chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented to ED with altered mental status.  Reportedly normally oriented x4 but currently oriented x1.  No fall or injury. Concern for possible TIA--patient had MRI/CTA head and neck/ECHO that were negative.  More likely that patient with mild dehydration resulting in poor po intake for several days after having had Moderna COVID booster(pt with some body aches/general malaise after getting booster).
Nausea. Started about 10 min after the shot and got progressive worse for the next 2 hours. Vomiting never occured. After about 2 hours it seemed to subside.
Patient presented to MD office with redness at site of injection. MD diagnosed cellulitis and prescribed cephalexin.
Fainting; Vomiting; Shingles R Herpes infection; Rash on the back; A spontaneous report  was received from a consumer concerning a 82- year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fainting (Syncope), Shingles R Herpes infection (Herpes zoster), Rash on the back (Rash) and Vomiting (Vomiting).  The patient's medical history included shingles but not had since 2006.. She received the old Shingles shot in 2006. Now receiving new Shingles shot a year before and later. The patient's current conditions included diabetes and heart disorders. Concomitant medications included,medications for heart conditions and diabetes.   On 04-Mar-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number-unknown) via unknown route on right arm for prophylaxis of COVID-19 infection.  On 18-Mar-2021,the patient experienced, about to Pass out, fainting followed by vomiting-3 episodes. On an unknown date in Mar 2021, she had Shingles R Herpes infection which broke out now. On an unknown date in Mar 2021, she also felt rash on the back. The event  about to Pass out and fainting was medically significant events.  On 18 Mar 2021, the laboratory data included, blood pressure was 128/84 and pulse rate was 94/50 .Treatment information included pain relievers and calamine lotion for rash.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events, Fainting (Syncope), Shingles R Herpes infection (Herpes zoster) and Vomiting (Vomiting) was unknown at the time of the reporting. On an unknown date, the outcome of the event, Rash on the back (Rash) was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
pt exp local swelling w/in hr vax;lt arm turned black & blue;systematic sx began 8/23/99 including inability to clear lt ear as well as throbbing & ringing in ear, dizzy spells, malaise, irritability, extreme joint pain, h/a, numb, vertigo;
it was rpt fr HC facility concerning pt who was exposed to niece who on 6/11/97 was vax & 2wks p/ daughter devel chickenpox, pt devel herpes zoster. addl info req
pt recv vax 2JAN98 1030AM & approx 5hr later @ 330PM devel fever 101 by 730PM fever up to 103-unresponsive to APAP;began crying-moaning then high pitched crying x 2hr;fever lasted 18hr p/shot;
After vaccine, Day #1: right arm swollen, no tenderness (DTaP, IPV). After vaccine Day #2: right arm swelling.
Only sore for a day after previous Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Only sore for a day after previous Moderna shots) in a 71-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Only sore for a day after previous Moderna shots). At the time of the report, PAIN (Only sore for a day after previous Moderna shots) had resolved.            No concomitant information was reported.  The patient stated that he only sore for a day after previous Moderna shots.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666024 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666024:Crosslink-MOD22-028059(Son case)
Eyes started burning after 1 hour of inj. felling dizzy, extreme fatigue, couldn't' drive home.  After sleeping woke up with chills, achy. It lasted 2-3 days before feeling better.  Prone to anaphylactic reactions.
tested positive for COVID-19 with symptoms; tested positive for COVID-19 with symptoms; Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 44 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Jan2021 as dose 1, single (Lot number: 030L20A), on 28Feb2021 as dose 2, single (Lot number: 011A21A) and on 11Nov2021 as dose 3 (booster), single (Lot number: 039F21A), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, on 07Sep2022 as dose number unknown, single; YASMIN. Patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "recovering", described as "Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2023, outcome "recovering" and all described as "tested positive for COVID-19 with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2023) Negative, notes: Nasal Swab; (29Apr2023) Negative, notes: Nasal Swab; (01May2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Six year old child was inadvertently given a dose of Tdap.  No immediate reactions.  Father instructed to take the child to the ER and contact us following the ER visit.  Follow up calls to client for report of any possible adverse reactions.  Parent reports that daughter is "fine" and "ok."  Will follow up on Monday, August 22, 2023 which will be the 7th day.
I got a big oval rash after a week I got my 1st shot. It was red and hot in the infected area. Covid arm
Heartburn; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) and VOMITING (Vomiting) in a male patient of an unknown age 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) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heartburn) and VOMITING (Vomiting). At the time of the report, DYSPEPSIA (Heartburn) had not resolved and VOMITING (Vomiting) outcome was unknown.            Treatment information not provided.
30 min after seasonal flu shot pt got visual hallucinations for 45 minutes followed by temp. 05 fever = 103.0 x 24 hours.
