chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AWFUL; GASSY; BURNING IN HER STOMACH; ACHING IN HER STOMACH; DID NOT THROW UP BUT SHE FELT LIKE SHE WAS GOING TO; BURNING IN HER STOMACH; ACHING IN HER STOMACH; This spontaneous case report was received from a consumer (PVX2019-655) on 14-Mar-2019. It described a 59-year-old female consumer who experienced the events burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer completed the Vivotif course on 14-Mar-2019. She was experiencing burning and aching in her stomach when she took Vivotif but she also experienced a bit on days when she did not take it as well. She stated that it helped when she did not eat food such as the second dose of Vivotif she took, she did not eat most of the day until 04:30 PM and that seemed to help. However, she was feeling uncomfortable (in regards to the burning and aching). The adverse events were worst for her after taking the first dose of Vivotif. She stated that she did not throw up, but she felt like she was going to and she felt awful. She also stated that the adverse event got better at night. She also felt very gassy. She stated that she did not take any treatment for the adverse events.  The action taken with Vivotif with respect to the events burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to was dosage maintained.  The clinical outcome of the events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" was resolving.  Company's Comment: In this case, it was reported that a 59-year-old female consumer experienced the following events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" following the intake of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif is assessed as possible to vivotif. However, lack of information on concomitant medication and past medical history precludes further assessment of case.; Sender's Comments: Company's Comment: In this case, it was reported that a 59-year-old female consumer experienced the following events "burning in her stomach, aching in her stomach, awful, gassy, and did not throw up, but she felt like she was going to" following the intake of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine. Hence, the causality of the events with Vivotif is assessed as possible to vivotif. However, lack of information on concomitant medication and past medical history precludes further assessment of case.
Severe chills, headache, mild nausea and diarrhea, and fatigue.
anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002798 Regulatory authority.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: On 01Aug2022, it was reported that a patient started treatment on an unreported date with an mRNA covid vaccine. It was reported that patients with PEG allergy experienced anaphylactic reaction to mRNA Covid Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Migraine headache for 4 days. Patient reports that she has had migraine headaches in the past but never lasted this long.
Day 1: Arm pain, low grade fever, joint pain, headache. fatigue, eye sensitivity.  Day 2: Redness immediately around injection site. Severe body aches, axial (underarm) lymph tenderness and swelling, mild asthma exacerbation (controlled via inhalers,) severe fatigue, light sensitivity/aversion. Difficulty concentrating, somnolence.  Day 3: Significantly reduced symptoms.  Day 4: Resolution of symptoms.  Day 5 - 15: No additional symptoms.  Day 16: Menstrual-like cramps (post-menopausal. Also happened after first dose. Has never happened outside this context.) Mild, self-limiting.  Day 17: Cramps resolved. No additional symptoms.
A 64-year-old female patient receiving her bivalent booster from Pfizer refers to feeling "warmth" throughout her body, additional minutes are observed and vitals are taken, which show no change, minutes later she begins to cough and, according to what she refers to, feeling tension in the neck. 2:03pm- BENADRYL P.O. x 1 tab 25mg and is observed for 30, cough improves but itching begins in the arms.
This non-serious spontaneous case, initially received from other health professional on 11-Oct-2018, concerns a 47-year-old, adult female patient. On an unspecified date, the patient (under 65 years) was administered FLUAD TIV [dose, route of administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, the patient did not experience any adverse events. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
AFTER PATIENT GOT 2ND BOOSTER SHOT FOR PFIZER, SHE FELT BURNING SENSATION.
I received the first dose of Moderna Covid-19 on this date 047C21A), followed by the second on July 13, 2021 (048C21A). My blood sugar levels have not returned to normal in three months. My endocrinologist has increased my dosage of NovoLog Mix 70/30 5 or 6 times.
Area around injection site swollen, red and itchy.  Presented 8 days after vaccine.   Approximate area 3? x 3?
pt recvd vax & 16 days p/dose 3 exp herpes zoster; sx were burning pain, itching & weeping rash;
DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1443) was received from a consumer on 02-Jun-2019. It describes a 50-year-old adult female consumer who "took two unrefrigerated doses" and "did not complete her immunization one week prior to travel ", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses and took two doses on 31-May-2019 and 02-Jun-2019, respectively. She had a planned trip on 09-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete her immunization one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "did not complete her immunization one week prior to travel" was considered as not applicable.
