chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: The patient received their flu vaccine at about 12:30. I noticed that the location I injected the vaccine at started to immediately bleed. So I offered to change to a regular Band id style bandage instead of the inject-safe barrier bandage that I used for the injection. When I placed the new bandage on her arm I noticed some very slight signs of swelling and asked her about it. She thought it was fine. I then proceeded to give the person with her their vaccine. After I was done with the second person's vaccine I went to look at her arm again to see the state of it. The injection site swelled more so I offered and gave the patient an instant ice pack for the swelling. I continued to talk to them in the OTC area for about 10 minutes or so. I called them at about 3:45 pm to check on them again and they said they still have a swollen arm but it is not getting worse and they are fine.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Narcolepsy, Sleep study abnormal, Sleep study normal, Somnolence, Weight increased
Clinical narrative: Severe daytime sleepiness despite normal nighttime sleep, weight gain.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Within 1 hour on 9-12-17 when the vaccine was given the patient had a bruise about 1 inch wide. Today 9-16-17 the patients arm looked bruised with a diameter of 3-4 inches and red around the injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT CALLED ON SATURDAY SEPT 16 AND STATED SHE HAD GOTTEN HER FLU SHOT TWO DAYS PRIOR AND NOW HER ARM IS RED AND SORE AND IS SWOLLEN THE SIZE OF A BASEBALL. SHE HAD NOT DONE ANYTHING AT THE TIME TO TREAT IT.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Cellulitis measuring 3in x 2.6in, + warmth, + redness, + tenderness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling in arm around injections site. Patient is going to take an ibuprofen and ice the area.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hyperhidrosis, Nausea
Clinical narrative: PATIENT CALLED AND SAID HE HAD SWEATS, CHILLS, NAUSEA AND WEAKNESS LAST NIGHT IN THE EVENING ON 9/15. BUT HE CALLED ON 9/16/17 THAT THE WEAKNESS, NAUSEA AND CHILLS ARE GONE BUT HE IS SWEATING LESS. I ADVISED HIM TO SEEK A DR IF HIS SYMPTOMS CONTINUE BUT HE IS TELLING ME THAT HE IS SWEATING LESS. HE WILL MONITOR THE SITUATION AND SEE A DR IF HE NEEDS TO. I spoke to patient and he told me he was fine and he did not have to see a dr or go to the hospital. He said, "it is all going away".
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Rash, Urticaria
Clinical narrative: AFTER THE PATIENT LEFT THE PHARMACY SHE NOTICED A RED SPOT ON THE FACE THAT SOON WENT AWAY. NO OTHER SYMPTOMS WERE NOTED UNTIL SHE WOKE UP THE NEXT MORNING. PATIENT BROKE OUT IN A RASH AND THICK HIVES ON EXTREMITIES. SHE ALSO HAD SWELLING IN HER FEET AND HANDS. SHE SOUGHT CARE AT THE WEEKEND CLINIC. EXAMINATION SHOWED RASH ON EXTREMITIES AND IT WAS NOT CONCENTRATED ON ONE ARM, ONE SIDE OF THE BODY OR THE OTHER. PREDNISONE WAS PRESCRIBED AND PATIENT WAS TOLD TO TAKE BENADRYL OTC.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Rash
Clinical narrative: Pt reported to pharmacy the day after the immunization with a bumpy, elevated rash from the R deltoid region, down to the elbow. She reported severe pain, pruritis, and erythema. I recommended pt to use cold compress/ice pack at different intervals throughout the day, tylenol at correct dosing for pain, and also recommended to alternate between diphenhydramine cream and hydrocortisone cream throughout the day. I did not recommend diphenhydramine PO since pt is 77 yo, and reported NO systemic allergic rxn s/sx. Pt came to pharmacy this AM, with rash still present. No bumps present, but pain still present. Pt went to urgent care this AM, and PA reported pt had cellulitis, and prescribed Bactrim DS x 7 days.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain at site of injection, patient took ibuprofen/ADVIL on 9/14/17-9/15/17. Redness around upper right deltoid/arm on 9/16/17, warm to the touch. Pharmacist advised patient to ice the upper right arm and continue to take ibuprofen as needed, also asked patient to report back to pharmacy on improvement or worsening of symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Headache, Insomnia, Nausea
Clinical narrative: Patient had difficulty sleeping the first night due to aching. She arose at 3 AM and felt pain everywhere, felt nauseous but did not vomit. She took TYLENOL and went back to sleep. On day 2 she continued to feel aches and pain, had a fever of 101.9 F and chills. She reached out to her doctor. On day 3 the arm was very red and painful. She endured a headache all three days.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had difficulty sleeping the first night due to aching. She arose at 3 AM and felt pain everywhere, felt nauseous but did not vomit. She took TYLENOL and went back to sleep. On day 2 she continued to feel aches and pain, had a fever of 101.9 F and chills. She reached out to her doctor. On day 3 the arm was very red and painful. She endured a headache all three days.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Pruritus, Pruritus generalised
