chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Headache, Oropharyngeal pain, Photophobia
Clinical narrative: sensitivity to light, headache - pain scale of 5-6 for 4 days; sore throat, dizziness on day 4; extreme fatigue for 6 days
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to right deltoid area.  Clindamycin and Cetirizine prescribed.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red raised rash to right and left forearms (right greater than left) with associated itching.  Employee encouraged to take benadryl unless otherwise contraindicated.  No allergy to eggs.  No reaction to previous influenza vaccines.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash erythematous, Rash pruritic
Clinical narrative: Pt reports an ongoing headache and an itchy, red rash on her chest (not at her injection site)
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the Patient received improperly stored VARIVAX (lot R023513 & expiration date 8/16/2020). The VARIVAX was reconstituted with properly stored STERILE DILUENT; This spontaneous report was received from a Medical Assistant and refers to a 15 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-AUG-2019, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023513 with expiration date of 16-AUG-2020, for prophylaxis (route and frequency were not reported), that was reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK) lot# S000130 with expiration date of 23-AUG-2021. No adverse effects were reported.    It was stated that the vaccine underwent a temperature excursion of -14°C (degrees Celsius) to -10°c (-13.2 C) for 46 minutes No previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1909USA007312: US-009507513-1909USA007177: US-009507513-1909USA007118: US-009507513-1909USA006939:
Sex: F
Vaccine: VARCEL
Symptoms: Meningitis aseptic, Varicella post vaccine
Clinical narrative: VZV aseptic meningitis and zoster; VZV aseptic meningitis and zoster; VZV aseptic meningitis and zoster; This spontaneous report as received from a physician refers to a teenage female patient of unknown age. No information on patient's medical history, concurrent conditions and concomitant medications was provided.      On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#, expiration date, dose and route of administration were not provided)  for prophylaxis.         On an unknown date, the patient experienced varicella zoster virus (VZV) aseptic meningitis and zoster. The reporter wanted to test her cerebrospinal fluid (CSF) for the vaccine strain. The outcome of the event was not provided. The relatedness between the event and the vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  Upon internal review, the event of aseptic meningitis was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Alcohol test negative, Blood glucose decreased, Blood pressure orthostatic abnormal, Computerised tomogram head normal, Drug screen negative
Clinical narrative: two hours after the vaccination the patient had a "psychotic break" described as the patient was seeing things and hearing things; only abnormal test result was a blood sugar of 69; Orthostatic blood pressure changes; This spontaneous report was received from a physician refers to a 19 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in September 2019 (reported as "last week"), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On the same day, two hours after the vaccination the patient had a psychotic break described as the patient was seeing things and hearing things (psychotic disorder). The patient's mother took the patient to the emergency department and all tests were normal including testing for alcohol and drugs. The physician reported the only abnormal test result was a blood sugar of 69 (unit not reported) (blood glucose abnormal). The patient's computed tomography (CT) scan of head result was fine. The physician reported the patient stayed in a quiet room in the emergency department and went to sleep and when the patient awakened she was back to her normal mental baseline. The patient was seen in physician's office a couple days later and had orthostatic blood pressure changes (pressure orthostatic abnormal). The outcome of the events was reported as recovering. Causality assessment was not reported by the reporter.  This is one of two reports received from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Hallucination, auditory, Hallucination, visual, Psychotic disorder
Clinical narrative: two hours after the vaccination the patient had a "psychotic break" described as the patient was seeing things and hearing things; only abnormal test result was a blood sugar of 69; Orthostatic blood pressure changes; This spontaneous report was received from a physician refers to a 19 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in September 2019 (reported as "last week"), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On the same day, two hours after the vaccination the patient had a psychotic break described as the patient was seeing things and hearing things (psychotic disorder). The patient's mother took the patient to the emergency department and all tests were normal including testing for alcohol and drugs. The physician reported the only abnormal test result was a blood sugar of 69 (unit not reported) (blood glucose abnormal). The patient's computed tomography (CT) scan of head result was fine. The physician reported the patient stayed in a quiet room in the emergency department and went to sleep and when the patient awakened she was back to her normal mental baseline. The patient was seen in physician's office a couple days later and had orthostatic blood pressure changes (pressure orthostatic abnormal). The outcome of the events was reported as recovering. Causality assessment was not reported by the reporter.  This is one of two reports received from the same reporter.
