrative: Felt flu like symptoms next day. Progressed with localized arm swelling where received shot, then trouble swallowing. Saw PCP who then prescribed abx. 10/25/2015 could not close mouth on one side. 10/26/2015 facial drooping to opposite side of arm where received shot. Went to ED that day CT scan was done and noted sinus inflammation and diagnosed as Bell's Palsy. Went to PCP next day and diagnosed Bell's palsy and stated from flu shot. Prescribed meds.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Concussion, Electrocardiogram normal, Fall, Head injury, Seizure
Clinical narrative: Few minutes after receiving the shot, stood up to leave and then fell, hit head, and had a seizure. No one knows if the seizure was first or as a result of hitting her head.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed pruritis and erythema on the injection site this morning when taking a shower. Patient only noticed this morning.
Age: 53.0
Sex: M
Vaccine: DTAP, FLU3, HEPAB, TYP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Directly after injection of Typhoid Vi and Twinrix in L Deltoid client stated he had arm pain. Pain continued for 7 days post injection. Each day pain diminished slightly. First 4 days client had difficulty lifting arm. Client did not take any OTC or Rx pain medication for pain. Denies swelling/rash/itching. Client stated the site of pain is 1 to 2 inches below the acromion process.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT COMPLAINS OF HER ARM BEING SORE.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient reported to pharmacy on 10/29 complaining of reaction to immunizations given on 10/27.  Patient received Prevnar and Fluzone HD in the left arm.  Patient has a 6 inch rash like area about 6 inches from where the immunizations were given. Not sure if the rash is due to the immunizations or not.  My assumption is yes since it is so close in proximity.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site started to swell and become hard and red and hurt. Injection site was the right arm where she had the Prevnar injection.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reports swollen arm and redness in the site where injected with Prevnar 13 vaccine (LD).  No other reactions reported - called pt's spouse on 10/29/15 and he reports swelling has gone down and is not as red - pt appears to be acting normally otherwise.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Lip swelling, Paraesthesia
Clinical narrative: Case number PHEH2015US020935, is an initial spontaneous report from a health care professional (physician assistant) received on 16 Oct 2015. This report refers to a 31-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly last year (2014). On 14 Sep 2014, the patient experienced lip swelling, shortness of breath, tingling and diarrhea. Final outcome of the events was recovered. Seriousness and causality was not reported. Seriousness of the events "lip swelling and dyspnoea" were upgraded based on information available in the source document.
Sex: M
Vaccine: FLU3
Symptoms: Convulsions local, Fine motor skill dysfunction, Nervous system disorder
Clinical narrative: Case number PHEH2015US021118, is an initial spontaneous report received from a Healthcare Professional on 14 Oct 2015. This report refers to a male patient of unknown age. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158425) intramuscularly on 13 Oct 2015. On the same day after vaccination, the patient experienced a reaction described as problems with fine motor skills in the arm where vaccine was administered and it appeared to be a neurological issue. There were also intermittent arm convulsions. Events stop date was mentioned as the same date of onset (13 Oct 2015). Final outcome of the events was not reported. Seriousness and causality of the events were not reported. Seriousness assessment of the events was upgraded (medically significant) based on the information available in the source document.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture negative, Full blood count, Injection site pain, Irritability, Metabolic function test
Clinical narrative: Fever of 103.1, irritability, leg pain and would not put weight on leg. Seen in ER on 10/23/15 at 2:50pm with same symptoms. Was sent to hospital.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: Fever of 103.1, irritability, leg pain and would not put weight on leg. Seen in ER on 10/23/15 at 2:50pm with same symptoms. Was sent to hospital.
