chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Primary reason for the visit today is local injection site reaction to COVID-19 vaccination.  A little over a week ago, she had a COVID-19 vaccine.  But 1 to 2 days ago, she start developing redness and warmth in the left upper arm around the injection site.  It started out kind of splotchy and slowly coalesced over the course of 24 hours.  She shows me a picture from yesterday afternoon where most of the left upper arm is red and slightly swollen.  Since yesterday afternoon, her redness and swelling has steadily gotten better.  She has some mild light pink discoloration and swelling in the area at this point.  Overall, I would describe this is a mild event.  She took a Claritin yesterday which seems to have helped.  No associated fever, pain, hives, mouth swelling/throat tightness/shortness of breath/wheezing.
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Fever of temperature up to 102.4(fahrenheit) began three (3) days after immunization and lasted for four (4) consecutive days. (fever reduced to 99.2 after administering Motrin or Tylenol).  Temperature after four days and no administration of fever reducer dropped to 96.5 (fahrenheit). Rash on chest, back and abdomen developed six (6) days after immunization. Also exhibited irritability and loss of appetite for one week post immunization. Patient was examined prior to immunization and displayed normal temp (97.9 fahrenheit) and no unusual behavioral traits.
am very tired; achy; somewhat nauseated; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and nausea. On an unknown date, the outcome of the tiredness, pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. Patient had second dose of shingrix and experienced tiredness, achy and nauseated. The patient was seeking advice as what was best for pain and was resting at the time of report. Reporter informed most common side effects with SHINGRIX to the patient. Reporter consented to follow up.
Flu-like nausea, chest tightness, muscle aches, joint pain, and fatigue increase. Symptoms ongoing at 10/11/2023. Could have been avoided if providers were directed to clearly specify the vaccine - "This is a [standard/high dose] of [name] which is a type [IIV4/ccIIV4/RIV4ex.] vaccine".  My son and I have had no problem with standard (IIV4) type vaccines over many years and would have declined the Flucelvax.  I am most likely reacting to a antigen/component in Flucelvax and your 'Postmarketing Experience' for Flucelvax is out of date. For reference, the more standard J&J Covid vaccine was fine, but the newer Moderna version gave me a reaction that was shorter term than Flucelvax.
Child received DTAP & HIB at clinic thursday 3/4/21 at around 4pm.  Child developed fever Friday evening 3/5 and on Saturday evening 3/6 developed a seizure to which parents called 911.  Seizure described as b/l arms flex/ eye deviation. Seizure stopped by time 911 arrived.  Child taken to hospital by EMS.  Father states that during the course the child had a Tmax of 40C/ 104F. rapid covid test negative. No other sick contacts at home. Older brother in school- elementary in person. Observed in the ED x 4-6 hrs and cleared for discharge as simple febrile seizure.  Unclear if had gotten tylenol with fever. Child returned to baseline, looks and acting well, child does have decreased appetite. Parents have been giving Tylenol round the clock.  this morning Mon 3/8,  temp was 100.4/38C , retemped at 11am - and had a temp of 37.1C afebrile but mother still gave tylenol. at that time. In the clinic, at approximately 4 1/2 hrs after tylenol  he was afebrile at 99.1, has scheduled f/u Wed March 10th.
Information has been received from a consumer concerning her 24 month old son with no medical history or allergies who on 03-AUG-2009 was vaccinated, 0.5 ml, with the first dose of MMR II injection (lot # not reported). The mother also mentioned that her son was administered with single dose of rubella virus vaccine live (MSD). There was no concomitant medication. On 03-AUG-2009, the next bowel movement the patient did was in green grass color. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician concerning the patient with no medical history or allergies, and no illness at time of vaccination who on 03-AUG-2009 was vaccinated subcutaneously with a dose of MMR II (lot # 663877/0356Y). The physician reported the patient experienced green stool for 16 days with no diarrhea, no vomiting, no blood in stool. The patient also experienced fever of 103 on 13-AUG-2009 for 1 day. Stool guaiac test, abdominal x-ray test and stool examination were performed and the results all were negative. There were no adverse events following prior vaccination. The patient had recovered on 19-AUG-2009. Additional information is not expected.
I experienced a ringing in my ears that sounds like a pile of crickets. Sometimes it's louder than others. I experience it in both ears more so in the right ear.
Started menstrual cycle 2 weeks early. Lymph nodes under left arm and throughout breasts extremely sore for 3 days. Regular but mild headaches behind left eye since vaccination (every 2 to 3 days). Sharp heart pains as of 11/01/2021.
