chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever, swollen legs for 1 wk 2RX, 2 vials;f/u #1 dx prolonged rxn to DTAP muscular hematoma vx infect;pt tx'd w/duricef for 10 days;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "Covid Vaccine has caused some reactions with women's cycles and post menopausal bleeding". The reported seriousness of the events was non-serious (as reported). This was not normal, she knew the Covid Vaccine has caused some reactions with women's cycles and post-menopausal bleeding. She has done research on my own, but reporter wanted to have access to the studies that Pfizer has done. She asked how can she get access to the studies and what Pfizer knows about this now. Because what was being discussed is a hysterectomy and she really did not want to have her uterus removed if she was needed to. She asked were there any studies that Pfizer has done on this, she understood she was not the only person this has happened to. She would like access to all the studies that Pfizer has done on this topic. Any research, any information about this that Pfizer knew so far, so she could make an informed decision about what to do. She had already called the CDC and already filed a report with the CDC. If she did not start to get somewhere with somebody, one company that was involved in this or somebody, she would just call the media. She did not believe that citizens should be, she thought that was needed to be transparent. We all took these shots, we trusted and it was important we all understand what it did to our bodies. What does she do about this, she should not be bleeding. The reporter was not saying it was the Covid vaccine, but we have ruled out everything else. She though it was funny when it was referred to as an emotional thing for women, when talking about women's health, it really bothered her. She was curious because she put this in her body. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
4/28 PM, 101.2 fever, vomiting. No runny nose or coughing. Fever 4/29, didn't temp. Fine 4/30, no fever. Fine 5/1 AM, no fever.  5/1 PM fever, 101.6, complaining of sore throat. 5/2 AM woke up with rash on body and neck, progressed to face, still sore throat. No coughing or runny nose/congestion.
10/31/2021, two weeks of feeling unwell, ENT ran a scope and could not find anything, gave a strong penicillin that broke me out, 11/09/2021. Acute strep throat and I was given a steroid shot. Amox-clav took those tablets and started break out over the medication back 12/16/2021 to see him. Allergy medication and Flonase and Claritin. Went to see another ENT Doctor.  02/20/2022 CAT scan of the throat biopsy Prilosec for heart burn and acid reflex. Sent in for CAT scan; did not show any thing. 03/15/2022 biopsy for a biopsies of the right lymph node and took four samples, lymphoma cancer have appointed 03/25/2022 received the results and schedule to cancer center 03/30/2022.
I gave the patient the vaccine on 05/17/2018. The patient has stated that he has had a flare up of his colitis ever since receiving the vaccine. Patient also states that this is the first episode of his colitis that he has had in a long time.
pediatric dose undiluted was given to an adult; pediatric dose undiluted was given to an adult; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 10Mar2022 (Lot number: FL0007, Expiration Date: 28Mar2022) as dose 1, 0.3ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (medically significant), PRODUCT  PREPARATION ERROR (medically significant) all with onset 10Mar2022 and all described as "pediatric dose undiluted was given to an adult".  Additional Information: The pharmacist made a mistake yesterday and gave a pediatric dose to an adult. They got 0.3 ml for pediatric dose but it was undiluted. The pharmacist was thinking it was Pfizer adult vial that doesn't need to be diluted so the pharmacist was just calling to see what recommendation Pfizer has if that happened.
Patient said that their arm felt like they had a pulled muscle starting  5/10/2021. She said it has become worse as time goes on. She said that she can barely pick up a spoon without it hurting. She is going to the doctor to have it evaluated soon she said.
pt recvd vax; at approx 7pm that noc,pt was awake,shaking & eyes rolled to back of head,lasted 45-50 secs;to er;had another episode;pt looked nl,was not fussy;1st 2 days p/ shots,ran t 100.2-103 ax;no rashes or oth sxs noted;
MMR was given to pt in his right deltoid, SC. After about 5 minutes, mom reported to us that he had welts on his arm. Benadryl was given, ice was applied and pt was watched. Left after 45 minutes. Phone call to MOC later and welts were gone and pt is doing fine.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
I have experienced irregular menstruation cycles for 5 months since my Moderna booster vaccine, despite being on oral contraceptive and having no prior history of irregular cycles. My cycles last between 20-36 days with my periods lasting between 1 and 11 days. No heavy bleeding or severe cramping - cycle timing is the only irregularity. I obviously can't say with certainty that the Moderna vaccines have caused this change in my cycles, but I was asked to report it after documenting my symptoms in a V-Safe check-in.
