chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of screaming in a 6-month-old male patient who received INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX. On an unknown date, several hours after receiving INFANRIX, the patient experienced screaming and stiffness. INFANRIX was discontinued. On an unknown date, the outcome of the screaming and stiffness were recovered/resolved. The reporter considered the screaming and stiffness to be almost certainly related to INFANRIX. Additional information: Patient reported that at 6 months he received "DTT" - vaccine containing Pertussis. He described a reaction of two days screaming and stiff body which he said occurred a few hours after vaccine or possible starting the next day. No intervention was required. Physician informed mother that he should not receive vaccine again. He has never received another pertussis containing vaccine since then. Patient did not know any other information regarding the incident.
Information has been received from a consumer concerning his son who was vaccinated with two doses of hepatitis A virus vaccine inactivated. The father indicated that some blood work recently came back indicating his son may have hepatitis A. He reported they still were not sure if he had it or not. Lot numbers were not available and it was unknown if treatment was required. No product quality complaint was involved. Unspecified medical attention was sought. Follow up information from the patient's mother indicated that there were no problems with the vaccines. She indicated that turns out it was an other related problem. Additional information is not expected.
Within a minute I could taste something odd and my throat felt funny.  I asked my husband if he could taste the funny taste as well.  Early the next morning I had a horrible headache, felt feverish and nausea.  Could not take a deep breath.  The second day after the shot was the worst.  I could not get out of bed, felt like someone had their hands around my neck, but I could breath, just not deeply.  Terrible headache, not wanting food or water.  Now is the fifth day and I feel much better.  Not so sure about getting the second shot.
Rash covering body from chin down to knees. Some areas were blotchy and some were totally red like a bad sunburn, itching everywhere. Rash and itching lasted about 6 days.
Rectangle on skin of right arm; Pain at injection site; Skin is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin is hot to touch), SCAR (Rectangle on skin of right arm) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site). On 31-Jan-2021, the patient experienced SCAR (Rectangle on skin of right arm). On 01-Feb-2021, VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SCAR (Rectangle on skin of right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were taken by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 does not contain any new information.
Pt recv vax on 1/25/99; on 1/26/99 pt exp fever; on 1/27/99 pt exp a tic/ twitch, red/ hot rt arm
pt devel herpes zoster rash on 26JUL98;seen by MD on 28JUL98 & dx w/herpes zoster;tx w/med;
Patient reported lingering shoulder pain after flu shot in Nov. Went to ortho and he said she had bursitis. Pain continued despite several steroid shots. X-ray and MRI were unremarkable per pt.
About 10 hours post second injection, I began to sweat profusely and have pain in my limbs which felt like my bones were breaking. I also started to have chest pain and I could feel my heart beating irregularly, confident I was having some sort of arrhythmia. Another side effect which started around that same time was severe stabbing pain in my lower back, about where my kidneys are. I also was in great pain when I urinated. All of these symptoms lasted about 48 hours, with the first 24 hours being the worst.
HIB vaccine #4 given (L) IM deltoid, immediately upper arm became bright red and swollen and warm to the touch. (2.25" of redness) pt given 1tsp. Benadryl. Monitored in office for 20 min. Ice compression used. Redness/Swelling subsided. Mom will monitor.
He had some cramps in his lower intestine; Couldn't go to the bathroom; He has some vertigo when he wakes up; sweaty; feels recovered and was able to exercise,feeling better; first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty) and THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concurrent medical conditions included Bladder cancer and Heart attack. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL, SPIRONOLACTONE and ATORVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021). At the time of the report, GASTROINTESTINAL PAIN (He had some cramps in his lower intestine), MOBILITY DECREASED (Couldn't go to the bathroom), VERTIGO (He has some vertigo when he wakes up), HYPERHIDROSIS (sweaty), THERAPEUTIC RESPONSE UNEXPECTED (feels recovered and was able to exercise,feeling better) and WRONG PRODUCT ADMINISTERED (first 2 vaccines of Pfizer and again third one of moderna on 16 Jun 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure is 150/125.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication has been reported.
Per medical note: Triage: 2+ edema, area red and warm to touch. Veteran received PNEUMOVAX 23 shot Tuesday and by late evening started to become painful and red. By Wednesday patient states the pain was extreme and he couldn't move arm. Hasn't taken any pain meds, used heating pad.
