chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site warmth, Neck pain, Pain, Paraesthesia
Clinical narrative: I woke up with pain in left shoulder and neck.  As the day went on noticed I had a knot that was red where I was injected in left arm. Pain shoots through shoulder and neck when I make certain movements and even sometimes when I take a deep breath. Over the course of the weekend, the not became more noticeable, red and warm to touch and had numbness and tingling in fingers on left hand.  The site of injection was even itchy with a burning sensation. It is now Monday and the pain does not seem to be getting better even thought the injection sight does not seem to be as irritated.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Contusion, Skin warm
Clinical narrative: Patient has a large bruise on her arm that has begun to radiate down her arm. She said it was not hot, when I touched it, it seemed warm. She reports no fever and no other allergic type of reaction.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain at site, site reddened and warm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: My arm and sholder are in so much pain, I can barely move my arm above my head.
Age: 64.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Nausea
Clinical narrative: Extreme pain in injected upper arm. Presented to ED @ 1226 on 10/06/2015. No redness or warmth @ injection site after receiving Flu and Prevnar.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain in left arm pain in shoulder and side of neck-next day head ache-treated with ice and Advil -headache gone -still have pain.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, fever, headache, redness and soreness at injection site.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, fever, headache, redness and soreness at injection site.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that his arm is still very sore and hurts to lift his arm.  It has been 17 days since he recieved his flu shot. He says that it is still sore to the touch and it hurts to sleep on it.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Client states she had approximately a 4 inch red band that wrapped around her left upper arm from the injection site.  Area on Left upper arm 10/12/15 now approximately 2 inches in diameter, red, warm to touch and slightly itches.  Client states she has put cold compresses to area on Left upper arm where injection was given and that has improved the redness and swelling.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Chills, fever (102 F), back pain, wheezing, SOB, extreme fatigue, cough.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Wheezing
Clinical narrative: Chills, fever (102 F), back pain, wheezing, SOB, extreme fatigue, cough.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Decreased appetite, Hypersomnia, Screaming, Tremor
Clinical narrative: She slept all night the night after her shot. Then every 15-20 minutes the second night she was screaming. She had brief tremors.  The next day at daycare she slept all the time, no twitching or tremors.  She's not eating as much but is alert and active today.
Age: 1.33
Sex: M
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Urticaria
Clinical narrative: Hives.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Arm hurt and overnight patient couldn't sleep because it became extremely painful.  Patient received steroids (methylprednisolone) and tramadol.  It was five days before she started to feel better.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: Itching on scalp and back, itching around lips, tingling on lips, and feeling of swollen lips.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Tremor
Clinical narrative: Began to have limb tremors and by evening over 103 temp body tremors.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site pain, Pain
Clinical narrative: Localized erythema and slight tenderness to palpation at site of injection noted by patient 6 days after injection. Pain 1/10.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Received Prevnar vaccine in right arm, by Sunday morning I was breaking out in hives. Raging hives. OTC hydro cortisone cream. RX Medrol pak.
