chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breaking out with rashes all over my body, keep coming up at different places every day and they are not subsiding, they are not going away; Everything else just feels burn (Unspecified medication), I cant even put lotion on it, it just burn, its like just this scaly nasty rash; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 61-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Right Arm on 08May2021 07:30 (Batch/Lot number was not reported, expiry date: unknown, age at the time of vaccination: 61-year-old) as dose number unknown, single for COVID-19 immunisation. No medical history was reported. No concomitant medications were reported. On unspecified date in May2021 the patient experienced breaking out with rashes all over my body, keep coming up at different places every day and they are not subsiding, they are not going away, and everything else just feels burn (unspecified medication), i cant even put lotion on it, it just burn, its like just this scaly nasty rash. The patient reported that since the patient got the shot, a day later the patient was breaking out with rashes all over there body, and they keep coming up at different places every day and they are not subsiding, they are not going away and they are curious. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. The patient haven't taken any treatment, all patient have done for there rash. They have been putting, and have been trying to put some cream on it because everything else just feels burn (Unspecified medication), the patient can't even put lotion on it, it just burn, it's like just this scaly nasty rash. The patient had not received treatment for all the events. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Metal taste in mouth;  soreness  around injection site;  tired;  headache;  aches all over body for couple hours.
Cluster of two female patients who each developed redness, pain, and "knots" at the injection site following the administration of ADACEL (lot number unknown). Initial report received on 05 August 2010 from a health professional (nurse). Two unidentified post-partum female patients, whose medical histories were not reported, each received a dose of ADACEL (lot number unknown) on an unspecified date. The patients each developed redness, pain, and "knots" at the injection site. Their outcomes were not reported. No other information was provided.
Client received vaccine at 9:40 am lying down because of vasovagal and lightheadedness with previous dose of COVID-19. At 9:43 am, client reported feeling nauseous and lightheaded, so we elevated her legs. At 9:49 am she reported feeling better so she sat up and drank some water. Client felt better at 9:47 am and left.
Pt feeling faint and dizzy. Pt felt nasal congestion Pt felt chest heaviness for a short period of time. Pharmacist tried to get her to lay down with her feet up but pt refused.  Pt was given water and Sprite to drink due to dizziness and feeling "off". Was sitting on a chair for fifteen minutes after vaccination and said she was dizzy and about to fall off the chair. Had the patient sit on the floor. Pt currently awake and talking  fine. No fainting episode of any sort. No s/s of allergic reaction. For treatment pt held cold compress instant packs on neck and wrists.
Nurse injected MENVEO diluent without reconstituting powder first. Only diluent given.
Redness, swelling, induration of left upper arm from lateral elbow to top of shoulder.
This is a spontaneous report from a RN referring to a 58 year old female who received her 1st dose of Lymerix on 4/1/99 and 2nd dose on 5/03/99, respectively. 37 days after 2nd dose, on 6/10/99, and 70 days after 1st dose, the pt reported that she had experienced fatigue and dyspnea. She was seen by a physician, who changed her treatment with atenolol to Norvasc. The most recent information, received on 8/17/99, reports the condition of the pt is recovered.
Heart Stroke; A spontaneous report was received from a consumer concerning a male patient of 76 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced heart stroke.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 18 Feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number: 006M20A) vaccine intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021,patient experienced stroke. The event was also considered to be medically significant.  Treatment for the event included Blood Thinners.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event of heart stroke was considered resolved on 02 Mar 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
pt recv vax 19NOV96 & 29NOV96 pt devel a rash w/50-100 lesions over whole body;it was reported that pt had no known exposure to chickenpox;
Large red lump at injection site. Very hot to touch. Better but still there after 4 days. Very sore elbow near injection site. Off-and-on headaches and stiff neck.
Pt had swelling at injection site that started within 4 hours after injection (at injection site in left deltoid and spread all the way to the elbow). Pt reports the arm was approximately twice the size of normal, red at injection site and had a lump in the injection site (was very painful).  This took 2-3 days to return to normal size, better now. Pt also reports, terrible headaches and fatigue/lethargy for these 3 days, also better now.
2am the night of the vaccine I got a fever, chills, aches and lost my appetite. These mostly resolved Sunday then came back Wednesday and are still around on the following Friday, one week later.
Erythema on right arm - posterior 3 X 5 cm area red, raised, & warm to the touch.
Client developed a reaction to 2nd dose of COVID-19 vaccine.  Client described symptoms as a burning sensation on top of her left hand.  At 8:32am on 6/1/21.  Client refused vital signs.  Ice pack was given.  Client verbalized feeling better.  Client exited the facility at 8:50am.
Developed hot erythematous tender rash on left deltoid area one day after receiving vaccinations.  No fevers, vomiting or seizures.
MODERNA VACCINE GIVEN 1/5/21 AND 2/4/21. PATIENT SEEN AT A HOSPITAL ON 8/8/21 TESTED FOR POSITIVE FOR COVID. PATIENT WAS THEN TRANSFERRED TO A DIFFERENT MEDICAL CENTER ON 8/11/21. DX; COVID PNUEMONIA, PANCYTOPENIA.
