chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having some chest pains and I went to the doctor to have it checked and it was discovered that I had a microvalve tear. Prior to this discovery, I had been diagnosed with left ventricular hypertense. When I got the vaccine, a few months later I would get short of breath, and I felt like I was going to faint from taking the stairs at work. I went back to my cardiologist, and this is when they found the tear. The doctor indicated that it was not a major tear. There was no recommended treatment since it is not a major tear but if I experience worsening symptoms. I was also experiencing pain in the liver area, and I had an ultrasound completed and was diagnosed with Fatty Liver Disease. This disease is more of a disease for alcoholics, but I do not drink. I was prescribed Omega 3 Fish Oil. This was making my blood pressure higher. I substituted this medicine for an over-the-counter medication. That seems to be working now as my blood panel is now normal. I have seen a gastroenterologist who did an upper GI endoscopy and checked my gall bladder via radiology to see if it was functioning properly and it was at 80%.
This spontaneous report as received from a registered nurse refers to her 14 months old male grandson with slight cold at time of vaccination. The patient was vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not provided) approximately on 15-DEC-2012 "11 days ago". No other co-suspects were reported. No concomitant medications were reported. On 25-DEC-2012 the child developed about 25 red raised rash like areas and the lesions were in groups of about 3 lesions. On 26-DEC-2012 "today" the lesions appeared to be drying over the top. It was unspecified if the patient had sought medical attention. The treatment of BENADRYL and cortisone cream were given for the adverse events. There were no laboratory diagnostics studies performed. The outcome of the child developed about 25 red raised rash like areas and the lesions were in groups of about 3 lesions was reported as not recovered/not resolved. The relatedness between therapy with VARIVAX (merck) and the events was unknown. Additional information has been requested.
Patient had a swelling at time of injection that we were told was normal. Patient did not feel well the week following vaccine. Patient continue to feel nausea, dizzy and fatigue headache. These symptoms continue to this day.
patient became unresponsive with acute L side hemiparesis on 2/20/2021. Hospitalized  and dx'd with small vessel ischemic CVA. Reporting via  this system as a serious event occurred within 12 days of COVID vaccination#2 administration, tolerated vaccination #1 well and minimal AE reported initially  after 2nd vaccination.
512PM MENACTRA .5cc IM RD, patient stated did not like needles. Sitting GARDASIL (HPV vaccine) #2 given 0.5cc IM LD. Less than 1 minute pt stated didn't feel well. Upon my ret w/ wheelchair, pt hunched over arms across & tonic. Awakened crying after ammonia inhalant.
(Withheld) sister caught COVID after vaccine; (Withheld) sister caught COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "(Withheld) sister caught COVID after vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: (Withheld) sister caught COVID after vaccine. Clinical course: Patient Age/Date of Birth: 10-17 years. Sister caught COVID after vaccine, so she came down with COVID, two weeks ago, um, one day of fever, tested positive, was fine afterwards. they tested him, and he was negative. At home test. Never had any symptoms, never got them the third booster. Reporter don't see the relevance in it right now, because, uh, number one, he never, um, contracted, even when the family got it. And, um, they had all their, they had their two.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Leg pain and weakness began approximately October 12, 2010. Hospitalized on Nov. 18 and diagnosed with GUILLAIN BARRE SYNDROME (GBS) on Nov. 21, 2010.
I felt numbness and tingling in my lips and Right cheek that lasted for 1 hour. I received the vaccine on my Right upper arm.
Headache. Severe. Level 9 of 10 (10 being worse). Unable to sleep because the headache was so sever I could not lay my head on a pillow.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. The patient was diagnosed with human papilloma virus shortly after receiving a dose of GARDASIL. It was not known as to type of HPV or what dose of GARDASIL was administered. The patient's HPV persisted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Swelling in the armpit of the same arm that the vaccine was administered; Pain  in the armpit of the same arm that the vaccine was administered; Experienced sore arm on the injection site; Low grade fever of 99.9-100degF; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (Experienced sore arm on the injection site). 29-Oct-2021, the patient experienced PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue). On 30-Oct-2021, the patient experienced LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered) and AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered). At the time of the report, LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 99.9-100 (High) 99.9-100degF.         Concomitant information was not provided.  It was reported that the patient experienced sore arm at injection site within 2 hours after the shot and also felt fever and fatigue at the same night. On 30-Oct-2021. at morning patient experienced pain and swelling in the armpit of the same arm.  Patient was reported to not take any treatment for the events.