Sex: M
Vaccine: HPV9
Symptoms: Epistaxis
Clinical narrative: nosebleed; This spontaneous report was received from office manager via company representative refers to a male patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route, lot number, expiry date unspecified). On an unknown date, the patient had nosebleed (epistaxis) after the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient never had nosebleed previously. It was unknown by reporter which dose of HPV series was received by the patient. No PQC involved. No further information provided. The outcome of epistaxis was unknown. Reporter's causality was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Muscle aches; Flu-like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced muscle pain and influenza-like symptoms. On an unknown date, the outcome of the muscle pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The medical assistant reported that, several patients experienced muscle ache and flu like reactions after vaccinatin with a dose of Shingrix. The medical assistant denied, she was reporting any adverse event, and refused to provide further details regarding patients, products or events. The reporter did not consent to follow up. This case has been linked with case US2019170910.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Parent states arm became swollen within an hour of the immunization.  The left shoulder is not red, swollen and warm to the touch warm to touch approximately a 3-4 inch round area.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Hyperhidrosis, Musculoskeletal pain
Clinical narrative: Red, warm swollen upper arm which over the course of the next three days spread to entire arm.  Contacted dr. office by phone and spoke with nurse. Was told to ice and take ibuprofen 3 X a day.  Which I did, Arm did not return to normal for 7 days and shoulder pain lingers.  Incident of overall warmth, sweating, light-headedness, which went away after sitting down, deep breathing and rest.   Did not return.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Red, warm swollen upper arm which over the course of the next three days spread to entire arm.  Contacted dr. office by phone and spoke with nurse. Was told to ice and take ibuprofen 3 X a day.  Which I did, Arm did not return to normal for 7 days and shoulder pain lingers.  Incident of overall warmth, sweating, light-headedness, which went away after sitting down, deep breathing and rest.   Did not return.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: all symptoms started 9/25-26-2019--vomiting, chills, headache, inject site reaction (red, heat), malaise, fatigue
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vomiting
Clinical narrative: all symptoms started 9/25-26-2019--vomiting, chills, headache, inject site reaction (red, heat), malaise, fatigue
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Injection site on left arm became more painful as the day went on, a patch of raised skin emerged, the raised area became warm to the touch.  The next morning, the raised area had doubled in size and was hot to the touch and very red.  A surgeon I work for looked at it and determined it was cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Fatigue, Malaise, Peripheral swelling
Clinical narrative: 1st.  Your neat system here would not let me go back to add: Not saying here they did anything wrong. 2nd.  Got Fluzone high dose in one arm and Pneumovax 23 in the other at the same time because they said I could do that.  Get flu shot yearly, no reactions.  So it's likely the Pneumovax 23.  Got the Pneumovax13 last year.  Do not recall any reaction.  This year from about two hours after the shot until the next morning, mid-morning, I felt sick.  For about 19 hours I felt dizzyish, a warm forehead, general malaise/fatigue, weakness, and some swelling in the right Pneumovax arm.  There was NO redness, muscle aches, fast heartbeat,  difficulty breathing.  I want you to know because we should be warned this may occur.  What if I had work the next day?  (Yes, I still work.)  Just tell them to tell us such a reaction MIGHT happen and we can set our schedules accordingly.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: 1st.  Your neat system here would not let me go back to add: Not saying here they did anything wrong. 2nd.  Got Fluzone high dose in one arm and Pneumovax 23 in the other at the same time because they said I could do that.  Get flu shot yearly, no reactions.  So it's likely the Pneumovax 23.  Got the Pneumovax13 last year.  Do not recall any reaction.  This year from about two hours after the shot until the next morning, mid-morning, I felt sick.  For about 19 hours I felt dizzyish, a warm forehead, general malaise/fatigue, weakness, and some swelling in the right Pneumovax arm.  There was NO redness, muscle aches, fast heartbeat,  difficulty breathing.  I want you to know because we should be warned this may occur.  What if I had work the next day?  (Yes, I still work.)  Just tell them to tell us such a reaction MIGHT happen and we can set our schedules accordingly.
