chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a pt was vaccinated with an influenza vaccine in November 2002 by the army. Three weeks later he experienced cerebellitis and was hospitalized. As a cause wasn't found, the treating physician felt a possible relationship with the influenza vaccination. He is treated with methylprednisone IV and slowly improving. At the time of this report he is not recovered yet. We asked for the hospital report. Further info is expected.  A 15-day follow up report received 04/17/2003 adds: The pt was hospitalized from 12/09/2002 till 12/17/2002 for further investigations. First symptoms as feeling unsteadiness while walking and clumsiness of speech occurred on 12/05/2002. These symptoms progressed during the following days and necessitated a neurologic consultation. The cranial MRI showed no abnormalities. Physical examination showed a gaze-evoked nystagmus to the left, marked cerebellar dysarthria, dysdiadochokinesis on the right, on the left, moderate broad-based gait ataxia, slightly dysmetric finger-to-nose test and heel-to-shin test, slight action tremor, markedly hypermetric finger-finger-test. No tremor at rest, no myoclonus. No sensory abnormalities. No vegetative dysfunction. Exam of heart, vessels, lymphnodes, lung, abdomen, thyroid, skin unremarkable. The pt was treated with corticosteroid (500 mg methyprednisolone/day IV from 12/12 till 12/14/2002. After this treatment there seemed to be a slight improvement of dysarthria and gait ataxia. The diagnosis of cerebillitis due to a viral disease or immunization or a paraneoplastic mechanism was discussed to be the cause of the cerebellar syndrome, but none could be verified. At the time of this report the symptoms improved slowly but the pt was not yet recovered. No further info is expected. File closed.
Started about 12 hrs after injection:  unable to sleep but sleepy, nauseas, migraine right eye affected, body ake, dizziness, and itchy  in the morning my throat started hurting and tongue swelling,  gums and teeth hurt,  right fingers swelled,  under right arm lymph nodes hurt, painful to touch, liver tender and bladder gave way- (urgency without notice) first time peeing in pants!   Took blood pressure and very low reading .  Started to feel like a human being again on April 2nd.
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 8 YEARS OLD AND PFIZER 0.3ML DOSE IS INDICATED FOR 12 YEARS AND OVER. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN QUALITY ASSURANCE AUDIT.
Pt was given 2nd pfizer dose @ 11:22am while in process of giving vaccine air pressure caused 5 percent of the vaccine dose to come out. Pt was notified and aware. Pt refused to be revaccinated and denies any symptoms or reaction after vaccination. Pt was informed that she only received 90% of the dose. Pt verbalized understanding.
No Adverse Event; Caller reported an AE for PROQUAD. The caller said an expired dose of PROQUAD was administered to a patient on 5/15/2023. Confirmed with caller no other AE occurred. AE letter sent to caller. No other AE. No PQC.; This spontaneous report was received from a nurse refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 15-MAY-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# u031562, expiration date: 06-APR-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Severe itching starting 10/24. Onset of hives (mainly on back of head, neck, armpits, thighs, stomach), some swelling, major discomfort on 10/25. Visited urgent care on 10/25 and was prescribed prednisone (1x/day for 3 days), pepcid (2x/day for ~1 week) and zyrtec (1x/day). Unclear if the medications helped as the discomfort and hives remained but fluctuated in severity. Went back to urgent care on 10/29, moved to 2x/day zyrtec only. 10/31 was first improvement in discomfort, but skin stayed sensitized and highly irritable (turning red easily and lasting for 2+ hours when lightly scratched). 11/3 was first day of no itching. Skin stayed reactive for another ~1 month. Still taking 1/day zyrtec. On 12/19 missed dose of zyrtec and was very itchy, taking daily since then.
On 2/16/10 noticed redness, rash, itching from site of injection to elbow of left arm.
LA red, swollen, non tender, mildly indurated almost entire upper arm 10x12cm warm compresses to area Tylenol for discomfort.