Sex: F
Vaccine: FLUN4
Symptoms: Pancreatitis
Clinical narrative: A report has been received from a health professional via medical representative concerning a female patient. Medical history of the patient was not reported. There was no information on the concomitant medication. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal) 0.2 ml, then hospitalised for pancreatitis. Action taken with FLUMIST and outcome of pancreatitis was unknown. Company physician considered pancreatitis to be serious with hospitalisation criterion.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Injection site reaction, Muscle spasms, Pain
Clinical narrative: Pain and cramps in left arm where shot was administered. Cramps and pain with any movement, any lifting. Have had to hire out household duties, getting groceries etc. In elbow up to shoulder.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). On 12th October 2015, the patient received FLULAVAL QUADRIVALENT. On 12th October 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On 12th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning. It was so painful that it woke her from sleep on the 2nd day after the vaccination and it was sore at the time of reporting. In October 2015, less than a week after receiving the vaccine, the patient subsequently experienced swelling at the injection site (right deltoid). This case has been linked to 3 other cases US2015150874, US2015150886 and US2015150875, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL QUADRIVALENT and or lot number of the vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 12th October 2015, the patient received FLULAVAL quadrivalent. On 12th October 2015, immediately after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL. Additional details were provided as follows: The patient experienced injection site burning (injection site pain), which was described as excruciating almost immediately after the vaccination. In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). This case has been linked to 3 other cases US2015150874, US2015150875 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent vaccine and or lot number of the vaccine.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Rash
Clinical narrative: Rash and injection site pain. Cephalexin 500 mg QID.
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site in a male patient who received FLUARIX quadrivalent. On 17th September 2015, the patient received FLUARIX quadrivalent .5 ml. On 17th September 2015, several hours after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On 18th September 2015, the patient experienced arthralgia and fatigue. On an unknown date, the outcome of the injection site pain, arthralgia and fatigue were recovered/resolved. The reporter considered the injection site pain, arthralgia and fatigue to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a pharmacy director. On 17th September 2015, the patient experienced pain at the injection site within a few hours of vaccine administration. On 18th September 2015, 1 day after receiving the vaccine, the patient experienced fatigue and arthralgia. The patient's birth date, age as well as lot number and expiration date of the vaccine were unknown. The concomitant medication or the other vaccines that might had been administered by the patient were unknown.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 3-year-old male patient who received FLUARIX quadrivalent (batch number 7HZ73, expiry date 30th June 2016). On 20th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 21st October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced injection site redness, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site warmth to be related to FLUARIX quadrivalent. Additional details were received as follows: On 22nd October 2015, the patient was better but the events were not completely resolved.
Sex: U
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of lip swelling in a adult patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent 1 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced lip swelling. on an unknown date, the outcome of the lip swelling was unknown. It was unknown if the reporter considered the lip swelling to be related to FLUARIX quadrivalent. Additional detials provided were as follows: The sales rep reportedthat, a pharmacist provided vacicnations to their hospital employees. An unspecified time after receiving the vaccine, the patient experienced swollen upper lip (lip swelling). The reproter did not have batch number, expiration date or any other information. This was 1 of the 3 cases reported by the same reporter (see cases US2015152961 and US2015152966).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a red ring and a swollen arm at the site of injection.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Rhinorrhoea
Clinical narrative: Trouble breathing, runny nose, headache.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Administered TDaP (Boostrix) and Meningococcal (Menactra) vaccines. Patient fainted approximately 5 minutes after vaccine administration. Hit back of head. Vital signs stable, alert and oriented. Referred to physician for evaluation. Resources provided. Left clinic in care of mother.
Age: 33.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Back pain, Body temperature decreased, Chills, Nausea, Pain
Clinical narrative: Patient awoke to a sore arm, severe rigors, chills (temp of 92.6 degrees F reported by wife), back ache, body aches, and nausea.
