chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness in ear, right jaw, and lower lip; numbness lip; This case was reported by a consumer via other manufacturer and described the occurrence of numbness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastroesophageal reflux disease, colitis and bleeding gastric ulcer. Concurrent medical conditions included her2 positive breast cancer. Concomitant products included trastuzumab emtansine (Kadcyla).   On 7th January 2021, the patient received the 1st dose of Shingrix. On 7th January 2021, less than a day after receiving Shingrix, the patient experienced numbness and numb lips. On an unknown date, the outcome of the numbness and numb lips were recovering/resolving.   It was unknown if the reporter considered the numbness and numb lips to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and experienced numbness in right ear, right jaw and right lower lip on the same day. Consent to follow up was not possible as no contact details were available.
Patient felt faint was sweating and pale.  Her blood pressure was fine.  She threw up and then immediately began to feel better. The patient never fainted.
Today she had a fever of 102.3/ has been about 101.3 most of the day; Body aches; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient), reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 03Feb2021, she had a fever of 102.3. She took some Tylenol and it went away but came back and had been about 101.3 most of the day. She also had body aches on 03Feb2021. The outcome of fever was not recovered; for body aches was unknown.  Information on the Lot/Batch Number has been requested.
Extreme diahrrea; Inability to control bowels; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 04Mar2021 at 12:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and vasoconstrictors. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 17:00, the patient experienced extreme diahrrea and inability to control bowels. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme diahrrea and inability to control bowels were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt nauseated; Headache; Pain visible swelling in right hand; Swelling in right hand; Joint swelling in left knee; Pain in left knee; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 14Mar2021 16:00 (at the age of 45-year-old) (Lot Number: EN6208) as dose 1, single for COVID-19 immunization, The patient was not pregnant at the time of vaccination. Medical history included Bechet's disease, Ehlers Danlos syndrome, chronic migraine, celiac disease, and asthma. Concomitant medication(s) included apermilast (OTEZLA), meloxicam (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID), all taken for an unspecified indication, start and stop dates were not reported. The patient previously received pneumococcal vaccine polysacch (PNEUMOVAX VACCIN) on an unknown date for an unknown indication and experienced serious adverse reactions including prolonged high fever and erythema nodosum. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 19:00, the patient experienced visible joint swelling and pain in the left knee with no injury. The patient reported that symptoms had lessened since 14Mar2021. On 15Mar2021, the patient woke up at 03:00 due to pain and visible swelling in the right hand. The left knee and right hand had continued swelling periodically during that time, usually in the late afternoon-evening. On 17Mar2021, for three days following the first dose, the patient felt nauseated and had a headache that felt different from usual migraines. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of felt nauseated, headache, joint swelling in left knee, pain in left knee, pain visible swelling in right hand, and swelling in right hand was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in the freezer and one to two vials were taken out and placed in fridge each day  as needed. No concomitant and treatment drugs were reported.
Patient developed pneumonia as well as having Covid.  Records taken from hospital.  Cough, Shortness of breath.
12:40p: sudden queasy and woozy feeling that went away entirely after a couple minutes 8-9p: brain fog, loss of alertness, dazed feeling 10p: diarrhea, followed by extreme difficulty staying awake & headache 10:30p: itchy eyes & throat, swelling in the face, complete nasal block in both nostrils, and wheezing -Immediately applied cold compress on face, took albuterol (several puffs), Zyrtec, and Pepcid. 11p: Eye itching, facial swelling, nasal block, and wheezing completely resolved All other symptoms resolved, excluding worsened hypersomnia
Combined initial consumer report received on 12 Jan 2010: This patient who was 2 year old received Novartis H1N1 (Batch number 102149P1) intramuscular dose on 07 Jan 2010. The dose was the second in the H1N1 vaccination series. Timing of the vaccination was unavailable. Outcome was not provided. No further information including the first vaccination time, was not available.
Given HIB, Varicella on 11/10/04 in right thigh. Swelling began that day, vomiting, fever up to 103. Will not walk on that leg. It was given at health department. Will not bear weight on right leg.
Had extreme fatigue, muscle (mostly back) pain, sinus congestion/clogged ears, shooting chest pain (not in the center of chest), symptoms of acid reflux, possible low blood pressure. Fatigue and low blood pressure symptoms subsided after a couple of days, but the other symptoms still persist.  I have had extensive tests on my heart in the past and heart issues have been ruled out prior to this shot.
