chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several pin sizes to quart size non inflammed and non-colored palpulas; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2014US001265).  This spontaneous report was received from a health professional refers to a 16 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 24-AUG-2019, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (batch/lot number# H021608, expiry date not reported but upon internal validation established as 13-AUG-2015) one dosage form via intramuscular route for immunization and varicella virus vaccine live (oka/merck) (VARIVAX) (batch/lot number# J003219, expiry date not reported but upon internal validation established as 15-MAR-2015) one dosage form via subcuteneous route for immunization.  On the same day, the patient received other co suspects included meningococcal acyw conj vaccine (crm197) (MENVEO) injection(batch/lot number# M12130, expiry date not reported) one dosage form(1 DF) via intramuscular route for immunisation and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid( ADACEL) (batch/lot number#U4567AA, expiry date not reported) one dosage form via intramuscular route for immunization.  On 31-AUG-2013, the patient experienced several pin sizes to quart size non inflammed and non-colored palpulas (palpable purpura). The outcome of palpable purpura was reported as recovered. The relatedness between the event and meningococcal acyw conj vaccine (crm197) (MENVEO) was suspected. The relatedness between the event and other suspect therapies was not provided.  The Agency considered the event palpable purpura as medically siginificant.; Sender's Comments:  509674:
I got the vaccine on 11/05/2017 at 02:00p.m. in the evening of that same day (11/05/2017) I started to feel bad: strong nausea, nearly vomiting. By next early morning the conditions got worse, even if I stayed in bed. I started vomiting, unable to reach a toilet, had fallen on the way. At about 07:00 a.m. 11/06/2017, I got in a hospital emergency room. Vomiting had increased. There were many medical personnel around me, asking many questions and discussing the problem. I suggested that this may be related to the vaccine. They answered this is uncommon and happens not often. They gave me medicines and fluid injections (using "dropper in vein" system, not sure what correct medical term is) to prevent vomiting, dizziness, and nausea, and made a lot of tests. After about 5 hours of the treatment, I started to feel better and was discharged from the emergency room with a final diagnosis: benign paroxysmal vertigo, bilateral. I was given prescriptions for "Ondansetron" and "Meclizine". I had been taking the medicines for 3 days and stayed at home. Then the symptoms ended and I returned to my work.
Was very lethargic, not moving, almost unresponsive. Violently vomitting with no response, eyes rolling back, slight fever Has since been diagnosed with allergies
Had a mild case; They hurt; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient for himself/ herself. The age at vaccination was not reported. The patient had a mild case of Shingles as per the physician and stated that it hurt. The patient was asked to get the 2nd shot also.
Patient hospitalized for High-risk pregnancy in third trimester, and delivery of healthy baby. Hospital course was uneventful.
Patient started experiencing substernal chest pain radiating to epigastric region and associated with palpitations in the morning. The symptoms lessensed as the day progressed, so the patient played basketball. In the evening the patient started experiencing severe left sided chest pain with sharp left sided shoulder pain and diaphoresis, so they decided to come to the ED. On arrival, the symptoms had resolved. The patient is currently admitted and in the ICU for monitoring.
Several small itchy bumps on both my hands and arms, mostly on my left hand.  I got a cluster of tiny bumps on my left pinky just below the nail which felt like a burn and developed into a blister which was 'weeping" a bit. I still have it, although it seems to be getting better. Even today, I get tiny bumps. I have two on the palm of my left hands. The bumps grow into small blister-like bubble bumps, especially on my fingers.  I do not have a lot of them to call it a rash, but enough to be annoying.  I try putting Calamine lotion on these bumps. Only problem is, I wash my hands often and it gets removed.  But it did help with the itching.
Spike in resting heart rate (145-189)  Shortness of breath Extreme fatigue
There is bruising and swelling on two toes on the right foot.; There is bruising and swelling on two toes on the right foot.; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809) intramuscularly in right arm on 10Feb2021 16:00 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EK9231) intramuscularly in right arm on 19Jan2021 18:00 as 1st single dose for COVID-19 immunization. The patient was 37-years-old and was not pregnant at the time of vaccination. Patient medical history included known allergies to sulfa drugs. The concomitant medications were not reported. The vaccination facility type was reported as Hospital. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior to vaccination. On 14Feb2021 patient experienced bruising and swelling on two toes on the right foot. The lab data and procedures included nasal swab test on 22Feb2021 with test result as negative. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatments for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
tinnitus; 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.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Lot number: GJ3275) 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: TINNITUS (non-serious) with onset Dec2022, outcome "unknown".  Additional information: The patient wanted to know if tinnitus was common after receiving the Pfizer COVID vaccine and if so, how long does it take to go away. Caller stated, "We started with the Pfizer COVID vaccine when it first came out 2021 and since that time, we received all the boosters and last month, I got another booster which was taking care of the new variants. A week later, i have what I call tinnitus, which is ringing in the ears. Have you had any other people complaining about of tinnitus after one or more doses of the vaccine."  Caller stated he received the shot on 13Dec2022 and the Lot was GJ3275. And was not able to confirm which vaccine he received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026676 Same patient/vaccine, different dose/event.;
PT DID NOT HAVE AN ADVERSE EVENT, PT WAS GIVEN NOVAVAX BY MISTAKE.  PT ALREADY HAD 4 PFIZER VACCINES  3/23/2021, 4/12/2021, 9/17/2021, AND 3/18/2022. PT TOLD TE MEDICAL ASSISTANT THAT SHE WANTED TO NOVAVAX AS A BOOSTER AND STATES CDC RECOMMENDS IT.  THE MEDICAL ASSISTANT DID NOT REVIEW THE PATIENTS CHART AND ADMINISTERD THE NOVAVAX.
