chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Incorrect dose administered, Injection site rash, Product preparation issue
Clinical narrative: Rash around the injection site; Diluent only was given; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 3425X, expiry date 18th December 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix and FLUAD. On 2nd October 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In October 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: A pharmacist reported that the diluent only was given for the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Also Fluad HD was co-administered in the same site. The patient developed a rash around the injection site. The reporter consented to follow up.  This case has been linked with US2019180863, reported by same reporter. It was unknown if the reporter considered the injection site rash to be FLUAD HD.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Aggression, Autism spectrum disorder, Constipation
Clinical narrative: Symptoms of Autism, Constipation, Tantrums
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Presyncope
Clinical narrative: DIZZINESS, ALMOST FAINTED OVER AND OVER
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt received MCV4. Bexsero and HPV9. 3-4 Minutes after vaccination pt stated she was feeling dizzy and proceeded to pass out.  Pt had LOC for about 5-10 seconds.  Dad and nurse supported patient in her chair until she regained consciousness and then was lowered down to the floor with feet up.  Pt stated she was feeling back to normal after just a few minutes.  Pt stayed in lying position for about 5 minutes and was given a juice box and alcohol pad to sniff.  After about 5 minutes patient slowly moved to the sitting position/ standing  Pt stayed in clinic for 20-25 minutes after incident and stated feeling completely normal before leaving with parent. No Nausea reports.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anxiety, Obsessive-compulsive disorder, Tic
Clinical narrative: Facial tics, OCD symtoms, Anxiety
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Lymphadenitis
Clinical narrative: Patient received injection of Shingrix and Pneumovax 23 on 10/7/19.  Stated she woke up with Right Arm Swelling  which was where the Shingrix was administered.  The injection site was not swollen but her elbow area and around her armpit area were swollen.  She stated she felt achy in that area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient said her arm started to hurt a couple days after the vaccination. Then her arm swelled up and was itching. This progressed through the week. She then stated that she had bad stiffness in her neck and shoulders.  So on Sunday, October 7th she went to Urgent Care.  They put her on oral Benadryl and Hydrocortisone cream and Tylenol.  They told her it was a localized reaction not a systemic reaction.
Age: 18.0
Sex: F
Vaccine: MENB, TD
Symptoms: Discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Client complained of Left arm pain and unable to move arm after receiving vaccine on 09-27-2019. Pain and discomfort had completely resolved by 10/03/2019. Client had a medical evaluation and has a follow up appointment.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Hyperhidrosis, Multiple sclerosis, Somnolence, Vision blurred
Clinical narrative: Symptoms like MS Lack of awake/awareness/lucidity Extreme fatigue, sweats, blurred vision
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: pt had redness irritation at injection site-- he left our inject safe barrier bandage on for 3 days also-- we generally recommend to take it off when pt gets home. He still has some redness to area but does not complain or pain or malaise
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: this is technically not a adverse event per vaccine , my boss wanted me to report this, the patient wanted a flulaval vaccine and i made an error and gave her at first a twinrix vaccine, after realizing the problem, I gave her the flulaval she really wanted.  The incident happened like 2 hours ago, as of right now she does not have any adverse problems from the wrong vaccine given
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Peripheral swelling, Rash
Clinical narrative: Swelling and rash started at knees and upper thighs, and also wrists and lower arms. Burning sensation that gets worse with activities. Need to apply ice packs every two hours to relieve pain. Doctor visit on Wed., Oct. 5, 2019; got prescriptions for: Prednisone 20 mg twice per day and Hydroxyzine 25mg taking 2 before bed. Also taking OTC Claritin or Benadryl.  The ?rash? spread or upper thighs and upper arms quickly. Over the past week, the rash has become more localized back at the knees and lower thighs, and also the wrists and lower forearms. The rash is very symmetrical on body location a when it appears anywhere.  Also applying Rx for Triamcinolone Acetonide Ointment, 0.1% to help relieve pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Severe right arm pain, and arthralgia of shoulder with inability to lift arm
