chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated at 1pm 10minutes post vaccine epigastric tightness & lightheadedness that improved with getting up and walking. Declined ED when encouraged during post vaccination observation. She left the clinic on her own after 30 minutes . She did go to ED at 1435 EKG  with normal sinus rhythm, hypertensive, admitted for observation r/t hypertension, oral medication change and discharged to home the next day..
Loosening of prosthesis of right total knee replacement, subsequent encounter. Hospital admission within 6 weeks of receiving the COVID vaccine.
Beginning about two hours after and the next day: very sore arm at injection site   headache very tired base of skull aches  I'm reporting on the second day.
Ringing in my ears started about 10-12 days after the vaccine and got worse about three weeks after. It is in both ears and constant.
Rash began 2/5/03 2-3 have after receiving vaccine. Begans as a roused, red whelt ? into a red one. The rash comes and goes and has spread all over. The rash began on her hands. Now today on arms and some at the feet. ? Has taken Benadryl oral has use local ? To go to MD today.
Red, splotchy, prickly and itchy and warm to the touch. It is about 8"x7" long around vaccination area.
Case number PHEH2014US023516 is an initial spontaneous report from a medical assistant received on 20 Nov 2014. This report refers to a 52-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1413101, expiry date: Jun 2015) on 17 Nov 2014. The FLUVIRIN vaccine given to the patient was stored out of range at 60 F before vaccination. No adverse event reported following this medication error.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The pharmacist reported that on 19-JAN-2015 the patient was administered a second dose of ZOSTAVAX (dose, route not reported, lot# J013134 with expiration date 17-JAN-2015) which was expired. Additional information has been requested.
Chills and high fever. Rash on thigh. Taking Benadryl, Tylenol and ibuprofen.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced fever, lethargy, diarrhea, myalgia, chills and back pain. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the fever, lethargy, diarrhea, myalgia, chills and back pain were recovered/resolved. It was unknown if the reporter considered the fever, lethargy, diarrhea, myalgia, chills and back pain to be related to BEXSERO. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The doctor reported she had the patient who suffered from fever and chills, diarrhea, myalgia and was lethargic for 2 days following the vaccination. The exact date of the vaccination or the date when the adverse events began was unknown.
She received vaccine on 2/22/14 and is still reporting a very sore arm with pain radiating in whole arm (as of 3/18/14).
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805414 was crossed linked to original case 201804863 due to same reporter.
h/a, eyes, legs, hands, toes jumping in progression;chest discomfort p/laying down p/pizza w/hx hiatal hernia;awoke w/leg discomfort;leg discomfort not r/t walking;
A consumer report has been received. The report concerns a 38 year old male consumer. Height: 175.0 centimeters; Weight: 170.0 pounds, who had been receiving nasal FLUMIST. FLUMIST started on 23-AUG-2013. The patient experienced cough, sore throat and runny nose which started on 25-AUG-2013. FLUMIST was discontinued on 23-AUG-2013. The patient recovered from the event of cough, sore throat and runny nose on 25-AUG-2013. The report was considered to be non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0202) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovered" (May2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) positive, notes: confirmed that day by a PCR; (09May2022) negative, notes: I tested negative on a rapid test; (10May2022) positive, notes: I took a second rapid test and was positive; (16May2022) faint line, notes: I took a rapid test and saw only a faint line; (18May2022) bold second line, notes: rapid test had a very bold second line. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10May2022 to 14May2022 and advil, as needed for covid symptoms. Clinical course: The Covid Symptoms (congestion) started on a Monday (09May2022) night and patient tested negative on a rapid test. On Tuesday morning (10May2022), he took a second rapid test and was positive, confirmed that day by a PCR. Started paxlovid immediately, with two doses that day. By Saturday (14May2022), symptoms were gone and Paxlovid regimen complete. On the next Monday (16May2022) morning, he took a rapid test and saw only a faint line. But that night had high fever again out of nowhere. By Wednesday (18May2022) morning symptoms gone again but rapid test had a very bold second line. Seems to be "paxlovid rebound". No Known allergies.
After the first shot I had a headache for about 24 hours. After the second shot, I had flu-like symptoms (fever, headache, chills, body aches) for about 24 hours. I also developed a severe pain in my left armpit. It was like someone punched me in the side and created a bulge like an ingrown hair, about the size of a golf ball. The pain in my armpit was so severe it made me neauseaus when touched or moved. The sever pain lasted for about 4 days. Total pain for one week.   I took tylenol for all symptoms.
