chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pretty intense upper right quadrant pain, pressure; pretty intense upper right quadrant pain, pressure; she got Covid last week; she got Covid last week; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 11:54 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 53 years as dose 2, 0.3 ml single and administered in arm right, administration date 16Mar2021 11:50 (Lot number: EN6199, Expiration Date: 30Jun2021) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 2005 (ongoing); "Breast cancer" (unspecified if ongoing); "she had a left mastectomy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Xeljanz for immunosuppressant, notes: she takes Xeljanz 5mg twice a day, an immunosuppressant, and her doctor had her stop it for 24 hours before starting Paxlovid. Caller states she held it about 30 hours before starting the Paxlovid.; Xeljanz for arthritis, notes: she takes immunosuppressive for arthritis; Levothyroxine for thyroid medication, notes: Caller states her doctor had her hold her Levothyroxine 88mcg a day, thyroid medication also. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Feb2022, outcome "unknown", COVID-19 (medically significant) with onset 09Feb2022, outcome "recovering" and all described as "she got Covid last week"; ABDOMINAL PAIN UPPER (medically significant), ABDOMINAL DISCOMFORT (medically significant) all with onset 14Feb2022, outcome "recovered" and all described as "pretty intense upper right quadrant pain, pressure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Feb2022) positive, notes: she had the Covid test done Wednesday, 09Feb2022 about 2pm and got result Thursday about 11 am. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient had not gotten her booster and got Covid last week. Patient is at higher risk so this was prescribed.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure, COVID-19, abdominal pain upper, abdominal discomfort and the use of suspect product BNT162B2 cannot be fully excluded. 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.
- Fever 99 to 100.5 - Severe pain in the: back bone, back to front ribs, shoulders to back head area to all the way coming to the forehead, cheeks, jaw. - Full body aches  - Extremely tired  - Dizzy but for short amount of time  - Nausea  - Started sweating on 05-23
10 hours after headache fever chills and muscle pain, then a occipital pain that ran across my head and lasted 8 days.
Patient woke up the night of the vaccine with symptoms of high BP. Patient's BP rose to 222/111 mmHg, therefore treated with clonidine. Patient did not have previous side effects to the other three shots. Patient believes pheochromocytoma to be the reason behind the reaction.
Information has been received from a registered nurse concerning a 23 year old female patient with a history of pertussis vaccine (unspecified) reaction/allergy, who on 28-DEC-2009 was vaccinated with the first dose of GARDASIL (No lot number provided) and on 30-APR-2010 was vaccinated with the second dose of GARDASIL (lot # 662304/1013Y). The nurse stated that the patient received the second dose of the vaccine and experienced redness in her hands and stomach. She also reported that the patient experienced the rash on 02-MAY-2010. Nurse stated that the patient was started on steroids on 05-MAY-2010. At the time of the report, the patient had not recovered from the redness in her hands and stomach and rash. The patient sought medical attention through a nurse's office visit. Follow up information has been received from the consumer who reported that the rash was getting more severe and darker. The patient was also developing significant scarring. At the time of reporting, the patient had not recovered. Additional information has been requested.
One post injection, pt c/o cold like symptoms of runny nose, easily tired and general malaise. Pt presents in office today post 3 days of injection with painful 3.5"X2.5" erythema to injection site, red patches noted to bilateral upper buttocks, bilateral upper ear lobes and bilateral cheeks. Pt denies itching or pain to areas besides injection site. No streaking or warmth around injection site.
Pt's upper left  arm from shoulder to elbow became red, hot and inflamed/swollen following receipt of immunizations. Parent brought child to ER on 9/8/04 around 6PM. ER Dr. administered Benadryl PO.
Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours fatigue. All resolved at 48 hours when mild asthma began.
12/31/20 - Pain and swelling at injection site, as well as pain and swelling in left arm pit that is not relieved with Tylenol.  This has continued beyond 72 hours.
