chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart palpitations; Dizziness; High fever; Body aches; Injection sites pain; Headaches; Chest pain/chest burning; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181 Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 27Aug2021 09:00 (age at vaccination 39 years) as dose 2, single for covid-19 immunization. Medical history included Hypothyroidism. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE). The patient previously took bactrim and experienced allergy. The patient took historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485 Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 08:15 for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Aug2021 22:00 The patient experienced heart palpitations, high fever, body aches, injection sites pain, headaches, dizziness, chest pain/chest burning. The event heart palpitations and dizziness was serious (medically significant). Patient visited doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram thorax was unknown, fibrin d dimer was elevated. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
symptoms started a few hours after vaccination. symptoms consist of body aches, chills and rigors, HA (at the back of head), decreased appetite, nausea, and diarrhea; symptoms have persisted x 5 days at time of visit
Fatigue, headache confusion, SOB, fainted. syncope, palpitations and body aches. Had symptoms for 2 weeks.
aching all over the body; very tired/sleepy; head ache; sore arm at injection sit e; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e). At the time of the report, PAIN (aching all over the body), FATIGUE (very tired/sleepy), HEADACHE (head ache) and VACCINATION SITE PAIN (sore arm at injection sit e) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatments were reported.
Vaccine given 815 am 1/31/13 - that day child felt "not right" - sleepy; next day redness at sites 2 days later with hives on body, pain, sore, itching, (R) arm 5 x 10 cm day 4; 9 x 13 cm (L) w erythema/hot.
7 days after the injection, the site became extremely red, firm, and sore to the touch. There was also some itching and slight sporadic muscle spasms. As of today (4 days later), the redness is still visible, firmness and soreness have lessened.
pt recv vax 30SEP97 & 1OCT97 pt devel a temp of 104;
RED, RAISED BUMPS NOTED RANGING IN SIZE 2MM TO 4 MM. SEVERAL APPEAR TO HAVE BBEN SCRATCHED. NO LESIONS ON TRUNK AND SCALP. 5-7 LESIONS ACROSS FOREHEAD AND UPPER CHEEKS; 5-7 LESIONS SCATTERED ON BOTH ARMS; LEGS; 20 OR MORE LESIONS ON LEGS. REFERRED TO PRIMARY DOCTOR.
Left side of chest gives pains. heart area.  It feels like pressure especially when I'm laying or sitting down. This pain comes random and I feel a shortness of breathe very often.
Vaccines received Monday 9/16/13. Child complained of itchiness on 9/17/13, woke with hives all over body on 9/18/13. Seen in clinic.
This spontaneous report as received from a Licensed Vocational Nurse regarding 6 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 31-AUG-2015, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L00529 and expiry date: 17-FEB-2017, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
the CA125 blood tests shows inflammation and is a marker used to detect cancer and liver disease; currently has slightly elevated CA125 levels.; Initial information received on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 72 years old female patient who had the CA 125 blood tests shows inflammation and is a marker used to detect cancer and liver disease and currently has slightly elevated CA 125 levels. After receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided.  At the time of the event, the patient had ongoing Cancer.   In end of December 2022, the patient received unknown dose of suspect yellow fever vaccine -, solution for injection, 9strength: standard, frequency: once) (lot number and expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient had the ca125 blood tests shows inflammation and is a marker used to detect cancer and liver disease (inflammation) and currently has slightly elevated ca125 levels. (carbohydrate antigen 125 increased) (unknown latency) following the administration of yellow fever vaccine.  It was reported as Patient who is a cancer survivor currently has elevated CA125(marker used to detect cancer and liver disease) levels and received YF-VAX in DEC2022. Wanting to know if there is a correlation between and vaccine and her elevated levels. No other symptoms reported Patient Information. she spoke to an infectious disease doctor and he thinks the levels could be a false high and wanting to know if there could be a correlation between the levels and the YF-VAX. Provided caller with information from YF-VAX prescribing information.  Relevant laboratory test results included: Carbohydrate antigen 125 - On an unknown date: [inflammation] Note: CA125 blood tests shows inflammation and is a marker used to detect cancer and liver disease  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
did not receive enough dose forpediatric; did not receive enough dose forpediatric; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  Patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: UNDERDOSE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "did not receive enough dose forpediatric".  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-202101820616 Different patient, same drug and event;US-PFIZER_INC-202101820617 Different patient, same drug and event
SWEATY; EARLY FLU SYMPTOMS; QUEASINESS; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and peg (polyethylene glycol) allergy, and other pre-existing medical conditions included: Patient was taking birth control pills daily. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 27-FEB-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism. On 27-FEB-2021, the patient experienced painful injection. On 28-FEB-2021, the patient experienced early flu symptoms. On 28-FEB-2021, the patient experienced queasiness. Laboratory data included: Body temperature (not provided) less than 100. On 01-MAR-2021, the patient experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from early flu symptoms, painful injection on 27-FEB-2021, and sweaty, and queasiness on 01-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211203600.