Clinical narrative: Localized redness and itching after 2 days, followed by generalized itching with diminished redness at injection site. Patient called their physician practice and were prescribed a 3 day course of Prednisone.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient comes over our pharmacy today. She got a discharged rx from the emergency room for NORCO 5. She says she may got allergic reaction from the IMZs that she got yesterday on 9/15/17. She reported the following symptoms: Tiredness, muscle ache, joint pain, fever, shakiness. She also shows her injection sites. Her left arm appears to have mild swelling with some redness. Patient has come here every years for her flu-shots and never has any problems. I suspect the reactions come from the PNEUMOVAX-23. Patient also stated that one of the doctors at Hospital ER said she was the 2nd case that have allergic reaction to IMZ. It is unclear if the other patient got IMZ with pharmacy or another location.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Patient comes over our pharmacy today. She got a discharged rx from the emergency room for NORCO 5. She says she may got allergic reaction from the IMZs that she got yesterday on 9/15/17. She reported the following symptoms: Tiredness, muscle ache, joint pain, fever, shakiness. She also shows her injection sites. Her left arm appears to have mild swelling with some redness. Patient has come here every years for her flu-shots and never has any problems. I suspect the reactions come from the PNEUMOVAX-23. Patient also stated that one of the doctors at Hospital ER said she was the 2nd case that have allergic reaction to IMZ. It is unclear if the other patient got IMZ with pharmacy or another location.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: PT CALLED TODAY, 9/16, REPORTING THAT SHE WOKE UP WITH A SWOLLEN FACE YESTERDAY.  SINCE SHE RECEIVED THE VACCINE ON 9/12, I TOLD HER THAT IT COULD BE A SIDE EFFECT OF THE VACCINE, BUT THAT IT WOULD USUALLY MANIFEST ITSELF SOONER THAN 3 DAYS LATER.  SHE TOLD ME THAT IT WAS GETTING BETTER TODAY. I ASKED ABOUT TROUBLE BREATHING, OR SWOLLEN TONGUE. SHE SAID SHE WASN'T EXPERIENCING ANYTHING BUT SWOLLEN FACE. I TOLD HER IF SHE DID NOT CONTINUE TO SEE IMPROVEMENT OR IF IT GETS WORSE, TO GO INTO THE ED.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Pt reports a red, swollen throat and some tightness in the chest; beginning a couple hours after vaccination. She reports no real difficulty breathing at this time. Advised to take some diphenhydramine and acetaminophen for symptoms, and to seek emergency medical attention if any irregular heart beat or difficulty breathing, and follow up with her physician.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash pruritic
Clinical narrative: The patient received the vaccine on 9/14/17 on his left arm administered by the pharmacist from a prescription sent in from his doctor for PREVNAR 13. The patient came back to the pharmacy on 9/16/17 to show that his body from the neck down is covered in itchy rashes that is spreading from neck down to his stomach. I, as the pharmacist recommended that he contact his MD as soon as possible and take an antihistamine to control the itchiness and spread of possibly an allergic reaction.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: The patient has a patch of redness at the injection site.  It is uncomfortable and itchy.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dehydration, Diarrhoea, Erythema, Heart rate decreased
Clinical narrative: Life Threateningly Low Vital Signs, Kidney Failure, Dehydration, Diarrhea Extreme Weakness, Vertigo, Extreme Pain at Arm for 5-days, Swollen Arm, Redness...Pulse - 38 BP - 48/30.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Renal failure, Vertigo, Vital signs measurement
Clinical narrative: Life Threateningly Low Vital Signs, Kidney Failure, Dehydration, Diarrhea Extreme Weakness, Vertigo, Extreme Pain at Arm for 5-days, Swollen Arm, Redness...Pulse - 38 BP - 48/30.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Chills, Decreased appetite, Injection site erythema, Pain
Clinical narrative: Patient stated she started having chills, achiness and had a temperature the evening of the vaccine and continued into the next day. Her arm developed redness from her axillary area down to her elbow on the arm she received the vaccination. She had decreased appetite on 9/15, but she said she has slightly improved and does not feel (hopefully) warranting a doctor visit since she has improved since yesterday.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has extreme itching at site and redness around area.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphonia, Fatigue, Pyrexia, Vomiting
Clinical narrative: Patient reports having a low grade fever, vomiting, hoarseness, chills, and fatigue that started on Wednesday 9/14/17 at 11 pm and lasted until Friday 9/15/17. Patient self treated with Ibuprofen 400mg at home.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient came back to the pharmacy and said he went to the emergency room because he said cellulitis was forming on his right arm down to his elbow.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness, Vaccination complication
