chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 62 year old male consumer with no known allergies or pertinent medical history who on 28-JAN-2008 was vaccinated IM with a 0.65 ml first dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 31-JAN-2008 the patient developed a case of shingles.  Medical attention was not sought, there were no lab studies performed.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
headache, sore throat, body aches, fatigue starting 12-24 hours after shot; development of oral ulcers 72 hours post vaccine
Initial redness, swelling and pain around injection site; left deltoid; Now: left arm numbness and pain; diffuse body pain, weakness, and difficulty walking
maculopapular rash all over; fussy x 3 days; poor appetite, lethargic; exam shows throat injected rt OM; suboccipital lymphadenitis; lungs clear;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000433, expiry date 10-APR-2014, route and dose were not reported). On an unknown date, the patient experienced swelling at the injection site after receiving ZOSTAVAX. Patient was treated with KEFLEX. The outcome of swelling at the injection site was unknown. This is one of the several reports received from the same reporter. Additional information is not expected.
The patient noted the onset of shortness of breath and chest discomfort which began a few days after his second Covid vaccine. He presented to hospital with shortness of breath and tachycardia and was diagnosed with a large pericardial effusion. Pericardiocentesis was performed in the cardiac catheterization laboratory with placement of a pigtail drainage catheter. Patient subsequently had a VT cardiac arrest. It was though that the pigtail catheter may have contributed to the tachycardia. Cardiac catheterization was then performed and the pigtail catheter was removed. Cardia catheterization was reported to be normal. The patient was then treated with colchicine and ibuprofen. A LifeVest was placed.
blood in stool; tested positive for ROTAVIRUS; This spontaneous report was received from a physician and referred to a 4-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter.  On an unknown date, the patient received complete series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided).  On approximately 17-APR-2023 (reported as 2 weeks), the patient experienced blood in stool (haematochezia) and tested positive for rotavirus. On an unknown date in 2023, patient was treated with Vancomycin and symptoms resolved within 24 hours of treatment.  The causal relationship between both the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.   Upon internal review, the event haematochezia was determined to be medically significant.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2305USA000766:
In January 2022 is when I got sick. I had a sinus infection, hard cough, very tired. I saw my doctor. I was told I had COVID-19 because I was suppose to have surgery on the 23rd of January and I had to cancel. Later, I had pneumonia. My doctor was doing x-rays to make sure I still didn't have pneumonia. The did not put me in the hospital. The doctor followed up with me. I was taking cough syrup and antibiotics. My symptoms lasted for 4 weeks. As a result of Hydrea, on 02/16/2022-  My blood count dropped, hemoglobin was 5. I had 3 pints of blood and a pint of iron.
On 3/25/2021, started seeing rash, hive and feeling itchy, got worse thru the night when it started throughout my body and feeling throat stuck, chest pain. Next day, allergic reaction started spread to my face, ear and eyelids. Went to urgent care immediately. The doctor immediately gave me steroid, Zyrtec, Benadryl tablets to calm down the allergic reaction and instructed that I continue to take them for 5 days. After 5 days, I still experiencing lingering and minor rash, itchy sporadically on my body mainly hands, arms, ankle and bottom of feat.  Consulted gastroenterologist and allergist, inconclusive of the root cause.  Was on prescribed Omeprazole 40mg, Vitamine De+K2, Probiotics prior the vaccination.  Also took half of Advil tablet for 3 days to relieve tooth ache prior to the allergic event.  Have stopped since then.
PATIENT REPORTED TODAY THAT HE WAS ADMITTED TO HOSPITAL 12/10-12/12/21 FOR LEFT LEG BLOOD CLOT AND PULMONAY EMBOLISM POSSIBLY CONNECTED TO COVID VACCINE. HE PRESENTED VISIT VERIFICATION PAPERWORK  STATING THAT. WORKUP IS CURRENTLY ONGOING FOR OTHER CAUSES OR RISK FACTORS FOR BLOOD CLOTS. UNTIL WORKUP IS COMPLETE AND REVIEWED BY OUTPATIENT PRIMARY CARE PHYSICIAN, WOULD RECOMMEND PATIENT DEFER FURTHER COVID VACCINATION UNTIL WORKUP IS COMPLETE
PT RECEIVED PEDIATRIC DOSE OF VAQTA (HEP. A) VACCINE O.5CC INSTEAD OF ADULT DOSE.
