chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported in the patient; A patient received a dose of ROTATEQ on 6/25/2019 after its labeled expiration date; This spontaneous report was received from a physician concerning a male patient of an unknown age. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.   On 25-JUN-2019, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) per oral administration, lot number N030176, expiration date 17-JUN-2019 (strength, dose and frequency were not reported) for prophylaxis. The vaccine was administered after it's labeled expiration date (expired product administered).  No adverse effects were reported (no adverse event).
Reported by mother 1/26/2020:  -Red circle shaped mark about an inch in diameter on Left leg -100 degree temperature -sore leg -headache -vomitting
Pain (sunburn-like) on left leg. Acyclovir 800mg, vicoprofen.
Mom states took child to ER, temp 101. Cellulitis on left arm (elbow to shoulder) red and fluid under skin. Told by doctor not to give the vaccines (given in left arm) again.
Breakthrough case admission after two vaccines  pfizer 2/1/21 Lot# EL9265;  Pfizer 2/22/21 Lot# EL9267
Numbness and tingling in arm and hand of vaccine administration.  Numbness and pain became worse over time where I was unable to work for several months.  Gradually I am now back to work but I still have pain and numbness in the arm and hand and have not recovered full use.
First dose received was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose received was expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose received was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose received was expired) had resolved.            Concomitant product use was not provided by the reporter.   No treatment information provided.  Reporter stated that when the patient received the second dose of the Moderna COVID-19 vaccine, the patient noticed that the first dose was expired.
MOTHER CALLED IN STATING SON HAD HIVES AND WAS VERY ITCHY. HIVES WERE NOT LOCALIZED TO SITE OF ADMINISTRATION AND SPREAD ONTO TORSO. RECOMMENDED BENADRYL, MONITORING AND IF IT PROGRESSED OR NOTICED TROUBLE BREATHING TO PROCEED TO THE EMERGENCY DEPARTMENT.
My atrial flutter was corrected by an ablation in 2014 and had not returned.  It suddenly returned on April 9, 2022.  My cardiologist claims that it is very unusual for atrial flutter to return that long after an ablation.
wrong dosage administered  Patient received 0.3mL Pfizer, he should have received 0.2mL
AFTER ABOUT 45 SECONDS ON ADMINISTRING THE SHOT AND INTERACTING WITH THE PATIENT. HE PASSED OUT AND FELL TO HIS KNEES FROM A SITTING POSITION TO THE FLOOR. WE PICKED HIM UP IMMEDIATELY AND HE RECOVERED ABOUT 3 SECONDS LATER. (SYNCOPE) IT TOOK ABOUT 10 MINUTES FOR HIM TO RECOVER FULLY. PATIENT STATED HE WAS FEELING OK AND DID NOT WANT TO GO TO THE HOSPITAL.
Patient developed an approximately 2 by 5 cm size inflamed, erythematous area that blanches.
Aching arm for 2 hours; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in arm on 27Jan2021 at 08:00 (at the age of 79 years old) as single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from 35+ years, gluten sensitivity from 35+ years, chronic fatigue came down on 24Nov2019 and no treatment for chronic fatigue syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, patient experienced aching arm for 2 hours in evening then ok. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Sep2020. The outcome of events was recovered on 27Jan2021.  Information on lot/batch number has been requested.
received a dose of Boostrix at a pharmacy and is pregnant; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. The patient's last menstrual period was on an unknown date and estimated date of delivery was 25th January 2021. The patient received Boostrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   Additional details were provided as follows: The pregnant patient received Boostrix, which led to vaccine exposure during pregnancy. The reporter did not had lot number. The reporter consented to follow up.   Follow up information received from consumer on 24th January 2022: This pregnancy is now considered as lost to follow up.
Mother described a "splotchy rash" to the left side of the face, with itching.
2 weeks after vaccination injection site on left arm was a little itchy and then the next day had a large red area with a portion like a tail about 5 or 6 inches down my arm.  It was itchy and warm to the touch.