Age: 36.0
Sex: F
Vaccine: FLU3, MMR, TD
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Patient stated the night after he got his vaccines he had chills and a low grade fever. The patient stated he did not go to the doctor and did go to work the next day.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Confusional state, Dysarthria, Echocardiogram, Fatigue
Clinical narrative: Right facial paralysis, slurred speech, confusion, fatigue.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Nuclear magnetic resonance imaging brain, Ultrasound Doppler, VIIth nerve paralysis
Clinical narrative: Right facial paralysis, slurred speech, confusion, fatigue.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Joint effusion, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Began having severe pain starting within 3-4 hours after administration of TDAP vaccine. Within 5-6 hours had significant decrease in range of motion due to pain. Was seen in Urgent care within 48 hours: severe pain, decreased range of motion and numbness in fingers. MRI done in August of 2014 showed moderate joint effusion. Developed adhesive capsulitis. Received 4 steroid injections over the last 14 months with no success. Have been on Ibuprofen, Percocet, muscle relaxers, Neurontin, Lidocaine patches. Have tried TENS treatment. Had 8 months of aggressive physical therapy. Had a complete capsular release in 02/2015 which showed severe adhesive capsultis with only some improvement. Continue to have pain and decreased range of motion to this date. Progress has plateaued at this point.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Periarthritis, Surgery
Clinical narrative: Began having severe pain starting within 3-4 hours after administration of TDAP vaccine. Within 5-6 hours had significant decrease in range of motion due to pain. Was seen in Urgent care within 48 hours: severe pain, decreased range of motion and numbness in fingers. MRI done in August of 2014 showed moderate joint effusion. Developed adhesive capsulitis. Received 4 steroid injections over the last 14 months with no success. Have been on Ibuprofen, Percocet, muscle relaxers, Neurontin, Lidocaine patches. Have tried TENS treatment. Had 8 months of aggressive physical therapy. Had a complete capsular release in 02/2015 which showed severe adhesive capsultis with only some improvement. Continue to have pain and decreased range of motion to this date. Progress has plateaued at this point.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Fatigue, Weight decreased
Clinical narrative: Pt went to ED for fatigue, weight loss, chest pain, and fatigue.  Fatigue started about 3 weeks before hospitalization after recieving Bexsero vaccine at doctor's office.  Pt was transferred to another hospital for further work-up.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Reported by spouse, pt began experiencing left arm pain and weakness which has continued to grow in intensity. Moved for treatment. Can only be contacted by e-mail.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Left arm began aching one hour following my flu vaccine, after that it has progressed into a sharp pain throughout my muscle. I have extreme difficulty moving my arm side to side or up and down and I have decreased strength in that arm as well.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm began aching one hour following my flu vaccine, after that it has progressed into a sharp pain throughout my muscle. I have extreme difficulty moving my arm side to side or up and down and I have decreased strength in that arm as well.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Palpitations, Vaccination complication
Clinical narrative: Patient said that she felt sweaty, her heart was racing and that she thought it was a stroke.  She went to her primary care doctor who said that he thought it was a reaction to Fluzone HD.
Age: 1.09
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Patient seen 10/12/15 with onset of rash 10/9/15; had measles like rash that started on face and spread to body.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis
Clinical narrative: Severe pain throughout entire left shoulder and arm, so severe that I went to the ER for treatment, received X-ray, and later MRI when pain did not go away. MRI results indicate tendonitis and bursitis. Going to see orthopedic surgeon on 10/17/15.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: X-ray normal
Clinical narrative: Severe pain throughout entire left shoulder and arm, so severe that I went to the ER for treatment, received X-ray, and later MRI when pain did not go away. MRI results indicate tendonitis and bursitis. Going to see orthopedic surgeon on 10/17/15.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bone marrow oedema, Bursitis, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severe pain throughout entire left shoulder and arm, so severe that I went to the ER for treatment, received X-ray, and later MRI when pain did not go away. MRI results indicate tendonitis and bursitis. Going to see orthopedic surgeon on 10/17/15.
Age: 34.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Oedema, Pain in extremity, Tenosynovitis
Clinical narrative: Severe pain throughout entire left shoulder and arm, so severe that I went to the ER for treatment, received X-ray, and later MRI when pain did not go away. MRI results indicate tendonitis and bursitis. Going to see orthopedic surgeon on 10/17/15.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: Feeling weak, tired, drained out, and dizzy accompanied by lower back pain.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient started with chills and shaking. Patient's son called pharmacy. We had them check BG and it was 98 despite patient eating 2 hours before. Had family give small glass OJ and recheck BG in 15 minutes, was only 114 but chills had gotten better. Patient also experienced fever near 100, myalgia, nausea and vomiting. We instructed family to use comfort care (ie Tylenol for fever; Pedialyte for electrolytes) and if patient stayed same or got worse by end of the night, to take patient to ER for more comfort care. Instructed them to call back next day if they had any questions. Did not hear back from family.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Patient started with chills and shaking. Patient's son called pharmacy. We had them check BG and it was 98 despite patient eating 2 hours before. Had family give small glass OJ and recheck BG in 15 minutes, was only 114 but chills had gotten better. Patient also experienced fever near 100, myalgia, nausea and vomiting. We instructed family to use comfort care (ie Tylenol for fever; Pedialyte for electrolytes) and if patient stayed same or got worse by end of the night, to take patient to ER for more comfort care. Instructed them to call back next day if they had any questions. Did not hear back from family.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Feeling cold, Neck pain, Somnolence, Tremor
