chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sick; had some of the typical symptoms like achy; weak; just threw up; it developed into a horrible, very severe case of shingles/still has shingles; did not feel very well/was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Had received the shingles vaccine). Concurrent medical conditions included AFib (She takes a blood thinner).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) (seriousness criterion medically significant) and MALAISE (did not feel very well/was not feeling well). On an unknown date, the patient experienced ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up). At the time of the report, HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles), MALAISE (did not feel very well/was not feeling well), ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up) had not resolved.            The patient was taken twice to the emergency room because she developed very severe shingles. The reporter got a message that the patient threw up and patient was taken to the hospital. treatment for the events included antibiotic and pain medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Red, swollen, hot area where vaccine was given. Left outer arm, SQ. Pt also has soreness in her left shoulder and neck. Started 10/11/16 at night. Reported 10/14/16.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain/experienced pain more in that area, with outcome of unknown. Additional information: Verbatim/Event description: 1st dose vaccine yesterday (Mar 18, 2021). When questioned if she had any shots for the last 3 weeks and she said "no." She remembered she had an Epidural shot and now experiences pain more in that area. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
swelling,mass lump  pain interfering with activities referred to orthopedic and physical therapy
tested positive; exposed to covid; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to covid) and COVID-19 (tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to covid). On 22-Mar-2021, the patient experienced COVID-19 (tested positive). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to covid) and COVID-19 (tested positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
ADVERSE EVENT: LIGHTHEADED, DIZZY & HOT. TREATMENT: GAVE WATER, HAD PATIENT SIT DOWN, TOOK VITAL SIGNS. PATIENT REFUSED ICE PACK. OUTCOME: PATIENT REFUSED TO HAVE MEDICAL TREATMENT DUE TO NO INSURANCE. PATIENT IS AWAITING TRANSPORTATION HOME FROM FAMILY.
Swelling at the site of injection that extends almost to the elbow. Redness, itching and very painful. Patient advised to take BENADRYL and TYLENOL and report prognosis the next day.
Redness, swelling, pain, and bruising around the injection site accompanied by headache and nausea.  Severe symptoms did not set in until nearly 24 hours after injection and then lasted roughly 48 hours.
Swelling, Heat, redness from shoulder to elbow. Redness and puffiness down in to axillary area. Treated with Ibuprofen and Ice.
Received shot to right shoulder.  It was painful and the pain has never left. Pain continued to increase until right arm is painful and can no longer be used for every day activities.
Received the vaccine, came home and both of her cheeks were bright well, as well as her forehead.  Her tongue is real sore and feels as if she burnt her tongue.  The top of her gums in her mouth were all red and hurting as well.  She got real nervous and antsy.  She had this for a few days, then about 4 days later called the doctor and went to the clinic and she has canker sores in her mouth.  They told her they would probably go away in a week or two, and it was 2 weeks  yesterday from her vaccine.  They have gotten better but they are not totally gone, and her mouth still does not feel right, but does not feel as bad as it did, does not feel normal.  The tip still feels like she burnt it.  He wants to check her again around the 17th, did not give her any treatment for it.  The pharmacy wants her to recheck with her doctor in regard to getting the 2nd vaccine or not, or to get it at a doctors office to watch her more closely.
He just got the shot, and he got sick a month later; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He just got the shot, and he got sick a month later) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ILLNESS (He just got the shot, and he got sick a month later). At the time of the report, ILLNESS (He just got the shot, and he got sick a month later) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that patient got sick first, did had his COVID-shot a month ago. Believe it was Moderna. He just got the shot, and he got sick a month later, and then all of his entire family got it.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747570 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747570:Case for neighbors
This retrospective pregnancy case was reported in a literature article and described the occurrence of neonatal hypoxia in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate was diagnosed with neonatal hypoxia. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of neonatal hypoxia was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the neonatal hypoxia may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of neonatal hypoxia in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient experienced neonatal hypoxia. This case has been considered as serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between neonatal hypoxia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
pt cranky on 22FEB95;on 23FEB95 woke up 8AM;mom noticed rt leg swollen & warm;had temp of 101R;does not want leg touched 23FEB95;
TD given 05/11/2001 approx. 3p.m. adm. with biojector "Burned"  as soon as administered and continued on.  Bruised immediatly redness and aching Sunday.  Fingers began going numb Sunday.  Went to ER Monday am (Headache after injection intermittent now)
Shortage of breath; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26May2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no known allergies to food, medication or other products. Concomitant medications were not reported. 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 14Apr2021, the patient experienced shortage of breath. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shortage of breath and included treatment with unspecified medications from an unspecified date in 2021 and unknown if ongoing. The clinical outcome of the event shortage of breath was not resolved at the time of this report.  Information on lot/batch number has been requested.
severe induration and erythema lasting 3 weeks.  then at week 2 became infected and required treatment for cellulitis
Information has been received from a consumer concerning her 3 year old son with allergies to certain epilepsy medication (unspecified which ones) who was vaccinated with the 2nd dose of MMR II on an unspecified date.  He received his 1st dose of MMR II in a foreign country.  Concomitant therapy included some unspecified medications.  Subsequently, after the 2nd dose, the patient started having epileptic episodes.  The now 10 year old patient was currently on a surgery list for epilepsy.  He did not recover at the time of reporting.  The patient sought unspecified medical attention.  Upon internal review, epileptic episodes was determined to be an other important medical event.  This is one of several reports received from the same source.  No further information is available.