Age: 33.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient awoke to a sore arm, severe rigors, chills (temp of 92.6 degrees F reported by wife), back ache, body aches, and nausea.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Premature delivery, Uterine contractions during pregnancy
Clinical narrative: I started to have contractions, which I thought were Braxton Hicks and they became stronger. On 6/17/2015 I went into Doctor's office for an unscheduled visit and was already .5 cm dilated and 25% effaced. My due date was 7/19/2015 and I gave birth to my son who was preterm at 35 weeks, 6 days on 6/20/2015. I had no prior complications and my pregnancy was easy and low risk. Yet I gave birth 8 days after getting the TDAP vaccination.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Odynophagia, Pharyngeal oedema, Pyrexia
Clinical narrative: Throat swelling, very painful to swallow, fever, chills, headache.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT COMPLAINING ARM IS VERY SORE AND SHE CAN'T EVEN LIFT HER HAND.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Lymphadenopathy, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Very bad sore throat, 102 fever, swollen lymph nodes in neck.   Lots of crying.  Could not talk without pain.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Bad sore throat, 102.5 fever, swollen lymph nodes in neck.  Lots of crying.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever (101+F), body aches started at around 7:30 PM. Sore/aching arm started around 1 PM.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fall, Generalised tonic-clonic seizure, Loss of consciousness
Clinical narrative: Grand Mal seizure while still in the store where the pharmacy is located she became unconscious, fell to floor and had a grand mal seizure which last a little less than a minute.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Seizure
Clinical narrative: Grand Mal seizure while still in the store where the pharmacy is located she became unconscious, fell to floor and had a grand mal seizure which last a little less than a minute.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Impaired driving ability, Injection site pain, Muscle oedema
Clinical narrative: Felt immediate severe pain upon needle insertion and injection of vaccine. Noticed injection was given high on shoulder, actually in shoulder joint. Immediate ache in shoulder, scapula area and down upper arm. Next day worsening symptoms. 2 days after injection went to hospital wellness center for evaluation and was sent to hospital clinic for employees. Injection site noted by APN and noted to be in shoulder joint. Was given prescription for Medrol dose pack. Symptoms much improved over next 7 days on Medrol dose pack. Then symptoms returned just as painful. Unable to turn steering wheel. Unable take clothes off over my head. Unable to reach across body. Saw family physician on Oct 22 and assessed. He agreed injury due to flu shot given in shoulder and recommended filing workman's comp since flu vaccine is mandatory, was given during work hours on job site and caused an injury. Filed workman's comp 10/22. Hospital generalist made me an appt to see Dr. that afternoon. Was evaluated by Dr. and an MRI of shoulder scheduled for 10/27/15. Received MRI report from Dr. on 10/29/15 And was told I would be referred to orthopedic surgeon. I have tendonopathy of supraspinatous tendon, fluid surrounding the supraspinatous tendon, edema into the muscle and infraspinatous tendon tear. With no prior problems in my left shoulder, I am positive this occurred from the injection, but Dr. is not. I may need help getting workman's comp to cover this injury. I know there have been others.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Felt immediate severe pain upon needle insertion and injection of vaccine. Noticed injection was given high on shoulder, actually in shoulder joint. Immediate ache in shoulder, scapula area and down upper arm. Next day worsening symptoms. 2 days after injection went to hospital wellness center for evaluation and was sent to hospital clinic for employees. Injection site noted by APN and noted to be in shoulder joint. Was given prescription for Medrol dose pack. Symptoms much improved over next 7 days on Medrol dose pack. Then symptoms returned just as painful. Unable to turn steering wheel. Unable take clothes off over my head. Unable to reach across body. Saw family physician on Oct 22 and assessed. He agreed injury due to flu shot given in shoulder and recommended filing workman's comp since flu vaccine is mandatory, was given during work hours on job site and caused an injury. Filed workman's comp 10/22. Hospital generalist made me an appt to see Dr. that afternoon. Was evaluated by Dr. and an MRI of shoulder scheduled for 10/27/15. Received MRI report from Dr. on 10/29/15 And was told I would be referred to orthopedic surgeon. I have tendonopathy of supraspinatous tendon, fluid surrounding the supraspinatous tendon, edema into the muscle and infraspinatous tendon tear. With no prior problems in my left shoulder, I am positive this occurred from the injection, but Dr. is not. I may need help getting workman's comp to cover this injury. I know there have been others.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Haemorrhage, Injection site bruising, Wrong technique in product usage process
Clinical narrative: The vaccine administrator was very rough and gave me a huge bruise at the injection site. I also bled quite a bit. I have never had a bruise in 10 years of getting the flu shot.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Musculoskeletal disorder