21 doses administered 26Oct2021 / lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 doses administered 26Oct2021 / lot number has an expiration date of 10/24/2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 doses administered 26Oct2021 / lot number has an expiration date of 10/24/2021). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (21 doses administered 26Oct2021 / lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vial Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021.   This case was linked to MOD-2021-367076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains No New information
low blood platelets; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low blood platelets) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (low blood platelets). At the time of the report, PLATELET COUNT DECREASED (low blood platelets) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Low platelet count.         No concomitant medications were reported. No treatment information was provided.
Immunocompromised patient recently had a knee replacement; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    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 KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement). At the time of the report, KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement) outcome was unknown.            Concomitant products included unspecified Blood thinners for an unknown indication. No treatment information was provided.  Patient stated that she was immunocompromised and wanted to receive the second booster but that she recently had a knee replacement done, she also mentioned that she was taking blood thinners and low dose aspirin. No more information was provided.
Patient presented to the pharmacy on 11/16/17 with swollen right arm and stated that she had flu like symptoms the day before (11/15/17).
CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard operating procedure as the case assessed as non-serious.
After the first shot 3 weeks before, I had pain at the injection site starting that evening, and lasting for 1 1/2 days, headache starting the next morning lasting 1 day, fatigue lasting 2 days. After this 2nd dose, I had pain at the injection site starting that evening, lasting 5 days with reddening and a lump forming. The lump is almost gone now after 7 days, Headache starting the next morning, bad for 1 day, off and on for 5 days. Severe fatigue for 6 days, improved but not gone on this 7th day. Just hadn't heard of anyone having a reaction that lasted so long, and thought you should be informed.
First few days after vaccine high fever and irritable. 7/20/15 Redness, swelling at site (LLT). 7/21/15 Vesicular cluster at site (LLT).
Fever, hypotension, elevated lactic acid, mildly elevated LFTs 5 days s/p 2nd dose Pfizer vaccine.  Similar sxs a few days after 1st dose.
pt recv vax 24SEP97 & 24-36hr later pt exp a local rxn of extensive redness;it started @ the inj site & became a red ring that went around the pt inj arm;
Swollen area about the size of softball at injection site for a week, hot to the touch, fever for three days(between 99.4 - 101.00), headache, not feeling well, fatigue.
Kawasaki disease - treated with IVIG and Aspirin. 10/08/07-records received for DOS 9/7-9/10/07-fever since 9/4/07-new onset rash on 9/9/07-PE: diffuse blanching papular rash on trunk and extremities, confluent on palms and soles. Fever 102, decrased actiity. Upper respiratory symtpoms. Scleral injection with small yellow green. Dry cracked red lips. Traveled on airplane recently. Nasal congestion and cough. Watery eyes. Treated with IVIG and high dose aspirin with rash, conjunctivistis and erythema of hands and feet progressively resolved.  11/1/07-DC Summary received for DOS 9/7-9/10/07-DC DX: Kawasaki disease. Information has been received from a physicain concerning a 16-week-old female who weighed 7lb 9 oz at birth, with no siblings, no pertinent medical history and no drug reaction/allergies who on 17-Jul-2007 was vaccinated PO with a dose of ROTATEQ(Lot # 656384/0237U). Concomitant therapy that day included a dose of DTaP (unspecified) and a dose  of ACTHIB. On 14-Aug-2007, the patient was vaccinated with a dose of PREVNAR and ENGERIX-B. There was no illness at the time of vaccination and no adverse events following prior vaccination on 04-Sep-2007 the patient had a puffy burise on the posterior neck. On 05-Sep-2007, the paitent had a fever of 101 degrees Fahrenheit and was cranky, but no rash was seen. On 07-Sep-2007, the patient had red, swollen feet and hands and scattered macularpapular rash over the trunk and limbs. The patient was admitted to the hospital on 07-Sep-2007 and was diagnosed with Kawasaki's Disease. The patient was given IVIO and baby asprin. "The patient was hospitalized for 4 days "lab studies included: complete blood count, erythrocyte sedimentation rate, liver function tests, and an echocardiogram. The echocardiogram was reoirted as "ok". As of 10-Sep-2007, the patient had recovered. There was no other information to report. Kawasaki's disease was considered to have been a life threatening illness. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Bilogics and Research and was released. Additional information has been requested.