Urticaria vasculitis lasting over a year; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: URTICARIAL VASCULITIS (disability), outcome "recovered", described as "Urticaria vasculitis lasting over a year". The event "urticaria vasculitis lasting over a year" required physician office visit. Therapeutic measures were taken as a result of urticarial vasculitis which included Steroid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors  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.
TIngling/numbness down arm and in hands immediately.  Apply ice pack this diminished.  Then proceeded to weekness in knees and tingling on bridge of nose.
Case number PHEH2044US020130 is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 46 years old male patient. Past medical history and concomitant medications were not reported. On 07 OCT 2014, the patient received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 146401) which had been stored at 55 degrees Fahrenheit for 2 hours. No adverse event was reported following this medication error (incorrect storage of drug).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was vaccinated with a dose of COMVAX (lot# 0807Z/expired date 04-APR-2013). No adverse symptoms reported. Additional information has been requested.
Client verbalized feeling numbness to left arm after receiving the vaccine.  Client was evaluated by Fire Rescue paramedics.  Client was released to go home after symptom was resolved at 9:25 am.  Per paramedics no further evaluation needed.
pt recvd vax; w/in 10 days of each dose, exp lightheadedness, fever w/out sweats, nausea & weak legs;resolved w/in 3 days;
pt has had chronic illness;pt being eval for poss immune deficiency;parents are questioning if immun in particular the MMR have contributed to the poss autoimmune problems;
Before the vaccination I had complete rangle of motion in  my right arm. Now I do not. I have continung pain.
Pt received immunization 4/23 @ 7pm and reported a rash starting on the am of 4/26. It was a red rash starting about 2 inches below where immunization was given.
about 7-12hr p/vax pt was noted to have symmetric, rhythmic contractions of legs for about 1min followed by arm for 1/2min;the contractions didn't extinguish when held;pt was staring ahead, not apneic;
Assessment/Plan      Pt is 100 y/o female with medical history of breast cancer, CAD s/p CABG in 1980s, CHF, HLD, HTN, CKD stage 2, OA, GERD, atrial fibrillation on Apixaban, recurrent diverticulitis s/p ostomy being admitted for respiratory distress 2/2 covid pneumonia. Pt at this time requiring 4L to continue with appropriate saturations. Will start pt on dexamethasone. Pt Crcl< 30 will hold off of remdesivir for now. Noted bilateral pleural effusions on CT will place pulmonary consult with plans to speak with them in the morning.  24 hour plan:  -Dexamethasone 6mg IV  -AM Covid labs  -Pulmonary consult; plan to speak with them in am  -doxycycline 100 mg qday  -Wean O2 as tolerated  Respiratory Distress  -etiology likely 2/2 to covid pneumoina w/ concurrent pleural effusions  -Pt on 4 L at this time  -Plan:      -See treatment below      -wean O2 as tolerated  Covid Pneumonia  -Pt vaccinated x2  -Pt on 4 L O2  -Plan:      -Dexamethasone 6 mg IV qday      -hold remdesivir due to Crcl<30      -continue to monitor O2 status      -AM covid labs  Bilateral Pleural Effusions  -etiology possibly 2/2 covid pna vs known CHF vs other inflammatory process  -Pt on 4L O2  -Plan:      -Consult Pulmonology; appreciate recommendations  CAP  -Ct with some possible consolidations with pleural effusion within lung fissure  -Pt afebrile with cough  -Plan:      -doxycycline 100 mg daily  AKI  -etiology likely 2/2 decreased oral intake with covid pna  -pt cr 1.2 (baseline roughly 1.1)  -Plan:      -hold home diuretics      -am CMP  HTN  -chronic  -Plan:      -monitor vitals      -hold BP meds due to AKI  A.Fib  -chronic  -Plan:      -apixaban 2.5 mg BID  CHF  -chronic  -Plan:      -continue to monitor fluid status      -holding home furosemide due to AKI    Disposition: Floor  Diet: NPO  DVT PPX: Apixaban  CODE: DNR/DNI   Pt discussed and examined with attending, Dr.