Patient given vaccine 9-28-10. Pt phoned complaining of arm/neck pain & decreased range of motion 10-5-10. Pt evaluated in office 10-6-10 with continuing symptoms. Pt advised ADVIL & icing 10/5 - Rx'd prednisone 10/6
Had cellulitis @ site of injection with redness, and site is warm to the touch. Site is 2"x3". Site is L deltoid. Mom instructed on comfort measures - cold cloth and TYLENOL. No fever.
sore arm after getting the first shot; This is a spontaneous report from a contactable consumer (patient) via an Agency. A 73-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 01Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On Feb2021, patient had a little sore arm after getting the first shot. Patient cousin died from COVID that was why he was scared. Patient want to make sure that he was protected. Patient was scheduled to receive the second dose of the vaccine 4 week after receiving dose 1. Patient stated that he will try his best to get the second dose within 3 weeks. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe pain in throat (like a dagger)when swallowing- lasted for 6 weeks, went of for few days and would keep comming back. Random ulcers, blisters, vescicles. Brushing teeth and eating became difficult.  Started bleeding thr' rectum by mid March '21( still present). Gums turned blue-black and with white marking. From 10-6-21 to 10-16-21 was ACUTE stage- eating, drinking, brushing teeth was impossible, Moth was full of ulcers, bleeding, coughing red clumps of blood, breathing stained because throat feels chocked.
Hives located over lymph nodes. The first reaction appeared behind my right knee (54 hours after second dose) which has been the most severe of all occurrences to date and left bruising as the swelling went down. The following week, additional spots appeared and faded from stomach, hips, inner thighs, under arms, right knee, and side of neck. Currently, I have new hives developing on my inner forearm (right) and wrist (left), waistline, hips, back and side of neck. A lymph node at the back of my neck/base of skull is swollen (I have not noticed any other swelling of the lymph nodes themselves, just the skin over top). I have continued taking an antihistamine allergy pill for relief, topical itch cream (Benadryl) has not been noticeably effective.
Light headed, dizzy night of shot.  Went to bed.  400 am fever and shivers for 5 hours.  Massive headache.  Lymph nodes and testicles swelled.  All pounded to my heart beat.  Kept taking Tylenol and didn?t seem to matter.  Last for 5-6 hours.  Massive headache continued...tired but hard to sleep sleep and in zombie like state.  Woke up Friday feeling a little better.  Went downhill  about 5pm Friday.  Headache returned.  Tired  and couldn?t sleep much.  Brain in fog.  Went to bed.  Woke up with headache on Saturday.  A wave of fatigue came over Saturday around 3pm.  Tried to nap but couldn?t sleep.  Persistent dry cough developed Saturday night.  Lasted through Sunday.  This is all to the best of my recollection.
Baby stared as if in a trance, making some jerking movements out of character. Picked up baby. Was awake but slumped over in my arms as if intoxicated. Stayed in a trance state for 3 whole days.
Patient called to report lump size of a half dollar at injection site and fever and feeling of malaise
started feeling lethargic approx 1 hr p/inject, funny fuzzy feeling, sore throat, runny nose & weakness in joints;
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up with patient: Patient was reported as confused and denied he reported adverse event to vaccine.
Extreme fatigue, increased tinnitus, increased asymmetric hearing loss, worsening joint pain, mental fog
Soreness in right arm at shot site:  immediately following shot and continuing at 4 days after shot Severe Fatigue: 12hr to 2 days after shot Fatigue: 2days to 4 days after shot Muscle aches: 12 hr to 2.5 days after shot Slight headache: 12 hr to 1 day after shot Tender skin: 12 hr to 1 day after shot Lack of alertness: 12 hr to 1 day after shot Fever (100+): 14hr to ~1 day after shot
dizziness; tachypnea; My temperature is 99.3 today; headaches; joint pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Fatty liver.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Mar-2021, the patient experienced DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain). At the time of the report, DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Liver function test: (Inconclusive) liver enzymes are elevated. On 08-Mar-2021, White blood cell count: (Inconclusive) over 10,000 13.03 on 06Mar2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received, Contact information updated
Didnt feel good.; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got second shot a few days ago and did not feel good. The patient was better on day of reporting. The follow up was not required.
got the vaccine, now has shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comments: This case was received from patient's friend via interactive digital media. The reporter reported that when they first brought out the shingles vaccine the reporter decided not to get it. The reporter best friend (patient) got the shingles vaccine. It had been several years, and she now had shingles and the reporter did not had shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
First episode was about 30 seconds first noticed cold hands feet and cheeks along with delayed breathing no response then resolved. Second episode lasted approximately 1 minute 30 seconds on 03/23/2017 at approximately 3:30 AM noticed cold hands, feet and cheeks no breathing no reflexes or response she was completely limp.
