chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated pre-vaccination that she feels lightheaded after any injection or blood draw Immediately upon vaccination, pt c/o lightheadedness, states " I feel like I'm about to faint".  Cold compress placed on back of neck, pt sitting forward with head close to knees.  Encouraged to take deep breaths.  Within 3 minutes, symptoms diminished.  Vitals 128/84, R14 even and unlabored, P87 strong and regular, O2 Stat 98%.  Released from site at 1454 with no remaining c/o of symptoms.  Encouraged to seek medical care if symptoms worsened.
feeling aches; sick; tired; heart palpitations; My normal heart rate is between 62-65, but noticed that it elevated to around 75 and palpitations; This is a spontaneous report from a non-contactable consumer, the patient via Pfizer sponsored program. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. After receiving the Pfizer COVID vaccine on 12Mar2021 and hung around for 15 minutes, patient started feeling aches, was tired and sick but not real sick around 10 hours after. Patient felt tired for the next month or 2, for some period of time. Patient had some heart palpitations. His normal heart rate was between 62-65 but noticed that it elevated to around 75 and had palpitations. Went to see cardiologist in April and he did not know if it was caused by the vaccine, the palpitations eventually went away. Patient did not feel that he had an allergic reaction. The clinical outcome of heart palpitations was recovered on an unspecified date, while the outcome of all other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
during out covid site visit from Agency on 12.15.22 It was discovered that we had a pfizer  batch in frig past BUD date. during the Agency investigation they went back through all the covid injections that were given and saw this patients lot number was given past BUD date. patient has been contacted and revaccination wsa offered. manufacture was notified and reports were filed pending outcome.
No additional AEs reported; two doses of an expired vaccine were administered to two different patients; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies was not applicable.  On 11-MAY-2022, the patient was vaccinated with the expired hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, (lot #T033304, expiration date: 02-APR-2022; strength, dose, and route of administration were not provided), administered for prophylaxis (Expired product administered). No adverse effects were noted (No adverse event). No additional AEs reported. No product quality compliant (PQC).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA005489:
5-10min p/vax rash spots came on face, chest, back & legs; rash lt body in 20 mins no complaints-body clear from rash; mo called this AM no problems doing evening or noc;
At some period after dose 3 I became ill and appeared to recover but had subconjunctival hemorrhage, bleeding gums, arthrology, (shoulders, elbows, and hips). I also experienced forgetfulness and extreme fatigue. I believe there are more symptoms, but these are most memorable. Most have resolved over time, but I remain easily tired and with extreme shoulder, elbow, and hip pain. I am an employee at a diagnostic center and have access inflammatory marker testing which revealed sCD40L levels more than 35000. Whole body diffusion MRI did not indicate lymphadenopathy but showed shotty lymph nodes. There was no evidence of pancreatic or diffusion, abnormalities in other organs or osseous structures. My ability to engage in physical activity is limited. However, I completed 2 5K runs and each took triple the time it would normally have taken me. I was advised to adopt an anti-inflammatory diet eliminating red meat, processed sugars, alcohol, and high sodium foods. I still experience pain.
On June 22, 2022 I woke up with minor body aches. I took Tylenol. Then I felt fine and rested that day. At 5:00PM I got body aches again. I took more Tylenol. On June 23rd I had  general aching in the morning. I took Tylenol. The same thing happened that evening again. On June 24th at 2:00AM I woke up freezing. My body was shaking really bad. I had a fever of 101 degrees. I took some Ibuprofen. I had severe shooting pains from my ear and inside my ear and back of my head along my scalp. The pains were alternating from my left ear to my right ear. It was constant. When I woke up in the morning later that day I had a fever that was 100 degrees. I started alternating Ibuprofen with Tylenol every 3 hours. It did help a little with the pain. I called my primary doctor, and she advised that if my fever spiked again to seek emergent care. On June 25th I had head pain. I took Ibuprofen. My fever started coming down slowly. By the end of the day my temperature was 99 degrees. My normal temperature is 97.3 degrees. It maintained from about 100 degrees to 99 degrees. I was extremely tired. On June 26th when I woke up, within 30 minutes, the shooting pain started again. I put an ice bag on my head and heating pads on my ears. I took Ibuprofen and Tylenol. That morning the pain was so bad that there were no gaps just a constant shooting electrical feeling in the back of my head. My fever was 101.5 degrees. I went to an urgent care. They ran test. The doctor said that they think that the booster allowed something to form in my body. They said it was like some type of virus that attached to the nerve in my ears. I was prescribed a 5 day course of Prednisone. On June 27th I laid in bed all day. I was so exhausted. I slept from 8PM to 6AM in the morning of the next day. I slept with no pain. On June 28th the pain started again but under my ears and traveling up my scalp. I felt it but not as bad. On June 29th my temperature was 99 degrees at the highest, and at the lowest my temperature was 97.4 degrees. On today, June 30th,  I woke up and felt good. 45 minutes later I had pain under my ears. I  took some Advil and that managed it.