While body is Achy, muscles pain everywhere,  joint pain, things that touch my skin are painful, very tired but unable to sleep, injection site is very painful to the point it hurts to move it
Pt attended a health fair and was given Janssen vaccine. He does not meet the 18+ age requirement for this particular vaccine. No adverse reaction noted. Mother aware immediately following administration.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FAINTED FOR A MOMENT. AFTER EXAIMING PATIENT. MOTHER EXPLALINED DEVELOPED SAME CONDITIONS BEFORE BECAUSE FEAR OF NEEDLES. PATIENT WAS OFFERED GATORADE AND A BAG OF CHIPS. AT THE SAME MOMENT WE CALLED 911. THE PATIENT WAS RESPONSIVE AND WAS FEELING FINE AFTER A COUPLE OF MINUTES. AMBULANCE ARRIVED AFTER AND PROVIDED EXTRA CARE FOR HIM. PHARMACIST IN CHARGE WENT TO AMBULANCE TO SEE PATIENT OFF.
fever, body aches, vomiting, diarrhea. BP 210/110, felt "raspy" in chest
I have a history of guttate psoriasis triggered by strep infections.  I have not had a flare in about 6 years, but just a few months after the COVID vaccine have had a flare of guttate psoriasis that is ongoing.  I have not had any other infections or illnesses in the last year that would have triggered the flare.
Pt contracted Covid, symptoms started 4 days after vaccine (feb 8 was vaccine). symptoms started feb 12, hospital feb 15, still in hospital as of march 3
Approximately 8 minutes after administering the vaccine, the patient began experiencing right-sided numbness.  Sensation did not radiate and was unclear exactly from where it was originating, but was persistent from right fingertip through the right shoulder, down the right side to her feet.
Client had no issues on 12/29/2020 - the day of the Covid 19 vaccine. At 6:00 AM on 12/30/2020 she c/o of nausea, headache, felt as if she had been hit by a sledge hammer and had chills. she stayed in bed from 12/30/2020 until she went to Hospital ER on 1/4/2020. She reported to me that she had a chest x-ray that showed "double viral pneumonia". On 1/5/2021 she received a telephone call that she tested positive for Covid 19.  She reported these events to her manager who reported it to County, Health Officer, who then reported it to me. I called the client to get all of the facts regarding the events.
Information has been received from a physician concerning an approximately 17 month old male who in May 2007 (five months ago), was vaccinated with the first dose of 0.5 ml ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On approximately 03-OCT-2007 (about a week ago) the patient experienced vesicles were formed around the injection sight and dermatome rash that traveled from patients head up to injection sight.  The physician believes  that it may be "something like shingles".  The patient was referred to a dermatologist and is waiting to hear from him with a diagnosis.  The dermatologist did a test to determine the diagnosis and results were pending.  Follow-up was received from the physician.  On 24-APR-2007, the patient was vaccinated with the first dose ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # "97586D1", invalid) SQ.  Concomitant vaccination included the fourth dose of PREVNAR (Lot # 808692F) IM.  Illness at the time of vaccination included left otitis media and was being treated with AUGMENTIN.  The patient had no pre-existing allergies, birth defects, or medical conditions.  On 05-OCT-2007, the patient had a rash on her left arm vesicular lesions in clusters following dermatomes C6-C8 and T1-T2.  The physician reported that the rash consistent with herpes zoster in same arm as MMR-V given 5 1/2 months earlier.  On 20-OCT-2007, the patient was seen by the dermatologist for initial consultation who stated "our impression of his dermatomal cutaneous eruption was herpes zoster vs. an allergic reaction dermatitis".  The patient's parent were advised to continue acyclovir, AUGMENTIN and ELCON ointment.  A punch biopsy and confirmed a diagnosis of herpes infection.  Unfortunately, we could not prove this viral culture as he was already on appropriate antiviral therapy when this test was obtained on 12-OCT-2007.  Given the linear distribution and histologic findings we favored a diagnosis of herpes zoster as opposed to cutaneous herpes simplex or primary varicella.  On 16-OCT-2007, his eruption was resolving well.  The patient's parents were advised to discontinue mometasone furoate and complete the acyclovir.  No further information was available.
Fever; Body aches; Arm hurt; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE SWELLING (Arm was swollen), PYREXIA (Fever) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) 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 (Arm hurt) and VACCINATION SITE SWELLING (Arm was swollen). On 27-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE SWELLING (Arm was swollen), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided.      This case was linked to MOD-2021-245670 (Patient Link).
left arm swollen, c/o pain (mild). 2nd such episode. erythemia, warmth, and extensive effusion.  8/17/07 Received provider medical records which included hospital medical records.  Patient experienced fever, red, warm, swollen & painful left arm on 7/27/07 w/extensive effusion of elbow..  Noted to be 2nd such episode. DX: severe immunization reaction involving a joint.  Sent to ER for possible drainage of elbow & IV antibiotics.  Admitted to hospital 7/27-7/30/07. Parent recalled insect bite on that arm where blisters on medial aspect of elbow approx 2-3 days prior.  Tx w/IV antibiotics. FINAL DX: Cellulitis of left arm, most likely secondary to possible insect bite, possible secondary infection w/o abscess. 8/23/07 Received hospital medical records of H&P, x-ray & US of elbow & labs.  No new info.
