chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2016US029262, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 72 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly following temperature excursion at 52F for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and last 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. The vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
She got her booster, the first thing she had was that her bones started hurting to the point that she could not walk.  She then felt a little light headed, had a headache, no fever, but did have chills. She stayed down for 2 days and then was feeling better as far as those symptoms.  But then she started breaking out on each cheek and her forehead, real red on each cheek.  Then she started waking up and full of phlegm, her nose every morning she has to blow her nose.  The mucus is as if she has a cold, and it's yellow in color.  There has not been a morning that this has not happened since the vaccine.  She also has pain which makes it difficult for her to walk.  This is on the right side (side of her vaccine).  She does not know if it's nerves, back or what it is and it's very painful, then it will just go away.  She did not have any of these symptoms prior to the vaccine.   She has an appointment coming up to see her doctor.  She is just tired all the time and has to force herself to do things.    She also got her flu shot  in September, but had no reaction from that.    Her ear feels like it is clogged as well, stays sore and also her throat.  She feels it may be from her coughing and from the mucus production.
Patient experienced anxiety, SOB, clammy hands, vomiting, sweating, arm numbness. BP 108/77 HR98 R16, then 10 minutes later 103/67 HR82, RR18. Patient stable, released with instructions to f/u with healthcare provider
cold sweat, lightheaded,  eyes swollen, throat felt like it had a huge ball in it, left side of throat also hurt as well as left ear, eyes were swollen for two days, very cold all one day, hurt all over, really hurt..not going to get  second shot.
No other AE/PQC reported; temperature excursion; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 15-MAR-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), for prophylaxis, lot # T013537 was verified to be valid, expiration date reported and established as 17-OCT-2021, (dose, frequency, route of administration and vaccination site were not provided).  The administered dose of vaccine experienced a temperature excursion of -6.7 Celsius degrees for 2 hours. There were no previous temperature excursions. The patient did not experience any additional adverse reactions. Digital Data logger was involved. The outcome, action taken and causality assessment were not provided.
Arm started swelling..applied ice pack. Took BENADRYL and TYLENOL but did not notice sx alleviation.
After receiving second shot of covid vaccine, I have experienced migraines and changes in my menstruation cycle. I have missed my period in the month that I got the covid vaccine (August 2021). In the following month (September 2021), I did get the period but it was heavier than previous cycles.
This is an instance of COVID-19 disease after which a death occurred (breakthrough).   The individual was vaccinated with the Pfizer product at 2 different pharmacies on 01/11/2021 and 02/01/2021.  The individual had a positive antigen COVID-19 test on 10/27/2021. There are also 3 positive PCR tests with collection dates of 10/27/2021. The individual was a resident of a long-term care facility. The individual passed away on 11/15/2021. Death certificate details are as follows:  Part I: Cause of Death: A. COVID-19 Part II: Other Significant Conditions: Peripheral Neuropathy, Coronary Artery Disease, Hypertension, Atrial Fibrillation, Dementia NOS
the results came back not immune.; the results came back not immune.; the results came back not immune.; the results came back not immune.; This spontaneous report was received from a physician and refers to a 21-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection,, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On 05-NOV-2009, the patient started therapy with varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient had titers performed,  the results came back not immune. The outcome of the event the results came back not immune was unknown. She was administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and had no adverse experience reported to our products.  The causal relationship between the events and suspect vaccines was not provided. No further information is available
About 1 hour after Hep B # 3 injection, feeling shaky, itchy, puffy eyes. Went to ER where he reports he had a shot.
No immediate adverse event. Patient was given a 3rd dose of the vaccine. doses given on: 01/02/2021, 01/30/2021, and 02/27/2021.
