chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 86 year old male with PMH of afib, complete heart block s/p pacemaker placement, HLD, HTN, CKD4, prostate cancer, gastric caner s/p distalgastrectomy with GJ anastomosis, leiomyosarcoma of upper GI tract on Gleevec  presented to the ED with 2 days history of chills, fatigue, mild shortness of breath and mild productive cough, this morning the patient took his temp and it was 100.4 so he decided to come to the ED. in the ED his vitals were stable, his X-ray showed no acute cardiopulmonary process, on the 7/29 he provided a uring sample that showed UTI and the culture grew Aerococcus which was not followed. The patient tested positive for COVID-19 in the ED, so the ED physician wanted to admit him for COVID-19 and UTI. Patient did not require oxygen. Ciprofloxacin was changed to Cephalexin due to QTc prolongation concerns.
Headache, Myalgia, Arthralgia, Fever, Rash, chills, lymph nodes/glands in neck sore/somewhat swollen Narrative:  Hands itching and red, took antihistamine; about one hour later body aches, chills, joint pain, headache, fever to 101. No breathing issues. NExt morning, feels fever is coming down, but not measured.
pt recv vax 3JUN96 & 19JUN96 pt exp typhoid;reporter felt that the typhoid was not r/t therapy w/MMR vax;
Joint pain, muscle pain, headache, sleep disturbance, neurological signs and symptoms, weakness, neuropsychological signs and symptoms, fatigue, skin rash, agitation, runny nose.
Patient developed fever over several hours post-vaccination and had an apparent generalized seizure approximately 6 hours after vaccination. Observed in hospital overnight. Normal basic blood work and normal CT of brain.  Nurse follow up on 06/18/04 states: "Add: Nasal congestion, rash."
p/vax pt exp mumps on rt side of neck;pt had a sl ear infect, sore throat & had no appetite;pt was afeb;mom noted rt side of face is all red like someone hit here;
I am little sick to my stomach; Dizzy; being dizzy that's a severe allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Jun2021 as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she was little confused, when got her shot yesterday, she was little sick to her stomach and then she was dizzy, being dizzy that's a severe allergic reaction, should she need to call 911. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient received FLUMIST (H1N1) on 11/17/09. Developed left upper lobe consolidated pneumonia on 12/6/09.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Upon internal review on 21-May-2021, the age was corrected to unknown.
pt recvd vax 1130AM & @ bedtime c/o h/a (holding head between hands) stating somethings getting me; also had staring episodes; pt had temp & a little redness @ inject site; ?hallucinations;
was given an adult dose of Hep A. He was 17 years and 2 months old at the time. He had no adverse reactions after this dose.
Ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and PREDNISONE for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced TINNITUS (Ringing in the ears). The patient was treated with PREDNISONE at an unspecified dose and frequency and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in the ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional document received on 25-JUN-2021: Contain non-significant information. No new information.
He fainted 5 minutes after vaccine administration.  After he came to on his own, he starting vomiting. Paramedics were called and took him to the emergency room for further evaluation.
patient stated she always gets a reaction from any vaccine.  She stated she felt nausea, migraine, chills, redness by injection site, blurred vision, low grade fever
A report has been received from a Pharmacist concerning a 35 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Milliliters (frequency not reported). FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported that entire dose went in one nostril of patient which started on 23-Sep-2013 and she did not feel anything go into each nostril. The outcome of the event of ENTIRE DOSE WENT IN ONE NOSTRIL and DIDN'T FEEL ANYTHING GO INTO EACH NOSTRIL is unknown. The report was considered to be non-serious.
