chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 2nd, approx 5 days after 1st Pfizer dose, I noticed a change in my mouth - roof of mouth and tongue especially, I have had a different taste ever since,  a mineral-ish taste in my mouth since that day that has not gone away.  On May 19th, the next evening after my second dose, I had intense radiating arm pain (not just like the sore arm I had the first time), more like what I imagine the radiating arm pain must be like when one suffers a cardiac event, it was very intense and scary and lasted for 15 to 20 minutes. Before and after the radiating arm/possible cardiac-like event, I noticed I was also extremely agitated before and after it happened. I was agitated to a state I am not accustomed to experiencing. It was all very unusual and unnerving for me.
Persistent, excessive crying >3 hrs w/in 24 hrs of DTP & lasting about 48 hrs to 72 hrs;
an administration issue, on 6-22-21 we administered vaccine that expired 6-18-21 (30 days after thaw) Moderna was contacted but had no guidance for us.
rash which gotten bigger on the chest/rash around the side it has gotten bigger and now she is having them in other areas/rash around the left side on the arm; Very tired/Tiredness; Itching; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 07Jan2021 in the left arm at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) which she uses a nebulizer for this. There were no concomitant medications. The patient previously received first dose of BNT162B2 (lot number: EJ1685) on 18Dec2020 in the right arm for COVID-19 immunization. The patient reported that she was very tired, tiredness started on the same day as she received the second dose of the vaccine on 07Jan2021. The patient also developed a rash which gotten bigger on the chest, a rash around the side it has gotten bigger and now she was having them in other areas 3 days later (10Jan2021). The patient further explained that it also developed rash around the left side on the arm. The patient was using Cortizone cream over the counter and it relieved itching (started in Jan2021) but it didn't totally take it away. She still felt tired today. The patient had no positive tests for COVID and no antibody test before the vaccine. She had no issues with vaccine in the past. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient passed away unrelated to covid vaccination Narrative:  The patient with PMHx significant for afib s/p failed ablation, chronic hep B, heart failure and skin cancer. Patient received his first dose of Pfizer on 1/14 and second dose of Pfizer on 2/4. Patient's wife notified facility that patient had passed away at his residence on 3/9 due to metastasized cancer. Cause of death is not related to COVID 19 vaccination.
no adverse event; stored at an improper temperature; the shingles shot (manufacturer unknown) at the same time as PNEUMOVAX 23); This spontaneous report was received from a the patients mother, and  refers to a female patient of unknown age.  The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   In August 2020 (exact date unknown) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (lot #, expiration date and route of administration were unknown) for prophylaxis. The reporter stated that the patient had the shingles shot (manufacturer unknown) at the same time as pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had been stored at an improper temperature, No additional adverse events or product quality complaints were reported.
From faxed correspondence from responsible physician stated that a 15 year old female patient received a Menomune A/C/Y/W-135 vaccination on 19-Jun-2001 at 3:00 pm. At 3:05 pm, the patient had Vasovagal reaction, fainted and hit wall with laceration 2.5 cm to posterior scalp. brief jerking movements as awakened. glucose ,80 after juice, blood pressure normal, pulse normal. Taken to emergency room for observation and suturing. The patient recovered from this experience.
Information has been received from a pharmacist concerning a female pt who in March 2005, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. IN March 2005, the pt experienced redness, swelling and tenderness from the elbow to the shoulder. Unspecified medical attention was sought. It was noted that the pharmacist was unsure of how long the pts symptoms lasted. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested.
Redness, swelling, some tenderness (R) upper arm (size 12 x 12cm). No relation to injection site.
Shots given at 11:15, Mother states upon arriving home child started with vomiting.  Vomiting continued throughout the night. "Sometiinmes like a waterfall", she called her Dr. this Am he instructed her to call us, and to take child off formula and begin Pedialyte.  Mother reports no elevated temperature and no diarrhea.
-Flu vaccine given on 10/22/13 - Morning of 10/24/13 - noticed red, warm, itchy area at injection site - Notified BOH of injection site on 10/25/13 red area 2 1/2 " x 1 1/2", red warm cont to itch.
This spontaneous report was received from a registered nurse and refers to a 6-month-old male patient. This patient was very behind on immunizations. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. Historical vaccine included unspecified hepatitis B vaccine on 08-SEP-2018. On 19-MAR-2019, the patient accidentally received both RECOMBIVAX HB lot # R021370, expiry date: 07-NOV-2020, 0.5 milliliter for prophylaxis (route of administration and injection site were not reported) and PEDIARIX for prophylaxis (dose, frequency, route of administration, injection site, lot # and expiration date were not reported). No adverse event was reported. The outcome of incorrect dose administered and inappropriate schedule of product administration was unknown. Sender's Comments: US-009507513-1903USA010025: US-009507513-1903USA010012.