This spontaneous report was received from a Medical Assistant regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 12-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L048464 with expiry date 06-DEC-2017 and dosing details not known). The administered doses experienced a temperature excursion of 6.8  F(fahrenheit) for a time frame of 26 minutes. The vaccine underwent a previous temperature excursion of 6.6 F(fahrenheit) for 25 minutes. The call was because of a "data logger". No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
After eating breakfast, got up, felt wobbly, sat on floor, shaky and not responsive for 4 seconds. Has had similar episode 2 months ago and other times sl dizzy if gets up too fast. Felt fire immediately afterwards.
no adverse reaction reported. patient got a 4th dose of covid vaccine. got 2 moderna at one place then got 2 Pfizer here
Patient given DTaP and IPV combination (Kinrix) at just shy of 4 years of age.  Vaccine not approved for under 4 years of age.
I had a vaccine reaction test on June 28, 2021 at UR Immunology.  At that time I was tested for the two ingredients causing adverse reactions/allergies and was told I was not allergic. Two days later, on June 30, 2021, a very large rash developed on my forearm and upper arm. It did not go away with topical applications. Dr. denied that it was a vax reaction, however I was highly suspicious; I've never had rashes before.  On July 21, 2021, I got my first Pfizer dose; days after, I developed rashes on my right side chest and upper/side of back and under left eye, resembling shingles (no puss). Again I was told by Dr.  and my GP that it was not a Covid vax reaction, and that it was dermatitis and I needed to see a Dermotologist. My GP suggested the dermatitis developed from food allergies. I am not allergic to the typical foods (mushrooms, strawberry, etc.).  This rash has not gone away. Two weeks ago, I noticed an enormous rash on my back (from neck to lowest part of back) but it looked like scratches and never raised above the skin. That rash went away after a week, however the rash on my chest and upper side under my arm pit has not gone away, even with topical treatment the dermatologist gave me. The next step is steroid antibiotics, which I refuse to do.
Fever, chills, body aches, head aches, joint pain, nausea, vomiting, diarrhea, injection site pain/swelling/rash, blister-like rash on face
Vaccine not given here, takes tamoxifen patient developed progressive upper arm "lumps" 4/5-4/15 prompting exam which was consistent with superficial venous thrombosis with axillary extension confirmed by ultrasound
Patient experience transient dementia-like symptoms of lack of awareness of where she was, not remembering who people around her were and not understanding what was being told to her. She also experienced shaking of her feet and repetitive movement of her hands. The episode began roughly 16 hours following the booster shot and resolved after 10 hours.
Had shot 4/7/21 at 2:30pm. Started getting aches and pains about 6:30pm the next day. The 2nd day after I have been experiencing weakness, dense feeling in my chest, breathing shallower, some upset stomach for a short time, ears ringing, woozyness. Had virtual appointment with P.A. and described how I felt.
states p/vax the next AM-heart racing, h/a,  pt felt was dying;states afraid to go to sleep now;
Developed significant side affects to second dose of the vaccine including: chills, night sweats, fever, body and joint aches, nausea and vomiting, and significant pain at the injection site. The day after the vaccine, cellulitis was present at the injection site.
pt exp an injection site reaction, described as swelling down to the elbow; redness & warm to touch; tx included APAP;
I was 7 months pregnant when I received the flu shot. Within 10 minutes after getting the flu shot, I was extremely dizzy and my heart was racing. It took hours for it to subside. In the weeks that followed I got dizzy spells and developed chronic dizziness and damage to the nerve in my inner ear. I am still dizzy to this day.
Headache, fatigue, weakness, chills, muscle pain in right arm  it came in 18 hours after injection. Symptoms lasted for 10 hours then it went away.  I felt 100 percent better after good nights sleep.
Myalgia, Loss of taste/smell, chills, cough, runny nose Narrative:
This 90 year old female received the Pfizer Covid shot on  3/25/21    and went to the ED on  4/27/21     and was admitted  on 4/27/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified
9-29-2008 - Mother called and stated pt has tingling; achiness, numbness from shoulder to elbow, and arm is cool. Mother states these symptoms "come and go" since vaccination was given. States this is on right arm only. 9-30-2008 - Phone call to mother - States symptoms less each day. Encouraged mother to take pt to see PCP.
