chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left deltoid swollen, red and hot. Began on 10/7/10. Prescribed MEDROL dose pack.
Awkward and very uncomfortable armpit pain; Lymph node swelling in the left armpit; Darker vein appear close to the skin on the same arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included daily vitamin (unspecified) taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) for an unknown 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 11Apr2021, the patient experienced awkward and very uncomfortable armpit pain and lymph node swelling in the left armpit, the same arm as the vaccine. Extremely uncomfortable to the point that the patient had to take a sleeping aid. It happened on day 3 and had lasted 3 days at the time of this report. On an unknown date in Apr2021, the patient also had a darker vein appear close to the skin on the same arm and did contact her doctor but had not heard back at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken for awkward and very uncomfortable armpit pain and lymph node swelling in the left armpit and included treatment with unspecified sleeping aid on an unknown date. The clinical outcome of the events awkward and very uncomfortable armpit pain and lymph node swelling in the left armpit were recovered on 14Apr2021 while the event darker vein appear close to the skin on the same arm was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Vaccinated arm swollen, red in color with bumps, sore, itching, area warm and hard.  Reaction started on Saturday, 10/8/22  & decided to take a Benadryl late evening on Sunday, 10/9/22.
Headaches have begun to plague me since receiving Moderna booster. I think the sugar is not a long enough preservative so after a few months it wore off and the COVID infected me.
70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss; Chewing; swallowing; sore throat; headaches/head pain; Vertigo; double vision in 3 months; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. On 14Apr2021, the patient experienced 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss, chewing, swallowing, sore throat, headaches/head pain, vertigo, and double vision in 3 months. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included covid-19: negative on 01Aug2021. The patient did not receive any treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and was negative on 01Aug2021. The patient had not recovered from the events.  That information on the Lot/batch number has been requested.
PATIENT RECEIVED VACCINE 10-8-08 , SHE CALLED THE PHARMACY ON 10-9-08 TO TELL ME HER ARM WAS HURTING  , RED AND SWOLLEN . I SPOKE WITH HER PERSONALLY TO SEE IF IT WAS ONLY RED AT THE INJECTION SITE SHE SAID IT WAS RED THERE FIRST , BUT NOW HER WHOLE ARM IS RED AND SWOLLEN. I TOLD HER TO PUT ICE ON HER ARM AND CALL HER DR ABOUT COMING IN THE LOOK AT HER ARM.
I received the vaccine and five minutes later my arm started to feel heavy and achy. Then as the evening went on it got worse and worse and my arm was hard to lift. Sleeping that night was impossible and I reached out to the doctor and they looked at the arm when I went to the doctor and they said it should go away. I have since lost a little motion in my arm.
Breakthrough case admission after 2nd vaccine 3/12/21 Moderna 010A21A 4/9/21 Moderna 025B21A
1 day post vax pt exp 2in diameter induration; on 2 days post immun, mom reported his whole upper arm to be indurated & warm to touch; Also c/o great discomfort in that arm; Recommended cool pack to arm & warmth tomorrow;
Nausea, abdominal cramping, diarrhea, fever, chills, site tenderness.
Vaccine administered 2/5/11 (L) deltoid. 2/6/11 pm notch 1/2 dollar size enlarged lymph gland Lt axilla.
Severe pain in left arm. Began roughly 14 hours after injection. Patient arm now in sling due to difficulty with muscle fatigue because of the pain.
Fussiness and crying for hours; will console to breast feed; prickly heat appearing rash on trunk; fever to 102F, onset 8 hours, post vax.
Patient was given influenza and pneumonia (PNEUMOVAX 23) and was swollen the next day. He requested to be given in same arm.
No adverse effect; Improperly stored VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant therapy were not reported.   On 20-MAR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # R018143 and expiry date: 25-JUN-2020, lot # R026715 and expiry date: 18-SEP-2020) for prophylaxis. The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent(DILUENT MRK INJ). It was reported that, the nurse did not know which lot number was administered to the patient therefore 2 lot numbers are documented.  The vaccine was stored in temperature 47 degree Fahrenheit (F) to 77 F (66.5 F) for 943 Minutes. No previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of two reports received from the same reporter.
There was no adverse event but patient was not due for a 2nd booster dose at the time it was given. He had a Janssen dose on 06/09/22 then his 2nd dose on 10/25/22 (Moderna). At the time the 3rd shot was given it was only 110 days from the 2nd shot and at that time the 3rd dose was not approved.  Patient was informed of error. He did not have any adverse effects from the shot.
Strong heart beat; heart palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jul2021 16:00 (Lot number: ER8734) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number ER8734,, administration time 03:00 PM, vaccine location Left arm), administration date: 11Jun2021, when the patient was 16 years old, for COVID-19 immunization.  The following information was reported: HEART RATE INCREASED (non-serious) with onset 06Jul2021 13:00, outcome "recovering", described as "Strong heart beat"; PALPITATIONS (non-serious) with onset 06Jul2021 13:00, outcome "recovering", described as "heart palpitations". The events "strong heart beat" and "heart palpitations" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of heart rate increased, palpitations.  Additional information: The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive no other medications within 2 weeks of vaccination. It was stated that Strong heart beat/heart palpitations stated 4 days after 2nd vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Arm at injection site and lymph node swelled to approximately 2 inches round the following morning when I woke up.  The arm is hot to the touch.  Both places were extremely painful (especially the lymph node).  The lymph node finally went down after 3 days. However, the lump at injection site is still large and now it's hard and it has the area has expanded to a "Covid Arm" rash, which covers my the majority of my upper arm.   I was symptomatic with chills, aches for the first two days and the lump/lymph node issue is still happening and it's been 5 days.