2/15/21  onset of symptoms began about 4-5 hours after injection with slight fever and body aches.  Woke up 2/16/21 about 5am with higher fever 102F and sever body aches.  I took extra strength Tylenol according to Tylenol directions for the remainder of the day. Fever lingered between 100.5 and 101F my body generally hurt all over.  I also slept most of the day  Took my last Tylenol about 10pm  slept through the night and felt fine the next morning.     The reason I am submitting this report now is because I have just experienced a near repeat of the above.  Over the weekend of March 25 I began to experience seasonal pollen allergy .  On March 28 I woke up with a fever (101) and body aches.  I again took extra strength Tylenol and slept most of the day.  My fever decreased to about 100.5 most of the day.  The next morning I felt better but still had a slight fever 99.5-100 and body aches had diminished.  By March 30 I did not have a fever and body ceased to hurt.   I am wondering if the reaction was a result of my immune system over reacting due to the vaccine.  This has never happened before.
ANXIETY; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergy to latex, allergy to potato, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from nausea, and anxiety. This report was non-serious.
had puffy eyes, reaction 1hr p/vax given;mom called ambulance to be taken to ER;DPH given;
Patient had minimal side effects including sore arm; Patient had minimal side effects including tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired). At the time of the report, PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-750219, MOD-2023-750226 (Patient Link).
Two weeks after the first dose I experience dizziness with ear pressure issues. My doctor is a neurological exam, said it was vertigo, and gave me meclizine. They said it could be from the vaccine, but they just don't know.  Two weeks after the second I experience even more severe dizziness with ear pain, inflammation, ear pain, and felt worse. My doctor said this could be an inflation response to the vaccine and said my left ear was red and swollen. Gave me antibiotics and prednisone.  A month later I had my annual checkup and explained I had three more dizziness and ear pain episodes. He then referred me to an ENT specialist.  Today the ENT specialist said what I described does not sound like vertigo from my ear pressure issue. He said it could from medication or a health issue. He asked have I taken any new medication since February and I said the Covid vaccine. He said that could be causing the dizzyness, but there is also no way to know right now.
Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph node swelling under her ear/lymph swelling increased to quarter size; shooting pain in my right ear; Headache; chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) intramuscular on 27Jan2021 15:30 in left arm at single dose for COVID-19 immunization. The patient did not have Covid prior vaccination. The patient did not have covid tested post vaccination. No known drug allergies and no other medical history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced headache and chills 3 days after Covid vaccine on 30Jan2021. On 03Feb2021, she had shooting pain in her right ear. On 04Feb2021, her ear started swelling, she also noticed her lymph node swelling under her ear. On 05Feb2021, chills, lymph swelling increased to quarter size with a rash under her jaw line and earlobe; she made an appointment with her PCP and was given Ceftin 500 mg two times a day for 7 days. She had blisters on the back of her earlobe on 07Feb2021. On 07Feb2021, she noticed more blisters in front of her right earlobe and on the rash under her jaw line. On 07Feb2021, she went to urgent care and was diagnosed of shingles, given valacyclovir (VALTREX) 1 mg three times a day for 7 days. On 10Feb2021, culture came back positive for Varicella zoster virus DNA, PCR. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Fever on 10/01/16, continued to 10/02/16.  Fever resolved.  On 10/04/16, reported a "loud buzzing, like a motor".  Rested, upon waking, stated that he could not hear anything, complete hearing loss.  One week later, developed dizziness, nausea, and weakness.  At this time, reports he has recovered 20% of hearing, but has been told that it may be permanent hearing loss.
Macular, papular, vesicular, itchy generalized rash on 4/01/2016. Reported less than 50 lesions. Dx with varicella on 4/4/2016.
