chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had significant decline in kidney function/ went from GFR 63 to 39/ GFR 27 stage 4; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant", start date: 1998 (not ongoing). Concomitant medication(s) included: ACT [ACETYLCYSTEINE]; AMLODIPINE BESYLATE; CARVEDILOL ADICO; CYCLOBENZAPRINE HCL; CYCLOSPORINE; LOSARTAN; MYCOPHENOLATE MOFETIL; NASONEX nasal; POTASSIUM CHLORIDE; PRAVASTATIN SODIUM; PREDNISONE; RYBELSUS oral; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 21Dec2020, for COVID-19 immunisation. The following information was reported: RENAL IMPAIRMENT (medically significant), outcome "unknown", described as "had significant decline in kidney function/ went from GFR 63 to 39/ GFR 27 stage 4". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (04Mar2021) Declined from 63 to 39, notes: GFR Declined from 63 to 39; (11Apr2021) Declined from 39 to 27, notes: GFR declined from 39 to 27; Renal function test: (11Apr2023) Unknown results, notes: Labs drawn today to check function. Waiting on results. Clinical course: Since getting vaccine has had significant decline in kidney function. Patient received Dose 3 (Booster), Single on 23Sep2021 for COVID-19 immunisation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162B2 vaccine  cannot be excluded for the reported event of renal impairment due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with history of renal transplantation. There is limited information provided in this report. Additional information, including complete medical history, diagnostics including renal function tests at baseline prior to vaccination, renal ultrasound, CT/MRI of abdomen/pelvis, kidney biopsy, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications, are needed to better assess the case.  This case will be reassessed once additional information is available. 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
Bloody stool day after and again on 10/18/2016. Mom reported dime size blood in stool.
large confluent rash of upper 1/2 of rt thigh w/some warmth; no induration; mom states pt ran high fever; fever 99F at doctor's ofc;
About 18 hrs after headache, body aches and arm swollen. Then few hrs later 100.5, chills, sore joints, nausea, vomiting and diarrhea. Fever spiked at 102 degrees. Dr said take ADVIL only. Still has symptoms now - next morning.
Very weak. Dizzy- could not walk straight ahead, chills, sweating, low appetite.
Left upper arm had redness which started 10 minutes after injection at 3:10pm and which proceeded to extend down to left wrist by 3:20pm, by 3:35pm redness started to recede, (per phone call to mother, rash receded after benadryl po
pt recvd vax & started crying p/vax; cried continuously; mom called MD 7PM & was told to use only DT in future; MD did not see pt; pt cried until 10PM until mom got pt to sleep; cry was high pitched;
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 17-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1412USA011762). Additional information has been requested.
I am not sure exactly when I started getting the side effect but it was not immediately after the booster. I would say 7-10 days after the booster. The date I noted is approximate.  I am getting an itch all over my body but mostly on my back and legs. Even my scalp, fingers, toes and bottom of my feet too. It itches more if I wear tight clothes. For example, when I wear a bra I get an intense itch and redness where the elastic touches my skin. When I scratch my skin becomes very red and welts. I can clearly see where I scratched. I think the condition is called Dermatographia. I've never experienced this before.  An urgent care center prescribed me hydrocortisone cream to spot treat the itch. I am not using because calamine lotion helps. They also advised that I take Aleve during the day and Benadryl at night. I've been doing this for the past 3 days and it prevents the itch most of the day. When the meds wear out the itch comes back with the same intensity. It has not improved since it began.
10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was elevated.  I went to the hospital and they found blood clots in both lungs and I had to be hospitalized.
DOSE 1: 12Mar201 and Dose 2: 30Mar2021; fever; Chills; Severe headache; This is a spontaneous report from a non-contactable other healthcare professional. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via intramuscular route of administration in the left arm on 30Mar2021 at 15:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Concomitant medication included unspecified birth control medication from unknown date . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the left arm on 12Mar2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced fever, chills and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events fever, chills and severe headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
2 hours after immunization broke out in rash each lesion approx size of a quarter. Skin hot to touch but no fever. Seen in ER @ 6PM. Gave Benadryl po, Albuterol 2mg tab & Loratidine.
"Not acting like herself" in classroom. Lying down on the bathroom floor, then classroom floor when moved. Staff unable to have her stand to bring her back to school health center. Vital signs: temp - 97.8. pulse 88, resp. 18, BP 100/68. Responded to her name being called by moving head but did not sit up upon request. Skin clammy to touch. Breathing normal and unlabored. No wheezing. No redness or swelling to face or lips. After a bit of time and with assistance, able to walk to the health center.
Information has been received from a nurse concerning a 47 month old female with significant disability and cerebral palsy and with no drug allergies who on 06-NOV-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). Subsequently patient's mom called the office to report the patient broke out with rash one day after receiving VARIVAX (Merck) (on 07-NOV-2010). Dose was not administered at the physician's office. Physician has not seen the patient yet as of 15-NOV-2010. Lab diagnostics studies were not performed. The patient sought medical attention by telephone. At the time of report, the outcome was unknown. Additional information has been requested.