UNCONTROLLABLE CHILLS STARTED AT 5:30PM ACHES THROUGHOUT BODY WENT TO BED UNDER COVERS WITH NO WARMING WOKE AT 1 AM TO GO TO BATHROOM NAUSEA CAME OVER ME. THE NEXT THING I KNEW MY DAUGHTER WAS SCREAMING AT ME TO WAKE UP I HAD LOST CONSCIOUSNESS WITH SHAKING OF LEGS AND BODY FELT WEAK AND COULD NOT SPEAK RIGHT AWAY.
I was already having palpitations, dizziness, and light headedness prior to getting the vaccine, but it was only when I was on my menstrual my cycle. In the last 6 months starting in January 2022 or February 2022 they have increased. I cant workout the week of or after my cycle. These symptoms are still present and more frequent now. I started noticing in March 2022 and April 2022 that i was having the symptoms even when I wasn't on my cycle. I would just maybe be sitting at my desk then it starts happening or even in the grocery store it would happen. I had a follow up with my rheumatologist. Then I went to see my PCP. She referred me to see a cardiologist. to see if I am having a cardiac issue.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L025735, expiry date 14-AUG-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of RECOMBIVAX HB underwent temperature excursion at 32.4 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right 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's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202300328361 same patient, different product/ event;
Parent stated child had fever 103-104 degrees for two days. Very irritable. Family did not take child to primary care provider.
Parent called to say that client had reaction approximately 24 hours after administration on 02/28/06 - when client was at volleyball practice (3/1/06) she began to experience itchy ears, nose and toes.  When client took off her shoes, her toes were red and rashy.  Client's body then got red and she was feeling weak and nauseated.  Client was then transported to E.R. and was given Benadryl and IV hydration fluids.  MD did state that she had an "allergic reaction".  Client was then sent home with instructions on the Benadryl and rest.  Parent stated that client is much better today (3/2/06) and that the rash had receded.
COVID-19 symptoms; COVID-19 symptoms; Reactive arthritis;   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-163-4241110-00 (AbbVie).  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and intramuscular, administration date 20Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 symptoms"; ARTHRITIS REACTIVE (medically significant), outcome "recovering", described as "Reactive arthritis". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for HUMIRA the event(s) of REACTIVE ARTHRITIS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 SYMPTOMS was not provided. The causality of Reactive arthritis, Suspected COVID-19 with respect to Drug PFIZER BIONTECH COVID-19 was Probable.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events Drug ineffective , suspected Covid 19 infection , Arthritis Reactive and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Headache, Myalgia, NauseaVomiting, upset stomach, injection pain Narrative:
No additional AEs; improperly stored adverse event with MMR II; This spontaneous report was received from an office manager referring to a 2 tears old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   The unit that had vaccine was making a noise. To prevent a loss of vaccine, all vaccine transformed to a unit that had intrinsic samples in it on 09-APR-2021. Due to the amount of product in the unit, the temperature got down to 35.2 on one day. On 22-APR-2021, the patient was vaccinated with first dose of the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin) (M-M-R II) (0.5 ml, strength was not reported, lot# S037503, expiration date 20-NOV-2021, albumin status recombinant Human albumin (rHA)) subcutaneously on left arm for prophylaxis operated by a healthcare professional. The event was supported by temperature stability evaluation. The vaccine administered experienced a temperature excursion of 35.2 F, with time frame 480 hours and 0 minutes. There was no previous temperature excursion. A digital data logger was involved. When a new unit was available and temperature at acceptable level, vaccine was put in the new unit on 04-MAY-2021. The vaccine was not available for return due to single use. No additional adverse events reported.  This is one of 6 reports received from the same reporter.