C/O red, swollen (L) arm related to Varicella immunization. Instructed per provider to apply ice pack and TYLENOL PO as directed follow up if symptoms persist.
This spontaneous report has been received from the patient's father concerning his 16 year old daughter. The patient did not have any relevant medical history, concurrent conditions and concomitant therapies to be reported. On 24-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (strength, route of administration, lot number, and expiration date were not reported) for the prevention of human papillomavirus. Subsequently, on that day, the patient experienced fevers and Itching. The patient did not seek medical attention, received treatment for the events, nor had laboratory diagnostic laboratory tests performed. At the time of this report, the patient had not recovered from pyrexia and pruritus. The causality assessment between pyrexia and pruritus with GARDASIL 9 was unknown. Additional information is not expected as there was no follow up consent provided.
Patient was laying on exam table approximately 5 minutes after HPV 9 injection reported feeling like fainting, very weak. Brother of patient came out of room calling for help. Per mother of child patient fainted few seconds. In the presence of nurse and medical assistants patient conscious reported feeling very lightheaded. Patient vomited clear content.  Patient was keep on supine position, BP not detectable at first check. As patient tolerated was prompt to sitting position, drank water and given crackers. BP detectable 90/50. Patient monitored for the following 15 minutes until stable to leave.  Patient  accompanied by mother and 2 brothers at all time. Left clinic walking to commute home by private vehicle.
Brought to ED by family due to confusion, weakness and frequent falls. Tested positive for covid on admission. Treatment includes anticoagulation, and monitoring.
102 degree fever  (measured via an old fashioned mercury thermometer, under my arm for 5 minutes); Tylenol was effective in bringing it down. I was feverish the whole day after the vaccine and fine on the next day (36 hours post-vaccine).
After receiving the vaccine I have been having a pain/pressure and sensation that comes and goes in my chest that feels like it's in my heart.  I have been receiving these symptoms everyday since 09/05/2021 till today 10/21/2021.
Pt was noted to have a thigh mass one month after administration of hib3 and flu vaccines.  The mass continued to grow and was removed on 12/23/08.  It was determined to be a subcutaneous granuloma annulare.
Redness in arm did not appear until 10 days post injection. Over the course of 3 days the redness increased in size. The redness is decreasing in intensity but still traveling down the arm as of today.
OVERALL BODY RASH; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to left arm, on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced overall body rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overall body rash. This report was non-serious.
Patient given vaccine 1418, cooperative and alert. Patient was walking down the hallway, went limp at the secretary desk 1422. Mom called out for help, staff assessed. Patient was pale and clammy. No witnessed LOC, mom states her eyes kind of rolled back in her head and she went limp. Vitals taken and stable. Patient had not ate since 930 this morning, offered part of a cookie and coke. Pt began to regain color and was responsive to questions.
I have red itchy patches that come and go. It first started on my stomach now I have rhem on my forearm, chest and knee. Started getting rhis after the 2 vaccine. I became sick rhat night then these patches appeared. I will have to see an allergist or dermatologist.
Pt given KINRIX on 7/5/10. Next am mom said felt warm and pt went back to bed. Then 7/8/10 went to pediatrician with lethargy, decreased appetite fever. 7/13/10 back to pediatrician with vomiting-fever. Pediatrician said probably viral but mom says pt had bad Rxn in 2005 from vaccine et says this is from KINRIX.
Metallic taste in mouth beginning about 10 minutes after injection.  Lasted for 1 hour.  No treatment. No other associated symtpoms.