Clinical narrative: Severe chills which caused shaking. It took him about 1&1/2 hours to get warmed up with blankets, warm wash clothes and heating pads.  He said at 4pm it stopped and he slept the rest of the day basically.  His neck did hurt slightly from shaking.  He took some Tylenol for that.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administration error, Immediate post-injection reaction, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: The flu shot, did not feel right, from the start.  It was much more painful than usual. It persisted to be sore and stiff at the injection site, and continues to be at the time of this writing. Also, the same pharmacist that gave me the shot; also, gave one of her co workers a shot a few days later.  And she reported to me to have the same problems, with stiffness and soreness.  And it continues to be a problem for her at the time of this writing.  However, it is too early to know if I will need to seek medical treatment or if any permanent problems will result from this adverse event.  As it has only been 18 days.  I have received the flu shot for 15 years, without having any kinds of problems.  I believe this pharmacist gave the shot in an incorrect manner.  The shot was given with the full size needle, and it covered four strains of the flu.  And it was the only vaccine I received that day and within 4 weeks before or after said flu shot.  I would never let this person give me another shot again!  I would go else where.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Shoulder pain originating at site of vaccination. Pain is now radiating down arm to area of wrist. No redness noted at this site.  Treated with ice packs, Tylenol, Motrin, Aspirin & Bengay type Creme. Planning on visit to Doctor.  Out come unknown at this time.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Skin warm
Clinical narrative: Lightheadedness, warm forehead. 911 called - medics evaluated patient. They were heard telling patient that blood pressure and pulse were normal, pt still transported by ambulance.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: Scratchy throat, runny nose, some sneezing, and some fever. Not debilitating but irritating.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: After the needle retracted, I noticed about a quarter-size swelled mass right where the vaccine was given.  I immediately asked the patient how they felt and she said she didn't feel any different and only was thrown off by the sound of the retracted needle.  I asked her to wait in the seat and immediately called the CDC to check if this was a common reaction.  The gentleman explained that it sounded more generalized and to just make sure the patient didn't exhibit any other symptoms.  I rechecked her arm and the swelling was completely gone just the redness at the injection site.  I had her wait another 15 minutes to make sure there were no new symptoms before I let her go ahead and leave.  I instructed her to contact the Dr. immediately if she noticed any new symptoms.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Nausea, Pain, Respiratory tract congestion, Retching
Clinical narrative: Approximately at 11:45 I because congested and nauseated.  I vomited 4 times and spent the rest of the night dry heaving.  The nausea subsided with phenergan around 0800-0900 am on 10/9/15. I experienced cough, congestion, and body aches through early Monday morning 10/12/15.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Approximately at 11:45 I because congested and nauseated.  I vomited 4 times and spent the rest of the night dry heaving.  The nausea subsided with phenergan around 0800-0900 am on 10/9/15. I experienced cough, congestion, and body aches through early Monday morning 10/12/15.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient passed out briefly after leaving the pharmacy following the immunization-- after the injection was administered, patient said she was fine.  She left pharmacy only to return after feeling light-headed.  She passed out and we were able to lay her down gently and called for management and 911. She was only out momentarily and within a few minutes said she was fine.  She also said that this had been a problem for her in the past but it had been a while since she had passed out   once the rescue squad arrived she said she was fine and refuse treatment.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing
Clinical narrative: Anaphylactic reaction, flushing, severe shortness of breath. administered a dose of Epipen Jr. Patient fully recovered after 5 minutes. Was observed for 20 more minutes by Paramedics. Sent home after.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abdominal pain upper, Chest pain, Cough, Drooling, Dysphonia
Clinical narrative: Anaphylactic reaction, flushing, severe shortness of breath. administered a dose of Epipen Jr. Patient fully recovered after 5 minutes. Was observed for 20 more minutes by Paramedics. Sent home after.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Erythema, Fall, Hypersensitivity, Throat tightness
Clinical narrative: Anaphylactic reaction, flushing, severe shortness of breath. administered a dose of Epipen Jr. Patient fully recovered after 5 minutes. Was observed for 20 more minutes by Paramedics. Sent home after.