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Father reported that the afternoon (24 plus hours after vaccines given) after vaccines 10/08/2019 they noted redness and swelling to the left upper arm. They took the child to the ER and they were asked about the vaccines given the day before. The child had full movement of arm. THe facility reportedly gave some medication there. I did not see the child after the vaccines, the father came alone to find out the sites of the vaccines.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 yo patient was seen for vaccine catch up schedule and due for 2nd dose of MMR and varicella.  The provider, recommended proquad which was given.  It was shortly after administration of the proquad that the clinic staff realized the patient was outside of the age range for proquad administration.   Mother of patient was notified of this error X3 days later, mother of patient reports that there were no adverse reactions to the Proquad administration
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis
Clinical narrative: Pt was hospitalized for possible bursitis after receiving the Shingrix shot on 09/03/2018
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Peripheral coldness
Clinical narrative: patient said pain in injection site along with nausea and cold extremities
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Blood culture, C-reactive protein, Culture urine, Full blood count, Hypophagia
Clinical narrative: Fever up to 103.6, decreased PO intake requiring hospitalization for observation
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever up to 103.6, decreased PO intake requiring hospitalization for observation
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Ill-defined disorder, Pyrexia
Clinical narrative: patient described as fever and illness lasting 3 days
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 18 yo patient was seen for vaccine catch up schedule and due for 2nd dose of MMR and varicella.  The provider, recommended proquad which was given.  It was shortly after administration of the proquad that the clinic staff realized the patient was outside of the age range for proquad administration.   Mother of patient was notified of this error, mother of patient reports that after 3 days there were no adverse reactions to the Proquad administration
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 60 year old patient was given HD shot. Not approved for age group
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: My son fainted 1 min after receiving his annual flu vaccine.  He was not injured when he fainted.  He recovered quickly and his BP and heart rate were within. normal limits 5 min after
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema
Clinical narrative: Redness on left deltoid area and chills for 1 week
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctival hyperaemia, Dyspnoea, Eyelid margin crusting, Vomiting, Wheezing
Clinical narrative: Pt had erythematous conjunctiva with yellow crusting, audible wheezing and sob.  Pt was given 50 mg benadryl IM, an albuterol treatment, and depomedrol 40 mg.  Pt also given a prescription for medrol dose pack.  Pt vomited during breathing treatment and following treatment.  Pt's wheezing had disappeared after breathing treatment.  Monitored pt.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm sore and can't lift above head
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Employee received a flu vaccine on 10/4/19 and later that same day around 10pm, experience left side face numbness that extended behind left ear and into bottom portion of lip. She describes some "droop" but stated "I knew this wasn't a stroke". Employee has had chronic headaches since 2017 and states she still has a headache today, 10/9/19. No arm pain, fever or other issues. Symptoms resolved on their own approx. 2 days later. Employee did not go to the ED and did not see her provider about this issue. Employee is at work today.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Employee received a flu vaccine on 10/4/19 and later that same day around 10pm, experience left side face numbness that extended behind left ear and into bottom portion of lip. She describes some "droop" but stated "I knew this wasn't a stroke". Employee has had chronic headaches since 2017 and states she still has a headache today, 10/9/19. No arm pain, fever or other issues. Symptoms resolved on their own approx. 2 days later. Employee did not go to the ED and did not see her provider about this issue. Employee is at work today.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Fall, Hypoaesthesia, Loss of consciousness, Pallor