Clinical narrative: The same day the arm started to hurt and felt tight, thing that I thought it was normal until next day that the pain got worse and by the evening my arm was swollen all the way to the elbow. The pain started to move close to the neck and down the whole arm. I went to a clinic to avoid an emergency care but besides a reaction they could not determine exactly what was going on and was sent to another walk-in clinic. Prednisone pills were prescribed.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient complained the day after the vaccine that the site of the injection is red and swollen, and she has headache and feels nausea. Patient is advised to take BENADRYL and apply cold/ice to the site of the injection. Monitor the adverse and seek medical assistance if the symptoms not resolved.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursa injury, Bursitis, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder and upper arm. Patient states injection was high up on the upper arm near shoulder joint. Suspect that the bursa was affected and causing bursa inflammation and pain in joint. Believed to be from injection technique and probably not vaccine. Patient to see physician.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in on 9/15/17 arm where injection was given was slightly warm and swollen. He said it hurt and then right before it felt like a belt was on it. He had movement and said it felt a little better. He went to Urgent Care.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Peripheral swelling
Clinical narrative: Pt received PNEUMOVAX in right deltoid and FLUZONE HD in left deltoid at 11:47 am on 9/12/17. Customers wife said that evening at bedtime patient was complaining of chills. The next morning 9/13/2017 8 am, the wife call the pharmacy and reported patient's right arm was swollen. RPh instructed them to go to emergency room. He was given antibiotic and steroid injections. 9/16/17 pt is fine with no problem.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Insomnia, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: Pain, unable to lift left arm as of 1 week, unable to sleep without pain. Decreased range of motion and strength.
Sex: U
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Rash generalised
Clinical narrative: Sick to the stomach, rash all over, dizziness, sweating-started the night of vaccine and felt bad for 3-4 days.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Fatigue, Loss of consciousness, Pallor, Seizure
Clinical narrative: After administration, patient leaned back with eyes rolled towards the back of his head. He began to convulse for a few seconds, then fainted. Moments later he regained consciousness and appeared pale and complained of being tired.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: After administration, patient leaned back with eyes rolled towards the back of his head. He began to convulse for a few seconds, then fainted. Moments later he regained consciousness and appeared pale and complained of being tired.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Patient developed a rash up and down her left arm with raised arm bumps that were red in color. She used BENADRYL and hydrocortisone cream and they are going away.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Asthenia, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Patient received two immunizations in left arm properly spaced and at first felt ill. Friday felt weak and joint pain. Saturday, 9/16, noticed redness from below two injxn sites extended to elbow. Warm to touch. Suspect phlebitis.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Phlebitis
Clinical narrative: Patient received two immunizations in left arm properly spaced and at first felt ill. Friday felt weak and joint pain. Saturday, 9/16, noticed redness from below two injxn sites extended to elbow. Warm to touch. Suspect phlebitis.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Feeling hot, Increased upper airway secretion, Lethargy
Clinical narrative: Chills, warmth down throat, lots of mucous, cough, fever, lethargy.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills, warmth down throat, lots of mucous, cough, fever, lethargy.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity
Clinical narrative: Upon return home after vaccination, patient experienced pain and heaviness of (L) arm. Arm was difficult to move. Following day, unable to move arm. Pt instructed to seek medical care. Seen at urgent care. Given sling and pain medication.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Tenderness, Urticaria
Clinical narrative: Welts on the left arm and extreme tenderness in the armpits started 11AM Friday peaked at 4 and 10om Friday. By 4pm 9/16 reaction is gone.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Red and swollen at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at injection site.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Discomfort, Erythema, Pain, Pain in extremity