increase of white blood cell count after being administered with PREVNAR 20; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 67-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Aug2023 at 16:30 as dose 1, 0.5 ml single (Lot number: GA5916, Expiration Date: 31Jan2024) at the age of 67 years, in left deltoid for immunisation. The patient's relevant medical history included: "Cancer" (ongoing); "diabetic " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 16Aug2023, outcome "unknown", described as "increase of white blood cell count after being administered with PREVNAR 20".  Additional information: the indication was also reported as over 65 and never had a pneumonia vaccine. The NDC number of Prevnar 20 was 0005-2000-02. The vaccination was given probably around 1630. The patient did not received any vaccinations within four weeks. The patient's wife said that she could not find anything about it in a package insert and the patient's wife did not say the event was from the vaccine. She was not sure if they increase in white blood cell count was found on 16Aug2023 or 15Aug2023, but thought it was 16Aug2023. The patient was also diabetic based off of his medication list.  Follow-up (16Aug2023): This is a spontaneous follow-up report received from a contactable pharmacist, program ID. Updated Information: reporter information, patient information, medical history, suspect vaccine information, event onset date.
Arm very sore. Very warm to the touch, arm appears a little swollen and red. Pt was given restricted duty.
Nausea the same day, then 1 week later experienced a red, warm rash on the arm, hives on feet and legs. All resolved except for a little rash on the legs when pt reported side effects 10 days after vaccine.
Probably about ten seconds after receiving my second dose of the vaccine I stood up and walked out of the room and all of a sudden I felt my face get very hot and go numb and tingly and then my I started having trouble breathing. I went back into the room and still couldn't breathe so they sat me down and told me my whole body was bright red and they stuck me with an epipen. The whole reaction probably lasted a  little less than a minute from the time it happened to when they stuck me with the epipen.
Mom reports cried for 3 days p/shots; 1st 24 hrs screamed & cried was inconsolable; next 48 hrs cried & whined;
Vaccines administered at 1037. Pt. c/o dizziness at 1038. Water and sucker given at this time, fan. N/V at 1043. Pt. ate granola bar at 1047. BP 91/53 at 1050. More water and another sucker given. BP 110/75 at 1055. Pt left with mother at 1059. Instructed to hydrate and eat lunch. Encouraged to notify Dr. of event. Dr for any follow up needed.
"A physician reported that a 2 month old infant received vaccines on 6/7/99. On 6/10/99, the infant developed a fever of up to 102F and diarrhea. The infant was seen in ER. The infant was discharged to home and prescribed Rocephin IM for 3 days. As of 6/28/99, the infant's stools were still positive for occult blood." From correspondence received on 2/22/00, it was reported that the stool guaiac was finally negative on 7/5/99 (4 weeks, post vax). The pt reportedly recovered from this experience. Additional pt and vaccine information was also provided. Follow up #1 (6/5/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse event coding (added diarrhea).
pt recvd vax; slept x 12 hrs;cont to be sleepy w/ poor breast feeding;
The injection itself was extremely painful.  Felt like a nerve was being hit.  Within hours, had bad pain in my right arm and could not move it.  Range of motion was limited.  Could not lift arm above shoulder level.  Next morning, same.  Called pharmacy and spoke with pharmacist, who said that is normal and to call him in another 2 days if no better.  He said if no better, he would contact my physician.  Range of motion is a bit better, but still painful to raise arm above shoulder level, and still painful to try to put on clothing.  I am concerned and worried that this may not get better.  It is now 12 days since the vaccine was administered.  I just tried to contact the pharmacy again, but I cannot get a "human."
Very heavy postmenopausal bleeding including large clots began evening of 3/12/21; ended 3/22/21.    Bleeding occasionally heavy for entire time.   No other symptoms.
I had a stuffy head and runny nose I was just kind of tired. I waited a day to test at home and it was positive. They really hit on the third day, I developed a cough and body ache. Laying down was painful. My family contacted a local pharmacy, and they prescribed a PAXLOVID. I was feeling better by that Friday the 16th. I feel good now but, occasionally I have this deep cough. I have tested negative and went back to work.
Patient here 10/5/07 @ 7:30am. Presented with 40 x 45mm slightly raised indurated circular area on right upper arm area and small pale ecchymosis area. Slightly warm to touch. Denies pain or tenderness.
Vesicles papules > 40 clusters at injection site. Temperature 104 axillary
Received Tdap vaccine in (L) deltoid on 12/19/11 & also a Tb skin test on (L) lower arm same day. Later that day (L) upper arm red & hot to touch by 1730 SOB, tightness in chest, nausea 1745 used my son's PROVENTIL inhaler 2 puffs & repeated q 4-6hrs. x 4 days. Body aches, fatigue, pillow orthopnea. Also used SINGULAIR, ALLEGRA & ZYRTEC: face looked sunburned & peeled.
