chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I found out I had an arrhythmia from my pacemaker on 04/23/2021.  I was involved in a car accident 04/26/2021 where I spent 28 days in the hospital. During that time they did put me on a heart monitor the 2 1/2 weeks after rehab and I had a heart monitor on for the good portion of my time in the hospital. I talked to my PCP 06/08/2021 and my heart was doing these arrhythmia's all the time. I don't feel them. My doctor didn't see anything unusual with my pacemaker.
Got the second dose of the COVID 19 vaccine. The next morning felt mild to moderate symptoms. Later in the day had more intense symptoms including headache, myalgia, and fatigue (needed to lie down).  Continued  throughout the evening with night sweats. Woke up Sunday morning feeling significantly better  but with persistent mild symptoms.
I woke up morning, with noticeable ringing in my ears. I scheduled a doctor's appt with ENT, took a couple of weeks to get in, ringing continued. He diagnosed it relating to TMJ and he had me go to the dentist for a mouth guard to relieve the TMJ grinding overnight. I did get fitted for the mouth guard. It will be available for me to pick up on Monday, but I'm hoping once I get the mouth guard, I will get some relief from symptoms.
Fever 101 degrees F, nausea, stomach upset, loss of appetite, muscle aches, fever blister. Pt was affected with these reactions the day of vaccination and recovered fully after 5 days. Had no prior reactions to any other/regular flu vaccines.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 32 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, stated that another excursion occurred on 15-Sep-2016. The doses arrived 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Mom noticed a small red area about the size of 50 cent piece on left upper leg.  Child would scratch the area.  Today the red area bigger so brought him for me to see.  Red area about 4 inches in diameter around where immunes administered but not raised.  Mom reports he has been scratching the.  She has not done anything or treated the area.
I couldn't lift a cup of coffee. When I wake up I can hardly move; loss of muscle strength/ It's like I've lost my muscle strength. It's like I've done a heavy workout far beyond the point that I should do one; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I couldn't lift a cup of coffee. When I wake up I can hardly move) and MUSCLE STRENGTH ABNORMAL (loss of muscle strength/ It's like I've lost my muscle strength. It's like I've done a heavy workout far beyond the point that I should do one) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE, RAMIPRIL, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), CHLORPHENAMINE MALEATE, HYDROCODONE BITARTRATE, PHENYLEPHRINE HYDROCHLORIDE (TRIANT-HC) and METHOTREXATE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPOKINESIA (I couldn't lift a cup of coffee. When I wake up I can hardly move) and MUSCLE STRENGTH ABNORMAL (loss of muscle strength/ It's like I've lost my muscle strength. It's like I've done a heavy workout far beyond the point that I should do one). At the time of the report, HYPOKINESIA (I couldn't lift a cup of coffee. When I wake up I can hardly move) and MUSCLE STRENGTH ABNORMAL (loss of muscle strength/ It's like I've lost my muscle strength. It's like I've done a heavy workout far beyond the point that I should do one) had not resolved.            No treatment information was provided.   This case was linked to MOD-2021-075434 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added patient details and concomitant medications. Updated the events outcome.
still have swollen area at the injection site; slight headache; place where she gave me vaccine was swollen; A spontaneous report (United States) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight headache, place where she gave me vaccine was swollen, still have swollen area at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Lot# 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) slight headache. place where she gave me vaccine was swollen. On 5 Mar 2021, the patient experienced the event(s) still have swollen area at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), slight headache, place where she gave me vaccine was swollen,still have swollen area at the injection site was unknown.
chills; The injection site is swollen; I feel a little lousy; get warm; hard; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel a little lousy), FEELING HOT (get warm), VACCINATION SITE INDURATION (hard), CHILLS (chills) and VACCINATION SITE SWELLING (The injection site is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 immunisation.     No medical history was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING ABNORMAL (I feel a little lousy), FEELING HOT (get warm), VACCINATION SITE INDURATION (hard) and VACCINATION SITE SWELLING (The injection site is swollen). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (I feel a little lousy), FEELING HOT (get warm), VACCINATION SITE INDURATION (hard) and CHILLS (chills) had resolved and VACCINATION SITE SWELLING (The injection site is swollen) outcome was unknown.        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 unknown. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. The patient was feeling fine, however, the patient did not feel well after the second injection, had to stay in bed with chills for about three days.    This case was linked to MOD-2021-160993 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021,the events chills and narrative were added.
