chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a small rash on r great about. Week prior to the shot. Since the shot the hives have spread to arms, belly, thighs and is super itchy and red, swollen. Benadryl not working.
Awoke at 6:00 am with severe upper back pain, hurt to breathe. The pain woke her up. Excuciating pain across entire upper back lasted an hour. Took Ibuprofen around 6:15 AM with any improvement. Took Zyrtec at 8:00 am and that seemed to help, was a dull pain. At 12 noon was seen in the emergency room for evaluation after being instructed to by clinic resource nurse. No further treatment and pain subsided around 4:00 pm.
auto immune de stabilization issues/autoimmune destabilization; Some of it looks like Cytokine storm type thing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), 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: AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "not recovered", described as "auto immune de stabilization issues/autoimmune destabilization"; CYTOKINE STORM (hospitalization, medically significant), outcome "not recovered", described as "Some of it looks like Cytokine storm type thing". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Result Unknown. Therapeutic measures were taken as a result of autoimmune disorder, cytokine storm.  Clinical course: His friend has been administered a couple of Pfizer's COVID-19 Vaccine and since has atypical health issues. Most of it seems to be "auto immune de stabilization issues he says. He wanted to know if long term there any reports of autoimmune issues after the vaccine per RA has been. Stated his friend's case has been gradually intensifying but it really got to a tipping point mid Dec and they have tried to treat these "atypical" symptoms what patient had. What the patient was experiencing, the caller notes that these issues have been noted with 10 people in the whole world. It was not necessarily COVID-19 specific, it could be a little bit of both he claims. The care team and family/friends have been working very hard and the patient was bed bound in ICU. Caller wanted to know if there was an internal or somewhere through Pfizer where they have any cutting-edge doctors that are looking at different types of "reactions" or conditions that the vaccine has caused on an a continued bases. He again notes It was not something that was wrong with the vaccine, but everyone's body was different. The family just hanging over the bed crying, they are not sleeping more than 1-2 hours a night, rushed back and forth to 1 MRI and then the next, given multiple injections. The hospital was good but has limitations and robotic and lack communication with outside entities. There was no definite way to confirm a correlation, but after his friend had the vaccine administered a couple of times, he developed atypical health issues. Things they were using to treat would exacerbate things for a few months. The treatment plans tend to complicate things further. His friend was appearing to have an autoimmune destabilization. Some of it looks like Cytokine storm type thing. But his friend's doctors are scratching their heads. Called on behalf of a family friend that has had some kind of adverse reaction to the COVID-19 Vaccine. Reaction has been going on for a couple of years.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low grade fever (99.9), chills, stuffy nose, joint aches, still muscles. Half of upper arm (site injection) painful,
immed redness swelling @ in site rt arm;resolved w/administration of PO DPH;
Got sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got sick) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was reported that it was over a year since the patient got last booster vaccination. The patient was having some difficult time in figuring out where to get the new vaccine. The patient got sick upon taking Moderna vaccine one time however, the Pfizer vaccine did well. Hence the patient wanted to take Pfizer vaccine again. The patient queried if in the pharmacy, they were administering the old vaccine or offering the new 2023-24 formula dose. The patient was informed that the patient might have a possible drug interaction since the patient received both the Moderna and Pfizer vaccines.  Treatment information was not provided.
This 64 year old    male received the Covid shot on  3/29/21 and went to the ED on 3/29/21 and was admitted for left-sided nontraumatic intracerebral hemorrhage and died on  5/4/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
I woke up one night with pain in the back of my jaw on the left side of my head. I first thought it was dental related. Over a few days it felt like my ear was getting congestion. The stuffiness in my ear was getting worse over time. I was getting headaches at the back of my skull. I usually get the congestion and headaches, but it was way worse. It got to the point where I called off work for a couple days. I called the doctor 11/16/2022 and he gave me some suggestions like to drink warm liquids. My congestion flushed out after doing what my doctor said.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in January 2017, the patient received first dose of VARIVAX for prophylaxis (dosing details and lot# were not reported). The patient has not received the 2nd dose yet (Inappropriate schedule of drug administration). No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
mom states had a softball size, lump, red, swollen, painful w/ a white ring around & a bright red spot w/needle went in; mom said pt had inc fever;
FEVER - 103, HEADACHE, MUSCLE ACHES, CHILLS, FATIGUE
This spontaneous report as received from a nurse refers to a male adult patient older than 20 years of age. Concomitant medication and pertinent medical history were not provided. On 24-JUN-2013, the patient was vaccinated outside of prescribing information with the first 0.5ml dose of RECOMBIVAX HB (injection, 5/0.5mcg/ml, route unknown). And the second dose was administered on 28-APR-2014. No adverse effects noted by patient. Additional information has been requested.