5 Vesicular like lesions at injection site with erythema. Low grade fever. injection site left thigh SQ route.
Agitation, Headache, Myalgia & Arthralgia Narrative: Employee was evaluated at ER on 1/11/2021 and was prescribed with Toradol 30 mg/ injection.
pt recvd vax & devel severe stiffness, aching, soreness, pain, swelling of all jts esp wrist, knees, ankles, hips, hands & pelvic area;
Patient experienced bruising and she could not move her arms at first, but now she can, is getting better slowly. Was also swollen.
who was pre-period, had 2 periods in less than a month; This is a spontaneous report from a contactable consumer. An 11-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. The patient who was pre-period, had 2 periods in less than a month on an unspecified date. Reporter was asking if it would be possible to transmit the spike protein that the body generates after vaccination via shedding like skin contact and inhalation. Reporter stated that he did not state that the girl or family died. He stated that he does not know whether the girl or family died but that the dog died. He stated that the 11 year old girl, who was pre-period, had 2 periods in less than a month after being exposed to her vaccinated mother. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
The day after i felt tired and weak, headache and body/joint pain, i started to feel better but then i woke up today feeling very dizzy and lightheaded
The patient was admitted to local Hospital where he was seen by PT, OT, Wound Care, dietician and Speech Therapy. Infectious Disease was consulted and the plan was to continue Ancef for 6 weeks through Nov 3rd.  During the hospital course, the patient developed acute kidney injury and was evaluated by Nephrology.  He also developed junctional rhythm for which Cardiology was consulted.  During the hospital course, he developed COVID-19.  He was treated with remdesivir and Decadron.  Initially his oxygen requirements increased. Pulmonary was consulted.  There was also possibility of aspiration pneumonia for which the patient's antibiotic was changed to Zosyn.  His condition gradually was getting worse and the patient's family elected to proceed with do not resuscitate and do not intubate.  On the evening of Oct. 21, 2022 the patient was unresponsive.  Pt was made comfort cares and passed away on 10/21/2022 at 2328.
EXPIRED VACCINE ADMINISTERED (3 DAYS PAST EXPIRATION DATE); This spontaneous report received from a consumer concerned a 55 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered (3 days past expiration date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (3 days past expiration date) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132415 and 20211121650.
Headache, Extreme pain at the injection site moving down to the wrist; Red splotchy rash below injection site, Nausea, Vomiting, Neck stiffness.
I contracted COVID-19 on 06/28/2022 with symptoms of cough, congestion, ears full of fluid, fatigue, headache, and runny nose. I was not prescribed any medication due to being out of the window to be prescribed the antiviral. I was ill for 3 days before my symptoms began to resolve. I am still experiencing lingering fatigue.
Hospitalized 11/8/2021; COVID-19 positive 11/8/2021; fully vaccinated  Discharge Information: Discharge Provider: (Privacy) MD  Primary Care Provider : (Privacy) DO   Procedures to be scheduled by PCP: None   Results/Procedures requiring PCP followup: None   Admission Date: 11/8/2021 Discharge Date: 11/09/2021   Admitting Diagnoses: Diarrhea due to COVID-19  PRESENTING PROBLEM:  Diarrhea due to COVID-19 [U07.1, A08.39]   HOSPITAL COURSE: The patient is a 66 y.o. female who presents today with one day of watery diarrhea, nausea, emesis, and persistent cough. She is fully vaccinated with 2nd dose of pfizer in April. She was in normal state of health yesterday and attended a hard rock concert. When she got home from the show she developed a persistent cough. She shortly thereafter began having uncontrolled watery diarrhea, incontinent at time with severe cough/ she continued to feel generally unwell and came to ED. Once in the ED she is hypoxic and placed on 2L. Rapid COVID is positive. She had used Cipro recently for a UTI and c. Diff collected which was negative. CXR without consolidation. Potassium is low at 3.2. She is transferred for further care. Once she arrives she is on RA and doing well. She continues to have persistent cough.   She received monoclonal antibodies on 11/9 and was safe for discharge. Cough was improved and diarrhea had resolved. She is asked to stop taking benadryl 75mg a day but was not interested. Suggested she try loratadine.
At 6 pm, 7 days post vaccination, the patient developed a red  urticaria rash starting on the back. This was extremely itchy, spread to the front torso, the upper legs , and the abdomen. The arms and face were not affected. This lasted almost 24 hours . Benadryl and hydrocortisone cream 1% were utilized. The patient also experienced some loss of appetite the first three days post vaccine.  The dates for this were March 18-19. By the 24 hour mark, the rash was clearing.
Chills, aches, pains, soreness at injection site, lightheadedness, disorientation, headache and stomach ache.
8 days after shot I started having lack of sensation and numbing in all fingertips and both legs. Started in feet and traveled up legs to my waist. Went to ER, diagnosed with Guillian Barre (GBS), received treatment IVIG for 5 days. THANK GOD, it didn't spread anymore upward than it did or I would not be typing this. 6 days in hospital, home now but still have numbness and walking difficulty, can't drive.
