chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after (4 days) receiving the vaccine I began to experience leg pain and minor cramping, in addition to mild general pain. This continued for about 1 week. I still have occasional pain, particularly in the legs, made worse by exercise (lighter exercise than would normally cause pan). I have also been experiencing hypertension that, to my knowledge, did not exist prior to receiving the vaccine. This has persisted since first measured 5 days after the vaccine until today, more than a month after receiving it.
Mother reported local reaction on the right thigh, redness and swelling from Dtap and Prevnar 13 injections. Mother also stated that the  lump is about two inches long, swollen, looks like a moskito bite. Advised mother to apply ice pack , HC cream 1 % TID & Tylenol 2.5 ml 4 hrs Prn.
Developed sudden onset of tinnitus/ringing/echoing in left ear while sitting on couch.  Received 1st dose of Moderna Covid-19 vaccine on 12/29/2020 and second dose on 1/26/21.  Tinnitus gets better or worse throughout day but never fully subsides.  Assessed by ENT and audiologist on 3/19/21.  Saw Dr of ENT and Allergy Associates
Tinnitus in both ears markedly worsened around 1 week after first dose of vaccine.  Saw my primary physician two weeks later (05/19) to discuss if ok to take second vaccine dose.  Dr referred me to an ENT whom I saw that same day; hearing test administered; ENT Dr advised the following: 1) tinitus possibly related to vaccine 2) tinitus might not improve 3) second vaccine dose may or may not further worsen and unsure of mechanism which may be neuro imflamation for which the Dr offered steriod perscription which we agreed to forego.
Pt recvd a series of Hep B vax 13DEC90, 15DEC90 & 30DEC90 & reporter indicated that pt tested neg p/series; pt was retested approx 12-15 wks & is still neg;
I was vaccinated with my first shot 03/03/2021. I had my second dose on 03/31/2021. Both at a drug store. Both times I had adverse reactions and was unable to work for 5 days. I reported this earlier today in another report.  I also had a breakthrough case of COVID and am just now stating to get better. 9/26/2021 I started having early symptoms of a slight fever of 100.5 and fatigue.  9/27 I had 103 and could not get out of bed. Extreme chills, extreme body aches, swollen glands, shortness of breath. Persistent cough and tightness in my chest.  Extreme fatigue. I began isolating then.  9/28 I went to patient first urgent care. The rapid test was negative. They gave me antibiotics for a lung infection and cough medicine prescription. They also conducted a PCR test. They told me I had bronchitis that was developing into pneumonia. I again had 103 - unless on Advil then it was between 101 - 102, chills, extreme body aches, tightness in my chest, shortness of breath, persistent cough.   9/29-9/30 - still unable to work same as above symptoms. New symptom on 9/30 extreme headache. Sinus pressure. Painful.  Fever 102.5  10/01 - test came back confirming I had a breakthrough case of COVID. Same as above symptoms. Still 102.5 fever. Still could not work. Went to my reg doctor for a check up. They confirmed the antibiotics were working for my lungs infection.  Later that evening I was better able to maintain a 100.5 fever with meds. They also prescribed new cough medication.   10/2-10/4 stayed at home. Continued to medicate with prescriptions given and and isolated. Each day over the weekend and Monday the fever improved.   10/5 - felt good enough to work a half day from home. I am still very fatigued and feel foggy. Like I cannot concentrate. Also like my ears are clogged even though I am not congested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. No concomitant medication were reported.   This case was linked to MOD-2021-363791 (Patient Link).
Pt developed sudden shaking, chills and myalgia with temperature of 101F approximately 27 hours post vax.
Fingers are so swollen. I can?t even budge my rings that were extremely loose yesterday.
It has been exactly 2 weeks since the shot was given of Maderna.  I still have a red rash that itches and burns on my arm.  Hard to sleep at night.  It seems to be getting worse.I will visit my general practice physician tomorrow.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
diffuse Utica in no particular pattern with the anticubital, forearms and hands with the most obvious presentation, due to scratching those areas, dry skin makes intra digit examination difficult to distinguish disease from self injury. All four extremities, and trunk with diffuse urticaria, B/L UE and left abdomen are the most concentrated regions.