I did not go to the doctor, but I used the PRN meds that I had. I started developing a sinus allergy problem. It was lots and lots of clear liquid out of my head, coughing and congestion. I had those probably about a week. And then after that went away, I had a lot of achiness and soreness all over my body. That lasted three weeks with all of the symptoms (includes the sinus stuff.) I was tired through that whole time. I wasn't running a fever. After the third dose, 9/30/2021 - 24 hours after the vaccine, (FE3592 - lot number; I received that intramuscular on right arm) I had some problems like this that were similar to the July symptoms but very mild compared to what I had had after the second dose in July. It only lasted about four or five days.
tested Ag positive 12May no symptoms; tested Ag positive 12May no symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 12Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 33 years and on 23Mar2021 as dose 2, single (Lot number: EL3247) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "tested Ag positive 12May no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19. Clinical course: It was unknown if patient had any other vaccine in four weeks. She was on vacation after wedding in (event occurred country name withheld) and tested Ag positive 12May no symptoms  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Numbness felt in 2 fingers of left hand; and left face, mouth, cheek, felt within 2 minutes if getting the shots. Symptoms have been on and off for 2-3 days, and came back consistently after that. Numbness is now felt still in fingers, face, mouth abs also ear and eye.  All left side only.   Noticed difficulty to focus, loss of some strength in left arm. Light headache. Increased blood pressure.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 2:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:06 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Dose taken on 27 Feb 2021 with batch number 014M20A underwent multiple temperature excursion on 27 Feb 2021 from 33 to 35 degrees Fahrenheit from 09AM to 05 PM. Vaccine was moved to fridge on 24 Feb 2021 and Beyond Use Date for the vaccine was 26 Mar 2021. Product moved to clinic on 27 Feb 2021. Age of the patient at the time of vaccination was 72.56 years.  Dose taken on 27 Mar 2021 with batch number 019B21A underwent temperature excursion twice on 27 Mar 2021 till 35 degrees Fahrenheit at 09AM and 10 AM. Vaccine was moved to fridge on 23 Mar 2021 and Beyond Use Date for the vaccine was 22 Apr 2021. Product moved to clinic on 27 Mar 2021. Age of the patient at the time of vaccination was 72.64 years.  No treatment medication reported by reporter.
21OCT98 swelling of legs, screaming @ the top of lungs was given combo shot for 15mos not 2mo;
Pulmonary Embolus, Hospitalized, treated with heparin, then rivaroxaban. Initially short of breath and chest pain, now asymptomatic.
Severe reaction to the SPIKEVAX 12+ manufactured by Moderna. Some of the severe adverse effects included comatose-like effects, nausea, extreme weakness, some loss of muscular functions. I have been around people that were under chemotherapy and this comes as close to chemotherapy as I imagine it to be. I have taken all 5 previous COVID vaccines, all made by Pfizer (2 original and 3 boosters) with some weakness and sleepiness reactions, but this immunization of SPIKEVAX by Moderna was far worse. Due to the unavailability of the Pfizer vaccine, I agree to take the Moderna vaccine with the CDC states is interchangeable with the Pfizer vaccine but based on my experience this does not mean equivalency in every respect, including adverse reaction. My conclusion after this experience is either never take a COVID vaccine in the future or stick to the Pfizer vaccines exclusively. The equivalency stated between the Pfizer and Moderna vaccines is overstated especially in adverse reactions.
First dose was only arm soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Fever t102 R, shaking episode w/screaming x 5 min not consolable; fell asleep p/shaking;
Five months after vaccine, tested positive for COVID-19; Doctor also said I tested positive for another virus as well, in addition to COVID-19. Don't remember the name of the virus; Was prescribed PAXLOVID.
Pfizer BioNTech COVID-19 Vaccine EUA: Administration Error NOT Diluted Patient received Pfizer Vaccine on 8/23/2021 that was not diluted prior to administration. Patient did not experience any untoward effects.
