chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breathing had dropped down and is on Oxygen; This spontaneous case was reported by an other health care professional and describes the occurrence of RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 21038012 and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. In October 2021, the patient experienced RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) (seriousness criterion medically significant). The patient was treated with OXYGEN for Breathing slowed, at an unspecified dose and frequency. At the time of the report, RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacy technician reported that patient had Moderna Covid-19 booster at their facility on 26-Oct-2021 came on 08-Nov-2021, yesterday and reported that ever since she received the booster her breathing had dropped down and was on Oxygen.  Company comment- This case concerns a 66-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Respiratory rate decreased. The event occurred unknown number of days after the booster dose of mRNA-1273 vaccine. Patient is currently on oxygen therapy. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first and second dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Also, there seems to be an error in the patient's date of birth (6-MAR-2021) provided in the SD.; Sender's Comments: This case concerns a 66-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Respiratory rate decreased. The event occurred unknown number of days after the booster dose of mRNA-1273 vaccine. Patient is currently on oxygen therapy. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first and second dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
blurred vision, dizziness, nausea & abd pain;3OCT94 f/u 930AM pt called day p/vax; c/o nausea & blurred vision;
Patient received HPV, MCV4 and flu vaccine shortly after 10am on 9/18/2020, patients mother called RN  around 12pm the same day stating that she has concerns about potential allergic reaction to vaccines. Patients mother states that patient has one hive to the left side of patients lip. No other signs or symptoms of reactions. patients mother states that patients reaction resolved after taking one dose of Benadryl. Denies SOB/ difficulty breathing or worsening symptoms.
Clinical Summary A 67 y.o. male with a history of HFmrEF, CKD IV, Chronic Hyperkalemia, Cirrhosis, CAD, NIDDM2, COPD, OSA, Polysubstance Abuse. Recent admission 12/11-12/16/22 for acute decompensated heart failure and progressive CKD IV and hyperkalemia with relapse of polysubstance abuse. Presents with AKI on CKD, hyperkalemia, COVID. Acute respiratory failure, Improved. Covid-19 Virus Infection Start of symptoms and positive test 12/29/2022 SOB & fatigue on admission Vaccinated Oxygen requirements on admission: 3L Medical therapy: Decadron 6mg every day x10 days (12/30 -1/9); CKD precludes remdesivir Weaned to RA prior to discharge   AKI on CKD IV Outpatient provider Dr.  Ddx: likely ATN from COVID vs. acute viral illness, dehydration, multimodal BP meds S/p 24hr of biarb gtt without improvement Cr remains elevated, 3.5-3.7 baseline 1/7 Cr 3.52 eGFR 18, BUN 79 1/8 Cr 3.97 eGFR 16, BUN 82 Renal diet & daily RFP Nephrology followed Continued home bumex 2mg daily   Hyperkalemia  Highest 6.1 on admission S/p Lokelma 10 g TID x 2 days; currently on 10 g daily, continue Bowel regimen: Miralax, Lokelma Continued home bumex Potassium 5.2 at baseline Has f/u with Nephro scheduled   Essential hypertension BP elevated to 170 systolic Cont coreg and Imdur, Bumex Cont home hydralazine at 50mg bid May need additional titration up to 100 TID as outpatient   Heart Failure with Reduced EF CXR w/ pulmonary edema Stress (11/2022): normal myocard perf, EF 47% Echo (4/2022): EF +/-55%, grade I dysfx Continued home carvedilol and imdur Held bumex in setting of AKI, restarted prior to discharge
Exactly one week after the second shot, I developed reactive arthritis in my left elbow. It was absolutely debilitating, in that it prevented me from doing normal activities like pick up a water bottle...let alone doing any type of weighted workouts with my left arm. This woke me up from sleep, was a constant state of very uncomfortable pain if I moved my left arm at all. It has lessened now 6 months later but it is still there. Always there. It has now also moved to my right arm-shoulder and scapula. Not as prevalent as in the left elbow but still the same type of dull achey pain that is a constant in my life.