Clinical narrative: Pain at the injection site, down arm, extreme pain in the shoulder joint, unable to lift arm or use it.  Continued pain in the arm and shoulder.  Not getting any better so far.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Upper arm swelled and red and painful.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Heart rate increased, Myalgia, Pain in extremity
Clinical narrative: Started with L hip joint pain, moved down to leg muscle pain in both legs, took Aleve and then 1130pm started chilling and rigoring, this continued for approx. 4 hours of severe rigors. Temp reached 102.6, muscle and joint pain became more severe and was awake for most of the night, with the rigors and fever increasing noted that pulse and Resp rate were increased during this time.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Started with L hip joint pain, moved down to leg muscle pain in both legs, took Aleve and then 1130pm started chilling and rigoring, this continued for approx. 4 hours of severe rigors. Temp reached 102.6, muscle and joint pain became more severe and was awake for most of the night, with the rigors and fever increasing noted that pulse and Resp rate were increased during this time.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on arms and legs; patient was prescribed 5 day course of Prednisone by Dr.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site erythema, Injection site warmth, Muscle tightness, Pain in extremity
Clinical narrative: C/O pain with muscular tightness from shoulder to wrist area & headache.  Symptoms continue throughout today, 10/29/2015. Client did not go to doctor for medical treatment.  Returned to health department.  RN assessed client.  No edema noted in arm.  Minimal redness with mild warmth at injection site.  Arm painful to touch.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Tenderness
Clinical narrative: C/O pain with muscular tightness from shoulder to wrist area & headache.  Symptoms continue throughout today, 10/29/2015. Client did not go to doctor for medical treatment.  Returned to health department.  RN assessed client.  No edema noted in arm.  Minimal redness with mild warmth at injection site.  Arm painful to touch.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: There were no adverse symptoms.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient developed rash around site of injection. No pain reported, only itchiness. As of 10/29/2015 1 pm, still has rash near site of injection.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule
Clinical narrative: Red raised knot in arm for a week.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Upper arm swollen, red, warm from elbow to shoulder.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Electrocardiogram, Flushing, Headache, Neck pain
Clinical narrative: Extreme flushing. Extreme headache. Extreme neck pain. Extreme back pain-traveling down spine. EKG and monitoring of vital signs; observation.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia oral
Clinical narrative: I got the shot in my left arm, noticed my tongue was starting to go numb on the left side almost immediately. Is still numb now, 2.5 hours later.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Localized urticarial, erythema; unsure treatment pt seen at her PCP office.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Erythema, Injection site erythema, Injection site induration
Clinical narrative: Small red circle in AM on 10/28, by 10 PM circle was 2 inches in diameter, chills and diarrhea, Tylenol taken, by 12 N on 10/29 red circle had increased to 2.5 inches in diameter and itching was prevalent; small red circle where injection was given was still present and was hard and swollen.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Small red circle in AM on 10/28, by 10 PM circle was 2 inches in diameter, chills and diarrhea, Tylenol taken, by 12 N on 10/29 red circle had increased to 2.5 inches in diameter and itching was prevalent; small red circle where injection was given was still present and was hard and swollen.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Influenza vaccination given on 10/27/15. On 10/29/15 the pt. presents with tenderness, redness, and swelling at vaccination site, well demarcated, 35 x 60 mm.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Upper extremity mass, Yellow skin
Clinical narrative: Yellow patch on upper arm and hard lumps under arm x 2 days. Lumps have subsided.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Hypotonia, Pulse absent, Respiratory arrest
Clinical narrative: Patient called out son's name, stuck both arms out straight, began to shake as though having a seizure then went limp with labored breathing. Breathing stop no pulse detected admin of EPIPEN 0.3mg left thigh NTG 0.4mg SL due to chest pain when patient recovered. 911 activated - patient transported.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient called out son's name, stuck both arms out straight, began to shake as though having a seizure then went limp with labored breathing. Breathing stop no pulse detected admin of EPIPEN 0.3mg left thigh NTG 0.4mg SL due to chest pain when patient recovered. 