A rash developed all over her body where the itching is unbearable; Her legs are hot to touch; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch). The patient was treated with MUPIROCIN at a dose of UNK dosage form, qd and TRIAMCINOLONE at a dose of UNK dosage form, qd. At the time of the report, RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Concomitant product used was not provided by the reporter. .   This case was linked to MOD-2021-081504 (Patient Link).
Rash R hand - Rash L arm - Hives both arms - itchy rash-started on hands moving up arms and elbows.
Patient was in usual state of health.  Had bottle at about 2:30 AM and then put back to sleep in bed with father.  Another family member checked on baby few hours later and found she was unresponsive with vomit in her mouth.  Father attempted CPR; CPR en route to ED by EMS.  Asystole noted on arrival in ED.  Patient deceased.
Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded. Entirety lasted for 30 minutes or so.
Day 1-3 I felt tired and like I was coming down with something.  Was back to mostly normal by day 4 and by day 5 I started having painfully itchy hives/rash all over my legs. When I took Benadryl the itching got better and the redness in my skin reduced.  Day 6 I woke up and had a lot of redness and rash/hives on my torso and legs.  I feel itchy all over and when the Benadryl wears off it gets very painful.
Administeredf what she thought was proquad but turned out to be Hib. Hib was frozen, diluted with sterile diluent and given subcutaneous. Contacted nurse on call and was informed no real danger to patient but dose will not count. She said patient may be sore as that is a lot of fluid to be given subq. Doctor was notified. Mom was also notified of error and that Hib vaccine would not count. Mom was given option to come back in for proquad but states she will wait until 15 mth appt that is already scheduled.
swelling of the face and lips. painful occurred 12 hours after vaccination. patient seen by provider and received prednisone prescription
Shot on 4/10 at 9:00 am; fatigue started at 3:00 pm; fatigue worsened, chills, body aches, headache & sore & swollen arm started at 6:00 pm and continued through 6:00 pm the following day 4/11.   4/12 woke up with a stiff neck. 4/13 still had a stiff neck, but not as bad as previous day.   4/14 Stick neck issue completely gone.
Six days after COVID vaccine I developed a small rash on my L wrist. I applied Benadryl cream & it seemed better by morning. Saturday I woke up covered in welts on both arms. I took PO Benadryl and applied Caladryl. Over the weekend they continued to spread. Nothing helped with the itch, nor with making the welts go away. Went to urgent care last Saturday- given Decadron, didn't help. Went to ER on Monday because rash was spreading and I felt some tightness in my chest. Given PO Hydroxyzine & IV Solu-Medrol.On the 31st saw allergist. Trying Ceririzine, Singulair, Pepcid, and Benadryl together. So far hasnt helped. He did notice my eosinophil count was high 2 days AFTER a steroid injection. Some of the large welts on my arms have changed into a raised, spotted rash. The skin feels completely different in these areas. Still very itchy and red, warm to touch. Rash/welts on neck, thighs, arms, lower back, upper lip,L breast, R cheek & a couple on each leg. None on hands, feet, scalp.
This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 75-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced itchy rash, painful rash, neuropathic pain and skin hyperpigmentation. On an unknown date, the outcome of the itchy rash and painful rash were recovered/resolved and the outcome of the neuropathic pain and skin hyperpigmentation were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, painful rash, neuropathic pain and skin hyperpigmentation to be related to Shingrix. Additional details were provided as follows: About a month ago before reporting, the patient received the vaccine (date was unknown) on an unknown arm. The patient experienced a painful itchy rash on her back, and neuropathic pain shooting down her legs. The neuropathic pain and hyper-pigmentation on the back remained ongoing till the time of reporting. The reporter stated that there was no additional information. The vaccine was not administered by the reporting facility. The reporter did not consent for follow up.
Fever of 102 degrees; Chills; Migraine; Body aches; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 12Apr2021 at 10:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid condition. The patient had no known allergies (Not that he knows of). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included only men's vitamins (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on the left arm on 24Mar2021 at 09:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 04:30, the patient experienced fever of 102 degrees, chills, migraine, body aches and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever of 102 degrees, chills, migraine, body aches and diarrhea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Post vaccination reports "feels faint and dizzy"; informs previous hx of these symptoms w/other injections (non-specific) Medical monitor x 40 min w/ improvement and symptom resolve; released from facility to home
Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The treatment information was not provided.   This case was linked to MOD-2021-337484, MOD-2021-337912, MOD-2021-338264, MOD-2021-338266, MOD-2021-338267, MOD-2021-338271, MOD-2021-338277, MOD-2021-338292, MOD-2021-338347, MOD-2021-338355, MOD-2021-338366, MOD-2021-338372, MOD-2021-338375, MOD-2021-338417, MOD-2021-338458, MOD-2021-338530, MOD-2021-338534, MOD-2021-338564, MOD-2021-338578, MOD-2021-338581, MOD-2021-338604, MOD-2021-338607, MOD-2021-338817, MOD-2021-338604 (Patient Link).