24 hrs - fever (100.6), aches, headache, fatique for 24 hours; took tylenol pm Day 5 - "Covid Arm" -3" wide red, swelling, itching about 2 inches below injection site; taking antihistamine & using cold compress
Pt given 4 vaccines (Tdap, MMR, HEP B & A). blood drawn for lab work. Loss consciousness for 8-10 seconds. Pt pale & clammy. Pt to take deep breaths coke given. Waited 20 min in observation. Talking obey simple commands. B/P 110/62 feet elevated. Pulse 99% cool compressor applied to head & neck EKG done, Pulse 49, Bld sugar 115, B/P 128/78, EKG: sinus bradycardia. Pt left anb. with friend. Pt referred to ER for any further LDC, weakness, sweats.
My Ulcerative Colitis flared up 2 weeks after I got my second dose of the vaccine on January 29th, 2021. And I have had to re-start on medication after being in remission for 2 years.  Then since April 12th, I have began to have daily spells of dizziness, numbness, tiredness and feeling like I'm having a stroke. I would feel better after I take a couple of aspirins and Tylenols two or three times day. I am getting ready to go to the ER after I turn in this report because I do not know if i will get better.
Arm was sore after injection but eventually got better in 2 days.  Several days later site became very itchy. By the following week, site was very swollen, hot to touch and redness spread around my whole upper arm. I called a pharmacist who advised me to take an antihistime and see a MD next day if not better.  I went the next day, and doctor said it was a normal reaction to an injection. I applied ice packs over the next couple of days.
Patient developed Varicella Zoster (Shingles) in the Left T1 distribution. Zoster rash in clusters along the left T1 dermatome developed on 4/8/18, patient was seen and evaluated in the emergency room and followed up in our office on 4/10/18. No medications administered as patient was otherwise asymptomatic. During the ER visit Infectious disease was consulted and agreed with plan to defer starting acyclovir as patient did not have pain or itching and we did not want to suppress immunogenicity of the vaccine.
Symptoms or extreme heat hives/flare ups due to body temperature rising either from the weather or the environment. Prior to this year I never had a hive nor is there anyone in my family with a history of chronic Hives. I took the shot on 09/07/21 and by January I started noticing this prickly, burning and stinging occurrence over my body. It still persist unless I stay in an relative cool environment.
pt recv vax & devel a fever;the fever went as high as 103 & resolved p/3 days;
Everytime i have a bowel movement i bleed; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FF2588), administered in left arm on 07Oct2021 at 05:45 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included other unspecified vaccine (lot number Wag4161) administered in left arm on 07Oct2021 as dose number 2 (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ff2587), administered in left arm on 15Sep2021 at 01:00 PM as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). On 08Oct2021 at 09:15 AM the patient experienced that every time she had a bowel movement she bled. The event was reported as non-serious, and no treatment was received due to the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved.  Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient sought unspecified medical attention. On an unknown date she terminated her pregnancy (WAES # 0810USA05365). Later in 2007 the patient became pregnant again, which ended with spontaneous abortion. Subsequently, during 2007 the same patient became pregnant 2 more times and each pregnancy ended with spontaneous abortions (WAES # 0811USA00648 and WAES # 0811USA00649). There were a total of 4 pregnancies in 2007 (the one that was terminated and the 3 that miscarried). Afterward, the patient became pregnant another time and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, spontaneous abortion was considered to be other important medical event. Additional information has been requested.