911 activated - patient transported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dry mouth, Nephrolithiasis, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 66 years old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI456AA, expiry date: 26-Apr-2016, dose details and site of administration was not reported) on 08-Oct-2015. The patient had no illness at time of vaccination. She had a history of Follicular lymphoma and kidney damage due to chemotherapy. Concomitant medications were not reported. On 09-Oct-2015, one day post vaccination, the patient had a kidney stone. On 15-Oct-2015, about 7 days after vaccination, she experienced body aches, fever as high as 102.8 degree F, poor appetite, her mouth was dry; her body was shaking when she had fever and when she did not. She was shaking so much that she could not hold her pills in her hands. There was no laboratory investigations done and corrective treatment was not reported. The kidney stone passed in a day or two while other events had not yet recovered. Upon internal review this case was considered serious due to important medical events: had a kidney stone. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 66 years old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI456AA, expiry date: 26-Apr-2016, dose details and site of administration was not reported) on 08-Oct-2015. The patient had no illness at time of vaccination. She had a history of Follicular lymphoma and kidney damage due to chemotherapy. Concomitant medications were not reported. On 09-Oct-2015, one day post vaccination, the patient had a kidney stone. On 15-Oct-2015, about 7 days after vaccination, she experienced body aches, fever as high as 102.8 degree F, poor appetite, her mouth was dry; her body was shaking when she had fever and when she did not. She was shaking so much that she could not hold her pills in her hands. There was no laboratory investigations done and corrective treatment was not reported. The kidney stone passed in a day or two while other events had not yet recovered. Upon internal review this case was considered serious due to important medical events: had a kidney stone. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, fever (100), chills. Symptoms developed 4 hours after injection per patient report.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Extensive swelling of vaccinated limb, Inflammation, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 71-year-old female patient who received FLUARIX QUADRIVALENT (batch number 32NZ7, expiry date 30th June 2016). Concomitant products included PREVNAR. On 19th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, inflammation localized and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, inflammation localized and pain in arm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, inflammation localized and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient received FLUARIX QUADRIVALENT in right deltoid. In October 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, swelling at elbow and swelling up and down the arm, increased swelling and pain. The reporter did not want to provide further details and stated that someone should contact the patient to obtain further information.
Sex: U
Vaccine: FLU4
Symptoms: Local swelling, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local swelling in an unspecified number of patients who received FLUARIX quadrivalent (batch number 5GF43, expiry date unknown). In 2015, the patients received FLUARIX quadrivalent .5 ml. In 2015, the dose was .5 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patients experienced local swelling and feeling unwell. On an unknown date, the outcome of the local swelling and feeling unwell were unknown. It was unknown if the reporter considered the local swelling and feeling unwell to be related to FLUARIX quadrivalent. Additional details were received as follows: The reporting nurse was infection control nurse at the hospital. An occupational nurse told to reporting nurse that, in 2015, there were many employees who experienced not feeling well and also having an arm swelling that was described as lump on arm. The reporter provided some batch numbers but was not able to provide the patient information and expiry dates of vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Paraesthesia oral
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of tingling tongue in a adult patient who received FLUARIX QUADRIVALENT. In 2015, the patient received FLUARIX QUADRIVALENT 1 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced tingling tongue. On an unknown date, the outcome of the tingling tongue was unknown. It was unknown if the reporter considered the tingling tongue to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, they vaccinated to their hospital employees. Out of them 3 patients were experienced adverse events. In 2015, the patient experienced tingling of the tongue and mouth. The reporter did not have any further information. This case was linked with case US2015152961 ans US2015152964, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a pharmacist  via sales rep and described the occurrence of injection site itching in a adult patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent 1 ml. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to FLUARIX quadrivalent. Additional details were received as follows: The reporter stated that, they vaccinated to their hospital employees. Out of them 3 patients were experienced adverse events. In 2015, the patient experienced itching at the injection site that went down the arm. The reporter did not have any further information. This case was linked with case US2015152966 and US2015152964, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: 6 x 6 mm - reddened, erythema, slty warm to touch, no fever, no systemic complaints.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Glossodynia, Nasal congestion, Pruritus, Respiratory disorder
