chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was stored more than 12 hours post puncture; no adverse event; Dose administered  more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered  more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored more than 12 hours post puncture).    Concomitant product use was not provided by the reporter.  Date the vials was initially stored in refrigerator was 03-Aug-2022.  Vials was first punctured on 10-Aug-2022 at 10:45 am.  The patient received vaccine on 11-Aug-2022  at 09:05 am.  Vials was stored in fridge post puncture.  Vials did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 30 minutes.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-628730, US-MODERNATX, INC.-MOD-2022-628730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628730:Case for adult Patient 2 of 2
itching, lip swelling - started ~45 minutes after vaccine administration, resolved w benadryl
went on Saturday afternoon to the  Arena where the 2nd dose was given. On Sunday afternoon he was not feeling well, achy, and by evening slightly light headed. Monday morning he had worsened, and tried to stand, and collapses, the home health nurse called for an ambulance. By mid afternoon on Monday March 1st he was blue around the lips and skin, doctor worked to try and stabilize  him throughout the evening, until his heart stopped at 1:30am on March 2nd.
Pt. developed a lump/swelling in his left deltoid about the size of a baseball. He also experienced a mild fever, nausea, and headache, along with general muscle aches throughout his body. When I followed up with this patient on the 23rd of February, the swelling was only slightly reduced with an intermittent headache. All other symptoms were resolved. Pt. treated himself with one ALLEVE a day.
To ED on 10/18/21. Stated that 30 minutes after vaccine on 10/16/21, he had a painful left arm and it became numb. Began to have vomiting and diffuse abdominal pain with increasing dyspnea.
Rash at injection site. Then the next day vomiting and diarrhea all day.
I experienced diarrhea that lasted for two months, using the restroom 3-4 times in the morning and 2-3 times in the evening.
This spontaneous report was received from a currently 70 year old (also reported as an adult) female patient refers to herself. The patient's medical history included unspecified previous illness. On an unknown date (when the patient was 65) the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date the patient experienced minor bronchiectasis which was probably not bacterial but from the unspecified previous illness. The patient also wanted to know if she should have the PCV 13. The outcome of bronchiectasis was reported as not recovered (at the time of the report). The relatedness between bronchiectasis and PNEUMOVAX 23 was not reported. Additional information has been requested.
pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing symptoms of vomiting, headache, muscle aches. I recommend you get tested for COVID just to rule out whether you have COVID or not, if test comes back positive you would have to wait till the symptoms subside prior to getting your second dose.
administered subq instead of IM. Patient notified of error. Patient states arm is sore but otherwise ok.
No adverse reaction. Patient was seen on 11 April by PCM told that he was having normal vaccine reaction, malaise, swollen lymph nodes. Went to ER 15 April with same complaint and was again told normal vaccine reaction. Was seen for ER follow up by third provider (myself) 16 April and again told this is a normal vaccine reaction. Report required by our local Joint Commission Coordinator/Risk Manager
Experienced high fever(102) x3 days, runny nose, headache, soreness in shoulders, arms, hands and nose. Day three experienced cough, sore throat and swollen lymph glands in neck.
5 inch round red circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (5 inch round red circle around injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (5 inch round red circle around injection site). At the time of the report, INJECTION SITE ERYTHEMA (5 inch round red circle around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Doctor prescribed antibiotics to counteract reaction.
wednsday - tired/fatigue friday - tingling sat - rash went to urgent care diagnosed with shingles.
pt recv vax;had swollen & red arm;hot to touch,arm swelling was 80mm;
Starting Friday, Aug 12th, I had breakthrough menstrual bleeding. It's a moderate flow and is still continuing. Today is day 5. I have not had any heavy bleeding for about 3-4 months. I had a uterine ablation in October of 2021.
Tongue and cheek Numbness; Swollen glands; Chest tightness; Tongue and cheek Numbness; This case was reported by a other health professional via call center representative and described the occurrence of numbness of tongue in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   Co-suspect products included benadryl (nos) (Benadryl) for an unknown indication.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Benadryl 100 mg at an unknown frequency. On 16th July 2019, 30 min after receiving Shingrix, the patient experienced numbness of tongue, swollen glands, chest tightness and hypoesthesia. On 16th July 2019, the outcome of the numbness of tongue, swollen glands, chest tightness and hypoesthesia were recovered/resolved.   It was unknown if the reporter considered the numbness of tongue, swollen glands, chest tightness and hypoesthesia to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in right deltoid. The patient took 100 mg of Benadryl approximately 30 minutes prior to the injection. It was reported that approximately 30 minutes after vaccination, the patient experienced tongue and cheek numbness, swollen glands, and chest tightness.  The events lasted for a couple hours and then resolved. It was unknown if the reporter considered the numbness of tongue, swollen glands, chest tightness and hypoesthesia to be related to Benadryl as well. The reporter consented to follow up.
