chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:38 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 30.28.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
My heart beats per minute went up to 75 from 57. (I wear a fitbit fitness tracker)  It started at about 5:30 pm and lasted for less than 30 minutes and then returned to normal the fifties again
Started getting ringing in my ears about 5 or 6 days after getting my second injection of the Moderna vaccine on March 7th. I received the first injection on February 7th. I didn't notice any side effects  from the first shot other than minor soreness in the injection site of my left arm. I had minor soreness with the second shot as well but it was less than the first. I did take two 400 mg Anacin plus caffeine (32mg) 3 days before my second shot for a sinus headache I  had at the time. I am going to see my ear, nose and throat doctor this Friday 3/26 to have him check me out and maybe get a hearing test if he thinks it's necessary.
Moderna shots given at a vaccine facility on 2/6/21 and 3/10/21. She has had a gradual onset of shortness of breath. Seen by me on June 1. Dx cardiomyopathy, Class 3 CHF. Hospitalized at local Medical Center. Currently still being treated by cardiology team.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium
Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat; Reaction; Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat), VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint) and HYPERSENSITIVITY (Reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety. Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Anxiety.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat) and HYPERSENSITIVITY (Reaction). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat) had resolved, VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint) had not resolved and HYPERSENSITIVITY (Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-249108, MOD-2021-271057 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-JUL-2021. No New Information was received.
pt recv vax 3SEP96 & devel a fever & a maculopapular rash dx w/fifth's disease;
Received influenza injection 10-7-08 at 11:30 AM.  By 2:30 AM, 10-8-08, was having difficulty swallowing.  Went to ER.  Symptoms resolved by 5:30 AM.  No treatment.
This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (Merck) (lot#: J005177, expiration date: 03-NOV-2014) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005558, 1404USA0055589, 1404USA005560, 1404USA005561, 1404USA005562 and 1404USA005563) from the same source. Additional information has ben requested.
My first vaccination on 3/1/2021 #014M20A I also had a reaction but did not appear until  about 10 days after my vaccination. Arm sore and a rash.   This second vaccination on 4/1/2021 the reaction was the next day, rash was worse than the  first time.  Area of the rash was spread out more, sore and itchy.
HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
Covid19 breakthrough.  1st vaccine received on 05/20/2021.  77 y/o female with PMHX of HTN, COPD, DM, HLD presented to ED with c/o SOB, cough, body aches x4 days.  Pt with hypoxia, room air O2 sat 85%.  Placed on O2 at 4L NC.  CXR-LLL opacities, atelectasis vs PNA.  Afebrile.  Pt started on IV ABX, Steroids and Remdesivir.
Acute onset (approx 3 hours) of left middle finger pain, swelling, decrease range of motion. No isolated joint swelling, erythema, increase warmth. WBC normal, ESR normal. Follow-up 2 days later, more swelling noted throughout hand, patient complain of pain in specific finger, but not over joint. Also reports remainder of left fingers and left wrist with some soreness. No erythema, joint swelling increase warmth. WBC normal, ESR normal.
FAINTED; SLOW MIND; BODY ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's past medical condition included patient typically faints after receiving vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fainted, slow mind, body ache, chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, chills, body ache, fatigue and slow mind was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210346239-covid-19 vaccine ad26.cov2.s-Fainted. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
fast heartrate ever since, especially when she starts to move herself; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included ALPRAZOLAM, ATENOLOL, HYDROCHLOROTHIAZIDE, AMLODIPINE and METFORMIN for an unknown indication.   On 10-Feb-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself). At the time of the report, HEART RATE INCREASED (fast heartrate ever since, especially when she starts to move herself) outcome was unknown.            No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02-AUG-2021 and contains no significant information. Reporters contact details updated, Address and email address. Patient identifier in initial source document was LEM and in FU document LM were updated.
c/o sever body aches, fever, nausea x 36hr;resolved w/o medical attention;
Syncope, lasted a few seconds immediately after vaccines were administered. No injuries, spontaneously recovered.
Severe headaches and diarrhea the day of and day after. Moderate stomach aches. Hot/cold flashes during the night and difficulty  staying awake. Only felt better once I slept, but quickly felt the same after waking up.
pt was adm to hosp 21AUG97 send home w/apnea;pt exp apnea;poss sz not confirmed, newborn apnea;pt devel fever 6PM;pt vomited x 1 & turned blue around mouth;dx sleep apnea;
My nursing 8 month old infant developed symptoms; Upper respiratory disease (nasal discharge, cough); Upper respiratory disease (nasal discharge, cough); Upper respiratory disease (nasal discharge, cough); This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 8-month-old infant patient (reporter's child) that a 8-months-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via transmammary route of administration on Apr2021 as dose 1, single for covid-19 immunisation. Medical history included infant has congenital heart disease. The patient's concomitant medications were not reported. On an unspecified date in Apr2021 reporter nursing 8 month old infant developed symptoms of upper respiratory disease (nasal discharge, cough) the evening of the date she received her first dose. Reporter considered events as non-serious. The outcome of events was unknown.  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-2021417489 maternal/child
Mom describes a red blotchy rash about a silver dollar size around the injection site. Her son complains that there is pins and needles all over his body.  He had a fever of 101.6 6/23/2014 and vomiting from 2:30 am to 3:30 am on 6/24/2016.  The vomiting has stopped but he still has a fever of 100 on 6/24/2016.