After both vaccinations, I got nodular episcleritis within 2 days of the vaccines.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Feb2021 at 09:45 (at the age of 65-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 04Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The medical history included Gastroesophageal reflux disease (GERD). 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. The concomitant medications included pravastatin (MANUFACTURER UNKNOWN) and fish oil(MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. On 06Feb2021, within 2 days of the vaccine the patient experienced nodular episcleritis. The event happened after both vaccinations. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the reported event and included treatment with antibiotic eye drop(unspecified) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nodular episcleritis was resolving at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Scratchy throat. Sore throat. Tightness of chest. Labored respirations,  elevated temp.
Pneumovax shot 10/6/05 left deltoid next day noted pain and swelling left upper arm. Went to ER treated with antibiotics.
Got one dose in 2020, now wants another dose; This case was reported by a other health professional via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that a patient got one dose of Shingrix in 2020 and was back at the time of reporting for another dose, asked if the patient required a 3rd dose in the 2-6 months time frame. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination.
Information has been received from a registered nurse concerning a 4 year old male patient who in January 2001 was vaccinated with a first (lot # 631778/1353J) and second (lot # 636568/0925K) dose of varicella virus vaccine live. On approximately 5/9/04, the patient experienced an outbreak of chicken pox. At the time of the report, the patient had not been seen by the physician and no treatment was ordered. There was no product quality complaint involved. The nurse also reported that the patient's older brother (WAES0405USA01259) also experienced chicken pox following exposure to varicella virus vaccine live. Additional information has been requested.
Patient reported redness and swelling at injection site plus swelling of the arm.  She also experiences some vertigo for a number of days which started a couple days after receiving the vaccine.
Sinus congestion (couldn't breath through nose), bad headache and achy, vomiting, swelling, feels like chemicals coming from my skin.
diarrhea; nausea; tired; lower back pain as if she had back labor it's so sore; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302), via an unspecified route of administration on 05Feb2021 at 11:45 at single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 05Feb2021 at 14:00, a few hours after getting the vaccine, the patient experienced diarrhea, nausea, tired, and lower back pain as if she had back labor it's so sore. The patient did not receive any treatment for the reported events. The patient underwent lab test which included saliva test with pending results on 19Feb2021. The outcome of the events was not recovered. The events were considered non-serious.
SWELLING IN CHIN AREA WHICH MOVED ABOVE THE EYE; ITCHING; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 administration not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 12-APR-2021, the subject experienced swelling in chin area which moved above the eye. On 12-APR-2021, the subject experienced itching. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and had not recovered from swelling in chin area which moved above the eye, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Pt. came in with 50 cent size red, raised welt on Lt. thigh, this was where the PROQUAD was given.
SWOLLEN GLAND UNDER THE ARM PIT ON THE RIGHT SIDE A LOT, AND LESSER AMOUNT IN THE LEFT SIDE
became tired and sleepy  with increasing joint ache, headache, sore arm and redness in the area of the injection and  painful around neck and neck area.  Some muscle pain but the worst was the joint pain even in my fingers and a general malaise.
Myalgia, Arthralgia, Fever, CoughWheeze, Diarrhea, fatigue,decrease appetite, injection site pain Narrative:
Patient received adult dose; patient was accidentally given an adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 11th January 2023, the patient received Havrix adult. On 11th January 2023, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 11-Jan-2023 Reporter's Comment: The reporter stated that a patient was accidentally given an adult dose of Havrix.  The reporter stated that information for the adverse event was given, including the vaccine information and patients details.  The reporter did not know which dose it was. The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up. Additional Supportive Information: The patient was accidentally given an adult dose of Havrix, which led to accidental overdose and adult product administered to child.
