chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flushness with face; soreness at the injection site; redness at the injection site; fever; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu (patient get the headache & soreness with the flu shot, too. she have to get the regular dose and because of side effect). Past adverse reactions to the above products included Headache with flu.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache). At the time of the report, FLUSHING (flushness with face), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and HEADACHE (horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.    This case was linked to MOD-2021-367636 (Patient Link).
Approximately 5.5 hours after flu shot administered, patient reported that she developed bilateral conjunctivitis - lasted < 24 hours and required no medical treatment. S/S included bilateral bright red eyes, bilateral burning in eyes. No discharge or pus, cough, headache, muscle aches, fever (did not check her temperature).
Redness and swelling started on 12/2.  Patient brought in on 12/3/08, 2.5X5cm area of erythema on left thigh, without tenderness or warmth.  Continued to spread overnight and was started on KEFLEX on 12/4/08 for ollulitis.
no adverse event; administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 27-APR-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) once for prophylaxis (lot# U003306, expiry date 15-OCT-2022, strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (occurred on 12-APR-2022, temperature: 62 Fahrenheit (F); time frame: 5 hours 12 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This was one of four cases from the same reporter.
SOB AFTER VACCINATION, DAUGHTER STATES HAS HX OF RESP ISSUES, AND HAD SAME S/S WITH 1ST DOSE. NO OTHER S/S TO SUGGEST V-V REACTION OR ALLERGIC REACTION PER ON-SITE MD. VSS EXCEPT ELEVATED BP DURING OBSERVATION. ESCORTED TO EXIT WITH NO ISSUES AND S/S RESOLVED OTHER THAN INCREASED BP, WHICH INSTRUCTED TO MONITOR WITH HOME BP CUFF AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED/WORSENED. 1122 INITIAL BP 167/91 HR 74 SATS 100% RA 1132 BP 162/85 HR 79 SATS 100% RA 1137 SITTING BP 157/96 HR 74 SATS 99% 1142 STANDING BP 162/106 HR 75 SATS 99%
On Feb 23 03 became weak, fatigued, dizzy , had myalgias and had fever of 102-103. This continued 6 days. On Mar 2 developed large blister on right nare which burst causing excoriation and subsequent blistering of area under exudate. On Mar 3 awakened with sore throat and blisters on tongue and inside of mouth. Currently continues to have generalized joint pain, intermittent fevers , sore throat, and fatigue.
This 15 year and 11 month old female developed fevers, abdominal pain, diarrhea and constant wrenching.  She was seen in the ED and noted to be hypotensive and meeting SIRS criteria so was admitted to the PICU and started on norepinephrine pressor support. She had fevers to 39 degrees C and about a day into hospitalization developed acute mental status changes.
diagnosed with Lyme's, rash, fever; facial palsy on right side; neck stiffness; Stiff joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: LYME DISEASE (medically significant), outcome "unknown", described as "diagnosed with Lyme's, rash, fever"; FACIAL PARALYSIS (medically significant), outcome "not recovered", described as "facial palsy on right side"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "neck stiffness"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "Stiff joints". Therapeutic measures were taken as a result of lyme disease. The patient had COVID shot and booster. Also, patient was just recently diagnosed with Lyme's and just took the last pill this am. The patient always outside for work and can't have it disrupt work again. Stiff joints, rash, fever, not fun! Currently have facial palsy, right side. Can't eat a hamburger unless cut the meat. The patient submitted a request to possibly get in on the Lymes trial. The patient recently came down with Lyme's and finished the last pill of the 14 got Monday. This was a nasty experience of which the patient didn't want to go through again! The patient just turned 50 and was in great health, great shape and fit. Work outside and was an avid hunter and fisherman. This disease was real and something that hit patient hard was the stiffness patient endured. The patient felt like the Tin man! That's the best way to put it. Fever, and very bad neck stiffness were hitting hard. The patient currently has facial palsy on right side. It's hard to even drink water, need a straw.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bruise at vaccination site right after vaccine administration, redness and induration, swelling , pain, itchiness and heat 2.5 inches below injection site  area 2.5 inch by 1.5 inch
never got Shingrix shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient received dose 1 of Shingrix at her doctor's office but never got Shingrix shot 2, which led to incomplete course of vaccination.  The patient did not have the lot number or expiration date of Shingrix shot 1.  The reporter did not want to share her medical doctor contact information. The reporter did not consent to follow-up.