Clinical narrative: The morning after she received the shot, her arm was hot to the touch, very red, and swollen. By that afternoon, her upper arm had swollen to almost twice its normal size, redness had spread down to her elbow and up to her neck(!!) and her arm was boiling hot. She cried for the next 3 days at school and at home about how much her arm hurt any time she moved, which was of course very often. She was in a lot of pain and did not sleep for 3 nights because of the pain. Even now, almost a week after the shot, although the redness has subsided and it's not as swollen, it is still swollen and uncomfortable.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling, Skin warm, Sleep disorder
Clinical narrative: The morning after she received the shot, her arm was hot to the touch, very red, and swollen. By that afternoon, her upper arm had swollen to almost twice its normal size, redness had spread down to her elbow and up to her neck(!!) and her arm was boiling hot. She cried for the next 3 days at school and at home about how much her arm hurt any time she moved, which was of course very often. She was in a lot of pain and did not sleep for 3 nights because of the pain. Even now, almost a week after the shot, although the redness has subsided and it's not as swollen, it is still swollen and uncomfortable.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, chills, aches and pains, weakness.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Skin infection
Clinical narrative: Patient received vaccination from pharmacy on 9/14/17. Patient returned to pharmacy on 9/16/17 with  a large red rash around injection site, and was warm to touch, stating it had appeared the morning of 9/15/17. Pharmacist recommended to outline rash in marker and take benadryl and if rash continued to spread, go to emergency room or urgent care. Patient was evaluated at local emergency department evening of 9/16 due to spreading rash and was diagnosed with unspecified skin infection. Patient was prescribed Cephalexin 500 mg four times daily for 7 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: I noticed I had hives on my thighs that evening. The next morning I noticed more hives on my torso while I was getting dressed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Pain in extremity
Clinical narrative: Received flu shot at pharmacy on 9/9/17, arm was sore the day after but woke up on 9/11 with red spot on the arm at the injection site. She said it was not itchy or warm, just red. She went to doctor office, diagnosed with cellulitis, was given antibiotic to treat infection.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: For 48 hours I experienced fever (between 101 and 102.4 degrees), severe body aches, chills and shaking, swollen red arm and weakness. I took Tylenol and used cool pack on arm and warm pack on low back.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: For 48 hours I experienced fever (between 101 and 102.4 degrees), severe body aches, chills and shaking, swollen red arm and weakness. I took Tylenol and used cool pack on arm and warm pack on low back.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Injection site pain
Clinical narrative: Injection site pain that spread to shoulders, back, abdominal regions.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient states she got a high fever on 9/15/17. The upper part of her arm down to right below the elbow is red and swollen. Advised patient to take BENADRYL and see her physician if symptoms do not decrease in a few hours. She stated she would if needed.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Acute muscle soreness, around the site, and into the armpit area. Very painful, child was unable to even lift her arm without pain. Duration was approximately a week.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic, Vaccination site reaction
Clinical narrative: Red bumps in right arm (where vaccine was given) that are itchy and have spread across the arm to the right side of the chest.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Injection site pain, Pain, Pain in extremity, Rash erythematous
Clinical narrative: 1. 9/14/17 No pain at flu vaccine site but injection site pain at PNEUMVOVAX-23 site. 2. 9/15/17 Rash about 4-6 inches long with diameter of 2-3 inches (red, inflamed, and tender). 3. When patient flexed and extended arm she had arm pain.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: 1. 9/14/17 No pain at flu vaccine site but injection site pain at PNEUMVOVAX-23 site. 2. 9/15/17 Rash about 4-6 inches long with diameter of 2-3 inches (red, inflamed, and tender). 3. When patient flexed and extended arm she had arm pain.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Erythema and edema approximately 8 cm x 7 cm to site, fever of 102.9 F on evening of 9/16/17, with fever resolved 9/17/17.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Dizziness, Visual impairment