Pt states that for one wk (beginning wk of 7OCT91) pt has had a sl fever & malaise & joint pain lt & rt hand w/swelling;
Pt reported "feeling funny" several minutes after receiving the vaccine. The individual was moved from a vaccination pod to an observation area where she was monitored and observed for 30 minutes. Vitals: 1340 95/63, HR 82, 94% on room air; 1350 100/64, HR 70, 94% on room air. Pt verified symptoms resolved and was escorted via ambulation out of facility.
ACUTE NON ST ELEVATION MI 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Baby was born at 35 weeks.; Mother did not receive 2nd dose of primary series vaccine; Mother was administered first dose of primary series in April 2022, became pregnant in June 2022; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE DELIVERY (Baby was born at 35 weeks.), PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) and MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001m21a) for COVID-19 prophylaxis.     No Medical History information was reported.   In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In June 2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022). On an unknown date, the patient experienced PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. In June 2022, MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) had resolved. At the time of the report, PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) had resolved.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.  It was reported that patient administered first dose of primary series in April 2022, became pregnant in June 2022. Patient did not receive 2nd dose of primary series vaccine. Baby was born at 35 weeks.  Company Comment: This is a spontaneous case concerning a 33 year-old, female patient with maternal exposure before pregnancy and no reported medical history, who experienced the non-serious unexpected, event of premature delivery, which occurred after the first dose of mRNA-1273 vaccine. It was reported that the patient became pregnant approximately 2 months after vaccination. The patient did not receive a second dose of primary series, thus Product dose omission issue was considered as an additional event. Baby was born at 35 weeks. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live follow up was received by safety on 30-Mar-2023 contains significant information: Event was added, description as reported and description to be coded, event LLT were updated and route of administration of suspect product was added.
pt devel fever, cellulitis & upper arm swelling p/vax;pt was treated w/DPH & has recovered;addtl into was recv 30JUL96;pt was also treated w/Advil q 6hr;
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Flu like symptoms first 3 days. Then continued week, lethargic, pains in body, pains in rims of ears, up back of neck still at 2 months after shot. Could hardly lift my blankets off me and sever pain in right arm and shoulder which was not the arm where shot was given. I could barely walk for almost 2 months.
Pain, discomfort with moving, redness, and swelling, as well as profound fatigue.
Patient with intussusception x 3. Barium enema then recurrent then surgery.
5 year old got DT, got swelling around injection right away. Then spread to upper arm on other side next day. Then all over body including face 3 days after shot.
got second vaccine 3 days ago. Second night I had fever, extreme sweating and nightmares. Woke at 5am today and had what I can only describe as vertigo? Could not balance, did not have control of my legs which were wobbly tensed and shaking. Vision is off room spinning and hallucinating. My dogs shoulders were made of wood boards my partners eyes were black marbles and the room I was in I did not trust to be real or even existing (I was in my bedroom in my apartment I?ve lived in for over a year). It?s now 9am and still difficulty walking with wobbly tensed legs, dizzy, heavy eyes, and one nausea and cotton mouth. This is terrifying
Vomiting; Fever; Feeling unwell; feeling very cold and had chills; Muscle stiffness; Stomach upset; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), PYREXIA (Fever), VACCINATION COMPLICATION (Feeling unwell), CHILLS (feeling very cold and had chills) and MUSCULOSKELETAL STIFFNESS (Muscle stiffness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Amoxicillin, sodium-penicillin and oxycodone. Concomitant products included METOPROLOL for Blood pressure, LORATADINE and AMLODIPINE BESILATE (PRODIPINE) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VOMITING (Vomiting), PYREXIA (Fever), VACCINATION COMPLICATION (Feeling unwell), CHILLS (feeling very cold and had chills), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), ABDOMINAL DISCOMFORT (Stomach upset) and DIARRHOEA (Diarrhea). On 27-Jan-2021, VOMITING (Vomiting), PYREXIA (Fever), VACCINATION COMPLICATION (Feeling unwell), CHILLS (feeling very cold and had chills), MUSCULOSKELETAL STIFFNESS (Muscle stiffness) and ABDOMINAL DISCOMFORT (Stomach upset) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018532, MOD-2021-018737 (Patient Link).
Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and still spreading; lateral joint foot pain 1/27
Received vaccine in the morning, reaction started in the 11/18 in the evening. Swelling was little bit less than half of the upper arm, along with redness. Improving, but still with symptoms.
Being observed for 30 min due to allergy history. Pt stated she felt like her throat was tight and closing., right at her 30 min time. EMS responded and took control of scene. No wheezing, moving good air, o2 was 96% on room air. Other VS stable.  Kept an additional 10min, VS remained the same and pt calmed down and stated she felt better.