pt recv vax 1130AM;mom returned w/pt @ 1:20 w/shaking chills x 5min&temp initially 102.5 tym w/nl BP 107/73;Motrin given;shaking,chills resolved by 1:30;temp rechecked @ 1:50&was 105.6;tonsils erythematous
I received a phone call from a representative of the CDC's V-safe program, on June 13, 2022, to follow up to my six-month post-vaccination V-safe check-in. During our discussion he advised me to report a breakthrough COVID-19 case (which I experienced since my booster) via the VAERS. The adverse event was a clinically mild case of COVID-19 for which I tested positive on May 29, 2022 using the Abbot COVID-19 BinaxNOW at-home test kit product. Signs and symptoms included fever (up to 103 degrees Fahrenheit), muscle aches, headache, fatigue, nausea, congestion, sneezing, and coughing. The time course was 2+ weeks, as I have some lingering symptoms that are clearing up (fatigue, congestion, coughing). I did not require in-person medical care and simply coordinated with my PCP's office via telephone and electronically, but I did miss a week of work and could not complete most normal daily activities due to being ill. The December 11, 2021 vaccination was a booster after I had previously received the first two courses of the Pfizer-BioNTech vaccine on April 3, 2021 and April 24, 2021.
Seriousness Criteria: Other- Medically Significant. Initial report received from another manufacturer (other manufacturer's control number: WAES 0904USA04463). The other manufacturer had received the original report from a physician assistant. The following is verbatim from the report: "Information has been received from a physician assistant concerning a 25 year old female with diabetes, hypothyroidism, sulfonamide allergy and penicillin allergy, who on 21-APR-2009 was vaccinated with PNEUMOVAX 23, 0.5mL IM left deltoid, (lot#: 662664/0981X). Concomitant therapy included SYNTHROID 0.15mg (manufacturer unknown), NOVOLOG (Manufacturer unknown) and LANTUS (manufacturer unknown). On 22-APR-2009, the physician reported, the patient had a significant left arm local reaction that was the size of a small orange. The patient also had fever of 102F and myalgias and had significant left arm pain. The physician assistant felt intervention to prevent serious criteria was prednisone and ibuprofen 800 mg for pain (manufacturer unknown). Also, the physician assistant would like a lot check on 0981X. The significant left arm pain was considered to be disabling. Follow-up has been received from the physician assistant who reported other vaccines administered on the same day (on 21-APR-2009); ADACEL (lot # AC52B024DB) (manufacturer unknown) in left deltoid and HAVRIX (lot # AHVB285AB) (manufacturer unspecified) in right deltoid. This is a one of several reports received from the same source. A lot check has been initiated. Additional information has been requested." It was noted that the lot number provided in the above narrative for the ADACEL vaccine (lot number: AC52B024DB) is not a valid Sanofi Pasteur lot number. Documents held by sender: None
DVT developed in Right Calf approx 24 hours after the vaccine administration; This is a spontaneous report from a contactable physician. This Physician reported for a 51-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included kidney stone from an unknown date and unknown if ongoing.    There were no concomitant medications.  Patient did not receive any vaccine in four weeks. Patient did not receive any vaccine in four weeks. The patient developed DVT in right calf approximately 24 hours after the vaccine administration on 12Mar2021 with outcome of recovering.  Therapeutic measures were taken as a result of event included Xarelto. Patient was not tested for covid post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event DVT cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Arm pain; Joiint swelling; Eczema worsened; Severe flu symptoms; Fever; Itching/burning at vaccination site; Itching/burning at vaccination site; Burning; Itching; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning) and ECZEMA (Eczema worsened) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza vaccine (Flu shot (thimerosal ingredient), In the past, localized reaction to thimerosal ingredient and but no longer a problem since it's no longer an ingredient). Concurrent medical conditions included Hypersensitivity, Sulfonamide allergy (Sulfa drugs- Reaction reported includes hives.), Fruit allergy (Allergy to apples.primarily, throat itching and swelling.), Fruit allergy (Allergy to Peaches-primarily, throat itching and swelling.), Seasonal allergy, Eczema (Worsened after Moderna vaccine) and Hay fever. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and TRIAMCINOLONE ACETONIDE (NASACORT) for Allergy, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In August 2021, the patient experienced PRURITUS (Itching), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), JOINT SWELLING (Joiint swelling), ECZEMA (Eczema worsened), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm pain), INFLUENZA (Severe flu symptoms) and PYREXIA (Fever) had resolved, PRURITUS (Itching), JOINT SWELLING (Joiint swelling), BURNING SENSATION (Burning), VACCINATION SITE PRURITUS (Itching/burning at vaccination site) and VACCINATION SITE PAIN (Itching/burning at vaccination site) had not resolved and ECZEMA (Eczema worsened) outcome was unknown.            Patient took injection on the right side. It is reported that patient continued to take Zyrtec but no other treatment information was provided.   This case was linked to MOD-2021-194570 (Patient Link).