Case number PHHY2011US85547 is an initial literature report received on 04 Sep 2011. The authors present a case of cerebellar ataxia following immunizations in an infant. This report refers to a one and a half year old infant of unknown gender (table 3). This healthy infant was vaccinated with Hib vaccine (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB INN), MMR (manufacturer and batch number: unknown), varicella (manufacturer and batch number: unknown) and DTaP (other manufacturer) on an undetermined date. Nine days after vaccination, this infant developed cerebellar ataxia. The causality was assessed as probable by the reporter. No further information about the outcome of the event was available.
Hives over entire body, feet up to neck. Swollen area under arm, into breast/chest.
Pt states he has began to feel tingling in his wrist and fingers. He also stated he has weakness in his wrist.
Patient received 2nd COVID vaccine on 3/30/21 so fully vaccinated on this date; patient seen at clinic 8/23/21 with symptoms of fever, cough, body aches, congestion and runny nose; patient tested positive for COVID-19
There is a possibility patient may have received 0.25 ml of vaccine rather than the recommended 0.2 ml. of the Moderna Bivalent presentation for 6 months to 5 years. A staff member was not aware of the correct dosing of the bivalent vaccine. The system in place for drawing up vaccine and administering vaccine may have allowed for staff member to have drawn up 0.25 ml and another staff member to give the vaccine. It cannot be determined if the correct or incorrect amount was drawn up or given. There has been no reported adverse reaction from the parents to date.
This spontaneous report as received from a physician refers to a 14 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-JUN-2011, the patient was vaccinated with a first dose of GARDASIL (lot# and exp. date were not reported). Subsequently on 31-AUG-2011 and on 24-OCT-2011 the patient was vaccinated with the second and the third dose of GARDASIL. The patient did not experience any adverse effect. Additional information has been requested.
was very cold from 10PM to 3AM / felt like bones were cold; extremities were very cold to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 10Mar2021 22:00, outcome "unknown", described as "was very cold from 10PM to 3AM / felt like bones were cold"; PERIPHERAL COLDNESS (non-serious) with onset 10Mar2021 22:00, outcome "unknown", described as "extremities were very cold to the touch". Additional information: Event was described as follows: The patient was given the Pfizer COVID 19 vaccine on 23Feb. The patient felt fine until March 10, 2021 at 10PM (reported as last night). The patient was very cold from 10PM to 3AM; The patient's extremities were very cold to the touch and it felt like bones were cold. The patient just couldn't warm up for 5 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt like throat was closing, gave epinephrine and Benadryl, called EMS who transported patient from building to ER.
I  experiencing unusual periods of dizziness, sometimes severe, sometimes mild after the first shot.  These became more severe after the second shot.  I have experienced periods of time where I feel slightly drugged.
3RD MODERNA COVID VACCINE GIVEN 12/30/21, #066H21A; pt had a positive COVID test on 10/27/22; brought to ED 11/1/2022 with worsening SOB and productive cough; AHRF; during admission pt started to have dark tarry stools;   consult; ICU; vasopressors; pt's status worsened requiring intubation; multiple blood transfusions; worsening renal failure; transitioned to comfort measures and he passed away in the hospital
8/19/2003 RIGHT THIGH INJECTION SITE WITH REDNESS GRADUALLY GETTING WORSE.  8/22/2003 PRESENTS TODAY WITH SWELLING AND REDNESS .  MEASURES APPROXIMATELY3 INCHES BY 1 1/2 INCH.  PARENTS HAVE APPLIED COOL COMPRESSES.
Broke out in very itchy hives and rash.  Started on back of neck and grew and grew.  Covered entire back and front of body.  Started taking  Benadryl tablets about 2:30 pm which didn't seem to do anything.   Went to emergency room around 11:00 pm since hives were advancing up my neck and the itch was unbearable.  Received a steroid shot and was given a dose of Pepcid.  Continued with the Benadryl and Pepcid every six hours Sunday, Monday and Tuesday, 3/21-23...
Pt reports since she went home after vaccination on Monday 7/25, redness/swelling/itching/pain at site of injection left deltoid. Measures 10 x 5.5 cm. 9/10 pain when she moves her arm. Not alleviated by ice pack and Tylenol. Pt reported fever yesterday morning-afternoon, alleviated by Tylenol.
Currently the third day of dealing with a lot of pain and discomfort due to a large rash (about 5 inches wide) that is hard and hot to the touch, red and swollen, and is causing itching and burning.  The rash does not seem to be going away yet, and the pain has spread to down my arm to my hand. Any pressure on the injection site is excruciating, and I have felt fatigued since receiving the vaccine.