My back pain is worse; Stomach pain; Cant move my arm; Left shoulder is swollen like a baseball; Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back pain is worse), ABDOMINAL PAIN UPPER (Stomach pain), MOVEMENT DISORDER (Cant move my arm), JOINT SWELLING (Left shoulder is swollen like a baseball) and NAUSEA (Nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was in the hospital for 3 days and her sodium went down. They pulled her off of the blood pressure medicine and put her on losartan but it went up to 170 so they put her on amlodipine. Her pulse has been in the 40s since she had COVID) in November 2020 and Hemorrhage (She had a hemorrhage in her eye from the COVID virus). Concurrent medical conditions included Back pain, Hypertension, Tricuspid regurgitation and Premature ventricular contractions. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Back pain, AMLODIPINE, FISH OIL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PANTOPRAZOLE, LEVOTHYROXINE, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (My back pain is worse), ABDOMINAL PAIN UPPER (Stomach pain), MOVEMENT DISORDER (Cant move my arm), JOINT SWELLING (Left shoulder is swollen like a baseball), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, BACK PAIN (My back pain is worse), ABDOMINAL PAIN UPPER (Stomach pain), MOVEMENT DISORDER (Cant move my arm), JOINT SWELLING (Left shoulder is swollen like a baseball), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol, Hydrocodone.
Local redness at site 2" around inject. site, warm to the touch, itchiness. Left arm reaction to DTaP.
Chills; mild fatigue; body aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (mild fatigue), MYALGIA (body aches) and ARTHRALGIA (joint aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Chills), FATIGUE (mild fatigue), MYALGIA (body aches) and ARTHRALGIA (joint aches). At the time of the report, CHILLS (Chills), FATIGUE (mild fatigue), MYALGIA (body aches) and ARTHRALGIA (joint aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
GI distress started 18 hrs after dose.; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6203 Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:00 (at the age of 78 years old) as second dose, single for COVID-19 immunisation in a Clinic. Medical history included chronic obstructive pulmonary disease (COPD) and arthritis, both from an unknown date. The patient did not receive any other vaccines in 4 weeks and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: E69266), via an unspecified route of administration administered in left arm on 13Feb2021, (at the age of 78 years old) as first dose, single for COVID-19 immunisation. The patient experienced GI (gastrointestinal) distress started 18 hours after dose on 07Mar2021 at 05:00. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered on unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US023712 is an initial, spontaneous report received from a pharmacist (who is also the patient) on 12 NOV 2013. This report refers to a 32-years old female patient. Her medical history and concomitant medications were  not reported. On 28 OCT 2013,, she was vaccinated with FLUVIRIN 2013/2014 (batch  number: 1309701) intramuscularly. Later, on the night of vaccination she experienced gouty attack on her large toe. It was reported that the toe was very painful and swollen. She did not have history of gout or risk factors for gout which could have precipitated the events. She took ibuprofen to reduce her pain. The reaction had lessened but did not completely go away. The causality and seriousness of the case were not assessed.
Information has been received from a registered nurse concerning a 5 year old patient who in 2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). It was reported that after vaccination on approximately 16-JAN-2008, the patient had a breakthrough of chickenpox. The patient had less than 50 lesions of chickenpox. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Long lasting dull left shoulder pain. Received (2) shots. 1- Flu/ 1- Shingles #2. Both shots given in the same left arm, one after the other. I was seated. The RX pharmacist was standing. No warning about side affects getting those (2) shots together. Paperwork did not list duel side affects.  Shingrix 50mcg susr NDC#58160-0819-12 Glaxo Smith Kline Fluad PF 0.5 SUSY 2018-19 NDC#70461-0018-03  Seqirus
Expired vaccine used; Excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients.  The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted and they were moved from freezer to refrigerator only on day they were used and they were not returned to freezer or refrigerator for storage.  No concomitant medications were reported.  No treatment information was reported.
