chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost went completely unconscious; scar tissue in my lungs; a syncope event; overwhelming heat and cold; overwhelming heat and cold; racing heart; extremely sick; I could barely move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "syncope" (unspecified if ongoing), notes: had happened before; "scarring in lung" (unspecified if ongoing); "get very tired" (unspecified if ongoing); "shortness of breath overall off" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,  prev dose dose number=1), for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered with sequelae", described as "almost went completely unconscious"; PULMONARY FIBROSIS (medically significant), outcome "recovered with sequelae", described as "scar tissue in my lungs"; SYNCOPE (medically significant), outcome "recovered with sequelae", described as "a syncope event"; FEELING HOT (non-serious), FEELING COLD (non-serious), outcome "recovered with sequelae" and all described as "overwhelming heat and cold"; PALPITATIONS (non-serious), outcome "recovered with sequelae", described as "racing heart"; ILLNESS (non-serious), outcome "recovered with sequelae", described as "extremely sick"; HYPOKINESIA (non-serious), outcome "recovered with sequelae", described as "I could barely move". About 12 hours after receiving the vaccine and flu shot. The patient woke up in the middle of the night with overwhelming heat and cold, racing heart, when she stood up to go to the bathroom she had a syncope event (had happened before), and almost went completely unconscious, the patient was able to get up off the floor in the morning (several hours later) and was extremely sick for about 3 days. She could barely move. Also, shortly after (a month or so. She got covid and was very ill for 3 weeks) as soon as the school stopped mandating students wear masks all of this during a surge in cases. The patient had been told that she have scar tissue in lungs. She also retired at that point from her 39 year teaching career. Therapeutic measures were not taken as a result of loss of consciousness, pulmonary fibrosis, syncope, feeling hot, feeling cold, palpitations, illness, hypokinesia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274683 Same product, patient, different event, different dose;
Within 60-90 minutes after receiving vaccine, patient developed runny nose, swelling of nasal bridge, neck swelling. Parent gave Benadryl and returned to office. Lungs clear. + swelling. Gave Epi Pen JK. Pt observed and was stable. Took 2 days of Orapred.
Pt initially received Pfizer EW0173 6/2/21 and today 7/16/21 was given Moderna 034C21A due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Moderna vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times.
Increased heart rate by 15-20 beats that started after 2nd dose of Moderna and lasted 3 months. Earlier onset of PMS and painful periods started near the end of April 2021 and still continues.
Pt received PEDIARIX, Hib, PCV13, ROTARIX in our office on 7/22/13. I spoke with pt's mother on 7/23 and she stated pt continuously cried in a shrill for 6 hours after the vaccines. Pt continued to cry through the night and is currently still crying now. Cry is not as continuous as yesterday.
I noticed I was starting to feel achey and my left armpit was a bit swollen. After a few days, the right armpit began to swell as well.  Swelling kept going up, but 8/21 my left armpit was swollen to the size of a grapefruit and I couldnt sleep on my left side, couldn't put my arm all the way down, felt very sick.  Right armpit was tangerine sized.   I went to urgent care on 8/22, they ran a CBC. They thought the glands being swollen could be from the virus or IVIG. THey also noted i had glands swollen on my scalp that i hadnt noticed before.  After that I called my PCP who suggested i follow up with breast care. I had to get a mammogram and 2 ultrasounds to monitor the swelling. I also had a hospitalization from 9/7-9/13, but it was due to an inflammatory reaction to a virus that shutdown my marrow blood production and injured my liver.  It was determined not to be caused by the vaccine or my IVIG, but rather since my body was still recovering from the inflammation due to the vaccine that it exacerbated the virus so much that I was in the hospital. If more information on that is required, please contact me, as the labwork was a huge amount.
My second dose was administered on April 15, 2021. Sometime after that but before my booster shot in November I noticed my bottom lip on the right side was numb. It extended down the chin and on the lower cheek on that side. I thought it was a passing thing. I mentioned it to my doctor in late Dec 2021. He asked if I?d experienced some trauma, like being hit, or falling, which I had not. It just appeared. We wondered if it might be related to the vaccine since there have been cases of Bells Palsy and facial paralysis noted.