Patient was sitting for his 15 minutes. At about 5 minutes after his vaccine he passed out and fell off his chair to the floor. The Pharmacy intern noticed that the color of his skin was like a purple and he was passed out. When she started to approach him he started slowly moving his head and adjusting his eyes. He said he felt really dizzy and we had him lay down. He was very sweaty and was shaking a little bit. I took his blood pressure at 11:53 and it was approximately 124/93. He was responsive but feeling dizzy and warm and I stayed with him until the paramedics arrived at about 11:54
after few hours, I started feeling dizzy; shaking; started having diarrhea; lost control of my body; wet my pants; I couldn't control my bladder; felt like this all day Friday; chills; threw up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body) and URINARY INCONTINENCE (wet my pants) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up). At the time of the report, DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included drank plenty of water
It was reported that a pt who rec'd a TD adult vaccination on 4/4/00. Reportedly on 4/7/00, the pt developed a local reaction of redness, warmth and induration.
Swollen lymph glands in throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph glands in throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph glands in throat). At the time of the report, LYMPHADENOPATHY (Swollen lymph glands in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information reported.
Approximately 7 days following the vaccine pt. called and complained of transient fever (100, but only in the evenings) as well as some weakness.  He decided to wait a few more days and see his physician to rule-out another cause.  He went to his primary care physician and the physician did a CBC (which was normal) and thought it may be due to the vaccine, but thought it may be Lyme Disease and put him on Doxycycline.  He had no fever at the time of the visit.  Due to continued symptoms, he called our office.  We ordered lab testing, including a CBC, LFT's electrolytes as well as kidney function tests.  He had a minimally elevated Alk phos and BUN, but the remainder of his testing was normal.  He went to see his internist.  He reported that his internist did further testing and it "came back completely normal." but he was still having symptoms.  I tried to return his calls and left messages to call back.
pt recvd vax;5-10mins later,collapsed & was unconscious;1 1/2 hrs later had generalized sz; unresponsiveness;in er;pale,dec tone;dec response;referred to ped neurologist;
No additional AE; VAQTA was in advertently administered past it's expiration date; This spontaneous report was received from a healthcare professional (HCP) and refers to a patient of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient was advertently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot # reported as U013169, expiration date: 07-FEB-2023 (route of administration was not provided), administered for prophylaxis (expired product administered). No temperature excursions for the product and no symptomatic side effects were reported for the patient. No additional adverse event (AE) was reported.
I had a bad dry cough that would not go away which lasted up to first week of April. On 20MAR2023, I had an eye infection which lasted for 6 or 7 days. I saw the doctor on 14Mar and 30Mar 2023 and prescribed an eye drop. I waited 5 days and was tested negative.
Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired). At the time of the report, DIZZINESS (Laying down and get up, I'll be dizzy for 6 or 7 seconds; 10 seconds in the morning) and FATIGUE (Really tired) outcome was unknown.            No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information include no new information. On 02-Aug-2021: Additional information contains no new information - consent for further follow-up declined. Added second dose details from the initial source document as it was missed in the initial version and action taken was updated.
It was reported that a pt did not respond to the hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) immunization series. The pt had no history of illness or significant medical history. The pt rec'd injections of Twinrix on 2/8/02, 3/12/02, and 8/26/02 (lot#HAB235A4). On 11/25/02, 3 months after the last injection of Twinrix, titers for hepatitis A (NOS), hepatitis B surface antigen, hepatitis B surface antibody, and hepatitis B core antigen were negative.
Awoke on 10/15/2003 with headache and much lower abdominal gas.  Rested the day, approximately 19:00 felt achy without low grade temp.  Awoke Thursday 10/16/2003 with headache gone, fever droke around noon.  MD was notified.  Patient was happy with my concern.
no adverse event; a pediatric vaccine was given to an adult patient; This spontaneous report as received from a licensed practical nurse refers to an adult patient of unknown age and gender. On 06-JUN-2022, the patient was vaccinated with a pediatric dose (0.5 mL) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # W002938 exp date 18-NOV-2023) (route not provided) (incorrect dose administered).
This spontaneous report as received from a healthcare worker refers to unspecified number of patients (no patient names or demographics known). The an unspecified amount of patients might had been administered with a dose of GARDASIL (lot#, dose, route and strength not reported) that were out of temperature range and may of not been supported by Merck's stability data on unspecified date. No adverse effects reported. No product quality compliant (PQC) was reported. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one several reports received from the same source. Additional information has been requested.
Swelling,hives,blisters in mouth, swelling lasted 4 days. I had to take Benadryl for the 4 days
Patient states that after getting vaccine he has crippling pain in his shoulder and can no longer raise his arm.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L208) for COVID-19 vaccination.     The patient's past medical history included Diabetic since an unknown date. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), QUETIAPINE FUMARATE (SEROQUEL), GLUCAGON (BAQSIMI), MODAFINIL, TROSPIUM, CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), GABAPENTIN, HYDROXYZINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), DICYCLOVERINE HYDROCHLORIDE (BENTYL), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Blood glucose decreased: 200 (Inconclusive) sugars were running about 200. On 28-Jan-2021, Blood glucose increased: 300 (Inconclusive) sugars were around 300 and are typically 126.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Fever for 1 day, runny nose for 2 - 3 days, cranky, no cough, no vomiting and diarrhea, good P.D. intake, rash, scattered papules on face, back and abdomen, 2 were slightly vesicular.