chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported a "prickly rash" on their back, around side, and underarm 2 days after receiving vaccine.  Patient reports is was itchy, she took Benadryl.  Patient reports is has since improved.
Experienced only mild arm soreness following first injection with no other noted side effects. Following second dose, experienced fever and muscle aches for approximately 24 hours following injection. About 30 hours after receiving dose, experienced painful red rash extending from shoulder to elbow that was hot to the touch and lasted approximately 2 days.
anaphylactic rxn-scratching, pink blotches, chest, arms, back, cheeks, legs;hives-20min p/vax;
Fever 102.3 chills headache body ache weakness until 8:30pm on 2/4/21
Muscle twitching-fasciculation, predominantly in the legs.  Onset not until about 9 days after vaccine.  Continuing  5 days after onset and at time of this submission.  General fatigue, sore lymph areas (under arms, side of neck).
very tired/very fatigued; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for Covid-19 immunization; Covid-19 vaccine (dose 2), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "very tired/very fatigued"; NAUSEA (non-serious) with onset Oct2021, outcome "unknown", described as "nauseated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101368325 Same drug/AE, different patient
pt brought to ED by daughter who states pt has had respiratory sx that have been worsening; admitted to hosp; positive for COVID; DNR; pt's condition worsened and she passed away in the hospital
I currently have a IUD and don't get a period. Its now been 4 days of heavy cramping and 2 days of a very heavy menstruation. Neither are normal.  I have never had such a heavy flow or such intense cramps. I've bled so much in the 2 days that I'm bruising easily now.
The pt developed a lump at the injection site with redness and tenderness. Now painless but same size.
This is a spontaneous report received from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is 1st of three reports. An adolescent female patient of unspecified ethnicity received on an unknown date a single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. Next day after vaccination, the patient experienced chills. Outcome was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2018031110 Same reporter/product/event, different patient.;PFIZER INC-2018031111 Same reporter/product/event, different patient.
THE DOSE GIVEN IS THE PEDIATRIC DOSE. THE PATIENT TURNED 12 TODAY, SO SHE SHOULD HAVE RECEIVED THE ADULT DOSE
Two days after being vaccinated, she developed an atoxic gait and was unable to sit up. She was taken to medical center.
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath.  She had an eppy-pin she used.
1/16/2021 Pain to injection site upper arm, Slight swelling of Lymph nodes to that arm,  Extreme fatigue resulting in sleeing most of the day and nausea without vomiting, loss of appetite. No fever 1/17/2021 pain and nausea subsided, fatigue improved but still not back to 100%
rash like hives on the whole deltoid; little bit of deltoid swelling; a lot of pain when raising the hand; a lot of pain when raising the hand; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Jul2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Poor kidney function" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Jul2023, outcome "not recovered" and all described as "a lot of pain when raising the hand"; MUSCLE SWELLING (non-serious) with onset Jul2023, outcome "not recovered", described as "little bit of deltoid swelling"; URTICARIA (non-serious) with onset Jul2023, outcome "not recovered", described as "rash like hives on the whole deltoid". Therapeutic measures were taken as a result of urticaria, muscle swelling, pain in extremity, pain.  Additional information: The patient was experiencing a rash like hives on the whole deltoid but there is no itching, a little bit of deltoid swelling and also a lot of pain when raising the hand. The rash like hives on the whole deltoid, little bit of deltoid swelling, and pain when raising the hand are still continuing. The patient was taking Tylenol as treatment.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
ADVERSE EVENT: AT INJECTION SITE WAS REDNESS AND INFLAMMATION. IT WAS TENDER AND HARD TO THE TOUCH TWO DAYS AFTER THE INJECTION. THE FOLLOWING DAY, IT TURNED PINK AND THE PATIENT STARTED FEELING SICK (SLIGHT HEADACHE AND WANTING TO THROW UP) TREATMENT: PLACE ICE ON THE INJECTION SITE WHEN IT WAS TENDER AND IT IMPROVED IT TO JUST BEING PINK.
Fatigue/tiredness; she had a rash that did not itch and was located at her right torso under her breast and under her arm; arm pain; warm to touch at the injection site; Chills; cold hands; ache on her back and hip; ache on hip; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix. On 1st September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and injection site warmth. On 2nd September 2020, the patient experienced fatigue and rash. In September 2020, the patient experienced chills, cold hands, back pain, pain in hip and influenza-like symptoms. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm and rash were not recovered/not resolved and the outcome of the injection site warmth, cold hands, back pain, pain in hip and influenza-like symptoms were unknown and the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site warmth, fatigue, chills, cold hands, rash, back pain, pain in hip and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had arm pain and warm to touch at the injection site. The patient had fatigue, tiredness, chills and cold hands. The patient reported that she had a rash that did not itch and was located at her right torso under her breast and under her arm and ache on her back and hip. The patient taking Advil.  The patient reported it was like having flu like symptoms. The reporter did not consent to follow up. Lot and expiration date were unknown.