Syncopal episode (dizziness, lightheaded, and fainted) - fell backwards and hit her head on the floor, cannot remember what happened after that incident, took 5-25 minutes to become responsive again. Was unable to walk afterward and had to be carried to the hospital. Also decreased strength in bilateral upper and lower extremities, legs feel heavy, decreased sensation to legs, very slow gait, very tired
This spontaneous report as received from a physician's assistant via a company representative refers to patient of unknown age who might be a female. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. On an unspecified date in May 2015 ("reported as" "within the last month"), the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were not provided). Immediately after the administration of ZOSTAVAX the patient experienced a really bad rash that made the patient end in surgery. The patient's surgeon stated that while the patient was "opened out" it was determined that the rash was actually shingles of a wild type of zoster and not caused by the vaccine. The specific method by which the determination was made was unspecified. It was also reported that the patient sought for medical attention and that was treated with an unspecified antiviral therapy. At the time of this report, the outcome of herpes zoster was unknown. Upon internal review the event herpes zoster was considered medically significant. Additional information has been requested.
Received COVID vaccine 1/26/21 and 2/12/21, and didn't have symptoms right after vaccine. Symptoms started Wednesday February 2/24/21 - started at 9PM that night preventing him from sleeping. Stated the chest pressure was like something "sitting on his chest". Also had body aches, chills, fever, fatigue, cough, and mild shortness of breath.  Found to have heart failure, EF 25%
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (in June or July 2022) in 2022.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient took four doses of the Moderna COVID-19 vaccines, with the most recent dose in Oct-2022. Patient had COVID-19. Patient had been having symptoms including running and stuffy nose for a few days. Patient went to urgent care yesterday where patient was diagnosed. No treatment information was provided.   This case was linked to MOD-2021-066255 (Patient Link).
Face swelling, throat swelling, sinus pressure, runny nose, sneezy, cough, itching 30 minutes after injection. Injection site pain, red, swollen, warm, itchy 6 hours after injection. Body aches, headache, itchy eyes 12 hours after injection. Injection site pain, red, swollen, warm, itchy continue to worsen over 1 week period.
Patient stated arms were itchy. Skin appeared red and scratched up when I went out to help patient. I asked his mom if it was ok to give Benadryl. 25mg (2 teaspoonfuls) of liquid Benadryl given to the patient. I observed him for approximately an hour with no further symptoms. Redness and itching subsided.
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A rash developed from neck down to ankles. Dr. instructed patient to take ZANTAC and CLARITIN OTC products daily as well as BENADRYL at bedtime. Rash lasted for roughly 5 days according to patient.
17 year old received 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose). On 22-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided by the reporter.  Patient had taken the first dose of Moderna COVID-19 vaccine in the age of 17, next month the patient turns 18 and wanted to find out if patient is eligible to get 2nd dose or not.  No relevant treatment medication information provided.
- eczema on my right hand (have seen a dermatologist and my doctor 4 times and gone through 4 tubes of cream to include a steroid ..still there.  never before in my life) - right eye tears up for no reason every few days - formication along my side rib cage and hips on each side, tickles like there is a hair or phone in pocket is buzzing - fatigue - just after shot I was sick like the flu for a day and tired for a few days
2 month old male presents with complaint of fever 100 or so and he seemed lethargic, but not floppy like a dish rag, just tired.  Complaint of diarrhea, loose stools, runny and ambery brown instead of golden yellow on the day of the shots only, denies vomiting.
Client reported 2 inch reddened area around injection site. No wheezing, no rash, just local. Patient instructed to ice area, and keep a close eye. Any changes let our office know, unless life threatening, and then ER immediately.
I went to the doctor in august and my bp was very high. I noticed I was feeling off about a week before my doctors appt. I have never had blood pressure issues in the past. I have white coat syndrome and usually my bp goes down when I leave the doctor. However, this time my blood pressure has stayed high since august. So about 2 months.