Clinical narrative: About 10 minutes after immunizations, patient had left the pharmacy area and started towards her car when she felt light headed, stomach pains, vision went dark. She made her way to her car and sat for 15 minutes there before the symptoms subsided.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient had localized soreness, redness, feeling hot to the touch, and swelling approximately 12 hours after injection. Applied an ice pack. Recommended further treament with ibuprofen for the pain and BENADRYL and diphenhydramine if any itchiness.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Circular rash about 3 inch in diameter, swollen and warm to touch. Patient referred to primary care physician.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Facial pain, Neck pain, Pruritus, Scab
Clinical narrative: Pain, itching, erythema on right side of face and neck, including around the eye. Some crusting also occurred.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient describes feeling light headed and dizzy starting 2 hours after vaccine administration and lasting for a period fo 3 to 4 hours. She does not report any other signs or symptoms.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Nausea, Pyrexia
Clinical narrative: Queasiness, fever of 100 degrees, left arm bright red from shoulder until the elbow.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient arm at the site of injection looks dark red, surrounded by a wide area of pale red. Patient stated that the area feels warm and itchy and raised as well. Patient stated that the adverse reaction started Friday night (About one day after the vaccine was given).
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Started with redness/swelling in the morning after vaccination. Developed itching throughout the day, which lasted about 2 weeks. Gave diphenhydramine 1-2 times daily for 2 weeks, until itching resolved.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Ataxia, Skin warm, Speech disorder, Swelling
Clinical narrative: She felt ataxic, difficulty talking, extreme swelling, heat in right arm.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Patient received vaccine at 1230 and reported to medical staff at around 1510-1512 of unusual pain and urticaria at injection site. Patient presented with a large wheal on injection site with pain radiating outward. Patient was treated with pressure and cold packs. Patient was released on their own recognizance as they are a Physician. Briefed to report to emergency care if any trouble breathing or anaphylaxis develops. Reaction was unprecedented to the patient who receives an immunization annually for multiple years.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called the pharmacy at 4:10pm stating that she had a large (4 inch to 5inch) red mark on the back of her arm where she got the zosta shot 2 days ago. She said it was mildly itchy and that was how she discovered it. I told her to take benadryl tonight and every 4 to 6 hours until tomorrow at noon (she knows it will make her drowsy). If the mark does not lessen or go away, she will make an appt with her PCP or go to urgent care to see if something else can be done.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Dyspnoea
Clinical narrative: Patient experienced shortness of breath, chest pain, and back pain. Patient sat down for about 15 minutes and symptoms abated. During that time EMS was called as precaution. They evaluated the patient and determined she was no longer in distress. Patient was advised to seek emergency care if symptoms returned. Patient left store.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Loss of consciousness
Clinical narrative: Patient receiving flu shot, first attempted and patient tensed up, so had to re-stick patient. Upon receiving vaccine, patient passed out and then regained consciousness within a few seconds. Patient felt very dizzy, EMS was contacted and arrived shortly after. Patient's blood pressure was taken and vitals were okay. EMS did complete a patient work up, but did not feel he needed to go to the ER. Patient was able to walk out of the store and mom was taking patient to urgent care.
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Malaise
Clinical narrative: Chills for a couple of days - similar to the on-set of the flu. Periods of lightheadedness started about the third day after vaccination and lasted two weeks. Vaccination site was tender for two weeks and slightly discolored. It was also puffy for more than a week. General feeling of not being well - tired, cold, moments of dizziness.
Age: 52.0
Sex: F
Vaccine: YF
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills for a couple of days - similar to the on-set of the flu. Periods of lightheadedness started about the third day after vaccination and lasted two weeks. Vaccination site was tender for two weeks and slightly discolored. It was also puffy for more than a week. General feeling of not being well - tired, cold, moments of dizziness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling, redness and itching. Patient said she maybe had run a small fever the night of the injection.