Symptoms: Widespread rash, hives, erythema in and around injection site of the L shoulder, upper back, chest and abdomen Treatment: 10/5/2020 = solumedrol 125mg IM, RX= prednisone 20mg BID x 5 days, OTC Claritin 10mg PO Daily, Zantac 150mg PO BID x5days, Benadryl 25-50mg PO BID PRN itching
PATIENT COMPLANED OF LIGHT HEADEDNESS AND THEN PASSED OUT TURNED COMPLETLY PAL ONCE AWAKEN STARTED HYPER VENTELATING AND URINATED ON SEL. AFTER BEING ASSESED BY EMS AND MP HE WAS STILL FEELING DROWSY
Rashes on both arms. Worse rash on left arm, where shot was administered. Rash appeared a few hours after shot and then disappeared. Then reappeared a week later, very itchy and hot. Took Benadryl for a few days until rash went away. Rash continues to reappear and linger.
Unusual menstrural cramps Earlier than expected by about a week, and much stronger than usual.  More and stronger than usual on March 24th as well- a few days earlier than expected. I rarely get strong cramps. I currently have a copper IUD.
About 2 weeks after the vaccine, my knees started feeling tight. I thought it was from exercise, This was in March and I thought it would just go away. In April I started having pain in my knees. In June I went to my primary care doctor who sent me to do an x-ray where they found fluids in my joints. I did physical therapy but got to a point where I could barely walk. In June I went to the doctor and they found inflammation. Since June, they've noticed the inflammation getting worse. I am ANA negative, my blood work is all normal except for my ESR sedimentation rate, inflammation is very high. These both kept going higher every couple of months. I went to a rheumatologist who took the fluid out of my knees. I have been put on Plaquenil for the inflammation for 2 months which did nothing. I am now on methotrexate but have only been on it for 2 days so I cannot draw any conclusions. They are calling it rheumatoid arthritis even though my blood work does not show this. They are treating it as rheumatoid arthritis. This has affected my quality of life as I have had to stop doing a lot of things.
Diarrhea, with stools 4-5 x per day - loose & watery. No fever, vomiting, or weight loss. This started the day after her flu shot and has continued for 3 weeks. Will try LACTINEX, avoiding milk products, & following BRAT diet will order stool studies if diarrhea persists.
Patient reports mild tinnitus starting on 10/15/2020 and lasting through until 10/19/2020.  She also reports mild dizziness on 10/18/2020, which she was not sure due to anxiety or a side effect of the vaccine.
As per mom after getting Prevnar injection child was very fussy and it for several hours then mom noted redness and what looked like hives at the injection site along with hardness. After the child started having blood and mucus in her stools she had that for 1 day now is resolved.
Received first dose from a vial that's been punctured for more than 24hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Received first dose from a vial that's been punctured for more than 24hour) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-090663, US-MODERNATX, INC.-MOD-2021-133697 (E2B Linked Report).; Sender's Comments:  MOD21-090663:Second patient case US-MODERNATX, INC.-MOD-2021-133697:Second patient case
Nurse documented that she gave an Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Yesterday morning, at the time she got up, it was a little swollen. She figured it was because that happened with the first shot but, she did not get any rash the first time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:00 (Lot number: FA7485) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery", start date: Jun2020 (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Jun2020 (ongoing). The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Yesterday morning, at the time she got up, it was a little swollen. She figured it was because that happened with the first shot but, she did not get any rash the first time.". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101225786 same reporter/patient/product, different dose/event.
Pt received vaccine and developed redness with a raised area. Warm to touch. Pt evaluated by MD and advised warm compresses and TYLENOL or ibuprofen for pain.
Gave a Dose of Expired Heplisav-B; Initial Report Received on 12-Oct-2023  A pharmacist reported that a 23-year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  The patient has no allergies.  The patient had no previous reactions to other vaccines.  No relevant concomitant medications were reported.  On 11-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #937780, expiration date: 04-Sep-2023, NDC #43528-003-05) in the left deltoid.  The dose given was expired.  No adverse events were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
The following day after my vaccination, I had a severe headache all over the top of my head and eventually only the left side of my head and face felt intense pain. It felt kind of like a stabbing or shooting pain down into my head. Then I started feeling a lot if pressure and pain in my left eye, eye brow, and the sinus area. I could hardly open my eyes. My left side of my face also tingled with tiny sharp pains or numbness. This pain intensified for about 5 days so I started taking aspirin. It would feel slightly better but then would feel even worse.  I decided to use a netti pot to remove pressure. After about 5 days of using that I started to feel better. I would say I started to feel back to normal two weeks after the shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID from 08Feb2023 to 24Feb2023 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
COVID arm - redness, itchiness, and swelling at injection site that began 8 days after shot. It is still occurring so duration is unknown.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; INSULIN; LANTUS; LIPITOR. The patient received PAXLOVID from 12Sep2022 to 17Sep2022 for the treatment of COVID-19 noted in 2022 (with positive COVID-19 test). Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant and refers to a 4-month-old male patient. The patient had no pertinent medical history and drug reactions or allergies. There was no information about concomitant medications provided. On 11-APR-2018, the patient received the first dose of ROTATEQ administered orally (dose, lot# and expiration date were not provided) as rotavirus prevention. On 12-JUN-2018, the patient was vaccinated with the second dose of ROTATEQ 0.5 ml, administered orally, lot # N013992, expiration date 27-JAN-2019 as rotavirus prevention. On the same date, the patient also received haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (poliovirus vaccine inactivated (unspecified) and PREVNAR 13. On an unknown date in June 2018, the patient developed a rash over his entire body. He came to the physician office on 14-JUN-2018 and was given diphenhydramine hydrochloride (BENADRYL) for treatment. At the time of the reporting the outcome of the event of a rash over his entire body was not recovered (also reported as the patient still has a rash over his entire body, but it is dissipating). The relatedness between the event of rash and ROTATEQ and haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) was not reported.