Clinical narrative: he stated he could " feel something go up my back" about 5 minutes after the vaccination.  About 15 minutes post vaccination he was standing next to the exam table and collapsed onto it, mom and I had to hold him upright, he was unconscious, he appeared to move his arms and neck in a jerking motion, color was pale to dusky, opened his airway, slapped his face. he appeared to revive. he had urinary incontinence.  rechecked vitals BP 100/60 pulse 80s. laid him on exam table. called 911. evaluated. oriented X3 by time of ambulance arrival was able to stand after sitting on side of exam table. he did not want to go to ER some mom took him home. he has fainted in the past but not the involuntary movement or incontinence. he complained of his hands going numb but the sensation returned.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Sensory disturbance, Urinary incontinence
Clinical narrative: he stated he could " feel something go up my back" about 5 minutes after the vaccination.  About 15 minutes post vaccination he was standing next to the exam table and collapsed onto it, mom and I had to hold him upright, he was unconscious, he appeared to move his arms and neck in a jerking motion, color was pale to dusky, opened his airway, slapped his face. he appeared to revive. he had urinary incontinence.  rechecked vitals BP 100/60 pulse 80s. laid him on exam table. called 911. evaluated. oriented X3 by time of ambulance arrival was able to stand after sitting on side of exam table. he did not want to go to ER some mom took him home. he has fainted in the past but not the involuntary movement or incontinence. he complained of his hands going numb but the sensation returned.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose normal, Headache, Presyncope
Clinical narrative: About 5 min after patient received shot she had a presyncope. Patient sat down on bed and we took her vitals in the office. Patients vitals were stable in office. Patient ate a lollipop in office; She waited about 40 min after shot was administered and patient was being monitored in office. Patient was feeling much better. We called mom about 2 hrs after patient left office and she stated patient was feeling good now, she was only having a mild HA but she had already taken ibuprofen and she was eating at the moment.  Vital Signs in office were BP: 100/60, O2:99, Pulse: 70, Glucose: 83
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has a sore arm that will not subside. Patient is treating the pain with Aleve.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Felt bad all over.  Woke up Tuesday, 8th, sweating, dizzy, faint.  CAlled 911.  They were concerned about heart.  spent 36 hours in hospital, many tests.  Sent home no findings, but left arm still badly swollen, red and hot.  Hospital did nothing about the arm.  Still feels sick and very tired
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Laboratory test, Malaise, Peripheral swelling, Skin warm, Syncope
Clinical narrative: Felt bad all over.  Woke up Tuesday, 8th, sweating, dizzy, faint.  CAlled 911.  They were concerned about heart.  spent 36 hours in hospital, many tests.  Sent home no findings, but left arm still badly swollen, red and hot.  Hospital did nothing about the arm.  Still feels sick and very tired
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Blood pressure decreased, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Felt bad all over.  Woke up Tuesday, 8th, sweating, dizzy, faint.  CAlled 911.  They were concerned about heart.  spent 36 hours in hospital, many tests.  Sent home no findings, but left arm still badly swollen, red and hot.  Hospital did nothing about the arm.  Still feels sick and very tired
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Flushing, Throat tightness
Clinical narrative: About 1 minute after receiving the injection the patient was starting to feel light headed.   Despite having the patient place her head between her knees, she still felt dizzy.  I had her lay down with her knees bent.  She was becoming flushed as noticed by her color on her face.  I asked about breathing and she was feeling a tightening of her throat.  She was given 50 mg of diphenhydramine and 911 was called.  Within 2 minutes of laying down and taking the diphenhydramine her color was returning to normal and she was feeling better.  The EMTs conducted a thorough exam and her declined transport to the ER as she stated she was now feeling fine.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Feeling hot
Clinical narrative: pt stated that she experienced severe shortness of breath, and a hot feeling several hours after the vaccine.  She stated that she does have an inhaler that she almost never uses, but did use  today. The inhaler did help her with her breathing. She also took 2 tablets of benadryl 25mg.  I asked to call her Dr also to inform them of allergic reaction to the flu shot. She stated that she has never had any reaction to the shot in the past.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: fever/shaking/chills for 24 hours, starting 6-9hours after administration
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain, Pneumonia
Clinical narrative: pain on initial injection (felt like many needle pricks rather than the one), persistent pain in left upper arm and shoulder starting with injection and continuing thru to current, very limited movement and use of left arm, not able to sleep on left side. Also, 3 months after injection, diagnosed and treated for pneumonia in right lung at Medical Center Emergency Room, no prior diagnosis of pneumonia ever.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Conjunctivitis allergic, Headache, Hypersensitivity, Joint stiffness, Pain
