chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturday evening aroun 7:30pm felt hot flash and had sweats and my back started to ache. Pain continued and also radiated from center abdomin and left side and intensified.  No sleep as I has fairly severe pain all night. Sunday consulted with  nurse and was advised Togo to the ER. Went to ER at Hospital around 5:07pm. Had several tests conducted including CT SCAN which revealed bloackage in the splenic  vein. Admitted and started me on morphine and also started Heparin blood thinner. Many many blood tests and additional CT scan conducted. Released on Tuesday around 12:30pm. Still have painful spasms as a result of the damage done to spleen. According to Dr, it may take 2-3 weeks before spleen is healed and spasms are gone. Follow up visit TBD in 2 weeks.
Presented with fever, diarrhea from assisted living facility; fully vaccinated; +covid test in ED; dx with Covid PNA; Received remdesivir, steroids, supplemental oxygen, Vit C, Vit D, zinc, steorids. eventually weaned off of oxygen; d/c back to assisted living.
Lymph node swelling starting around 2/8/2020, still swollen as of today,  3/6/2021.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at an urgent care, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2012, the patient was treated at an urgent care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Cough; Chills; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Apr2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included zolpidem tartrate (AMBIEN), alprazolam (XANAX), diphenhydramine / paracetamol / phenylpropanolamine hydrochloride (BENADRYL) and paracetamol (TYLENOL); for unknown indication from unknown dates and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 13:30, the patient experienced cough, chills, fatigue and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough, chills, fatigue and sore throat was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a office manager concerning an 18 week old male patient who on an unspecified date was vaccinated with the first dose of ROTATEQ.  On an unspecified date, when the patient was 6 and a half months of age was vaccinated with the second dose of ROTATEQ.  The patient did not receive his third dose because it could not be given before he turned 32 weeks.  No adverse effects were noted.  Medical attention was sought with an office visit.  Additional information has been requested.
Information has been received from a healthcare worker concerning a 24 year old female with hypersensitivity to AMOXICILLIN (+) AUGMENTIN who on 20-NOV-2008 was vaccinated with the first dose of GARDASIL, lot 660620/0571X, 0.5 ml, intramuscularly.  There was no concomitant medication.  On 20-NOV-2008 the patient experienced persistent arm pain since she received her first dose of GARDASIL.  Patient not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/12/2008.  Follow up information has been received from a registered nurse concerning the waitress (weight 202 pounds, height 67 inches) with AUGMENTIN allergy (hives) who on 20-NOV-2008 was vaccinated with the first dose of GARDASIL, lot 660620/0571X, 0.5 mL, intramuscularly, in her right deltoid.  The nurse indicated that on 25-NOV-2008 the patient called with complaint of right deltoid sore (onset 20-NOV-2008) and stated that the injection site swelled.  She had the patient stop by the physician's office, the physician didn't find swelling, erythema or skin induration at the injection site.  On 22-Jan-2009 the patient received her second dose of GARDASIL (lot # not reported), no complaints of or problems, just soreness for 1 day.  Additional information is not expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 20220560492(0) (Janssen Research & Development, LLC).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medical included Lisadexmefaine and Trandazaole hydrochloride. The following information was reported: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Patient reported as she was taking other medications within 2 weeks of starting of COVID-19, her con current condition included Auto immune disease and drug allergy. She t received covid-19 vaccine ad-26 cov2 dose was not reported 01 in total was administration on 11Mar2021 14:00 to left arm for prophylactic vaccination at the age of 53-Years old. She received non-company suspect vaccine included tozinameran (Pfizer biotechcovid-19 vaccine) (dose number in series 2) dose was not reported total on ad mistered on 09Dec2021 16:00 to right arm for prophylactic vaccination. On an unspecified date the she experienced covid-19 and was hospitalized (dose number in series) which led to suspect cynical vaccination failure. On 09May2022 she received paxlovid (form of admin. Route of admin were not reported, batch: FY0461 and expiry: Jan2023) does not reported for treatment of covid-19. The she received the course of 4 days of paxlovid treatment and discontinued on 12May2022.  Company Remark (sender's comment): Covid-19 vaccine AD26, cov2. suspected clinical vaccination failure. The event has a compatible /suggestive temporal relationship is unlabeled had unknown. They are other factors more likely to be associated with the events than the drug specifically: special situation. Therefore this event is considered not related.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Multiple Severe Flu like symptoms, nerve symptoms and then developed a shingles-like rash about 4 - 6? from injection site
Severe hives all over trunk (front and back). Hives presented on 4/21, within 24 hours of vaccine dose 2. Severely itchy. Initiated round of prednisone on 4/26 with limited results. Hives and rash returned on 5/1 with spread to arms. Formally diagnosed at pityriasis rosea on 5/4 following consultation with dermatology
Pt came in today (12-6-10) and complained about their arm still hurting from a shot given on 10-9-10, she said she had been taking ALEVE and APAP but her arm still hurts. I told her I would make a report and to see her own doctor.