Information has been received from a health professional concerning a patient in the fourth grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20.  He had known cardiac disease.
PER MOM PT 10 MINUTES AFTER LEAVING CLINIC TN THE CAR, BEGAN NOT FEELIING WELL HER EYES ROLLED BACK AND BECAME STIFF, UNSURE IF SHE HAD ANY CONVULSIONS ALSO UNDURE OF HOW LONG THE EPISODE LASTED.
numbness of fingers right hand, ever tingling, right hand. Arm swelling, swelling of fingers and hand rt. Itching.
Patient was being given a flu shot and the fluid came out at the bottom of the needle /top of the syringe hub. Patient had to be give another injection as a result. During the investigation the needle was removed and placed on a standard syringe. The needle and syringe worked normally at that point. when the needle was reapplied to the flu vaccine, it appeared that the fluid came out of the hub of the flu vaccine. Vaccine was Fluarix Quadrivalent Lot number 9CE79. NDC 5816090941.
This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of M-M-R II lot # L001336 expiration date 13-JAN-2017 (dose and route were not reported) and lot # L009213 expiration date 17-MAR-2017 (dose and route were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Insert needle right below shoulder. Black and blue mark - size 2 1/2 inches in diameter yellowing out. Purple mark was immediate.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: temperature between 0 and 2 degrees Celsius for 30 minutes and temperature of more than 8 but less than 25 degrees Celsius for 45 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010824: US-009507513-1702USA002794:
in the early am she had bad diarrhea , she went to work and then started having really bad stomach pains and before noon she had to  go home because she started puking. She laid down to take a nap around 3:30pm and never woke up.
Started feeling itch and swelling start in throat, within 15 min after receiving shot. Pharmacist gave me 25mg of liquid Benadryl. Someone from the pharmacy sat with me, with an eppi pin, incase it got worse. Approximately 20 min I could tell swelling was going away, and itching became very minor.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient said he was not feeling well. When I responded to him he said he did not feel good. I told him to put his head between his knees, but before he could do it, he became non-responsive. He remained seated as I shook him gently asking if he was ok, his eyes were open. When he became responsive, he said he must have fallen asleep. He said he felt nauseated. He was sweating. We called 911. The paramedics came and checked vital signs. His BP was 110/68, blood glucose was 107.Pt left on his own.
Mile to moderate tinnitus predominately in the right ear, but sometimes also sensed in the left.  The sensation began within 5-10 minutes of the injection and continues to date.  The intensity of the ringing varies, and seems a bit less pronounced as time goes by.
PT COMPLAINT WITH SORENESS, REDNESS, PAIN, SWELLING AT THE INJECTION SITE; NO FEVER AND CHILLS.
I had my vaccination on 09/09/2022. In 12/2022 I had been trouble sleeping and went in for a Sleep Apnea test. I went to the rheumatologist and verified that I had fibromyalgia. I feel that it showed up 15 years ago but this was a flare up. I was also diagnosed with Chronic Fatigue System. I am currently being tested for Postural orthostatic tachycardia syndrome and I am waiting on the results.
10/4/2022  1st occurrence atrial fibrillation. Shortness of breath, fainting.  Diagnosed with cardiomyopathy. EKG test indicate possible pericarditis.  Atrial fibrillation re-occurrence, requiring pharmaceutical intervention (metoPROLOL), and surgical intervention (cardiac ablation).
one hr after given, developed nausea/vomiting, fever of 102/headache/lethargy..today, he is still having nausea/vomiting/fever/headache/lethargy and a 12 # wt loss in 2 days     He will be seeing Dr. today at 2PM.
I had chills.  I was very cold and shivered continuously for about 30 minutes.  After the shivering stopped, I went to sleep and slept normally.  I had no lingering adverse effects and did not see a doctor related to this event.
