chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began to have "looser than usual" stool during the first few days after administration of ROTATEQ dose #3. Seven days after administration, stool frequency increased to 4 per day and was liquid. Symptoms finally resolved 3 weeks later.
RASH/SEVERE RASH ON FACE NECK AND ARMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 12-APR-2021, the subject experienced rash/severe rash on face neck and arms. Treatment medications (dates unspecified) included: cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/severe rash on face neck and arms. This report was non-serious.
Allergic reation, hives, alot of itching all over my body and the site of the injection.
soreness at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection). On 29-Mar-2021, VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Stood up and walked a few feet away following vaccination, then passed out and hit head on door frame.
- NUMEROUS JOINT PAIN IN SHOULDERS, HIPS, BACK - DIZZINESS - LETHARGIC FOR 3 DAYS
This spontaneous report was received from a physician and refers to a 23 month old female patient. The patient had none medical history, concurrent conditions or drug reactions/allergies. There were no significant concomitant medications. On 20-APR-2016, the patient was vaccinated with VARIVAX, (dose, frequency, lot # and expiration date were not reported) subcutaneously for preventive health maintenance.    Around 03-MAR-2017, the patient developed a rash and that day, she was hospitalized. During the hospitalization, the patient was treated with acyclovir 200 mg four times a day and with an antibiotic, cephalexin (KEFLEX) 100 mg, four times a day. Additionally, a punch biopsy of the skin where the rash was located was performed and the result was infected keratinocytes, positive Varicella-Zoster Virus (VZV), herpetic infection (varicella zoster virus infection). The patient was discharged on 08-MAR-2017. The outcome of rash and varicella zoster virus infection was reported as recovering.  The causality between the events and VARIVAX was not provided. Additional information has been requested.
"Right foot: 2nd toe swelling and redness,.swelling of the 4th toe of the left foot There was minimal pain" Narrative: As reported by Employee on 6/22/2021:******************************************** "Right foot: 2nd toe swelling and redness started day 5 and slowly improved over several weeks. Took about 3 moths to resolve. There was a day when I also noticed swelling of the 4th tow of the left foot. There was minimal pain."
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were unknown. On unknown dates in June 2015 the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010535, expiration date 27-AUG-2016, dose and route   were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
FEVER; CHILLS; HEADACHE; NASAL DRAINAGE; DECREASED HEARING; BLURRED VISION; LIGHT HEADED; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced nasal drainage. On MAR-2021, the subject experienced decreased hearing. On MAR-2021, the subject experienced blurred vision. On MAR-2021, the subject experienced light headed. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, light headed, blurred vision, and decreased hearing, and had not recovered from fever, headache, and nasal drainage. This report was non-serious.
Went to bed on 2/26/2020 but could not go to sleep, even after taking sleep aid. Around 1:00am on 2/27/2020 heart began pounding in my head, rapid heart rate. Still not sleeping. Around 4PM I got out of bed and measured my heart rate at 100bpm. Around 5pm my wife measured my heart rate at 100bpm. My resting heart rate is 55-60. When I got up at 1am I began shaking quite hard with the chills. I took 400mg of ibuprofen. Shaking stopped 5-10 min after getting back into bed. I noticed that I had body aches and my injection site shoulder was sore. At 1am I noticed it was taking a little extra effort to swallow. At 4am my tongue felt enlarged, but my wife indicated it did not look enlarged to her. My mouth was very try and due to the dryness it was more dificult to speak. At 5pm I phoned my insurance carrier's Ask-A-Nurse number. The nurse asked me lots of questions and in the end felt I was not in immediate risk but should go to my PCP within 4 hours. Temperature was 99.2 By 6 or 7am by heart rate had dropped down to 80-85. I was able to schedule an appointment on 2/27/2020 with my PCP at 11am. BP and oxygen was normal. Heart rate was 88.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 013F21A, 016B21A and 029A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LATANOPROST for Ocular discomfort.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 04-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 16-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2022, SARS-CoV-1 test: Positive.         No treatment information was reported.   This case was linked to MOD-2023-747291 (Patient Link).
Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2021. On 11-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 11-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications include Prenatal medicines.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs and pregnancy outcome.
By that evening I felt lethargic, had chills with a temp. of 100.5 and a sore arm.  I took one tylenol and one ibuprophen and went to bed. During the night I woke up with generalized aches and severe pain in my lumbar spine.  Again waking up with aches and severe pain in my shoulder joint (not the shot arm).  And again woke up with severe spinal neck pain, generalized achiness and headache.  During the night the  achiness was so severe that I could hardly turn over in bed.  The next morning my temp was 100.8 I took 1 tylenol  and 2 ibuprophen. I was so tired and weak I just sat there in the house.   By the second morning I had recovered from the side effects.  Really, the booster side effects were just like the way I felt when I was sick covid breakthrough infection.   In my entire life I have never had such a reaction or any reaction to any vaccination for any disease ever.