Nausea/vomiting and diarrhea loss of appetite tachicardia sent to er for hydration.
This spontaneous report was received from a Licensed Practical Nurse (L.P.N) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 24-JUN-2016, the patient inadvertently was vaccinated with an unspecified expired dose of M-M-R II (Lot # K008815; expiration date on 16-JUN-2016. No adverse effects reported. Additional information has been requested.
Broke out in small patch of hives on (R) side of face within 1/2 to 1 hr of receiving vaccination.
Routine TD given 12/22.  A day or two later, she noted hive in the area of the shot.  This itched and stared to fade, then a flat red area appeared below the area of the hive.  There was no pain.  There was no fever.  She noted no swollen glands in her right axilla.  Her previous tetanus shot prior to this one was in 08/94; she does not remember any problems with it.  The other concern is the right upper arm.  She has two erythematous areas; the upper one is fading, it is approximately 10 x 9 cm.  The bottom area is a little brighter, but not raised, not tender to palpation, approximately 12 x 3 cm.  Her problem list is reviewed and update. O: On exam, vita signs are as noted.  Note the patient is afebrile. A: This appears to be allergic in nature and not infectious.  The axilla is negative for any adenopathy as is the supra and subclavicular areas. P: Hydrocortisone applied locally.  Report to state filed.
Received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. Reports feeling well and denies all symptoms  at this time during f/u call on 11/24 and 11/26.
over 42 days, 1st dose 08/13/21, 2nd dose 10/25/21
They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They gave a patient his 2nd dose yesterday, 23Aug2021 after giving him his first dose on 2Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Seen in ER 10APR90, temp 104 mom had already given APAP q4hrs  x 3 - fever started night of immun 9APR90;
Left arm soreness; He slept for about 8 hrs during those 2 days, usually he sleeps for just 5-6 hrs.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm soreness) and HYPERSOMNIA (He slept for about 8 hrs during those 2 days, usually he sleeps for just 5-6 hrs.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left arm soreness) and HYPERSOMNIA (He slept for about 8 hrs during those 2 days, usually he sleeps for just 5-6 hrs.). On 04-Feb-2021, VACCINATION SITE PAIN (Left arm soreness) had resolved. At the time of the report, HYPERSOMNIA (He slept for about 8 hrs during those 2 days, usually he sleeps for just 5-6 hrs.) outcome was unknown. Not Provided      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.   No concomitant medications reported. No treatment information provided.
2 different adult patients who received VARIVAX and PROQUAD; The patients were supposed receive MMR-II and VARIVAX.; This spontaneous report was received from a medical assistant via company representative, referring to an adult patient in the 30s-40s. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated once with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (for both of them the strength, dose, routes of administration, vaccination scheme frequency, anatomical sites of vaccination, lot numbers, and expiration dates were not reported), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age and wrong product administered).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA002048:
Dizzy, anxiety, R.S., feels lightheaded, Hot,  Rested, gave water, calmed pt down, pt is nervous, normal behavior for pt per the pt.  Nervous for the last 3 days
Information has been received from a Certified Medical assistant (C.M.A) concerning an 18 year old female patient who was vaccinated with her first dose of HPV. The patient called the office back within 24 hours reporting a large rash on her back. Concomitant therapy included albuterol. The patient's outcome was unknown. Additional information has been requested.
Tachycardia on 4th day after vaccine, the onset started in the morning while at rest, heart rate returned to normalcy after an hour but had intermittent episodes of tachycardia.  I went to the ER on 12/30/2020 due to continued tachycardia.  An EKG, chest xray, and blood was drawn, which showed slightly elevated troponin, stayed most of the night in the EC with second lab draws. I was given a prescription of metropolol 12mg to be taken twice a day for 14 days.  Went to see a cardiologist on 1/05/2021, another EKG was preformed along with an ECHO which was normal but was placed on a heart monitor to be observed for 30 days
Fever over 100.4, intense tiredness, body aches, sore arm, headache.
UPSET STOMACH/FEELING SICK TO STOMACH; PAIN IN BONES; SWEATS; THROWING UP BILE; DIARRHEA; FEELING TIRED; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced upset stomach/feeling sick to stomach. On 03-DEC-2021, the patient experienced pain in bones. On 03-DEC-2021, the patient experienced sweats. On 03-DEC-2021, the patient experienced throwing up bile. On 03-DEC-2021, the patient experienced diarrhea. On 03-DEC-2021, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upset stomach/feeling sick to stomach, throwing up bile, diarrhea, pain in bones, sweats, and feeling tired. This report was non-serious. This case, from the same reporter is linked to 20211238076.
Less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15-NOV-2022) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 08-JUL-2021, the patient received the 2nd dose of Shingrix. On 08-JUL-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter asked about Shingrix vaccine as what information was available about the administration of Shingrix at less than the recommended interval.  The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 19-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.