chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt drained, tired & yucky; felt drained, tired & yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Aug2023 at 11:00 as dose 6 (booster), single (Lot number: GK0928) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in Fingers/Toes" (unspecified if ongoing); "Osteoarthritis in Fingers/Toes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "known allergies: Macrobid". Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 13Sep2022, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Jun2022, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2589, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 30Sep2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 14Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "had no reactions". The following information was reported: FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset 10Aug2023, outcome "recovered" (12Aug2023) and all described as "felt drained, tired & yucky". Therapeutic measures were not taken as a result of fatigue, feeling abnormal. The next day and the day after, patient felt drained, tired & yucky. The 2nd day was a bit better. Full energy returned on 3rd day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276406 same patient/drug, different dose/event;
Headache for 3.5 weeks,  fatigue which is profound and persists.
SENSATION OF PULSATING ON THIGH ABOVE THE KNEE ON THE QUADRICEPS WHEN LYING DOWN; ACHING BONES; FEVER; NAUSEA; This spontaneous report received from a patient 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 admin 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 APR-2021, the subject experienced sensation of pulsating on thigh above the knee on the quadriceps when lying down. On APR-2021, the subject experienced aching bones. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 38 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching bones, fever, and nausea on APR-2021, and had not recovered from sensation of pulsating on thigh above the knee on the quadriceps when lying down. This report was non-serious.
This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # K009753 with expiration date 28-APR-2016 and lot # K024700 with expiration date 30-JUL-2016; dose was not reported). No adverse effects were reported. Additional information has been requested.
Had typical side effect within first 24 hours: fever, chills, muscle and joint pain, weird loss of taste (everything tasted bad) soreness at site. Today I woke up with red swollen splotch near site and wrap around additional red blotches along front of shoulder. I have now developed enlarged swollen lymph node along collar bone and swelling upward along side of neck. No shortness of breath no noticeable swelling in the back of the neck or towards ear.
During 15 minutes post observation period, patient c/o mild posterior headache and neck pain. BP 166/103, HR 124, SaO2 99%. Pt taking HCTZ antihypertensive but missed medication today.  Patient received IV hydration at treatment center.
Received 1st Moderna vaccine on 3/23/21. Within 15 minutes developed bloating and epi gastric in abdoment along with warm swelling and redness beyond injection site on left arm,  which progressed to both left and right  full arm warm swelling within 4 hours and  over the next few days then gradually resolved after 1 week. On April 1 after the vaccine awoke wih nausea without emnsis , diarhea or fever. Later that morning noted left subclavicular subcu mass which was fluctuant and moveable  The soft tissue over that area extending to pectoral area and left supraclavicular are was extremely painful to touch (no redness or itching) but pain is felt and expanded from left side of head, behind left ear (feels clogged), left side of neck and shoulder, and back of shoulder in subsequent weeks wih no resolution in 4 months. On April 1 by early afternoon at work (stationary sitting position) felt light headed and tingling paresthesias in fingers of both hands and both feet and then gradually resolved same day. By mid- April skin discoloration/ shading at base of neck but most prominently on left side with no resolution over 4 months. Chronic pain is ongoing in thoracic region (day and night, awake and sleeping) with no resolution.
He got his vaccine, when he got the vaccine he got just a little bit of headache which went away.  He smelled something chlorine smell when he got his vaccine and then it went away.  Had no further symptoms and didn't feel anything.  Then Wednesday night he went to bed and started getting muscle aches in his arms like he had the flu.  He also then noticed a headache.  He got up because he was feeling weird around 3:00 AM this morning, with the arm bothering him.  He kept feeling on the outer arm where the shot was he could feel something.  He raised his left arm up and he noticed that it was swelling under it.  I thinks it was his lymph nodes in his armpit area.  Then all of a sudden he laid back down and when he woke up all of the symptoms went away except for the armpit which is still a little puffy.  He did not take anything for his symptoms.   He did call his doctor and they told him that it was very normal for that to happen, that the lymph nodes swell up sometimes but should go away within 2 weeks.  He then called his job and spoke with the nurse and he told her that he was having a reaction, and she told him that it was perfectly  normal, and told him the same thing that his doctor told him.     On Tuesday he ate dinner and he was talking his dog out for a walk, and he started throwing up like crazy outside.  Then it just went away.  It did not happen again.
Rash on inside of both arms from wrist to armpit. Small raised pimples. Right side of arm red and swollen. All rashes gone on 10/21/04.
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 11-Dec-2013. The reporter mentioned that patient had received expired FLUMIST on 11-Dec-2013. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
p/vax pt erythematous rash;no fever, no chills, no SOB, no angioedema, no sore throat;
Tinnitis. This shot made the tinnitis that began with my first covid shot worse.
Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.
Nausea, vomiting, diarrhea, fatigue, weakness, fever 101.1. Symptoms lasted until 10/25/2012 11:00 AM.
This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 36 year old female patient with no drug allergies. The patient's medical history was reported none. On 25-JUN-2014 (reported as today) the patient was vaccinated with GARDASIL (Dose/Frequency: 0.5 milliliter (ml)) intramuscular in the left arm. The concomitant medications were not reported. Approximately on 25-JUN-2014 (reported as today) the patient was 32 weeks pregnant. The patient was 32 weeks pregnant. The patient became pregnant with LMP on 13-NOV-2013 (approximately) and EDD of 20-AUG-2014 (approximated). Initial exposure to GARDASIL was at 32 week(s). The pregnancy outcome was unknown. On 25-JUN-2014, the patient was inadvertently vaccinated with GARDASIL instead of DTaP. This was reported as staff error only. The reporter stated that the patient was previously vaccinated with GARDASIL series on unspecified dates. No adverse effects reported. The outcome of 32 weeks pregnant client was inadvertently vaccinated with GARDASIL was unknown. The patient sought medical attention. Additional information has been requested.
My eyes started to get itchy and ached all over. My skin started to get itchy and hurt. The following day I felt like I had the flu. I also had a slight fever. I was sick for several days.
3 to 5 second Syncopal episode after HPV vaccine given.  Twitching of right arm noted, recovered alertness quickly after postictel.  Hematoma left brow/temple and chipped left lower incisor.  NV intact. Observed patient for 1 hour.  Had not had a meal in 15 hours(skipped breakfast).
The medical assistant that was providing care and administered the vaccine asked for assistance with documenting the expiration date in the EMR. While I was assisting her I was reviewing all of the vaccine information with her. I asked her if she gave 0.3ml of the vaccine and she said no. She explained that she gave whatever was in the vial as she did not realize it was a multidose vial. I informed Dr, pt's PCP as well as the patients daughter. Reviewed s/sx to monitor for. Daughter verbalized understanding.
This spontaneous case, initially received from other health professional (nurse) on 07-Dec-2017, concerning a 60-year-old adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX was out of recommended range for a few days which occurred on 12-Nov-2017 for about 30 minutes lowest temperature 34.7 degrees F and re-occurred on 27-Nov-2017 through 01-Dec-2017 with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QUADRIVALENT (batch number: 195250 and expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported) which was out of recommended range. The reporter assessed this case as non-serious. Non-significant follow up received on 29-Jan-2018: No new information received.
Fatigue, sore throat, headache started 24 hours after injection. Took Tylenol, felt better. 48 hours after vaccination, fever started - got up to 102.2. Took aspirin, fever slowly started coming down - 16 hours later, slight fever of 99 remaining.
In March 2021, had stroke like symptoms and face started drooping, slurring of speech and can't close my eye and left side of my face is still impacted. Diagnosed Bell's palsy. Had it 15 years.
Inconsolable irritability, high fever > 103. 1/14/12: Patient was seen in ER for right otitis media.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of GARDASIL improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Blepharitis; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLEPHARITIS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left upper arm is weak and has pain when turning to pick up item or buckle a seat belt.  This has been continuous since the first vaccine.  It is difficult to flex the muscle.
On 10/2 patient developed rhythmic jerking in the right arm.  During the episode which lasted about 20 minutes according to parents, he had altered mental status and was unresponsive.  EMS was called and he was taken to the ER.  By the time he arrived at the ER he was back to baseline.  He had no documented fever according to the parents - although that day he was sleeping more than usual.  He had no prior episodes of seizure or febrile seizure.  Unclear if this was directly related to the vaccine or if there is another underlying issue.  The patient has been referred to Neurology.  But out of an abundance of caution the office decided to report this to the VAERS system.
Mom states @ 730PM on 12FEB91 infant vomited x 1 & got pale; Taken to ER had fever of 102() was sponged off & given suppositories for fever; Cried some off & on that 1st night;  DR in ER told mom child had rxn to DTP shot;
black speck in my right eye that moves as my eye moves and clouds my vision in that eye, pain in heart area for the first time
Covid test it came back positive; Covid test it came back positive; Respiratory tract congestion; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256978-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 15Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Covid test it came back positive"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "recovered", described as "Respiratory tract congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Causality for Humira(Adalimumab): The reporter's causality for the event(s) of covid test it came back positive/congestion unknown onset, had first covid vaccine was tender at the injection site, soreness in arm with covid booster and covid test it came back positive/congestion unknown onset was not provided.  Causality for Pfizer Biontech Covid-19 Vaccine:COVID-19 virus test positive Probable and Respiratory tract congestion Probable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19, Vaccination failure, Respiratory congestion.