Ductal carcinoma in situ left breast. Detected on screening/diagnostic mammogram. Grade 3. Underwent lumpectomy and radiation. Currently on tamoxifen.
pt recvd vax & had sz x 1 mo; t 105; pt under care of MD; dx probably encephalitis;
Initial pain localized at injection site over time the pain intensified and spread to shoulder and abdomen.  Pain was intense with expansion of lungs and rib cage.  Pain continued at the intense stage for several days and then slowly decreased to present day (12/5/16) and patient is now experiencing mild pain and discomfort at the injection site.
56 year old female had second dose of moderna vaccine, became dizzy and diaphoretic after administration. pt monitored for 30 mins. symptoms did not improved, patient appeared pale, VS 154/77 , Hr 62 95 RA Hr 65. pt report increase dizziness . EMS called , patient to be transferred to Er
Patient reports itching at site of injection during the night of 8/26/26. Woke up at 6 a.m. on 8/27/13 and noted site of injection down to elbow as red, hot, swollen, burning.  Saw school nurse 8/27/2013. Has been using hydrocortisone cream patient has not seen Dr. Says since using cream that swelling has decreased some.
First moderna. Never, ever, been so sick in my life. Felt like I was drying. Pain entire body 10/10. Felt like body frozen in block of ice. Couldn't breathe. Family wanted to call 911, but body in so much pain, couldn't imagine someone touching or moving me.
EXTREME ARM PAIN. DOCTOR DIAGNOSED IT AS TENDONITIS. ADMINISTERED A CORTISONE INJECTION IN EARLY NOVEMBER, 2013. HE ADVISED ME THAT IT SHOULD GET BETTER. NEVER GOT BETTER. WENT BACK TO IN LATE NOVEMBER, 2013. HE RECOMMENDED PHYSICAL THERAPY. AS OF TODAY, MY ARM IS NOT BETTER AND HURTS ON A DAILY BASIS. I CAN'T USE IT NORMALLY OR SLEEP ON IT.
Bell's palsy; significant right-sided facial droop persisted 6 days since its onset.
Patient received the 2nd dose of the 5-11 Pfizer-BioNTech and it was over diluted.  Physician was immediately notified by the nurse.  Risk Management was notified. It was recommended that the patient be revaccinated.  Family was notified.
Period was two weeks late. When it did happen it was very heavy with significant cramping and bloating, much more than normal. Since then I?ve had left armpit and left breast soreness, with increased soreness in both breasts before and during every period, more than normal. Had a mammogram in July, 2021 which was negative.
Patient presented to emergency department on 9/2/2021 with shortness of breath with symptoms starting approximately 10 days ago. He also admits to cough, nausea, and loss of taste and smell. He stated he had tested positive for COVID-19. He had increased his home oxygen from 3L to 5L at presentation.  He was admitted for further management. He was treated with dexamethasone, remdesivir and continued supplemental oxygen at 3L. His symptoms improved and he was discharged home on 9/7/2021.
Pain in legs; Pain behind ears; Cough; Arm became red and inflamed; Arm became red and inflamed; Head ache; Fatigue; Trouble breathing; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears) and COUGH (Cough) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS. Concomitant products included MONTELUKAST and DUPILUMAB (DUPIXENT) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Trouble breathing) and CHEST PAIN (Chest pain) was resolving and PAIN IN EXTREMITY (Pain in legs), EAR PAIN (Pain behind ears), COUGH (Cough), VACCINATION SITE ERYTHEMA (Arm became red and inflamed), VACCINATION SITE SWELLING (Arm became red and inflamed), HEADACHE (Head ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: unknown Unknown/ Pending.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested for COVID-19 (result pending). Treatment medications included antihistaminic and ibuprofen.
Allergic reaction to left thigh. Thigh was red, hot and hard. Hurt pt to walk. Received a decadion 4mg injection, Zyrtec rx and bactroloon cream.
Severe redness and swelling at injection site. Roughly 3? in diameter. Extreme soreness, very painful to any contact
patient vomitted after about 5-10min of vaccination. patient's mother said he vomits even when he goes to do the blood work.
Pt presented to ER 11/17/11 0009 by EMS with T 102.9 (R) with new onset febrile seizure Mtr. had given TYLENOL per hx Mtr in after hr T 100 - due to abnormal labs, elevated B/P, seizure hx, transported to another hospital 0200.