A couple of hours following the vaccination I felt general myalgias, headache, nausea, sinus pressure, and general malaise. These flu-like symptoms persisted all the following day. On 16Jan2022 many of the myalgias went away but the headache persisted, and most of all I experienced a sharp pain in my eyes and forehead/brow area any time I moved my eyes. This continues the next several days and at the time I?m writing this continues to be uncomfortable. A week after my vaccine my complaints are fatigue, random onset of nausea intermittent throughout day, headache, and eye pain.
Taken vaccine, ended up with shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Taken vaccine, ended up with shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she know that most of the people had received the Shingles vaccine and experienced shingles. The patient stated that it seems to his or her it was just as effective as the Covid vaccine which mean it was not good at its job. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Called Sick to work; Threw-up, Could not eat,could not hold anything (Food), Threw up every day; Nauseous; Pounding head pain; Shaking; Stayed in Bed; Chills; fever 102 F; Severe Body Ache; Lightheaded; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), DIZZINESS (Dizzy), ILLNESS (Called Sick to work), TREMOR (Shaking) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Apr-2021, the patient experienced DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache). On 14-May-2021, the patient experienced TREMOR (Shaking) and FATIGUE (Stayed in Bed). On an unknown date, the patient experienced ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, DIZZINESS (Lightheaded), DIZZINESS (Dizzy), CHILLS (Chills), PYREXIA (fever 102 F) and MYALGIA (Severe Body Ache) outcome was unknown. On 17-May-2021, FATIGUE (Stayed in Bed) outcome was unknown. On 24-May-2021, TREMOR (Shaking) outcome was unknown. At the time of the report, ILLNESS (Called Sick to work), VOMITING (Threw-up, Could not eat,could not hold anything (Food), Threw up every day), NAUSEA (Nauseous) and HEADACHE (Pounding head pain) outcome was unknown.            No concomitant medication was reported   This case was linked to MOD-2021-163918 (Patient Link).
Patient received FLUZONE 0.5 cc . Color good. No distress. reported patient walked with husband across the room, sat down, got up and walked a few steps, then fainted, hitting head on windowsill. Reported feeling nauseous, dizzy, felt hot flash. Nurse reported immediately. Patient stable, blood pressure 110 over 84, temperature 97.3. Aroused with ammonia inhalant. Left forehead abrasion, left knee hit wall. Blood pressure 114 over 88. Paramedics responded and took over care at 11:40.
ITP - he received the Pfizer COVID vaccine the day prior to admission.  He subsequently felt fatigued and awoke this morning with intermittent petechiae.  While golfing, he subsequently noticed increased bruising over his left shoulder.  He had two episodes of epistaxis for which urgent care and then ED evaluation revealed evidence of thrombocytopenia.  Platelets found to be 3,000, normal Hb, normal WBC, no splenomegaly, no lymphadenopathy,. Oncology saw recommended decadron 40mg daily for 4 days
p/vax pt examined w/mult crops of erythema numerous papular-vesicular & OM;
I received my Covid-19 vaccine on 09/02/2022. In the afternoon of 12/30/2022 I started to have a sinus infection with a persistent cough. The next day I was tested for Covid -19 and was positive.  After contacting my doctor, I was prescribed Molnupiravir. Mild symptoms are still ongoing however I tested negative 5 days later.
sore arm; This is a spontaneous report from a contactable consumer (Reporter's Husband). This is report two of two. A male patient of an unspecified age received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient experienced, sore arm. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Could not move legs or walk. Purple rash all over feet and small spots various places of his body, 103 temperature, extreme pain.
Pt became nauseous approximately 5 minutes after receiving the influenza vaccine. She also felt heart racing. Began itching about 10 minutes following innoculation. Gave 25mg diphenhydramine po. "Felt better within 20 minutes."
