chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer COVID vaccine EUA  Pfizer Dose 1 2/17/21 (EN6200) Pfizer Dose 2 3/11/21 (EN6208) COVID Positive 5/30/21  5/30/21: 89-year-old male with history of coronary artery disease status post stenting, most recently on 4/13/2021, hypertension, aortic stenosis, hyperlipidemia, neuropathy, peripheral vascular disease, GERD, pulmonary nodule, hard of hearing and glaucoma has presented to the emergency room at hospital with complaints of chest pain.  Patient reports that his whole lower chest was hurting on and off which was sharp pain which would come and go at rest.  Patient initially reported that he had the pain when he woke up today but also reported for a week he was having some pains which was not as bad as today.  Patient denies having any radiation of pain other than the lower chest across.  He did not have any nausea or emesis or sweating associated with it.  No aggravating or alleviating factors. In the emergency room patient's initial workup with troponin and EKG were not showing any elevation in troponin and no acute ST-T changes suggesting acute ischemia.  Patient's chest x-ray did show possible left lower lobe pneumonia.  Patient did not have any fever or chills or cough.  Patient has some baseline shortness of breath.  He denied any headache, nausea or vomiting or abdominal pain or diarrhea.  He had no other acute health concerns.  6/3/21: Chest pain, resolved, ACS ruled out. Patient is chest pain-free, troponins x3 normal, ACS ruled out. The chest discomfort is likely related to the pneumonia. Community-acquired pneumonia - clinically improved, on CTX Rocephin and Azithromycin.  Also received vancomycin as cultures as noted below.  On room air not working hard to breathe    Acute episode has resolved.  GPC in chains 2/2 and GPC in clusters 1/2-likely contaminant - true bacteremia vs contamination, vancomycin was initiated. Has old systolic murmur due moderate AS & AR. Low probability of IE by Modified University's criteria. ID was consulted Considering 2 different blood cultures Gram-positive cocci in chains and Gram-positive cocci in clusters based on ID recommendations this represented contamination rather than true infection. Follow-up blood cultures are also negative after 72 hours. Per Infectious Disease no further treatment/intervention was required. Severe AS & moderate AR: stable, plan to f/u as an out patient for evaluation of TAVR.  HFmrEF 45%: stable, not in decompensation, continue GDMT. CAD s/p DES : Continue on aspirin 81 mg daily, Plavix 75 mg daily, Coreg 3.125 mg twice a day and rosuvastatin.  Peripheral arterial disease : He underwent left common femoral and superficial femoral artery intervention in 2015 per records, on dual antiplatelet therapy and statin. Positive COVID 19 test- initial with PCR negative.  Patient has been vaccinated. Pulmonary nodules:  Patient undergoing evaluation for pulmonary nodules as an out patient.
left arm still sore on a 3 inch diameter from where shot was given- now 3 and half weeks later; Under arm lymph swollen on left side; Under arm lymph swollen on left side, tender; Inappropriate schedule of vaccine administered to Dose 1: 30Mar2021; Dose 2: 10Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on 10Apr2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included Epstein barr active, Hashimoto's disease and sulfonamide allergy(sulfa drugs). Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included low dose naltrexone (MANUFACTURER UNKNOWN) and glycerine monolaurate (MONOLAURIN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, the patient's left arm was still sore on a 3-inch diameter from where shot was given even after 3 and half weeks later and the patient's under arm lymph was swollen on left side and was tender. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, the patient underwent Nasal swab, SARS CoV-2 test and the result was negative. The clinical outcome of the events left arm still sore, under arm lymph swollen on left side and tender were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling and pain of armpit, axillary lymph nodes, axillary breast tissue, under arm at axilla. Pain and swelling of deltoid
Patient had immediate pain following injection with the vaccine. This pain has persisted for 6 weeks. There was no injection site reaction (swelling or bruising or bleeding). She has pain, limited ROM, stiffness if she sleeps or leans on the arm.
NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.
102.5 degree fever lasting 24 hrs with Tylenol. Shaking chills lasting 6 hours. Body aches with pain level a continuous 8/10 on a 0 to 10  numeric rating scale lasting 24 hours with Tylenol. Throbbing headache with pain level 7/10 on a 0 to 10 numeric rating scale lasting 72 hours with Tylenol. Severe fatigue lasting  24 hours, moderate fatigue lasting an additional 24 hours.