Vaccination given to patient (age 17). No other adverse events besides headaches that began 3/3/21 (the day after the vaccination)
Pt devel t103.7R about 9PM mom checked temp; Given Tempra & a bath; While in bath, had sz lasting about 9 sec according to father;
experienced shaking for about one hour; This case was reported by a pharmacist via call center representative and described the occurrence of tremor in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had taken first dose of Shingrix and experienced shaking for about one hour afterward. The health care professional did not have time during the call to answer additional questions. The reporter not consent to follow up via Email.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has a PMH significant for advanced age (90), HF, lymphoedema, AF. Per note "The patient's condition continues to show decline he is actively dying and comfort measures are in effect. He is not eating or drinking and is had concentrated urine output. He appears to be comfortable."
At approx 9:30 at night - I received chills and then was hot and cold through out the night.  My back began to hurt and that then moved into my neck and muscles as a whole with a little headache. The next morning I took Tylenol which I then started to feel a little better but  then at approx 3PM, my muscles began to hurt again, I took another tylenol which did not seem to help and felt nauseated. I then took a shower hoping it would help, but instead thew up after getting out. For the remainder of the night - my overall body felt week and standing up for long periods, I felt dizzy.
No further AE/PQC reported; she received the first and second shot but I did not received the 3rd; This spontaneous report was received from a consumer on behalf of her daughter, referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  In approximately 2018 (also reported as a couple of years ago), the patient was vaccinated the first and second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, anatomical site of injection, lot number and expiration date were not reported) as prophylaxis, but she did not received the third dose. It had been 2 years since the patient received the last dose (inappropriate schedule of product administration). No further adverse effect reported.
He could hardly walk, legs gave out and he fell and could not get up; Can't lift legs; No strength in the legs and arms; A spontaneous report, was received from a consumer (patient), a 78 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced he could hardly walk, legs gave out and he fell and could not get up (monoplegia), can't lift legs (muscular weakness), and no strength in the legs and arms (muscular weakness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient stated that the morning on 13 Feb 2021, after the vaccine was administered, the patient could hardly walk legs gave out and he fell and could not get up, no strength in the legs and arms, and can't lift legs. The patient was now able to feel everything normal as of this morning on 14 Feb 2021. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events he could hardly walk, legs gave out and he fell and could not get up, can't lift legs, and no strength in the legs and arms were considered resolved on 14 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 30-SEP-2014, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) injection, (lot # K007798, expiration date 29-NOV-2015) (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Cellulitis LA Left elbow swelling also noted minimal swelling below left autocabetal area, pain to are, slight redness not known
Around two weeks after vaccination, started to have left breast pain and left axillary pain. Symptoms worsened over the week and then noticed left breast enlargement. Presented to my office on 8/10/23 for persistent symptoms and noticeable left breast enlargement. Exam otherwise normal expect with enlargement and some mild pain with palpation. Sent for a STAT breast US and started on keflex for possible mastitis. Ultrasound completed on 8/11/23 and showed an enlarged left axillary lymph node, likely reactive, BIRADS 3 short interim follow up recommended. Has slight improvement with abx. Plan was to re-ultrasound in 4 wks. However, on Sunday 8/20 developed severe pain to left breast and some to right breast border. ER visit on 8/21/23. Had labs and a negative chest xray. Current still in pain and pending a consult with breast specialist on 8/24/23
vomiting, measles like rash on trunk, and arms, temperature of 101.5