chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypothyroid; thyroiditis; Hypertension; Missed her menstrual cycle; Vaccination site pain; urticaria; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTHYROIDISM (Hypothyroid) and THYROIDITIS (thyroiditis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heartburn since an unknown date. Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced HYPOTHYROIDISM (Hypothyroid) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Missed her menstrual cycle). 23-Mar-2021, the patient experienced THYROIDITIS (thyroiditis) (seriousness criterion medically significant), HYPERTENSION (Hypertension), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria). At the time of the report, HYPOTHYROIDISM (Hypothyroid), THYROIDITIS (thyroiditis), HYPERTENSION (Hypertension), MENSTRUAL DISORDER (Missed her menstrual cycle), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 98.2 98.2. On 23-Mar-2021, Thyroid function test: positive (Positive) Thyroiditis confirmed.         Concomitant medications include treatment for heartburn. The patient was started on medication to treat hypothyroid and hypertension.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-058198 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up received on 7-JUL-2021. New events added(Hypertension, Hypothyroid) Race information added, pregnancy information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-058198:Case for first dose
pt arrested @ nursing home; presented to ED being positive for COVID, pupils fixed and dilated, asystole, CPR was being done on pt by EMS; CPR done for 20mins; pt in asystole; pronounced dead in the ED
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EW0177) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (27Jun2022) Positive, notes: Tested Positive again for rebound covid on 27Jun2022 5 days after stopping plaxovid. Therapeutic measures were taken as a result of covid-19. Clinical course: It was reported that patient did not take any other medication in weeks of vaccination. The treatment details for COVID-19 treatment were reported as patient was treated with plaxovid with treatment start date as 17Jun2022 and treatment stop date as 21Jun2022.
Starting a few hours after receiving the vaccine, my heart felt like it was fluttering. It was mild at first but then over the next couple of days it increased. It would take my breath away for a second. Then, it would come and go for a few days at a time or less and vary in intensity for about a 3 week period of time. Then, I considered it as going away. I went to the same pharmacy for the 2nd and they told me that likely it was an adverse event and I needed to get evaluated before I could have the 2nd dose. I ended up going to see my cardiologist and he said, since it had been 4 weeks since the last event, it would not show up in blood work but it sounded like I had a mild case of myocarditis. The doctor had seen side effects in his practice. I was concerned about getting COVID-19 so I discussed with him about getting the 2nd dose. He advised me that I should get it but warned me that there is no cure for myocarditis so he left the decision up to me. When I saw my PCP and my neurologist, they both advised against receiving another vaccine due to my reaction. For the past few months I've been having intermittent chest pains.
A few hours after receiving the SHINGRIX vaccine on July 17, 2018, patient experienced a headache. He self-treated for several days and we continued to follow-up with him. We advised him to see his doctor for which he did. After a week his headache was started to limit his activities of daily living. On July 27 he saw his doctor. On July 30 he came into the pharmacy and said that his headache was finally easing.
eyelid kind of swollen; flu like symptoms; achy; soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the arm), SWELLING OF EYELID (eyelid kind of swollen), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of the arm). On 08-Mar-2021, the patient experienced SWELLING OF EYELID (eyelid kind of swollen), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy). At the time of the report, PAIN IN EXTREMITY (soreness of the arm), SWELLING OF EYELID (eyelid kind of swollen), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
TRAUMA PROGRESS NOTE 1/21/2022 REMAINS HOSPITALIZED 1/24/2022 ASSESSMENT/PLAN: The patient is a 52 y.o. male who was admitted on 1/13 with R-sided weakness and abnormal speech after unwitnessed fall on 1/8. HCT with left temporal lobe parenchymal hematoma with surrounding cerebral edema and local mass effect. He was also discovered to have COVID pneumonia, he was treated for CAP with 5 day course of ABX. Repeat HCT 1/14 was stable, MRI/MRA 1/14 without evidence of underlying vascular lesion, tumor, or pathologic reason for left temporal lobe hemorrhage. He did receive lactulose for elevated ammonia in context of ongoing encephalopathy likely attributed to TBI and medications. He was transferred to the floor 1/17. Tube feeds were initiated but he ended up self pulling this 1/18, however he is cleared for PO diet and he is doing well with this so decision was made to defer replacement of FT for now.    Active Hospital Problems Fall - tertiary completed    Left temporal lobe parenchymal hematoma with mass effect complicated by Acute Metabolic encephalopathy  - nsgy consulted.  - Repeat HCT 1/14 was stable - MRI/MRA 1/14 without evidence of underlying vascular lesion, tumor, or pathologic reason for left temporal lobe hemorrhage. - Na goal 140-145 - Na tabs 2g TID.  - Free Water restricted 1L  - SBP goal <160 and maintaining    Prediabetes - A1C 6.2 - low SSI  - BS goal <180 and maintaining. Did have a single reading of 190s last night but since his PO intake is somewhat inconsistent, will hold off on Lantus for now.   COVID pneumonia - Finished Zithromax and Rocephin course 5 days to cover for CAP - on RA.  - Deep breathing exercises, IS therapy. Up as able. - DDIMER 1.6 1/18  from 4.4.  - given TBI and thrombocytopenia, contraindicated for therapeutic AC. Continue on heparin ppx.  - PCT 1/17 0.04, no leukocytosis, afebrile.  - Blood cultures on admission 1 of 2 showing GPC. Likely contaminant. Hold off on ABX. Repeat BC pending. No growth so far.  - Off full barrier precautions on Sunday.    Chronic Pancytopenia due to chronic disease Chronic thrombocytopenia  - Outpatient records with PLT at ~50s. Now trend ~30s. Trend every other day. If continues to decrease will reevaluate ppx therapy, consider repeat HCT and stop dvt ppx if PLT <25. hgbs are stable. No evidence of active bleeding    Dysphagia - Due to TBI - Speech following, diet per them - much improved, having better PO intake    Urinary incontinence - UA neg, monitor. - Strict I&Os    Left upper arm hematoma - from in hospital fall  - mark with marker and compression wrapping - XRs negative for fracture.    Hx of hepatic cirrhosis, unspecified hepatic cirrhosis type, unspecified whether ascites present (HCC)  - Child-Pugh class B  - avoid hepatotoxic medications. - hold lactulose due to large vol. Stools. Ammonia 49 improved to 43. Low suspicion for encephalopathy of hepatic origin, suspect is largely due to TBI.
