chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Early thyroid problems; This case was reported by a consumer via interactive digital media and described the occurrence of thyroid disorder in a female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced thyroid disorder. On an unknown date, the outcome of the thyroid disorder was unknown.   It was unknown if the reporter considered the thyroid disorder to be related to DTP vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's mother. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced thyroid problems. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
Client stated that she started noticing numbness and tingling in her left hand on her thumb that had progressed up her hand, then states that it went up her arm and across her chest, then notified EMS that she was having tingling in her legs by the time of arrival of EMS
Area just under injection site appeared raised and puffy. Also had a light red/pink color with some slight bruising. Patient said site was painful when being touched. Patient was recommended to put a cold compress on site, and take an oral pain reliever such as Motrin or Tylenol. Also advised to notify physician and pharmacy if anything changes or progresses.
devel measles-like rash 16JUL95; t99 R 19JUL95;
Allergic to the vaccine; injection site is red; Painful; Itching; Swollen; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), VALSARTAN, AMLODIPINE, MAGNESIUM and OLOPATADINE HYDROCHLORIDE (PAZEO) for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form and DOXYCYCLINE at a dose of 100 mg. At the time of the report, VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE PAIN (Painful), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swollen), PYREXIA (Fever) and ALLERGY TO VACCINE (Allergic to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to her doctor on 09JUN2021. Treatment also included ice- pack.
Improperly stored dose of PEDVAXHIB was administered to the patient; No adverse effect; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not provided.   On 21-AUG-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dosage form (strength, formulation, frequency, route were unknown) ( lot# S000352 and expiration date 17-OCT-2021) for prophylaxis. On an unknown date, the patient was administered with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (product storage error) and no adverse event was reported.  The temperature excursion was 1.2 degrees Celsius for 41 minutes; however, the vaccine did not have a previous temperature excursion and this call was not a data logger.
Pt arrived back to clinic @ 1700 on 11/13/23 with mother. Mother stated pt's HR was beating too fast, after receiving the flulaval shot earlier today at 1500. This nurse auscultated pt's apical pulse: 400BPM.  Pt denied pain, denied SOB. Dr. came to bedside immediately and ordered a cold compress and cloths to be placed on pt's forehead and abdomen. Pt was transported to emergency department via mom, as she declined an ambulance to save time.  Pt has been admitted to Hospital.
Initial report received from a health care professional on 13 March 2009. The reporter stated that two of his patients "got the Flu" after receiving FLUZONE; however information was received for only one patient. An elderly female patient had received FLUZONE SV 2008-2009 (lot number, route/site of administration not reported) on 16 October 2008 and an unspecified amount time later she developed the "flu". On 09 March 2009, the patient had laboratory testing performed for Influenza virus A & B IGG, IGM, and IGA ABS with the following results: Influenza A: IgG (4.94), IgM (1.09), IgA (1.4) and Influenza B: IgG (3.38), IgM (<0.80), IgA (<0.80). Reference ranges - (<0.80 = negative); (0.80 - 1.20 = Equivocal); (>1.20 - positive). According to the laboratory report received, "This test(s) was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by (the laboratory). This test should not be used for diagnosis without confirmation by other medically established means." The patient's recovery status was not reported. No additional information was provided at the time of the report. Follow-up information received 17 March 2009 from a health care professional. The reporter confirmed that patient had been 74-years-old at the time of the event. The patient had received an intramuscular right deltoid injection of FLUZONE on 16 October 2008 and 140 days later, she developed sinus congestion; aching behind eyes, red pharynx and her face was flushed. She had no adenopathy and her lungs were clear. Laboratory test results had been positive for influenza A and B and additional labs revealed Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff: PMN (70.3), Lymph (23), Prolymphs (6.3). A throat culture grew normal flora. The patient had no pre-existing illnesses or medical conditions and no illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE. The patient was recovering as of 17 March 2009. It had been previously reported that a second patient had developed the "Flu" after receiving FLUZONE; however new information received noted that the second patient had not received an influenza vaccination prior to contracting the flu. No additional information was provided at the time of the report. Documents held by sender: Lab titers.