pt recvd vax 2SEP93 & w/in 36-48 hrs pt exp generalized urticaria; no fever; no treatment initiated; lasted approx 48 hrs described as appearing 20 mins in duration, then fading, & reappearing; pt recovered;
When vaccine administered to patient,  part of the vaccine (unknown amount) was see running down patient's arm.  Vaccine had leaked from syringe.  Reported submitting event states that she did tighten the needle prior to administering.  Patient was given a repeat vaccination after consulting with infectious disease physician.  I am submitting this based on the VAERS criteria related to administration errors/issues.  Patient has not suffered any medical consequences from this (other than needing a second revaccination).
Patient stated that beginning on 11/17/21 he began having  a sore, achy arm all the way up to his neck that lasted 2-3 days. He also complained of losing his balance since that Wednesday. He states "his legs give out" and has to hold onto something at all times. It has been an ongoing issue since the day after his Covid Moderna Booster. He has not contacted his doctor about this issue. Encouraged him to contact doctor today. Patient saw his cardiologist on 11/18 and has another appoitment with his cardiologist on 11/29 for an echocardiogram.
Had his booster on Oct 11,2021  . One Nov 9 he was taken by ambulance to  Medical Center  and diagnosed with a heart attack. He had an elevated D-Dime of 0.54 indicating clotting although a subsequent CT show no " detectable" clots. He was on a Heparin drip with three increase in dosages that we are aware of. It took 9 hours to get his vitals WNL, most notably his BP, HR and respirations.  He was in the ER 4 days subsequently developing pneumonia and was admitted to the med surg unit for two additional days for a total of 6 days. He went home  on oral antibiotics. Then on Dec 2 at approximately 4 am, with c/o shortness of breath,  he was transported by ambulance again to   and diagnosed with Congestive Heart Failure. He was on a heparin drip again.  He underwent a heart catherization on Dec 3, 2021 that showed no new damage and has now been placed on two additional medications, Lasix and Potassium with an increase in his Metoprolol from 25 mg daily  to 50 mg daily.
Numb pink and ring finger on left hand. Feels like the fingers "fell asleep". Been this way for over a week now.
symptoms from 10/14/2019 to present: low fever, headache, chills, 6 hours of extreme nausea, exttreme malaise,  muscle aches, fatigue.
About 30 hours after receiving the 2nd Moderna shot, I developed a hard, red and hot knot at the injection site. A few hours later a large, about the size of my hand, raised, red, very hot, and extremely itchy patch appeared separate from the knot, beginning at the top and going down to my elbow on the inside part of my arm. I used Benadryl cream and an ice pack off and on for the next two days. Five days after first appearance, the large area started to fade, but still itched. The knot was disappearing. The itchy area did not clear until 10-12 days after the vaccination. No reaction, except tender arm, to the 1st injection.
Swelling at injection site, red, tender, itching, large as a goose egg.
Abdominal cramps; night time awaking, can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramps) and INSOMNIA (night time awaking, can't sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps) and INSOMNIA (night time awaking, can't sleep). At the time of the report, ABDOMINAL PAIN (Abdominal cramps) and INSOMNIA (night time awaking, can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
it was rpt fr HCP concerning pt who was vax 5jan96 & on 4feb99 pt exp shingles noted as 4 papular dermatomal strips. addl info requested
Headache, Rash, After 1st dose-rash below injection site. After 2ns dose -HA and fatigue Narrative:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported experiencing symptoms above approximately 8 hours post vaccination.  She reports no prior adverse reactions to 4 COVID vaccines or flu shots received for many years. She also reports no history of diabetes or hypotension.  Patient was home alone during reaction and lost consciousness alternating between partial and full loss resulting in a fall for about 2 hours until spouse returned home and helped her into bed.  Patient reports feeling back to normal today after awakening.