Saturday, 10/1 Extreme exhaustion started around 6:30 pm on day of Vaccination., and loss of appetite for 2 days. Sunday, 10/2 Patient had fevers up to 99.5 F off and on during the day.  She also had full body aches, including aching eyes.  Her legs were itchy and she had projectile vomiting twice (4 pm & 11 pm).  She also reported an episodic rapid heart rate.  Monday, 10/3 Patient reports her fever broke and she began having a migraine.  She started having more of an appetite and was able to eat on Monday.  She reports an episodic rapid HR up to 100 bpm/some shortness of breath.  She took some benadryl for itchiness.  She says shes unsure if it could have been related to poison ivy.   Tuesday, she met with teleheatlh doctor. She had episodic heart racing.   Wednesday, she went to the emergency room.  Her heart was racing again.  She had a chest xray and CT scan.  Her heart was okay she says.  They did find a spot on a lung and diagnosed her with pneumonia.
This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (flu). At time of reporting, the outcome was Unknown for the event flu.
Along with severe fatigue that  started the day after the vaccine and lasted one full day, I  also experienced SEVERE EYE PAIN  in both left and right eyes that lasted 5 days. My eyeballs hurt!  The first three days were torture when moving eyes left to right or up and down. It was better to just keep them closed. The fourth day was still painful, but the left eye was less painful than the right and by the fifth day, there was little to no pain toward the end of the day. There were no redness, itching, draining, or swelling just severe eye pain- I was very concerned that I would to end up  with vision problems, or worse, blindness. It was just a miserable 5 days of eye pain- kind of like what eye pain you experience when you have the flu but intensified making you worry  because it's just so painful.  On a scale of 1-10 with 10 being the worst, I would rate the pain over the first 2 days at a 9, the third day at a 7, the fourth day at a 5, and the fifth day started at a 3 or 4 and then went away at some point by the next morning.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH Significant for T2DM, arteriosclerosis of coronary bypass graft, AF, cardiac arrhythmia, sleep apnea, diastolic dysfunction, cerebrovascular accident, hyperlipidemia, HTN. No recent hospitalizations or illness documented. Patient deceased 5/09 with no information regarding death noted. Pt was 69 years of age
That evening states difficulty breathing and heart racing- itchy bumps on legs that worsened through Saturday.   Encouraged to call PCP to speak about incident and about 2nd dose.
Patient reported the following to employer via email on 1/8/20201: "I have been experiencing a reaction to the vaccine all week and this morning it got worse. I called my doctor and they want me to go to urgent care this morning. She told me that 100% of healthcare workers are seeing the same thing 7-10 days after the Moderna vaccination.  My lymph node (armpit where vaccination was administered) is swollen and painful, neck hurts, and have a very low fever.  The vaccination site is swollen, warm, hard and has a red circle below injection site that was the size of a nickel day 1 but now it takes up my entire deltoid region".
My 5 month old woke up screaming, kicking, pinching, Unconsolable. Second bowel movement had blood, I saw bowel at his rectum, taken immediately to Hospital. Diagnosed as intussusception. Failed barium enema, emergent exploratory laparoscopic surgery to correct. Day 2 of hospitalization, reoccurrence with a successful barium enema to correct. 4 days hospitalization with antibiotics flatly and rocephin given. No lead points or etiology visualized during his surgery. Otherwise perfectly healthy, robust and thriving for his age.
Intermittent dry single cough (blasts) even on 6th day thru the day, like feel like coughing once every 15 mins. Never had anything like this before 2nd Dose.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was the day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Patient was underage when we gave her Covid 19 Moderna dose 2. She received dose 1 in center
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (lot number and frequency unknown) (dose regimen and frequency unknown) that was out of temperature and was not supported the in house stability. No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010833 and 1404USA010834 via same reporter link. Additional information has been requested.
Haven't received second dose/Missed step 2 of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Hyperlipidemia, Hypothyroidism, Parkinson's disease, Major depression, Allergy to antibiotic (Sulfa.) and Allergy to antibiotic (Tetracyclines.). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, VALPROATE SEMISODIUM (DEPAKOTE) for Major depression, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Major depressive disorder, ASA for Prophylaxis, METFORMIN for Type II diabetes mellitus.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine). On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) to be not related.    No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-154614 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographic details, medical history, allergy information, concomitant medications added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154614:same reporter case
Developed a small wheal immediately adjacent to both MMR + Varicella injections (opposite thighs)
Flu-like symptoms: fever, chills, body aches, nausea, from Friday afternoon through Saturday afternoon.  Large rash, with swelling and itching on left arm, about an inch below injection site, began Saturday evening and persists through today, Monday evening.