I experienced heart racing and my throat swelled up. Pain at the injection site. I also experienced chills, weakness sensation to my body no fever and body aches. To this day I still have the pain at the injection site, left arm and no chills.  At times I feel my joint feel stiff and I am able to move a bit better.
The patient presents with near syncope, She was sitting in a chair playing bingo when all of a sudden she started complaining of feeling weak and dizzy and became briefly unresponsive
Pt telephoned two days post vaccination stating te shot went into the "back" of her arm and has a quarter size mark at the injection site that is red, swollen and itchy. Pt is given Tylenol for pain, applied ice to the affected area. PCP states it was a localized reaction.
Bell's Palsy; This spontaneous report was received from a lawyer regarding a case in litigation and referred to male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the routine health maintenance prevention of shingles (herpes zoster) (strength, dose, route, lot number and expiration date were not provided). On an unspecified date in 2016 (reported as shortly after vaccination), the patient experienced bell's palsy. The outcome of the event was not recovered. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event bell's palsy was determined to be medically significant. The reporter considered the event bell's palsy to be disability.
17MAY fever started;highest temp 104.4;18MAY rash generalized small started on stomach/back, now on ears, over face And trunk;
High fever beg 22JAN w/cough, cold, watery eyes followed by rash; would not eat 22JAN-25JAN; Seen by MD 27JAN92; MD felt could be viral; prescribed Amox;
A week after injection, on evening of 2/10, I noticed a large red rash, very warm at vaccination site.  I called Dr. next morning and saw her that afternoon on 2/11.  She told me it was a reaction to the vaccine, and put me on antibiotics for 7 days. She traced the area with a pen, and told me to watch it. If it got worse and  spread a lot, I was to go to the hospital, as their office would be closed over the weekend. I started the antibiotics that day, and it has gotten better,  but not completed resolved.  It did spread slightly, but not enough to be concerned.
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 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 11:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021 at 11:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021 at 11:31 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
Became dizzy, pale, c/o metallic taste in her mouth. Transported to ER at 11:20 AM.
10/24/05 at 7:00 pm, patient having chills, joint pain, headache and nausea. 10/25/05 at 7:30 am, she has rash on trunk, neck and upper arms. Rash did not itch or have discomfort was a spotty appearance. 10/26/05 at 7:20 am, rash was solid red, did not itch. Felt like a fever. 10/27/05, all symptoms were gone.
incorrect amount of dilutant was mixed with the pfizer bioNtech covid vaccine age group 12 yrs and up . 0.8 was mixed instead of the 1.8
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: low heart rate-Severe
12/18/2020 Patient developed a rash on forehead, burning sensation in the back of throat, and chest heaviness. Patient stated that she had similar reaction to a previous vaccine that she received.  Patient was reluctant to go to the ED and refused to ride in wheelchair, but was walked assisted by staff.  ED RN reported patient was feeling better approximately 1 hour after injection.     FROM ED REPORT 12/18/2020  Had a vaccine about 10 minutes later she states she felt a little warm. A little tingly. Had some blotchiness to her forehead and chest. She reports that she also had some similar symptoms after receiving vaccines. These were short-lived. She presents now for evaluation. She denies any chest pain abdominal pain. No trouble breathing. Pulse ox on arrival is 100%. No abdominal pain  Patient does have some papules to the forehead. She states this is chronic. It is little red. Cheeks are little red. I see no urticaria on inspection
the next morning lt arm red & hot the size of a silver dollar & a bump;as time went cont to get larger w/redness from elbow to shoulder w/water blisters by 48hr;22APR saw PMD;a brown indurated spot @ inj site lasted a mo;
21:00:  Tetanus shot administered 21:05, patients mom yells out she's feeling numb all over and sat patient down in chair.  Mom states she's seizing.  Turned head to side and shook to side.  Witnessed patient pale, prespiring. Not able to answer to questioning.  Epipen 0.3 administered right arm, above tetanus shot.  Pulse 60, responding verbally, states feeling of numbness, difficulty focusing eyes.  States feeling lump in throat.  2nd epipen administered.  EMT advised, taken to hospital.  Discharged after observation.
This is a spontaneous report from a non-contactable physician. An infant patient (age and gender unknown) received a dose of PREVNAR 13, a dose of PENTACEL, and a dose of ROTATEQ all on an unknown date. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient experienced a rash on the face and neck. The infant was recovering from the event at the time of report. No follow-up attempts is possible. No further information expected.
pt recvd vax; pt had fever & szs; Pt dx w/ autism & encephalopathy;