1st dose on 04Oct, 2nd on 12Oct; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 25-year-old male patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B ADULT).   On 12th October 2022, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: The operations specialist reported that the patient received second dose of Engerix B on 12th October 2022.  The reporter consented to follow up by mail. Additional Supportive Information: The patient received a dose of Engerix B adult earlier than the recommended interval, which led to shortening of vaccination schedule.
itching at the injection sight.; three red sores on her arm near the injection sight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection sight.) and VACCINATION SITE ERYTHEMA (three red sores on her arm near the injection sight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
none, pt was given the bivalent instead of the 2nd dose of the primary Pfizer vaccine.
Diagnosed as Covid-19 positive 04Apr2021; Diagnosed as Covid-19 positive 04Apr2021; This is a spontaneous report from a contactable consumer reporting for a patient (grand mother). A 95-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination 95 years old. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient was diagnosed with covid-19 positive on 04apr2021. She is currently in the ICU (Apr2021) and end of life planning is currently under discussion. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Apr2021. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted 2-3 minutes after getting vaccinated with the first dose of moderna covid vaccine. She recovered immediately but had her front teeth bent from fallling forward. Pt was talking as usual after regaining consiousness and her bp was within normal range.
Started with itching, progressed to rash then welts noted initially over lower back, side to side then top to bottom.  Over the next 48 hrs progressed to entire torso(front, back, and sides) neck, arms, and legs to knees.  Severe itching entire body at sites of rash.
Pt recvd series of 3 Engerix-B vax (0, 1, 6 months schedule) given Deltoid; Testing about 2mo p/3rd dose indicated titer borderline (low titer of HBsAb detected), 2 boosters given 1 mo apart.
pt recv vax 7/7/98 & 2 days later pt devel an inj site rxn characterized by a 3mm area of redness & induration;
Patient got shaky at first, then passed out completely at about 2 min post injection. Patient was passed out for about 1 to 1.5 min. Patient was pale, sweaty, teary eyed, semi lucid. Gave patient cool compresses, spoke with her continually to help regain consciousness, Sent for her husband. She claimed injection  could be felt going in. Patient stayed in IMZ booth for about 30 minutes, She left looking much better with her husband ,guiding her out to their car.. Patient seems to have recovered pretty well
This spontaneous report as received from a Licensed Visiting Nurse (L.V.N.) refers to a 50 year old female patient with allergies of skin rash/hives to SIMCOR, hypercholesterolemia and being a smoker. On 22-APR-2013 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX lot # J000427 (Exp: 10-APR-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included LEXAPRO, NASONEX and VYTORIN. On 23-APR-2013, the nurse reported that the patient developed redness, swelling, warmth and pain of her left arm, at the injection site, after receiving ZOSTAVAX. The affected area of her left arm had increased in the past two days, and on 25-APR-2013 the area affected was from her shoulder down to her elbow. The patient sought medical attention by calling to physician's office. Treatment of BENADRYL and ADVIL or ALEVE was given. None lab diagnostics studies were performed. At the reporting time, the patient was not recovered. Additional information has been requested.
FEVER OF 101.6 AT 430 AM THE NEXT MORNING ALONG WITH SEVERE BODY ACHES AND A HEADACHE. RESOLVED BY 8AM NEXT DAY. LASTED ABOUT 27 HRS
Information has been received from a registered nurse concerning a female who in approximately August 2010, was vaccinated with a dose of GARDASIL (LOT# not reported). "Yesterday", on approximately 09-AUG-2010 the patient experienced fainted. Unspecified medical attention was sought. At this time of reporting, the patient's outcome was unknown. Follow-up information has been received from the registered nurse who reported that the 17 year old female student with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 09-AUG-2010 was vaccinated intramuscularly at right deltoid with the first dose of GARDASIL (LOT# 662304/1013Y). On the same day at 10:00 AM, the patient fainted after receiving injection. The patient recovered on the same day. No further information is available.
COVID-Arm; The injection site is hot; The injection site is painful; The injection site is swelled/The injection site is round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Gastrointestinal disorder.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included blood pressure and stomach medicines.
A day after had severe chills, body aches all over, fatigue, headaches, nausea, vomiting. Two days ago started having bumps on skin on the arms, back, and legs, and few on belly with red dots. It itches not a lot. I want to know if it?s ok to take 2nd dose of Pfizer vaccine.