Clinical narrative: Severe allergic reaction with headache, body pain, swollen tongue, swollen throat,  allergic conjunctivitis, stiff jaw.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Severe allergic reaction with headache, body pain, swollen tongue, swollen throat,  allergic conjunctivitis, stiff jaw.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: Red Swollen Rash on 90% of left upper arm, hot to touch ,swollen bump at site of injection,headache, flu like symptoms. rash started within 24 hours of administration. rash still same size on Wednesday (10/2/19) as on Sunday( 09/29/19) per patients statement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Red Swollen Rash on 90% of left upper arm, hot to touch ,swollen bump at site of injection,headache, flu like symptoms. rash started within 24 hours of administration. rash still same size on Wednesday (10/2/19) as on Sunday( 09/29/19) per patients statement.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Oropharyngeal pain, Paraesthesia oral, Pyrexia
Clinical narrative: redness, high fever, sore throat, allergic symptoms: tingling in lips, bumps in throat
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: redness, high fever, sore throat, allergic symptoms: tingling in lips, bumps in throat
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was accidentally given two doses of the high dose fluzone vaccine
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Eye pain, Feeling cold, Headache, Nausea
Clinical narrative: 5:45pm I recieved the shot in my left arm. A few hours afterward left arm was sore. Next morning, 10/8, I woke up around 7am and my whole body was sore. Went to bed that night and could not get warm, especially feet. Woke up next morning, 10/9, nauseous,  extremely weak, headache especially behind my eyes, and sore all over.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Peripheral coldness
Clinical narrative: 5:45pm I recieved the shot in my left arm. A few hours afterward left arm was sore. Next morning, 10/8, I woke up around 7am and my whole body was sore. Went to bed that night and could not get warm, especially feet. Woke up next morning, 10/9, nauseous,  extremely weak, headache especially behind my eyes, and sore all over.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypersensitivity, Ocular hyperaemia, Throat tightness
Clinical narrative: She said it started later in the afternoon and she had a headache, her eyes got very red and was not very lucid. Her throat felt obstructed and she went to the hospital where they treated her for a major allergic reaction she said.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: patient said arm was sore and had to have an ultrasound
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Ill-defined disorder
Clinical narrative: IMMUNIZATION WAS GIVEN INTRAMUSCULARLY IN PT LEFT ARM. PT ON ELIQUIS. LARGE RISE FORMED ON INSIDE OF LEFT ARM. PT WENT TO DOCTOR 4 OR 5 DAYS LATER AD DOCTOR SAID IT WAS FROM THE FLU SHOT THAT WE PROBABLY NICKED A VEIN WHEN IT WAS GIVEN. PT CAME BACK TO REPORT TO PHARMACY
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscle contusion, Pain, Pain in extremity
Clinical narrative: prolonged arm pain at injection site. unable to raise arms without pain. difficulty lifting lightweight items. felt like intense muscle bruise. no visible bruise. pain in left arm lasts 11 months. pain in right arm lasted 7 months.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Injection site pain
Clinical narrative: Considerable pain at the injection site. Did not respond to acetaminophen or ibuprofen. Often too painful to even concentrate.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Redness at cite, cellulitis present. Treated with Augmentin for 10 days. Symptomatic treatment. Is to return if symptoms worsen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: HD Flu vaccine given on 10/7 and 48 hours after (10/9) flu vaccine was given patient began having redness and swelling to entire left upper arm. Skin is warm to the touch. No issue with ROM of the shoulder or pain at the joint. Patient was treated with Keflex 500mg capsule QID x 10 days. Patient was scheduled for a follow up call tomorrow 10/10 to see if symptoms are improving. History: Patient did receive the HD Flu vaccine last year with no issues.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Prolonged Pain at injection site, unable to raise arms without pain, difficulty lifting lightweight items, felt like intense muscle bruise, no visible bruise, pain in left arm lasted 11 months, pain in right arm lasted 7 months.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling at the injection site and further redness roughly six inches down the right arm. The flu shot given on her left arm caused no reaction.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient received vaccine on 10/4/2019, around 1pm. Patient came back into the pharmacy on 10/6/2019, stating that when she got home later in the evening after having the shot,  she noticed some itching and hives ear the injection site. She states that the hives and itching slowly spread across her back and neck, eventually to the other arm. Pharmacist on duty on 10/6/19 confirmed patient never experienced any breathing issues, was mainly concerned about the itching. Pharmacist recommended patient to take benadryl and contact her primary care provider.  Reporting pharmacist followed up with patient on 10/9/19, patient said the rash had faded and she did not end up contacting her doctor.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling, itching, pain, possible infection