patient had only 18 percent immunity; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (patient had only 18 percent immunity) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (patient had only 18 percent immunity) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (patient had only 18 percent immunity) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.  The patient received Moderna vaccine booster dose on 01-Mar-2022. Company comment:  This spontaneous case concerns an unknown-years-old patient, with  no medical history reported who experienced the unexpected events of sensation of immunodeficiency,  unknown days after a booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an unknown-years-old patient, with  no medical history reported who experienced the unexpected events of sensation of immunodeficiency,  unknown days after a booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
side effects that included a rash on face and chest/redness on my chest; ill; weak; red mask across my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (received 1st dose on an unknown date and had rash on face and chest, for tolerance refer case US2022AMR011098).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red rash, unwell, weakness and eye red. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the red rash, unwell, weakness and eye red were unknown.   It was unknown if the reporter considered the red rash, unwell, weakness and eye red to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR011098  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received a dose of Shingles shot and experienced side effects that included a rash on his/her face and chest. Ever since then, every time he/she got ill or weak, he/she had the same symptoms as a red mask across eyes and redness on his/her chest. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR011098:same patient - 1st dose
NO immediate reaction occurred, pt stated she observed red streak the night of and then it started itching and redness formed a round circle and started putting lotion on it.  Dr. looked at reaction and informed patient to take Benadryl and if reaction worsens to follow up in emergency room.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. Between the dates of 05-JUN-2015 and 27-JUL-2015, the patients were vaccinated with unspecified doses of GARDASIL 9, lot # K026246, expiration date 28-JAN-2017 (dose, strength and route of administration were not reported) which were improperly stored. No information on patients concomitant medication was provided. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling to be related SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to report that the patient was vaccinated at her doctor's office and thought SHINGRIX was given subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The pharmacist did not wanted to provide any additional information since, it wasn't given by the reporter. The pharmacist did not want to be contacted for any follow up information. No further information would be provided.
Sudden cardiac death. Received CPR for 2 hours. Transvenous pacemaker placement.
Full body rash started about 24 December 2021. Red skin and hives when scratching. Been taking Cetirizine about once a day to control symptoms for the last 4 months. Rash was aggressive at the start and has been gradually getting better as time progresses but is still present at 21 April 2022 and I am still taking Cetirizine. Dermatographia (Skin writing) is also present and last about 30 minutes after I scratch. Also tinnitus (ringing in the ears) is very noticeable since the rash outbreak in December 2021.
This spontaneous report was received from a healthcare worker refers to a 12 month old male patient. On 11-MAR-2014, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously. On the same day, the patient was vaccinated with VARIVAX (merck), .5 ml, subcutaneous. The VARIVAX (merck) was inadvertently reconstituted with PROQUAD (merck) 0.5 ml (route was not reported). No adverse effect was reported. No further information was provided. Additional information has been requested.
Sudden onset of diarrhea, lasting 10 days,  resulting in urgent care visit with lab work, prescription Sucralfate and Famotidine. After no relief, follow-up with gastroenterologist on March 29.  Ordered abdominal x-ray and colonoscopy
He began to have lower extremity weakness on Sunday 7/18/21.  He went to an outside hospital ER on Sunday due to LE weakness and diagnosed with a heat stroke and discharged home.  On 7/20/21, he came to ED and reported the weakness had moved up into his upper extremities.  Admitted to the hospital on 7/20/21.  He has been unable to stand or use his upper extremities for the past 3 days.  On exam he has tremor of the jaw, he reports he does not notice this.  He does have sensation intact.  Intubated and placed on ventilator on 7/20/21 for respiratory distress. Diagnosed with  Guillan-Barre syndrome  requiring a trialysis catheter placement acutely for plasmapheresis.  Plan plasma exchange 6 times, with treatment every other day.    As of today, 7/28/21 patient remains hospitalized.
The day after the shot and For three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 09:00 (Lot number: En6204) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SIMBICORT TURBUHALER; ZAFIRLUKAST. The following information was reported: NEURALGIA (non-serious) with onset 14Mar2021, outcome "recovered" (2021), described as "The day after the shot and For three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily.". The event "the day after the shot and for three months had up to 10 episodes a day of extreme nerve pain in chest area for up to 2 minutes then went away and return again and again daily." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of neuralgia.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
patient felt light headed and woozy, provided ice pack and water and patient felt better within 10 minutes
LOSS OF TASTE BUDS BY 1/3 / ONLY 1/2 OF TASTE BUDS WORKED; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced loss of taste buds by 1/3 / only 1/2 of taste buds worked, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste buds by 1/3 / only 1/2 of taste buds worked, and tired. This report was non-serious.