I had the chills 101° fever feelings of nausea , muscle weakness , extreme fatigue had to leave work and slept for 15 hours straight I am currently taking today off to to fully recover
At 12:55 PM-patient noted at doorway of room-patient pale and stated she thought she fainted and hit head against room door-doesn't remember leaving bed to get to door.
did not have second dose of Moderna until 9 months later after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Macrobid), Allergy to animals (dust animals), Pollen allergy, Blood pressure high, Thyroid disorder NOS and Anxiety. Concomitant products included PAROXETINE from 01-Apr-2015 to an unknown date for Anxiety, HYDROCHLOROTHIAZIDE from 01-Jan-2000 to an unknown date, LISINOPRIL from 01-Jan-2000 to an unknown date and METOPROLOL from 01-Jan-2000 to an unknown date for Blood pressure high, LEVOTHYROXINE from 01-Jan-1995 to an unknown date for Thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose). On 16-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose) had resolved. Not Provided          No treatment medication was reported.   This case was linked to MOD-2021-287478 (Patient Link).
On 12/19/18 patient returned to Employee health stating 2 hours after Tdap given on 12/18/18 her chest began to itch. She took an ALLEGRA which did not help. She states a few hours later she developed hives on her upper chest and hairline. She took a BENADRYL, went to bed and when she woke up in the AM on 12/19 the symptoms had resolved. There was no issues at the injection site; she states the area where the BAND AID was slightly reddened but no swelling or pain.
Arm (deltoid) swollen. About 5 x 5 inches red and puffy. Feels warm to tuoch. Painful.
Fever up to 100.4, extreme whole body pain/aches in joints,  headache, fatigue.
3-4 minutes after getting the vaccine. Suddenly my throat felt like my throat was swelling up. Shortness of breath, and palpitations. Lasted about one minute and then I was fine.
Child received DTaP injection for school requirement. No unusual events noted. Mom noticed redness with pain the next day. Today child has a 65x80mm area of redness with induration on upper right deltoid.
1. Severe insomnia (meaning CANNOT get to sleep at all) for three nights (6/29, 6/30, & 7/1). Poor sleep continued until recently. 2. Had a feeling of elevated heart rate during the period of insomnia. 3. Nausua for awhile, then "bloated stomach" feeling and loss of appitite until it finaally subsided around 8/1.  4. Feeling extremely fatigued. This also seemed to finally improve around 8/1. 5. Frequent urination. Meaning having to urinate almost immeditedly following a previous urintion. Except there was little or no flow. This too seemed to inprove around 8/1. 6. Unusually runny nose. This has also gradually improved.
Patient is complaining of fatigue, generalized body ache, fever, sore throat, nausea, vomiting, diarrhea.
pt recv vax & exp limited rang of movement, weakness, discomfort & tingling in arm p/vax;pt c/sx about 1mo p/vax;duration of these sx not reported;pt sought hosp attention but not admitted;pt exp pain;
Headache, Myalgia, Angioedema, Nausea Vomiting,   INJECTION SITE PAIN, EXTREME  EXHAUSTION   Narrative:    Other Relevant History:
This spontaneous report was received from a health professional refers to a patient of unknown demographics. Pertinent medical history and drug allergies were unspecified. On 23-MAR-2015 the patient was administered with 1 dose of improperly stored (Oka/Merck) VARIVAX, .5 ml, subcutaneous. Concomitant medications were not provided. No adverse effects were reported. Reporting health professional considered the adverse event to be related to (Oka/Merck) VARIVAX. Additional information has been requested.
I received this vaccine at 12:30 PM and by the following day February 12 at 4:30 in the morning I woke up with a high fever sweating and shaking uncontrollably I got in the shower and this helped along with some Tylenol I went to work that morning and was sent home due to my appearance  and  rested that day. A very scary experience I though.
Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after first vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:32 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.04 for dose administered on 27-OCT-2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion 27-OCT-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 32 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge 29-SEP2021 and 05-OCT-2021 and beyond use date for the vial was reported as 29-OCT-2021 and 04-NOV-2021. Product moved to clinic on 27-OCT-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient called pharmacy around 4:15pm and said that her arm was really sore. She described it as her entire arm being sore. Vaccine administrator recommended that the patient take some OTC pain reliever and to follow up with us on 10/15/15 if the pain continued.
Chills (from 10:00pm-12:00am), fever of 104.6F (from 10:00pm-7:00am next morning), rapid heart rate (10:00pm-7:00am next morning).
Received shot 11/25/03 at Okubo Clinic in left shoulder (smallpox vaccine). Not primary vaccine. Also received Typhoid, tetanus booster, and had PPD placed few days prior. First noted itching at local site then feeling warm at site. Couple days later noted bumps in pectoral area on 11/30/03. Then noted back area, started itching. Also felt warm/fevered on 11/30/03. Some odynophagia and congestion on 12/1/03.
This spontaneous report was received from a physician refers to a 33 years old nurse student. The nurse student was vaccinated with two dose of MMR II on an unspecified date (Lot #, dose, route unknown). It was reported that at the time of reporting, on 20-JUL-2012, the patient has a low antibody titer to mumps. At the time of reporting, the outcome of low antibody titer to mumps was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Last weekend my child came home for the weekend and he had stayed at my house. He found out his girlfriend tested positive for COVID, and so did he. My husband then tested positive and then I did. The symptoms I have are a mild sore throat, a mild cold and some fatigue. If I didn't test positive on Friday, I probably would have just taken some Sudafed and gone to work.