Weakness, profound, in 4 limbs with a "pulling sensation" down length of the limbs, fever, cough. Weakness in arms resolved nearly fully by noon, weakness in legs persisted at least 3 weeks.
I felt light headed after getting the vaccine and my arm ached for a few days. I was fine for a few days after that then, below the vaccine site I got a red itchy rash which stretches all across my arm below the vaccine. The rash is big and itched for a few days and now the rash area is very warm. The rash is still there and hasn't gone away and my arm hurts again.
patient fainted in the chair 5-10 minutes post , suspected vasovagal response. reported history of previous fainting episodes after vaccinations
Headache, pain at injection site, muscle soreness, nausea, vomiting, fatigue, and decrease in appetite. Headache, pain, and soreness occurred and increased the day of the vaccine into the following day. Decreased by second day after injection. Appetite decreased day following vaccination and maintained decrease into second day after injection.  Fatigue occurred day of and day following vaccination. Nausea and vomiting appeared on second day following vaccination.
This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of PEDVAXHIB (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA004881: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
on his 3rd sick day after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (on his 3rd sick day after 2nd shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (on his 3rd sick day after 2nd shot). At the time of the report, ILLNESS (on his 3rd sick day after 2nd shot) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-187139 (Patient Link).
devel a morbilliform measles-like rash p/14 days of recv vax;afeb-non pruritic-rash began on face then spread to trunk & then to extremities;
Three hours after inoculation, injection site pain became quite noticeable and became worse as the day progressed. The pain has remained since the inoculation 11 months ago. The should became frozen after the first two days. The range of shoulder motion was reduced to less than a fourth of normal. The pain level when moving close to the range limit was excruciating (tears, yell, 10). Have not been able to sleep on the right side since then. The range of motion has improved the last two months to about 40% of normal. The pain level in the last two months also went from 10 to 7 when going to the range limit. Have been regularly doing frozen shoulder exercises, and believe it will eventually return to normal. Did not get an mri to check for torn rotator cuff, since it was obvious it was the injection that caused it. Have waited to report at nearly 11 months to see how shoulder would respond to exercises and time. Was seen by provider a little over a month after injection. Physical therapy was recommended, but refused since I knew the exercises involved.
Woke with pink, warm, raised, rough, itchy rash 6cmX5cm on right thigh.  Coincidental R otitis media discovered on exam.  Treated for OM and possible cellulitis with Augmentin 600 PO BID.
Immediate severe burning feeling and numbness in left hand.  Loss of range of motion that resolved mostly on 10/26/21.  Severe pain in left shoulder joint that interfered with sleep that resolved 10/25.  Numbness, tingling, cold sensation in left hand have not resolved. Experiencing "flare-ups" of shoulder pain and frozen joint periodically that have not resolved.  Unable to lift items more than a couple pounds with left arm, specifically cannot pick up 10 pound dog or backpack that has not resolved.  Unable to grip lighter weight items for more than a few minutes and frequently dropping items.   Tried alternating Tylenol and Ibuprofen, used maximum recommended daily doses with no relief.  Tried using ice pack for 20 minutes on several occasions with no relief.   Vaccine was injected anterior to midline and less than 1 finger width below the acromion process.   May need follow up with physician or physical therapist.
have a headache; how long does the increased heart rate last; I was shivering a bit; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 5th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, 1 days after receiving Shingrix, the patient experienced headache. In August 2020, the patient experienced heart rate increased and chills. On an unknown date, the outcome of the heart rate increased, chills and headache were unknown.   It was unknown if the reporter considered the heart rate increased, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient's heart was beating at about 100 bpm and the patient was shivering a bit and had headache.
