chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. On an unknown dates the patient received all 3 shots in GARDASIL series. On an unknown date the patient's mother reported that GARDASIL had caused the patient to have polycystic ovary syndrome (PCOS). The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Suspected vaccination failure; I had the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient had shingles and also got the Shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Swelling with redness and swelling of right thigh. No purulent discharge was seen in emergency room and given KEFLEX. 4 days after area woke better. No fever, no systemic effects.
Pt had tetanus toxoid shot on the right buttock 10 days ago he noticed swelling and pain at site of injection, no fever.
I was positive for COVID- 19 on 18DEC2022, I had runny nose, stuffy sinus, very fatigued and a bit of a cough. I called my doctor, I was prescribed paxlovid. I started feeling better after few days to really feel better.
Mom noticed lt leg was red & swollen around immun site on 10JUL91; 12JUL91 called clinic leg swollen & seemed to be sore & was asked to bring pt in to have leg checked; Appeared to have local rxn to DTP;
LT ARM, LT AXILLARY PAIN. HARD KNOT TO LT DELTOID. DIFFICULTY BREATHING AND CHEST PAIN STARTED IN THE EARLY AM OF 10/06/2011 AS OF 10/11/2011 CONT WITH ARE AND AXILLARY PAIN. DENIES DIFFICULTY BREATHING AND CHEST PAIN.
Chills, fever, headache, body aches, rash on arm that shot was received in
"Moderna COVID-19 vaccine EUA" Patient received 0.5ml instead of 0.25ml COVID booster vaccine.
Pain at injecting site, painful to move my  arm hours later. Server abdominal pain/ cramping
Severe pain in left arm a few hours after vaccination.  Within 10 Hours, awoke in the middle of the night with body aches all over, severe pain in left arm, head pulsating, increased blood flow, head pounding, severe ringing in ears.  Within days, massive swelling of sinuses, head pressure, post nasal drip, feeling of 'hot ears', nausea, brain fog, no appetite, Massive ear ringing continues, cannot function properly due to severity of noise.  Severe anxiety, nervous system activated.  Tachycardia during the night for several weeks.  Dizziness and vertigo on occasion for several weeks
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.  This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
On my first dose without 1 hour I experienced chills within three hours I experienced headaches and the high grade fever also unable to eat and when I did I vomited the following day midday I started to feel better and as of this report no side effects. However I?m concerned about taking the second dose
Initial symptoms on days 2-3 were fatigue and mild dizziness.  Starting yesterday, 6 days after treatment, my ears began clogging.  It comes and goes, but is noticeable.  Given the current events it made sense to report since it is also accompanied by mild cold symptoms affecting my sinus area.   No headache or other pain currently.  Breathing is normal.
diffuse welt-like rash, erythematous. Sporadic body sites/locations
patient received Gardasil vaccine on 12/20/06; 2/20/07; and 6/20/07.shortly after the last dose she has developed an pains in the ankles and feet, and numbness and tingling of the legs and hands.  Evaluation by her current primary care doctor, neurologist and rheumatologist has yet to provide an explanation or treatment.  Provisional diagnosis is neuropathy.consultant records received 11/18/08-C/O pain and swelling of both medial legs and ankles 7/07, pain worsened with weight bearing with swelling in ankles. Three weeks ago swelling and pain spontaneously improved. Assessment-possible that this represents a self limiting viral illness. Consultant visit 9/2/08-two months prior developed numbness, paresthesias and pain affecting bilateral plantar aspect of feet radiating to ankle and leg. Symptoms worse at night. Also right hand numbness. Assessment-bilateral feet pain consistent with neuropathic process likely bilateral tarsal tunnel. Right hand discomfort consistent with carpal tunnel syndrome. swelling in both feet. Started last summer. DX: peripheral neuropathy. Dysmenorrhea. Diarrhea.