dizziness; little nausea, like vertigo; little nausea; Chills; Fatigue; dry heaves; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201, expiration date: not reported) dose 2 via an unspecified route of administration on 20Feb2021 at 09:21 (at the age of 68 years) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318, expiration date: not reported) dose 1 via an unspecified route of administration on 29Jan2021 single for covid-19 immunization. On 22Feb2021 she experienced 3 episodes of dizziness and one being severe. When it happened, she needed to sit down, or she was going to fall down. She asked if dizziness a symptom or an after effect. The dizziness did not occur until 48 hours later. She experienced chills and fatigue which she expected. The first day she was fine she got it around 9 in the morning and the rest of that day, Saturday she was perfect. In the middle of the night, she got some chills, not bad and she expected that then fatigue, Sunday afternoon she had to nap then she was fine but Monday she started experiencing dizziness and a little nausea, like vertigo. She was healthy, she has never experienced dizziness, this was to the point that she had sit or lay down or she would have fallen. She is a pusher, she is active prior to the COVID pandemic she was at the gym 5 days week, she is a runner she is healthy, she is not on any meds. She went with her husband to purchase plants in and on the way back she got dizzy. If she had been driving it would not have been a good circumstance. That was one concern that there was no precaution about driving, she says it seems like this was a rare instance from what she can find online, but she was nervous about it. She does not really know there was no predisposition of what happened before the episode. When she was in the car she does not know if that motion impediment but she was pretty energetic, she moves around fast and yesterday morning she was just changing the linens on the bed and she got extremely dizzy and had to lay on the bed, that passed and she decided to push through and go to get plants with her husband and on the way back in the car experienced it was like an earthquake the roads were curving badly it lasted about 5 seconds but then she got the dry heaves and then it passed. Clinical outcome of all the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
left deltoid pain x 1 month. Tingling down left arm into left hand and fingers.
Into clinic 6JUN91 afternoon from 4PM-9PM pt cried uncontrollably;
In January of 2022 I noticed a hearing deficit in my left ear. I went to a an ENT doctor in April of 2022 and I was found to have a mild to moderate hearing loss. I have imaging to rule out a tumor.   I don?t know if the vaccine is the cause or not.  But after doing some research I read people have experienced hearing problems and tinnitus after receiving a Covid vaccine. I have not had Covid.
Patient with history of 4 COVID vaccines who admitted with hypoxia and COVID detected PCR.  Provider d/c note:  "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) treated for COVID-19 pneumonia, oxygenation gradually improved Acute Respiratory Failure due to COVID-19 pneumonia -clinically stable on 3 liters , labs stable, increase activity,prone positioning,  continue decadron, remdesivir day 4/5 - no known history of COPD or CHF - O2 saturation at 88% on RA, Initially needed 4 liter/nc, 96% with supplemental oxygen - dexamethasone, remdesivir, vitamin D3, remdesivir stopped on 11/29"
Restless; Feet is so cold;  can''t warm up and when I get them warm, there is sweat; lost seven pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 16Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 13Apr2021, for COVID-19 Immunization.  The following information was reported: RESTLESSNESS (non-serious) with onset 2021, outcome "unknown", described as "Restless"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Feet is so cold; can't warm up and when I get them warm, there is sweat"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost seven pounds".  Additional Information: Side effect: Consumer stated, "Okay, I am restless. Now my feet is so cold. I can't warm up and when I get them warm, there is sweat and I have lost seven pounds."  Follow-up (18Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient's medical history included no drug reactions/allergies. On 13-OCT-2012 the patient was vaccinated with ZOSTAVAX (vial. lot number reported as H011431, expiry date 12-SEP-2013), 0.65 ml subcutaneously (dose number not reported). No other co-suspects were reported. No concomitant medications were reported. In October 2012 (exact date not reported) the patient experienced a small rash the size of 2 half dollars at the site of injection. The patient sought medical attention by visiting the pharmacy. No treatment was given, no labs were performed. The outcome of 'small rash the size of 2 half dollars at the site of injection' is unknown. A reporter causality for 'small rash the size of 2 half dollars at the site of injection' was not provided for ZOSTAVAX. Additional information has been requested.