Developed pain at injection site, pressure in chest and feeling of shortness of breath within an hour after first injection
AT 5pm the same day, felt a little fatigued and slight headache. The next morning 12-30-20 at 730, was so fatigued, couldn't hardly stand. Felt like when I had mono. Had headache, back and neck aches, fever of 100.2. Felt like glands were swollen. After 4 hours, symptoms began to subside, but still mildly present. Fever subsided and was gone from 11AM on. Injection site pain still present with redness. Skin felt very sensitive on the arms Today, 12-31, felt good, no fever, slightly tired, but good enough to work. Came to work and when in the process of writing this RL, I was reviewing the side effects and looked at my injection site. It looked red so I asked a coworker, who thought it looked like hives. We had our medical director and PA look at it and although they didn't feel like it looked like hives, I developed hives on my chest, neck and chin while they were in here. Called employee health who recommended either PCP or urgent care. Went to urgent care. During visit, hives began to subside, had 99.6 fever at the beginning of the visit, 98.7 at the end of the visit. Rapid COVID test was negative. Received inhaler for asthma and returned to work at 1245 today.
At 10:30, patient assessed for contraindications for vaccine.  No contraindications, consent signed, vaccine given.  No s/d of reaction.  13:50, patient found by staff, unresponsive, no pulse, no respiration's.  MD notified.  Stated patient expired due to disease and secondary diagnosis.  6/3/08 Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial fibrillation, CHF & cerebrovascular disease.
pt recvd vax & 48hrs post vax pt exp a papular non-erythematous rash over extremities & trunk;seen by MD who treated w/DPH;
high fever, swelling of gland of neck, pain and stiffness in the joints, hoarseness, weakness,  dizziness.   no treatment so far.
Since she got the first shot, she haven't had her period for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for Covid-19) in July 2021. Concurrent medical conditions included Blood pressure high (has high blood pressure since she was born). Concomitant products included AMLODIPINE for Blood pressure high.    On 07-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Feb-2022, the patient experienced MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months). At the time of the report, MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Did a blood work and everything is fine.     mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       It was reported that patient had no allergies but was sensitive to everything. Patient always had to take the lowest doses of medications, if not patient will experience the worst side effect. Patient did not receive any other vaccine within one month prior to Moderna.   No treatment medications were reported.   This case was linked to MOD-2022-533259 (Patient Link).
24JUN94 30 x 40mm hard, reddened area @ lt deltoid inject site; suggested APAP, cold compresses PRN;
1) Left arm swollen, painful, turned brown color could not lift arm for 2 days (at injection site). 2). Chills. 3) Throat swollen such that can hardly swallow.
Chills and shivering before bed, (could not get warm).  Lasted until morning 10APR. Headache in the AM 10APR.  Lasted a few hours. Achy feeling all over.  Very tired. Lasted until morning 11APR.
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of the vaccine administered after the refrigerator lost power in vaccine clinic and lost temperature control.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, the vaccine administered after the refrigerator lost power in a vaccine clinic and lost temperature control, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old, female patient who received her first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection after a refrigerator in a vaccine clinic lost power and temperature control. There we no reported adverse events associated with the event of vaccine administered after a refrigerator in a vaccine clinic lost power and lost temperature control.
chest pain Saturday morning actually resolved, but had troponins 3800 then  4160, trending down. Telemetery and check labs going down. Our ECHO and EKG were  fine, as was proBNP, d-dimers.
The patient was to receive a PPD TB skin test sub-dermal in the left forearm. The technician used Typhiod (lot#J1631.1) instead on accident. After the patient left the immunizations clinic, it was discovered that she gave injected the wrong vaccine. I immediately went downstairs in brought him into an exam room. I notifiedour medical director. He came in to evaluate the patient at 0820. He exposed his arm and there was redness and swelling around injection site. The patient c/o a burning sensation. We got his vital signs, which were normal. As he was being evaluated, the redness and swelling increased. Dr. instructed him to go to the Emergency room to be evaluated for possible chemical reaction. The patient has received the Typhiod vaccine (IM) 6 times in the past without any reaction, so it was our belief he was not having an allergic reaction. The patient left at 0941 and went to ER.
extreme heartburn in  first and second dose (3/30/2021). Onset of heartburn is at bed time, lasting several days,  each succeeding night was progressively better, over the counter meds were no help whatsoever
Injection site to right deltoid noted to have mild edema, erythema to a 2in by 3in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to right arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing. Reports headache and has emesis twice.