Was a 17 year old who was given Janssen COVID vaccination by Dr. approximately 2:20 pm on 4/8/2021. No adverse effects noted. Client was advised Janssen is not approved for people under 18 years of age. Host parents were contacted by phone and notified that client received vaccination.
Local reaction (3 x 3cm erythema) to Prevnar given in left thigh. Followup 05/11/02
Sore arm after 1st dose; Fatigue after 1st dose; Headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 1st dose), FATIGUE (Fatigue after 1st dose) and HEADACHE (Headache after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048a21a and 032b21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Shingrix vaccine. Past adverse reactions to the above products included Hives with Shingrix vaccine.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after 1st dose), FATIGUE (Fatigue after 1st dose) and HEADACHE (Headache after 1st dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after 1st dose), FATIGUE (Fatigue after 1st dose) and HEADACHE (Headache after 1st dose) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment includes Benadryl and Benadryl cream   This case was linked to US-MODERNATX, INC.-MOD-2021-079296 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079296:
Patient woke up with all over body aches, stiffness, fatigue, Raised temp (99.5F), lasting 12 hours, then developed headache. Fully asymptomatic after 48hrs.
fever reported as t104, measured @ 99; 10 cm area of induration & erythema @ site of Td inject;
Joint pain throughout body. Began around day 4. Worse at night. Most frequently in ankles, shoulders, and wrists. Occasionally in knees, toes, fingers, elbows. Taking ibuprofen. Have not reported to dr as it is pretty mild and mostly more of an annoying discomfort. Fearful it may become worse but hopeful it will go away.
Red irregular shaped raised welt like area surrounding the shot point- the welt area is mildly irritating and itchy
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA006189:
Inflammation / cellulitis at injection site. One week after injection. Requiring Doxycycline.
increase in loudness of tinnitus.  I've noticed i've had tinnitus for approx a year or two, but after the 2nd moderna vaccine, it is extremely loud, especially in my right ear.
Left breat pain-continuous Headache-4-6 days post covid vaccine injection Chest pain-Infrequently but present
body aches restlessness, headache will not go away. not helped with Tylenol or advil.  couldn't sleep couldn't get comfortable. then runny nose, cough, sneezing, then dizziness, had to call out of work on Friday 6/11. then Saturday 6/12 significant face swelling. Tiredness-sleeping all day now for past week. called out of work Monday, Tuesday and Wednesday, severe weakness.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-MAY-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L013063 and expiration date 14-APR-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 29F and the time frame was 2 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Report A0371113A describes mercury poisoning  in a male child, now five years old, who received hep B vaccine. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The child received an injection of hep B vaccine on 11/18/1995. He also received hep B vaccine (Recombivax-HB) on 01/12/1996 and 05/21/1996; diphtheria an dtetanus toxoids and pertussis vaccine adsorbed  on 01/12/1996 and 03/18/1996; diphtheria and tetanus toxoids and pertussis vaccine adsorbed on 03/14/1997; combination diphtheria and tetanus toxoids and pertussis vaccine adsorbed/Haemophilus influenzae type b conjugate vaccine (Tetramune) on 05/21/1996; Haemophilus influenzae type b conjugate vaccine (ActHIB) on 01/12/1996 and 03/18/1996; Haemophilus influenzae type b conjugate vaccine on 03/14/1997; Orimune on 01/12/1996, 03/18/1996 and 05/21/1996; MMR II vaccine on 03/14/1997 and Varivax on 11/18/1997. The vaccinee's attorney alleged that "As a direct and proximate result of the administratio of Thimerosal containing vaccines, the vaccinee received toxic levels of mercury and has suffered damages relating to mercury poisoning. As a result of the mercury poisoning, the vaccinee has suffered neurologic damage, has required medical treatment, including hospitalization, has suffered from physical pain and emotional anguish, ahs suffered a diminution of both the quality of life and life expectancy and has suffered a loss of earnings capacity. All of his damages are permanenet and progressive." Time to onset from immunization and treatment were not provided. Lead screening was performed on 03/14/1997; results were not provided. The vaccinee was referred for audiological evaluation on 11/18/1997; results of the evaluation were not provided.
Approximately 2 weeks post vax pt experienced high temperature, disorientation, nausea and vomiting. Pt evaluated and given Phenergan.
Headache, Myalgia, Arthralgia, Fever, runny nose,chills Narrative:
left arm swelling , redness, itching at the injection  site; Narrative:  resolved at this time; lost few hours of  work;