Sharp increase in glucose reading; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading). At the time of the report, BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading) outcome was unknown.            Other concomitant medications included medications for blood pressure, atrial fibrillation, and COPD, not otherwise specified. No treatment details provided.
feeling pain/pressure in my chest; feeling pain/pressure in my chest; my heart was racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN , Dose number unknown), for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious), CHEST DISCOMFORT (non-serious) all with onset 08Jan2022, outcome "recovered" (Feb2022) and all described as "feeling pain/pressure in my chest"; PALPITATIONS (non-serious) with onset 08Jan2022, outcome "recovered" (Feb2022), described as "my heart was racing". The events "feeling pain/pressure in my chest", "feeling pain/pressure in my chest" and "my heart was racing" were evaluated at the emergency room visit.  Additional information: Patient reports that she and her husband (31 years old, female) received their booster shot on 06Jan2022. She reports that 2 days later she "started feeling pain/pressure in chest, her heart was racing. After 1 month she went to emergency room, the doctors said everything was fine, but last Friday my husband starts to feel the same thing, he went to the hospital today everything looks good. this is heart pain. They wanted to know because the doctors say everything is okay. They never had this before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I am very thin and have thin arms.  I asked the pharmacist to use a smaller needle or a pediatric needle.  She said NO, " I will just not go as far".    She gave me the shot and I had excruciating pain as she gave the shot.   It is now 5 months later.  I still have left arm pain.   I cannot do the side stroke when I swim.  I cannot lift weights or do push-ups any more.    When I turn my head to the left the arm pain is worse.   There is often numbness and tingling in the whole arm, not just where the shot was.
Migraine for 1-2 days then subsided. Had to take OTC migraine medication on day 2
Local erythema and redness and firmness at lower right thigh, at left thigh, and at lower left thigh. Fever the next day.
Chills, body ache, slight fever, fatigue, sleeplessness night of.
Pain and cellulitis in right arm. Went to walk in MD clinic. Treated with Cipro for 10 days, Zepharin and then given ? Nambutol. Received vaccine at store.
5hrs p/vax pt awoke w/fever, cough & myalgia;acute sx passed w/in 24hrs;fatigue for 48hrs then fully recovered;
This spontaneous report was received from a pharmacist via employee and refers to an elderly patient (age reported as over 65 years old) of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient experienced injection site pain, injection site peeling of skin, injection site warmth and injection site swelling. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
No additional AE reported; the patient received the third dose in the series before the minimum 16 week interval from the first dose; This spontaneous report was received from a medical assistant referring a 49-year-old female patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 09-SEP-2022, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-OCT-2022, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 09-DEC-2022, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 milliliter (mL) (route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis (only 13 weeks from first dose). No additional information provided.
INSOMNIA; CHILLS; MINOR MUSCLE SORENESS FROM THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced insomnia, chills, and minor muscle soreness from the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor muscle soreness from the injection site, chills and insomnia was not reported. This report was non-serious.
Patient is a 80 y.o. male patient of MD with history of CHF, CKD, Depression, DM Type 2, CAD,  Hypertension, Peripheral Neuropathy, nephrolithiasis,  TIA, Chronic diarrhea, Hyperlipidemia presented to Hospital with shortness of breath  weakness, Fever and Cough .   Pt medically ready for discharge, but lives alone with wife who is also admitted. Possible discharge of both on 3/5   Acute hypoxic respiratory failure due to   Sepsis due to COVID-19 Infection hypoglycemia, tachypnea, fever up to 102.7 on adm. Now resolved Symptoms since 2/27,  weakness, Fever and Cough. Tested positive 3/1/2023. Vaccinated x 2 plus 1 booster. Chest x-ray prominence of the bronchovascular markings Lactic acid unremarkable, CRP; 48.6. Procal nl Initially required  4 L of supplemental oxygen, now weaned to baseline room air.   Started on dexamethasone, changed to Prednisone due ot adrenal insufficiency  Received a Rocephin azithromycin, no clear signs of bacterial infection and procal nl so   discontinued Cont IS/PEP   Dizziness Intermittent for weeks now improved Orthostatic VS normal Meclizine ordered. PT/ OT consulted.  Ambulating with walker   AKI On CKD Stage 3 Hypokalemia Admission CR 2.58, baseline 1.7-2.1.  