The injection site got really red and hot, like it had a fever. I came home and started feeling nauseous and feverish. My head hurt really really bad and the temperature kept rising. For about two days I did not really get out of bed. About the 3rd day, I was a little better but still weak and feverish. I don't recall really doing anything for about a week. Highest fever was 102. I may have taken some Advil to try to reduce fever, and I know I put ice on my head. Didn't see my doctor after this specific dose, but had seen an allergist at some point after the second shot but I'm not sure if it was before or after the 3rd dose. It came out that I had become allergic to dairy, whey and pineapple. I was still suffering from a rash and hives from my other Covid vaccines, so continued to take the prescribed topical cream for that, as it continued during this time. I've been taking a lot of bath soaks to try to treat the itch and redness. I've had some nausea as well.
Two weeks after vaccination 04/02/2021 soreness in the arm which turned into muscle pain and potential site issue on not on  how vaccination was given.  Dr. directive was to continue to exercise, put cold compress at 20 minutes at a time and by an onement to help give the muscle relief and aspirin. and if it did not improve to let him know.
Received 2nd dose on 1/25/21, on 1/27/21 I broke out in a full body rash that burned and itched.
vaccine administered 4/26/22 , expiration date was 5/31/2022, beyond use date was 4/18/2022
felt a little funny and tired after Covid vaccine; felt a little funny and tired after Covid vaccine; fell down and has to go to emergency room; This a spontaneous report from a contactable nurse. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiry date: Unknown) via an unspecified route of administration in deltoid left on 27Jan2021 at 08:28 as a 1st dose, single for COVID-19 immunisation. Co-suspect medication included tetanus vaccine (Lot number: unknown), via an unspecified route of administration in deltoid right on 31Jan2021 for fall. The relevant family medical history was reported as none. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccines was reported as none. It was reported that, the caller had the first Covid vaccine on 27Jan2021. On 31Jan2021, the patient took a walk and fell down and had to go to the emergency room and had to have a CT scan of her head, on an unspecified date, experienced felt a little funny and tired after COVID vaccine. While there she was given a tetanus shot, which was 4 days later. She didn't really have any reactions with the COVID vaccine really, felt a little funny and tired and she took a nap and felt better later. It was half a day and she was fine. The patient has been looking on information about the tetanus shot and the COVID vaccine and her concern was on the fact sheet for COVID it doesn't say anything about other vaccines, concerned about the time span between vaccines. The patient was due for the second vaccine on the 19th of an unspecified date and her concern was since she was getting it a little over 3 weeks or almost 4 weeks from the first was that okay. Reviewed the fact sheet she had for the tetanus and read online about getting vaccines 14 days a part, but not sure whether that was on CDC website or Pfizer's. Again, mentioned that she was to get the second dose 3 days after what Pfizer recommends and talks about how hard it was to get an appointment at that time frame and trying not to reschedule. Stated that, she did see the primary care provider today and talked with her a bit, but she didn't have the information she needed. So, she called Pfizer about the time span between vaccines. No history of problems with vaccines in past. The seriousness criteria and causality were not provided. The patient had received the vaccine and she believed they need to do better. The caller then redirected. No further details were provided. The AE(s) following prior vaccinations were none. The adverse event fell down required a visit to the emergency room and physician office. The investigation assessment was reported as yes. On 31Jan2021, the patient underwent lab tests and procedures which included CT scan of head, resulted as unknown results. The outcome of the events for fell down and has to go to emergency room was unknown while for the other events was recovering.  Follow-up attempts are completed. No further information is expected.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/23/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Soreness in face; Redness in her face; Itching in her face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Soreness in face), ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025520A and 013l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-Jan-2005, Acid reflux (oesophageal) since 01-Jan-2000, Depression since 01-Jan-2011, Drug allergy (codeine) and Sulfonamide allergy (Sulfa drugs). Concomitant products included CHLORTHALIDONE from 01-Jan-2015 to an unknown date, POTASSIUM CHLORIDE from 01-Jan-2019 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-2005 to an unknown date for Blood pressure, VALSARTAN from 01-Jan-2005 to an unknown date for Blood pressure high, ARMODAFINIL (NUVIGIL) from 01-Jan-2005 to an unknown date for Sleep apnea.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FACIAL PAIN (Soreness in face), ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 50 milligram; STEROIDS for Adverse event, at a dose of UNK dosage form; ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for Adverse event, at a dose of 1000 milligram and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for Adverse event, at a dose of 2000 milligram. On 01-Mar-2021, ERYTHEMA (Redness in her face) and PRURITUS (Itching in her face) had resolved with sequelae. At the time of the report, FACIAL PAIN (Soreness in face) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 April 2021 added patient demographics, medical history, vaccine information, concomitant medication,event outcome, treatment information.
