chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breaking out in swollen hives from head to toe. Visited urgent care on 12/13/21 and given a steroid shot and Benadryl shot. Prescription sent for steroids to take for 5 days and Benadryl (50 mg) to take for 2 days. I continue to break out in hives. Went to urgent care again on 12/19/21 and the ER.
Breakthrough case of COVID-19: I had congestion and sore throat. I had a virtual appointment and the doctor prescribed benzonatate and guaiatussin. I took three take home rapid test and one PCR test.
Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of PREVNAR.  The physician stated that there was an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) were ordered instead of PREVNAR because both products were next to each other on the order form.  It was reported that 40 doses were administered with the belief that they were PREVNAR.  It was reported that there was no confusion in regards to product packaging.  The physician stated that the problem had been corrected at the office and did not foresee any future problems.  On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of PREVNAR.  There were no adverse experiences reported.  Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.  Additional information is not expected.
2/8/17 Pt stated her neck started to feel sore but not on the inside.  Denies SOB and difficulty swallowing but neck is tender to touch and uncomfortable when she moves and looks up. 2/9/2017 spoke to pt again approx. 1130 and she states there is now a palable tender lump at the base of her throat.
red, hot, hard, tender, inflamed arm from crux of arm to armpit and half way around arm.
heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) intramuscular in the left arm on 12Jan2021 15:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included hypertension, asthma, hysterectomy and tumor debulking (reported as on 21Dec2021). The patient was not pregnant. Concomitant medications included hydrochlorothiazide, asthma medication and antibiotic; all from unspecified date for unspecified indication. The patient previously took erythromycin and experienced allergies. On 12Jan2021 15:45 (also reported as approximately 9 minutes post injection), the patient reported feeling her heart rate increased, was pale and diaphoretic. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events heart rate increased, pale and diaphoretic was recovered on Jan2021.
immediate feeling like numbness in left index finger followed by thumb, odd feeling in left armpit with in 6-7 minutes continued in forehead 20 minutes later and continuing until I took benedryl. 1/28/21 stabbing pain im various spots but not continuous, left triceps, headache,  and some index/thumb numbness continues 1/28/21. New is shoulder /neck pain on left side.
830AM TC from mom 23APR93 states pt cried all noc unconsolable, fever 101; no sz; encouraged to call MD; 4PM TC to mom states did call MD given APAP seems better but still real irritable;
Information has been received from a lawyer regarding a case in litigation concerning an unspecified patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date in 2015, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were reported as related to the therapy with ZOSTAVAX.
Had headache 48hrs after vaccination and was not responding to OTC NSAIDS.  While Dr. diagnosed patient with allergies, the patient is having the same response to the 2nd shot administered on 1/2/21 (separate report to follow)
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick, worst sickness), CHILLS (feel extremely chilly), HEADACHE (feeling headache) and PYREXIA (fever of 103.4) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (very sick, worst sickness), CHILLS (feel extremely chilly) and PYREXIA (fever of 103.4). On 26-Feb-2021, the patient experienced HEADACHE (feeling headache). At the time of the report, ILLNESS (very sick, worst sickness), CHILLS (feel extremely chilly), HEADACHE (feeling headache) and PYREXIA (fever of 103.4) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.4 (High) 103.4. No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable. Reporter did not allow further contact.
Case number PHEH2015US021445, is an initial spontaneous report received from a nurse on 21 Oct 2015. This report refers to a 53 years old female patient. Historical condition and concomitant medication were not provided. Patient had received expired FLUVIRIN (batch number: 1413101) intramuscularly on 13 Oct 2015. No further information was provided following this maladministration (expired vaccine used). Outcome of the event was reported as unknown. Event was reported to be non-serious and causality of the events was not reported.
Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriate schedule of vaccine administered; Joint pain; Significant body aches; Lethargy; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient previously took augmentin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:30, within 30 min the patient experienced warm sensation from left cheek down left arm. Within 3 hours headache. Within 12-18 hours post: dry mouth, significant body aches, joint pain, headache and lethargy. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events warm sensation from left cheek down left arm, headache, dry mouth, significant body aches, joint pain, headache and lethargy were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving  home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad  was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
Approximately 12 hours following immunizations, infant became fussy, shaking, and developed fever 102. Tylenol was administered. He was seen by healthcare provider 20 hours after immunization with severe fretfulness, 102 temp, rigid arms in flexed position and body slightly tense. After 24 hours in hospital, infant was much better. Given Rocephin. The discharge summary received on 2/19/04 states leukocytosis resolved, gastroenteritis, and possible allergic reaction to immunizations.
