chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Odd metallic taste in mouth; Severe diarrhea; This is a spontaneous report from a contactable consumer. This 39-Year-Old female consumer (patient) reported that.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:00 as (At the age of 39-years) dose 2, single for covid-19 immunisation. None Other medical history and None Known allergies ware reported. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 02:15 PM as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time vaccination. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. The patient experienced odd metallic taste in mouth, and severe diarrhea on 22Apr2021 14:30. Patient did not receive any treatment for events. The outcome of events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Heart palpitations, fever, muscle and joint aches, swollen arm at injection site and large redness at injection site, sore arm at injection site, tiredness, headache.
headaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "headaches"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea". Additional information: She was having a very uncomfortable experience after the second dose of the vaccine and she still suffers these side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a constant high frequency ringing in my ear; getting regular headaches; Pain in my lower neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "a constant high frequency ringing in my ear"; HEADACHE (non-serious), outcome "unknown", described as "getting regular headaches"; NECK PAIN (non-serious), outcome "unknown", described as "Pain in my lower neck". Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, Customer Verbatim: Since getting the Covid 19 vaccine patient had a constant high frequency ringing in patients ear and getting regular headaches. It was stated that, Dates for High frequency pitch in ear; Ringing has been constant from the last, as patient don't know since patients first vaccine: (From: Unspecified To: Unspecified). Dates for Headache and dates for Pain in patients lower neck (From: Unspecified To: Unspecified). Patient stated regarding lot number, " patient can't read it very well, first one is FF2, looks like 593 and I really can't read the next one very well. The last four is 8762, patient don't know it's either KL or KI. Concern patient stated, ever since I got the COVID Vaccine, I have been getting this very high frequency pitch in my ear and I am also getting like a headache and like pain in my lower neck. Patient stated, I got about 6 minutes because I am going for another appointment. 2 hours I had been calling to see if you all to know or if there is another option I can do. Patient just received over the counter Advil. Patient already went to an ENT.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccination Monday 8/22/2022, began getting localized skin reaction on Tuesday afternoon  that has continued to spread and become come diffuse starting at the injection point and  spreading up to my shoulder and down to my elbow. Blistering with vesicles have appeared as well. I have been taking Tylenol, Motrin, and Benadryl and icing the area around the clock. I have contacted my doctor, but have not heard back
Syncope, roused after roughly 4 minutes.  Patient seen by MD, had juice, observed for 30 minutes, experienced dizziness, see again by MD, eventually DC to home @1100 with significant other.
He got his vaccine, started having trouble breathing about 5 days later . He had a very very bad brain fog, made him start stuttering.  Made his anxiety go out of control, depression, not able to work as he could not figure out how to get on his computer to work.  Loss of strength, cannot bend over to tie his shoes due to the weakness causing shortness of breath.  He can walk about 100 yards and has to sit down.  He went to his doctor after the symptoms, and she did blood work on him, and increased his medicines after he got his results back.   She believed it was related to the vaccine as there had been nothing else that changed.    He would drink a few beers after the vaccine, would get verbally ugly with people and was  hospitalized as his body was reacting to it, and now he does not drink any longer.    Prior to the vaccine he was employed as a manager and did estimates, doing a lot of computer work, crawling, a lot of walking.  He also running heavy equipment for the company without any difficulties.  His condition has gotten progressively worse since the vaccine, and finally tried for disability and that will not kick in for another 5 months.  He does not still have no stamina, cannot breath, his anxiety is still out of control but is stabilized and he does not feel like he needs any more.  He just wants to feel like himself again.    When he got his blood work back from his doctor she discovered that his estrogen was out of control and had tripled and went crazy.  His sodium was messed up, his thiamine and other lab work.  He was having to take Testosterone shots every week as it was blocking him from having any testosterone.  He also went from 232# down to 170# in a period of 3-4 months as he was not able to eat due to loss of appetite, shortness of breath, etc.  His wife was begging him to eat.    He is glad that he did not die, and hopes that he does not.
9 days after injection patient developed cellulitis on the injection site.  Required course of antibiotics to stop spread of infection.
Patient was supposed to get the Moderna Covid vaccine for patients ages 6 months - 11 years of 0.25ml.  Medical assistant administering vaccine grabbed wrong vial and administered 0.25ml Monovalent Spikevax (intended for 12 years and older). Physician notified, patient observed in clinic for 20 minutes with no adverse events.  Patient followed up via phone call 2 days later with no adverse effects.
