chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They are puffy/They swell like welts; She has bruised her body from scratching,she can't help it; They start as red dots; Extremely itchy/ they itch so bad; They swell like welts; A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad) and URTICARIA (They swell like welts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN SWELLING (They are puffy/They swell like welts), CONTUSION (She has bruised her body from scratching,she can't help it), ERYTHEMA (They start as red dots), PRURITUS (Extremely itchy/ they itch so bad), URTICARIA (They swell like welts) and RASH (A rash in the inner side of her left forearm and is now all over the body / started in the left arm and then went to the right arm, ankles, legs, waist, hip area, stomach and side of the breasts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she is on some medications.  It was reported that patient experienced adverse events 7 days post her first dose and  thought the adverse events occurred was due to poison ivy.The patient is unsure about getting her second dose. She had an appointment with her rheumatologist on 14-Sep-2021.
Slow onset of Tinnitus started in December 2021, grew to constant and continuing three months later.
RIGHT DELTOID AREA WARM ERYTHEMA >3CM DIAMETER, NOT SPECIFICALLY TENDER TO PALPATION
My 14 yr old daughter and I went to get our flu shots at our local pharmacy last Friday, 10/12/2018. That night I slept fine till about 2 am or so and woke with what I call RLS, Restless legs. I could not get back to sleep for a hour or so and was very restless. I am in good shape with no health issues and workout regularly. The day after the Vaccine my entire legs were sore, not the joints, but the muscles. It was I had done a all event of leg exercises and dehydrated and cramped my calf muscles. My calfs hurt the worst all day, but the quads also were sore. I stayed busy all day, but the muscles were still sore all that day. My Daughter who is 14 and in perfect health woke Sunday, 10/14/2018 and told me her legs were killing her. I asked is it the muscles and she said it was. I had not said anything about my pains the day before after getting the vaccine and did not mention it to her. She kept complaining about her leg muscles most Sunday being very sore. Myself on Sunday had only mild pains left. Neither of us went to a doctor for treatment and by Monday I was pretty much over it.
fever and body aches beginning at 2AM. treated with Ibuprofen with resulting reducting in fever but continued body aches/myalgias that lasted until 1pm on 1/10/21. Fatigue starting 5pm 1/9 and lasting until 5pm 1/10
Asthma attack Fever Fatigue Headache Lethargy Body/Muscle aches
DOSE # 2 GIVEN 23 DAYS AFTER DOSE #1 INSTEAD OF 28 DAYS
pt report stiffening of body for about 6 hours. was laid on side in bent position, stiffened.
This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route and anatomical location of administration were not reported). On unknown dates, after vaccination, each of these patients developed "discomfort" at the site of PNEUMOVAX 23 injection (No description about the "discomfort" was specified). No Product Quality Complaint (PQC) was involved. The outcome of injection site discomfort was unknown. Additional information has been requested.
Awoke the next morning feeling dizzy and sore. Went into bathroom to get pain reliever. Syncope and hit head upon falling down.  Felt hearing was off and felt dizzy.  Mother put him to bed and called us. Had got him up and sent him to school - in school he had worsening dizziness and his speech was off and went to Emergency Room in afternoon.
This spontaneous report as received from a healthcare worker refers to two unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of 0.5 ml improperly GARDASIL that exposed to 32F for 39 hours, intramuscular. No adverse effects were reported. Additional information has been requested.
Flu like symptoms and leg swelling.  Pain in legs and arms for over for several days.
tightness on left upper shoulder and left side of the neck; tightness on left upper shoulder and left side of the neck; felt like having the flu; WEAK; COLD; difficulty sleeping because of the pain; body aches; burning in the arm of injection; chills; A spontaneous report was received from a  43-years-old  female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 3 Feb 2021, the patient experienced the events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  was unknown.  Based on regulatory authority comment, Myalgia and Chills (listed). Injection site pain coded Vaccination site pain
Sore, Itching and large red warm ball around shot access. for one day so far.  Treating with cold compress. Benadryl and Acetaminophen .
Arthralgia, Fever, Fatigue, chills, injection site pain and swelling Narrative:
4.5 x 1.5 inch area of erythema, tenderness at injection site 48 hrs post injection. (L) axillary lymphadenopathy (< 1 cm), tender. 3.5 x 1.0 inch area of small developing vesicles within larger area of erythema.
This spontaneous report as received from a nurse refers to a 65 year old male patient who is also a physician. On 26-SEP-2013 the patient was vaccinated with single standard dose of PNEUMOVAX23 (lot # reported as H022280) subcutaneous in the right arm. Concomitant therapies included influenza virus vaccine (unspecified) administered on 26-SEP-2013 in the left arm. On 26-SEP-2013, the patient developed redness and warmth in a 2" diameter sized area at the PNEUMOVAX23 injection site that later turned into a hard golf ball sized reaction under the skin that was hard and very tender. The hardness and tenderness went away after about 5 days on approximately 01-OCT-2013. On 26-SEP-2013, the patient also developed chills that lasted for 5 days, but did not develop a fever. The patient did not seek medical attention. The outcome of all the events was reported as recovered. Additional information has been requested.
patient passed out, she was clammy and sweating.  She stated that it was the same feeling that ct dye gives. We called the ambulance and the paramedics checked her an her husband out. He was feeling nauseated and lightheaded after she started feeling better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 on 20Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "history of stroke" (unspecified if ongoing); "Known allergies: Latex" (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 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Sep2023 to 16Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Cluster of red rash at injection site on left leg, spread across arms, legs, back, face, belly, chest, hands and feet.  Erythematous maculopapular rash.