Pt became feb w/in 2hrs of receiving vax; Temp reached 106R & was extremely irritable & inconsolable, exam revealed no source of fever, UA-nl, WBC 13,500 w/ 56 SEG, 44 Lymph;
This spontaneous report was received from a pharmacist referring to a "baby" female patient of unknown age. Patient's medical history and concurrent condition were not provided. On 28-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Initial report received from a health care professional on 12 October 2009. The same health care professional reported another case which is described in case 2009-04286. A patient whose age and gender were not reported received an injection in the left deltoid of FLUZONE (lot number not reported). One day after vaccination, the patient developed nausea, decreased appetite, fever greater than 101 degrees Fahrenheit, chills, headache and body aches. Illness at the time of vaccination and pre-existing conditions were reported as none. No additional information was provided. List of documents held by sender: none.
redness and warmth 2-3" below the deltoid where shot was received.  Mild itchiness in the arm.  No pain or tenderness in the area.  Mom instructed to use cold compress and give oral Benadryl.  If any worsening of symptoms or fever she is to bring him into the office to see the physician.
Significant redness and swelling.  Swelling lasted for 1 week.  1 week later redness still present.
Severe muscle pain,  weakness and stiffness. Lasted 6 days Treated with antihistamines
Patient was administered an over diluted dose of Pfizer covid vaccine. No signs or symptoms of reaction reported, patient is due to be boosted.
Patient reports feeling dizzy and lightheadedness. No shortness of breath and no rash. Cleared by EMS. Refused transport to ER. Blood pressure - 156/97
Numbness L-hand, arm, neck and back of jaw. Hand and neck are most numb, mid-forearm is tingly. Pt states gets a little better as day goes by but still numb. Worse in the AMs. Nickle sized bruise at vaccine site.  11/16/09  Medical records received for DOS 11/5/09-11/13/09 Pregnant. recieved vaccine and developed subjective numbness L occipital nerve region.  Ear pain. Numbness in neck and jaw.  Numbness L hand/fingers.
Dose received 3; Chills in the night following vaccination.; Arm soreness through D3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: unknown) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills in the night following vaccination"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Arm soreness through D3". Therapeutic measures were not taken as a result of chills and pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
breast swelling; Tenderness in Breast; Slow Brain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (breast swelling), BREAST TENDERNESS (Tenderness in Breast) and BRADYPHRENIA (Slow Brain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M20A) for COVID-19 vaccination.     No medical history was reported.     On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced BRADYPHRENIA (Slow Brain). On 08-Mar-2021, the patient experienced BREAST SWELLING (breast swelling) and BREAST TENDERNESS (Tenderness in Breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BREAST SWELLING (breast swelling), BREAST TENDERNESS (Tenderness in Breast) and BRADYPHRENIA (Slow Brain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information was reported. Patient reported that she was still not feeling well.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Contact details updated (Mail id)
Rash on left inner shoulder, neck, jawline, around mouth, Cheek, next to eye, forehead and left back of hand Looks like eczema but larger pimply red bumps as well
Face Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face Swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history were reported.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced SWELLING FACE (Face Swelling). At the time of the report, SWELLING FACE (Face Swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021 including form patient decline to give Email address. Patient stated that events resolved
Pt presents to the ED c/o  altered mental status noticed this morning by her husband.  Last known normal was reportedly 2300 last night.  She received her Covid booster shot yesterday.  She does complain of fever today but presents to ER with 103.2.  She denies headache.  She denies chest pain, shortness of breath, nausea, vomiting, abdominal pain.  She reports that she is having difficulty getting words out.