I got my shots about two and a half weeks apart, just to give some context. After both shots I felt a great hormonal shift and got my period two days after. It was not due either time. I also ovulated heavily between both shots. Totally unusual for me. My cycle is now totally messed up.   *First Shot: Felt hormonal and got my period two days after (it was not due for a couple of weeks and I'm usually pretty regular). *Just days after my period ended I ovulated heavily for days. Also very unusual and off schedule.  *Second Shot only two and a half weeks after the first shot and sure enough two days later I am having a heavy period again.
Partial deafness in both ears appearing the morning after the injection.  The deafness lasted two full days and then seemed to be better the following morning.  Not sure if any longer-term effects on the hearing.
Client informs clinic on XX-XX-09 that her child received both FLUMIST and H1N1 mist with 24 hours of each other.  Client brought child to out of office flu clinic on XX-XX-09 for seasonal FLUMIST.  Child received H1N1 mist at her school on XX-XX-09.  Parent had been provided vis and consent through school with questionnaire prior to child receiving either mist.  Parent did not update questionnaire prior to child receiving H1N1 mist.  Parent had turned questionnaire in prior to either vaccine being administered.
Re: Item 17  This was the second shot in the COVID-19 series. The next day (3/26/2021)  my left breast was uncomfortable.  I ignored it for a time and had read that there could be some lymph node that may swell and it was a good idea to wait 3 months before a mammogram.  I waited expecting the pain to go away.  It did not affect my normal routine and was annoying mostly in the morning before I got dressed.  I kept filling out the v-safe check-in with "I am am fine - no negative side affects".   There were some days I felt more tired than usual, but I don't know if that is related.  In May, it had not gone away and on May 13, 2021, I went to my  PCP who examined me and did not find anything of concern.  June 22, 2021 I had a screening Mammogram on the right breast and a diagnostic mammogram and ultrasound on the left breast.  The results of these exams were normal.  I still have the pain.
Localized rash around injection site for 2 days. Non bloody n/v/d for one hour before presentation to ED.
1/25/2020  -  Fever, arm pain, nauseous, weak, headaches, tiredness, chills, body pain. 1/26/2020  -  now  -  Arm pain, headaches, tongue blisters and swollen gums
Loss of Taste and Smell on April 15, 2021 the day after receiving my 1 shot. I took Benadryl.
Awoke with eyes swollen shut and stuck shut. Eyes red and photophobia. Lips swollen.
This spontaneous report as received from a pharmacist via a company representative  refers 3 or 4  patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patients developed an irritation about the size of a palm around the injection site. Two of the patients took diphenhydramine hydrochloride(BENADRYL) or an unspecified antihistamine to treat the adverse event. The injection site irritation went away after a couple days (unknown date). No product quality complaint was involved. Causality assessment was not provided. Additional information has been requested.
Information has been received from a physician concerning an 8-year-old male with no allergies or medical history who on 17-Oct-2003 was vaccinated with a dose of varicella virus vaccine (lot #644563/1147M). There was no concomitant medication. The reporter indicated tat 14 days after vaccination the patient developed a varicella like rash at the injection site. There were about three or four lesions at the site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities.  Lasts hours at a time and changes location.  Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.
wife passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (wife passed away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 19-May-2021 The patient died on 19-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
The patient received the Moderna vaccine for the 2nd dose of her primary series, instead of the Pfizer 12+ vaccine.  EDC: 07/10/2022
Lips are swollen; Itchy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Mar2021 the patient experienced lips are swollen, itchy. It was reported that, the patient administered the Pfizer-BioNTech COVID-19 Vaccine yesterday, 22Mar2021. They told her she can do her regular activities, so she went to work today; but her lips are swollen, and she was itchy. She did not know if this is an allergic reaction to the vaccine or what she should do regarding this event. The outcome of both the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FEVER; COULD NOT MOVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and could not move. This report was non-serious.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2011, the patient was inoculated at Physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient had a febrile seizure on 2/22/23 beginning at 6:47pm.   She was transported by EMS to local hospital.  She had fever upon arrival to the hospital, Tmax 104.7.  Per parents, work-up was negative for acute infection.  She was discharged home.