Flu-like symptoms (fever, nausea, and headache); Flu-like symptoms (fever, nausea, and headache); Flu-like symptoms (fever, nausea, and headache); Flu-like symptoms (fever, nausea, and headache); This is a spontaneous report from a contactable consumer. A non-pregnant female patient with an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 28Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 29Apr2021 a day after receiving the second dose of the Pfizer COVID-19 vaccine, the patient experienced flu-like symptoms (fever, nausea, and headache). Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu-like symptoms (fever, nausea, and headache) was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
60 second generalized tonic-clonic seizure followed by a second one 6 hours later; MRI negative; EEG markedly abnormal with frequent burst suppression activity; LP normal.  No active infectious or neurological etiology found.  Treating with antiepileptic and seeing slow recovery of mental status. 12/10 12/23 12/24 1/5/09:  Hospital records received for dates of service 11/13/09 to 12/19/09:  Dx:  Encephalopathy, seizures, spinal lesion.    Hospitalized after onset of tonic clonic seizures with bilateral upper and lower extremity shaking lasting 30 to 60 seconds with no respiratory compromise and urinary incontinence,  unusual fatigue, fever,  headache,  sleeping more than normal.  Hx. of enuresis worsened with admission,  taking Dilantin and Trileptal.  EEG abnormal but without epileptiform discharges.  Also poor memory, poor appetite, ten pound weight loss over past month,  nystagmus on lateral gaze both right and left, ataxic gait and slow, slurred speech. Intensive care unit admission after seizure with prolonged apnea. PICC Line placed.  Treated with IVIG with marked improvement, though she did have a reaction to the IVIG with fevers, abdominal pain and a few days of low blood pressure.   Discharged on antiepileptics.
Onset ~3/24/21 c/o SOB, DOE, intermittent fever and N/D. SOB/DOE worsened. Sought care at Medical Center 3/31/21 and admitted to another hospital hypoxemic on room air and tachycardic w/ respiratory distress. CHF Dx w/ EF 15-20% on 4/1/21. OGT placed 4/6/21. Multiple infarcts 4/15/21. NGT placed 4/16/21. Acute Motor Axial Neuropathy (variant GBS) on 4/19/21.
Pt devel a fine red rash 24 hrs p/1st dose of vax on legs only; @ this time no assoc was made; p/2nd set of immun devel a similar rash, only involved legs, arms, & trunk again this rash occurred 24 hrs p/immun & lasted 3 days & no other sx;
This is unknown as to whether this is related to the vaccine, but it should be considered/noted. Patient was vaccinated with Pfizer vaccine on 3/4 and 3/25. He tested positive for Covid-19 via PCR test on 8/21. Symptoms were very mild - cold-like. But after a few days, a growth developed on his lower jaw. It was determined via biopsy at MD that he had a plasmacytic neoplasm tumor. It was removed, and looked at by a number of people at both as well as the Clinic. They thought that this was indicative of either Amyloidosis or Multiple Myeloma, and a series of tests were completed. Upon completion of these tests, it was determined that there were no more cancerous cells, and this tumor was apparently a random isolated occurrence. sidenote: Patient's identical twin was unvaccinated, and contracted Covid-19, and while symptoms were much worse, he ultimately came out of it unscathed.
A female pt (age unspecified) experienced headache, belly ache, and mild diarrhea after receiving RabAvert for post exposure vaccination. Less than forty eight hours after receiving her first dose of RabAvert on 16Mar04, she experienced flu symptoms of headache, bellyache and mild diarrhea. The symptoms were ongoing at the time of the report.
Chills, fatigue, body aches, headache, injection site arm pain, nausea
Headache, Soreness in the arm, shoulder and neck, lump or knot in shoulder, Fatigue, muscle aches. Narrative:
Mother brought the patient (her daughter) back to our clinic on Monday, 9/10 stating that on Friday, 9/7 her daughter complained of a rash all over her body. Upon inspection, the mother noticed "welts or hives" all over her daughter's body. These welts itched. The school nurse advised the mother to put hydrocortisone cream to the welts. Upon inspection at our clinic, there were hive-like lesion over the entire body, more so on the trunk. Each hive was discreet, erythematous and raised. The child did complain of pruritus. There was evidence on some of the hives of scratching, such as light abrasions. I advised the mother to apply the hydrocortisone cream or give oral BENADRYL for itching and to see medical attention if it does not get better in a few days or gets worse.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 11:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 11:49 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.83 years.  Concomitant and Treatment medications were not reported.  On 18-May-2021, the vaccine with batch number 026C21A was moved to fridge. On 24-May-2021, 3 vials were moved to the clinic. On 24-May-2021 at 8 AM and 9 AM vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 17-Jun-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.   This case was linked to MOD-2022-566976 (Patient Link).
I had the j&j shot. I had an extremely high fever and excruciating sinus headache, and chills.
Adverse event was the administration of the vaccine to a person that did not meet the age criteria of 18 or older. He was observed by the Public Health Nurse for at least 15 minutes post-vaccine. No adverse reactions were observed during at that time.