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site extravasation, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient stated that when she received the vaccination, it was very painful and she felt liquid running down her arm. She was told the pneumonia vaccine had "extra liquid" in it and the patient should not be alarmed. That evening her arm swelled up and caused significant pain to her. When she came in on 10/9/19, her arm was still red and swollen. Patient had to take off of work due to the pain in her arm
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that when she received the vaccination, it was very painful and she felt liquid running down her arm. She was told the pneumonia vaccine had "extra liquid" in it and the patient should not be alarmed. That evening her arm swelled up and caused significant pain to her. When she came in on 10/9/19, her arm was still red and swollen. Patient had to take off of work due to the pain in her arm
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Impaired work ability, Inappropriate schedule of product administration, Insomnia, Mobility decreased
Clinical narrative: Patient stated that when she received the vaccination, it was very painful and she felt liquid running down her arm. She was told the pneumonia vaccine had "extra liquid" in it and the patient should not be alarmed. That evening her arm swelled up and caused significant pain to her. When she came in on 10/9/19, her arm was still red and swollen. Patient had to take off of work due to the pain in her arm
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient stated that when she received the vaccination, it was very painful and she felt liquid running down her arm. She was told the pneumonia vaccine had "extra liquid" in it and the patient should not be alarmed. That evening her arm swelled up and caused significant pain to her. When she came in on 10/9/19, her arm was still red and swollen. Patient had to take off of work due to the pain in her arm
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypoaesthesia oral, Pyrexia
Clinical narrative: Participant reports numbness of tongue for 2 days  with fever of 100.4 degrees Farenheit, chills after receiving vaccination, resolved spontaneously.  Participant has  indicated prior sensitivities to medications,  no prior noted reactions to flu vaccinations in 2017-2018, 2016-2017 or 2015-2016 years.
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: I have always gotten flu shot and it's always a little sore for a day or two. This time it was beyond sore that night and for about 3 days where injection went in. Then pain down the arm started. It goes into my hand. My range of motion has changed. It hurts to push, pull, lift. It for some reason really hurts at night while sleeping. I've never had such pain in my arm till this vaccine. I believe it was given to high causing some sort of nerve damage or inflammation in my rotator cuff. It hurts to wash hair, drive ect. This has become a constant problem now.
Age: 13.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chest X-ray normal, Differential white blood cell count abnormal, Granulocyte percentage, Injection site erythema, Injection site pain
Clinical narrative: The patient started with fever, nausea, vomiting, and arm pain roughly 11 hours after receipt. He then progressed to have injection site erythema and pain, along with fever to 104 F, nausea/vomiting, tachycardia and extending injection site erythema over the next 24 to 36 hours.
Age: 13.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Leukocytosis, Metabolic function test normal, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The patient started with fever, nausea, vomiting, and arm pain roughly 11 hours after receipt. He then progressed to have injection site erythema and pain, along with fever to 104 F, nausea/vomiting, tachycardia and extending injection site erythema over the next 24 to 36 hours.
Age: 13.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Tachycardia, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: The patient started with fever, nausea, vomiting, and arm pain roughly 11 hours after receipt. He then progressed to have injection site erythema and pain, along with fever to 104 F, nausea/vomiting, tachycardia and extending injection site erythema over the next 24 to 36 hours.