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site swelling, Surgery
Clinical narrative: A BIG RED BUMP PROTRUDING FROM HIS ARM WHERE I GAVE THE INJECTION.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient fainted immediately after receiving vaccine. Fell from sitting position to floor. LOC for approx. 30 seconds. Then awake with no memory of prior event. Had red, raised, quarter-sized bump on left forehead from hitting floor.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Memory impairment, Swelling face, Syncope
Clinical narrative: Patient fainted immediately after receiving vaccine. Fell from sitting position to floor. LOC for approx. 30 seconds. Then awake with no memory of prior event. Had red, raised, quarter-sized bump on left forehead from hitting floor.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Haemorrhage subcutaneous
Clinical narrative: LARGE RED AREA (APPROX 2 INCHES IN DIAMETER), LOOKED LIKE BLEEDING UNDERNEATH SKIN.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient experienced swelling starting the day after vaccine administration. Starting 1.5 inch by 1.5 inch square at 24hrs. At 72 hours most of the upper left arm is swollen down to elbow. Patient will try taking BENADRYL tonight 9/17/17.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity, Sleep disorder
Clinical narrative: Woke up middle of the night with severe pain in left shoulder radiating down to hand. Developed redness of entire bicep/deltoid area of left arm. Hot to touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Influenza, Nausea, Retching
Clinical narrative: Patient came in complaining of flu symptoms, such as dry heaves, aches, nausea and dizziness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis post injection.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient reported that after receiving the PNEUMOVAX vaccine, the area became red, hard and swollen the next day. Two days after administration, patient reported that her entire arm down to the wrist area became red, hard and swollen. Patient made no mention of any treatment or how long the swelling lasted to pharmacist.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Hot flush, Laceration, Loss of consciousness, Mydriasis, Pulse abnormal
Clinical narrative: Incident report Thursday September 14th 2017 Pharmacy front store incident from the front store. Flu shot vaccination fainted / passed out due to vaccine. Two customers came into the pharmacy for seasonal flu shots. Mother and daughter both have received prescription medication from the pharmacy in the past. Both patients had received flu vaccinations in the past without incident. Mother approached and inquired about the availability of flu shots. I greeted them and informed them we have the 17-18 flu shots available and we could take care of their vaccinations. I organized the clipboards with the paperwork for the vaccines and handed them to mother for completion. I returned to other issues in the pharmacy which required my attention while the paperwork. Once the paperwork was completed I brought them into the pharmacy for processing. There were no issues noted on the paperwork with allergic reactions or issues with previous vaccinations. After the AFLURIA had been injected daughter mentioned a hot flash and fanned herself for a moment. No other complaints or concerns when mentioned. I checked her ABCs no swelling noted or difficulty breathing reported. After administrating mother's vaccine I returned to the pharmacy to complete the paperwork to finalize the transaction. At this point I was called back to the front store daughter had felt faint and started to pass out. When I arrived in the waiting room mom was helping daughter back up to her chair. I check daughter's eyes for contact and noted they were dilated. I then assessed daughter's pulse and found it to be weak but assessed at 50. I check the ABCs and no other conditions were noted or worsening. I reassessed the pulse rate and due to the laceration on the forehead requiring attention the pulse rate could not be fully evaluated. I was able to retrieve an automatic BP cuff from the pharmacy to assist with the monitoring of daughter's vitals. First reading the BP cuff generated was 80/65 pulse 60. No worsening of condition was noted. Airway was fine, no signs of anaphylaxis noted or other distress. I continued to provide first aid to the head laceration and assess vitals and ABCs. A new BP test was run and improvement noted 82/70 and pulse 66. Due to an emerging issue with another patient I had to use the BP monitor for another patient. Pt was improving, alert to time and place and able to hold conversation and report verbally to me any distress or issue she was having while I began to assess the other patient. No other test were done. Daughter was able to leave around 5:15pm with no other issue to report.