Pfizer vaccine was diluted with Bacteriostatic 0.9% which is not recommended for use with Pfizer. CDC recommendations are to repeat affected dose. Patient was notified, all questions answered. Patient repeated dose on 9/14/21. No s/s reported by patient.
itching; being uncomfortable; arm was sore; dizziness for a week, severe for 3 to 4 days; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days), ASTHENIA (Weakness), PRURITUS (itching) and DISCOMFORT (being uncomfortable) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Blood pressure, FENOFIBRATE for Cholesterol.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days) and ASTHENIA (Weakness). On an unknown date, the patient experienced PRURITUS (itching) and DISCOMFORT (being uncomfortable). On 19-Jan-2021, PAIN IN EXTREMITY (arm was sore), DIZZINESS (dizziness for a week, severe for 3 to 4 days) and ASTHENIA (Weakness) had resolved. At the time of the report, PRURITUS (itching) and DISCOMFORT (being uncomfortable) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication were provided   concomitants were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: email  updated. patient information updated .vaccine information updated and event verbatim were updated
pt had hospitalization for fall, acute stroke, acute encephalopathy; positive COVID test while in the hospital, asymptomatic and on RA; pt had a poor prognosis from stroke; admitted into hospice; per death certificate, pt died in the hospice facility (Hospice) with the causes of death being CVA and HTN
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates on approximately 2015 (since the initial temperature excursion was reported on 14-MAY-2015), the patients were vaccinated with 12 doses of (Oka-Merck) PROQUAD subcutaneous injection, lot # K025760, expiration date 08-JUN-2016 (strength, dose and route of administration were not reported) which were improperly stored and exposed to a temperature excursion. No information on patients concomitant medication was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the two reports from the same reporter.
5 minutes after I left the site, about 20 minutes after receiving the shot in my RIGHT arm, I got hives on the underside of my LEFT arm.
Approx 2 min or less/p admin pt arched back & became rigid & unresponsive.P=80,regular;R=16.Pt was warm touch,nl skin color,not diaphoretic.Pt unresponsive 30-45secs.Upon regaining consciousness pt tired,but alert&oriented.Dr reported nl PE
I've had diaherra ever since the vaccine, thought it would go away in a week or so. I'm been taking immodium ad every day since
Moderna COVID-19 Vaccine  Aches, chills and fever first night - also very tired and right arm sore Aches, chills and fever on & off thru 2nd day - fatigued and arm still sore 3rd day - felt much better, maybe a bit tired but not too bad.  Arm is still sore with a red rash around the area where the shot was given      and is itchy 4th day - everything is good except shot area still a bit sore & itchy
It started 10 days after the vaccination, intense headache , never went away for 8 days, very moderate fever, never went above 101. Chills, pretty intense chills, no nausea, never lost sense of taste or smell, no appetite for 5 full days, forced myself to eat. I couldn't sleep more than a couple of hours. I became sleep deprived, for 5 nights. My arm was sore for 24 hours, never had a rash, never had redness.By the 5 th day my fever wouldn't go down I couldn't sleep and that's when i called the doctor about midday, January 29th. Nurse line, referred me to online call. urgent center call: Covid test, and flu A and Flu B test. By 3 pm that day, test were given in a parking lot. took swabs for the test. The 1st time in 5 nights I had a better night sleep. On 25th & 26th Sharp joint pains on each knees, to ankles to wrist,  a sharp pain that would last for 20 - 30 minutes intermittently, less than 10 times each day. didn't happen at nights. The pain moved all over  but never in multiple locations at the same time. Back to day 5, I took the test, my headache had lessened but it was still there, and i had an appetite. By Monday, February 1st, in afternoon, my fever had gone away, I was totally normal. The results  on Sunday, on the 3 test were all negative. Since the last month, I had 1 covid test because I went out of the country.  were negative.
On 4/26/09 patient started to develop red rash in which progressively increased in numbers and intensity.  Rash was coalescent.  Patient seen on 04/27/09 with servere rash.  Pictures were taken.