Age: 43.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Back pain, Injection site erythema, Injection site swelling, Pain, Rash
Clinical narrative: Patient described injection site redness, swelling. soreness and rash across his back and torso.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Malaise, Vision blurred
Clinical narrative: After I received the flu shot I became very ill and my vision was  blurred, I also had a real bad headache  and I  became very tired. As of 10/09/2019 I am still feeling the same. I usually get the flu every year after the flu shot but this year I became ill right after the shot and things were different.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Px experienced redness and swelling up to almost the elbow on 10/05/19 on her right arm where we administered the Pneumovax23 and was reported to us on 10/07/19. Px said she put ice on it and on the time it was reported it doesn't feel as hard anymore as the previous days. Px was asked if there were any other reactions besides the redness and swelling and she said it was a little itchy but not painful and no reaction on the other arm where we administered the Fluad. Advised px to continue to put ice and to take ibuprofen for swelling and diphenhydramine if it continues to itch. Followed up with px the following day 10/08/19 and px said swelling has gone down and she didn't take diphenhydramine but she took advil and everything was fine
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dry skin, Genital herpes, Pain
Clinical narrative: 12 day after receiving the shingles vaccine, the patient had an outbreak of genital herpes.  The patient was already a carrier and the outbreak site was the normal site of reaction.  Patient reported an unusually long and painful outbreak lasting until 9-12-19 (although the rough skin lasted until the end of September.)  Patient stated this was the worst outbreak she has had in years.   Patient did not seek any medical treatment or inform her doctor.  Patient did not inform pharmacy of her reaction until she was contacted that she was due for her second shot.  Patient was advised to follow up with her primary doctor to see if they would like her to get her 2nd shot.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RECEIVED SHINGRIX SHOT ON 10/5/19 ALONG WITH FLUZONE QUAD IN LEFT ARM. THE FLUZONE WAS GIVEN AT TOP AND SHINGRIX WAS GIVEN BELOW FLUZONE. SHE SAID THAT THE SPOT WHERE SHE GOT SHINGRIX IS THE SPOT WHERE REACTION WAS LOCATED. PATIENT SAID THAT ARM BECAME ITCHY, RED, SWOLLEN AND WARM TO THE TOUCH ON 10/6/19. SHE TRIED ICE PACK AND BENADRYL. IT DID NOT GET BETTER SO SHE WENT TO DR ON 10/9/19 AND WAS DIAGNOSED WITH CELLULITIS.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Joint range of motion decreased, Pyrexia
Clinical narrative: fever 102 that evening that improved to 101 at the time patient reported 24 hours later.   Patient also experiencing pain in left shoulder and loss of range of motion.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Borrelia test negative, Headache, Inflammatory marker test, Laboratory test normal, Nervous system disorder
Clinical narrative: A couple days after the 2nd shot I got a bad sore throat, headache across front of my face, moved into my hands tingly and aching then into my feet same tingly aching, then into my back and across front of stomach and lower legs ached. No over the counter pain meds helped. Symptoms lasted about 48 hours, bad enough you can't sleep and can't get relaxed. I have kept a journal and the exact same symptoms have happened 10 more times since then. I went to the doctor on February 13, 2019 with symptoms and he ran labs for, inflammatory stuff and everything was negative. I did not have any swelling in joints. I went back to the doctor august 9, 2019 when I had symptoms again and they reran labs and even checked for lyme disease. All negative. I am in excellent health except for these weird events that happen at random. In July 2019 I burned two fingers lightly and within hours the whole body ache crap kicked in again. I think when |I got the 2nd vaccine it messed with my nervous system and now when something stressful happens my stress reducers are not able to kick in because that vaccine is stopping them. Is there a doctor at Clinic who can help me? The local doctor prescribed Sulindac but without a diagnosis I don't feel that's the right treatment. I need your help.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Pain, Paraesthesia, Sleep disorder
Clinical narrative: A couple days after the 2nd shot I got a bad sore throat, headache across front of my face, moved into my hands tingly and aching then into my feet same tingly aching, then into my back and across front of stomach and lower legs ached. No over the counter pain meds helped. Symptoms lasted about 48 hours, bad enough you can't sleep and can't get relaxed. I have kept a journal and the exact same symptoms have happened 10 more times since then. I went to the doctor on February 13, 2019 with symptoms and he ran labs for, inflammatory stuff and everything was negative. I did not have any swelling in joints. I went back to the doctor august 9, 2019 when I had symptoms again and they reran labs and even checked for lyme disease. All negative. I am in excellent health except for these weird events that happen at random. In July 2019 I burned two fingers lightly and within hours the whole body ache crap kicked in again. I think when |I got the 2nd vaccine it messed with my nervous system and now when something stressful happens my stress reducers are not able to kick in because that vaccine is stopping them. Is there a doctor at Clinic who can help me? The local doctor prescribed Sulindac but without a diagnosis I don't feel that's the right treatment. I need your help.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: patients arm was swelling the day after. it was on the inner part of the bicep and was very hot and swollen. It looks as if the doctor thought it might have been cellulitis as well as they prescribed diphenhydramine, prednisone, and cleocin. Patient stated that it hurt and was very hot but the pain was local and no systemic effects.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Soreness at injection site within 2 hrs after injection and red rash developed at injection site on right arm and extended into arm pit.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Malaise, Nausea
Clinical narrative: Injection site pain and selling starting within a few hours of injection and continuing for about 3 days. The day after the injection, the patient experienced fatigue, nausea, and malaise which lasted about 24 hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Per the patient's mother the patient had swelling in the arm that the immunization was administered in, along with itchy and a very hot arm. The patient's mother contacted the patient's doctor and treated the adverse event with high dose benadryl every 4 hours as needed. The symptoms did resolve after 4 days and the arm has since returned to normal with no continuous adverse events reported.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Child fainted when she got her shot.  She recovered quickly.  Parents were called.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Local reaction, Musculoskeletal pain, Neck pain
Clinical narrative: Redness, swelling of the upper arm three times normal size that spreads to upper arm, pain in the scapula, neck, and armpit.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Redness, swelling of the upper arm three times normal size that spreads to upper arm, pain in the scapula, neck, and armpit.
