chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began noticing a sharp pain in my left side of my chest about 2 hours after I received the shot. The following morning I had the worst pain in my heart. I felt my heart beating so fast and harder than ever in my life. It has hurt equally as bad since then during these past 3 days.
seizure; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. According to the physician, the patient received a dose of TRUMENBA and the patient had a seizure. Event took place after use of product. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event seizure based on the temporal association  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Beginning the morning after the shot (NDC: 59267100002), brain zaps, fatigue, headache and itchy skin on my face. These have continued. During the night after my shot, I had itchy skin on my neck, arms and trunk, but these have subsided. The brain zaps happen frequently, especially when I am standing and move my head. These are super annoying.
This case was reported by a physicians assistant and described the occurrence of pain in a 36 year old male patient who received hepatitis B vaccine recombinant (Engerix B). On 02/11/2005 the patient received the first dose of Engerix B in the left arm (Lot AHBVA062AA). At an unspecified time following the administration of Engerix B, on 02/11/2005, the patient experienced neck pain, elbow pain and fever. The fever resolved on 02/12/2005. The neck pain and elbow pain were on going at the time of initial reporting, 02/15/2005.
Swollen, inflammed, itchy area left deltoid.  Size 5 inches by 5 inches in size.
7 days after vaccine hives on neck chest and both ears. Itchy not relieved with po Benadryl 75mg 3 times daily for 3 days? added Zyrtec 12/30/2020
p/3rd inject numbness rt arm, heavy sensational in chest, weakness, extremely fatigue; seen by MD; myelitis;
Rash appeared on right arm near (not on) injection site on 1/25/2021 and faded over 2 days. ?Covid arm? except 17 days after vaccination. Anterior to bicep.
Within 10-15 minutes after giving her boostrix and fluarix, patient fainted twice. Rashes developed on her arms about 20 minutes after vaccination. Paramedics came and took her to the hospital.
Severe arm pain, chills, nausea  The worst is excruciating arm pain. It hurts to move my arm at all. Constant pain, shooting pain when I move.  On scale of 1-10, 9 or 10! I have high pain threshold usually so I can hardly believe how much pain I?m experiencing. I?m beginning to get a headache. Please help me. Can I take Aleve for pain? I can?t even sleep.
a red spot at injection site; a red spot that hurts and itches on the injection site; A red spot that hurts on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site), VACCINATION SITE PAIN (A red spot that hurts on injection site) and VACCINATION SITE ERYTHEMA (a red spot at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site) and VACCINATION SITE PAIN (A red spot that hurts on injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a red spot at injection site). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (a red spot that hurts and itches on the injection site), VACCINATION SITE PAIN (A red spot that hurts on injection site) and VACCINATION SITE ERYTHEMA (a red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes: Ventolin (Inhaler Device)
Severe dizziness started around 10:00pm then got a little better around 6 am the next day. Hardly got any sleep that night. Then around 8am I started to have chills which then I checked my temp and it was 101.0 degrees F. Then I started to get a headache and severe body aches. Around 3pm I tried to eat something which I then threw it up. I tried to drink water and flavored water which I also threw up the water. I also went into the bathtub 7 times that day to stop the chills. Which it did but right when I got out they started again which then I felt worse. Around 11pm 1/23/2021 I ended up going into the ER which then they gave me IV fluids and then Benadryl and Toradol by IV. After those were administered I started feeling better which then I was discharged and went home.
This spontaneous report as received from a healthcare worker (medical assistant (MA)) refers to a 6 month old patient. It was reported that the patient had received the first dose of HIB vaccine (manufacturer unknown), 0.5 ml intramuscularly on 15-OCT-2014 and received the second dose of PEDVAXHIB (lot #, expiration date were not provided) on 16-DEC-2014. On 16-FEB-2015, the patient was vaccinated with PEDVAXHIB dose 3 (0.5 ml, intramuscular, lot # and expiration date were not provided) and PENTACEL (dose and route of administration were not provided). No adverse effects were reported. No further information was provided. Additional information has been requested.