I received 2 infusions of the Horizon Pegloticase product (Krystexxa) for gout in September 2021. Uric acid tests 2 weeks after each infusion indicated that I was an immediate non-responder to the therapy. I am not a health care professional but conducted some research online to better understand the possible failure mode of Pegloticase treatment. I am contacting you because I was inoculated with the pegelated Moderna mRNA Covid vaccine in March-April of 2021. I had never knowingly been treated with any other pegelated medicinal product prior to the Moderna inoculation. For 6 weeks prior to my first infusion of Pegloticase I was pre-treated with methotrexate as an immune-suppressant to lower the rish of anti-PEG anti-body generation upon infusion of Pegloticase. After reading the paper, my layman's conjecture for my treatment failure is that the Moderna vacine may have induced anto-PEG anti-body formation. And therefore I was infused with Pegloticase with pre-existing anti-PEG antibodies present that neutralized the product making me an immediate non-responder. As a layman I understand that PEG compounds are found in various consumer products and some are ingested. My layman's interpretation of the paper is that the family of PEG compounds span a range of molecular weights with specific stereo-configurations. And that specific anti-PEG antibodies are only bio-active against specific PEG configurations. My layman's question is if the PEG backbones of the mRNA vaccines resemble the PEG backbones of the PEG therapeutics causing anti-PEG antibodies produced by mRNA vaccination to attack and neutralize PEG therapeutics administered later. It seems that a notional study would be to test the level of anti-PEG antibody production in a population of mRNA inoculated subjects and compare the sample results to control group. And also test the levels of anti-PEG anti-PEG antibody response from both groups against the specific PEG compounds used in pegelated therapies. If my layman's conjecture makes theoretical sense, then the implications could be very consequential. Because if over 150 million people are inoculated with pegelated Covid vaccines, then some significant fraction of those may develop anti-PEG antibodies that could disqualify them from access to other very valuable for treatments chronic conditions that also utilize pegelated technology.  The apparent follow on public health question then would be why use PEG technology in vaccines when other vaccine formulation methods are available? Given the highly relevant analysis, is FDA cognizant of this potentially important issue given the massive distribution of pegelated mRNA vaccines to combat Covid?
Blood clotting with spotting and pain; Irregular period; Pain in lower left side of abdomen; Blood clotting with spotting and pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose on 05Mar2021 08:00 as single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The patient experienced irregular period after second dose, pain in lower left side of abdomen and blood clotting with spotting and pain on 16Apr2021 12:00. The outcome of the events was unknown.  No treatment received for the events.   Information related lot/batch number has been requested.
hands swelled up; hand and wrist joints got sore beyond what caused by osteoarthritis; hand and wrist joints got sore beyond what caused by osteoarthritis; lost strength in fingers; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 27Feb2021 (at age of 71-years-old) 20:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included not sure this is shot-related; may be reaction to blood pressure meds on unknown date and unknown if ongoing. Concomitant medications were not known (reported as quite a few). The patient had known allergies to morphine. The patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left shoulder on 21Mar2021 (Batch/Lot Number: ER2613) as DOSE 2, SINGLE for covid-19 immunisation. 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. On 27Feb2021, the patient experienced hands swelled up, hand and wrist joints got sore beyond what caused by osteoarthritis and lost strength in fingers. The patient received treatment for adverse event as steroid shot. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
23OCT95 saw MD red half dollar-sized spot on lt hip;no fever seen in AM;23OCT95 PM saw MD had red half dollar sized spot also now on rt hip;25OCT95 afternoon saw MD for what babysitter described as sz activity
Chills, low grade fever up to 100.00, loss of smell, loss of taste, fatigue, body aches, insomnia, injection site pain and soreness, dehydration. Remedy with rest, electrolytes, fluids, ibuprofen. Most symptoms lasted 24 hours, however total loss of smell and taste was 48 hours and is now selective at 72 hours. Have full sensation of taste (can recognize bitter/sweet/etc) but can only taste sweet/bitter. iE can taste coffee with or without sweetener but cannot taste food such as pizza or french fries.
Injection site red, warm, swollen, painful.  6 cm x 11 cm in size
MA calling to report child received PEDVAXHIB vaccine in addition to PENTCEL on same date.   Caller was difficult to understand and obtain information from. Associaed Req. case # 02460164 and 02460217.  No additional AE.  No PQC.; No additional AE; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2024 (conflicting information since report was received in 2023), the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) for prophylaxis (Overdose). No additional adverse events were reported (No adverse event).
Since then, I have had severe nausea, increased stomach bloating/pain/digestion problems, immobilizing fatigue, general ill feeling, light headed, and the inability to function.  I did have many of these symptoms as a result of a condition a couple years back but they finally slowed down and I started to slowly be able to function again. Since the 2nd vaccine, they have re-activated intensely and I am still unable to function.  I don?t have a way of knowing if this just happened to coincide with the time of the vaccination and was causally related or not. Could it be possible that it triggered/re-activated the condition? I don?t know for sure but I do know that was the timing. I was encouraged to provide this information.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX lot # K016318, expiration date 24-DEC-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested.
3PM 'FEELS A LITTLE ANXIOUS'. A/O, PINK, W/D, RESP WITH EASE. BP 130/70, HR 53, R 20, 02 SAT 94%. 3:05PM PT STATES 'DOING OK NOW AND OK TO GO HOME.' NO ACUTE OR OBVIOUS DISTRESS. 4-8-21 12N TC: PT STATES 'FEELS FINE TODAY.'
Information has been received from a pharmacist concerning an 11 year old patient who in approximately 1994, when the child was a toddler, was vaccinated with a dose of varicella virus vaccine live. On approximately 7/3/03 the patient developed chicken pox with a fever. The number of lesions and the location of the lesions were not provided. The case was reported as more than a mild case of chicken pox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.