chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainting; Horrible dizziness; tierdness; loss of feeling in arms and legs; heart racing; high cholesterol; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization. The following information was reported: CHEST PAIN (life threatening) with onset 16Sep2022, outcome "not recovered"; DIZZINESS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "Horrible dizziness"; SYNCOPE (medically significant, life threatening) with onset 16Sep2022, outcome "not recovered", described as "fainting"; PALPITATIONS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "heart racing"; BLOOD CHOLESTEROL INCREASED (life threatening) with onset 16Sep2022, outcome "not recovered", described as "high cholesterol"; SENSORY LOSS (life threatening) with onset 16Sep2022, outcome "not recovered", described as "loss of feeling in arms and legs"; FATIGUE (life threatening) with onset 16Sep2022, outcome "not recovered", described as "tierdness". The events "fainting", "horrible dizziness", "tierdness", "loss of feeling in arms and legs", "heart racing", "high cholesterol" and "chest pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2023) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of syncope, dizziness, fatigue, sensory loss, palpitations, blood cholesterol increased, chest pain. Clinical course: The patient experienced horrible dizziness, tierdness, loss of feeling in arms and legs, heart racing, high cholesterol, fainting. Chest pain. The patient wanted answers to all this and treatment. The patient was perfectly fine before and was thinking about to sue the company. Stated that the doctor told him it was the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Events were reported to be life threatening illness (immediate risk of death from the event). The patient had no covid prior vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Caller received the 1st dose of the Moderna vaccine on 21Apr2021 and hasn't received the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 21Apr2021 and hasn't received the 2nd dose yet) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 21Apr2021 and hasn't received the 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller received the 1st dose of the Moderna vaccine on 21Apr2021 and hasn't received the 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was given no concomitant medication was given
c/o weakness to left arm since GARDASIL vaccine  given on 8/8/08. 11/24/2008 Office records received from PCP. WCC 8/8/08 with vax given.  PE WNL except papular lesions on the face. Seen agin 9/15/08 with c/o L arm pain which radiates to L hand since receiving HPV vax. Assessment: Paresthesia. X-ray 9/16/08 for knee pain.  Seen again 9/29/08 with pain sx now also to the shoulder and breast. Awaiting neuro appt. 1/7/09 Neuro consult received from PCP dated 11/11/2008 with DX: Left Ulnar Neuropathy Symptoms.  Left thigh Meralgia Paresthetica.  Tendency to Migraine. Pt presented with 3 month hx of L sided head pain, L hand numbness and L thigh numbness which began after receiving HPV vaccine.  PE (+) for altered sensation in ulnar distribution of L hand and no sensitivity of the nerve at the elbow. Unable to see association to immunization.
All was well initially after receiving the injection on 03/15/21.  At 3:30 A.M. on 03/20/21, I was awakened from sleep by persistent itching.  I discovered light hives running along the inside of my right arm and along the right side of my torso, from the side of my right breast to my waistline.  I immediately took two (2) Benadryl capsules that we had in the house.  I also washed the hives with soap and water in case this was from an external source.  I had immediate relief from the itching and the hives immediately began to disappear, so I returned to bed and slept.  When I awoke in the morning at my normal time, I did not have any additional itching and there were no hives present anywhere on my body.  I went about my day and was at an appointment outside of the home when itching returned at approximately 1:00 P.M.  on 03/20/21.  This time it started on the outer side of my right breast and spread completely across the torso beneath both breasts within 45 minutes.  Also at 1:45 P.M., I felt a couple of episodes of light chills and "goose bumps."  When I arrived home by 2:00 P.M., I discovered that there were hives not only beneath my breasts, but also across the torso from one side to the other underneath the waistband of my jeans, as well as in a couple of random spots on my stomach.  I immediately took two (2) Benadryl capsules and took my temperature as well, which indicated a low-grade fever of about 100 degrees even.   I called at 24-hour Nurse Hotline, described my situation (including that the Benadryl I had just taken was immediately working on the new set of hives and itching), and was told to continue taking the Benadryl for a complete 24-hour cycle, as well as given information about what to watch for regarding the hives and instructed to obtain further medical help if the hives worsened despite taking the Benadryl.  Over the next several hours, the hives continued to recur (as well as the itching) and to spread throughout my torso and onto my back and arms.  I ended up in the Emergency Room after midnight when the Benadryl no longer did anything and the hives continued to worsen in both color and size.  I received an IV treatment of Benadryl, Prednisone, and Pepcid, and got immediate relief.  My heart rate reached 105 for a bit in the ER, but lowered to 95.  I had to continue taking these meds over the next several days at home, during which my hives eventually left some areas but spread down my legs to the tops of my feet before disappearing completely by 03/25/21.