had both shingles vaccines, had shingles three times/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shingles vaccines and had shingles three times since the vaccines.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient further stated unfortunately, he/she was in the small percentage of people who became sick from the vaccine injections but the vaccines did not deter thee infections. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR011001:same reporter (invalid case)
I received the vaccine on August 26th at about 1330. I initially felt ok, but started to get tired around 1930 and decided to crawl in to bed. Shortly after, I broke a fever and my body was starting to feel achy. As I starting to fall asleep, my body started to feel tingly. This was alarming, but as I continued to try to fall asleep, I felt as if my body was ballooning over my body, like an out of body experience. This terrified me so I got out of bed and started pacing back and forth, afraid to fall asleep in fear of this out of body like experience happening again.  After pacing for as long as my body could, I laid back down again, and began to feel the tingly again which then turned to the numbness. I sat up and turned the light on and decided that trying to sleep was not a good idea. I sat there as my body went numb again, and this time felt the numbness in my brain. Even more terrified now, I paced for hours occasionally needing to lay down on the floor in child's pose (the only comfortable position for my very achy, fatigued body, and now also the worst headache I have had in my entire life). I was unable to stop moving for long as the body numbness would set in again shortly after I would stop moving. I was then experience muscle spasms/jerks in my arms. When I was finally able to lay down long enough to fall asleep, I would wake myself up crying due to the terrible headaches. Thankfully my numbness was better the next day. The headaches stayed for days. Dizziness for weeks.
Running a fever since the 2nd vaccine on 14May2021.  My entire body is itching all over.  I want to the doctor and emergency room.  Nothing helps including oral steroids,  Tylenol and Benadryl.; Running a fever since the 2nd vaccine on 14May2021.  My entire body is itching all over.  I want to the doctor and emergency room.  Nothing helps including oral steroids,  Tylenol and Benadryl.; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14May2021 12:15 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Asthma, hay fever, ulcers,  lactose intolerant. Concomitant medications included montelukast sodium (SINGULAIR); cisapride (MOBID); buspirone (BUSPIRONE); taken for unspecified indications, start and stop dates were not reported. The patient previously took aspirin for hypersensitivity, visceral for hypersensitivity, cafergot comp for hypersensitivity. Prior the vaccination the patient was not diagnosed with COVID-19. The patient received first dose of BNT162B2 on 25Feb2021 at 10:30 AM in right arm for COVID-19 immunization. Running a fever since the 2nd vaccine on 14May2021. My entire body is itching all over.  I went to the doctor and emergency room. Nothing helps including oral steroids, Tylenol and Benadryl. The patient received treatment for the events: Benadryl, Tylenol, oral steroids, cortisone cream. The outcome of the events was not recovered.   Follow-up attempts needed. Additional information has been requested.
on  6/16/21 day after 2nd dose of vaccine, while at orthodontist appointment, was standing to get xrays done and  fainted for a few seconds. prior to fainting felt nauseous and dizzy,   after that happened, went home and then slept for 5 hours. When work up had headache and vomiting x2 , and headache continued, medicine taken,  the next morning 6/17/21 all resolved. felt completely normal.  came to doctor for regular scheduled appointment not for syncopal episode, no cough, no fever, no chest pain, no heart palpitations,
Rash on arm about 3 inches long and 1.5 inches wife, starting at injection site and extending to the inside of arm. No itching, swelling or tenderness.
Palpitations, chest pain, strong muscle spasms started at about 9 pm (12-Oct).  The muscle spasms felt as if they were in every muscle, but most notably arms, shoulders, back, legs.   I noticed a rash on my back and shoulders at 3 am (13-Oct).  The muscle spasms ended by approximately 6 am (13-Oct).  The chest pain ended by approximately 9 am (13-Oct).  The palpitations had significantly reduced by 9 pm (13-Oct).  The rash was gone when I woke up on 14-Oct around 7 am.
pt recv vax 3OCT97 & same day pt exp inj site swelling, redness, & warmth;pt did not have a rash or fever;site did not look infected at all;it was the size of a baseball for 1 wk & the size of an egg or golf ball the second week;
Pressure when receiving, sore that evening. No apparent swelling. Pain on moving arm forward and backward denies numbness or tingling, no weakness.
Information has been received from a consumer concerning her 13 month old son with no pertinent medical history, drug reactions/allergies or concomitant medication use who on 28-NOV-2007 was vaccinated (route and site not reported) with COMVAX (lot#657380/0377U).  Two or three days post vaccination, the patient developed crankiness and a runny nose.  Per the patient's mother, the child was not cranky prior to the vaccination.  The patient's crankiness has lessen but the patient still has a runny nose.  The patient did receive unspecified medical attention.  No diagnostic lab test were performed.  At the time of this report the patient was recovering.  Follow up information has been received from the physician's office.  They are reporting that they have no information regarding an adverse reaction.  No additional information is expected.
SWELLING IN THE ARM INCRASED TO UP ON CHEST UNDER CLAVICLE AND TO THE BACK ON SCAPULA AND ELBOW. NO SHORTNESS OF BREATH OR TONGUE SWELLING. WENT TO ER. SWELLING SPREAD TO HAND AND WRIST. PT GOT STEROID AND PEPCID FROM ER.