Age: 59.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Erythema, Herpes zoster, Rash vesicular
Clinical narrative: Patient developed herpes zoster rashes on 9/23/2019 and was seen by me on 9/27/2019. Raised erythematous vesicular patches extending from mid back to front along the chest wall on L side in a band. He was put on Valtrex for treatment.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Dizziness, Retching
Clinical narrative: temporary hearing loss, dizziness, dry heaving
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Headache, Insomnia, Mobility decreased
Clinical narrative: o 2 hours after her arm swelled and e=she couldn't move her arm o Headache o Nausea o Some redness o It itched a lot o She felt light headed o Couldn't sleep  she soaked in epsom salt and the hives went away
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: o 2 hours after her arm swelled and e=she couldn't move her arm o Headache o Nausea o Some redness o It itched a lot o She felt light headed o Couldn't sleep  she soaked in epsom salt and the hives went away
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: redness and swelling  extending 3-4 inches away from injection site with pain and soreness extending past the injection site
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza like illness, Lethargy, Nausea, Pruritus
Clinical narrative: Flu like symptoms, nausea, itching to body, lethargy, chills
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Contusion, Peripheral swelling, Skin warm
Clinical narrative: Patient came to pharmacy counter about 10 min after shot-to report a burning feeling, no redness or swelling noted. On Sat 9/22, pt came to pharmacy & the inner portion of upper arm was a bit swollen, red and warm to the touch. On 9/24/19 pt called and stated doing much better and report is no more swelling, no warmth to touch & only a bruise 2 inches past injection site yellowish in color. Pt. Did not seek Medical attention as she felt not necessary.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein, Hypoaesthesia, Pain in extremity, Red blood cell sedimentation rate, Swelling face
Clinical narrative: (L) Arm pain after given shot within 24 hrs. Also reported (L) sided facial swelling and numbness, swelling resolved but numbness persisted. Pain improved next day
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Eye movement disorder, Muscle rigidity, Tonic convulsion
Clinical narrative: AFTER ADMINISTERING THE VACCINES WITH THE NECESSARY PRECAUTIONS, INTRAMUSCULARLY IN BOTH ARMS, THE PATIENT REFERS FEELING DIZZY. WHEN THE FATHER WAS TRYING TO MOVE HIM TO HAVE HIM LAY DOWN, THE PATIENT SEEMED TO HAVE A TONIC SEIZURE AND RIGIDITY, EYES ROLLED BACK AND LOSS OF BLADDER CONTROL. AFTER LAYING HIM DOWN AND LIFTING HIS LOWER EXTREMITIES, THE PATIENT RECOVERED CONSCIOUSNESS AND SLOWLY STARTS FEELING BETTER.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chest discomfort, Injection site rash
Clinical narrative: Per mom, patient experienced tight chest, rash on site of injection. Was seen at urgent care and prescribed Epipen, Prednisone, steroid medications.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left leg Start clindamycin powder for reconstitution 75mg/5ml.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: redness and "heat" spreading to shoulder, subsided somewhat by now
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, X-ray
Clinical narrative: -sore are at site of injection for 2 days; then more generalized shoulder pain, progressing to limited range of motion;  then inability to lay on that side while in bed. -revisited APN at Family Clinic and was referred to Orthopaedic physician.   -Orthopaedic physician injected the shoulder and prescribed Meloxacam along with at home physical therapy. He stated I should get back to 90% functioning.  Two years after flu shot that has occurred.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: c/p pain, in R upper arm extending to R shoulder, r proximal forearm starting morning after vaccination
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Left upper arm red, swollen and hot to touch.  Complaints of fever and body aches.  Diagnosed with cellulitis.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Left upper arm red, swollen and hot to touch.  Complaints of fever and body aches.  Diagnosed with cellulitis.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash pruritic, Urticaria