He got his vaccine in the afternoon around 1:30.  Later that evening he started getting chills.  The following morning he was fatigued, did not want to get out of bed, just wanted to sleep, chills.  He had extreme weakness for a few days, and then started getting better.  On Thursday afternoon he was getting better, tired, chills.  Friday morning he was talking with his immunologist as he had a Denopatch test earlier this year and found out that he was allergic to the mineral gold, no indication other than he was allergic.  He mentioned to her that his legs felt weakness, and told him there was an enzyme from the liver that could give him issues, and suggested to have blood work.  On Monday he was scheduled for the blood work.  Over the weekend he felt tired, but that was it.  On Monday morning he felt a little tired, did not sleep well.  Once he got to the hospital it was Labs and everything started at that point.  He was walking back to his car and he had to sit, and was breathing hard and had extreme weakness.  When he got home after that he had to go to Hospital he had to go to the cardiologist and he told his wife to take him to the ER.  They did a lot of blood work and did not find anything.  While he was sitting the extreme fatigue started to subside.  He then went home and since then he has had good and bad days.  They told him to see his PCP which he did the following day and noticed that he has weakness in his right leg and said it sounded like his bad and to get x-rays.  He went to a neurologist who suggested an MRI and he cannot do that due to his MRI as it is not compatible.  They did a CAT scan 2 weeks ago for his back and he does have some issues with that, but no pain.  So he is waiting to see the neurologist again, but the weakness, tiredness and fatigue he does not believe has anything to do with his  back.    Prior to the vaccine he felt great.  He had no issue taking the booster and was looking forward to it as he is a diabetic and has been very very careful and wears a mask, and does not go into grocery store and stays masked for those visits.    Neurologist; cardiologist; endocrinologist
Pt stated she currenty has a post nasal drip and she feels like her throat swelling comes and goes. Pt stated she just got very nervous and wanted to be checked out. Pt seen by EMS on site BP: 158/88, P:100, O2:99% on RA. Pt declined to go to hospital. EMS educated pt on signs and symtoms to report and go to the hospital. RN
trembling; fever that got up to 106/ fever for 48hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer, The first dose he got the smaller dose because he was under 5 she thinks it was  0.3 mLs), when the patient was 4 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant), outcome "recovered", described as "fever that got up to 106/ fever for 48hrs"; TREMOR (non-serious), outcome "unknown", described as "trembling". The patient underwent the following laboratory tests and procedures: Body temperature: 106. The patient's mother reported that the patient had a bad reaction to the second dose of Pfizer COVID 19 Orange top vaccine. For the second dose he got the larger dose because he had turned 5. The patient's mother stated the patient is tiny so she thinks it was too much for him. His Reaction was fever that got up to 106, trembling, fever for 48hrs, it was horrendous. She will not give him, or her other kids the booster. She was done with the vaccine and she was not an anti-vaccine person. She does not understand why vaccines are not given by weight. The patient only weighs 30 lbs. She already made the report with the safety dept.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lymph node in my neck seems swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Sep2023, outcome "unknown", described as "Lymph node in my neck seems swollen". Additional information: the patient stated "I got the new Covid Vaccine last Thursday and I just wanted to check because yesterday, I had it done in my left arm so my left lymph node seems swollen" and specified that "Not my left arm in my neck like my lymph node in my neck seems swollen. That happened 6 days after I got the shot."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
swelling and pain in the arm.  The swollen spot was sizable for her small arms. There was no evidence of bruising or bleeding under the skin and no redness just swelling. We placed an ice pack on her arm for about 15 minutes and the swelling did go down some.  By 5 pm the swelling was gone.
Large redden area, most of upper arm at injection site. Patient describe area as "hot" and painful.
C/O lightheaded, dizzy Had brief <5 second nonresponsive to speech episode.  Arousal with Ammonia inhalant Pt went home
I had vaccination on 11/08/2021. About a month later I started to exhibit face and cheek sloped down my eyes were red.  I was tested for a stroke which was negative. I was diagnosed with Bells Palsy. I cannot remember if I was given a prescription. It took me about a month to feel better.
Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.
already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated; already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "already was vaccinated 2 times plus 1 booster/ still got COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical  course: The caller's brother was tested covid but he already was vaccinated 2 times plus 1 booster. She would want to know if her brother would still  get COVID-19 vaccine once she takes him to the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna Arm -  Red rash, raised area, warm to touch and itchy.  I used Caladryl lotion and took Benedryl at night. It is better today.
My wife started to fall and pass out had no strength to get up this happened two to three times cinch she got the shot the last time she past out in the shower and i rushed her to hospital were she pasted away from blood clots to the right side of the neck and stated bleed on the brain
moderna booster dose 0.5ml was given instead of 0.25ml. no adverse effect noted
sore arm; low iron; pediatric crohns diasease flares with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4512191-00.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Batch/Lot number: unknown), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2022, outcome "unknown", described as "pediatric crohns diasease flares with Humira"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm"; BLIROOD ON DECREASED (non-serious), outcome "unknown", described as "low iron". The patient underwent the following laboratory tests and procedures: Blood iron: Low. The action taken for adalimumab was unknown.  The reporter considered "pediatric crohns diasease flares with humira" and "low iron" not related to BNT162b2. The reporter considered "sore arm" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event VACCINATION SITE PAIN cannot be completely ruled out given the known suspect drug profile and/or implied temporal association.  The other events  are considered most likely associated with intercurrent or underlying medical conditions, appear unrelated to the suspect drug.