chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ0A1) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
Onset of a feeling like I was drunk the afternoon of the vaccine.  The evening on 3/9 sleeping was difficult and I was very restless. When I awoke the next day (3/10) the only symptom was pain at the injection site. The afternoon of the 10th I began to experience flu like symptoms and was lethargic. No fever but did have chills. Slight headache. Awake the morning of 3/11 and symptoms had subsided.
MARCH 9: BODY ACHES AND HEADACHE, SLEEPLESSNESS.  CONTINUED OFF AND ON OVER FOLLOWING DAYS. MARCH 18:  BLOOD PRESSURE AND PULSE WERE TOO HIGH TO DONATE PLASMA MARCH 21: DIDN'T FEEL NORMAL, GASTROINTESTINAL ISSUES, FATIGUE, SLEEPLESSNESS, ABDOMINAL PAIN, RAPID WEIGHT LOSS, LOSS OF APPETITE MARCH 26: URINE STARTED DARKENING TO ORANGE COLOR DESPITE STAYING HYDRATED, FEVER, MALAISE.   APRIL 1: WENT TO DONATE PLASMA AT BIOTEST PLASMA CENTER AND NOTICED BLOOD PLASMA WAS AN ODD COLOR. APRIL 4:  EMERGENCY ROOM PRESENTED WITH ABDOMINAL PAIN, JAUNDICE, WHITE/LIGHT COLORED STOOL. BLOODWORK, ULTRASOUNDS, CT'S WERE DONE AND SHOWED INFLAMMATION IN LIVER/GALLBLADDER/GI TRACT.  HIGH BILIRUBIN. APRIL 5:  COLONOSCOPY PERFORMED.  DIAGNOSIS:  ULCERATIVE COLITIS.  ERCP PERFORMED WITH LIVER BIOPSIES.  DIAGNOSIS:  COMMON BILE DUCT BLOCKAGE WITH CHOLECYSTITIS AND HEPATITIS.  STENT WAS PLACED.  POSSIBLE PRIMARY SCLEROSING CHOLANGITIS- DEPENDING ON BIOPSY RESULTS. APRIL 6:  CHOLECYSTECTOMY, MORE LIVER BIOPSIES TAKEN. APRIL 7:  LIVER BIOPSY RESULTS/DIAGNOSES:  OVERLAP SYNDROME OF AUTOIMMUNE HEPATITIS & PRIMARY SCLEROSING CHOLANGITIS.  PLACED ON PREDNISONE.  AWAITING APPROVAL FOR REMICADE INFUSIONS WITH POSSIBLE NEED FOR LIVER TRANSPLANT IN THE FUTURE AS PSC PROGRESSES. AS OF APRIL 18:  JAUNDICE STILL PRESENT, BILIRUBIN NOT DECREASING.  BEING REFERRED TO MEDICAL CENTER FOR FURTHER OBSERVATION AND TREATMENT.
6MAR97 pt recv vax;10MAR97 phone call to office by mom-states pt broke out w/little bumps to abd & all over;red raised;no fever;tx DPH for itching;recheck 18MAR97;
Client stated that:  Left shoulder pain started one day after flu vaccine.  Level of left arm pain increases along with burning, tingling  and numbness started at left arm radiate to fingers as days progress.   left hand has difficulty movements and can't move  backward. 12/4/2019  Was seen by MD.   Meds given.  X-Ray scheduled next week.
Slight fatigue; Soreness at the injection site after a couple hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 17:00 (Lot number: EP6955) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number: EP6955,, administration time: 05:00 PM,, vaccine location: Left arm,, dose number: 1), administration date: 18Mar2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "Soreness at the injection site". The following information was reported: INJECTION SITE INFLAMMATION (non-serious) with onset 08Apr2021 19:00, outcome "recovered" (09Apr2021 07:00), described as "Soreness at the injection site after a couple hours"; FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered" (2021), described as "Slight fatigue". Therapeutic measures were not taken as a result of injection site inflammation, fatigue.  No follow-up attempts are possible. No further information is expected.
Severe headache and dizziness and told that to my doctor and she gave me an additional blood pressure medicine but my blood pressure was still high and i went to the ER. The ER doctors sent me home without medicine but my blood pressure was still high. After three or four weeks later it became normal
At appt for bivalent Moderna booster 2/17/23, pt reports last COVID vaccine shot, Moderna booster, in first 5 minutes felt dizzy, felt like BP dropped and was about to faint. Was not mentioned at time of vaccine. Pt given Moderna bivalent booster 2/17/23 in supine position and observed for 30 min. No adverse reaction noted.