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Incident report Thursday September 14th 2017 Pharmacy front store incident from the front store. Flu shot vaccination fainted / passed out due to vaccine. Two customers came into the pharmacy for seasonal flu shots. Mother and daughter both have received prescription medication from the pharmacy in the past. Both patients had received flu vaccinations in the past without incident. Mother approached and inquired about the availability of flu shots. I greeted them and informed them we have the 17-18 flu shots available and we could take care of their vaccinations. I organized the clipboards with the paperwork for the vaccines and handed them to mother for completion. I returned to other issues in the pharmacy which required my attention while the paperwork. Once the paperwork was completed I brought them into the pharmacy for processing. There were no issues noted on the paperwork with allergic reactions or issues with previous vaccinations. After the AFLURIA had been injected daughter mentioned a hot flash and fanned herself for a moment. No other complaints or concerns when mentioned. I checked her ABCs no swelling noted or difficulty breathing reported. After administrating mother's vaccine I returned to the pharmacy to complete the paperwork to finalize the transaction. At this point I was called back to the front store daughter had felt faint and started to pass out. When I arrived in the waiting room mom was helping daughter back up to her chair. I check daughter's eyes for contact and noted they were dilated. I then assessed daughter's pulse and found it to be weak but assessed at 50. I check the ABCs and no other conditions were noted or worsening. I reassessed the pulse rate and due to the laceration on the forehead requiring attention the pulse rate could not be fully evaluated. I was able to retrieve an automatic BP cuff from the pharmacy to assist with the monitoring of daughter's vitals. First reading the BP cuff generated was 80/65 pulse 60. No worsening of condition was noted. Airway was fine, no signs of anaphylaxis noted or other distress. I continued to provide first aid to the head laceration and assess vitals and ABCs. A new BP test was run and improvement noted 82/70 and pulse 66. Due to an emerging issue with another patient I had to use the BP monitor for another patient. Pt was improving, alert to time and place and able to hold conversation and report verbally to me any distress or issue she was having while I began to assess the other patient. No other test were done. Daughter was able to leave around 5:15pm with no other issue to report.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site pruritus
Clinical narrative: Appears main discomfort is in the left arm where the PNEUMOVAX was administered. Pt has great difficulty with any movement of the left arm now. Onset of reaction appeared in about 4 hours after administration. The area is said to be sore, itchy, and pt aches all over, has headache, and is not able to sleep well at all because of the discomfort. Pt has tried some ibuprofen for relieve, and is monitoring condition. If situation becomes worse, or not any better by Monday 18, 2017, pt will go into see dr about condition.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain, Poor quality sleep
Clinical narrative: Appears main discomfort is in the left arm where the PNEUMOVAX was administered. Pt has great difficulty with any movement of the left arm now. Onset of reaction appeared in about 4 hours after administration. The area is said to be sore, itchy, and pt aches all over, has headache, and is not able to sleep well at all because of the discomfort. Pt has tried some ibuprofen for relieve, and is monitoring condition. If situation becomes worse, or not any better by Monday 18, 2017, pt will go into see dr about condition.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Emotional distress, Infantile back arching, Injection site mass, Limb mass, Pyrexia
Clinical narrative: One hour after his 2, 4, and 6 month vaccines he had inconsolable screaming for 4-6 hours. Arching of back and stuffing in his body. He ran a slight fever and had lumps on his legs for a few days.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Screaming
Clinical narrative: One hour after his 2, 4, and 6 month vaccines he had inconsolable screaming for 4-6 hours. Arching of back and stuffing in his body. He ran a slight fever and had lumps on his legs for a few days.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Muscle spasms, Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever. Chills/aching. Leg Cramps. Sore arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Customer came in with severe bruising at injection site, it had described to purple and yellow on 9/14/17 - started late day of injection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Baseball sized warm and swollen injection site reaction post 48 hours. Told to take 2 BENADRYL. Patient already drew line around area and is watching for tracking or growth.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot (emitting heat) worst first 24 - 48 hrs. Decreased by 72 hours but still slightly warm after.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Nodule, Skin warm, Swelling
Clinical narrative: Red swollen area, warm to touch, white circle around area, hard knot, TYLENOL, cold compress.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Right arm-4inx1in rash and swollen around injection site, pain to touch at injection site, feel warm around injection site, feel a lump at injection site. Per patient reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pt. reported pain and range of mobility limitations. 3 weeks post vaccination referred to clinic for eval.