Information has been received from a physician concerning a 21-week-old female with no pre-existing allergies, birth defects, or medical conditions who on 09-APR-2007 and 11-JUL-2007 in the PM was vaccinated with the first and second (PO) dose of Rotateq (Lot # 656833/0407U - second dose). There was no illness at the time of vaccination. On 11-JUL-2007, within a minute (also reported as 15 seconds) of vaccination, the patient vomited. There was no adverse effect after the first dose was administered. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic tests or laboratory data. Additional follow up information indicated that the baby was fine and she believed that the baby was "worked up" over getting the shots and threw everything up. The baby will receive her second dose of Rotateq at 6 months of age. No additional information is expected.
Pt recvd 3 doses of Hep B vax 31JUL90, 4SEP90, & 24JAN91; P/ each inject pt exp chills, fever, aches, lethargy, nausea, burning when injected & soreness of arm which lasted 2-3 days;
PATIENT RECEIVED J AND J ( JANSEEN VACCINE)  EARLIER FROM DIFFERET LOCATION  BUT ON 06/24/2021  PATIENT  CAME TO PHARMACY AND RECEIVED PFIZER COVID VACCINE  (DOSE NUMBER 1)  WIHTOUT INFORMING ABOUT PRIOR VACCINATION RECORD . ALSO PATIENT MARKED NO ON THE CONSENT FORM FILLED AT THE PHARMACY BEFORE RECEIVING VACCINE  , WHILE BILLING TO THE INSURANCE ,PHARMACY FOUND OUT THAT PATIENT ALREADY RECEIVED DIFFERETN VACCINE BEFORE  AND LATER ON PATIENT CONFIRMED THAT ALSO.
doses given after temperature excursion; doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion   ) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion   ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion   ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and medication information provided. No treatment information provided
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series 2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced off label use.(dose number in series 2)  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210549, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211209775, 20211209798, 20211209874, 20211209884, 20211209679, 20211209706, 20211209740, 20211209843, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210107, 20211210133, 20211210141, 20211210143, 20211210159, 20211210160, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210590, 20211210662, 20211210670, 20211210684 and 20211210824.
Hidradenitis suppurativa flare; Flu like symptoms; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Arm Pain) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.  The reporter's causality for the events of  hidradenitis suppurativa flare,  arm pain and flu like symptoms was not provided.
extreme arm soreness after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme arm soreness after receiving the vaccine.) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extreme arm soreness after receiving the vaccine.). At the time of the report, PAIN IN EXTREMITY (extreme arm soreness after receiving the vaccine.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.       This case was linked to MOD-2021-095271 (Patient Link).
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 4:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 4:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient ethnicity. The patient received Moderna vaccine on 03-Feb-2022 16:59:33, past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
CLIENT STATED SHE HAD DIARRHEA, VOMITING,COUGHING AND A TEMP OF 99.9
Swollen lymph nodes; left arm pit lump. I mean it wasn?t a lethal side effect. But I didn?t go to the doctor?s for it, and it?s still there. So, that?s why I reported it. It?s been since the day I got the shot through now still. I just got my second vaccine today, on my right arm so I can track the left side and see if this really does correlate with the vaccine.
Hospitalization for syncope (tested COVID-19 positive as an outpatient) on dates 8/25/22-8/29/22. Treated with no COVID medications.
Fever - 101F lasted 48 hrs began 12 hours post vaccination Mental fog / depression  - for about 4 days Nausea/GI discomfort - 48 hours Fatigue - 48 hours Injection site soreness - patient is still experiencing this today 9/4
Pt passed out about 10 min after receiving GARDASIL #3. Did not faint with other 2 GARDASIL vaccines.
Pt is a fully vaccinated individual as of 3/19/2021 when he had his 2nd Pfizer covid 19 vaccine. He presented to the Emergency room on 5/18/2021 with concerns for covid 19 pneumonia. He is a 72-year-old male undergoing chemotherapy for follicular lymphoma through cardiology center who stated he had a PET scan done at other facility earlier today and stated the oncologist did not like the results and sent him to the emergency room.   They were concerned about Covid pneumonia and sent him  to be evaluated and admitted as well as treated.  Patient stated he has been having trouble over the past several weeks where he has been weaker and more tired, just the week prior he had a syncopal episode.   He has since felt more tired than usual and he has had a chronic nonproductive cough. He was admitted to the hospital after testing positive on nasopharyngeal PCR for covid 19 with PET scan findings of ground glass opacities and b/l pneumonia. He was treated with remdesivir and decadron and sent home on 5/19 to recover. He did not require oxygen during his hospital stay or on discharge.
Itchy rash and raised hives around injection site 9 days after injection was givien. Tender and warm to touch. Very itchy and red still on day 11.
Sore arm, nausea, vomiting, diarrhea with onset 24 hours after injection time with a duration of 24 hours