Imovax given IM on 9-11-07 to employee of office. This is booster dose 7 yrs after initial dose in 2000. 7/24/07, hives and urticaria started on buttocks. 7/27/07, spread to wrist and past abdominal area. 9/24/07 9 pm, pain (R) arm w/burning approx 40 min. Took Baby Aspirin and Benadryl. 9/27/07-still w/hives and urticaria as above, but better. No new symptoms. No headaches, nausea, dizziness.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old female patient. On 13-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
pt recvd vax & exp urticaria, redness & stinging in the arm of the inject;
Rx Heart Failure (L bundle branch block with 25% ejection fraction found in 7/2022 by MD via an echocardiogram) Symptoms: extreme SOB, lethargy angiogram done no blockages in cardiac arteries
Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). This nurse reported in response to HCP letter sent via follow-up letter which included that a 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via intramuscular, administered in deltoid right on 21May2021 at 15:00 (vaccinated at the age of 55 years) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination facility type was other and not administered at facility. Medical history, prior vaccinations and concomitant drugs were none. Family medical history includes Heart disease and diabetes mellitus (DM). The patient experienced soreness at injection site on 21May2021. First vaccine adverse reaction except arm soreness at injection site. Relevant tests were none. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a researcher, and refers to an unspecified patient of unknown age and gender. Concurrent condition or medical history were not reported. On 28-FEB-2015, the patient received an improperly stored dose of ZOSTAVAX lot # K007548; Exp date 23-AUG-2015, subcutaneously (strength, dose #, dose and anatomical location were not provided). There was not concomitant medication reported. No adverse experiences were reported. There was not a product quality complaint involved. At the time of the report, the outcome of incorrect product storage was unknown. This is one of several reports received from the same reporter (1507USA005687 and 1507USA005686). Additional information has been requested.
Complaints of itching, noticed redness on both sides of injection.   Swelling at injection sight.  Cool water bottle given to help with redness and itch. Relieved within 5 minutes.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share,  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 02-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
-9:30am patient reported feeling shaky, chest pain and pressure.  - 9:40am 911 was called and assistance from leaders requested . -patient with h/o diabetes, hypertension, stage 4 kidney failure, "cardiac problems". sees Dr. Did not eat prior to coming for vaccine until right before receiving it. -Patient seemed slight pale on forehead, appeared shaky, but oriented to time and place and alert at all times and able to answer all questions. bp 144/90, p74, RR16, O2SAt 100%. -9:42am emergency sercive arrived. 9:48am ECG did not ID any cardiac event at the time pain 8/10, per the paramedic. Glucose 89, bp 128/69. 9:53am chest pain rated 7/10, 10:00am chest piin 6/10. -paitent monitored by paramedics
One week after 2nd dose noticed left ankle and calf area swollen much larger than right ankle.  Slight pain and tightness in left upper chest, upper back, and into left arm occurring often.  Symptoms have persisted for over a month.  Was checked for a blood clot in left leg but results were negative.  Seeing my doctor for additional tests, probably an echo next.  Symptoms have persisted daily since about one week after the 2nd dose.  Concerned symptoms are consistent with myocarditis.
February 2, 2023, my vision turned into a kaleidoscope. The doctor advised me to go to the ER. I was told I was having an ocular migraine. On February 14, 2023, I could feel my heart beating very heavy. I had another ocular migraine the next day. I got a chill over me and getting a headache and was feeling shaky. I tried to take my blood pressure. I called the ambulance and went to the emergency department. They found bradycardia. My heart rate was down to 46 beats per minute. I was given a monitor for a week on my heart. It showed I am having heart palpitations. I have an appointment with a cardiologist at the end of April.
Covid brain (fogginess, focus issues, confusion, memory issues) severe within the first day, then moderate on day 2, then mild on day 3-4.   gut dysbiosis starting on day 3, followed by increasingly worse diarrhea. I am unable to digest food from day 3- day 8 (today.)
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 48 year old female patient who received BOOSTRIX (batch number 4BN7L, expiry date 2019) for prophylaxis. Concomitant products included TWINRIX. On 21st June 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness to be related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX on left arm. The pharmacist said that one of their patient's was still having tenderness at the injection site. The patient was also given TWINRIX on that same day. However, the patient's symptoms were on the same arm where the patient received BOOSTRIX.
Patient with previous reaction to 1st dose of Pfizer and states did not have reaction with 2nd dose. After 13 minutes post vaccination, patient had a repeat of symptoms which included increased heart rate, elevated blood pressure, dizziness and strong urge to pass out. Patient states he did not pass out either vaccine. Patient kept in office post vaccination for 1 hour and vitals monitored. At the one hour mark, patient was back to near baseline and able to ambulate to car as wife drove to pick him up and take him home. Patient stated that the first dose with these symptoms lasted a little over an hour as well.
I'm not sure of the Flu shot so I just checked the top one.  I had both shots the same day.  By the next morning I felt like I had the flu and was extremely tired.  I also started experiencing menstrual  cycle symptoms.  I had bloating, cramps, headache and spotting for 5 days.  Almost exactly a month later it came back and I had spotting for 8 days.  My doctor was contacted (not my primary but my Nurse Practitioner) and she suggested I let her know if it continues.  After the second month they made an appointment to do another PAP.  I have not had a period in 15 years.  This happened the next day after my 3rd shot which is too coincidental.