Scheduled 2nd dose but did not received it/No vaccines left at the facility; Chest pain; Felt slightly dizzy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Felt slightly dizzy) and PRODUCT AVAILABILITY ISSUE (Scheduled 2nd dose but did not received it/No vaccines left at the facility) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Thyroid disorder. Concomitant products included LEUPRORELIN ACETATE (LUPRON).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Jan-2021, the patient experienced CHEST PAIN (Chest pain) and DIZZINESS (Felt slightly dizzy). On 17-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Scheduled 2nd dose but did not received it/No vaccines left at the facility). The patient was treated with PARACETAMOL (TYNELOL) on 23-Jan-2021 at an unspecified dose and frequency. On 21-Jan-2021, CHEST PAIN (Chest pain) and DIZZINESS (Felt slightly dizzy) had resolved. At the time of the report, PRODUCT AVAILABILITY ISSUE (Scheduled 2nd dose but did not received it/No vaccines left at the facility) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Relevant concomitant medications were reported as tynelol for arthritis, thyroid medication, cholesterol medication, vitamins, lupricon vaccine for every 3 months 0r 6months depending on results.    Reporter did not allow further contact
sore scratchy throat; slight cough; it feels like he has a cold; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date in 2021 the patient experienced sore scratchy throat, slight cough, it feels like he has a cold. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I awoke to severe upper abdominal pain centralized in the midline, just distal to Xiphoid process, and radiating across abdomen at 2AM (Approximately 14 hours post vaccination). Pain was an 8/10 and felt like somebody was squeezing my guts. Pain was worse when laying down or sitting and completely interfered with any type of sleep. I?m a paramedic and didn?t seek treatment.  Pain subsided for about and hour and I was able to sleep a little bit until it came right back and lasted from about 07:00 AM until now at 09:18 AM. The pain finally seems to be subsiding. No Nausea, vomiting or Diarrhea.
Suffered 100% blockage of Right Coronary Artery requiring stent to be placed.  Had not been feeling well before I took the two Moderna shots.  Never felt better after the 2nd Moderna shot and was progressively getting worse until heart attack.
shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.
After a few days, my husband noticed a rash on the right side o f my back. I also developed aches and pain to my bilateral legs. I ran a fever , also felt nauseated and dizzy and sweating like crazy, lasting 15-20minutes and the fever lasted all day. I went to see a doctor who did an ultrasound of my legs to check for DVT but it was negative.  My symptoms went away.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in Dec2017 at single dose as pneumococcal vaccine administered in physician office. Medical history included: the patient is a cancer patient and she had non-Hodgkin's follicular lymphoma. She was also highly allergic to a lot of medications. The patient's concomitant medications were not reported. In Dec2017, the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine, the same afternoon she broke out with red welts all across her body. She clarified that she broke out between her breasts, under her arm, and around her back to the mid part of her back. The patient went back to doctor and she was told to take BENADRYL and TYLENOL and she stated that it seems like it might be going away. The outcome of the event was recovering. The information on the batch number has been requested.
Breakthrough COVID-19 case with symptom onset 8/22/2021:  Fever >100.4,  Subjective fever (felt feverish),  Muscle or body aches,  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting,  Diarrhea (>/=3 loose/looser stools in 24 hr period). Hospitalized 8/23/2021-8/25/2021. In the ED patient was noted tachycardia heart rate into 130s and on blood work potassium 3.3, WBC count 15.4 and COVID-19 reported positive.  Chest x-ray suggestive of Confluent right upper lobe opacity consistent with pneumonia. A mass cannot be excluded but is considered less likely.
patient developed 2 days of bradycardia to low 40s with occasional PVCs.  No other cause found.  apparently this is a potential known  side effect to vaccine
My breasts became swollen and painful, and I noticed raised bumps which were probably lymph nodes on the side, under my arm, and also a few inches down on the side.  This lasted a few days, and was very uncomfortable and worrisome.   By the time I got the doctor appointment on Feb 17, the condition was a little better.   The doctor examined me and said that she now did not feel anything that would be cause for alarm.   She recommended that I wait two months, and then go for a mammogram and sonogram.   I did that on May 19.   I told the radiologist about this experience, and she told me that my test results were good, but that I should be vigilant because I had that experience.
Left wrist pain which drastically affected.; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left wrist pain which drastically affected.) and PYREXIA (Fever) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). In September 2021, the patient experienced ARTHRALGIA (Left wrist pain which drastically affected.). In 2021, PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Left wrist pain which drastically affected.) had not resolved.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of LEFT WRIST PAIN WHICH DRASTICALLY AFFECTED was not provided. The reporter's causality for the event(s) of FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JUN-2016, the patient was treated at a medical facility for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.