Pt. broke out in a rash, swelling, vomiting, lethargic.  Pt. was administered BENADRYL, EPI-PEN JR. and escorted to Emergency Dept.  Anaphylaxis symptoms developed within 1-2 minutes of vaccine administration.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 15-APR-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # M015925, expiration date: 15-JUN-2017, subcutaneously (dose was not reported). Other suspect therapies included properly stored sterile diluent (STERILE DILUENT) administered subcutaneously (lot#, expiration date and dose were not reported) to reconstitute ZOSTAVAX. The temperature excursion lasted for 1 hour and 33 minutes and indicated 9.9 degrees Fahrenheit. There was no previous temperature excursion. No side effects were reported. Product quality complaint was not involved. Additional information has been requested.
Six hours post injection throat started to become scratchy and wheezing in lungs. Wheezing and shortness of breath became more severe. O2 sat 89-90%. Immediately self administered back to back albuterol breathing treatments via nebulizer and 50 mg Benadryl. Continues breathing treatments for the next 36 hours until wheezing subsided and breathing and O2 sat returned to normal.
My 3 years old daughter has extreme O.C.D. now. Her tantrums are unmanageable. She throws herself to the floor uncontrollably which she can harm herself seriously. My daughter is unable to control herself, she has to slam every door in the house 3 times. If she hears someone open the a door in the home, she will run towards the door screaming to slam it. If she can't close it she will hit you, flop to the floor until she slam the door 3 times. (The same in school and outside). She has to enter the room, the home and classroom last, also.
This case was reported by a lawyer and described the occurrence of short term memory loss in a 58 year old male patient who received Lyme disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced "severe joint pain, fatigue, tingling, mental confusion, short term memory loss, and fibromyalgia type symptoms" time to onset, treatment, and outcome were not reported.
I received my first dose of the Pfizer vaccine on April 7th. The same day that I received it my eyes turned red, blood shot. Specifically the left eye, and I had my shot in the left arm. I thought it was odd but after a day or so it went away. On 4/17 I went to the beach, and my eyes got almost sun burnt even while wearing sun glasses with a hat, under an umbrella. I go to the beach all the time and this has never happened before. I do not know if any of this is related to the vaccine and my symptoms are not drastic enough to warrant a trip to the doctor yet, however I felt that I should report this.
Approximately 15 minutes after getting injection, patient felt light-headed and "not right like I needed to eat".  Felt better after eating.      t  felt off balance and had trouble standing from working on his knees,   Felt OK the next day.  Two days later felt off balaace and had trouble standing after working on his knees.Three days later started having diarrhea, that only lasted a few hours.  Four days later, "just didn't feel good".  States he "feels like he was run over by a truck, with aches and pains"  Very tired.  shoulders and neck are sore.  Has a headached, back and hips are sore.
This medically confirmed spontaneous report (initial receipt: 13-Nov-2012) concerns a 92-year-old female patient, who had a medical history of hypertension, high cholesterol, PMR (polymyalgia rheumatica), multi-nodular goitre and TIA (transient ischaemic attack). She was allergic to PETHIDINE, tramadol and hydrocodone. Concomitant medications included nifedipine, hydrochlorothiazide, potassium chloride, meclizine, nystatin; triamcinolone combination, oxycodone; paracetamol combination, clopidogrel, pravastatin, hydrocortisone, metoprolol, diazepam, ranitidine and simvastatin. On 24-Oct-2012 the patient received AFLURIA (batch number: 07449221A) injection at a dose of 0.5 mL once intramuscularly. The patient became weak and congested 17 days after vaccination, and went to the ER (emergency room) on 09-Nov-2012. The patient was not admitted to hospital. She was tested positive for type A influenza. She also had a chest x-ray and blood tests. The patient was following up with her doctor and was currently at home. The doctor advised the patient and her daughter to have the patient come to the hospital if she becomes dehydrated or her respiratory symptoms worsen. Treatments included oseltamivir phosphate, guaifenesin and levosalbutamol. The event outcome was recovering.
On 02/21/2023 I was running a fever of 102.6 so then I went the emergency room and seen a doctor there. I tested positive for COVID-19 and was prescribed Paxlovid. My fever did stay for around about 4 days going in between 99.0-101.0, stuffy head, bad cough, headache. I did experience a rebound case after completing the medication. With the rebound case I did lose taste and smell.
rash; hives; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek), PRURITUS (itchiness) and RASH (rash) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Patient takes allegra as needed for seasonal allergies), Sulfonamide allergy, Dust allergy, Asthma and GERD.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek) and PRURITUS (itchiness). On an unknown date, the patient experienced RASH (rash). At the time of the report, URTICARIA (pin size pimples (hives) on top of feets and legs bilaterally/Hives started on wrist and cheek), PRURITUS (itchiness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Benadryl for hives, allegra for hives started on wrist and cheek and prednisone. The dermatologist thought that the patient's immune system was ramping up in response to vaccine. No concomitant medication was provided.