Several days after patients were vaccinated, it was discovered that the refrigerator that housed the vaccine had temperatures ranging from 32.8 - 33 degrees F for up to 3-4 days. No adverse events noted but manufacturer of vaccine instructed facility to fill out VAERS form. Rest of vial discarded and replaced.
have pain when I lift my left arm; hot flashes at night; experiencing sleeplessness. I used tofall asleep very easily, now I wake upmultiple times at night from the hotflashes (every 1-2 hours); Under arm (armpit) swollen ever since; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced the under arm (armpit) swollen ever since. On an unknown date in May2021, 3 weeks later, the patient had pain when he lifted his left arm. On 19Apr2021, the patient experienced hot flashes at night and experienced sleeplessness ever since. It was reported that the patient used to fall asleep very easily and later the patient used to wake up multiple times at night from the hot flashes every 1-2 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events under arm (armpit) swollen, pain when lifted left arm, hot flashes at night, sleeplessness was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Vaccine expired on 13-Oct-2021/ refrigerated on 29-Oct-2021/ administered on 05-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 29-Oct-2021/ administered on 05-Nov-2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 29-Oct-2021/ administered on 05-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021/ refrigerated on 29-Oct-2021/ administered on 05-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The healthcare professional (HCP) wanted to know about the protocol for this situation and whether the doses were viable or not. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code is scanned.  There was no temperature excursion and the patient did not experienced any adverse event.  The vaccine was place in the refrigerator on 29-Oct-2021.  No treatment medications were reported.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On multiple unspecified dates that patients received doses of improperly stored ROTATEQ (lot#/expiration date, dose were unspecified) orally. The reporter stated that the thermometer temperature were out of correct storage range for an unknown time frame. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted a few minutes after shot, upon awakening ~45 seconds later had tremors, cold sweat, light headedness.
Nausea started around 12:30pm 3/22/21, lasted for up to 6hrs Tightness in chest around 1:40pm 3/22/21 lasted for about 2.5hrs
Breast cancer; This is a solicited report from the non-Pfizer-sponsored program FACILITATED COLLECT, based on information received by Pfizer from a Facilitating Company, manufacturer control number: 21K-163-4081465-00.   Solicited report by a consumer of a 59 year old female with events of right breast cancer and non-serious lack of efficacy with adalimumab (HUMIRA). The patient had a relevant medical history of 'father had stomach cancer on an unknown date'. On an unknown date, the patient experienced lack of efficacy. In Sep2021, the patient experienced right breast cancer. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. The patient initially discontinued taking Humira because it stopped working. She was diagnosed stage zero lump/breast cancer in Sep2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Fe 2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer.  On 29Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient s past medications include: Orencia for rheumatoid arthritis  Enbrel for rheumatoid arthritis  Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of right breast cancer with adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event(s) of lack of efficacy was not provided. Facilitating Company's opinion is that the event of right breast cancer is not assessable. Facilitating Company's opinion is that there is no reasonable possibility that the event of lack of efficacy is related to adalimumab (HUMIRA).  Relevant Laboratory & Other Diagnostic Tests Sep2021 Genetic cancer testing: No markers.  Sep2021 Right breast biopsy: Confirmed Cancer on the right breast  Change History On 17Sep2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The event of "lack of efficacy" was added. The event of "female breast cancer" was amended to "right breast cancer".  According to the reporter, the event breast cancer was possibly related to BNT162b2.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per available information in case, the causal association between the event breast cancer and the suspect drug BNT162B2 cannot be excluded.
This is a cluster of 4 cases linked with AER 2012-09425, 2012-09427 and 2012-09435 developed adverse events following the FLUZONE HD administration (lot number UT4467AA). This case is also linked with 2012-09426, 2012-09424, 2012-09431. Initial report received from a healthcare professional on 08 October 2012. A 37-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal vaccine (lot number UT4467AA) in the left/right deltoid on 18 September 2012 or 19 September 2012 or 25 September 2012 or 28 September 2012. Within about 24 hours of vaccination, arm had 3 inch round welt and swelling and redness from side to side of shoulder and markedly raised. Lab investigations and corrective treatments were not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Pt received pfizer booster on 10/7/21.  Pt called hospital call center injection site is red, swollen, sore, and itches from covid and flu vaccinations last week. Pt has used ice packs but no relief.  Pt was scheduled for urgent care visit that same day.  Pt was prescribe loratadine 10mg PO qAM  and hydroxyzine 25mg PO QHS PRN for itching.
RED SQUARE ON ARM AT VACCINATION SITE 2 WEEKS POST IMMUNIZATION.  NO TREATMENT . RESOLVED
14 y/o girl had distal swelling of both hands with erythema and some petechiae within one day of receiving 1st dose of gardasil.  No other symptoms.  Mother gave benadryl
Swelling of tongue and throat, gagging, difficulty breathing. Treated at E.R. With Benadryl and prednisone. Dr. also noted same reaction could be from Lisinopril, so Lisinopril replaced with Cozaar.