Child noticed rash on right shoulder, right face and neck.  Looks like flee bites.  Rash started several hours after vaccination. Family physician notified and will follow up with the child. Child is feeling fine. No fever or local reaction at injection site per school health nurse.  Mother says rash started at injection site. Both school health nurse and mother say it looks like flea bites.
Skin sensitivity; Chills; Arm pain; Achiness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "Achiness"; PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "recovering", described as "Arm pain"; CHILLS (non-serious) with onset 08Oct2023, outcome "recovering"; HYPERAESTHESIA (non-serious) with onset 08Oct2023, outcome "recovering", described as "Skin sensitivity". Therapeutic measures were not taken as a result of hyperaesthesia, chills, pain in extremity, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RN administered Moderna 0.5ml vaccine IM into patient left deltoid at 8:00am. At 8:20am, patient reported he had a 'sharp pain going down the left side of his neck into his left pain.' At 08:30am, pt stated that the root of his mouth was tingling and this tongue. Patient was able to speak full sentences and denied any shortness of breath. Provider evaluated patient, due to tingling in root of mouth and tongue, provider verbalized to administered an EPI pen. EPI pen was administered at 08:43am and EMS was called due to office policy. Patient was transported via EMS to hospital.
PHARMACIST INTERN GAVE 0.3ML PFIZER INSTEAD OF MODERNA.
Several hours after a flu and pneumonia shot the patient required an ER visit for arm pain and impaired movement.
COVID-19 Arm: redness around injection site, area large as tennis ball and warm to the touch, slight swelling (lump on arm at injection site). Also experienced mild sweating like in a fever.
Pt claims that a rash formed roughly 12 hours after first dose of the Pfizer Covid-19 Vaccine. Started on his back/abdomen area and moved up both arms. Itchy rash with no throat swelling, dizziness, etc.
Patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose; Patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age 68 (unit: unknown) received second dse of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. The historical vaccine included 1st dose of BNT162B2. On an unspecified date, It was reported that, "patient has been experiencing soft and mushy stool for 8 days after getting the 2nd dose". Patient wants to know how soon after the 2nd dose will she be at 100 percent immunity. The outcome of the event was unknown.  Information on lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Right leg twitch; Right leg numbness; Left side facial twitch; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Left side facial twitch), MUSCLE TWITCHING (Right leg twitch) and HYPOAESTHESIA (Right leg numbness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced MUSCLE TWITCHING (Left side facial twitch). On 08-May-2021, the patient experienced MUSCLE TWITCHING (Right leg twitch) and HYPOAESTHESIA (Right leg numbness). On 08-May-2021, HYPOAESTHESIA (Right leg numbness) had resolved. At the time of the report, MUSCLE TWITCHING (Left side facial twitch) and MUSCLE TWITCHING (Right leg twitch) outcome was unknown.            The patient called with complains of possible delayed symptoms following their second vaccine dose. On an estimated date 30-Apr-2021, the patient developed a left side facial twitch, twitch close to nose going to cheek that persists most of the day as well as minor right leg twitching that began as numbness on 8-May-2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-114625 (Patient Link).
Dizzy spells, vertigo. Feeling like I was going to pass out. Intense pressure in head, ears and sinuses. Tingling in arms, hands and feet. Has not subsided 3 weeks after first dose.
There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  There was an excursion from freezer on 01 Oct 2021.  Used the excursion tool but there was no option for the excursion. The tool only gave options for excursions above one hour and not less than, so  does not know how to do the analysis. The minimum temperature reached was minus 4.2-degree Fahrenheit and maximum was 5.2-degree Fahrenheit. Excursion duration was 6 minutes. Vials were returned to freezer. All the vials were thawed before administration and there was no color change or anything abnormal. 10 vials were impacted. There  another excursion happened on September.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received included reporter, patient and product details updated.
This spontaneous report was received from a pharmacy intern refers to an approximately 70-year-old female patient. On 14-MAY-2012 the patient was vaccinated with ZOSTAVAX lot # (672605/1658AA), expiration date 21-JAN-2013 subcutaneously 0.65 milliliters (ml). No concomitant medications were reported. The patient came into the pharmacy because of itchy, painful bumps on the scalp on an unknown date in September 2012 (last week). The patient called the pharmacy on 17-SEP-2012 to report she was diagnosed with shingles. The reported event did not resolve at the time of this report. The patient sought medical attention for the event. She visited the pharmacy and the physician office. Additional information has been requested.