Patient reports that she experienced no issue or discomfort immediately following vaccine administration. She states later that night she was woken up by intense pain in her shoulder/shoulder blade area. The next morning she reports having significant swelling on her left arm at and around the injection site. She reports having sensitivity in her left shoulder/upper arm due to pre-existing nerve issues and associated physical therapy. Continued pain/discomfort of the affected arm caused her to make an appointment with the doctor. Her doctor was unsure of the exact nature of the reaction and suspected it could be related to her nerve sensitivity and vaccine administration in the area. She was advised to utilize ice packs to address the swelling and she reports she additionally used Advil OTC to help with some of the pain. She claims to have some lingering aches in the arm, though the swelling and more intense pain have subsided.
My arm was sore the next day which was fine and then on Tuesday I woke up and fell over, was dizzy until Friday and went to the er I had a horrible headache along the dizziness and they did a cat scan and blood work which all was normal and said it could be the vaccine, 2 weeks as of today and I?m still just as dizzy. I can?t even drive
A few weeks I started to have heart palpitation Went to cardiologist. They ran stress test and sonogram (echo) 14 day heart monitor. Magnesium was given. This lasted till beginning of March. Always had small amount of palpitations but nothing like this.
Child's mother states that pt was a little feverish the morning following her vaccines and that she had some redness at the DTAP vaccine site. Yesterday (06-03-09), mother reports redness/swelling of an area about 3-31/2" across. Mother to call if symptoms worsen. 06-04-09 mother called back this A.M. and states that the area of redness is now about 5" in diameter. States that there is no additional swelling or firmness (induration). Advised her to take child to her pediatrician. She states that she has an appt tomorrow.
Mild, normal symptoms were pain at the injection site and mild headache for several days after.  Some fatigue. 9 days after the injection and several days after all other symptoms seemed to subside, a very itchy injection site, raised and heated injection site and red area around site approximately 2-3 inches in diameter
Swelled up badly from it, my face was swollen and my arms and my back and my chest; Red upper body; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swollen up badly in the face, neck, arms, back and chest, and redness on whole upper body.  The patient's medical history was not provided. Concomitant product use was not provided.  On 15 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that on 16 Jan 2021 he bad swelling in the face, neck, arms, back and chest and redness on whole upper body. Treatment for the event included an emergency room visit with hospitalization and steroids on 17 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced swollen up badly in the face, neck, arms, back and chest and redness on whole upper body, was considered unknown.; Reporter's Comments: This case concerns a male patient, who experienced serious unexpected event of swelling (face, neck, arms, back and chest) and non-serious unexpected event of erythema (upper body). The event occurred 2 days after mRNA-1273 (Lot# Unknown). Treatment included steroids. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
patient began on Wednesday with funny feeling face that then progressed to numbness of the right side of her face. no numbness or weakness of any other extremities.
After getting the vaccine, patient fainted for about 1 minute. Mom told me at that time, this did happen with his flu vaccine in the past. We kept his head between the knees and also laid him down with legs up, he came back to normal within a minute after. Ice pack was also provided per mom's request. Patient felt really good and normal after. We kept them under observation at pharmacy and he was totally normal.
Identified after the patient was administered COVID vaccine that their screening form indicated they were treated with passive antibody therapy for COVID19 within last 90 days.  Administering clinician coached on inclusion and exclusion criteria and who to contact for any questions that are answered opposite expected result.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jun2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: vicodin, reaction(s): "Known allergies: Vicodin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Oct2022 at 15:00, outcome "not recovered", described as "Vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), 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: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).