Resident is smacking lips  and chewing, nothing noted on his mouth, non-verbal NP was in to assess patient,911 called, resident transferred to medical center by EMT.  pt is awake but no longer able to speak, has a low-grade fever and chills noted, and additionally has worsened limb weakness,  The patient returned to baseline; however, residual symptoms from stroke noted.  Send to medical center for evaluation and TX.  , The patient returned and no new orders  Records noted a massive CVA in 6/2020
Reaction noted with Dose #2: Hives s/p COVID vaccine at 1100. Pt noted w/ hives on forehead. Denies difficulty breathing or swallowing at this time. Took 50mg of benadryl PTA. Pt reports mild improvement of symptoms after benadryl and prednisone. Skin signs remain unchanged.
a 3 year old patient received a dose of an expired Daptacel vaccine on 14-FEB-2020 and the vaccine was expired on 07-FEB-2020/No AE; Initial information received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA042252 (same reporter).  This case involves a three year old male patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 14-Feb-2020 , the patient received a 0.5ml booster dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366 BA, expired date: 07-Feb-2020) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever up to 101.7, severe chills, some nausea, sever headache
Information has been received from a Registered Nurse referring to a 11 week old patient of unknown gender. information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe intense burning pain left shoulder and posterior neck started approximately 24 hours after injection. Pain got Progressively worse, unable to sleep at night attempted to treat pain with Alleve and warm compress.  Unable to get doctor appointment with primary, had video visit with Dr. 4/26/21 who ordered Voltaren gel 2gm 4 times a day, Naproxen 1 tab Twice a day started on 4/26/21. Neurology appointment with Dr.ordered 3 times a week and started 5/11/21 current treatment ongoing Tens, heat, massage
No issues at the time. But now 7 months later soreness with pencil eraser sized red broken pinmpilish looking  skin at vacinesite. Unread area has  movable sore lipoma feeling that can be pushed around, feels bruised, but only red at the pencil sized pimplish area. Under the skin of harder lump is about an 6 inch area circumference
No additional adverse effect reported; temperature excursions; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 29-OCT-2021, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, and route were unknown; lot #T031820, has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 10-MAY-2022) for prophylaxis following a temperature excursion (product storage error). The reporter did not have any cycling information available, so there wasn't sufficient time and temperature data for evaluation. There was no previous temperature excursion. No adverse event was reported.       This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA009917:
failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) outcome was unknown.        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 concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received contains significant information. Added event.
02/24/23 presents to ED for "SOB and covid infection". PMHx of "Severe uncontrolled Asthma, eosinophilia +elevated IgE"
L leg received that received KINRIX injection reportedly cleaned in sterile technique as usual prior to injection. On 4/3/19, left thigh became erythematous in small area of a few centimeters, and by the afternoon of 4/4/19, the leg become almost completely erythematous and swollen. He was referred and admitted to Medical Center, where he was treated for cellulitis with IV clindamycin, and he subsequently improved and was discharged on 4/5/19 in the afternoon. He continued antibiotics afterwards (prescribed 10 day course and was confirmed to have completed 7 days at follow up) with significant improvement.
This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with birth defects. Serious criteria included congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the birth defects may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of multiple birth defects in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed multiple birth defects. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between multiple birth defects and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Patient moved during injection and a small amount of vaccine made a drip on the arm before rest of vaccine was injected.  Family was offered another COVID vaccine booster as recommended by MD, but declined.
Patient received Fluarix flu shot on 9/29/22. Patient received vaccine they were not eligible. No adverse reaction noted. Patient and facility notified.
fell asleep while standing; fall; A1C high; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (fell asleep while standing), FALL (fall) and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (fell asleep while standing) and FALL (fall). an unknown date, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high). At the time of the report, SOMNOLENCE (fell asleep while standing) and FALL (fall) had resolved and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high) outcome was unknown.            No concomitant or treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-033738, MOD-2021-170199 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd 3 doses of Engerix-B & w/in hrs p/1st dose had abdo pain; p/3rd dose 12 hrs later had abdo cramps, flu-like sx, queasy;
Woke up morning after receiving vaccine with 1/2" diameter "knot" at vaccination site. Tender to touch, no redness, no fever. By 7/28/03 at 5PM "knot" no longer noticeable, no tenderness at site. No medication taken during interval.