MMR II was administered at 3:00pm. About 5 minutes after receiving the MMR II vaccine subcutaneously in the right thigh, a single hive developed right below the injection site. Observed infant for 30 minutes post-vaccines, observed only a local response and no diffuse or widespread hives, no signs of respiratory or GI symptoms.
patient received bivalent COVID 19 vaccine at an outside facility and two days later present to our clinic with nasal pain and facial numbness.
I was running a low-grade fever, occasional chills, sneezing, coughing, generally not feeling well, taking naps. I used a home COVID-19 test that came back positive. I went into my doctor's office for a visit, they also tested me using a PCR rapid COVID-19 test that also came back positive. I was prescribed the PAXLOVID antiviral medication that I was able to start that evening. I started to feel better the next day. I feel better but I am still testing positive.
Breakthrough case of COVID, so I had a fever, my blood oxygen dropped and my heart rate accelerated, I had a headache, I had a deep cough in my chest, a sore throat, sinus congestion, body, muscle and joint aches, crawling skin, chills, weakness and fatigue, and brain fog. I was super sick. I think I am long hauling and that is the reason why I wanted to do the survey. I have new symptoms now such as skin rash, extreme joint pain, fatigue, and brain fog, and all of these things came after I tested negative for COVID after being positive. I thought this was all over but then I began felling bad again and got the rash and extreme joint pain, lookin for a physician to go to to check on the symptoms that I currently have.
Severe vomiting for 48 hrs; weak & limp, diarrhea; temp 105;
Pt recvd flu vax; 1/2 hr later had worsening of steroid dependent asthma; required transport to ER & then discharged home + larygospasm; unresponsive to 2 doses of Epi;
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Information has been received from a physician concerning a 13 year old female, who on 29-OCT-2007 was vaccinated with her first dose of Gardasil vaccine, IM (lot# 658558/1061U). Concomitant therapy included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-OCT-2007, the patient fainted after she stood up after receiving the vaccination. The patient developed a small cut to her lip and hit her head as she fainted. The patient's blood pressure an heart rate were low. While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range. Subsequently, the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted. The patient sought medical attention in the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007;  1/7/2008.  Information has been received from a physician concerning a 13 year old female who on 29-OCT-2007 was vaccinated with her first dose of GARDASIL IM (Lot# 658558/1061U).  Concomitant therapy included influenza virus vaccine (unspecified) in the left deltoid (lot# 80822) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  On 29-OCT-2007 the patient fainted after she stood up after receiving the vaccinatinon.  This never occurred before with vaccines for this patient.  The patient developed a samll cut to her lip and hit her head as she fainted.  The patient's blood pressure and heart rate were low (BP = 90/60 and HR= 53).  The patient complained of dizziness.  She was diaphoretic, weak and cold to the touch.  While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range.  Subsequently on 10-OCT-2007 the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted, weakness, cold to touch and being diaphoretic.  The patient sought medical attention in the office.  No additional information is expected.
Pain in sternum, spreading across rib cage; Pain in sternum, spreading across rib cage; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old female patient received unknown dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via an unspecified route of administration on an unspecified date (at the age of 17-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the 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 vaccines within four weeks prior to the vaccination. The patient experienced pain in sternum, spreading across rib cage on an unknown date. The clinical outcome of the events was unknown. This report was reported as non-serious by reporter.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event was recoded to Skeletal pain and Rib pain.
LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain behind his eyes. On MAR-2021, the subject experienced flushed. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced low grade fever. On 29-MAR-2021, the subject experienced minor or brief headaches. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, flushed, hot flashes, fatigued, and minor or brief headaches, and the outcome of pain behind his eyes was not reported. This report was non-serious.
exhaustion, lethargy, able but reluctant to get out of bed.  Can feed & care for myself.  Not worried; expect recovery in day or two.
On 3/11/2021 started rash on my left and right arms.  On my stomach around belly bottom and under it but not on my back and stopped at the sides.  On my thighs close to my bottom
Sore Bones; Diarrhea; Loss of taste; Fever; Chills; Sore Muscle; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Sore Bones), DIARRHEA (Diarrhea), AGEUSIA (Loss of taste), PYREXIA (Fever) and CHILLS (Chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.   On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 28-Mar-2021, the patient experienced BONE PAIN (Sore Bones), DIARRHEA (Diarrhea), AGEUSIA (Loss of taste), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Sore Muscle), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, BONE PAIN (Sore Bones), DIARRHEA (Diarrhea), AGEUSIA (Loss of taste), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Sore Muscle), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: positive (Positive) Had COVID-19 Disease with positive PCR test in JUNE 2020.         No relevant concomitant medication information provided. Treatment Medications were not provided by the reporter.
