chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph glands in both armpits; Pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "not recovered"; LYMPHADENOPATHY (non-serious) with onset Sep2022, outcome "not recovered", described as "Swollen lymph glands in both armpits". The events "swollen lymph glands in both armpits" and "pain" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: It now has been over 6 weeks an the pain was still intense, got worse in the morning. Patient did not have COVID-19 or COVID-19 test positive prior vaccination. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed tinnitus within a day of my first vaccine dose that subsided after roughly two weeks, developed the same symptoms again within a day of receiving my second vaccine dose.
Pfizer booster vaccine administered IM without incident. patient walked  to vaccine observation  area without incident. Within 15 minutes of have body shaking - in arms  and legs. He drank large cup of water. Shaking continued. He states he is diabetic and had just eaten pizza for lunch but had not taken his oral diabetic medication yet. He stated the same shaking happened the last two times he received the covid vaccines - had recevied Moderna for initial series. EMS was present because they were at the clinic for a separate patient., Assessed patient blood sugar 220. BP 180/101. Transported to ER
01/10/22 presents to  ED for "Left leg weakness". PMHx of "glaucoma, hypertension, cardiomyopathy, GERD"
Hurt her face as it hit the floor; Became bruised; Fainted about 6 times in different episodes/had to get a pacemaker; Began experiencing symptoms of fainting/ does get a fainting feeling about once a week; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) (seriousness criterion medically significant) and DIZZINESS (Began experiencing symptoms of fainting/ does get a fainting feeling about once a week). On an unknown date, the patient experienced FACE INJURY (Hurt her face as it hit the floor) and CONTUSION (Became bruised). At the time of the report, SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) had resolved, DIZZINESS (Began experiencing symptoms of fainting/ does get a fainting feeling about once a week) had not resolved and FACE INJURY (Hurt her face as it hit the floor) and CONTUSION (Became bruised) outcome was unknown.            Concomitant medication was not provided. Patient had to get a pacemaker since she had multiple episodes of fainting. Treatment information was not provided.  Company comment: This case concerns a 67 year-old, female subject with no medical history reported, who experienced the unexpected events of syncope, dizziness, face injury and contusion. The events syncope and dizziness occurred 12 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as no information about the first dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 67 year-old, female subject with no medical history reported, who experienced the unexpected events of syncope, dizziness, face injury and contusion. The events syncope and dizziness occurred 12 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as no information about the first dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.
Narrative: patient back in today with c/o redness/swelling of injection site where his PNEUMOVAX was given on rt upper arm, left upper arm where location of flu vax was given is unremarkable. Patient started running fever and soreness over injection site within last 24 hours. He has had PNEUMOVAX one time few years ago without any side effect or reaction. No cough/sob/puritis. Assessment-cellulitis from injection site of PNEUMOVAX. Plan-stat cbc/ua/chem 7, CIPRO 500 mg every 12 hours, TYLENOL, warm compress, if worsening patient advised to go to er for recheck, if improving finish med.
I had two Shingrix vaccines in 2019 / Today I was diagnosed with Shingles/ suspected vaccination failure; Today I was diagnosed again with Shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles in November 2018, on right side and back).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 57 or 58 years. The patient had two Shingrix vaccines in 2019. Now the patient was diagnosed again with Shingles.  The patient was guessing if she was a part of the 3 percent. The patient received started antivirals. The patient asked if you were tracking shingles after Shingrix. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation for shingles were not provided.
extreme fatigue - unable to work the day after vaccination Narrative:  extreme fatigue - unable to work the day after vaccination
Pt given YF in clinic. Pt did not wait 15min: CHM. Pt called at 2:12pm. Pt stated as  he was driving home he began having cold sweats and pulled over on side of road. Pt said he then blacked out for 10-15 min in his car. Pt felt it was better to drive home than head back to clinic because he was closer to his house. Talked to patient at 1431, reports he got Yellow Fever vaccine felt ok & was driving home felt sick pulled over to the side of the road and had LOC approximately 10 min came to & drove home. Advised to have his wife drive him to ER.
