chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states they had a hard painful lump at injection area and went to urgent care. Pt was diagnosed with an infection and prescribed doxycycline 100 bid.
Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves male patient of unknown age, who had tiny red spot at the injection site (vaccination site erythema), after receiving PENTACEL. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination, before he turned 3 (years / months unspecified). On an unknown date, the patient developed a non-serious tiny red spot at the injection site (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Case details: Patient's mother reported that QUADRACEL vaccine for her 5-year-old son who needs his 5th dose of DTAP and to satisfy his school requirements, now he needs his 5th dose of the polio vaccine, as well, because he got his 4th dose before he turned 3. On speaking with the health department where they do have vaccine but the nurse said the QUADRACEL was not approved, at least not by her, for a 5th dose. So, wanted to know, is it approved for a 5th dose of Dtap plus polio and is it safe. Question number 1. Question number 2 is: Is it possible to help her locate it somewhere closer, instead of having to go to another facility, which was a 2-hour drive away. Called every pediatrician, every family doctor, every pharmacy and she can think of in the area and everyone orders through one particular pharmacy and for some reason, on their computers are unable to order QUADRACEL whether that's due to manufacturer restrictions. She doesn't know if there's a pharmacy (unintelligible) like contract. Everyone in town seems to give KINRIX, which she doesn't want to give to her son and want to give him QUADRACEL because she know, in the past, he's tolerated PENTACEL really, really well and want to stick with what works for his body and, like, want to spend money and buy and pay for QUADRACEL vaccine and just running into a million brick walls trying to get it. So, if she could be helped, so she will be appreciative. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reports, the outcome was not reported for the event vaccination site erythema. There will be no information on the batch number for this case.
Low Grade Fever, Weakness, Fast Heart Rate, Dizziness, Behavior Change(anger/short temper), Low Back Pain, Sharp Head Ache at left eye and forehead.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:39 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Age of patient was reported as 56.24 and 56.31.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Four days after I received the second shot, I broke out in severe hives after dinner, took Benedryl and fell asleep. I woke at 4 am to swollen lips and difficulty swallowing, and went to ER. It took two doses of epinephrine, IV antihistamines, steroids, breathing treatments for me to respond and then they gave me Valium to calm me down. I was discharged after 8 hours of care with several medications. The hives continue to reoccur as my medication doses wear off.
No reaction to vaccine #1 or #2. Booster caused very serious increase in dementia, sleeplessness, total confusion
Flushing, headache, lightheadedness, hypotension, nausea     this morning and had oatmeal.     NKDA       Vitals:  87/56 P 46  RR 18 O2: 100% - Patient: reports he is a runner, unknown baseline BP/HR    Exam:   General: Alert, diaphoretic, pale   HEENT: Normocephalic,  Neck: ROM normal
Discharge Provider: Private MD Primary Care Provider: None Physician, DO Admission Date: 7/31/2022 Discharge Date: Aug 2, 2022 PRESENTING PROBLEM: Hypoxia [R09.02]- Chronic obstructive pulmonary disease, unspecified COPD type (HCC) [J44.9]- Acute respiratory disease due to COVID-19 virus [U07.1, J06.9]- COVID-19 [U07.1]. HOSPITAL COURSE: Patient's symptoms of respiratory distress, fatigue, malaise are into a resolved by day 2 of admission. Feeling very much back to baseline functional status. Is wanting to go home at this time. Understands need to continue steroid course and follow-up outpatient with PCP for further optimization of his chronic obstructive pulmonary disease as well.
Broke out in generalized hives 2 days after receiving shots. No local reaction . Hives lasted 3 weeks
The patient was the given the rsv shot 8/29 and another second shot 9/22/2023
Fever, right arm, hot and large swelling at injection site and hurt for 4 days, flu like symptoms, fatigue and exhaustion for 5 days. Still feel extremely tired, after 2-3 hours of moving around, have to sit down, worn out.