Pt reported glossitis, "racing heart", and eye tearing 4 minutes after vaccine administration. Assessed HR at 121 initially; down to 74 after 20 minutes of rest.
Evaluated in Health Services for complaints of SOB on 4/13/21, states he felt 'winded and weak after the 2nd moderna vaccine."
Due to my Pericardial Effusion my cardiologist has been monitoring me twice a year for 18 years. After receiving the 3rd dose of moderna my cardiologist began to express concern about the size of the effusion.  I had an echo cardiogram with him 11/01/2021 and from that point on he wanted to see me monthly which is very unusual. After multiple months of monthly echocardiograms my cardiologist decided that he wanted me to undergo a  pericardiocentesis to address the size of my effusion. That was done on 3/30/2022.  Since then, the effusion has returned somewhat and my doctor wants to continue monitoring. He also ordered a blood test to inquire the level of my antigen load because he would prefer me to hold off on getting any more Covid vaccines unless it is absolutely necessary. I am awaiting the results from that blood test.
Patient received vaccine and is less than 18 years of age.  EUA is for 18 years of age and older.
The adverse effect is that I've had lower back pain on my left side for a week now.  Haven't seen a Dr. yet, but will soon if it persists.
Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported product excursion was occurred on 10-Mar-2022. Storage condition at the time of the excursion was reported as refrigerator. Max temperature reached was 64°F. Excursion duration was approximately 7 hours. Three was no changes in visual inspection. It was reported patient had not any adverse events post injection.  No treatment information was reported.
exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (outcome: Live, full-term birth none complications) from August 2015 to 13-May-2016, Pregnancy (outcome: Live, full-term birth none complications) from October 2017 to 31-Jul-2018 and Alcohol use in 2020. Concurrent medical conditions included Gestational diabetes. Concomitant products included DOCOSAHEXAENOIC ACID (PRENATAL DHA) for Pregnancy, PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Aug-2020 and the estimated date of delivery was 11-May-2021. On 22-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 22-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Glucose tolerance test: failed (Inconclusive) failed. On 10-Feb-2021, Glucose tolerance test: failed (Inconclusive) failed. On 01-Sep-2021, Pregnancy test: positive (Inconclusive) positive. On 28-Oct-2021, Ultrasound foetal: normal (Inconclusive) normal. On 16-Dec-2021, Ultrasound foetal: normal (Inconclusive) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that her Father is a diabetic.   This case was linked to US-MODERNATX, INC.-MOD-2021-082277 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received contains NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082277:Case for dose 2
tingling @ inject site & feeling of vax migrating are reported in a pt who recvd flu vax;
Very dilated right pupil; A report was received from a health care professional concerning a patient female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event very dilated right pupil.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Soon after they experienced the event of very dilated right pupil. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, very dilated right pupil was unknown.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious unlisted event of very dilated right pupil.  Based on the current available information and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Blotchy redness at injection site beginning less than 5 minutes after administration of VARIVAX.  C/O intense burning.  Gave Benadryl dose orally.  More comfortable (pain gone) and rash nearly gone in < 10 minutes).  No other symptoms.
Began itching, especially on neck. In the morning noted red rash on chest and neck. Itching persisted. Denied difficulty breathing or swallowing. Felt well other than rash.
Hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of bnt162b2 (BNT162B2, Lot Number: ER8737), via an unspecified route of administration on 31Mar2021 (received at the age of 20-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The COVID-19 vaccine was administered in a Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient was not pregnant at the time of vaccination and adverse event. There was no relevant past drug history or known allergies to report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced hearing loss in right ear on 01May2021. The event resulted into a Physician Office Visit. The patient underwent hearing test and MRI (magnetic resonance imaging) on an unspecified date. Therapeutic measures were taken as a result of hearing loss in right ear which included steroids. Outcome of the event was not recovered. The reporting consumer assessed the event as serious (disability). The patient has not been tested for COVID-19 since the vaccination.   Follow-up attempts are completed. No further information is expected.
pt recv vax 10DEC97 & exp sore arm & felt feverish;
developed severe, arthritic event in right foot, soon after it spread to my right arm down to my fingers, debilitating and swollen, hot to touch, can't turn door knob, frozen. Severe RA reaction.
Patient had c/o nausea and lightheadedness approximately one minute after administration of Gardasil. Pt laid down and applied cold compress to neck and forehead. Symptoms persisted for approximately 15 minutes and began to improve. Of note, patient also presented back to office on 07-25-07, 5 days after injection with severe LLQ pain and diagnosed with hemorrhagic ovarian cyst. Patient also received Menactra that day but not until after all s/s had cleared. Gardasil was given first.