Clinical narrative: I broke out in a horrible itchy rash with welts all over my trunk.  I call the pharmacist who administered the vaccine. She told me to take benedryl and said i may need a steroid shot. The next day, 9/26/2019, when I woke it at was far worse. I phoned my dr and made an appt.  He gave me a steroid shot and had me start taking  24 hour xyzoz antihistime.  It did clear up a lot but im coming up on the dosage time and Im getting red and itchy again.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: arm became swollen, red, and hot . also had rash down arm. went away after a week
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Localized redness induration measuring 4cmx5cm, pruitic Given zyrtec, advised cool compresses, symptoms improved within 48hours
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: pt started with tremor RUE>LUE>legs  'shortly after' the vaccination, was improving by the time she was seen by me a couple of weeks later - no new medications or other decline in health
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: There were no adverse reactions; patient received improperly stored vaccine; This spontaneous report as received from a medical assistant refers to an 18-month-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 29-APR-2019, the patient was vaccinated with the improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) injection (lot number: S002460, expiration date: 15-MAY-2020; dose was not reported) administered intramuscularly. The vaccine was stored in temperature 52.5 degrees Fahrenheit for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data lodger was involved.  There were no adverse reactions.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect; A 17 years old female patient was administered properly stored PROQUAD on 14-NOV-2018 and 19-DEC-2018; A 17 years old female patient was administered properly stored PROQUAD on 14-NOV-2018 and 19-DEC-2018; This spontaneous report was received from a pharmacist referring to a 17 years old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 14-NOV-2018, the patient was vaccinated with a dose of properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# R011214, expiry date: 15-OCT-2019, therapy type: rHA, dose, strength and route were not reported) for prophylaxis. On 19-DEC-2018, she was vaccinated with another dose of properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# R011214, expiry date: 15-OCT-2019, therapy type: rHA, dose, strength and route were not reported) for prophylaxis (inappropriate age at vaccine administration). The sterile diluent (lot# M041688, expiry date not reported, but upon internal validation established as 12-JUN-2019) used to reconstitute the vaccines was also properly stored. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Vaccination complication
Clinical narrative: This literature marketed report has been received from authors in a published literature article titled as above.  This literature referred to 3 children patients of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown date(s), the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, route and lot # were not reported) for prophylaxis. On unknown date(s), the patients were diagnosed measles within 30 days of vaccine administration, which are most likely measles vaccine-associated adverse events. The outcome of the event was unknown. The causality was related.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: ANTH