On Monday 11/8 patient and her mother arrrived to the site requesting a Moderna vaccine.  The patient was registered, all covid 19 screening questions answered appropriately.  Patient sat down at the vaccine table, the RN went over the paperwork confirming all the information was correct.  RN state she was not feeling well and had to step away, the LEAD RN stepped in,  at 1615 patient received her first dose of the Moderna vaccine without any difficulty.  The patient sat in observation for a full 15 minutes with her mother at her side. no adverse reactions noted.  Upon completion of her observation the nurse reviewed with both the patient and her mother expected side affects and when to seek medical attention.  The patient verbalized understanding and left the site in stable condition via private vehicle.  On 11/10 an audit of consents was performed and it was noted the patient did not qualify for the Moderna vaccine she received on Monday due to being an adolescent.
Pt received vaccine approx 9:10 AM, received called from health dept. 9:30 AM from human resource director stating pt having trouble breathing and dizzy, started approx 9:25 AM - instructed to call 911. (Pt states tingly all over, nausea, light headed, states "feels drunk".
4 year vaccines given in AM. No adverse reaction reported. MD was informed of event. No treatment required.
Moderna COVID-19 Vaccine EUA  Distortion of vision in both eyes but predominantly in the left eye. First noticed the morning after receiving the vaccine, and unchanged at this time (5 days after vaccination).   The left-eye distortion is along vertical lines, such as when viewing an icon or a box on a computer screen. The distortion is very crisp and unwavering (not flashes or floaters) and forms a very clear half-circle that bends toward the left, as if the line is being pushed to the left by a ball. There are no dark spots or "missing" vision, just that what I'm looking at is pushed to the side at the point where I'm focusing. The right-eye distortion is much smaller but definitely present, and distorts to the right instead of the left.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female patient with drug hypersensitivity to VICODIN and with no pertinent medical history who on 07-FEB-2012, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 29-FEB-2012 a urine pregnancy test was performed and the patient tested positive. The estimated last menstrual period was on 06-FEB-2012 and the EDD was on 05-NOV-2012. The patient sought unspecified medical attention. At the time of the report no adverse effect was reported. All attempts to obtain follow up information have been unsuccessful. Additional information is not expected.
No additional AE information provided; Patient was administered an improperly stored dose of PNEUMOVAX 23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 27-NOV-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient received COVID vaccine series at nursing home. This information was not available in the medical record at the hospital. Patient offered COVID vaccine at the hospital and did not disclose that he had already received the series. In which case, patient received a third dose. (first 1/5, second 1/26, third 3/30, ALL pfizer). Followed up with the nursing home on 4/1, patient not displaying any ADEs.
Mom reports redness to right deltoid area and red round area to right upper lateral side of arm. Mom states via interpreter she noticed areas on 2/20/18 the day after pt. received shots.
Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart.  Facility called 911 administered Benadryl via IV transported to ER  Once in ED given Epipen at 2:21  and Decadron @ 6:05, discharged at 6:60 pm
Patient received DTaP, HIB, IPV and Prevnar on 1/7. No apparent immediate problems but was found dead at home 1/12 AM. Apparent SIDS; autopsy pending.
At approximately 30 minutes after the shot, I experienced a tightness in the back of my throat. It lasted for approximately one hour and subsided without any interventions.
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt  ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
A COUPLE DAYS AFTER VACCINATION , FATIGUE AND DIZZY, AND REALLY BAD NAUSEA FOR PERIOD OF 2 WEEKS.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 93 days after 2nd dose.  Patient received 2nd dose of COVID vaccine on 1/23/21.  Tested positive for COVID on 4/5/21.  NOT hospitalized. Likely was exposed through husband &/or son who both tested positive for COVID recently. Symptoms reported: nasal congestion, runny nose, headache.  Symptom onset date:  4/4/2021
On the 8th and 9th day after vaccinations, high fever ranging from 102-103 degrees. Same exact symptoms and timing as fraternal twin brother-vaccines were 2 weeks apart!
Aches, Chills, Fatigue during the following day. Took TYLENOL and Ibuprofen to ease the discomfort. Felt better 2 days after the shot.