No adverse effects; Received improperly stored ROTATEQ; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 19-JUN-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R025731 (expiry date: 14-JUN-2020) for prophylaxis (strength, anatomical location, route and dosage details were not reported) (Product storage error). The vaccine was stored at a highest temperature above 47 degree Fahrenheit (F)/ 9 degree Centigrade (46.5F) for a time frame of 30 minutes. The patient did not experience any adverse effects. There was no previous temperature excursion. The call was because of a "data logger". No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009509: US-009507513-1906USA009082: US-009507513-1906USA009513: US-009507513-1906USA009514: US-009507513-1906USA009510:
Headache, stomach cramping, nausea, metallic taste, fever, chills, tricep red and sore.
I received the Johnson and Johnson Covid 19 vaccine on 4/6/21 and the dose code is 041AZ1A. I received it at the Community Center.  I'm writing because beginning with the evening after I received the Johnson and Johnson Covid 19 vaccine I've been having abdominal / stomach cramps and stomach pain. Sometimes it is on the top of the abdomen / stomach, other times it's at the bottom. Sometimes it hurts to the point of waking me up in the middle of the night. This morning it started moving into my chest.  Do you know if this pain will subside shortly or what is known about this potential side effect? Is there anything I can do to mitigate the issue?  I'm contacting my Dr for a visit.
Client c/o dizziness and "burning in throat" with difficulty swallowing a few mins after Pfizer Biontech vaccine.  Was given Benadryl 50 mg po.  In 20 mins, dizziness resolved but burning in throat and dysphagia remained.  Vital signs were normal range throughout observation period.  Was advised to seek tx if it worsened. Transported home by family member and "slept off the Benadryl".  States throat burning lasted through the next day.  Dysphagia resolved that evening.  Spoke w/her dr. 2 weeks later at routine visit who advised not to get 2nd dose right away.  Pt. states she was having a flare of her lupus at the time of 1st dose.  Said dr. advised to wait until her ANA levels decreased before 2nd dose.
Client lives alone and had dinner at his home with family members after the 4:40 appointment. Client stated that in general he did not feel well but did not give any specific symptom. Family states they asked the client to go to the ER and the client refused. Family states they helped the client to his chair in the living room and then left to go home. Family states that the client was found in his bedroom the next morning at 7:54 a.m. deceased.
Mom Called in and states that child has chicken pox despite receiving the vaccine on 05/24/2002
25 Minutes after receiving vaccine he got numbness and tingling in his face, lip, under his eye and temple. he also had red whelps on his neck, right arm
Debilitating headache, burning skin, and muscle spasms in the legs, arms and torso.  Lasted for 3 days and she could not get out of bed.
The first 2 days had awful headache and muscle aches, could not leave the bed. Then a week later, I got a horrible rash all of my body, worse at my hands and feet. The rash included many blisters. Loss of appetite and cannot sleep. I still have the rash now, and it is even getting worse in some parts, while other parts are better due to a steroid cream prescribed by my dermatologist.  On April 26, I felt very dizzy and weak and went to urgent care. I have since recovered from those symptoms.
01/24/22 presents to ED for "Fatigue, poor appetite". PMHx of "breast cancer, dementia and HTN"
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was not reported. ON an unknown date in August 2014 (reported as two weeks ago), the patient was vaccinated with a expired dose of PNEUMOVAX23 (INJ 25/0.5 Y) (Dose/frequency were not reported, lot # unknown and expiry date: 03-AUG-2014) intramuscular. No adverse events were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information has been requested.
Initial misuse report received from a healthcare professional on 01 July 2014. A 24-month-old (2-year-old) patient received first dose of TD who was an unvaccinated child (No other information was provided regarding the patient). Thus wrong vaccine administered. No adverse event was reported. List of documents held by sender: none.
Injection site hot; Injection site was red; Lump on the injection site; Injection site hurt to the touch; Arm was swollen; Black and blue on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 10 year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5127), at the age of 10, in left arm, on Nov 19, 2021, at 17:00, single dose, for COVID-19 immunisation. Medical history included mild seasonal allergies (unspecified if ongoing). Concomitant medication(s) included Zyrtec (cetirizine hydrochloride). The patient reported urticaria/moderate urticaria (generalized), onset Nov 19, 2021, at 21:00, with outcome of unknown. Moderate urticaria (generalized) evaluated at a physician office visit. Additional information: The event did not cause hospitalization. It was unknown if treatment received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. No further information expected.
Per patient history, after receiving hep A and rabies #3, within 20 min to 30 min, patient reports persistent itching to hair and sweaty areas. Within 4 hours, skin, arms and palms of hands became red and blotchy. No medical treatment sought. Condition resolved on its own. Doctor made aware.
Fever 101.8, chills, stomach upset, diarrhea, muscle aches, fatigue (flu-like symptoms)
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST Quadrivalent. FLLUMIST Quadrivalent started on an unknown date. The patient accidentally administered expired FLUMIST Quadrivalent which started on 22-JAN-2015. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious by the reporter.
Fever chills diarreah pain several days later ears itching pain in ears mouth ulcerations can?t drink or eat