930PM pt was given APAP pt refused to eat; pt then started panting, became stiff w/head thrown back, eyes became crossed & pt had blank stare; started trembling; mom called pts MD while on the phone pt sx subsided;
syncopal episode  40 min after vaccine.  Nurse on floor took vitals 80/62   pulse 55, pulse ox 82%     temp 96.9, FS 120, put on oxygen 2 liters pulse ox up to 98%.  Called 911, transported to hospital
suffered from pain in the vaccine area; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "suffered from pain in the vaccine area". Additional information: The reporter was reporting on AE/medical inquiry after the COVID vaccine and was reporting product complaints on other products. When the reporter had called the patient (daughter) this morning, patient said that she had experienced pain but just in the vaccine area.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse practitioner reporting on herself via company representative, refers to a female of unknown age. In February 2013 a few days ago the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (lot # and route not reported). The morning after vaccination (in February 2013), the patient experienced pain across her body down to her legs. No treatment was given for the patient's events. The outcome of pain across her body down to her legs and in her joints was reported as recovered/resolved (date unspecified). The patient did not seek medical attention. Additional information is not expected.
Swollen nodule just below armpit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29May2021 11:45 (Lot number: ew0191) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MONTELUKAST. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: ew0176 , Anatomical Location: Arm Left  , Route of administration: Intramuscular, Time: 11:45 AM), administration date: 08May2021, when the patient was 49 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30May2021 08:00, outcome "not recovered", described as "Swollen nodule just below armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Relevant past drug history: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if  the patient was diagnosed with COVID-19 prior to vaccination and the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information expected.
Administered a dose of improperly stored MMR II,  PROQUAD, or VARIVAX; No adverse effects reported; Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided.  On unknown dates, the patients were administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # was R024897, expiration date was 30-AUG-2020; strength, dose and route was not provided), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # was S003171, expiration date was 30-JUL-2020; strength, dose and route was not provided) or varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was R030611, expiration date was 23-OCT-2020; strength, dose and route was not provided) for prophylaxis; reconstituted with properly stored sterile diluent.   The vaccine had temperature excursion of 8.49 C degree for 15 minutes, 50 C degree for 26 minutes. No previous temperature. The call was due to the digital data logger. No adverse event was reported.  This is a non-valid case due to lack of patient identifiers.  As of 03-DEC-2019, all telephone attempts trying to obtain additional information has been unsuccessful.
I took the vaccine early in morning, six hours later and I lost my sense of smell and taste. I began throwing up and had chills and fever. It lasted for 48 hours. It took four days for my taste to return.
Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped  the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given.  I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.
This shot triggered four days of Polymyalgia Rhuematica symptoms that finally cleared up and a day or two later it triggered Ankylosing Spondylitis symptoms (severe lower back pain) that lasted one day.  I have had both diseases in the past but had no symptoms prior to the flu shot.
Pt.'s Wife states that after pt. received the 1st dose of (High-Dose) Influenza 09/29/2021, started experiencing symptoms of nauseous, chills, low-grade fever, headache, and muscle aches. Pt. still continuing to experience symptoms.
Information has been received from a registered nurse concerning a 5 year old caucasian female patient who on 09/10/1998 was vaccinated with Varicella virus vaccine live SC. The registered nurse reported that the patient "got chicken pox twice". On 06/23/00, the pt presented with a "erythmatous papular rash. The registered nurse reported that on 04/06/01, the pt presented again with the same type of symptoms. The patient's outcome was not reported. Unspecified medical attention was sought.  In follow-up, the registered nurse reported that the pt experienced "no adverse effects. The registered nurse reported, "pt received vaccine 09/10/1998 then had chickenpox looking rash 06/23/00 and again 04/09/01. the registered nurse also reported on the pt's sibling, WAES #01041029, who had an experience following vaccination with Varicella virus vaccine live and on an unspecified number of children who developed chicken pox following vaccination with Varicella virus vaccine live (WAES01041411). Additional information has been requested.