side effects started with arm soreness at injection site Woke up the next day with body aches that progressed/worsened throughout entire day Additional symptoms on day two: runny nose, joint pain especially in knees, chills, back pain, some nausea, severe orbital muscle pain more in the left Day three woke up with no body aches however had swelling in axilla of left arm that was sore and tender to touch, pain at injection site remains, orbital muscle pain remains and increased Symptoms did not include: fever, headache, abdominal pain, rash, vomiting  Day 4: pain in arm with swelling remains in axilla, new soreness with tender to touch minimal swelling area also at inner elbow, orbital muscle pain remains but less severe
8/4/2018 seizure - unable to lift Rt. arm for half an hour. Temp of 100.5 degree. (R) arm and leg were shaking, went limp and lost consciousness for about 2 minutes.
Subsequent to receiving first and second doses of Lymerix, the pt tested positive for Lyme disease. The pt had no symptoms. As of 10/02/2000, the outcome of the event is ongoing.
This spontaneous report as received from a consumer refers to her son, who was a male patient of unknown age. On an unknown date, the patient was vaccinated by unknown physician with M-M-R II (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced autism and seizure (medically significant). The outcome of events was unknown. The causality of events was not reported. No product quality complaint (PQC) was reported. Upon internal review the event seizure was considered to be medically significant. Additional information is not expected.
PT WAS FINE IMMEDIATELY AFTER VACCINATION. PT GOT UP AND WALKED TOWARD THE SEATING AREA WHILE WAITING FOR HER HUSBAND AND SAT DOWN. WITHIN 2 MINUTES, SHE PASSED OUT AND FELL INTO THE FLOOR. RPHS IMMEDIATELY ATTENDED TO PT AND SHE STARTED TO COME TO. BP WAS NOT DETECTABLE AND PULSE WAS 54. RESPIRATIONS WERE 40. EMS ARRIVED AND BP WAS 80/60, HR 80 AND RESPIRATIONS 20. THEY STRONGLY ENCROURAGED HER TO GO TO THE ED TO GET CHECKED OUT AND SHE AGREED. NO MEDS NEEDED OR ADMINISTERED. PT RETURNED TO CLINIC FROM ED AT 4:40 PM TO SET UP 2ND APPOINTMENT AND STATED THE ED TOLD HER IT WAS JUST A REACTION TO THE NEEDLE STICK.
DIED; COULD NEVER WALK AGAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. 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, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient could never walk again. On 25-APR-2022, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of could never walk again was not reported. This report was serious (Death).; Sender's Comments: V0-20220519096-covid-19 vaccine ad26.cov2.s-.Died The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Swelling noted on arm same day after vaccine administration. Patient was seen in ER on 7/31/2009 and was admitted at hospital for possible cellulitis. Patient has history of CROHN's disease on Rx with methotextrate.
She got her vaccine, that evening she started with ill feeling, developed a fever of 100.5, and then she broke out completely with a rash that she had not seen before similar to hives . She also had the soreness in the arm and felt like she was hit by a truck and it put her down for a few days.  She then woke up not feeling the ill feeling.  Then four days later she woke up and part of her vision was gone.  She then went to the eye Dr. and was informed that she had a blood clot and an eye stroke in the right, and has to get injections in her eyeballs themselves now to resolve the issue.  She will not get her sight back as the blood vessel that goes to her optic nerve has ruptured and there is blood and fluid leaking due to the stroke.  She has to go through these injections every month for life, and trying to reduce the swelling to have laser surgery.  She has significant swelling right now behind the optic nerve and if it does not go down then they will not be able to perform the surgery.  She had previous 20/20 vision and was able to see long distances without any problems, and now she has limited vision.
34 year old female patient received her first dose of GARDASIL 9 vaccine 13 years ago and never received another one.; No other AE information reported; This spontaneous report was received from a nurse and refers to a 34-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in June 2008 (reported as "13 years ago"), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that the patient never received another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered). There was no additional adverse event reported.