Symptoms: Influenza like illness, Nausea, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Seizure like episode; Migraine; Vomiting; Nausea; Flu-like symptoms; Information received on 14SEP2019 from a consumer via a website.  A 35 year old female experienced seizures like episode (PT: Seizure like phenomena), flu-like symptoms (PT: Influenza like illness), nausea (PT: Nausea), vomiting (PT: Vomiting), migraine (PT: Migraine), following the administration of BioThrax.  The consumer claimed to have suffered progressively worse symptoms after anthrax vaccinations in December 2017, April 2018 and August 2018. It was reported that after the first vaccine, she experienced flu-like symptoms including headaches, sweats and coughing. After the second shot, she experienced nausea, vomiting and migraines, in addition to her prior symptoms. She also received emergency room treatment for migraines during this period.  The progressively worsening reactions to the first two vaccines led the consumer to withdraw her informed consent to the third administration of the vaccine, and she repeatedly requested a waiver from vaccination from the doctor, her patient advocate, and her chain of command. Although she received a week-long delay in vaccine, she did not obtain a waiver.  After the compulsory administration of the third anthrax vaccine, she developed nausea within a day. More symptoms developed over the course of weeks resulting in multiple overnight stints at the hospital. Medical staff instructed her and her husband, to wait out the reaction at home and avoid seeking treatment, as reported by the consumer. But when she became non-responsive during episodes of seizure-like shaking, her husband paid out-of-pocket for emergency room treatment. The seizure-like episodes continued for at least three weeks after the administration of the vaccine.   Outcome of the reported events was unknown at the time of report.   Company Comments: The described events of seizure-like episode, flu-like symptoms, nausea, vomiting and migraine have been reported with reasonable time relation to intake of Biothrax, with flu-like symptoms having recurred with repeated administration.  No medical history nor diagnostic evaluations were reported in the article, therefore causality cannot be ruled out.  That being said,  the causality assessment is considered to be probably related to the administration of vaccine.; Sender's Comments: Company Comments: The described events of seizure-like episode, flu-like symptoms, nausea, vomiting and migraine have been reported with reasonable time relation to intake of Biothrax, with flu-like symptoms having recurred with repeated administration.  No medical history nor diagnostic evaluations were reported in the article, therefore  causality cannot be ruled out.  That being said, the causality assessment is considered to be probably related to the administration of vaccine.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Having sore, redness at injection site; Having sore, redness at injection site; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative.  A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced having sore and redness at injection site on an unspecified date. The events lasted 2 or 3 days and were non serious. The outcome of the events was resolved on unspecified date.  No follow-up attempts are possible, information about batch number cannot be obtained
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash around the injection sight. About 2 inches in diameter and has begun to itch. Has not gotten worse since first noticed
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: On 9/25/2019, pt received the High Dose Flu vaccine at a Clinic. No other vaccines given. Pt reported pain after injection. On 09/27/2019, pt reported to the Medical Center Injection Room. Pt reported that on the morning of 09/27/2019, he had arm swelling. Nurse assessed. Erythema that was approximately 10 cm in length and 6 cm  in width on Left lower arm. It was warm to touch. No pain on palpation. Denied fever. PCP notified via Electronic Health Record.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1 week post administration, developed redness, swelling, warmth, and pain at injection site
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Myalgia, Peripheral coldness, Pyrexia
Clinical narrative: Fever of 101.5 recorded at 6:00 pm on 9/25/2019 which was the day after the vaccination.  Throughout the day, I felt miserable at work.  I could not keep my hands warm.  I had to wear a jacket which is very unusual for me.  I had a headache and muscle aches all day.  When I got home, I slept for 12 hours and felt much better the next day.  I had these exact same reactions to the first dosage of Shringrix vaccine (101 fever) which I received on 3/7/2019 [I did not file a VAERS report for that].