48 hours after shot left arm began to ache from elbow - neck then head ache.  Had history of arm and shoulder problems in the past. 11/17/2003 follow up "maybe I hurt it exercising".
Mild tremors in left arm following vaccination. The tremors started the next day and continued through present day. Tremors only affect the left arm and left hand. Consulted general practitioner with condition. His counsel was to wait and see if it resolved on its own. Tremors remained consistent and have not gone away. No other symptoms noted.
pt recv vax 10JUL98 & 17JUL98 pt presented w/bacterial meningitis & was hosp the following day;pt was treated & the bacterial meningitis resolved w/o further complication;
Swelling, itching, redness, heat at site of injection about 24 hours after vaccine.
Received normal dose (not HD) flu vaccine around October 13. On October 20 had sudden onset of numbness of left face, jaw, and neck. No weakness. 50% resolution by next day, but 10% residual one week later. Has been lethargic since 10/13.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient lost consiousness within one minute of receiving covid-19 vaccine. Regained consciousness within a few seconds. Checked vitals which were stable and had patient lie on floor with feet up. Monitored patient for at least 30 minutes and rechecked vitals which were stable. Patient reported no further issues upon follow-up a few hours later
8cm X 6cm tender erythematous area around vaccination site  Administered at Clinic as part of pre-deployment to .
Patient presented to pharmacy with mildly swelling, redness, and mild heat in arm. Patient presented to pharmacy about 36 hours after immunization. Patient claimed there had been some pain (throbbing). Upon presentation, pharmacist gave patient acetaminophen, cold compress, antihistamine. Requested patient to return to pharmacy if symptoms didn't resolve in next 2 days or got worse. Patient said after cold compress, the site felt better. Picture taken at time presented to pharmacy. Patient received the PNEUMOVAX on front of right deltoid, and flu about 1 plus inches behind that on more rear side of deltoid.
Muscle pain; Chills; Nausea; Difficulty in breathing; She was very scared; This is a spontaneous report received from a non-contactable consumer (patient friend). A female patient of unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 31May2021 (Batch number/Lot Number: UNKNOWN) as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Reporter stated, patient just got second vaccine (Unspecified Vaccine) and she did not feel anything horrible or bad at the first one, now after the second one she was having some side effects on 31May2021, like muscle pain, chills, nausea and difficulty in breathing. Patient does not wanted to go to ER. She was very scared. Reporter told her to take a pill of Allegra. Seriousness of the events was not reported. The outcome of all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
elevated temperature of 103+, projectile vomitting, continued high pitched crying.  Medical examination by treating physician & released.
I know a physician in died afterwards; This is a spontaneous report from a Pfizer-sponsored programs from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient knows a physician and died afterwards on an unspecified date. It was unknown if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: I know a physician in (name) died afterwards
I woke up with a scratchy, sore throat. I took a COVID test and it came back positive. Then, I had a sore throat and developed a chronic cough. The sore throat lasted about a week and the chronic cough lasted about 3 weeks. I still have a mild cough, but I only have to take the breathing treatments once a day. If I am active, I have to use my inhaler more than once a day and take a breathing treatment along with it. I'm still dealing with this at this time.
More than 42 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) had resolved.            It was reported that caregiver was willing to know whether  92-year-old mother could get the second shot.  Concomitant product use was not provided.  Treatment product information was not provided.
Initial reaction (within 5 min)  was minor chest tightening and at the 15 min mark I started to get hives, I let the nurses know of my reaction and they provided me with Benadryl, I then stayed for about an hour after.   It has now been about a week, hives still present and starting to present as a rash.
03-20-17 - Grandmother of child called to report child has hives "all over her body." Started 03-14-17 on right arm. Has been giving BENADRYL OTC with no change. States child was "sick with cold x 3 days ago. Did have a fever (number unk) advised to see PCP ASAP. Grandmother called back 3 hours later to say PCP put child on a oral steroid. PCP thinks hives could have been from varicella vaccine.
pt recvd vax 13JUL95 & 29JUL95 devel skin eruptions, which were dx @ medical center;24AUG95 had a red rash & no vesicles;No further details were provided;
Pt was at a sleep over and had a seizure.  Pt taken to Emergency Department, but was not admitted.