Clinical narrative: Employee receives annual flu vaccine and has a mild reaction - this was she had more intense symptoms that lasted longer and received BENADRYL. Symptoms included nasal congestion, sore tongue, thick tongue, tightness in chest and airway. Hives and pruritus within 30 min.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue disorder, Urticaria
Clinical narrative: Employee receives annual flu vaccine and has a mild reaction - this was she had more intense symptoms that lasted longer and received BENADRYL. Symptoms included nasal congestion, sore tongue, thick tongue, tightness in chest and airway. Hives and pruritus within 30 min.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt called 10/28/15 complaining of severe arm and neck pain after vaccine administration on 10/21/15. Started as tingling in legs, then moved to arms/neck, both sides. Denies injection site irritation, or BP issues.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site scar, Injection site swelling, Injection site warmth
Clinical narrative: About 24 hours post vaccination, pt noticed a swelling at injection site approximately 4-5" diameter. It was hot, red, itchy. Swelling resolved approximately 1 1/2 wks later. As of 10/29/15, it still itches but is not hot. Treating itchiness with hydrocortisone cr. Pt states it looks like a scar,
Age: 0.51
Sex: U
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temp of 101.8 after imms decreased to 100.4 with APAP. Fussy.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Cough, Headache, Ocular hyperaemia
Clinical narrative: Chills, fever, red eyes, cough, headache, stomach distress.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills, fever, red eyes, cough, headache, stomach distress.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: PATIENT REPORTS PAIN IN VACCINATED (RIGHT) ARM FROM SHOULDER TO ELBOW, ESPECIALLY WITH ACTIVITIES OF DAILY LIVING. DESCRIBES PAIN AS ACHY, NOT BURNING. TYLENOL AND IBUPROFEN NOT HELPING. ICE DOES TEMPORARILY RELIEVE PAIN. WENT TO MD AFTER SPEAKING WITH PHARMACIST ABOUT REACTION. MD PRESCRIBED KEFLEX AND PREDNISONE.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: LEFT ARM IS RED AND SWOLLEN AROUND INJECTION SITE.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Electroencephalogram normal, Intensive care, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Recieved 4 month vaccine including Tdap at PCP clinic during the afternoon. Patient had a fever in the reaching 102 F. Generalized seisure at home. Transfered to hospital. Had witnessed generalized seizures in ED and on floor. Transfered to the PICU and treated with fosphenotonin, Tylenol.  Defeverenced and returned to baseline.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Seizure
Clinical narrative: Recieved 4 month vaccine including Tdap at PCP clinic during the afternoon. Patient had a fever in the reaching 102 F. Generalized seisure at home. Transfered to hospital. Had witnessed generalized seizures in ED and on floor. Transfered to the PICU and treated with fosphenotonin, Tylenol.  Defeverenced and returned to baseline.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time abnormal, Chills, Cough, Culture urine, Differential white blood cell count
Clinical narrative: Cough, rash, low grade fever, chills.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Henoch-Schonlein purpura, International normalised ratio, Prothrombin time, Pyrexia
Clinical narrative: Cough, rash, low grade fever, chills.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urine analysis
Clinical narrative: Cough, rash, low grade fever, chills.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Syncope
Clinical narrative: Feeling unwell after shot, put head down, was giving smelling salt and ice pack, was helped to walk to room, fainted on the way.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of redness around injection site. Area is warm to touch, non tender.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vaccination complication
Clinical narrative: Patient got reaction 4 hour after Pneumococcal vaccine was given.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Loss of consciousness, Palpitations
Clinical narrative: 9-23-15 First day headache. 9-24-15 Second day heavy weight on chest. 9-28-15 Sixth day passed out. 19-4-15 Twelfth day pounding heart beat.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Headache, Neck pain, Pain in extremity
Clinical narrative: Later in evening after shot, patient started having arm soreness over entire length of arm that lasted about 24 hours. Next morning patient had swelling, redness, and heat entire length of arm. Also experienced headache, neck pain, and felt "funny". Swelling is reduced and patient managing pain with acetaminophen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Later in evening after shot, patient started having arm soreness over entire length of arm that lasted about 24 hours. Next morning patient had swelling, redness, and heat entire length of arm. Also experienced headache, neck pain, and felt "funny". Swelling is reduced and patient managing pain with acetaminophen.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Nodule, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Lg red spot oval shape. Knott, hot to touch. Itchy, achy pain from shoulder down to hand. Still have pain two wks later. Still have red spot.