Information has been received from a physician concerning a 9 week old male who on 25-APR-2007 was vaccinated with an oral 2 ml dose of Rotateq (Lot# 656194/0024U). Concomitant therapy included aspirin, corticosteroids (unspecified), and globulin, immune, IV. On 27-APR-2007, two days after taking Rotateq the patient had a fever and congestion. Then on 02-MAY-2007 the patient still had a fever and also developed a red throat. When the physician saw the patient on 01-JUN-2007, the fever was still there, and the patient had a rash, congestion, diarrhea, and conjunctivitis in the eyes. On 12-JUN-2007 the patient fever still continued and he had thrombocytopenia. Also on 12-JUN-2007 the patient went to the emergency room. While in the emergency room the patient was diagnosed with Kawaski syndrome. The patient had two huge cornea aneurysms. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be life threatening by the reporter. A lot check has been requested. Additional information has been requested. 7/25/07-records received without DC summary. Consulation report 3 month old admitted on 6/13/07 for Kawasaki Disease. Fifteen days prior to admission began with fever max of 102.7 on first day of illness. Daily fevers between 100-101. Fine rash over trunk and dorsum hands. Bilateral conjunctivitis. Over course of illness developed intermittent cracked lips with occasional bleeding followed by pale appearance was reportedly gummy. Cyclic resulting in return of cracked lips and bleeding. Fussy. On day 15 in ED noted to have desquamation of fingertips and toes. RX with IVIG.  12/17/07-DC summary received for DOS 6/13-6/20/07-DC DX Kawasaki Disease
ADVERSE EVENT: ACUTE MYOCARDIAL INFARCTION  TREATMENT: LEFT HEART CATHETERIZATION, CORONARY ARTERIOGRAPHY, LEFT VENTRICULAR ANGIOGRAPHY, PLACEMENT DRUG-ELUTING STENT IN MID LEFT ANTERIOR DESCENDING ARTERY.   OUTCOME: DISCHARGED HOME WITH FOLLOW UP APPOINTMENTS WITH CARDIOLOGY AND PCP.
This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip), PARAESTHESIA (Tingling in left neck), ERYTHEMA (Neck, from left to right, was red) and HYPOAESTHESIA (numbness to nose/soft palate numbness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.  Concurrent medical conditions included Allergy to chemicals (Allergic to bleach), Allergy to insect sting (Allergic to bee sting), Adhesive tape allergy (Local skin reactions to adhesives) and Allergy (Allergic if in a closed room). On 08-Mar-2021 at 1:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip) and PARAESTHESIA (Tingling in left neck). 08-Mar-2021, the patient experienced HYPOAESTHESIA (numbness to nose/soft palate numbness). On 08-Mar-2021 at 1:50 PM, the patient experienced ERYTHEMA (Neck, from left to right, was red). At the time of the report, HYPOAESTHESIA ORAL (Tip of tongue became numb/numbness of upper lip), PARAESTHESIA (Tingling in left neck), ERYTHEMA (Neck, from left to right, was red) and HYPOAESTHESIA (numbness to nose/soft palate numbness) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
ADMINISTERED EXPIRED DOSE; This spontaneous report received from a health care professional concerned a 46 year old male. 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, intramuscular, batch number: 204A21A, and expiry: 21-09-2021) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administered expired dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018746, 20211018754, 20211019478 and 20211006668.
Fatigue, body aches/weakness and general  flu-like symptoms with fever of about 101. Fever came on about 24 hours after vaccination.
COVID breakthrough. Patient reports loss of smell and weakness beginning 12/20/21. Tested positive for COVID on 12/21/21 at her Facility and was sent to the hospital.