The evening of the vaccine (approximately three hours following) I experienced a rash on neck and wrist with itching.  The following day, November 5th, the itching continued but the rash had subsided.  At approximately 6PM I felt tired and experienced chills.  At approximately 9 PM my Watch alerted me to a rapid heartbeat - which reached 120 bpm at one point.  My blood pressure was high also.  I also experienced pain in the right arm and tingling in hands.  I became hot and nauseous at about 11PM.  The symptoms continued and my husband transported me to the emergency room at 12:15AM November 6th. A series of lab tests was done which mostly came back normal.  I was put on a saline IV and was given Zofran for the nausea.  By 4AM I was feeling better and was able to be released.
temp is keep going up today, went from 100.5 then I manage to lower it to 99.2; Chills; Fever; I think it is messing up my kidneys; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (I think it is messing up my kidneys), BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L209) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RENAL DISORDER (I think it is messing up my kidneys), CHILLS (Chills) and PYREXIA (Fever). On 22-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2). At the time of the report, RENAL DISORDER (I think it is messing up my kidneys), BODY TEMPERATURE INCREASED (temp is keep going up today, went from 100.5 then I manage to lower it to 99.2), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.     No relevant concomitant medications were reported.  No treatment information was provided.
chills; fever; low grade temp the whole day; just achy; The arm was just sore; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (tradename unspecified, solution for injection in pre-filled syringe, lot number and expiry date were not reported), via an unspecified route of administration, administered in arm on an unspecified date as an unknown, single dose for immunisation. Medical history included hypertension, blood cholesterol increased (high cholesterol), and rheumatoid arthritis, all from an unknown date and unknown if ongoing; and patient had 2 heart blockages and got stents in heart but that was 20 years ago (the first one when patient was 48 and the second when patient was 52). The patient's concomitant medications were not reported.  Patient have been treated for rheumatoid arthritis (unspecified) but being almost 75 and patient did take medicine for it one time but didn't take any medicine for, patient haven't had any medicine in probably 3 years for it. Patient had infuenza vaccine (FLU) shots every year as immunization and experienced arm was sore. On an unspecified date, the patient had chills and fever; low grade temp the whole day and just achy; the arm was just sore. Patient further stated that the arm was just sore like was normal like patient have had Flu shots every year, pneumonia vaccine, just like normal thing. The outcome of the events chills, fever/low grade temp, achy, and arm was just sore was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
pt recv vax 31DEC97 & 12JAN98 devel a rash on buttocks, breast & back;pt required ER/MD visit;tx w/DPH & keflex;
First shot, the following morning it felt like I had a 20 lb weight on my chest.. Latter on that morning I had a sever headache and knees and shoulders ached.  I had to pee about every half hour and that hurt.  These symptoms lasted for four days. The second shot was similar but the symptoms but lasted two days. No treatment was taken other that acedimetafin (sp).
pain from the tongue going to the jaw and back; pain from the tongue going to the jaw and back; swelling in the lymph nodes; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the vaccine at around 11.35 mins ago (21Jan2021) then she experienced pain from the tongue going to the jaw and back (pending clarification), and after that it still hurts a bit. She also mentioned some swelling in the lymph nodes (21Jan2021). The outcome of events was unknown. This case is non-serious.   Information about lot/batch number has been requested.
The first 2 shots I had very little issue with.  A sore arm and some tiredness.  The third shot (booster) I had no significant  reactions except a sore arm for less than 12 hours.  June 26, 2021 I had a flutter of my heart that was anomalous lasting 20 minutes or more.  This was different because it lasted more than the usual few seconds to a couple of minutes.  On September 21, 2021, I was admitted to emergency room after a flutter/afib event lasting ~2 hours.  An EKG was anomalous and I was transferred to the hospital for an Echo and angiogram.  The diagnosis was miocardial bridging and atrial hypertrophy believed to be congenital in nature.  After getting back home I have worn a heart monitor for 30 days. and completed an MRI for my heart.  Between the heart monitor and MRI I suffered another event that lasted over 3 hours.  This event came after the booster shot I received on 09/26/2021.  I apparently have clean arteries, but the arrhythmia appears to be electrical in nature.   The increased time intervals of afib/flutter may be coincidental to the timing of the injection and more related to my age heart defects that I didn't know I had until the recent hospitalization.
PATIENT'S ARM  AT AND AROUND INJECTION SITE VERY RED AND SWOLLEN COVERING THE BACK FOR HER BICEP.
I developed what I and my doctor believe to be a significant sinus infection in 1/22. I had sinus pressure, bloody mucus, ear pressure, slight cough, foggy brain, etc. I had been experiencing symptoms about 2 weeks prior to my doc visit and only went when the brain fog began affecting my work and functions. I was placed on a 10 day regimen of 825 Augmenten. Interestingly enough, my husband developed the same symptoms as me about 2 weeks later. I did not have a flu or covid swab but he did and both came back negative.