fainted, dropped to floor but was supported, hit back of head;then appeared to have jerky movements of arms & legs, was incontinent of urine & didn't respons for approx 30seconds;
pt recvd vax 930AM; 1PM high fever-fussy, redness on face, eyes red, hives on shoulder; next AM hives worse; 445 seen by MD;
pt recvd vax; 7oct94 devel t of 100 & arm red & swollen; 8oct94, t 102 & arm red, swollen 10cm diam; h/a; fever responded w/ apap;10oct94, still some redness & tenderness at inject site; recommended warm compresses;
Malaise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Malaise) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension since 15-Mar-2021. Concomitant products included AMBRISENTAN (LETAIRIS), WARFARIN SODIUM (COUMADIN) and TADALAFIL (ADCIRCA).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MALAISE (Malaise). The patient was treated with TREPROSTINIL SODIUM (subcutaneous) ongoing from 15-Mar-2021 at a dose of 10.0 mg and TREPROSTINIL SODIUM (subcutaneous) ongoing since an unknown date at a dose of 0.081 microgram/kilogram. At the time of the report, MALAISE (Malaise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The medical history included secondary pulmonary arterial hypertension. On 1 Apr 2021, 18 days after initiating SQ Remodulin, the patient had received the second COVID-19 shot and since then the patient was feeling under the weather. It was also reported that the patient was on Remodulin Remunity cartridge. Action taken with SQ Remodulin was not reported for the event of malaise. Action taken with unspecified Covid-19 vaccine was not applicable for the event of malaise. At the time of reporting, the outcome of malaise was unknown.   Reporter did not allow further contact
This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B22A, 071F21A, 022M20A and 029L20A) for COVID-19 prophylaxis. The patient had no allergies to medications, food and other products. The patient had not had COVID + test or diagnosis.  Concurrent medical conditions included Hypertension Concomitant products included ATENOLOL and TRIAMTERENE for Hypertension. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore) had not resolved. The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient had not experienced a similar event in the past. No treatment medications were reported.
4 day hx of fever w/max temp 103;seen w/erythematous papular rash behind ears spreading rapidly to entire body >50 lesions;
I woke up on May 25th 2021 with chills and a sore throat and a splitting headache and chest congestion. i still have these symptoms as of today June 2nd 2021.
ICHING HIVES,  SKIN DOCTOR PRESCRIBED TRIAMCINONE  0.1 CRM, ICHING HAS NOT STOPPED OR LESSENED.  IS DRIVING ME CRAZY.  IF YOU KNOW OF A REMEDY PLEASE ADVISE ASAP
Chills, shivers, muscle aches, headache (especially in right eye), vague nausea, flu-like symptoms peeked approx. 17 hrs. after vaccination and gradually receded until approx. two days after vaccination.
DONOR HAS MACULAR RASH TO RIGHT ARM AROUND INJECTION SITE EXPANDING APPROX 3 INCHES. DONOR DENIES HAVING ANY PAIN OR ITCHING, DONOR STATES NOT NOTICING RASH UNTIL 5/16/2015.
Patient called this morning to say she got hives from the vaccination she received last night. She stated it started on arm where she got the injection and then moved to the other arm. Hives are mostly on her elbows and wrists. She put hydrocortisone cream on and that seems to help. I told her to take benadryl also.
Swelling and a large knot at injection spot, rubbed with alcohol and iced, brought swelling and soreness down, now small knot, no pain or soreness.
No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001892: US-009507513-2104USA001896: US-009507513-2104USA001895:
Information has been received from a 65 year old female patient via hall partners concerning herself, who enter a patient support program, title as H-5432, ZOSTAVAX patient segmentation message testing. The patient's concurrent condition included premature arthritis, high blood pressure and diabetes. The patient's medical history included heart valve (mitral valve) replacement. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dose and lot # were unknown). Concomitant therapies included HUMIRA, COUMADIN, simvastatin (manufacturer unknown) and metformin. On an unknown date of November 2014 the patient experienced redness and soreness at injection site for 1 1/2 weeks. The outcome of events was reported as recovered/resolved with sequelae an unknown date of 2014 (reported as 1 1/2 weeks post injection). The reporter the events to be related to PNEUMOVAX 23. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored doses (11 doses) of M-M-R II injection (dose, frequency and route were not reported) lot # L037356 with expiration date of 28-SEP-2017 (4 doses) and lot # M028131 with expiration date of 03-SEP-2018 (7 doses), for prophylaxis. The M-M-R II doses were reconstituted with sterile diluent (lot # and expiration date were not reported). The temperature of the M-M-R II was between 47 F and 77 °F for a time frame of 2 hours and 24 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. Additional information has been requested.
Pt. is a 60 y.o. male who presents to the Emergency Department with complaints of fever shortness of breath and weakness.  Status post varicella-zoster vaccine yesterday.  Weakness.  States he felt like he was going to pass out.  Body aches.  No vomiting or diarrhea.  No paresthesias.  Moderate severity worsens with activity relieved with rest.  No chest pain.  Has had shortness of breath."  BP 169/82  | Pulse 86  | Temp 99.1 °F (37.3 °C) (Oral)  | Resp 16  | Wt (!) 103.4 kg (228 lb)  | SpO2 93%  | BMI 30.92 kg/m²   Pt given duoneb nebulizer solution and IV decadron, normal saline, and toradol before being discharged.