Received around 2pm on Friday, 1/15/21. Not sure exactly when this started, but noticed redness around injection site  that evening around 8pm, mildly itchy. Also felt a little bit tachycardic and anxious about 2 hrs after (4pm Friday) for 15-30 mins, but I think that may have been lack of sleep and my own nerves! But redness persisted at injection site, and had intermittent hives around injection site (smaller area within area of redness, about silver dollar sized hive area intermittently), noticed probably 5x over the next 8 days (last had hives on 1/23 PM, 8 days after). Hives were sort of raised white weals with red border. Redness persisted and began to resolve at around 10 days s/p shot, fully resolved by about 12 days s/p shot. Also seemed to have decreased appetite over that time, but also could be totally unrelated with stress
Sweats; Unable to walk; Felt sick; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (Sweats), GAIT INABILITY (Unable to walk), VACCINATION COMPLICATION (Felt sick) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-045138 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Follow-up: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pre-existing tenitus, Meneirs's Disease.  These problems greatly exacerbated with 2nd vaccinationand contune to worsen.  New "noises" within a week of vaccine not before heard (sounds like a gas generator next door and a flock of birds chirping).  Also, marked decrease in hearingvoices poorly heard and distorted.  Marked development of vertigoloss of balance is alarming at times.
Patient had generalized anxiety disorder.  Onsite EMS was called vitals BP 110/76 100% 02 room air HR 92.  Patient refused evaluation/care and released against medical advice.
Red, welt at immunization site about 2 inches in diameter. Very warm and hard to the touch.
Severe swelling on face on same side as vaccine; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 10:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa from an unknown date. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and buprenorphine hydrochloride (SUBUTEX); all were taken for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:15 (also reported as at 14:00), 46 hours after receiving the vaccine, the patient experienced severe swelling on face on same side as vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe swelling on face on same side as vaccine was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe left upper arm pain x 24 hours (unable to lift or move arm). Fever (T 101.6 Max), chills, myalgias x 24 hours, then fatigue for 2 more days. Headache, mild x 1 day
Information has been received from a physician concerning a patient who was vaccinated with 2 doses of MMR II. Subsequently, the patient developed mumps symptoms (mumps around the jawline). The patient was seen in the physician's office, who conducted unspecified tests which revealed "positive with mumps." The patient outcome was not provided. Additional information has been received from a physician indicating that the 10 year old female patient was vaccinated with MMR II on 07-OCT-1999 and 02-SEP-2003. On 07-MAR-2008, the patient was diagnosed with parotitic (mumps) and R swelling. Laboratory tests included a mumps titer on 07-MAR-2008 with a value of 0.32 and another mumps titer on 19-MAR-2008 with a value of 1.15. Additional information is not expected.
DIAGNOSIS: #1.  CVA #2.  Aphasia, acute Number 3.  Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care.
Patient developed swelling and redness at site of injection on right thigh within the hour of administration and within a few hours developed hives (wheal and flare) to face and neck. No anaphylaxis. Treated with cetirizine. Hives resolved after one dose.
SICK; BURNING NERVE PAIN IN FEET; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sick, and burning nerve pain in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and burning nerve pain in feet was not reported. This report was non-serious.
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/1/2021. She received dose at 10:25. She complained of facial numbness, no throat swelling, or hives. Dr. evaluated her and gave Benadryl 50 mg x1. She was observed for 30 min and sent home.
ON 4/17/2021 PT DEVELOPED BACK PAIN  SIMILAR TO WHEN HE WAS FIRST DIAGNOSED WITH TRANSVERSE MYELITIS.  PT WAS SEEN AT EMERGENCY ROOM.  MRI WAS ORDERED AND COMPARED TO PREVIOUS MRI WITH NO SIGNIFICANT CHANGE SHOWN.  PT WAS FEELING BETTER ON 4/18/2021 WHEN I CHECKED ON HIM
Felt lightheaded post-vaccination. Staff had him lie down, he felt better. Seated in observation over x 20-25 mins more - given water/snack. Left with parent - no further problems.
3/16/2022 Right arm and right neck painful, generalized body pain and muscle tightness with difficulty walking due to muscle tightness. 3/18/22 ED visit Dx. Bell Palsy.