Information as received from a certified medical assistant (C.M.A.) refers to a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Had large area of redness and swelling 4 1/4" by 4 1/2"- itching, not painful.  CBC normal limit except Eosinophil increased. 8.9>_13.3__<200, P 55, CRP increases 1.4 (0-0.8)
Patient reports "itching" with visible hives to her RUE. This occurred about 15 minutes after receiving her injection.  No other s/s of anaphylaxis present. 10 mg of Cetirizine administered in the vaccine clinic observation unit per Dr.   Patient cleared to go home Per Dr. at 11:27.   Patient received her second dose of Pfizer vaccine, Lot # EW0217, at about 1040 in the morning. Approximately 15 minutes later she reported "itchy red spots" on her right upper extremity. No other s/s of anaphylaxis present at that time. VS stable, BP 146/81, O2, 99% on RA, HR 69, Temp-98.3F.  Resp 16-18. Dr. assessed the patient. 10 mg of Cetirizine administered per Dr. at 1100. Patient tolerated well.   Follow up VS 120/70, 100% on RA, 75-pulse, Resp 16-18.
a rash started shortly after 1st shot more after 2cnd shot started in 1 spot then increased got both shots in the same arm
Pt. became lightheaded, and clammy.  noted heart rate to be 51, oxygen saturation 100%.  after sitting for a few minutes, she felt better, but then became dizzy and had some chest tightness and bilateral hand tingling.  Pt. noted to have respiratory rate 22-26 with deep breath, but other vital signs were stable.  (Blood pressures 108-138/70's to 80's)  Heart rate remained stable in the 70-90's range, lungs remained clear to auscultation through out.  No rash or swelling noted anywhere.  No itching, no throat tightness.  Pt. repeatedly stated "I think I am having a panic attack".  Due to the continued complaint of chest tightness, pt. sent to the emergency department for evaluation.
administration of multiple Flu vaccines in one flu season with no reported adverse event; Initial information received  on 23-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered multiple flu vaccines in one flu season with no reported adverse event with influenza quadrival A-B vaccine [fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Oct-2023, the patient received a dose 1, 0.5 ml of suspect influenza quadrival A-B vaccine, Suspension for injection lot UT8134MA, expiry date: 30-Jun-2024 via intramuscular route in the left arm for immunization, was administered multiple flu vaccines in one flu season with no reported adverse event (inappropriate schedule of product administration) (latency same day).  Action taken: not applicable.   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 the 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.
Pt, at time of immunization had a very quick local reaction of swelling. The next day pt had an out break along side of neck.
A few hours after I got vaccinated I notice that my temperature slowly started  going up. The next day I had chills and my fever was up to 103 . I throw up once and also had diarrhea. I had a headache for two days and up to today I still have soar muscles . Until today I have a occasional  cough.
Information has been received from a health professional, concerning a child patient who was vaccinated with ROTATEQ and developed diarrhea for an unspecified period of time (presumably for about a month).  The child was diagnosed with severe combined immunodeficiency (SCID).  Molecular analyses performed on the virus recovered from the stool revealed the presence of the W179-9 reassortant, referred as to G1 for simplicity, from ROTATEQ.  Test revealed that several gene products (NSP1, VP6, and NSP4) shared almost 100% nucleotide identity with the corresponding gene products of WC3 (the backbone of ROTATEQ), conforming the presence of vaccine virus.  In addition, the VP7 of the virus was shown to be 100% identical to that of W179, which makes up the VP7 protein of the G1 reassortant.  In addition, VP4 analyses revealed the presence of a wildtype human VP4 of serotype / genotype P1A(8) - suggesting that the G1 reassortant of the vaccine reassorted with a wildtype human rotavirus possessing a P1A (8) VP4.  Note that the VP4 from the virus in the stool was not a match to that of the W179-4 reassortant, also known as P1.  This is one of the reports received from the same source.  No further information is expected.
Patient experienced a herpes outbreak after flu shot. Patient took acyclovir and "felt better". ACYCLOVIR 800MG TAB TAKE ONE-HALF TABLET BY MOUTH THREE TIMES A DAY FOR 10 DAYS.
Complain of erythema progressing to small blisters at site of DTaP done 2 days ago.  Skin: firm, red, swollen area with vesicles at injection site.  Assessment: adverse drug reaction
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY  12/13/2022 - RECURRENCE OF SAME SYMPTOMS
I had the chicken pox shot and it was okay that day the next day it was red and puffy. It was sore and warm well today the redness has gotten bigger.
patient is actively taking Paxlovid; patient is actively taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient is actively taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
1 week after immunizations were given client began experiencing severe muscle pain in both arms. The pain was relieved with Motrin. The pain re-appeared 1 week later in both legs. The pain is so severe he had weakness in his legs. It later went to his back. The pain causes a writhing which last about 1 hour and comes and goes without predictability. Motrin/Tylenol make the pain tolerable. Client was seen by his DR twice. DR ordered lab tests on 5/3/2000. Telephone call to mom. Mom states the blood tests on patient were all negative. Patient continues to have intermittent back, arm, and leg pain which seems to be less painful than 2 weeks ago. He continues to take Motrin for pain relief.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients' were vaccinated with improperly stored doses of PEDVAXHIB (lot # M027882, expiry date 14-APR-2019) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The vaccine underwent temperature excursion of 1.6 degree Celsius for 2 hours and 1.7 degree Celsius for 1 hour 30 minutes. Data logger involvement was unknown. There were no previous temperature excursions. No product quality complaint was involved. This report is linked with case# 1611USA007953, due to same reporter source. Additional information has been requested.
