chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gastroparesis; Mild Gastritis; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) and GASTRITIS (Mild Gastritis) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criteria hospitalization and medically significant) and GASTRITIS (Mild Gastritis) (seriousness criterion hospitalization). At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis) and GASTRITIS (Mild Gastritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: abnormal (abnormal) mild gastritis. In 2021, Helicobacter test negative: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment included an unspecified proton pump inhibitor (PPI).  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Symptoms started evening of the day she received the Flu Mist. Headache and sore throat that evening. By next morning very stuffy head, severe sore throat dizzy and low grade fever. Temp of 100. These symptoms lasted 4 days. She took Tylenol and throat lozenges.
A physician reported that a 41 year old female received an inadvertent Intradermal injection of Pnu-Imune 23 in her forearm on 10/24/00. PPD was to have been administered. Within 24 hours, the pt experienced diarrhea. Additionally, she experienced total body discomfort, serum sickness symptoms and swelling at the injection site, described as a "quarter-size" local reaction.
This report describes limb swelling in a 5-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This reort was received from the subject's mother and has not been verified by a physician or other healthcare practitioner.  The subject was described as a "healthy child" with no relevant medical history or concurrent medications.  On 01/29/2003, the subject reportedly received his first injection of Infanrix administered in the right arm.  The mother stated that one hour later, the subject's "arm swelled up between shoulder and elbow.  [The] size doubled, very red, hot and itchy, and [the child was] fussy.  Swollen for five days and still somewhat obvious."  Reportedly, the subject was seen by the physician.  The mother stated that no follow-up treatment was provided; the physician reportedly only advised the mother to "watch it for any further problems."  The mother considered the events to be probably related to Infanrix administration.  As of 02/10/2003, the events had reportedly improved.
Beginning 9/29 -Patient describes not feeling well - headache, body aches, sore joints, sore abdomen, and a cold sore on her lower lip.   She states a fever of 100.8.  She took Tylenol and ibuprofen that controlled her fever and body aches.   As of 10/3 she was fully recovered.
Only site of injection pain.; We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Only site of injection pain.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered) 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 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered). On an unknown date, the patient experienced VACCINATION SITE PAIN (Only site of injection pain.). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We received a third Moderna covid vaccine on Sept.1, 2021. Our second shot was administered) had resolved. At the time of the report, VACCINATION SITE PAIN (Only site of injection pain.) had resolved.            No concomitant product use was provided by the reporter.   No treatment medications were reported.  During the time of reporting, the reporter stated that her husband is fine.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-141325:Wife case
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 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 43 years, 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: "Asthma" (unspecified if ongoing); "known allergies:Ivp dye" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (17Jan2023) Negative, notes: Rebound COVID case 4 days after testing negative after COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started from 11Jan2023 to 16Jan2023.   Clinical course: Rebound COVID case 4 days after testing negative after COVID. Other medication in 2 weeks product: Pulmicort (Budesonide) - Brand: AstraZeneca.  No follow-up attempts are possible. No further information is expected.
Severe arm pain Saturday and Sunday with the pain being tolerable Monday. I also had chills and body aches for 8 hours but no fever
Joint pain that started in feet, wrists, hips around 5:00 pm. This was followed by an ever increasing headache, body aches. By about 8:00pm started to have extreme chills, headache got worse, body aches increased. Took temperature around 10:00pm 101.8 F. Took ibuprofen for pain. Took temp again around 2:00 am:  100.6 F.  At 8:00am, still had headache, body aches fever of 101.1 F.  Very tired.  Took 600 mg ibuprofen at 9:00 am. Helped with the headache. Not much of an appetite. No energy.
This spontaneous report as received from a nurse refers to a multiple patients of unknown agea and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042171 expiration date 19-SEP-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010515:
Starting on the day of the 1st dose vaccine, I started feeling dizzy.  The next day, I started to have flu-like symptoms.  I had fever, cough and feeling very achy.  I went to see the doctor and was advised to let the vaccine run its course.  I started to feel better a 3 days later. It took about 4 days to be fully recovered.
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control.  Bp normalized with Clonidine , neurological exam is stable.  Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin.  Discharge after 24 hours
For 4 days had severe arm pain (left) and on 3rd day developed muscle cramps, abdominal pain. Also had chills, no fever. The symptoms were off and on for about a week. On the 3rd week after the vaccine, I noticed a swollen and painful to the touch lymph node under my left armpit. I still have it but it has been diminished in size it is much smaller and it just hurts if I apply pressure.
Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; Received the first dose of vaccine almost three weeks ago and developed COVID-19; illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in 2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife received the first dose of vaccine almost three weeks ago and developed COVID-19 on an unspecified date in 2021 and their primary doctor said to delay second shot because of illness. The patient's wife wanted to know if this was okay. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021331412 Same reporter, drug, and events; different patient
1 hr later pt had c/o pain, burning & tingling down to the elbow from lt deltoid muscle on 19OCT98;20OCT98 c/o arm being warm to touch & pain w/movement down to elbow;bruising on site;inflamed deltoid;throb & ache;warm to touch;
Received Varivax 12 days prior to mom noticing the immunization site turning red that progressed over 24 hours to a 1 inch blotchy red rash all around the site. Remains Afebrile; Does not itch or bother the patient Mom states sites feel  "hard and bumpy"
Body aches, low back pain, minimal nausea, redness and swelling around injection site noted 2 days after injection
This case was reported by a other health professional (patient) via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at left arm. After receiving SHINGRIX, the patient had pain in her arm at the injection site and felt tired. This is 1 of the 5 cases, reported by the same reporter.
7yo presented for COVID vaccine only.  A vial was open on both prep trays in the med room. Staff member #1 drew up given 0.2ml dose from Pfizer-BioNTech COVID 19 in med room. Staff member #1 handed this syringe off to #2 to administer in room. Staff member #2 administered the vaccine and pt left. Staff member #2 was charting the NDC/lot/etc and noted the vaccine was not the correct dose. Staff member #2 noted that a 12 yr old and older bivalent COVID 19 vial was opened on both trays. That is when the med error was noted.    Pharmacy was called: as pt should have received Pfizer-BioNTech 5-11 yr old Bivalent COVID 19 vial.  Pharmacy reported that there should be only mild side effects if any with this error.  Parents of the child were notified of the error and concern to monitor for. The NDC and lot info was not entered until after the child had received the vaccine.  This is when the error was noted.
Pt reports soreness in left deltoid after vaccines 1/17/12 which subsided then on Saturday 1/21 began with redness, itchiness, swelling & warmth. On 1/22 went to ER redness was 4x5 cm. Was started on Doxycycline was discharged & then returned back to ER & was admitted waiting cultures. Denies fever.
Increase in muscular and joint pain; partial loss of hearing in left ear; eventual diagnosis of psoriatic arthritis; no cause found for hearing loss.
Patient fainted after he received his first dose of vaccination. No hospitalization needed.  Vital signs taken.
nausea, vomiting, extreme chills, body ache, high temp, breathing problem
Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (was on anti-diabetic medicine.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medication included was anti-diabetic medicine. The treatment information was not provided.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: heart attack
fever, swollen neck glands, h/a, nausea, dizziness, blurring of vision; stiff neck;  pos meningeal signs; Labwork bloodwork, LP;
Vaccine booster administered 11/12/2021. Expiration date: 11/07/2021. Mistook expiration date to be 11/17/2021. No adverse event or outcome to recipient.
Caused servers flare- severe swelling of all joints, ligaments, and intense pain, migraine, as well as a cold sore on my lip. ER gave me steroids and pain med and I?m treating the cold sore with valtrex rx.
after shot was given, realized they were given intramuscular and they were supposed to be subcutaneus. we called manf and they said not necessary to redo the shot. pt notified.
No adverse event to report per MOC. Child was given a non-constituted dose of Covid 5-11 orange cap vaccine.