PATIENT STATES SHE EXPERIENCED EXTRA ERYTHEMA AT THE INJECTION SITE THAT SPREAD DOWN HER ARM. SHE IS GOING TO A MEDICAL PHYSICIAN FOR FURTHER EVALUATION.
baseball sized lump in left armpit near the crease; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 as (at the age of 49-years-old) DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. No Relevant Tests were reported. The patient experienced baseball sized lump in left armpit near the crease on 27Feb2021. It was reported that Caller is calling about the Pfizer vaccine, clarified the COVID 19 vaccine. She got the injection 25Feb2021 and on Saturday, 27Feb2021 she noticed a lump under her arm pit. The lump is on the left side, the same side as she received her shot. The lump is the size of a baseball, the lump is not hard, the lump feels uncomfortable. Caller would say it's right below where the crease is. Located more south in her armpit. It was reported that she was taking vitamin c, elderberry, and natural supplements. No AE following prior vaccinations. Patient did not require a visit emergency room or physician Office. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fever to 103 erythema of upper arm L mild generalized rash day 14 post immunization.
rashes on her elbow, wrist and inner thigh/ rash on her legs, arms; rash at the injection site; seriously ill; throat tightened; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number and expiration date was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Mar2021, she feel uncomfortable. Caller stated that the patient got her first dose of the Covid 19 vaccine last March 30, 2021. She waited 15 minutes after getting the vaccine and had no symptoms, after some time she experienced that her throat tightened. On 31Mar2021, she was seriously ill. Also added that 2 days later she had rashes on her elbow, wrist and inner thigh and rash on her legs, arms, and at the injection site. Mid December she said that she had covid. Caller asking if she should take her second dose of the vaccine. The caller's primary care provider told her to take 2 Benadryl's before the shot, but she knows the allergic reactions can be worse with the second dose and doesn't know if the 2 Benadryl's will do it. The patient did not receive any treatment. Outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Pt was administered .5cc of Influenza vaccine, 20-30 mins later, pt came back c/o severe itching, urticaria down left arm, and chest tightness, sob. I administered .3cc of EPI 1:1000 IM in left deltoid at 12:02 while a desk clerk dialed 911. Obtained VS as ER staff came in. BP 182/96, P 199, SP O2 99%,
First was arm pain which started within a couple hours of injection. Shoulder pain, neck pain and muscle cramping followed. The next morning headache and lethargy and a feeling that something was not normal but nothing out of the ordinary and I thought I was lucky until 10 am (16 hours after injection) I had chills with violent shaking and could not get warm (temp never went above 100) not matter how many blankets or heating pads. Stomach upset and diarrhea. Loss of appetite and taste buds off. Severe headache (like an explosion)   with sensitivity to light and sound. Muscle cramps, joint pain and lethargy. Inability to get warm. Some symptoms still persisting 4 days later. No bruise this time and arm pain is less severe than first injection which several nurses looked at an think the first shot went too deep.
patient was supposed to get the Pfizer pedriatic bivalent but got the Pfizer padriatic  original series instead. patient parents already informed and an incident report done in store
Systemic: Confusion-Medium, Systemic: Diarrhea-Mild, Systemic: Exhaustion/Lethargy-Medium, Systemic: Hypertension-Medium.
Overall significant body rash with itching and burning that has lasted for almost 2 months and is getting worse.
Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021. In a retrospective chart review that was conducted in 2 HIV primary care clinics. Patient is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA 89 copies/mL, CD 4 count 260 cells/uL, CD 4 19%, negative for anti-HBc and HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt presented with intussusception 3 days following vaccination with emesis and bloody stool. Reduced by fluoroscopy and air enema.
Swelling, hives, shoulder pain on arm where injection was received (began 1 hr post injection and continued for 4 days). Nausea, dizziness, fever, fatigue (continued for 4-5 days after injection). Treated with Benadryl.