Fully vaccinated patient admitted for COVID originally on 08/11/21.  Following note taken from pulmonology's dischage summary after second admission/discharge:  "78 yo M, hx of AAA, T2DM, prostate cancer, and recent COVID PNA, who came in with SOB. He was admitted 8/7-8/11 for similar symptoms, found to be COVID positive, received dexamethasone and remdesivir, completing his course. On admission, he was tachycardic, satting in the low 90's on 2.5 L NC, but quickly desatted to the 70's when ambulating on 4 L. His D-dimer was elevated but the rest of his labs were unremarkable. A CTA showed moderate bilateral airspace disease suggestive of evolving COVID-like changes with no PE. COVID test was negative. He was suspected to have a superimposed infection, received antibiotics and finished his course of Zosyn.    He continued to require oxygen, eventually requiring high flow nasal canula, at one point. Pulmonology was consulted, and they determined that he likely had pulmonary fibrosis 2/2 post-COVID syndrome. He was given Solu-medrol during his stay. His symptoms slowly improved, and he was eventually brought down to 4 L NC at rest, requiring more with ambulation. On discharge day, he desatted to mid-70's on 6 L going up 2-3 steps on the stairs. We discussed with the patient what he wished to do knowing that information, and he still maintained that he wished to go home. He understood the risks of going home when he was hypoxic with ambulation and increased oxygen. He has stairs at home, but is willing to take breaks when going up stairs. He was advised to come back if he became short of breath at rest even with his current level of oxygen. "
01/11/22 presents to ED for "COVID and shortness of breath". PMHx of "COPD, hypertension, CAD, CKD, seizure"
Large red rash 4 inches diameter at the injection site. . It?s hard to the touch , swollen, and  very itchy.
Nausea, diarrhea, muscle aches, headache, chills, sweats, mild fever, fatigue
Patient presented to office at 0830 AM for shot visit with no recent health concerns.  Tolerated shots prior well.  Given Pentacel, Prevnar, Fluzone #2 and Rotavirus vaccines ~ 0840 without issues.  Returned to office at 11:40 with report of rapid onset facial and upper body hives with mild cough; onset ~ 11:10.  Upon arrival, mild swelling to lower right eyelid with visible hives to the face and neck area which resolved within 10 minutes of arrival. Mild cough without diffuse facial/lip/tongue swelling, no wheezing. Alert and appropriate. Within 15 minutes of arrival, symptoms resolved without medication.
Janssen COVID-19 Vaccine  Vaccine Lot Number: 202A21A  Pt reported feeling light-headed 1-2mins after shot. unconscious for 15-20 sec. diaphoresis before passing out. 911 called. M410 transported to HEC Pt suffered no trauma or fall. 12 lead ekg performed with sinus brady and 1st degree. no daily meds, nkda. ran 4 miles today; oatmeal/granola, milk protein bar; 13:28 92/43 p 57 ; 105/71 P 42; 112/66 p 49
Swollen bump above the left shoulder near the neck. Possible contra-lateral Lymphodenopopathy or other adverse reaction causing Severe muscle pain.
she had a patient that got covid last Sunday.; she had a patient that got covid last Sunday.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:   A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) 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 05Nov2023, outcome "unknown" and all described as "she had a patient that got covid last Sunday.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Nov2023) Positive, notes: Got covid last Sunday. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)  cannot be excluded.  This case will be reassessed should additional information become available.
pt recv vax 6MAY97 & 16MAY97 pt devel a fever & varicella-like lesions that were primarily on back;
Fever and chills for 24 hours, hives for about 12 hours, body aches for 8 hours until Tylenol was taken. Fatigue and mental fogginess for 36 hours.