Age: 82.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: When injecting FluBlok IM into the left deltoid, the needle had not been fully screwed onto the pre-filled syringe, as a result, most if not all of the volume of liquid escaped through the sides of the needle where the lock is rather than through the needle and into the arm, resulting in the patient losing the dose. A second dose of FluBlok was then given two inches below the injection site with no further issues. Patient was advised to watch for a sore arm and to let dr know if bothersome flu-like symptoms occur.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives started little by little in the evening time around 5:00 pm after immunization was given. By 10:00pm, hives were all the body causing great itchiness. Took Benedryl around 10:15pm to alleviate symptoms.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient returned to pharmacy on 10/9/19 stating she was still experiencing painful soreness starting at the injection site in the deltoid and extending down to a point of pain in the elbow and then continuing down to the hand.  She described numbness and tingling on the dorsal surface of the hand.  These effects started after the vaccination.  She will be following up with her physician for evaluation.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: About 24 hrs after vacc. noted itchy + erythema distal to injection site decreased about 5 x 7 cm
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose, headache, sore throat, sneezing & cough & fatigue current temp orally 98.2 10/9/19 @ 1056.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing
Clinical narrative: runny nose, headache, sore throat, sneezing & cough & fatigue current temp orally 98.2 10/9/19 @ 1056.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Erythematous rash, 5 x 7 cm (L) ARM just below the injection site, Not tender, Not raised.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient reported on 10/6 that she developed hives and welts from the vaccine. She self treated with Benadryl and then xyzal. By 10/6 she said most of it had resolved. Patient said she had flu shots before without incident. She did not contact her doctor. On 10/9 reported it to her doctors office and they are going to contact her.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: LOCAL INJECTION REACTION INCLUDING: SWELLING ON THE AREA, REDNESS, HOT TO TOUCH, AND PAIN. REACTION STARTED THE NEXT DAY AFTER RECEIVING VACCINE. VACCINE WAS ADMINISTERED 10/3 AND PT CAME IN TO CLINIC TO INFORM OF REACTION ON 10/7/19. PATIENT DID NOT WANT TO BE TREATED OR SEEN BY A DR SINCE SYMPTOMS WERE IMPROVING.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: Attempted to give IM flu shot. Pt moved leg between father's leg. Approximately 3/4 was given but unknown of what total was given as some was running down pts leg as well. Pt is coming back in November to be given another flu shot with 2nd Hep. A.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia, Skin warm, Swelling
Clinical narrative: Tenderness, soreness, difficult to move (R) arm, warm to touch along with fever. Took Advil on yesterday, that did help with fever. Swelling still present.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Tenderness, soreness, difficult to move (R) arm, warm to touch along with fever. Took Advil on yesterday, that did help with fever. Swelling still present.
Sex: U
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling, Redness on the site of injection. Shortness of Breath next day. Pain and Fever.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Fatigue, Full blood count, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Pt returned the day after immunizations with feelings of fatigue + malaise, soreness in L arm. Labs drawn. Pt returned the following day to review lab results, L arm with clear demarcated erythema along L deltoid, no significant swelling or heat. Pt afebrile the whole duration.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: White blood cell count increased
Clinical narrative: Pt returned the day after immunizations with feelings of fatigue + malaise, soreness in L arm. Labs drawn. Pt returned the following day to review lab results, L arm with clear demarcated erythema along L deltoid, no significant swelling or heat. Pt afebrile the whole duration.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Increasing area of redness, warmth, firmness, around the flu vaccine site
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Local Redness / warmth + mild tenderness
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nasal congestion
Clinical narrative: Pt stated that she had fever of 101 degrees Fahrenheit, body aches, chills, mild headache, congestion runny nose, soreness and swelling at the injection site.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pt stated that she had fever of 101 degrees Fahrenheit, body aches, chills, mild headache, congestion runny nose, soreness and swelling at the injection site.