Fever for 3 days-mild, every inch of my body is sore to the point that wearing clothes is uncomfortable, many joints ache, headaches, every hair follicle on my body is sore. Unable to sleep well for past 3 days.  I am rotating through tylenol and advil to alleviate symptoms.
persistent crying for 4 hrs in afternoon p/receiving vax; felt real hot but temp not checked; seen by MD on 5MAR93 t101;
pt recv vax; muscle twitching & shaking for an estimated 5 min;advised mom to check pt's T & notify MD;to er as recommended by MD;
Patient developed pain in the left armpit with a feeling of swelling and problem with elevating arm.  Also complained of pain in left flank and left hip.  Exam on day 4 post vaccine did not reveal any redness but paitient was tender to palpation and had decreased active range of motion in left shoulder
Experienced tingling in lower extremities with extreme coldness exactly like u would if ur feet fell asleep and were just coming out of it. Was scared while driving. Slight similarities in upper extremities just not as strong of tingling sensations. Approximately 30 min after vaccination, lasting about 6 minutes.
This case was reported by a consumer via call center representative and described the occurrence of bronchopneumonia in a female patient who received FLUARIX QUADRIVALENT for prophylaxis. Concurrent medical conditions included renal disease. On 27th September 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced bronchopneumonia (serious criteria hospitalization and GSK medically significant), diarrhea (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the outcome of the bronchopneumonia, diarrhea and fever were unknown. It was unknown if the reporter considered the bronchopneumonia, diarrhea and fever to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The reporter was the patient who developed bronchiolar pneumonia and was hospitalized for 2 days. The patient also experienced fever and diarrhea. The reporter did not have phone or address for the pharmacy. The patient had denied permission to contact their physician.
A day after the booster shot, around late afternoon, armpit near the breast side became tender and needle like pain, increasing pain as it approached night time.  Fever 99.9F started around 5:00pm. Toss and turn during bedtime due to fever. Body feel week and tired. I woke up at 5:30am on 12/24 and did not feel cold but temperature is still at 99.9F.  Armpit is still tender but less painful.
Pt received Pfizer Bivalent Booster that was not mixed with the diluent resulting in a higher than anticipated dose.
BUD was 11/17/21. Vaccine administered 11/19/21. Vaccine was refrigerated until 1:00pm on 11/19/21 when it was removed from refrigerator and mixed. Given at 2:15pm.
Symptoms: Chills, Severe Shakes, Nausea, Vomiting, Headache Time Course: Approx. 2 hours Treatment: Tylenol and bed rest
Horrendous night sweats-  I soak through clothes and bedding- I would change clothes in the middle of the night and soak through a second pair of clothes- sometimes this would happen 3 times and my bed would be soaked.   I developed blurry vision, multiple chemical sensitivities and very bad hives.  Very low blood sugar and shakiness.
Lethargic; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0177, Expiration date and NDC number: unknown), via an unspecified route of administration on 14May2021 (3 weeks ago) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of May2021, patient was just lethargic for 2 days and after 48 hours she was fine. Patient's husband stated that vaccine shot did not bother her. Patient's husband declined to complete a report for the patient. The event recovered on May2021. Investigation Assessment: Not Provided.
Presented cool, pale, diaphoretic. BP 119/82. HR 39. Approximately 5 minutes later he was pink, warm and dry. His BP remained the same but his HR returned to 66. He stated that he has a history of fainting from needles and hasn't had anything to eat or drink since dinner the night before. Pt was AOx4 and vitals were stable. He denied transport to the hospital and his wife said that she would drive him to be evaluated at St Joe's Hospital nearby.