Testicles swelled up to about three times their normal size; Extremely sensitive testicles; This is a spontaneous report received from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 19Mar2021 at 15:45 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Em9809), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 20Mar2021 at 01:00, the patient experienced normal side effects, additionally testicles swelled up to about three times their normal size and were extremely sensitive. This persisted to about the 16-hour mark after the patient received the vaccine. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events testicles swelled up to about three times their normal size and extremely sensitive were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
One day post immunization, pt had nickel sized bruise at injection site on L delt. Next day developed three more slightly swollen bruises in line at slight angle down from injection site about 2" apart. Bruises resolving 10 days later. No other injuries at that time noted by pt.
Vaccinated Mon. 9/25. Felt ill in PM. Had fever Tues and Wed. Thurs. felt OK. Friday had chest pain and admitted to hospital on Sat. with pericarditis/myocarditis. 5 vaccines given on 9/25.
weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison; weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison; soreness within a few hours after the vaccine; This is a spontaneous report from a contactable Nurse. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 at 08:00 as a dose 1, single for covid-19 immunization. Medical history included High blood pressure and COVID positive in Nov2020. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was hospital; clinic set up in the hospital for workers. No prior vaccinations within 4 weeks. No aes follow prior vaccinations. No family Medical history reported It was reported that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced a weird smell and taste. It was Like a chemical bleach smell and taste that feels like it's poison on 29Jan2021. She said it was like a chemical bleach smell and taste that feels like it's poison. She said this has been going on for 2 weeks straight since receiving the 1st dose. HCP wants to know if it was still safe for her to receive the 2nd dose of the vaccine if she had this kind of reaction to the 1st dose. Had first COVID-19 Vaccine on 27Jan2021. Due for second dose on 17Feb2021. Two days after first dose, had a weird smell in her nose and a weird taste. Occurring even today. Went to taste soda and still has it. Started after the COVID-19 Vaccine and has been on and off. It is a chemical or bleach smell and taste she was experiencing. Her son is non-verbal and autistic. No further details provided. Scared to get second COVID-19 Vaccine. Known people to only have symptoms for a day or two. Feel like it is almost in her pores. Doesn't know if this is normal or if she needs to get blood work done. She had never known symptoms to last for two weeks straight. Weird smell and taste is off and on. Started with a strong chemical, bleach smell. She could smell other things, but it was a mixture with the chemical smell. It was overpowering. It was all she could smell if she was outside or took a deep breath. Hasn't really tasted food. Went to take a drink of Sierra Mist and had the same taste as what she is smelling. Would try to take a small sip and it felt like it was on her tongue. It threw her off. She could taste the Sierra Mist, but the chemical taste made the soda disgusting. This was all the symptoms she has had. The outcome of event weird smell and taste./ like a chemical bleach smell and taste that feels like it's poison was not recovered and recovered for soreness within a few hours after the vaccine on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
HEAVINESS IN CHEST AREA; HOT TO THE TOUCH; LEFT EAR INFLAMMATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was currently 3 months post-partum.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-JUN-2021, the subject experienced left ear inflammation. On 16-JUN-2021, the subject experienced hot to the touch. On 17-JUN-2021, the subject experienced heaviness in chest area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left ear inflammation, heaviness in chest area, and hot to the touch. This report was non-serious.
Since my second Pfizer vaccine I have tinnitus in both ears. Loud, unrelenting, constant, 24/7.
Swollen lymph node in armpit on side where vaccine was given. First noticed 3/8/21 after shot on 3/3/21. Previously had only arm soreness after shot on 3/3/21 until 3/6/21.
pt recvd MMR vax & 13SEP91 was found to have neg titers; 8JUN92 administered measles vax &  lab eval in SEP92 revealed a rubella titer of 1.8 & a measles titer of 0.79; no further details were provided;
Sore arm; This is a spontaneous report from a contactable other hcp (Nurse). This female nurse reported that a female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 08Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (BNT162B2 Batch/Lot number: not reported), via an unspecified route of administration on 18Dec2020 as first dose single for covid-19 immunisation. On an unknown date, the patient experienced sore arm. The patient underwent lab tests and procedures which included antibody test: negative on 01Feb2021. It was reported that patient had no side effects from either dose Only a "sore arm" which is her normal after a vaccine. The clinical outcome of event was unknown.  Follow-up attempts have been completed and no further information is expected.