PATIENT RETURNED TO OFFICE WITH SUSPECTED REACTION TO VACCINES. WERE AT A RESTAURANT AFTER THE OFFICE VISIT WHEN SHE STARTED FEELING NUMBNESS IN HER UPPER LEFT ARM WHERE HER MENACTRA AND ADACEL WERE ADMINISTERED.  THE NUMBNESS STARTED PROGRESSING DOWN HER ENTIRE LEFT ARM, AND NOW SHE CANNOT FEEL OR MOVE HER LEFT SHOULDER/ARM/FINGERS. THEN MOM SAYS SHE STARTED FEELING DIZZY, BECAME VERY QUIET, PUPILS LOOKED DILATED, SHE STARTED MOVING HER MOUTH/LIPS/TONGUE IN AN UNUSUAL MANNER THAT MON HAS NEVER SEEN BEFORE. WHEN SHE ARRIVED TO OFFICE, VITALS WERE NORMAL. PULSES AND PERFUSION WERE NORMAL. THERE WAS NO SWELLING/ERYTHEMA, INCREASED WARMTH AT INJECTION SITE. SHE WAS ALERT, AWAKE, ANSWERING QUESTIONS (ALTHOUGH NOT QUICKLY, SOMETIMES HAD TO BE ASKED TWICE), BUT SEEMED VERY QUIET AND WAS STARING AT THE WALL A LOT. SHE SAYS SHE IS UNABLE TO FEEL ANY SENSATION IN LEFT HAND/ARM, AND COULD NOT MOVE ARM/FINGERS. SHE WAS PUSHING TONGUES BETWEEN LOWER TEETH AND LIP REPETITIVELY BUT INTERMITTENTLY. Poor performance and concentration in activities and school weeks and months afterwards. Evaluated by neurology.  Exam, MRI normal.  Suspected somatization disorder. Symptoms lasted months - still in speech therapy as of today.
Experienced two TIA events - first at noon & 2d again at 3 pm on 4/7/21 upon returning from 1 hour of water aerobic exercise at gym. Then I went straight to local ER where I was admitted for observation & testing. No other cause of TIA's was found, so my doctor urged me to make this report.
Diagnosis on 4/14/2021 of Polymyalgia rheumatica by personal pysician. Treatment of prednisone prescribed.
On 2/7 I noticed a quarter sized  red area at the injection site also itchy.
first signs of were in last week of February and first week of march. approximately 5 times between Feb 21 and April 15  I had what I thought to be indigestion, constant belching with a little pain in center of stomach area,  these symptoms disapeared after a few hours and tums. All started in early morning around 630 am. On April 15 it happened again but continued all day, went to urgent care at around 330n they did egg which was fine but advised going to emergency room for better tests,
Localized hives appeared up to shoulder 3 hours after injection. Firm, red, itchy rash about 2.5 inches in diameter persisted for 2 weeks
Patient developed coronavirus 4 weeks after last dose/Nasal Swab (SARS-COV-2): positive; Patient developed coronavirus 4 weeks after last dose/Nasal Swab (SARS-COV-2): positive; This is a spontaneous report from a contactable physician. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) second dose via an intramuscular route on 26Jan2021 and first dose on 05Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. On 23Feb2021 the patient developed coronavirus 4 weeks after last dose, had weekly negative tests prior to vaccine and immediately after vaccine. On 23Feb2021 the patient underwent lab tests and procedures which included Nasal Swab (SARS-COV-2): positive. No other vaccine in four weeks. No covid prior vaccination. No treatment received. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.
T0104 evening 5/18/06, vomited x 1 evening 5/18/06. Injection site with large surrounding erythema 3cm, warm to touch, no fluctuance.
4 1/2 hrs post vaccine felt throat discomfort and tightness chest with some difficulty breathing. Resolved within a few minutes. Felt tired afterwards.
8/2/99 devel migraine & T102, numbness in rt arm w/tingling in rt hand, knee & hip joint pain;generalized rash;
BUD expiration 04/13/23  Manufacturer expiration 06/13/23
7:45 am received vaccinations.  At 11:30 received a phone call from Mother that client had been taken to the ER.  He had severe shaking, nausea/vomiting/and a temp of 104.3.  IV was started and a full liter administered and then was released.  Was told it was a reaction to the vaccines.
The injection site began to hurt like there was a knife in the arm and I started running a fever. This was followed with extreme fatigue and muscle pain. Headaches began the night of the 2nd. On the 3rd and 4th I could hardly move my arm. Pain was excruciating.