Information has been received from a third party claims administrator on behalf of a pharmacy concerning a male patient, who on an unspecified date was vaccinated with PNEUMOVAX23 (lot # H012972, expiration date 09Mar2014). On 06NOV2013, the patient experienced an adverse reaction (not further specified) to the PNEUMOVAX23 vaccine. The patient received unspecified treatment for the adverse reaction. The outcome of the adverse reaction was unknown. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # unknown, 0.5 ml) intramuscular on 24-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The patient would receive her second dose of GARDASIL today (on 20-SEP-2012) and no adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Shot at 3:00 pm...pain at about 6:00... felt warm at9:00-did not look at it.   Next morning at 7:00 red bump about 2 fingers in diameter, just hot and hurt at this time...Mid afternoon appeared bigger and started itching. I applied neasporan cream with pain relief. By bed time it was close to 3 fingers wide. Next morning more itchy, lighter in color, applied cortozone 10 cream and cruel itch defender cream throughout the day.. it felt and looked bigger closer to 4 fingers in the evening.  Used ice pack in afternoon and when I went to bed. Next morning today  8:00 big grit than 5 fingers and spreading into my arm pit.  Swelling noticeable under my shirt. More constant pain.
Vial was initially stored in the refrigerator on 22-JUN-2023 and administered to patient on 03-AUG-2023; No adverse event; patient received an expired first dose; 25-year-old patient received an expired first dose Bivalent Moderna COVID-19 vaccine on 03-AUG-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired first dose), WRONG PRODUCT ADMINISTERED (25-year-old patient received an expired first dose Bivalent Moderna COVID-19 vaccine on 03-AUG-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 22-JUN-2023 and administered to patient on 03-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No medical history information were reported by the reporter.  Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE (MEASLES), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS B VACCINE (HEP B VAX) for an unknown indication.    On 03-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired first dose) and WRONG PRODUCT ADMINISTERED (25-year-old patient received an expired first dose Bivalent Moderna COVID-19 vaccine on 03-AUG-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 22-JUN-2023 and administered to patient on 03-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired first dose), WRONG PRODUCT ADMINISTERED (25-year-old patient received an expired first dose Bivalent Moderna COVID-19 vaccine on 03-AUG-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 22-JUN-2023 and administered to patient on 03-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired first dose), WRONG PRODUCT ADMINISTERED (25-year-old patient received an expired first dose Bivalent Moderna COVID-19 vaccine on 03-AUG-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 22-JUN-2023 and administered to patient on 03-AUG-2023).    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.
Patient not himself, afebrile but has staring spells, rolling up of eye balls, like seizure activity, and not responding to his name being called. It happened the night after vaccine are given. Admitted in hospital.
Shaking all over- not the chills SOB Chest Pain/ Jaw Pain Pain in between shoulder blades Lump in the collar bone Lump in lymph node armpit- Rightside
No additional AEs reported; Consumer reports that he received his third dose of GARDASIL 9 too early. Consumer reports 1st dose: 2/24/2022, 2nd dose: 4/12/2022, and 3rd dose: 7/12/2022; This spontaneous report was received from a male patient of unknown age referring to himself. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 24-FEB-2022, 12-APR-2022 and 12-JUL-2022, the patient was vaccinated with the first dose, second dose and third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, routes of administration, vaccination scheme frequencies, anatomical locations, doses, lot numbers and expiration dates were unknown). The patient reported that he received his third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) too early (inappropriate schedule of product administration). No additional adverse event reported (no adverse event).