01/05/23 presents to ED for "cough, palpitations". PMHx of "COPD, CHG, A-fib"
HE WAS UNDER 16 YEARS OLD WHEN HE RECEIVED BOTH DOSES
Starting the night of the vaccine, flu like symptoms began (extreme body aches, severe neck/back pain, fatigue, elevated temp), which then progressed into chest pain, chest tightness, shortness of breath.  Went to  hospital on day four due to continued chest pain, tightness and shortness of breath and was then admitted due to elevated troponin levels and continued symptoms.  Seen by cardiologist and diagnosed with myocarditis and pericarditis.   Was started on nsaids (ibuprofen) and colchicine.  Discharged later the next day and to follow up with primary care doctor and cardiologist.  The symptoms continued for well past a week after leaving hospital.
was sick for two weeks; body aches; really bad cough; Runny nose; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was sick for two weeks), MYALGIA (body aches), COUGH (really bad cough), RHINORRHOEA (Runny nose) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick for two weeks), MYALGIA (body aches), COUGH (really bad cough), RHINORRHOEA (Runny nose) and HEADACHE (headache). At the time of the report, ILLNESS (was sick for two weeks), MYALGIA (body aches), COUGH (really bad cough), RHINORRHOEA (Runny nose) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
11/27 began having symptoms. Just began not feeling well, nothing specific just not feeling well. Tested positive for COVID-19 on 11/28 at PCP's office. PCP prescribed PAXLOVID. Symptoms were extremely mild. 11/29-11/30 where my worst two days. The main symptom was fatigue. 12/2 I was completely recovered.
SOME UNSPECIFIED LOCALIZED DISCOMFORT/MUSCULAR DISCOMFORT ON LEFT LEG AND SPREAD ALL OVER BODY; MUSCULAR BURNING SENSATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis on right leg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and muscular burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and had not recovered from muscular burning sensation. This report was non-serious. This case, involving the same patient is linked to 20220254096.
Left deltoid pain/redness day after vaccination, swelling to softball size (10cm across per ER MD), appears infected at this time.
On 10-14-14 pt was given 0.5 ml of the quadrivalent influenza vaccine in the left deltoid. Patient was supposed to be given 0.25 ml of the influenza vaccine due to his age.
After 24 hrs I was exhausted, headache, nauseous, body ache, chills, low grade temp, and acute stomach pain
pt recvd vax 16NOV92 & flu sx 18NOV92, numbness in feet 19NOV92; numbness knees & difficulty to speak & swallow 20NOV92 dx;
Information has been received from a physician concerning a 4 year old (also reported as "18 year old") male who on 18-MAY-2006 was vaccinated with the 1st dose of MMR II. On 30-NOV-2009 the patient developed mumps on the left side without fever and was diagnosed with parotitis on 01-DEC-2009. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. No further information is available.
Information has been received from a nurse concerning a patient who in approximately December 2004, was vaccinated with pneumococcal 23v polysaccharide vaccine , lot 649732/0513P. Subsequently, the patient developed a cellulitis like injection site reaction. The patient received unknown treatment for the reaction at a local emergency room Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. The nurse reported 4 other patients who developed injection site reactions after the administration of pneumococcal 23v polysaccharide vaccine  (WAES0412USA02760).
did well acted right, felt right up until 5 AM this morning (6/4/21), she woke up throwing up over and over again, she couldn?t keep even a dissolvable Zofran down.  > I immediately contacted her Hematologist and he told me to take her to the E.R.   >  blood disorder, ?Hereditary Spherocytosis? came to life, flared up.  >got extremely sick, where she could not walk or stand by 8:00 am this morning, when we arrived at the E.R. she had to be placed in a wheelchair because she was so weak.  > Fluids, Pain medicine, Motrin, and nausea medication were given, plus rotating cool rags on her head to get her body temperature down.  >  CBC, was off the charts, she has developed Anemia and was diagnosed this morning. >  blood pressure dropped to 91/42.  > I spoke with two hematologist on top of speaking with the 2 E.R. Doctors.  >reached over 110%  immunity if not more.  > Both Hematologist I spoke with plus the E.R. doctors determined she was at 100% immunity with just the first dose. > Due to her reaction her Oncologist/Hematologist are communicating with other hematologist in the U.S.  about a reaction of a ?12 year old pediatric patient with Hereditary Spherocytosis?, further research will begin according to the Director of Onoccologist/Hematologist in the next few weeks to help other pediatric patients with Heriditary Spherocytosis in the U.S., the main point of this research is determining that one dose of Covid vaccine reaches 100% immunity vs 2 doses which would be equivalent to ?2 doses plus 2 booster shots of Covid vaccine? to someone with hereditary spherocytosis.  >  > After 8 hours of going through this, she was able to walk and stand. She was back to her old self.  > If you can please reach out to CDC and let them know about a 12 year olds patient with Hereditary Spherocytosis  reaction to second dose of Phizer Vaccine.
Bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time / She's worried about her arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time / She's worried about her arm". Additional information: The patient would like to know if there's any report of bruising immediately or right after receiving the new 2023-2024 formulation of the COVID-19 vaccine, and that gets worse with time. She's worried about her arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I had a pulmonary embolism that required hospitalization.  I had blood clots in my lungs which traveled from my left calf.  I noticed a shortness of breath when running 4 days after my first vaccination.  Subsequent runs featured extremely elevated pulse rates, too high in my opinion given I was only running at a moderate pace.  That led me to think there was something wrong.  I went to the doctor who ordered tests for me.  The tests confirmed that I had blood clots and I was told to go to the emergency room immediately.  I was hospitalized for 2 days, and was prescribed Eliquis.  I have to take Eliquis for 6 months.  Bloodwork confirmed that I was not genetically predisposed to blood clotting.  If I was not active, I would never had known a problem existed.  I was told that I could have died if I did not go to the doctor to check this out.
She is very active in her daily life as she continues to train race horses. She reports she had been feeling well. She received her 2nd COVID vaccine on 2/22/2021. On 3/3/2021 she began feeling achy, foods no longer tasted good to her, over the next day or so she developed nausea with dry heaves, diarrhea, and burning with urination. She then stopped eating. She has a dry non-productive cough. She denies any melena, hematochezia, hematemesis, chest pain, fevers, chills, shortness of breath. She is now complaining of generalized weakness. She denies any abdominal pain, but admits to some tenderness in the right side of her back. She denies any known ill contacts. She and her Husband mostly stay at home since COVID began. She reports they have not even traveled with the horses since COVID started.  3/15/21 In the ED she was found to have a right pyelonephritis, acute kidney injury, elevated LFT's, leukocytosis. She had an abdominal CT that showed concern for dilated CBD. She went later for a gallbladder US. This showed no dilations of CBD.   3/16/2021: Today there was a significant improvement in leukocytes. Her blood pressure has dropped and is low to low normal. She continues to feel generalized weakness. She is eating ice chips and tried a jello this morning that she has kept down. She denies any further diarrhea or active vomiting overnight. She denies any abdominal pain, but does have tenderness to the epigastric area with palpation.  Creatinine is unchanged this morning. I gave an IV fluid bolus this morning to support BP. She does continue to have the dry cough. She reports she had a rash to her right arm around the COVID injection site that was itchy for a couple of days. It has resolved. She denies any other rashes, joint inflammation or redness. She denies any shortness of breath.   Eosinophilia, with 1600 AEC. Concerning for possible delayed hypersensitivity to COVID vaccine. Will continue to trend. Cough non-productive. Continue to monitor respiratory status/sx. CRP. LDH, ESR, and CRP added on to labs. Will draw D-dimer tomorrow morning as well.
VACCINATION ADMINISTERED AFTER BUD OF 6/22/22 WITHOUT REPORT OF ADVERSE EFFECT
Within one hour after administration of vaccine, begin to have tightening of chest, chest pain, coughing, difficulting breathing. Approx. 15 mins later, swelling of the throat, & difficulty speaking & walking, racing heartbeat,& weakness. Approx. 15-20 later, was taken to the ER in a  wheelchair by nurse from Employee Health. Got to ER, feeling very weak, chest pain & tightness, difficulty breathing & unable to speak. Received 4L of O2, Nubulizer treatment 2x, was hook up to continuous heart monitor; Also had an EKG & lots of blood work. Some of the blood work came back abnormal. Was given sodium medral?? or some kind of steriod, 2 benadryl, 4 baby aspirin, & liquid potassium...ER doctor recommended hospitalization & a stress test for my heart. I didn't want to be admitted. ER doctor made arrangements for me to see my primary care doctor the same day of incident. Was given several Rx upon release from ER; Predisone, Benedryl & Albuterol Inhaler. Was release from ER @ 1455 on 04/03/08. ER doctor excused me from work for 3 days. It was a rough 3 days, especially on day 2. Return to employee health on 04/07/08 to see in-house doctor. Still weak & lacking dexterity in right hand; with poor handwriting skills.