Narrative:  Patient reports skin rash on the chest, neck, arms, and legs after administration of the second COVID vaccine.
Day after 2nd vaccine: fever, muscle soreness, extreme fatigue and itchy red rash at injection site.  2nd day after 2nd vaccine: itchy red welt at injection site worsened.
Information has been received from a physician concerning a 10 year old female patient who on an unspecified date was vaccinated with varicella virus vaccine live.  On an unspecified date she experienced a breakthrough of chickenpox.  There were over 50 pox marks and the lesions varied from mild to more severe.  The patient possibly had a fever as well.  It is unknown whether the chickenpox improved and the patient's present status is unknown.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
crying, fever 104, dec appetite from 11PM 17FEB95 through evening of 19FEB95;
Patient developed fever and swollen arm at night on the same day received vaccines.  Patient had telemedicine visit on 10/8/20 and was told that she has developed an infection and started taking antibiotics on the same day.
Rash development at 3:00AM on 4/9/05 by 10PM entire body was covered (red, welts, itchy). Rec'd cortisone injection 6:30AM on 4/10/05. Seen at ER on 4/10/05 at 9:30PM (given prednisone and Vistrel). Shortness of breath (4/10-4/13). Dizziness, disoriented (4/11-4/13), tingling in hands and feet (4/11-4/14/), began to feel better on 4/16/05. Saw doctor again on 4/12/05 swollen glands 4/9/05 present, very tender.
pt report pain, swelling & reddness rt arm & h/a p/receiving 3rd shot Recombivax; seen in ER dx allerg react;
This spontaneous report was received from a registered nurse, referring to a 12 year old male patient with seasonal allergy. The patient presented no drug allergies/reactions. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048459 with expiry date on 22-FEB-2018, intramuscular (dose and anatomical location were not reported). No concomitant medications were reported. On 07-JUN-2016, the patient experienced stomach cramps shortly after getting the dose and that hives started about 4 days after the vaccination. Patient sought medical attention via a phone call; however, no lab diagnostic studies were reported. Nurse reports that the patient's mother gave the patient an unspecified dose of BENADRYL on unspecified date, and that the hives and stomach cramps did resolve on an unspecified date. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Around 9:45I started to feel like I was about to puke, then I got the chills, then a fever, then really bad body aches. I felt tired but couldn't sleep because my body hurt so bad. I had also felt numb and tingling in my hands, feels, and face. I also had cramps being to happen. They all ended up fading with 48 hours.
102.3 degrees fahrenheit fever starting 7 am morning after second COVID shot. She took 6 Tylenol throughout the day and still had fever, and aches. She took cold and flu medication and that helped a bit. Second day after shot and third day at night she had a fever. Finally, on fourth day, she woke exhausted but fever was gone.
Patient complained of bad bruising  at the injection site that started the day after the shot. She reported it on the 9th day after the shot. The bruising is still present, but patient states it is getting better.
I developed a ringing in my ears (mostly right ear) a short while father getting the first vaccine. Tinnitus.
patient vaccinated 2-4-2021, 3-4-2021 and 11-23-2021, found to be covid + on 12-2-2021
5.5 cm x 5.5 cm of induration/erythema site warm to the touch.
CHILD HAD LOW GRADE FEVER FOR 2 DAYS, WAS SCREAMING AND CRYING ALL DAY AND ALL NIGHT, BROKE OUT INTO A RASH AT THE SITE OF ADMINISTRATION, WOULDNT SLEEP FOR 2 NIGHTS, THEN ON THE 3RD DAY SHE HAD A FULL BLOWN SEIZURE AS HER FEVER SPIKED OVER 103 DEGREES, TAKEN TO HOSPITAL- COULDNT FIND THE SOURCE OF THE FEVER, CHILD THEN BEGAN TO REGRESS IN HER DEVELOPMENT AND WAS EVENTUALLY DIAGNOSED WITH AUTISM WHEN SHE WAS 21 MONTHS OLD.
Information has been received from a physician and a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with improperly stored doses of stored GARDASIL (dose strength, route, lot# unspecified). No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Admitted for post-op management following a pancreatodenectomy. This visit is within 6 weeks of receiving vaccine.
Injection site got swollen and a darker red rash appeared around the site. Rash became more rounded overnight but not worse per se. Not painful or itchy. No medical attention at this time.
Within 3 hrs of administration, achiness, extreme fatigue, slight nausea, head and extremties felt "heavy".
howlong am I supposed to be sick after the 2nd COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (howlong am I supposed to be sick after the 2nd COVID shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (howlong am I supposed to be sick after the 2nd COVID shot). At the time of the report, ILLNESS (howlong am I supposed to be sick after the 2nd COVID shot) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the event was reported as not applicable.