The following morning headache, fever, chills, and weakness. I did recover that evening within 16-18 hours. I did not need care from a doctor.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EL3247), via an unspecified route of administration in right arm on 02Feb2021 at 00:00 (at the age of 77-years-old), and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6200), via an unspecified route of administration in right arm on 25Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included IBS, diabetes insipidus, gastroesophageal reflux disease (GERD), osteoarthritis, hypertension and high cholesterol on an unknown date. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medications within two weeks of vaccination. On 02Feb2021, the patient experienced diarrhea lasting from first dose to current date 18Mar2021 which was uncontrolled by budesmide. The patient had undergone treatment with budesmide for diarrhea. The outcome of the event diarrhea was not recovered at the time of reporting and had resulted in Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are needed. No further information is expected.
Narrative: 84yo pt died during inpatient hospice. Death was caused by: Respiratory arrest secondary to failure to thrive to end-stage dementia per MD deah note. Pt had received covid vaccines in unknown location (not agency) on 2/2/21 & 2/23/21. Likely his death is not related given patient's advanced age, comorbidities, and long length of time between date of vaccines and date of death.
Information has been received from a registered nurse concerning a 72 year old female with drug hypersensitivity to sertraline (ZOLOFT) who on 07-SEP-2006 was vaccinated with Pneumovax 23 (Lot number 651374/0485F). Concomitant therapy on 7-SEP-2007 included tetanus toxoid "in the same arm". On 08-SEP-2006 the patient experienced red area, cellulitis and warmth at injection site. The patient was not seen in the physician office. Ice, acetaminophen (TYLENOL) and ibuprofen (MOTRIN) were recommended as treatment. No laboratory studies were performed. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL that was improperly stored and administered with a lot # reported as L001442 and expiration date: 04-NOV-2016. No adverse effects reported. Additional information has been requested.
Eyes are swollen; Blurry vision; Cannot open eyes in the morning; Pain in the shoulders; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches). At the time of the report, EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079204 (E2B Linked Report).
Pt admit 3/22/22 w/ acute hypoxemic respiratory failure d/t COVID19 (positive test result 3/18/22). Pt had previously received 3 doses of Pfizer on 12/28/20, 1/18/21, & 10/29/21. Pt had also received 6 of 10 doses of Paxlovid prior to being admitted.
I was given the 3rd dose of the Moderna, the booster shot, on October 29, 2021. I started to feel unwell on October 30, 2021. At first, I felt the symptoms I was told I was going to feel such as the fever, body aches, and chills. Later that same day, around 4:30 p.m., I started to experience a sharp pain at the beginning of my spine. I felt extremely dizzy along with a headache. Throughout the night, I felt the pain get worse and I took Tylenol in order to relieve the pain. I took Tylenol and it helped put the pain at ease, although the pain never seemed to have went away.  Starting on November 28, 2021, the pain came back even worse than before. I am unable to move nor walk due to this pain. My spine and back appear to be inflamed. I feel extremely dizzy and my legs feel very weak. I felt an unbearable amount of pain so I went to the Emergency Department on November 30, 2021. There, the doctor told me I have acute bilateral low back pain without running any tests or listening to my other symptoms.  I was sent home the same day with 4 medications: Naproxen (Naprosyn 500 mg oral tablet), Diazepam (Valium 5 mg oral tablet), Hydromorphone (Dilaudid 4 mg oral tablet), Methylprednisolone (Medrol dosepak 4mg oral tablet). I was still unable to  move or walk, my legs still felt extremely weak, and I was still in immense pain. I went to Hospital on December 1, 2021. There, I was given Lidocaine and Pantoprazole. I was discharged at 4:38 p.m. on December 2, 2021 and was prescribed 2 medications: Ibuprofen and Lidocaine. I was told to return  if the pain becomes worse or if other symptoms appear. I am currently at home taking the prescribed medication unable to move. I can barely make it out of bed. I have not been able to work since November 29th, 2021. It is December 3rd, 2021 and the pain remains and I am waiting for this medication to help.
On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.
Patient vomited and was itching left arm post vaccination. BP was high (185/100), pulse was good, patient reported some chest tightness. Patient given Benadryl 50 mg and famotidine 20 mg.
temp 101.1; HR - 78; BP 120/74; feeling weak; fever; personality change - weepy; moody
Fever of 100.2; Headache; This case was reported by a consumer and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020 14:30, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd December 2020, 4 days after receiving Shingrix, the patient experienced headache. On 23rd December 2020, the patient experienced fever. On an unknown date, the outcome of the headache was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix and on night patient had headache. Five days after,the patient woke up with headache and a fever of 100.2 degree F also fever went down and the last reading was 96.8 degree F. The patient did not take any anti-fever medications. Patient did not want to share her pharmacy's contact information. The reporter did not consent to follow up.