PATIENT HAD A REACTION TO ALL 4 MODERNA COVID INJECTIONS. PATIENT ALSO HAD SIMILAR REACTION TO SHINGLES VACCINE. PATIENT ALSO DEVELOPED THE SAME REACTION TO THE ANNUAL FLU SHOT. PATIENT DEVELOPED RASHES (HIVES) ALL OVER THE BODY. THE INJECTION WAS WARM TO TOUCH. PATIENT TAKES XYZAL FOR ALLERGIES. SHE WAS ADVISED TO TAKE BENADRYL BUT STATED IT MAKES HER TOO DROWSY. SHE BOUGHT CLARITIN AND SARNA LOTION OTC. PATIENT WAS ADVISED TO MONITOR SYMPTOMS AND SEE A DOCTOR. SHE WAS HESITANT TO SEE A DOCTOR AS SHE THINKS MD WOULD PUT HER ON PREDNISONE WHICH SHE DOES NOT LIKE TAKING.
Approx. 24 hours after receiving PCV-13 vaccine patient broke out in a full body rash, worse on trunk and less severe on limbs/extremities. Grandmother noted patient to be more fussy than usual. Noted nasal congestion, possible low grade fever, and mild decrease in urine output.   Grandmother was advised to encourage plenty of fluids, use nasal saline drops,  and use of Benadryl per bottle instructions PRN Q6H.
Patient was administered with the Covid Vaccine 2023/2024. The Vaccine is 3 dose multi dose vial. This was not diluted with the Sodium Chloride.  Patient received the full vial that was unconcentrated.
Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right.  A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.
ACUTE NON ST ELEVATION MI; 5/20/2022 - RECURRENCE OF SAME SYMPTOMS.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that the patient received the third dose of GARDASIL (intramuscularly, exact dose, anatomical location, lot number was not reported) too early. The patient received a first dose of GARDASIL (intramuscularly, exact dose, anatomical location, lot number was not reported) and the second dose of GARDASIL (intramuscularly, exact dose, anatomical location, lot number was not reported). No adverse effects were reported. Additional information has been requested.
20 MINUTES AFTER ADMINISTRATION CLIENT "FEELS VERY TIRED, HEAD LIGHTEN AND WEAK" AND SLEEPS FOR 2 1/2 HOURS CLIENTS TAKES TRAMADOL AT NIGHT BUT IS NO ABLE TO SLEEP. CLIENT FEELING BETTER THE NEXT DAY (TODAY) BUT NO TOTALLY FINE. ARM I S SORE. SPOUSE HAS THE SAME VACCINES AT THE SAME TIME AND HAS NO SIDE EFFECTS.
Complained of itching - tingling of hands and hives. No shortness of breath or tongue swelling. BENADRYL IM.
22SEP face red, felt hot (mom states 102), saw bumps on face, gave APAP; 23SEP felt warm did not take temp, rash only on face, taken to MD 23SEP91;
shortness of breath; congestion and slight cough; chills; sore muscle; fatigue; congestion and slight cough; when I raise my arm above my shoulder a sharp pain strikes down my upper arm from injection site to now; intestinal trauma; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN 6205) via an unspecified route of administration, in left arm, on 08Mar2021 11:45 (at the age of 68-year-old), at dose 1, single for covid-19 immunization. The patient had no medical history. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 05:30 the patient experienced shortness of breath, congestion and slight cough with some chills, sore muscle, and fatigue. It was also reported that the injection site also caused problems on the 4th day (Mar2021), when he raised the arm above the shoulder a sharp pain strikes down the upper arm from injection site until the time of report. The patient also had intestinal trauma on an unspecified date in 2021, lasted about 6 to 8 days and a little longer with some issues. The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.