fatigue, sneezing for a couple of days and then she has severe nausea and headaches
Developed chest pressure on 10/4/21. Started gradually and was intermittent. By the end of the week, was present upon waking and until falling asleep. Pressure worsened in intensity and felt fatigued. Went to urgent care on Monday 10/18/21 after developing palpitations and having 2 weeks of constant chest pressure. Had a work-up in the ER and was not treated. Had a visit with a cardiologist on 11/23/21 after having continued symptoms since 10/4/21. Cardiologists diagnosed pericarditis with pericardial effusion secondary to the vaccine. Was started on high dose Ibuprofen and Colchicine. Was on treatment for 4 weeks and then developed a stomach erosion/ulcer from the treatment. Started a proton pump inhibitor twice a day and was continued just on colchicine for the pericarditis. Did not have full resolution of symptoms and daily prednisone was added on Friday 1/7/22. As of writing this, I continue to have symptoms and am getting scheduled for a cardiac MRI for further evaluation.
Woke up the following morning on Saturday with major back pain.  Was pretty miserable that day, i don't normally take pain meds but i took some that evening.  Sunday I was still pretty miserable and went to the chiropractor on Monday morning for an adjustment in case it wasn't just the shot that created the pain. I was feeling much better by monday though.  however i had shot 2 and the same thing happened again. as i assumed it was related to the shot and not the actual back i didn't see the chiropractor after that shot and the accompanying pain.
This occurred 1 day after influenza vaccine and per ER records: "Pt. is a 3 y.o. female who presents with a chief complaint of loss of consciousness. HPI per patient's mother and father. The mother was dressing a paper cut on the patient's left 5th finger when the patient lost consciousness, falling face first onto the tile floor. From this, she incurred a 1 cm chin laceration. The patient's mother immediately grabbed her from the ground. She hung limp with her eyes closed in her mother's arms. She then began to have an episode of seizure-like movements with extension, flexion, and drooling. This lasted less than 60 seconds. Upon waking, the patient was groggy but responsive with reactive pupils. She denies neck pain, back pain, headache, shortness of breath, or any other concerns. Upon exam, no tongue biting is evident. Bleeding from the chin laceration is mild upon presentation. She received her bivalent COVID booster one week ago and her annual influenza shot yesterday."
Right lateral arm tenderness and redness 5x9cm area by 05/12/04.
Sore injection site first two days (slight difficulty laying on that side), then Day 9 developed a rash and itching close to injection site, Day 11 noticed swelling on the upper arm and tenderness in armpit; Day 13 rash about doubled in size and some itching returned  Applied Cortizone-10 to relieve itching - it helped
This spontaneous report as received form a nurse practitioner  refers  to female patient of unknown age. Five years ago, in approximately July 2008 the patient was vaccinated with the first dose of GARDASIL (lot number, indication and injection site were not reported) (0.5 ml, intramuscular). The patient was in the office on 02-JUL-2013 to receive her second dose of GARDASIL. No adverse effect reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information is not expected.
Patient developed substernal chest pain ~ 24 hrs after vaccination w 2nd dose of Pfizer COVID 19 vax. Pain continued x 2 days, came to ED 5/9/21; EKG abnl and had elevated troponin; was admitted for myopericarditis. Started on ibuprofen and colchicine.
About 10 hours after receiving the vaccine I became nauseous and weak.  I sat down on a kitchen chair and then passed out, falling to my right onto the floor.
Complaining of persistent "fainting spells-syncope, headaches, wooziness or dizziness" since receiving AVA in 1999-2000. This 46 year old reported receiving "first 2 AVA vaccinations and pills in 1991"; however "no documentation was placed in his records nor was he told what he was taking". A medical record review found vaccine documentation for "A-1 and A-2" on 03 Jan 1991 and 13 Jan 1991. He does not remember any resulting adverse events. He began "a second series of Anthrax shots" 19 Feb 1999. AVA #2 was administered 05 Mar 1999, AVA #3 on 19 Mar 1999, AVA #4 on 13 Aug 1999, and AVA #5 on 26 Apr 2000.   During the summer of 1999, 3-6 months following his third AVA vaccination, he experienced loss of vision with blurriness, nausea, and urge to "pass out" while driving. He described his blurry vision as "dots in his eyes lasting for 30 minutes". He denied any headache and stated this sensation passed quickly without incident. Review of available medical records document similar episodes "passing out", blurry vision, headaches (pressure) about eyes/back of head, and fatigue beginning in 1997 with diagnoses of subclinical thyroid disease with right exophthalmos and sinusitis. There are no medical records available from 1999 to 2004.
Vasovagal syncope. This was a known issue as the patient notified us prior that he usually has this problem with injections. Patient was seated in waiting area after being vaccinated and went unconscious, slid down the chair onto the floor in a sitting position where he was caught by an employee before any secondary injury occurred. He was conscious within seconds and was given water. Patient's emergency contact (spouse) was notified immediately and she came to pick him up. He had recovered sufficiently to ambulate.