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: pt cam e in today with rash/redness at site of injection. around injection site is red/black and blue and sore.  Pt said she was feeling lightheaded/dizzy at after receiving injection and reaction showed up following morning. Pt took 2 benadryl night after injection, just 1 dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Presented to ER 2 days post vaccine with itching, red and swollen thigh.  No pain with palpation or walking.  Most likely localized reaction to vaccine, but placed on antibiotics proactively.  Spoke with parent on 9/27/2019 and redness and swelling resolving.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Macule, Papule, Rash pruritic
Clinical narrative: woke up with very itchy rash to arms and legs the next day after receiving flu vaccine. Immediately after receiving the vaccine, he felt a little light headed.  Used atarax x 2 doses; triamcinolone cream, allegra x 1. It has helped someone. But still had symptoms when he presented on 9/23/19 for evaluation.  On exam he had multiform wheels, papules/macules to lower arms and legs. No angio edema or HEENT sx. No nausea/vomiting.  Rx provided for benadryl 25mg 1-2 tabs qid for the following 2 day then prn. rtc 2 days for recheck. Did not follow up as of report date
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Nausea, Pyrexia, Rash
Clinical narrative: Rash on upper part of body and under arm.  She also had a headache, fever and nausea
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: noted red macular rash over LLQ and RLQ abdominal wall and lower back.  Also macular rash on R upper arm
Age: 64.0
Sex: F
Vaccine: HEPA, TDAP, TYP, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The patient reports that a few days after her 1st Shingrix shot, she developed her usual outbreak of localized vesicular shingles in a dermatomal pattern (same distribution that she has had several times in the past) on her left shoulder; the same side as the Shringrix vaccine was administered.  She took Valtrex bid for a week after first noticing the rash and it ultimately resolved with no sequelae or symptoms of post herpetic neuralgia.  She was administered her 2nd Shingrix dose in the series 13 weeks after the first dose, but in her contralateral deltoid (right side)
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: large red area from shoulder to elbow  with fever, itching, soreness
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient states she experienced severe pain that led to being admitted in hospital
Age: 44.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Wrong product administered
Clinical narrative: Pt refused flu vaccine. Was suppose to get Hep A. I drew up flu instead and administered to pt. Pt did not receive Hep A.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: swelling and pain in the arm where the shot was given. Extreme fatique next morning and feeling of fogginess and lack of concentration. The top of my right hand (shot side) hurts when I make a fist or type.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: swelling and pain in the arm where the shot was given. Extreme fatique next morning and feeling of fogginess and lack of concentration. The top of my right hand (shot side) hurts when I make a fist or type.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Disorientation, Eye movement disorder, Hyperhidrosis, Lethargy, Loss of consciousness
Clinical narrative: After checking out and leaving the doctor's office after a routine well-child exam, we got in our car. Right after my son closed the door and fastened his seat belt, he reclined his seat slightly. I jokingly asked if he was already feeling lethargic. We were warned that he might be lethargic for about 3 days. He did not respond. His eyes rolled back and his upper body began shaking. His head was shaking as well. I began yelling at him and grabbed his arm, but he didn't respond to me. The movement lasted approximately 30 seconds, but could be slightly more or less. (It seemed like forever.) I was about to get out of the car and run for help inside the doctor's office when his body relaxed, and his eyes closed completely. He then opened his eyes and looked at me. He did not know what had just happened and thought he had just fallen asleep. He was slightly  disoriented,  alert, but slightly lethargic. He was extremely pale, diaphoretic and his pulse was approximately in the 40s. It had been 84 in the doctor's office. He was able to stand and walk and we went back into the doctor's office. I explained what had just happened.  They took his temperature and led us into a room for him to lie down. The doctor came out and looked at him. He explained that he just passed out and that it is common after shots and blood draws. It was a blood pressure thing and he needed to rest. No exam was done and no vital signs taken. I took his pulse and it was 70. He was told to rest there for a bit. After 15 minutes, he felt stronger and we left the doctor's office.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: After checking out and leaving the doctor's office after a routine well-child exam, we got in our car. Right after my son closed the door and fastened his seat belt, he reclined his seat slightly. I jokingly asked if he was already feeling lethargic. We were warned that he might be lethargic for about 3 days. He did not respond. His eyes rolled back and his upper body began shaking. His head was shaking as well. I began yelling at him and grabbed his arm, but he didn't respond to me. The movement lasted approximately 30 seconds, but could be slightly more or less. (It seemed like forever.) I was about to get out of the car and run for help inside the doctor's office when his body relaxed, and his eyes closed completely. He then opened his eyes and looked at me. He did not know what had just happened and thought he had just fallen asleep. He was slightly  disoriented,  alert, but slightly lethargic. He was extremely pale, diaphoretic and his pulse was approximately in the 40s. It had been 84 in the doctor's office. He was able to stand and walk and we went back into the doctor's office. I explained what had just happened.  