Age: 25.0
Sex: U
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 25 years old patient of unknown gender. The patient's pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 12-JUL-2017, the patient was administered with M-M-R II (albumin status rHA, lot # M042846, with expiration date 21-OCT-2018) or VARIVAX (lot# N014366, expiration date 09- MAY-2019) (dose, dose#, route of administration and anatomical location were not reported for both of the vaccines) for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009993: US-009507513-1707USA002673: US-009507513-1709USA008416:
Age: 25.0
Sex: U
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 25 years old patient of unknown gender. The patient's pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 12-JUL-2017, the patient was administered with M-M-R II (albumin status rHA, lot # M042846, with expiration date 21-OCT-2018) or VARIVAX (lot# N014366, expiration date 09- MAY-2019) (dose, dose#, route of administration and anatomical location were not reported for both of the vaccines) for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009993: US-009507513-1707USA002673: US-009507513-1709USA008416:
Age: 25.0
Sex: U
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 25 years old patient of unknown gender. The patient's pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 12-JUL-2017, the patient was administered with M-M-R II (albumin status rHA, lot # M042846, with expiration date 21-OCT-2018) or VARIVAX (lot# N014366, expiration date 09- MAY-2019) (dose, dose#, route of administration and anatomical location were not reported for both of the vaccines) for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) (lot # N003192 with expiration date at 05-JUL-2019). The administered doses of vaccine were exposed to a temperature excursion between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) on 09-JUL-2017, which lasted for a 12 hours and 10 minutes. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009993: US-009507513-1707USA002673: US-009507513-1709USA008416:
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Anxiety, Computerised tomogram head normal, Electrocardiogram normal, Fall, Lip injury
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 16 year-old male patient received the first dose of TRUMENBA and the second dose of MENACTRA, both intramuscular in the arm on 22Jun2017 approximately between 18:00 and 18:30 at 0.5 ml, single for vaccination. Medical history was none. There were no concomitant medications. The patient had received for immunization the first dose of meningococcal vaccine a/c/y/w conj (dip tox) on 19Jul2012 without adverse event. The patient experienced syncope on 22Jun2017 within 15-30 second after having received the vaccines and also incurred in a head injury as a result of the syncope event. The patient went to the emergency room where CT scan of head, electrocardiogram and x-ray of left shoulder were performed and all had negative results. The patient was not hospitalized due to the events. He recovered the same day, on 22Jun2017.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Mouth haemorrhage, Nervousness, Pallor, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 16 year-old male patient received the first dose of TRUMENBA and the second dose of MENACTRA, both intramuscular in the arm on 22Jun2017 approximately between 18:00 and 18:30 at 0.5 ml, single for vaccination. Medical history was none. There were no concomitant medications. The patient had received for immunization the first dose of meningococcal vaccine a/c/y/w conj (dip tox) on 19Jul2012 without adverse event. The patient experienced syncope on 22Jun2017 within 15-30 second after having received the vaccines and also incurred in a head injury as a result of the syncope event. The patient went to the emergency room where CT scan of head, electrocardiogram and x-ray of left shoulder were performed and all had negative results. The patient was not hospitalized due to the events. He recovered the same day, on 22Jun2017.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Syncope, X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 16 year-old male patient received the first dose of TRUMENBA and the second dose of MENACTRA, both intramuscular in the arm on 22Jun2017 approximately between 18:00 and 18:30 at 0.5 ml, single for vaccination. Medical history was none. There were no concomitant medications. The patient had received for immunization the first dose of meningococcal vaccine a/c/y/w conj (dip tox) on 19Jul2012 without adverse event. The patient experienced syncope on 22Jun2017 within 15-30 second after having received the vaccines and also incurred in a head injury as a result of the syncope event. The patient went to the emergency room where CT scan of head, electrocardiogram and x-ray of left shoulder were performed and all had negative results. The patient was not hospitalized due to the events. He recovered the same day, on 22Jun2017.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Face injury, Fall, Head injury, Immediate post-injection reaction, Limb injury
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son. A 16 year-old male patient received the first dose of TRUMENBA and the second dose of MENACTRA, both intramuscular in the arm on 22Jun2017 approximately between 18:00 and 18:30 at 0.5 ml, single for vaccination. Medical history was none. There were no concomitant medications. The patient had received for immunization the first dose of meningococcal vaccine a/c/y/w conj (dip tox) on 19Jul2012 without adverse event. The patient experienced syncope on 22Jun2017 within 15-30 second after having received the vaccines and also incurred in a head injury as a result of the syncope event. The patient went to the emergency room where CT scan of head, electrocardiogram and x-ray of left shoulder were performed and all had negative results. The patient was not hospitalized due to the events. He recovered the same day, on 22Jun2017.