Itching, redness, hives...obvious allergic reaction; escorted to ER by RN; treated by ER physician.
p/vax pt broke out w/rash to face, back, abd & few to legs on 10/2/99;pt states that area do not itch but do hurt;had low grade fever 99.6;sore throat 2 days p/vax;pt seen by MD;
Information has been received from a pharmacist referring to a patient of unknown age and gender. The pharmacist reported the patient was administered the first dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) on 31-JUL-2013, the second dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) on 21-AUG-2014, and on 23-JAN-2015, to be administered the third dose of GARDASIL (0.5ml, intramuscular, lot# and expiration date were unknown) in the pharmacy. The patient experienced an inappropriate schedule of drug administration. No product quality complaint was involved. No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
"I didn't feel right". I had "shortness of breath" coughing. It subsided. Then I was "tried and didn't want to eat." It progressed to a cold. Sore arm also.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt moved to chair after vaccination and fell forward about 10 minutes after his shot, hit his head on the floor and cut his forehead. paramedics came and evaluated him and he decided to go home rather than seek medical care.
There was no adverse event to my knowledge, patient was being COVID tested for placement and came back positive.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 04Nov2021. Dates of administration of vaccine was 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
On 1/1/2022, I started to noticed my entire body was warm and itchy. Over the next few hours my head became increasingly itchy. I developed a raised red rash on my upper back. The next day the rash spread to other areas of my body- raised red, itchy welts / hives. This continued daily for the next week or so. Started on medications and mostly controlled. Do have some breakthrough hives when I do not take medications on time.
Seven days later I was short of breath as though I had pneumonia and thought I was having a heart attack,  I felt as though I was being stoned with a board and rocks piled on top.  Difficulty breathing when in bed.  All 12 lead ekg fine  Blood work fine, but mildly elevated D Dimer.  Did ct and X-ray  and found a benign pulmonary or lymphatic module.    I never had one on a scan X-ray previously.    Saw cardio. Score of 21 on calcium test, snd having stress test this week. It is 3 weeks since the event. I am very tired (exhausted) most of the time. I wind easily, although shortness of breath is improving.
On 4-4-19 patient woke up to redness on left palm and severe itching which eventually spread to his right palm. Initially the Dr. put him on Keflex 500mg which did nothing. The patient completed two rounds of 5 day Prednisone 20 mg which helped but did not completely take it away. The patient went to a dermatologist on 5-8-19 and was diagnosed with a herpes type infection and put on a 10 day taper of prednisone.
Information has been received from a 65 year old male patient referring to himself. The patient had a weakened immune system. The patient's medical history included heart transplant. The patient did not have any drug reactions/allergies. On 01-OCT-2016, the patient had a headache. Concomitant therapies included TYLENOL, tacrolimus and mycophenolate sodium. On 03-OCT-2016, the patient was vaccinated with ZOSTAVAX (one time vaccination, dose and route unknown) (product use in unapproved population). At time of the vaccination, the headache was persisted. No treatments or labs were performed. Additional information has been requested.
Patient experienced pain about vaccination site (Adacel) followed by radiating pain to shoulder and neck over several days. Vaccine given on 5/11/07. Over the next several weeks she experienced worsening pain that radiated to her back, hips and lateral aspect of her knees. Pain was severe enough to decrease activity and cause an antalgic gait. She had no objective weakness, ataxia or other neurologic finding but did have weakness in her hip extensor/flexors on exam 7 weeks after vaccine reciept. Labs drawn on 6/20 - at time of evaluation for pain revealed a CRP that was elevated at 71 and a ESR of 30 that was drawn at the same time. Repeat CRP today is pending. Labs suggestive of a more global inflammatory response.
Day 8 after the shot, awoke to very deep pain in right shoulder (felt like a bee or wasp sting). Red area where vaccinated, got larger and swelled to about 6.5X7" in a couple of days. Very itchy, warm, painful but not at bad as at first. Applied ice and topical corticosteroid cream 2-3x per day. Started to subside a bit by day 12 post shot and continued to subside until 6-7 days after the initial day 8 post shot occurrence. Stopped using ice after swelling subsided, still use light amount of topical corticosteriod to counter slight itchiness.
Three days after receiving varicella virus vaccine live the pt developed 2 small pea sized red marks with white tops at the injection site on the left arm. The pt was fussy but had no fever. It is uncertain whether or not the rash was varicella like.
Information has been received from a physician concerning a 70 year old male with no medical history who on 27-OCT-2008 was vaccinated with PNEUMOVAX, injection (lot # not provided). On 27- OCT-2008, after getting vaccination, the patient experienced swelling at the injection site, fever and chills. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Additional information has been requested.
Client developed hives on face, head, neck and arms after vaccination. Per Dr not to give Benadryl due to drowsiness and client did not have someone to drive her home. Client self medicated with Zyrtec while onsite and symptoms started to improve. Client requested to leave AMA. Client advised by MD and client verbalized understanding. Vitals WNL. Client left site AMA.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX. Previously administered products included Flu vaccine with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness. On an unknown date, the outcome of the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, body temperature increased and tiredness to be related to SHINGRIX. Additional information was received as follows: The patient experienced arm soreness occurred in the left arm greater than anything experienced with flu shots in the past. The patient experienced events which occurred within 12-24 hours after receiving SHINGRIX. The elevated temperature reported as 99 degrees F. Events resolved within 36 hours after SHINGRIX dose. The contact details of the physician was also provided. This case was linked with cases US2018049831 and US2018049830, reported by the same reporter.