They took his temperature and led us into a room for him to lie down. The doctor came out and looked at him. He explained that he just passed out and that it is common after shots and blood draws. It was a blood pressure thing and he needed to rest. No exam was done and no vital signs taken. I took his pulse and it was 70. He was told to rest there for a bit. After 15 minutes, he felt stronger and we left the doctor's office.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient husband called saying patient had baseball size welt under injection site.  Site was not part of injection area, and husband was concerned due to clotting issue.  Verified patient allergies and checked adverse rxn of shot.  Nothing showing corroboration with either.  They proceeded to ED for evaluation.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site mass, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Although patient "did not feel" the shot, a few hours later it felt tender and looked bruised & swollen. There was also pain that went up the shoulder to the neck area. She has been using cold compress, then Ibuprofen. Today the lump is gone and pain is better (pain was worse first 24 hours). Advised patient to see her doctor if not all better; discussed hi-dose versus quad -will try quad next year and changed to right arm...left arm weak from stroke 2 yrs. ago.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Neck pain
Clinical narrative: Although patient "did not feel" the shot, a few hours later it felt tender and looked bruised & swollen. There was also pain that went up the shoulder to the neck area. She has been using cold compress, then Ibuprofen. Today the lump is gone and pain is better (pain was worse first 24 hours). Advised patient to see her doctor if not all better; discussed hi-dose versus quad -will try quad next year and changed to right arm...left arm weak from stroke 2 yrs. ago.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: The patient passed out after leaning over to tie her shoelace; This spontaneous report was received from a physician via company representative, referring to a 11-year-old female patient. The patient's medical history, concurrent condition, drug allergies/reactions and concomitant medications were unknown. On 13-AUG-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, anatomical location, lot# and expiry date was unknown) via intramuscular route for vaccination. On the same day the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (strengths, doses, schedules, anatomical locations, route of administrations, lot#s and expiry dates not reported) for prophylaxis. On the same day (13-AUG-2019), the patient passed out after leaning over to tie her shoelace (loss of consciousness). The patient sought medical attention. The patient did not receive any treatment or undergo any lab diagnostics/studies for the event. The physician observed the patient for about an hour and after the patient recovered completely she was sent home on the same day. There was no associated product quality complaint. Cancer and overdose were not involved. The reporter did not provide the causality assessment between the suspect therapies and the reported events.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; the patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as office manager), concerning a patient of unknown age and gender. The patient's pertinent medical history, and past drug reactions / allergies were not provided. The patient's concomitant therapies included sterile diluent.  On 24-SEP-2019, the patient was inadvertently administered a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot # S008692, date of expiration: 21-MAR-2021, lot # S019463, date of expiration reported as 24-JAN-2021, upon internal validation established as 24-JUN-2021, and lot number R035222, date of expiration: 04-DEC-2020; all lot number have been verified to be valid lot numbers) (strength, dose, route of administration, and anatomical location were not reported), that had been improperly stored (Product storage error). All lots of varicella virus vaccine live (Oka/Merck) (VARIVAX)  were reconstituted with properly stored sterile diluent. No adverse effects were reported.   The administered dose of the vaccine experienced a temperature excursion of 27.1 Fahrenheit degrees for 40 minutes, as recorded by a data logger. There was no previous temperature excursion. No product quality complaint was filed.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu like symptoms; Headache; Body aches; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, general body pain and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, headache, general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and developed flu like symptoms including headache and body aches. These symptoms were resolved. The patient had sore arms but that resolved. The reporter consented to follow up. This case linked with US2019169078, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Inflammation, Joint swelling, Neck pain