The child was seen by a doctor for a viral illness and diagnosed with the flu. The father requested a flu shot for the child. The child screamed, held breath, left side tonic clonic seizure lasting 2-3 minutes, post ictal axillary temp during seizure of 101.
Hospitalized 1/2/2022; COVID-19 positive 1/2/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider:, MD Primary Care Provider:  MD Admission Date: 1/2/2022 Discharge Date: Jan 6, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COPD with acute exacerbation (HCC)  Community acquired pneumonia of right lower lobe of lung  COVID-19    HOSPITAL COURSE: Patient is a 85 y.o. female who presented with cough, weakness.  Patient has a history of COPD, chronic respiratory failure on 3L NC at baseline, Hx pseudomonas pneumonia, chronic diastolic CHF, hypothyroid.  Patient's symptoms started on 12/31 with a cough and malaise.  Per patient, she was having severe coughing up a greenish sputum so she called her pulmonologist who started the patient on Levaquin 2 days ago, she was able to take 2 doses, but then began having pain in both her ankles, and called her pulmonologist again who recommended she come to the emergency department for IV antibiotics.  Patient took a COVID test at home which was positive.  She was admitted to HCF and maintained on cefepime/azithromycin. Oxygen weaned to baseline 4L. Patient continued to improve though would desaturate to low 80's with activity.  Local rehab consult was placed who recommended patient remain on 4 L nasal cannula at rest, with activity she will need to increase to 5-6 L.
I woke up the day after the vaccine with a very painful arm, about 25% more painful than my flu vaccine. My arm hurt for about 5 days. I felt under the weather, like I was coming down with something. That lasted 3 days. I didn't feel well for several days after. My auto immune system acts up before I get my transfusion so I am not sure if that's why I was feeling unwell or if it was because of the vaccine. I called out of work that following Monday. I was throwing up. I came down with a migraine about 4 hours after receiving my vaccine. I did not feel well a week after receiving my infusion and I normally do. I did have blood work done about a week after my vaccine and everything looked normal.
After administering vaccine, about an hour later patient started feeling shaky but not seizure like. Patient went to ER and was diagnosed with pneumonia and double ear infection. Patient didn't let office know beforehand of not feeling well. ER stated no signs of allergic reaction.
pt recvd vax;awakened w/ arm red, hot & induration at inject site; edematous down to hand; to MD & began wheezing;shot of epi & mom instructed to give dph;
Grandma phoned in AM with concerns of swelling in L thigh, "hard lump" and warm to touch. Called PCP, PCP advised to call where vaccines were admin. Called back in PM to say swelling incresed down to client's knee. Took to Urgent care 08/15/13 PM. Treated with antibiotics, Benadryl, Advil, and ice packs. Symptoms improved 08/16/13 AM.
administered a half dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received HBV (Engerix B adult) for prophylaxis.   On 29th September 2021, the patient received Engerix B adult .5 ml. On an unknown date, unknown after receiving Engerix B adult, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The pharmacist reported that a nurse only administered a half dose of adult formulation of Engerix-B (0.5 ml) to adult patient, which led to underdose. The reporter consented to follow up.
Hives developed on leg where Prevnar given and spread to feet and soles of feet. Denies swollen lips, SOB, wheeze. No F/C/S, no N/v/D. Reaction occurred same day as injection time frame unknown. Started on Benadryl 9mg q6 prn. Report to ER is SOB, wheeze, swollen lips or tongue.
pt was vaxed 10AM 22JAN96 & on returning back to site of origin pt was noted to be cyanotic & was brought to clinic-mottled,temp initially 100.6,RR 40/HR 140;95% on 02;1:45 0 sat 85-95;PR 176;adm to hosp dx pneumonia;
After injection was given patient became pale. She had a blank stare and her eyes rolled back. Patients body then started to stiffen up and her arms started to jerk. Patient did come through quickly. She began to yell and say that she was scared and did not feel well. She immediately knew who she was and where she was. She was also aware of time and date. We did get a full set of vital signs on patient during the event, and after the event. Patient was examined by a physician.