Extreme muscle and joint pain in my back. Pain was excruciating to the point I couldn't move without screaming, particularly when lying in bed. This extreme pain lasted 4 days and currently have less severe symptoms at this time. Also had reoccurring chills.
Sore left arm the first evening. The next morning I woke with a fever and chills with a temp of 99.7 degrees fahrenheit which stayed around that number for about 48 hrs. I also woke with body aches which lasted about 48 hrs also. I also had a mild headache which would come and go.
Itchy and uncomfortable; Raised hives on the stomach, arms, and eyelids; Elbows felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Elbows felt itchy), FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 31-Jan-2021, the patient experienced PRURITUS (Elbows felt itchy).   On 01-Feb-2021, the patient experienced FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 02-Feb-2021, PRURITUS (Elbows felt itchy), FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
11/13 AM - not feeling well. By afternoon, had headache, nausea, dizzy, fever of 101.4 degrees and weak. Went to ER, they said "classic flu signs" but cultured neg. Gave anti-emetic & fluids. Noticed 3" x 3" red spot at injection site. 11/15 - went to primary doctor because rash spreading on entire upper arm. Started on CIPRO 500mg twice daily. 11/15 - no longer nauseous, feeling a little better, but still very tired. Treating with ice, TYLENOL, ALEVE and lots of water.
Patient received immunization on 10/29/04. Then on 11/2/04 had seizure episodes.  Follow up: The pt is a 2 month old male who was admitted to a seizure episode. On admission a CBC and blood culture and CSF status and culture were done. The pt was started on Rocephin and ampicillin. A pediatric neurological consultation with Dr. was done who recommended an EEG whicih was done and was normal. A CT of the head revealed prominance of the CSF spaces in the bi-frontal region representing a small subdural hygroma as well as a TORCH titer. During the hospitalization, there was no recurrence of seizures. There was no fever. The pt continued to be active, feeding well and when the blood and CSF cultures were negative at forty eight hours, the antibiotics were discontinued. The pt was discharged home. The physical examination on discharge reveals the baby to be generally awake, not in distress. HEENT showing the anterior fontanelle open, soft and flat. The oropharynx is clear. Normal tympanic membranes. Lungs clear to auscultation. Good air entry. Heart has regular rate and rhythm. No murmur. Abdomen soft. No hepatosplenomegaly. Nontender, non distended. No guarding. Extremities are well perfused and moves well and equal. Neurological showing no focal deficit.  Discharge instructions: As per the discussion with the neurologist, subsequent immunizations with pediatric DT, continue breast feeding and formula feeding ad lib. Seizure precautions. Follow up in our office on Nov 8, 2004 or sooner for any problem or concern.
The first sign of an issue was a stiff neck and lower back ache.  It never went away.  My husband could handle those symptoms until mid October when the stiffness was the worst in his shoulders/deltoids, groin, legs and one knee.  Symptoms were debilitating.  Couldn't get in and out of bed, stiff for hours until a bath helped to get his day started.  After bath still in pain - a lot of pain.  Researched and discovered that shingles vaccine could have very serious side effects - one of them being polymyalgia rheumatica.  Went to family doc who did blood work.  Blood work came back showing inflammation.  Our family doc put me on prednisone on 11/20/12 for 6 days starting at 60 mg then going down to 10 mg the last day, 11/25/12.  The next day the same symptoms were back but not as strong but within hours the pain and stiffness got progressively worse as the hours passed.  My husband called our doc and she put him on 5mg per day.  It helped only very, very little, so on 11/27/12 the doc increased the prednisone to 10mg which is relieving the pain enough that my husband can function right now.  We have a rheumatologist appointment in January to see what the diagnosis is.  The below question can't be answered yet because we don't have a diagnosis or an exact cause.
Pt vomited 5 minutes after administration of flu vaccine. No hives or SOB. Pulse = 64.
Patient experienced an rapid increase in body temperature with a rectal temperature of 103.6F registered at approximately 5:45pm on 2/1/2018. At approximately 5:50pm, patient experienced a Febrile Seizure which had convulsions of less than 2 minutes followed by approximately 2 minutes of non responsiveness. Patient did not stop breathing, but was unresponsive to vocal commands and did not focus attention from his blank gaze. Within 5 minutes, patient was fully responsive and began chattering and crying. At approximately 6:45 when we arrived at the urgent care facility and his temperature was taken temporally, he registered 99.9F with no introduction of fever reducing medications being given.
mom states lt deltoid muscle swelled & reddened to baseball size area; pt c/o pain as well; pt taken to MD who felt bacteria may have been injected w/vax-(to mom's understanding of MD's statement); pt on ATB 20APR95; 25APR95 pt back to nl
Erythema and pruritis of right bicep. Temporary itching relief from topical steroid. Improved when added cetirizine 10mg QD.
about 12 hours after administration- knees down to feet were paralyzed for about 4 hours.  she had trouble walking all day and for the following week but paralysis is improving and she is starting to get stronger. she now has no taste or smell with no current improvement. She states herpes simplex was also exacerbated by vaccine and now has an active infection. She may have had a potentially lesser case of guillien barre syndrom per partient's son who is a physician.