Age: 22.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Fall, Head injury, Loss of consciousness, Seizure, Syncope
Clinical narrative: Syncope, fatigue, abnormal blood pressure
Age: 22.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Blood pressure abnormal, Blood test, Chest X-ray, Computerised tomogram, Fatigue
Clinical narrative: Syncope, fatigue, abnormal blood pressure
Age: 22.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Syncope
Clinical narrative: Syncope, fatigue, abnormal blood pressure
Age: 8.0
Sex: F
Vaccine: UNK, MMR
Symptoms: Abdominal pain upper, Attention deficit/hyperactivity disorder, Condition aggravated
Clinical narrative: Terrible  itchy rash all over neck and chest  Complained of headache which she NEVER gets. thank you for  taking away our rights for our healthy children. ADHD flare
Age: 8.0
Sex: F
Vaccine: UNK, MMR
Symptoms: Attention deficit/hyperactivity disorder, Condition aggravated, Headache, Rash, Rash pruritic
Clinical narrative: Terrible  itchy rash all over neck and chest  Complained of headache which she NEVER gets. thank you for  taking away our rights for our healthy children. ADHD flare
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; was administered a dose of ROTATEQ that expired on 09/01/2019; One vial/ 0.5 ml/ one dose; This spontaneous report was received from a medical assistant and refers to a 6-month-old (also reported as 7 months) female patient. There were no pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was no illness at the time of vaccination.  On 03-SEP-2019, the patient was administrated a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # N030152, 0.5 milliliter, orally, for prophylaxis, that expired on 01-SEP-2019. It was reported that there were two previous doses. On the same day, the patient was vaccinated with hib vaccine, diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR).  There was no adverse effect reported. No prescription drug treatment was required. The action taken was unknown. The outcome was reported as recovered/resolved.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; was administered a dose of ROTATEQ that expired on 09/01/2019; One vial/ 0.5 ml/ one dose; This spontaneous report was received from a medical assistant and refers to a 6-month-old (also reported as 7 months) female patient. There were no pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was no illness at the time of vaccination.  On 03-SEP-2019, the patient was administrated a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # N030152, 0.5 milliliter, orally, for prophylaxis, that expired on 01-SEP-2019. It was reported that there were two previous doses. On the same day, the patient was vaccinated with hib vaccine, diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (PEDIARIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR).  There was no adverse effect reported. No prescription drug treatment was required. The action taken was unknown. The outcome was reported as recovered/resolved.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Asthenia, Contusion, Erythema, Mobility decreased, Nausea
Clinical narrative: subsequently developed a fever of 102 F; subsequently developed a fever of 102 F, nausea; subsequently developed a fever of 102 F, nausea, dizziness; she could not lift her arm; weakness in the arm where the vaccination was administered; This spontaneous report was received from a medical assistant concerning to a 70 year old female patient. The patient's medical history included diabetes mellitus and hypertension. The patient doesn't referred allergies. Concomitant therapies included pioglitazone hydrochloride(ACTOS), amlodipine(AMLODIPINE) and atorvastatin calcium (LIPITOR).      On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot number S005857 and expiration date 03-DEC-2020, for prophylaxis (dosage schedule, and anatomical location were not reported). And subsequently on 28-SEP-2019, the patient  developed a fever of 102 F (pyrexia), nausea, dizziness and weakness in the arm where the vaccination was administered (muscular weakness). The reporter stated the patient reported that the patient could not lift her arm (injected limb mobility decreased). Laboratory diagnostics and studied were not performed. The patient sought for medical attention.   The outcome of pyrexia, muscular weakness, injected limb mobility decreased, dizziness and nausea was unknown.  The causality between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.