Hives/almost anaphylaxis; This spontaneous case was received on 15-Jul-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-01739) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose and indication: not reported). The batch number reported was 252679.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had reaction of hives and almost anaphylaxis.   The outcome of event was not reported.  The reporter assessed the event of 'hives' as related to Flucelvax Quadrivalent. She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.  The event of 'hives' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  This case is linked with case 202202828 (the same patient).  Company comment: A patient of an unreported age developed urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Reporter's Comments: She had reactions of hives and almost anaphylaxis and she was asking if Flucelvax Quadrivalent contain any mRNA technology as she heard they snuck mRNA into vaccine starting in 2017.; Sender's Comments: A patient of an unreported age developed urticaria an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent. It is reported that the patient almost had anaphylaxis. The patient's medical history and concomitant drugs were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
After experiencing expected sore arm and fatigue the day after vaccination, I was symptom free for three days.  On the evening of the fourth day I developed pain, itching and redness around the vaccination site that is still present the following day.
The left arm at the injection site had redness, swelling, skin felt tight, and skin was hot to the touch. Some tenderness at the injection site. Occasional low grade fever. These symptoms continued from Friday, March 12, 2021 through  Wednesday, March 17, 2021.
Headachea; Achy; This case was reported by a other health professional via interactive digital media and described the occurrence of headache in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix 2 weeks before the time of reporting. Till the time of reporting, the patient had headaches and achy. This case has been linked to US2020AMR011237, reported by the same reporter
Fever/ 101.0, Sweating, Chills, Headache, Body aches.
Fever 102.5 degrees F the night of the shot and the next day.  Treated with Tylenol rapid release, which broke the fever.  Body aches, chills, headache.  Headache still continues.  Rash under bra line to half-way to hips, which is just now mostly gone away.
Acute chest pain and SOB followed by delayed onset of diffuse rash (20-30 minutes) across torso and back and left arm paresthesia. Managed with  25mg PO Benadryl, supplemental oxygen at time of reaction and home use epi.
Change in menstrual cycle from monthly or every twenty-three days to having four cycles in six weeks. Cycle gradually went back to normal over four months.  Extreme bloating due to SIBO (Small Intestinal Bacterial Overgrowth), diagnosed with SIBO, was treated for SIBO.
New Onset Multiple Sclerosis with transverse myelitis with initial presentation. Onset 1 week after shot. Progressed 2 months later.
Reported that she experienced slight blurry vision. Moved to observation chair- BP 124/76 pulse 72. Had 5 oz bottle of water. Reports that she has had high blood pressure. After 5 minutes- vision no longer blurry. Reported that she believe she  was anxious.
Information has been received from a physician concerning a pt (gender unspecified) who on 1/18/02 was vaccinated with 1 dose of MMRII (lot 639615/0734L). On 1/28/02, the physician's office received a telephone call that the pt developed a temperature and localized rash. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before". The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. F/U info on 3/7/02, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever", was because she has been in practice for a number of years and always gave pt/parents standard information on the benefits/risks of a vaccine before its administration and also instructed them to call the office if the child experienced any problems post-vax. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post vax reaction. It was very unusual for their office to receive as many calls as they did in 1/02, including this pt and other pts who were vaccinated and experienced similar events (WAES0201USA03018, 0202USA00428, 0202USA00429, 0202USA00430 and 0202USA00431). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10, post vax. It was noted that there were no additional cases reported and the increase in calls was just in the month of January, 2002. They did not experience any unusual volume of calls in February or thus far in March, 2002. Additional info has been requested.
recurrent herpes zoster outbreaks; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 29-OCT-2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance an for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2015, shortly after receiving zoster vaccine live (ZOSTAVAX), pt experienced multiple recurrent herpes zoster outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of herpes zoster was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). The event of zoster vaccine live (ZOSTAVAX) was considered to be disabling.
This was my second Moderna booster. I had similar side effects from the first booster in Nov 2021, though this time was a bit worse. I felt fatigued within an hour of the shot. I developed a fever (102.5 at its high point), muscle aches, tremors/shaking extremities, scratchy throat and was so tired that -- except for bathroom breaks -- I slept from Sat. at 4 pm until Monday at nearly 8 am. Almost 40 hours.
Fever of 100.1 for 2 days with fever 98.6 by end of second day. General body aches.
Swelling and redness in large circle around injection site.  Very itchy.  Lasted about 4 days.  Treated with cold compresses
Symptoms are as following:  2 weeks after getting vaccine started with BRAIN FOG, tingling in my head which then lead to severe pain in my joints, nauseous, severe pain in my lower back , extremity weakness, FULL BODY itching of skin, equilibrium issues, ringing in ears and pain and my bowels no longer work without medication.