injection site is itchy; warm to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PRURITUS (non-serious) with onset 19Oct2023, outcome "unknown", described as "injection site is itchy"; INJECTION SITE WARMTH (non-serious) with onset 19Oct2023, outcome "unknown", described as "warm to touch". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Infection. Experienced COVID-19 symptoms and tested positive on PCR Test; COVID-19 Infection. Experienced COVID-19 symptoms and tested positive on PCR Test; dose 1 and dose 2 both 25Jan2021; dose 1 and dose 2 both 25Jan2021; This is a spontaneous report from a non-contactable consumer. A non-pregnant 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm (Batch/Lot Number: EL9262) as 1st dose, single dose, dose 2 via an unspecified route of administration (Batch/Lot Number: EM9810) as 2nd dose, single dose, both on 25Jan2021 for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced COVID-19 symptoms and tested positive on PCR Test (nasal swab) on 13May2021. The patient does not receive treatment. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Lethargic.  Yelled unless he was held "clingy".  No appetite.  High fever x2 days.  All reactions occurred for about 2 days.
Gave vaccine to a 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, gave vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
pt had temp 103, red raised area around inj site lt deltoid;lt arm turned red w/a hard area surrounding the inj site & a fever was assoc w/it;
Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). Subsequently, the patient developed a lump at the injection site. The lump lasted 3 to 4 days. No further information was provided. Additional has been requested.
Patient was admitted for surgical fixation of his hip fracture. ED to hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Healthy pregnancy no complications, 36 weeks at time of administration, due date 11/18/2023 and no birth weight baby isn?t born. Starting 10/22/23 my blood pressure went from 112/73 or lower throughout by whole pregnancy to consistently staying above 130/90. Readings increased on 10/26/23 to 146/99 and haven?t dropped back below 130/90. On 10/28/23 blood pressure was 136/96 upon awakening. I have never had a history of high blood pressure and never had a high reading during pregnancy until after vaccination.
Immediate pain at injection that went down arm. RPH dismissed as burning from shingrix. Patient came back to pharmacy on 7/21 after seeing PCP about the pain in arm. Right arm is visibly bruised at injection site which seems to be given in acromium process. Patient's arm was swollen with neuropathy going to arm. Patient is a massage therapist and this affected her line of work
The shot was ia the left arm.  however, within one hour my right arm began hurting. I woke up a couple of days later in excruciating pain - my right arm had sharp pain throughout it, I couldn't pin point it because it felt like everywhere. I lost the ability to grip with my right hand and lost some range of motion.  The pain started decreasing after a  couple of days then plateaued.  I I have regained full motion and most grip but I?m still in a lot of pain.
I was having a lot of shortness breath and was very tired and fatigued whenever I walked. I ended up going getting tested and I was positive for COVID-19. I slept for about 14 days but after this I started having the shortness of breath and fatigue and in one instance I almost passed out and my Apple Watched indicated that I was having AFIB, and I went to the ER. They did lab work and then and an EKG, and we found I had a UTI as well. I was admitted to the hospital overnight. They increased my medication for my heart, and I had a follow up with the cardiologist two weeks later. They added a blood thinner to my medications and kept the higher dose of the medication from the ER. We ended up doing a stress test as well because of a non-related surgery I had coming up.  I have been able to manage this new condition through medication
Rash on the low right arm showed up in the afternoon of 2021-05-15.
SLEPT FOR LIKE 16 HOURS THE FIRST DAY; SORE ARM; FATIGUED; SLIGHT FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slept for like 16 hours the first day, sore arm, fatigued, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for like 16 hours the first day, sore arm, fatigued, and slight fever. This report was non-serious.
Patient had her PREVNAR 13 injection November 11 and 2 days later she had myalgias and fatigue that lasted into the Thanksgiving time frame. Now her myalgias are intermittent and more in the hands and right shoulder.
Female patient 49 years old came to the area of observation looked pale and making faces of feeling bad. She gets transferred to the area of observation of incidents to be evaluated by EMT and her vitals are BP 170/100 mmHg, Sat 98%, P91, Dx 107, R16. A 15g of glucose pill is given to the patient. Case was consulted with Doctor who orders juice for patient and to apply ice to the back of her neck and to keep her in observation for 30 minutes. At 1pm she is reevaluated and her vitals are BP 150/90 mmHg, R16, Sat 99% and DXT134, Doctor takes her pressure with her head nurse.
16 year old received 0.25 ml of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 0.25 ml of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 0.25 ml of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 0.25 ml of Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was a clinic manager.  Concomitant medication of the patient was not reported.  The reporter reported that, the patient did not experience any side effects and was following up with the patient's mother later on 14-Apr-2022.  No treatment information was provided by the reporter.
Pfizer 3/18/21, 4/8/21, 12/3/21. Positive on 12/9/22
On 2/20/21  when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself.  Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
Pain at injection site, lost hearing and fainted for short period of time, fever and severe chills and sweating for about 1 hour