Information has been received from the mother of a male child who on 7/25/00 was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient experienced a light case of chicken pox live. Subsequently the pt experienced a light case of chickenpox with 100 lesions or a severe case of chickenpox (one sibling developed a severe case, and one developed a light case); the reporter did not specify which sibling developed which case. It was noted the pt had been exposed to varicella approximately 24 months after vaccination with no problems. the pt's sibling had a similar reaction following vaccination with varicella virus vaccine live (WAES00090699)
Approx 12 days post vaccine administration, some dizziness, intermittent pain around ears and a major increase in the volume of tinnitus (2-3x what I experienced previously).  No treatment to date, just happened last couple of days. NOTE: I had a surgical procedure (to fix a hiatal hernia, laparoscopic procedure) on Monday 03/29.  Outpatient procedure but was under general anesthesia.  This procedure was done in a hospital 5 days post the first vaccine dose.
On 5/13/2008, pt was administered #4 Anthrax by LPN. Pt reported to immunization clinic on 5/15/08 at 1115 with a large local reaction tot he Anthrax injection (LA). Administered 25mg of oral Benadryl, applied ice pack for 30 minutes.
Swollen painful lymph nodes (3) left axillary, tylenol/ibuprofen
severe itching all over body-on arms, neck & face;went to MD given meds;
This spontaneous report has been received from an office manager, via a company representative, referring to a 4 years old male patient. Information about the patient's pertinent medical history, concomitant medications, drug reactions and allergies was unknown by the reporter. On 15-JUL-2018, the patient was vaccinated with VARIVAX and M-M-R II for prevention (dose numbers and frequencies were not provided; routes and anatomical locations of administration, lot numbers and expiration dates were unknown by the reporter). On 16-JUL-2018, the patient developed swelling of an unspecified leg, which continued until 17-JUL-2018, when the patient visited the physician for medical attention and was diagnosed with cellulitis. The physician prescribed KEFLEX as treatment. It was unknown by the reporter if any laboratory or other diagnostic studies were performed to the patient. By reporting time, the patient was recovering from cellulitis. The reporter did not provide the causality assessment for cellulitis occurrence in regards with VARIVAX and M-M-R II vaccination. Upon internal review, cellulitis was determined to be a medically significant event.
Extreme edema in legs, bilateral. Subsequent sonogram showed greatly enlarged saphenous veins. I did not have any significant edema after quad bypass/myocardial infarction in December 2017, and the ONLY new variable was the vaccine.  The enlarged saphenous veins are causing cramping in legs and I need surgery on those veins with Dr.
No treatment needed at this time, reporting that patient is 17 years of age and not 18. She was given a EUA.  I did inform her of other vaccines due to risks of blood clotting. She said,  "she would prefer Johnson & Johnson, because they were going out of state and did not have enough time for the other vaccines." Since this event, we have implemented safety measures and a more through verification process.
Pt experienced a high fever, lethargy, irritability for 3-4 days. Seizure on the 2nd day of fever. Symptoms started on 3/22/00. Pt was back to normal on 3/27/00.
administration to patient under the age of 4 years old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   On 12th October 2021, the patient received Kinrix (intramuscular). On 12th October 2021, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were reported as follows: The health care professional reported the administration of Kinrix to a patient under the age of 4 years old, which led to inappropriate age at vaccine administration. The health care professional stated that the formulation was a vial and batch number confirms this. The reporter consented to follow-up.
Hives, blisters, swelling, and itching, pain covering both feet, legs  The problem is ongoing and has not resolved itself
date of death 05-03-22   His PUI forms note he was asx for covid at time of his + test  07-24-2021
Localized swelling and redness. To right arm, ice, Benadryl.
Patient is complaining of dizziness, headache, cold sweats and nausea 3 days following vaccination.
Patient received COVID Pfizer vaccines during pregnancy (03/05/2021, 03/26/2021 and 10/05/2021). She delivered a baby girl on 10/29/2021 at approximately 38 weeks gestation. Baby was diagnosed with a Hemangioma on right upper arm above elbow, dxd by pediatrician on 12/17/21. All three in same location, size is 2 mL, 5 mL, 10 mL. Per mob ped said it will decrease with time, should resolve by age 6. No attribution specified.