Patient observed by mother with cough, wheeze, and rash. Pulse OX was 97% so we gave albuterol neb and oral pred and child cleared and pulse OX was 100% on discharge to home.  No EPI given always with good perfusion.
Rotavirus given 7/22/10. 8/14/10 fussiness/abd pain, bloody stool. Transferred to tertiary care for intussusception. Reduced surgically.
After vaccines given pt felt faint and nauseous, RN placed in supine position, cold wash cloth applied to forehead, neck.  Pt stated she had not eaten that morning.  After 5 mins in supine position pt placed in semi-supine position, pt fainted and again placed in supine position.  Pt opened eyes to name being called.  Started vomiting and complaining of numbness in arms, buttocks, and legs.  Started screaming reporting severe abdominal pain and positioned self in fetal position.  Stated she started menses last night 10/24/21 and stated, "I think the vaccines are causing me to have severe cramps."  VS remained stable, O2 was applied at 2 L/NC because pt wasn't taking deep breaths due to pain.  EMS was called at 0915 when pain continued to become more severe.  Pt's Father called and came and followed ambulance to hospital.
DIFFICULTY BREATHING; BACK PAIN; PAIN IN HIP; DRY MOUTH; SWEATS; SHAKINESS; CHILLS; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty breathing, back pain, pain in hip, dry mouth, sweats, shakiness, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain, dry mouth, sweats, shakiness, chills, difficulty breathing and pain in hip was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Achy, slight light headedness almost immediately.  During night sleep had 2 disturbing type dreams.  Next morning mostly achy and lethargic.   2 acetaminophen x 500mg seemed to improve effects some.
burning chest; no appetite; fatigue; Generally feels miserable; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 26Sep2022, outcome "unknown", described as "Generally feels miserable"; CHEST PAIN (non-serious) with onset 26Sep2022, outcome "unknown", described as "burning chest"; FATIGUE (non-serious) with onset 26Sep2022, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 26Sep2022, outcome "unknown", described as "no appetite".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After 1 dizzy for about 5 minutes, then okay.    After 2, dizzy a little after, then about 5 hours chills and low grade fever,  then few days have been dizzy and muscle ache in neck,  had an regular appointment with dr. on the 7th and told him about the dizziness and put me on medicine for vertigo and today still have it some times really bad,  going to eye doctor on 20th as vision is messed up too.  Then going from there.  Really not good at all.  Scared I might pass out.
Went to park, talking with mother. Mom looked over at patient, she slumped back, arched head and neck, rolled her eyes back and was unresponsive (but breathing) for 1-3 minutes. EMS arrived, vitals stable. Pt groggy but awake, could not recall any of the event. Syncopal vs seizure.
pt recv 3 doses of vax & reporting MD noted that pt did not administer the vax;pt exp failure to seroconvert for rubella using an EISA test;
I got that shot and still got them/ suspected vaccination failure; still got them; try and stay out from under stress; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got that shot and still got them. Doctor told, try and stay out from under stress which causes it.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
The patient presented to the health department on 10/25/2021 for a Moderna booster. The RN administered a full- dose (.5ml) Moderna vaccine. The patient was notified of the error. He denied any side effects at that time and was advised to call the health department with any questions or concerns.
Right after my 1st vaccination, 02/24/2201, my arm turned red and was swollen and it stayed swollen, for a month, when I was receiving the 2nd dose, and I had to get it in the other arm. With my 2nd Dose, I took it in the other arm, and my arm did not get swollen. Around the beginning of March, I was having pain in my stomach. When they did x-rays they discovered that I had cyst on my pancreas. An MRI showed I had a gall stone and a 2 cm cyst on my liver, fatty liver, and my kidneys were not filtering like they were supposed to. I do not know if I have recovered from the AEs. I have to go in  on 10/01/2021 and have an endoscopic and I am still being monitored. I went to the endocrinologist and was diagnosed with GRAVES disease. I was put on a special diet.
No reaction or illness was noted after vaccine until the morning of 3/11/00. The child was playing and then laid down on couch and started shaking and stopped breathing. Autopsy showed cause of death to be consistent with seizure. Other findings of pulmonary vascular congestion and edema, atelectasis of the lungs, hepatic congestion, petechiae of the thymus, splenic congestion, reactive lymphoid hyperplasia of the mesenteric lymph nodes, renal congestion, fetal lobulation of the kidneys, cerebal edema.
RAISED RASH - STARTED ON TRUNK THEN SPREAD TO FACE, NECK, ARMS AND LEGS.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  The nurse had no standing order other than what they had for second booster when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL instead of 0.5 ml to uncompromised patient. They administered an invalid dose which was lower than authorized dose of the Moderna COVID-19 bivalent booster. No adverse events were reported. It was reported that CDC had recommended to revaccinate the patient with full dose of 0.5mL.  No treatment medication reported by reporter.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with MMR II (lot H020255, expiration date not reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
No appetite. Diarrhea fatigue  Lasted 7 days.Then normal.