Received my second done of the Pfizer vaccine on 3/25/2021 and started showing  symptoms of IgA Vasculitis on 4/3/2021, with edema and erythema of the lower extremities. Was hospitalized due to persistent GI disturbances on the 4/8/2021
Within 24 hours pt had fever 104 degrees F and febrile seizure with no found source of fever.
cold sores; sore lymph nodes; chills; Headache; Fever; muscle pain; Felt tired; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (cold sores), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). On 12-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (muscle pain). On an unknown date, the patient experienced ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), CHILLS (chills) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.
Diarrhea, 101° fever, vomiting, redness & swelling at the injection site.
Moderna COVID-19 Vaccine EUA Rash (redness) and itching over approx 2 inch wide by 5 inch high area of my left upper arm. It lasted about 3 days. OTC cortisone cream didn't help much, but OTC diphenhydramine cream did. Used several times a day for at least 2 days.
Patient had no reaction.  Patient received Pfizer for dose 1 and Moderna for dose 2.
Pt. was given Influenza immunization 11-05-07.  Wife states approximately 10 days later, he experienced neck pain, tingling in hands and feet.  Seen at ED, and followed up with Primary care physician.  Treated for muscle strain.  Symptoms worsened, pt became weak and was unable to stand. On 11-22-07 he was sent to hospital by ambulance, transferred to Hospital.  Was placed on ventilator.  Wife states dx: Guillain Barre syndrome.  Pt has had several episodes of pneumonia.  Is currently hospitalized at Hospital and Clinic on the Ventilator unit.  06/16/2008 MR received for DOS 11/22/2007-01/08/2008 with D/C DX: Severe Guillain Barre Syndrome.  Ventilator-assisted pneumonia of the LLL. UTI.  HTN. Respiratory Failure s/p tracheostomy.  Dysphagia s/p PEG tube placement. Neuropathic Pain.  Major depressive episode and anxiety.  Stage II skin breakdown.  Hyperglycemia. Pt presented to ER with 6 day hx of ascending weakness and tingling of the fingers and toes. Unable to ambulate, several recent falls. (+) shortness of breath while walking and talking.  PE (+) for decreased inspiratory effort, tachycardia, lower extremity flaccidity and decreased strength. Reflexes decreased. Pt developed respiratory failure and was intubated and vent dependant. Trach placed on 12/4/07. (+) Autonomic instability with tachycardia and hyper and hypotension. Tx with IVIG with no significant improvement.  Neuropathic pain present.  Pt developed some depression, anxiety, a LLL pneumonia, a stage II ulcer of the R buttocks.  PEG tube place for nutrition. Discharged to a ventilator unit for continued rehab.
4 hours post vaccination developed severe itching, next morning  after shower full body hives back and stomach, under arms, behind knees and full body redness. Saw PMD and they stated to use Benadryl for relief 3 days later. Called dermatology and they gave her cream (trimcinolone acetonide) to help with hives along with allegra and symptoms have resolved after 17 days.
Information was received on 11-JUL-2017 from a company employee who learned of an adverse experience from a female patient approximately "in 16 to 18 years of age range" at an unspecified pharmacy. No medical history or concomitant medications were reported. The patient reported that her arm developed "a lot of soreness" (arm unspecified) after her last dose of GARDASIL (lot, expiration and dose not reported)  that she received from an unspecified physician. It was not specified which dose in the series that she developed the soreness. The patient has recovered from the event. No further details are available. Additional information is not expected. No further details available.
10 days after vaccine.  Injected  arm became itchy and red near injection site.  Hot to touch. Faint red circle.
Sudden sensorineural hearing loss; This is a spontaneous report from a contactable physician. An 84-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine) at the age of 84 years old, via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced sudden sensorineural hearing loss on 13Apr2021. Seriousness criterion was reported as disability. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received high dose prednisone as treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was not resolved.   Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event sudden sensorineural hearing loss and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
erythematous reaction to left deltoid swelling, pain and warmth, tender/firm to touch.