Age: 11.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Vaccination complication
Clinical narrative: Anaphylactic reaction, flushing, severe shortness of breath. administered a dose of Epipen Jr. Patient fully recovered after 5 minutes. Was observed for 20 more minutes by Paramedics. Sent home after.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Lymphadenopathy
Clinical narrative: Lymph node in Left axilla was swollen for 3 days, slight induration, measuring 6 cm across.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, fatigue, muscle pain all over the body.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Conjunctivitis, Eye discharge, Eye pain, Ocular discomfort, Photophobia
Clinical narrative: Severe conjunctivitis, drainage, eye pressure, and pain as well as light sensitivity.
Age: 92.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pain in extremity, Swelling
Clinical narrative: Pt states immediately after receiving the vaccine she felt sharp pain.  Today 6 days later it is still extremely red, swollen and tender.  Very painful to move arm.
Age: 92.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tenderness
Clinical narrative: Pt states immediately after receiving the vaccine she felt sharp pain.  Today 6 days later it is still extremely red, swollen and tender.  Very painful to move arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PAIN AND SWELLING IN ARM. DECREASED RANGE OF MOTION.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Skin discolouration, X-ray
Clinical narrative: Patients arm turned black from shoulder to the elbow.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Patients daughter called. Patient complained of: fever, pain at injection site (worse than previous flu shots), throat pain/soreness.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Itching, stinging at site of shot.  Next day continued itching, warm, small dots.  Benadryl cream stopped itching.  Sore like after getting shot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Big red itching area the size of a pancake under the administration site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dysphonia, Fatigue, Flushing, Pyrexia
Clinical narrative: Fever, Flushing of face, Hoarseness, Acheing joints, Tired.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Ear discomfort
Clinical narrative: Patient awoke the next morning reporting limited hearing in left ear.  Patient's wife described a feeling similar to trapped water, but patient had not been swimming or doing anything that would explain the loss of hearing ability. Patient was advised to be examined by a medical provider as soon as possible.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Rash
Clinical narrative: PT COMPLAINED OF RASH AND SWELLING OF ARM FROM COLLARBONE DOWN TO 2 INCHES ABOVE ELBOW THAT DEVELOPED A FEW HOURS FOLLOWING VACCINATION. PT PRESENTED TO PHARMACY 48H AFTER VACCINATION; RASH AND SWELLING HAD GONE DOWN (PER PT) WITH ICE APPLICATION, BUT WAS STILL EVIDENT.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Deformity, Epstein-Barr virus test, Fatigue, Headache
Clinical narrative: Patient began having headaches, hurting in her joints and feeling extremely fatigued shortly after Gardasil vaccine was administered. No one thought it was attributed to the vaccine so she was treated with pain meds and tested for mono and Epstein Barr. It wasn't until we heard of many other girls with the same symptoms after having the Gardasil shot that we realized that it was very probable that the vaccine had caused the symptoms. Her joint pain is now progressing to Rheumatoid arthritis and her fingers are becoming disfigured.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Mononucleosis heterophile test, Rheumatoid arthritis
Clinical narrative: Patient began having headaches, hurting in her joints and feeling extremely fatigued shortly after Gardasil vaccine was administered. No one thought it was attributed to the vaccine so she was treated with pain meds and tested for mono and Epstein Barr. It wasn't until we heard of many other girls with the same symptoms after having the Gardasil shot that we realized that it was very probable that the vaccine had caused the symptoms. Her joint pain is now progressing to Rheumatoid arthritis and her fingers are becoming disfigured.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: Pain in upper left arm where I was vaccinated. As the days went on pain was steady and would sometimes travel down the arm.  Pain when I tried to lift arm over my head or in back.  Broken sleep. I now have very bad pain and stiffness upon waking up in morning.  Finally decided I need to have it checked out by physician.  Just a note, I was sitting and the pharmacist was standing when he injected vaccine.  I am now on prednisone for a few days and prescribed topical creme. Just another note, after this experience I will never have another flu shot.  Had my first flu shot last year with no problems.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Case number PHEH2015US019100, is an initial spontaneous report from a pharmacist received on 28 Sep 2015. This report refers to a female patient of an unknown age. The patient had a known egg allergy even to cooked eggs. Historical conditions and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number unknown) on an unknown date. Post vaccination the patient had an allergic reaction described as cellulitis reaction. Outcome of the event was unknown. Seriousness and causality of the event was not reported. Seriousness assessment of "cellulitis" was upgraded based on the NVS-IMS list.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via call representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX season, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX season, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a 63-year-old female patient who received Flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. The reporter considered the adverse reaction to be probably related to Flu vaccine. Additional details provided were as follows: This case was reported by an unspecified adverse reaction after receiving a dose of Flu vaccine. The reporter did not provide any further details.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash around site of injection warm and tender to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: RUE with erythematous tender wheal 3.25" in diameter.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Nausea, Rash
Clinical narrative: Next day (10/9/15) pin prick rash stomach and back, no itching. Didn't feel well over weekend. Headache this AM now nauseated ?fever (didn't know).