Cr  1.9 at discharge On Lasix, dose recently decreased by Nephrologist as outpt. Avoid Nephrotoxic agent Nephrology consulted, Lasix ordered IV x 2. Will cont PO lasix 40 mg daily and resume BID at discharge PO potasium   Adrenal insufficiency In context of acute infection. Hypoglycemia and hypotension on adm.  Cortisol 3.8 random Pt with hx of DM, hypoglycemic on adm, has remained off medication and with BS <180 despite steroids treatment.  Started on prednisone 40 mg, will wean to 20 mg at discharge x 7 days, then 10 x 7 days then cont 5 mg until seen by PCP    Thrombocytopenia Platelets 138k, probably due ot COVID and sepsis.  No signs of bleeding Monitor. DM with neuropathy Pt presented with hypoglycemia, required multiple doses of dextro, will stop MIVF w/ D5 now.  Etiology multifactorial, poor PO intake and noted adrenal insufficiency Hba1c 6 Pt with hx of DM, hypoglycemic on adm, has remained off medication and with BS <180 despite steroids treatment.  On Amaryl and Tresiba at baseline, will hold at this time, will not cont  at discharge as pt controlled on steroids.  Cont  SSI    Acute metabolic encephalopathy- resolved History of TIAs, cerebral infarcts stroke Does have occasional intermittent baseline confusion. Now complicated by hypoxemia COVID, acute on chronic renal failure and hypoglycemia CT head without contrast mild chronic small vessel white matter changes. Remote bilateral basal ganglia lacunar infarcts.  Remote right thalamic lacunar infarct. Ammonium nl. B12/ folic elevated   Chronic HFpEF Hx of PAF on coumadin Bradycardia, sinus Shortness of breath cough likely triggered by COVID infection. No other signs of volume overload. Does not have acute exacerbation  Echocardiogram  2/8/2023 with EF 65.0 %. ProBNP 4656.   Cont coumadin, pharmacy to dose, INR therapeutic.  Strict input and outputs, daily weights Fluid restriction.   Contaminated Blood culture BC 1/2 + Coag neg Staph. Monitor
Hives for over 2 weeks - (Also had corn for the 1st time this day).
4 years old male received vaccines 5/8/07 who has swelling, redness and warm to touch at the injection site on left upper arm since yesterday 5/9/07
Same as Dose 1.  Chills, then fever started on Monday evening.  Chills, fever, body aches and pains, and slight headache worst on Tuesday with fever high of 100.9 F.  Continued Wednesday and finally felt ok Wednesday night.  Almost identical side effects as Dose 1.
hot, red approx 4 inch swelling @ site area which lasted several days, nodules lasted @ least 2wk;
ACUTE NON ST ELEVATION MI 1/29/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recv vax; T 102.4; fussy, chills; dec appetite; apap  given;
Rash on upper arm, itching. warm to touch, very very significant pain, swelling. Started slow, got worse and worse. Started to subside slowly and on day 4 after vaccination was much better. Tylenol, ice, and benadryl cream helped.
VERY SORE LEFT ARM, lasted a few days and went away.  Started again in beginning of November with severe pain when sleeping on shoulder and certain movements.  Now it hurts mostly with certain movements only.  Also have numbness, weakness in both hands when sleeping and during the day.  Hands are numb during night regardless of which side I sleep on.  Not sure if more neuropathy or from the flu shot.  Had MRI of neck 2 weeks ago.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Relapse of mild symptoms/ positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment with anti-viral product, brand paxlovid, treatment start date 05may2022, treatment stop date 09may2022. Patient experienced relapse of mild symptoms and positive test.  No follow-up attempts are possible. No further information is expected.
Taste in mouth initially after shot 10 hours later: awful body ache; exhaustion; nausea
Narrative:  Pt reports day one of his vaccine he had joint pain, soreness at the injection, day 2-5 rash, itching, chills, headache day 5-8, then continued with rash and itching through current time. Is also using a prescription cream from Dermatologist to assist with symptoms
Felt like he had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like he had the flu) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like he had the flu) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-366041, MOD-2021-366140 (Patient Link).   Reporter did not allow further contact
Cellulitis at injeciton site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with sulfamethoxazole (Bactrium (Sulfamethoxazole)). On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient developed cellulitis at injection site after receiving vaccine. The reporter consented to follow up. The reporter did not have lot or expiration date, as the vaccine was given somewhere else. The reporter did not provide vaccination facility information. This case has been linked with case US2019160454, reported by the same reporter.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported.   No treatment details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  This case contains information for 179th out of 190 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case