Age: 75.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash on body excluding head, face and bottom of feet - started 7 days after flu and shingles shot on September 21st, 2015. Rapidly increased in severity - visited dermatologist on Oct 1st 2015. Prescribed steroid cream for itching.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient has shortness of breath the evening after receiving FLUZONE HD. She considered ER visit, but s/s subsided < 24 hrs.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Throat tightness, Urticaria
Clinical narrative: Hives from head to toe, tightening of throat over 2 weeks. Placed on steroids and BENADRYL.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever started 10/16/15, arm (L) began to swell evening of 10/16/15, 10/17/15 (L) arm red, warm to touch, area is swollen but no lump, area not uncomfortable to child and is not bothering her. No streaking.
Age: 20.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Urticaria over abdomen, back and face.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Res. rec'd HIGH DOSE flu vaccine on 10/11/15 (L) deltoid. 10/15 (L) arm red, warm, pain, itchy. Moist heat pad after ice for 20 min. DURICEF 500 mg q 12 hr x 7 days.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Ultrasound Doppler normal
Clinical narrative: Resident given High Dose Flu vaccine on 10-11-15 (L) deltoid. 10-12-15 Temp 99.3. Upper (L) arm site redden, warm to touch and tender.  Denies trauma. Warm compresses tid ordered, TYLENOL prn pain. Venous Doppler (-) neg, DURICEF 500 mg Bid x 7 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: Skin red rashes with itching on face, back, neck and upper chest.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Pain, Skin warm
Clinical narrative: Pt complained of a large hematoma that formed the day following vaccination (10/19/15). They stated it was painful and very warm to the touch. They showed me Friday 10/23/15 and there was a 4 inch bruise present.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed hives over entire body including palms approximately 24 hrs after flu shot. On no meds. No new foods, soaps, etc. No trouble breathing or swallowing.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Red patch in area of injection, worsened, mild tenderness, local inflammatory reaction HCT cream - CLARITIN 10mg.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Approximately 7 minutes after vaccines were administered, patient fainted from a standing position. No injury. Patient responsive but dizzy and pale. Patient's BP WNL. Full recovery after about 7-10 minutes of rest.
Age: 1.25
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site on left upper leg, red, warm to touch, hard to touch and painful.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: A day after vaccine started to have fever, sore throat, cough, body fatigue.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Flu-like symptoms and generalized achiness began on 10/28/15. Noticed area of erythema around injection site this AM. No fever/hives/SOB/wheezing. Dx: cellulitis KEFLEX 500 mg prescribed TID x 7 days.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: PAIN AT INJECTION SITE.  ARM SORE AND INJECTION SITE RED AND WARM TO THE TOUCH.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain on left arm radiating to the shoulder and neck. Consultation sought with Primary Physician.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Discomfort, Injection site erythema, Peripheral swelling
Clinical narrative: Patient stated that their arm swelled up with red marks at the sites of injection. They also experienced some discomfort.
Age: 64.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Discomfort, Swelling
Clinical narrative: Patient stated that they had about 4.5 inches of swelling and they experienced discomfort while sleeping. The swelling has started to go down on 10/28/15. They have not taken anything for the swelling.