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse event were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the adverse event were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Age: 4.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Child required vaccine for completion of vaccine scheduled. HIB vaccine ordered. Hep B vaccine administered in error. Child did not require Hep B, 4 doses had already been received.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash, Skin warm
Clinical narrative: As of 10/12/15: pt. initially had small area of redness/swelling at injection site -> now a flat, diffuse rash has spread down the arm to 4 or 5 inches. The rash is warm to touch. Pt. will apply ice and may take some BENADRYL.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Low grade fever, erythema and warm at inj. site, diarrhea, fatigue, malaise.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Low grade fever, erythema and warm at inj. site, diarrhea, fatigue, malaise.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and itching  below injection site. Size of area about like playing card. Slight swelling. No fever. Pt did not go to dr. Is using topicort cream for itching-right arm only.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in unspecified number of patients who received FLUARIX quadrivalent. In 2015, the patients received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was reported by a nurse practitioner. The reporter that unspecified number of patients received FLUARIX QIV and they experienced multiple adverse events after the vaccination. The reporter did not have details regarding the initials, date of birth, demographics of the patients and adverse events (side effects) experienced with each of her patients. The reporter did not have details regarding the date of vaccinations, when the side effects occurred, batch number and expiration date of the vaccines.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis, Erythema, Inflammation, Pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pruritus in a 54-year-old female patient who received FLUARIX. Concurrent medical conditions included celiac disease. Concomitant products included ZETIA and Atorvastatin. On 2nd October 2015, the patient received FLUARIX .5 ml. On 3rd October 2015, 1 days after receiving FLUARIX, the patient experienced pruritus. On 4th October 2015, the patient experienced skin inflammation, inflammation and redness. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus, skin inflammation, inflammation and redness were not recovered/not resolved. The reporter considered the pruritus, skin inflammation, inflammation and redness to be related to FLUARIX. Additional details provided were as follows: This was reported by a patient herself. The patient has Celiac disease and this was the typical reaction that she experiences when exposed to gluten. On 3rd October 2015, about 24 hours after receiving FLUARIX, the patient's jaw line began itching. On 4th October 2015, 2 days after vaccination, the itching spread to full face and down neck. Also she described as the area becoming inflamed and red. The patient was treated with BENADRYL, but it did not relieve the events.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Patient received two vaccines in the same arm separated by an inch apart. A few hours after administration he said he had a sore arm and a knot about the size of a quarter. By the end of the night the knot grew larger. The next day of about 24 hours after administration the patients arm on the area of administration was swollen, red, hot to the touch, tender, and about 6 inches wide. The patient will follow-up with his doctor.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient received two vaccines in the same arm separated by an inch apart. A few hours after administration he said he had a sore arm and a knot about the size of a quarter. By the end of the night the knot grew larger. The next day of about 24 hours after administration the patients arm on the area of administration was swollen, red, hot to the touch, tender, and about 6 inches wide. The patient will follow-up with his doctor.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in an unspecified number of patients who received FLUARIX quadrivalent (batch umber 3L9LD, expiry date 30th June 2016). In 2015, the patients received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patients experienced injection site redness, injection site swelling, injection site pain, injection site warmth and pharmaceutical product complaint. On an unknown date, the outcome of the injection site redness, injection site swelling, injection site pain, injection site warmth and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling, injection site pain and injection site warmth to be related to FLUARIX quadrivalent. Additional details were received as follows: In 2015, about 60 percent of the patients who received FLUARIX quadrivalent, experienced redness, swelling, pain and heat warmth at the injection site. The reporter stated that, they had used FLUARIX quadrivalent last year but did not experience any adverse events. The reporter had called to ask whether there were any changes in the formulation of FLUARIX quadrivalent this year and regarding the frequency of occurrence of the events after FLUARIX quadrivalent this year. This case was associated with product complaint. No further information was available regarding events.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Bed sharing, Body temperature increased, Depressed level of consciousness, Musculoskeletal stiffness, Seizure