Left thigh swelling from mid thigh to knee 4-5 hours after vaccine administered.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 11-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA005376:
After the second vaccine, my period was late. I had 10 weeks between my periods. For the booster shot, my period was late by 8 weeks
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up
12/30/21  Patient is a server at a restaurant.  Last week general manager was positive and the restaurant closed for 1 week.  He had a test done on December 23 that was negative for Covid.  Had one a couple weeks prior to that that was also negative.  However on his own he went to Pharmacy and had a rapid test done there on Tuesday the 28th.  That test was positive.  He had a little bit of a scratchy sore throat otherwise per review of systems below negative.  He wanted to be tested again to see if he really has it or not.  Feels fine today. Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for rhinorrhea, sore throat and voice change.   Respiratory: Negative for cough.   12/30/21   Musculoskeletal: Negative for myalgias.  Neurological: Negative for headaches.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated at a facility on 01/18/2021 and 02/15/2021. They tested positive for COVID-19 on 09/10/2021 after being seen briefly in the Emergency Department to have a difficult catheter placed. The individual had been admitted to a facility for a surgery, not for anything related to COVID-19. The individual reported they were not symptomatic and stated that cough and shortness of breath were typical for them, since they had COPD. The individual died on 09/29/2021. It seems they were hospitalized up until their death.
Fever (100.3), chills, nausea, headache, fatigue Lasted three days
Body aches; Arn pain; swelling around neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Fatigue (still ongoing),  Swollen lymph nodes in neck and underarms (still ongoing),  Fever (day 1 evening and into day 2),  Nausea (day 1 evening and into day 2),  Headache (day 1 and into day 4), Chills (day 1 and into day 4), Red itchy rash  causing swelling on top of wrists on both arms (started day 3 and still ongoing)
Redness, swelling, and a signficant pain. Patient states that vaccine was administered too high which caused these symptoms.
No other AE; The patient did not receive the full dose of GARDASIL 9; The patient did not receive the full dose of GARDASIL 9; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 26-OCT-2020 and on 28-DEC-2020, the patient was vaccinated respectively first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis.  28-DEC-2020, during the second vaccination, the needle broke (product administration interrupted) and therefore patient did not receive the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (underdose). There was no product quality complain (PQC) because the needle was made by other manufacturer. No other adverse event (AE) was reported. Due to that the patient did not received full dose of vaccine the dose was determined to be invalid. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
COVID-19 I received my 2nd booster shot on 05/25/2022 and my COVID symptoms  started on 06/18/2022 congestion, sneezing, fever. I  felt like  i had a bad cold. I had no cough or sore throat. I tested on the 06/19/2022 positive.  I did a telehealth on 06/20/222 with my doctor.  She gave me prescription for PAXLOVID.  I also took Benadryl r 2 nights.  I took COVID test again on the 06/20/2022.
pt recv vax; lips were very swollen;was drooling excessively; seen by MD; also had rash on trunk;
Intense upper body pain, mostly around neck/should/upper back; accompanied by blood in mucus. Similar pain occurred with the 1st shot, but without blood in mucus. Later determined to be pulmonary embolism.
Inconsolable crying for 4-5 hours straight. Refusal to eat, followed by neurologic changes. Became "spacey". Otherwise, easily consolable, happy infant. Never cried. First time not consolable. No other medical problems such as otitis media present.
Main side effect was it raised the acidity in my body system to where my body temperature goes up, very similar to menopause hot flashes. Feeling off, not quite 100% during the day, but when it got to the evening, then everything got going, and overnight I would be drenched. I started to see doctors for it because I was not sleeping well, it was very disabling and I wanted to get to the bottom of it. I went to an urgent care 24 hr. clinic and I went in they checked my blood pressure and assessment of the lung area. All of it was clear. Lung and heart was clear. I told the doctor that the heat starts at the top of intestinal tract and she and I both were suspicious it was GERD. I already had gone through menopause, it was all done and now that I took the Moderna, we both (I work in the medical field as well) that the vaccine was not adjusted enough for everyone and that it was to strong and it started to hyperdrive the immune system. I have gone vegetarian, I watch my diary, I am now gluten free now. I no longer go outside because of the heat. It's been an eye opener. And this is still ongoing.
Principal Problem: Fall      Overview Note:     2014, got up from coutch, fell, no recollection of fall, remained on floor for 1 week, brother came over and patietn transported to HCF and DX with fractured hip requiring 2 surgeries.   ? Closed wedge compression fracture of T5 vertebra (CMS/HCC) ? Recurrent falls ? COVID-19     Assessment & Plan Note:     Positive NAA for SARS CoV 2. The patient is completely asymptomatic for Covid at this time. As such, there is no indication for initiation of any sort of therapy at this point. Continue to monitor her clinical course
very very sick; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who was very very sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was very very sick (illness, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Good for y'all I can't bc it makes me very very sick."  It was unknown if the patient experienced any additional symptoms/events.   There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.