Twenty minutes post vax, this child became extremely agitated and his voice became very hoarse. He tried to hit himself and threatened to kill his mother. No previous history of aggressive. The next day, the aggression resolved without treatment. As of 11/01/1999, pt remains recovered.
I tested positive for COVID-19 on 5/23/22, I had a sore throat, dry cough, and nausea. I started taking PAXLOVID that day and my symptoms were gone in 2 days. I am still a little hoarse, but other than that I feel good.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Other medical history: mild COPD" (unspecified if ongoing), notes: Other medical history: mild COPD. The patient took concomitant medications. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 02Feb2023 to 06Feb2023. Clinical course: The name of the concomitant drug was reported as unknown, and administration period was from Jul2005 to Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1, pain in left deltoid, left elbow and left shoulder, multiple myalgias and inflammation. Day 2, increased arthritic symptoms and myalgias in left arm, wrist, hand, neck. Day 3, increased arthritic symptoms and multiple myalgias throughout both arms and upper torso. Day 4, continued spread of symptoms to entire upper body and hips. Day 5, continued spread to legs and knees. Visibly swollen fingers and knees. On day 2-3, visited physician for evaluation. Instituted 3gm acetaminophen/day. Symptoms continued to worsen and spread through day 7, then began to subside by day 10, and had resolved by day 14. * The underlying auto-immune disease had be well controlled and an event of this magnitude had not been experienced for at least 10-15 years.
One day after the vaccine with extreme fatigue and malaise.  About 9 days after the vaccine I noticed parasthesas in my hands and tingling/numbness in my right 5th toe.  It felt as though my hands were intermittently numb/tingling (both hands) and when I had different sensations to hot and cold. About a month after the vaccine I noticed that i had intermittent visual blurriness in my right eye. I saw my MD in April and she suggested I see a Neurologist to rule out another auto immune disease. Throughout the summer my neurological and visual changes persisted intermittently. I saw a Neurologist in September 2021 (the earliest they could get me in). I explained that my symptoms started 9-10 days  after the vaccine and wondered if it may have triggered another autoimmune disease.
Lost vision for 2 minutes, felt lightheaded, faint. Those effects dimished after 5-10 minutes of deep breathing.
This spontaneous report as received from a consumer refers to daughter of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL IM around February 2012 (lot number not provided). Around April 2012, the patient received dose 2, 0.5 GARDASIL IM (lot number not provided). Around June 2012, the patient received dose 3, 0.5 ml GARDASIL IM (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. The patient's mother was concerned the third dose was give outside the recommended dosing scheduled. No adverse event was reported. Therapy with GARDASIL was reported as discontinued in around June 2012. Additional information has been requested.
ANCA-Associated Vasculitis Associated With Cardiac Tamponade; ANCA-Associated Vasculitis Associated With Cardiac Tamponade; This is a literature report.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (medically significant, life threatening), CARDIAC TAMPONADE (medically significant, life threatening), outcome "unknown" and all described as "ANCA-Associated Vasculitis Associated With Cardiac Tamponade". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: titer of 1:160; Positive, notes: MPO-ANCA antibody with a titer of 1:160; Biopsy kidney: showed MPO-ANCA mediated crescentic focal, notes: necrotizing and focal sclerosing glomerulonephritis; Computerised tomogram thorax: showed moderate to large pericardial effusion; Echocardiogram: moderate to large pericardial effusion, notes: which was subsequently confirmed on Echocardiogram; Protein urine: nephrotic range proteinuria; Urine protein/creatinine ratio: 4, notes: Unite: g/g. Therapeutic measures were taken as a result of cardiac tamponade.  74- year-old woman with history of Hypertension, Diabetes presented with generalized fatigue and occasional cough after getting Pfizer-BioNTech covid vaccine in June 2021. She had nephrotic range proteinuria with UPCR of 4 g/g, serum positive for MPO-ANCA antibody with a titer of 1:160. CT chest showed moderate to large pericardial effusion which was subsequently confirmed on Echocardiogram. Kidney biopsy was done and showed MPO-ANCA mediated crescentic focal necrotizing and focal sclerosing glomerulonephritis. The patient later developed transient episode of SVT which required higher level of care and a pericardiocentesis was done for cardiac tamponade and impending cardiac collapse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS, CARDIAC TAMPONADE and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.