No other adverse effects were reported in the patient; A patient received a dose of PNEUMOVAX23 on 4/22/2019 and a second dose on 2/8/2020; Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 22-APR-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number R018732 with expiration date in 27-FEB-2020 (route of administration, strength and anatomical location were not reported) and on 08-FEB-2020, was received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S026366 with expiration date in 17-SEP-2020 (route of administration, strength and anatomical location were not reported) (inappropriate schedule of vaccine administered).  No other adverse effects were reported in the patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R018732; expirationdate: 27-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a nurse via a company representative concerning a two month old infant who on 25-SEP-2012 received a first dose of ROTATEQ (lot number not provided). Concomitant medications included "multiple vaccines" (not specified) that the infant received that day at the 2 month visit. The baby was reported to be a "little wheezy" when they administered the vaccine. After the infant received the first dose orally, the mother was trying to burp the baby and the baby vomited. The mother of the infant was cleaning up the vomit off of the floor and found a piece of plastic. It was reported that the mother felt that the plastic was in the ROTATEQ but both the physician and the nurse felt that the plastic happened to be on the floor. The infant's condition improved and the nurse was "not aware of any" treatments or medical attention that was received. No additional information was provided. Additional information has been requested.
I had dry, itchy skin all over.  If I touch any area, it will itch and get a rash.  If I touch another part, it will do the same.  I went to my doctors about it.  She told me to try Benadryl.  I try over-the-concern medicine cream and aloe.  Nothing is helping.  The rashes are light, and they do fade away if I do not touch them.  It still does itch. I also had a couple of headaches as well.
Admission Date: 7/25/2022 Discharge Date: 8/1/2022  PRESENTING PROBLEM: Septic shock Sepsis    HOSPITAL COURSE: DATE OF ADMISSION: 07/25/2022     BRIEF HISTORY OF PRESENTING ILLNESS: 75-year-old male with a past medical history significant for end-stage renal disease on Monday Wednesday Friday dialysis as well as history of diabetes and coronary artery disease with known aortic stenosis who presented due to hypotension fever noted after dialysis.   In the emergency department the patient was hypotensive despite fluid.  He was found have a normal white blood cell count and lactic acid level.  Chest x-ray showed no acute infiltrate.  COVID-19 testing was found to be positive although he has tested positive for COVID-19 in the past.  He was empirically started on piperacillin/tazobactam and was started on vasopressors as well and moved to the intensive care unit.   Patient had quick resolution in regards to his hypotension and was able to wean off of vasopressors and move out of the intensive care unit.  Etiology behind his infection was uncertain but it was suspected that it was related to his dialysis catheter.  IR was consulted to remove his tunneled dialysis catheter and although the patient had been on Zosyn and vancomycin, after blood cultures show no growth and with the thought that MRSA would have grown or at least been isolated by now, vancomycin was discontinued on 07/28/2022 and dialysis catheter was removed on the same day.   Patient's dialysis catheter tip was cultured and this came back growing Gram-negative rods.  He was continued on Zosyn and ID was consulted.  Id recommended repeating blood culture morning 07/30/2022 and also recommended 7 days of antibiotic therapy based on sensitivities with route to be determined.    His cultures came Klebsiella arginine ease.  This was pansensitive.  Infectious Disease is okay with giving an oral antibiotic today and tomorrow and then following up with blood cultures on 08/08, which they will order.  Patient is feeling very well.  He has no fevers or chills.  Ultrasound was done of his right upper extremity rule out septic thrombus which was negative.  Patient was getting ready to get discharged today on oral antibiotics however it would appear that his dialysis bed tomorrow at 06:00 at Fresenius has been given up and he is scheduled for a.m. here.  If this cannot be arranged to have him have dialysis as an outpatient tomorrow unfortunately he will have to stay overnight, get dialysis and then discharged immediately after that.   He can go back on his torsemide, hydralazine and home dose of insulin.
Pt receive second dose of Pfizer vaccine and 5 minutes later started to have chest heaviness and cough. Allergy paged and recommended 2 puffs of albuterol which were given and for pt to be observed 20-30 minutes longer.  Pt then started to have itchy throat and Rapid response called.  epi IM and zrytec 10 mg given.  Emesis X1.  Pt transported to ED in wheelchair.
Cough, sore throat, rhinorrhea, with hypoxia.  Patient treated with Tamiflu, azithromycin, ceftriaxone, oxygen and admission to hospital. 11/10/2009 ED record for 11/8/2009, patient with c/o's sore throat, SOB, cough, fever, nausea/vomiting and diarrhea. Tx: IV ABX and Tamiflu.  12/10/09 DC summary and medical records received for 11/08/09. Pt presented with cough x 1 1/2 weeksand c/o gasping for air in the middle of the night. Also has nausea, sore throat, diarrhea. Pt admitted for observation. Antibiotics and Tamiflu were withheld because of negative rapid strep. Discharged stable.  DC DX: bronchitis, obesity
RIGHT ARM NUMBNESS; RIGHT ARM TINGLING; CHILLS; FEVER; INTENSE PAIN FROM INJECTION SITE TO BACK OF EAR; This spontaneous report received from a patient concerned a 50 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced intense pain from injection site to back of ear. On 21-MAR-2021, the subject experienced right arm numbness. On 21-MAR-2021, the subject experienced right arm tingling. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, had not recovered from right arm numbness, and right arm tingling, and the outcome of intense pain from injection site to back of ear was not reported. This report was non-serious.