Employee Recollection: Wednesday and Thursday  felt kind of weak and more tired than normal, but thought nothing of it.  In the early afternoon on Friday the symptoms got worse.   Tired and confused.  I slept through my alarm and woke up to my mom, who was watching my daughter for me, trying to wake me up.  I was very confused, dizzy and weak.  My mom said I was really out of it, and that I had a really hard time focusing on what she was trying to say to me.    When I checked in for work my O2 stats were in the upper 80's lower 90's.  My temp was also in the lower 90's.  That was after numerous attempts at taking my o2 stats and temps.  Co-worker said I was very confused, tired, dizzy and weak.  She said there were times when I was walking that I would reaching for walls and railings to regain my balance.  I left work at 6am Saturday morning.  I went home and went straight to bed.  Slept all day long until a few hours before my shift started at 9:30 P.M.   since then I've been feeling better, but my temp and 02 stats are still low.  But I'm continuing to monitor symptoms.  I'll keep you posted if anything changes.
Patient had headache and arm pain and redness/swelling of the injection site after injection. She reports that it has not subsided and the arm pain has gotten worse. She has taken Tylenol for the headache and pain with no relief. She states she woke up this morning and the arm pain had worsened and reports a burning sensation as well as stiffness in her fingers. She also states she continues to have redness and swelling around the injection site along with a knot where it was injected. This has not radiated or spread but has not subsided
Neck pain right side.  Ear pain right side.  Numbness on half of tongue.
On March 26, I had a sharp pain in my legs and it started to swell up.   I could not walk because it was swollen really bad.  On March 27, I went to the ER.   They did blood work and sonogram.  I diagnosed me the an acute DVT.
Headache; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (fatigue) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (fatigue). On 23-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-056130 (Patient Link).
low grade fever of 99.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.8 F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever of 99.8 F). At the time of the report, PYREXIA (low grade fever of 99.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient was fine.
On about the 12th, headaches and extremely tired. I rested over the weekend. The following Monday and Tuesday - I felt like crap. I had to leave work at noon. On the 18th, because I knew I had been exposed to COVID, I took a test. Negative result. Ears were draining and I was still having headaches and my whole head was stuffed up. Monday, 23rd, I called my Dr. - he prescribed an antibiotic and a steroid ointment for my ears and I am doing well now. It cleared up.
High pitch crying lasting nearly 3 hours, swelling, redness, and heat at injection site.  Severe pain at injection site.  Muscle cramping.
On 6/13/18 I awoke with hearing loss in my right ear. (In retrospect, it may have begun the evening before). Audiometry on the afternoon of 6/13/18 showed 20 DB sensorineural hearing decrement across all frequencies in the right ear. On 6/15/18 tinnitus developed in that ear. Treatments: beginning 6/13/18 oral prednisone at 60 mg for 7 days, then 30 mg for 3 days, then 10 mg for 3 days. On 6/13, 6/18, and 6/22, transtympanic injection of dexamethasone into middle ear. Outcome: as of 6/22/18, hearing restored in right ear to greater than 90% of pre-incident level; as of today it is 100% restored subjectively and as measured by audiometry.
This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 14-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient came in on Wednesday October 3, 2019 stating that she had a normal doctor visit scheduled and when she went the Doctor looked at her arm and was concerned about the swelling under her arm. She then said she had received a flu vaccination and it had been hurting. She assumed that due to the swelling that she may have received the vaccination in the wrong location. However the pharmacist that gave her the vaccination knew she gave the vaccine in the correct location in the Left deltoid of the arm. She did not want to report any thing but let us know of her concern.
Less then 2 hrs after vaccine to left thigh developed fever to 101F with very pink and swollen leg thigh from hip to knee; able to walk
Approx 30-36 hrs post vaccination, donor experienced fever, stiffness, achiness, and fatigue. Donor called to tell the center on 12/14/21. She was advised to seek further medical attention.
Started feeling tired about 4 hours after the vaccine.  Then around 5pm 8 hours after the vaccine, I was very cold and shaking.  I had a fever of 100.    The next day the fever was gone but still cold and very tired all day.   Friday, about 75% back to normal, only a little tired.