Fever of 99-9 t0 100.9, lethargic, went to bed a 5pm day of shot and was there over 24 hours.  Could not keep my eyes open, pain in my entire body, red rash on upper body under my arms and across my chest
Got home about a half hour after I got the vaccine. Got out of my car and my lower back started hurting and has only gotten worse since. Took Advil, but got no relief
lips tingling; lips swollen especially her lower lip; lips burning; tired and sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips swollen especially her lower lip), ORAL DISCOMFORT (lips burning) and FATIGUE (tired and sluggish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008b21a and 029a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (AUROVELA 24 FE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips swollen especially her lower lip), ORAL DISCOMFORT (lips burning) and FATIGUE (tired and sluggish). On 03-Apr-2021, FATIGUE (tired and sluggish) had resolved. On 07-Apr-2021, ORAL DISCOMFORT (lips burning) had resolved. At the time of the report, PARAESTHESIA ORAL (lips tingling) and LIP SWELLING (lips swollen especially her lower lip) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069615 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069615:Dose 1
Information has been received from a physician concerning a 25 year old female with no pertinent medical history or drug reactions/allergies, who on approximately 11-Jan-2007 was vaccinated with Gardasil (0.5 ml). The physician reported that 30 seconds following vaccination, the patient experienced an intense metal taste in her mouth, however immediately recovered. No further details were provided. Additional information has been requested.
Patient was given the HIB part of the PENTACEL reconstituted with Sterile Water. Parents aware and will be coming in for correct dose.
A week after my 2nd booster I started to feel like I had a head cold but only on my right side. Couldn?t hear out of my right ear. Felt very ?full?. Shortly after that the vision in my right eye got very blurry. I was treated with an oral steroid for my ear and topical steroid for my eye.  Hearing returned to nirmal after 10 day course of steroids. Vision gradually improved over months.
24 hrs after imms given. Pt. developed a temp of 100.3. 2 episodes of 'projectile vomiting' + crankiness. Foster mom took him to ER for eval.
COVID +, presenting with worsening shortness of breath, cough, and chest discomfort over the last week. CXR showed evidence of vascular congestion consistent with heart failure. ABG showed elevated CO2, likely due to OSA and pt body habitus. Her new O2 requirements are likely multifactorial as she is also COVID +.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-OCT-2008, 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, and the patient subsequently contracted a persistent strain of herpes zoster. During 2017, the patient was treated at a medical center for the onset of a severe vesicular rash, 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.
Itchy, red, raised rash measuring approximately 3 inches (h)  x 2.5 inches (w) appeared about 5 days after the vaccine was given around the injection site. I have seen people referring to this as "COVID arm". It has been 48 hours and is still itchy and red, but appears to be fading slowly. Additionally, about 24 hours prior to noticing the rash, I developed axial lymphadenopathy on the same side.
Severe and daily migraines...much worse and more constant and debilitating than underlying migraines have ever been.   On 2/7 I developed a severe migraine that lasted 86 hours. I took a medication which produced a 24 headache free period.  But then migraines returned lasting between 2-91 hours at a time.  Essentially, I had nearly continuous migraines for 8 weeks with brief portions of the days that were sometimes headache free.  After 8 weeks, the severity has decreased and is more variable(2-8/10) and the current frequency is a migraine for part of 5 out of 7 days per week. I am not yet back to my baseline migraine frequency/severity.
On the morning of 1/21/21 I noticed a 2" in diameter red circle around my injection site. I sent a picture to my doctor and I was seen on 1/22/21 and at that time I had just a red outline of a circle around the injection site that appeared to have moved/grown some since the day before. The doctors weren't able to say of it was an allergic reaction to the vaccine or not. They adviced me to use cortisone cream if it becomes itchy and to be seen again if continues to grow or I get a fever. As of today 1/23/21, the outline of the circle has seemed to have moved down towards my elbow. The area is not itchy or painful and that is the only place this has appeared. I've been taking pictures daily of the area to be able to see if it's changed at all.
shooting pain in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (shooting pain in the left eye) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced EYE PAIN (shooting pain in the left eye). On 18-Jan-2021, EYE PAIN (shooting pain in the left eye) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
3OCT96 pt recv vax & 4OCT96 swelling, erythema;6OCT96 ssen for significant local erythema, induration, edema, vesiculation of upper arm;rx pred, cool compress-gradual improvement;
Chest pain/occasional chest pain after 3 days; irregularly high heart rate (even when stationary); fever; severe headache and abdominal pain. Most symptoms lasted for ~3 days.
Nauseated x 5 days following 2nd inject. No problems p/1st inject; Reporter indicates "in my opinion rxn was not due to vax - rather obtained virus at the same time."
Significant lymphadenopathy requiring STAT Ultrasound and antibiotic coverage.  May require additional care and treatment based upon ultrasound results.
Immediately after I rcvd the shingles vaccine my arm became sore. Few hours I started developing a  redness, lump, swollen hot to touch to the injection site. Symptoms lasted over a week, but the pain has not gone a way. I still have a lump in my arm as well. I'm also experiencing weakness in my arm.  I have been applying a heating pad and using voltran cream. About a month ago I tried to schedule an appointment with my PCP but it's not until Jan 6, 2021.
Anaphylaxis - Diffculty breathing, chest heaviness, wheezing Reaction began 1:05 pm, Admitted to ER at 1:52, Released at 4:00 pm