I started hurting under my chin on both sides below my jawline and where my collar bone is on both sides. My collar bones and my sternum area on both sides. Maybe they were lymph nodes, but they were consistent on both sides. I looked up symptoms on Day 10 and sore lymph nodes came up as a side effect after the vaccination. I took Tylenol and a heating pad on me. Sometimes during the day were more painful than others. To where it really hurt. That pain lasted all the way through after the 2nd vaccination as well. February 23, mammogram. Read online that I shouldn't have had a mammogram after vaccine for 6-8 weeks, but nothing showed up. That just continued into my 2nd vaccine. Pain increased on Day 5 after 2nd vaccine. Inner sides of trunk at the side of arms were new pain on both sides. Pain continued for weeks. Every once in a while, it still pops up, still sometimes reoccurs. Wasn't as painful as before, but it's an uncomfortable feeling that I'm well aware of. I did not make an appointment for this pain, but the last time I saw my PCP or PA, I noted that at the appointment. I mentioned this to my GYN and she said others reported this as well. Mentioned this health event at a regular checkup.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, County took the following steps: ? Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  o A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
This is my 2nd dose. The first one was about six months ago, August timeframe. That time, only my arm hurt. This round, my 2nd, the arm hurts a bit again, but this time I feel chilled, maybe a little weak. This started about 8-9 hours after this dose.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; BODY ACHES; RIGHT ARM PAIN; DIFFICULTY IN SLEEPING; HEADACHE; FEVER AROUND 100F; This spontaneous report received from a consumer concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025, and expiry: UNKNWON) dose was not reported, administered on 22-MAR-2021 16:00 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced body aches, right arm pain, difficulty in sleeping, headache and fever around 100 F. On 05-APR-2021, the patient had an antibody test and no antibodies were shown in the test which suspected immunological vaccine failure. Laboratory data included: Body temperature (NR: not provided) around 100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever around 100F, body aches, and right arm pain, and the outcome of difficulty in sleeping and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 06-Apr-2021: The following information was updated and incorporated into the case narrative: AER at units, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: personnel units present, reporter details, patient's demographics, additional event of suspected immunological failure, causality updated; facility type and flag updated, labelling, and case level outcome. 20210344672-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
The mother honked the horn to summon help. Pt was in the vehicle and was looking very pale, white lips, weak, clammy, and slightly disoriented. Pulse was thready and in the 50s. Employee called 911 around 1220/1225. EMS evaluated patient. Color returned to face, pulse improved, and patient was alert and oriented. Mother advised by EMS to take patient to ER if condition changed again. Mom took patient home. Patient was monitored for 30 minutes after event. No further intervention needed.
Pt had cellulitis at injection site of pneumovax (left arm).  Redness and swelling began one day after injection.  Was seen in the office 2 days later and given dicloxicillin for 10 days
6 days post vax fever 102.4, runny eyes, runny nose, nighttime congestion, saw MD suspected rxn; 8 days post vax started rash on body;
My daughter was given her 2nd COVID shot at approximately 9:00am on 4-16-2021. We waited 30 minutes after the shot. No issues. That evening at approximately 6:00pm, she had a red rash on her upper chest and throat. She stated that she was having a hard time breathing and swallowing. I gave her  a Benadryl tablet and watched her for approximately 15-20 minutes. she continued to feel tightness in her throat and said it burned when she swallowed. She confirmed again that she felt her throat was swelling. I drove her to the closest ER located at. My daughter was seen and it was determined that she was having an allergic reaction. DR recommended continue Benadryl tab every 4 hours for the next 12-24- hours. We were discharged to home. I administered another does of Benadryl at approximately 10:15pm. My daughter went to sleep. I woke her up at 3:00am to check on her and she stated she did not have a rash and her throat was fine. She was running a low grade fever of 100.5. I gave her 500 mg of Tylenol for the fever. When my daughter woke later that morning at approximately 8:30am, she still did not have a rash or throat swelling. Her fever was gone.
First symptom was an ache in the abdominal area which began 12 hours after infection of the flu vaccine.  The abdominal discomfort woke up the patient and he remained uncomfortable with this for a few hours and then it subsided.  Chills and Fever of 101.6 degrees farenheit began about 8 hours later or approximately 18 - 20  hours after receiving the flu injection.  Chills and fever remained for 3 days.  During this time the patient had almost no appetite but would drink orange juice.  The chills and fever disappeared at the beginning of day 4 and his appetite and some energy returned.  On day 5 (today) a low grade fever of 99.6 degrees is present and he feels very weak and cold again and he does not have an appetite.  If he is still the same tomorrow I'm taking him to our Internist for evaluation.   Unknown resolution at this time.
Child slept for more than 6 hours immediately following vaccination, and ran fever for 48 hours (from Friday to Sunday).  Was not eating/breastfeeding as normal.  Parents were unaware that the flu shot contained eggs.  Child obtained allergy to eggs following vaccination and now has an Epi-Pen for allergy to eggs.
BODY ACHES; RUNNY NOSE; MILD FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, runny nose, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, mild fever and runny nose was not reported. This report was non-serious.