Who: Patient What: A Movovalent Covid-19 vaccine was given instead of a Bivalent dose to patient. Both vials have gray top's and the PHN pulled the wrong gray top vaccine. Where: location Notification: Via phone on 11/14/22
COVID toes; This is a spontaneous report from a contactable consumer or other non hcp. A male patient (caller's friend's husband) of an unspecified age received BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not provided) via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date he patient experienced covid toes. Additional information: Within the original report the caller was following up on two previous reports that she had made for side effects from the COVID vaccine. Within the original report the caller mentioned that her friend's husband had the same kind of side effects with the COVID toes and he said that the good news is that the vaccine was rolled out early but the bad news is also that the vaccine was rolled out early. Reporter seriousness for COVID toes was reported as unspecified. Investigation Assessment was not provided. The outcome of the event was unknown.   Additional Context: The report is cross referenced to report ID: 6L9I1WGJ  Information about lot/Batch number has been requested.
Intermittent chest pains starting 3 days after second injection lasting about 7 days.   Pain was sufficient to disrupt sleep and was more noticeable during period of rest / low heartrate.   Also had intermittent severe fatigue over same 7 day period.
Student received a flu shot at a school based clinic and reported redness and swelling at the site beginning that day.
numbness/tingling in right hand, progressed to chin and up face, 24 hours later only numbness remained on the left side of face. No sweiing, no drooping, no loss of taste, no loss of chewing ability, no loss in eye site.
enlarged lymph node under his left armpit after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses). In 2021, LYMPHADENOPATHY (enlarged lymph node under his left armpit after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. In 20Sep2021 patient got a booster of the Moderna COVID-19 vaccine Lot no 046C21A, patient had CAT scan done and next to the sternum,on the right side had an enlarged lymph node. patient had few side effects after third dose as well.   This case was linked to MOD-2021-350370 (Patient Link).
This spontaneous report as received from a registered nurse (clinic supervision) refers to a 44 year old male patient who was reported to be student. The patient had azithromycin allergy. On 26-AUG-2016, the patient was vaccinated with the third dose of hepatitis b vaccine (manufacturer unknown) (intramuscular, lot # reported as C7EPS, expiration date reported as July 2016, dose not reported). The vaccine was administered in the left deltoid. It was reported that the office was notified the vaccine was still effective. The patient was notified that he received an expired vaccine and was told to call the office if he had any issues. Until the reporting time (21-OCT-2016), no adverse events were aware of. On the same day, the patient was also inadvertently received a dose of VARIVAX (related case ID: 1608USA015764). Additional information has been requested.
No aditional adverse event reported; RECOMBIVAX HB administered while improperly stored; This spontaneous report as received from a other health professional referring  to a male infant patient . Information regarding the patient medical history, concomitant medications, drug allergies or reaction was not provided.     On 19-JAN-2022, the patient was vaccinated with improperly stored dose  hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # T021327expiration date 14-NOV-2022, 0.5 milliliter for prophylaxis (strength and administration route were not provided)(product storage error).  The vaccine was exposed to 49.9 Fahrenheit degrees for 2 hours and 30 minutes. No previous excursions were reported. No adverse events were reported.
still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot; shivers and shaking all night long; shivers and shaking all night long; She slept on and off; hungry all the time; a little dizzy; she is not steady on her feet; she gained weight making the comment "roly-poly"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACICNE), intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 88 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Left arm, Route: Intramuscular), administration date: 02Feb2021, for COVID-19 immunisation, reaction(s): "no adverse effect". The following information was reported: CHILLS (non-serious), TREMOR (non-serious) all with onset 23Feb2021, outcome "recovered" (2021) and all described as "shivers and shaking all night long"; IRREGULAR SLEEP WAKE RHYTHM DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "She slept on and off"; MALAISE (non-serious) with onset 24Feb2021, outcome "unknown", described as "still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot"; HUNGER (non-serious) with onset 2021, outcome "unknown", described as "hungry all the time"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "a little dizzy"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "she is not steady on her feet"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "she gained weight making the comment "roly-poly"".  Additional information: The vaccination was given between 10-11am. The patient confirmed she no longer was shivering and shaking at night. She slept okay at night, other that getting up to go the bathroom. She did not have the shivers and shakes any longer. She just did not feel steady on her feet. The events did not result to emergency or physician's office visit. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccinations (within 4 weeks). The patient did not undergo any relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.