Vaccine seemed to be administered too high on my shoulder - very near the joint. Pain was immediate and persistent for a year. Due to Covid, provider and I elected to defer diagnosis and treatment in December 2020. After I received Covid vaccine, I requested a referral from my provider to an orthopedic surgeon for April 2021.
had a bad headache; stomach was queezy; chills; temp was 100.5F then up to 101.8F; joints ached knees and toes ached; had headache and some aches; I've never been so sick in my life/I was dry heaving all night; This is a spontaneous report from a contactable consumer. Follow up (15Apr2021) received in response to an outbound call requesting a mailing address was processed together along with initial information.   A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 06Feb2021 at 11am at single dose for COVID-19 immunization. The patient medical history included COVID-19 twice an unspecified date (70days before), pneumonia and lung problems from an unspecified date. The patient Concomitant medications were not reported. On 06Feb2021 at 8pm, the patient's stomach was queezy, body ache all over, chills, temp was 100.5F further raised to 101.8F and joints ache knees and toes ache also had bad headache, and he was dry heaving all night. He was never been so sick in his life. On Sunday temp 100.6F-101.8F, felt miserable Monday morning had headache and some aches, temp. was 100F and he took a nap after when woke up at 4pm felt fine, so for 44hours". He added "he know 50 teachers who had the vaccine, and they say they had high temp. 100F and they felt tired, some had body ached and headache, but no one had anything like he had. The lab test included body temperature, results: 100F. He was told and wanted to know, that if had covid before patient react more severely to the 1st dose of the vaccine and will be milder for 2nd dose. He also further wanted to know if he could take second dose. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Patient is a otherwise healthy 4 yo female with mild eczema that was admitted from 4/28 to 5/2 due to concern for a abscess in her right thigh at the site of a recent vaccination.  Of note, patient last had vaccines at 6 months of age which were complicated by a abscess requiring I&D at a vaccine site.  Patient had vaccinations on 4/8/19, which were her first vaccinations since 6 months of age.  On 4/26, patient developed pain in her right thigh to the point where she was refusing to wear pants.  She then developed a limp and hard knot in her right thigh.  At this time Mom took her to a urgent care who referred her to the PED.  Mom notes that at this time patient had fevers that were associated with URI symptoms.   On admission, patient was started on clindamycin.  She had elevated inflammatory markers with ESR 44 and CRP 1.6.  WBC 11.7 with 30% PMN.  A fluid collection in her right thigh was confirmed on ultrasound imaging with concern for possible pyomyositis-related abscess. The fluid collection was incised and drained on 5/1 via ultrasound guided needle aspiration. Abscess cultures were negative although Gram stain showed 3+ WBC and no organisms.  Patient did well after drainage so was discharged with a total 3 week course of clindamycin 40 mg/kg/day divided TID (end date 5/19). Due to recurrent vaccine-related reactions, patient had general assessment of her immune function which raised no concerns. Notable results are negative HIV, normal respiratory burst, measurable measles IgG, and normal humoral immune competence profile (total Ig's and Tdap responses).  On 05/06/19 Peds ID clinic follow-up, her mother reports that patient is doing well.  Her gait has improved but is not completely normal.  Sometimes she bends at her waist to pick up toys and seems to not want to bend her right knee.  Overall, Mom feels that patient is significantly improved. She is taking 16 ml three times daily - using a 10 ml syringe.  Mom reports that patient had diarrhea in the hospital but this resolved prior to discharge.  Patient eats Gogurt most days and has a normal appetite. No other rashes or abscesses have been noted. Interval decrease in size of R thigh collection/induration (from 6x5cm to 0.5cmx0.5cm).
Severe body aches over entire body, chills, fever (known high of 102.1), headache, fatigue, light headed, very sore in arm near and around injection site, slight upset stomach.  These symptoms began within approximately 7 hours of injection.  It is now 24 hours later and I am still having them.   This is the 2nd injection in a series of 2.   The first injection was given in November 2019 (about 5-1/2 months ago).  I had all of the exact same symptoms then also.  But I think  it was dismissed because the side effects are seemingly rare?
The adverse effects of fever, urine burn, aching back and dizziness for one day after the vaccine given. Approximately, four days later the same symptoms returned.
Pfizer vaccine was taken out of cold storage 04/06/23 and is good refrigerated for 70 days. The vaccine was given 74 days after taken out of cold storage thus was given after the beyond use date. Pfizer was notified. Discussed situation with Dr. Patients who received the vaccine after the beyond use date will be revaccinated.