4/8/04 Patient presented to office nurse for preschool immunizations. Patient was given DTaP, MMR, and IPV. As patient was leaving he became nauseated, foaming at the mouth, red spots on back. Physician notified. Given SC Epinephrine and continued to deteriorate. Pulse and Heart rate 10 and O2 administered. Epi 1 was administered IV, as well as Decadron and Benadryl. Patient began to stabilize and was transported to ER via ambulance with doctor. Discharge Summary received on 4/27/2004 states anaphylaxis.
Received it before noon on 9/23/15 - by 6 pm - fever (next day was 103) chills, aches, nausea, dizziness, malaise. Sickest I have ever felt after flu shot.
About 3 hours afterward for first 16-18 hours I felt dizzy, woozy, lightheaded and "out of body" Felt some swelling/tingling in my fingers/extremities. Facial flushing Overnight fever/chills Foggy mind  Intermittent / On and off effects for the first 7 days:  Lightheadedness/dizzy/woozy feeling Foggy brain Swollen-feeling fingers Facial flushing  On the 6th day I had decaf coffee which is usually fine for me (though I'm extremely caffeine sensitive) and thought I was having an adverse caffeine reaction - Felt shaky and a little unsteady. But I was able to sleep fine, and I don't think it was caffeine, I think it was a bout of shakiness tied to the vaccine. Morning of 7th day still feel a little shaky with facial flushing.
This spontaneous report as received from pharmacy technician refers to 2 patients of unknown age and unknown gender. The 2 patients pertinent medical history was not reported. On an unknown date (reported as within the past few days), the 2 patients were vaccinated with improperly stored ZOSTAVAX. No symptoms reported. No product quality complaint (PQC) was reported for zoster vaccine live. Additional information has been requested.
Post vax, the patient experienced an anaphylactic reaction, including tightening of the throat and dizziness. The patient was treated with epinephrine with good result. Symptoms were resolved within a few hours, although some wheezing remained for a day.
Received varicella in RASQ 6/4/15. Noticed swelling at 12P on 6/5. Became very tender, red and hard and swollen by 2P- showed RN at work and was marked at 35mm. to urgent care at on 6/6/15. Started on cephalexin 500mg QID until resolved-6/9 approx 3mm reddened area afebrile (T-37.4). Recovering pt. states swelling much less and tenderness much improved.
Patient originally complained of feeling dizzy and lightheaded. She was laid to the ground. Her BP was taken 3 times and rose from 177/104, 192/98, 199/108. Other symptoms reported include heart racing, legs shaking and weakness. EMS was contacted to check out the patient.
I experienced what I would describe as a cardiac event. My heart started racing out of no where. I have an activity tracking device and it was pacing me at 184 bbm for thirty minutes then a subsidence to 120 bbm for the next couple hours. By the evening my heart rate had decreased to the 70 - 80 ish range.  Sleep time and the following morning it was what I would consider normal. This event made me dizzy and my skin paled. I was also very tired. It was as if I had done an intense cardio workout with no warm up. 0 to max. I didn't seek medical attention but did consider it.
FELT LIKE ABSOLUTE CRAP; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent via a company representative concerned a 27 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like absolute crud, chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like absolute crud, chills, fever, and nausea. This report was non-serious.
Inconsolable crying. T 100.5. Red, warm, indurated right thigh. 9cmx7cm. Tender to touch. 8 wk infant. First immunization.
Sporadic nystagmus within days after 1st shot. 12 hours after second dose, dizziness started. Had  nystagmus and vertigo episodes for a week, then full vertigo at 2am for 9 hours, , vomiting could not keep in solid or liquid.  In ED for CT scans and medications.   After that, dizziness and severe headache for 1 week. Treated one week of meclazine. Sent to DPT for nystagmus. . After ~ 4 weeks, dizziness, headache,  and nystagmus still occur. Daily ibuprofen. occasional Dimenhydrinate. Can not work, on short term disability. Unknown if there will be permanent damage