Around 10 PM the day I received the vaccine I experienced chills, fever, swollen glands, sore throat, and body aches. I estimate these symptoms lasted about an hour. When I woke up the next morning I was completely fine.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 1st of 4 reports. Only 2 cases are serious. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in the deltoid on an unspecified date. PREVNAR 13 was the only vaccine given. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness after the vaccine was given. The patient called the office and returned for an office visit to see the doctor for the occurred events. It was unknown with what the cellulitis the patient may have been treated. The outcome of the events was unknown. Based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the events, redness and cellulitis, the Company cannot completely exclude that the suspect drug PREVNAR 13 contributed to the development of the reported events.
Patient hasn't received 2nd dose; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose) and HERPES ZOSTER (Shingles) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported.). Concomitant products included AMLODIPINE, OMEPRAZOLE and PYRIDOXINE HYDROCHLORIDE (VITAMINE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose) had resolved and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 013L20A  with no associated AE shingles. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, fever, chills, myalgia, nausea, pain at injection site and pain and swelling in axilla of arm that was injected. All symptoms other than pain in arm started around 11 hours after injection. Pain at injection site was immediately after injection. Swelling and pain in axilla started around 5 hours after injection.
Extreme fatigue leading to only a few hours per day of functionality (for working, doing household chores, exercising, etc.- anything but resting).  I had fatigue for a week and a half after the first shot and then so far for 3 months since the second shot (it?s been approximately 3 months since I had the second shot).  This is really really bad. I can now only work for around 4 hours per day.
No relevant medical or drug history information was reported.  The patient was given FLUMIST at 10:00AM on 16-Nov-2007.  by 5:00PM on 16-Nov-2007, the patient was "throwing up and had a high fever."  Exact temperature was not stated.  Rechallenge is not applicable.  Causality assessment is not applicable.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Systemic: Stroke-Severe, Additional Details: pt says he experienced a stroke ~5 hours after receiving the second pfizer shot. pt did not mention experiencing a stroke after the first shot
In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.; In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4476265-00 (Agency).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis, uveitis; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular 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) all with onset Jul2022, outcome "recovered" (Jul2022) and all described as "In Jul2022 patient experienced COVID positive. In Jul2022, the COVID positive resolved.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. The action taken for adalimumab was unknown.  The reporter considered "in jul2022 patient experienced covid positive. in jul2022, the covid positive resolved." related to BNT162b2.  Clinical course: The reporter's causality for the event(s) of COVID Positive with Humira (Adalimumab) was no reasonable possibility and Janssen covid-19 vaccine was related.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient is a 83 y.o. male patient Local MD with history of GAD, HD, HTN and afib presented to local Medical Center with stroke like symptoms .   Covid-19 Virus Infection Date of onset of symptoms: Unsure Symptoms present on admission: Confusion, maybe some mild dyspnea Date of covid positive test: 11/24/22 Vaccination status: vaccinated Imaging: CXR Oxygen requirements on admission: RA Current oxygen requirements: 2L Medical therapy: steroids-- plan for 10 day course Consultants following: None Anticipated special isolation end date: 12/4/2022 Patient high risk for readmission   Acute Hypoxemic Respiratory Failure Etiology: covid Baseline O2 requirements: none Current O2 requirements: 2L Continue pulmonary hygiene Wean O2 to baseline oxygen requirements as able Continue treatment of underlying etiologies as outlined Plan for home O2 on DC- 2L   Acute Metabolic Encephalopathy Cognitive Impairment Fall Patient with no formal diagnosis of dementia, wife reports patient with recent memory impairment Patient with inpatient fall overnight Confusion likely related to covid-19 Delirium precautions Fall precautions Haldol prn Home xanax resumedPermanent Atrial Fibrillation Follows with Dr. at local Hospital Initial rate control with cardizem gtt Anticoagulated with xarelto Home coreg switched to metoprolol Cardio cs'd Weaned off cardizem gtt as able; HR controlled Stable for DC per cardio   Stroke-Like Symptoms Patient presented from outside hospital for neurology evaluation and MRI Symptoms include- confusion, dysarthria, right sided grip weakness Patient has not taking home xarelto for one week-- resumed CT head 11/25 with no acute intracranial abnormality visualized.  MRI stroke 11/26 without acute abnormality HA1C 7.7 LDL 18 PT/OT/ST ordered Stroke ruled out Cleared per neurology for DC   Essential HTN Home losartan, coreg, imdur continued on admission Amlodipine held-- restarted 11/27 due to elevated BP IV hydralazine prn   DM2 HA1C 7.7 11/2022 Uncertain if new onset Consider metformin versus lifestyle modifications, outpatient PCP follow-up SSI, accuchecks ordered   GAD Patient takes scheduled Xanax at home and will continue for now, though would not recommend this medication for his age Patient would benefit from geriatrics evaluation as an outpatient   Hypokalemia Treatment per electrolyte replacement protocol Replace, recheck