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Dec2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 29Jun2023 to 04Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250753 same  patient/reporter, different drug/AE;
This case was reported by a physician and described the occurrence of seizure in a 15 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject had no pre-existing medical conditions and did not receive concurrent medications. On 8/4/05, the subject received the first dose of Infanrix (lot MSD0208R-incorrect lot number). At an unspecified time following the administration of Infanrix, on 8/4/05, the subject experienced a fever and was see in an emergency room. In the emergency room, the subject was observed to have a seizure lasting 30 to 45 seconds. The subject was treated with ibuprofen and the fever resolved on 8/4/05. The physician considered the seizure and fever to be probably relate to vaccination with Infanrix. Comment: Seizure was assessed as medically serious (OMIC).
deep breaths; anxiety attacks; fear; heart was beating fast; nausea for a little bit longer than yesterday; sore arm; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via an unspecified route of administration in arm left on 01May2021 (at the age of 86-year-old) as a dose 1, single for COVID-19 immunisation. The patient medical history included arthritis, diagnosed some years ago. Its in both of her knees. The patient's concomitant medications were not reported. Enquired that, the caller was called about the Pfizer COVID vaccine. This was the caller first dose of the vaccine. She went to her grandson union, where they were giving shots. The caller was not going to get the vaccine but her grandson tricked her into getting it, she was so scared. She did not really want it, her grandson did it because he did not want her to get the virus. The caller had the first dose of the vaccine yesterday or two days ago and she thinks she had some side effects. On 02May2021, the patient experienced nausea, it was not too long, the nausea lasted about 10 minutes, it was a couple times, then it kind of went away, she had it twice. Stated that, she had so much fear that she could not even think on an unspecified date. Stated that, then the caller heart was beating really fast on 02May2021 and after a while it stopped. Then today, the caller had the nausea and then it went away, she drank some ginger ale and kind of helped it. The nausea and heartbeat could have been an anxiety attack because she got really scared. Yesterday she just took deep breaths, because she had anxiety attacks, so thought to do that and it helps. This morning, the caller feels a little better now but she still has a lot of fear. The caller had a sore arm yesterday, it was really sore but its kind of going away, today she could move it and it does not hurt, just very little. She had asked, how many days more or less do side effects from the vaccine last. The caller declined to wait and stated that, her PCP was (name withheld), but she has not seen him for a year. The caller declined further information. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & the next day exp reddened areas on the opposite (lt arm),such as the tips of fingers;these sx lasted approx 3 wks;
Per MR: Extreme difficulty in walking; On 12/5 to 12/6 was at one facility but then on 12/6 transfer to 2nd facility (d/c on 12/21 to Rehab); Ped neuro; Ped; Treated for mycoplasma, fever for a couple of days, chronic cough, nasal congestion (11/29). Cough x 6 weeks (12/2); Weakness of first lower extremities, progressive weakness of upper extremities with tremor, extreme fatigue, c/o tingling/burning of lower extremities/milder in upper extremities. Ascending weakness, possible GBS (12/6). Weakness presumed to be steroid induced myopathy? (12/24). Referring med Dx: Progressive weakness after treatment, hospitalization for chronic cough (has asthma), no neuro dx, possible psychosocial component (12/11). Note: There have been several case reports of Mycoplasma-related rhabdomyolysis and transverse myocitis in the literature.  Pt noted to have normal reflexes which makes GBS unlikely. Steroid myopathy may be a possibility given pt has been on long.  GBS surveillance neuro consult, not GBS or variant GBS.  No comment in MR about temporal-association with vaccines.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N027000, expiry date: 28-SEP-2019) for prophylaxis. It was unknown if sterile diluent (dose, frequency, lot #, expiry date, route and indication were not reported) used for reconstitution of VARIVAX was properly stored. The VARIVAX was stored in temperature of 6 degree Fahrenheit (F) to 14 F for 5 hours 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.