Clinical narrative: Swelling of knuckles; Code Knuckles Pain/ Hip is hurting; Jaw hurt / Felt like she had a toothache; Fingers and knuckles became inflamed; Fingers and knuckles became swollen; Pain; Neck became sore; Knuckles again became red; This case was reported by a consumer via call center representative and described the occurrence of inflammation localized in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included unilateral renal agenesis, celiac disease and hypothyroidism.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 9 days after receiving Shingrix, the patient experienced inflammation localized and swelling of fingers. On 14th September 2019, the patient experienced toothache. In September 2019, the patient experienced pain, neck pain and red hands. On 17th September 2019, the patient experienced pain in hip. On an unknown date, the patient experienced swollen joints. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the inflammation localized, toothache, pain in hip and swollen joints were unknown and the outcome of the swelling of fingers, pain, neck pain and red hands were not recovered/not resolved.   It was unknown if the reporter considered the inflammation localized, swelling of fingers, pain, neck pain, red hands, toothache, pain in hip and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her fingers and knuckles became inflamed and swollen.  She took Alleve for 4 days and the pain got a little better but then then her neck became sore and her knuckles again became swollen, red, and painful. she said it almost felt like she had a toothache and her hip was hurting. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. Unable to obtain additional details the reporter was difficult to follow she reported adverse events seen with her husband.   This case linked with US2019170058, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Toothache
Clinical narrative: Swelling of knuckles; Code Knuckles Pain/ Hip is hurting; Jaw hurt / Felt like she had a toothache; Fingers and knuckles became inflamed; Fingers and knuckles became swollen; Pain; Neck became sore; Knuckles again became red; This case was reported by a consumer via call center representative and described the occurrence of inflammation localized in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included unilateral renal agenesis, celiac disease and hypothyroidism.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 9 days after receiving Shingrix, the patient experienced inflammation localized and swelling of fingers. On 14th September 2019, the patient experienced toothache. In September 2019, the patient experienced pain, neck pain and red hands. On 17th September 2019, the patient experienced pain in hip. On an unknown date, the patient experienced swollen joints. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the inflammation localized, toothache, pain in hip and swollen joints were unknown and the outcome of the swelling of fingers, pain, neck pain and red hands were not recovered/not resolved.   It was unknown if the reporter considered the inflammation localized, swelling of fingers, pain, neck pain, red hands, toothache, pain in hip and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her fingers and knuckles became inflamed and swollen.  She took Alleve for 4 days and the pain got a little better but then then her neck became sore and her knuckles again became swollen, red, and painful. she said it almost felt like she had a toothache and her hip was hurting. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. Unable to obtain additional details the reporter was difficult to follow she reported adverse events seen with her husband.   This case linked with US2019170058, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Neck pain
Clinical narrative: Swelling of knuckles; Code Knuckles Pain/ Hip is hurting; Jaw hurt / Felt like she had a toothache; Fingers and knuckles became inflamed; Fingers and knuckles became swollen; Pain; Neck became sore; Knuckles again became red; This case was reported by a consumer via call center representative and described the occurrence of inflammation localized in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included unilateral renal agenesis, celiac disease and hypothyroidism.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 9 days after receiving Shingrix, the patient experienced inflammation localized and swelling of fingers. On 14th September 2019, the patient experienced toothache. In September 2019, the patient experienced pain, neck pain and red hands. On 17th September 2019, the patient experienced pain in hip. On an unknown date, the patient experienced swollen joints. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the inflammation localized, toothache, pain in hip and swollen joints were unknown and the outcome of the swelling of fingers, pain, neck pain and red hands were not recovered/not resolved.   It was unknown if the reporter considered the inflammation localized, swelling of fingers, pain, neck pain, red hands, toothache, pain in hip and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her fingers and knuckles became inflamed and swollen.  She took Alleve for 4 days and the pain got a little better but then then her neck became sore and her knuckles again became swollen, red, and painful. she said it almost felt like she had a toothache and her hip was hurting. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. Unable to obtain additional details the reporter was difficult to follow she reported adverse events seen with her husband.   This case linked with US2019170058, reported by same reporter.