Clinical narrative: "Seizure" - pt. stiffened in his sleep (co-sleeps with parent) - not arousable approximately 5 min. T 100.2 - 10/07/15 and 10/8/15.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Nodule
Clinical narrative: 9/8/15 pt received immunization left arm deltoid. Pt complained of a "knot" feeling in arm 3 days post shot. About size of a quarter. No visible mark. Knot feeling lasted 7-10 days. Then went away without further complaints. Pt was concerned enough to document.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Oral pruritus, Pruritus, Rash, Throat irritation
Clinical narrative: Rash (itching) both arms/legs, back mouth/and throat itching.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt with (L) arm pain, swelling and erythema.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Burning sensation, Cough, Dysphonia, Erythema, Eye pain
Clinical narrative: Soreness, red, hurting in both arms. Hoarseness, sore, red itchy eyes/still problem cough, fever aches, headache, itching, very fatigue and tired. Hands burned and shedding skin.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Eye pruritus, Fatigue, Headache, Ocular hyperaemia, Pain
Clinical narrative: Soreness, red, hurting in both arms. Hoarseness, sore, red itchy eyes/still problem cough, fever aches, headache, itching, very fatigue and tired. Hands burned and shedding skin.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: Soreness, red, hurting in both arms. Hoarseness, sore, red itchy eyes/still problem cough, fever aches, headache, itching, very fatigue and tired. Hands burned and shedding skin.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Ear congestion
Clinical narrative: Feels like ears are plugged.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Discomfort, Pyrexia
Clinical narrative: Patient indicated diarrhea, fever, general body discomfort. Recommended acetaminophen, fluids, and phone primary care Dr. if symptoms not improved in 24-48 hrs.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, itching, hot to touch.
Age: 51.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pruritic rash consisting of wheals that presented within 1-2 hours of FLUCELVAX vaccination. Treated with BENADRYL 25mg prn. Rash covers face and neck only.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red and itchy entire outside upper arm, left. Was much better after 5 days.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Abdominal pain, Constipation, Urticaria
Clinical narrative: 24-36 hrs after mom describes hives x 4 d. 7 d after abdominal pain - felt due to constipation.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Abdominal pain, Blood alkaline phosphatase increased, C-reactive protein, Differential white blood cell count normal, Full blood count
Clinical narrative: 24-36 hrs after mom describes hives x 4 d. 7 d after abdominal pain - felt due to constipation.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Laboratory test normal, Lymphocyte percentage increased, Nausea, Neutrophil percentage, Pyrexia
Clinical narrative: 24-36 hrs after mom describes hives x 4 d. 7 d after abdominal pain - felt due to constipation.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Urticaria, Vomiting
Clinical narrative: 24-36 hrs after mom describes hives x 4 d. 7 d after abdominal pain - felt due to constipation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Local swelling, Nausea, Swelling face
Clinical narrative: Patient reports that after receiving FLUZONE HD that side's neck and face swelled for several days. Also she experienced nausea and headache.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness on arm near injection site and felt fatigued. She is using ice and naproxen for the arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Nausea, Oedema, Pain
Clinical narrative: Nausea - 10/8/15. 10/7/15 local erythema/edema/discomfort/soreness approximately 7 cm x 3.5 cm where Inactivate Flu vaccine given in left upper arm - deltoid.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Approximately 90 minutes post vaccination patient reported vomiting and diarrhea as well as lightheadedness and dizziness. Patient sought treatment at ER. Given nausea medication. Connection to vaccine not determined.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Started evening of 10/5, swelling of arm. Woke up in morning w/swelling and redness. She said it felt like a bad sunburn. She called the pharmacy on 10/7, told her to ice and Ibuprofen. By 10/9, swelling and redness have gone down.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Local rash, redness, and swelling that developed the following day. Apply ice to area as well as hydrocortisone cream to area.