chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise Below the Injection site) and VACCINATION SITE RASH (Rash Below the Injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash Below the Injection site). On 23-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruise Below the Injection site). On 16-Mar-2021, VACCINATION SITE RASH (Rash Below the Injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise Below the Injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No complications after the second dose of Moderna COVID-19 vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 included crosslinked case information, second dose details added and action taken updated.
10 days after receiving the first COVID vaccine, I noticed a rash forming on my arm at the injection site.  The next day, today, it is more fully formed, triangular in shape. I don?t really have noticeable itching but the area is warm and rather firm to the touch.  As my daily online check-ins with the CDC  V-Safe site ended several days ago, I am reporting this reaction here instead. I am feeling fine.  Initial reactions on days one and two were mild - fatigue, arm swelling and pain / tenderness.
Swelling 3 inches larger than right thigh. Induration, reticular rash 2 cm above knee to groin, Diff walking on leg. Discharge summary states cellulitis, pain. msv
04/27/2019: Patient's arm was red and appeared to have large patches from injection site down to her elbow. Patient also complained of itching. Patient took BENADRYL OTC and Dr prescribed PREDNISONE.   patient's arm was red and appeared to have large patches starting from injection site to elbow. patient said area was itchy
Patient complained about tiredness the remaining day after the vaccination. Next day, didn't get a time, she noticed redness and heat coming from an area below the injection sites. She came to the pharmacy on 9/26/18 and I could see the redness and feel the heat myself. I called to check on her today (9/28/18) and she said it is not as red or warm, but is moving around her to the backside. She did call her dr and they just advised her to use benedryl cream and ice on the area. I told her if it continues to move around or down her arm, she needs to call the dr back.
Information has been received from a pharmacist concerning a female who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced small rash at the injection site on the arm.  Additional information has been requested.
Red circle 7.5 cm x 7.5 cm, warm to touch, swollen, itchy.
Dizziness; Hypoglycemia; Hypotension; Generalized rash; This is a spontaneous report from a non-contactable healthcare professional. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; dose 1) intramuscularly on 25Jan2021 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Jan2021 during the 15 minute waiting period after the vaccine, the patient experienced dizziness. He denied difficulty breathing and swallowing. A differential diagnosis of systemic reaction (hypoglycemia, hypotension, generalized rash) was provided. The patient was given unspecified treatment and follow-up response was good. The patient denied dizziness when standing up and walking to leave the medical evaluation bay and clinical outcome of dizziness was completely resolved prior to discharge.   No follow-up attempts are possible. No further information is expected.
Patient received the first 2 vaccines and developed mild symptoms for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (he only has little issues with dairy products) and Hypercholesteraemia (High cholesterol started before receiving the vaccines).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day). At the time of the report, VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day) had resolved.            Treatment medication was not provided by the reporter.  Patient received the first 2 vaccines in February and March 2021 and developed mild symptoms for a day. Patient never tested positive for COVID 19. Patient had taken medication for his cholesterol once in a while. Patient also stated that he can help by giving his blood for research.   This case was linked to MOD-2022-504209, MOD-2022-504199 (Patient Link).
sore throat; had a 101.4F temperature starting on 17May2021 at 5am that gradually lowered to 98.6F on 18May2021 at 6:45am after taking OTC acetaminophen; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 16-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736, Expiry date: not reported, age at vaccination: 16-year-old), via an unspecified route of administration, in Arm Left on 16May2021 at 14:15 as single dose for COVID-19 immunisation administered in Pharmacy or Drug Store. The patient medical history and concomitant medication was not reported. Previously the patient received first dose of bnt162b2 (Lot number ER8731), in Arm left on 25Apr2021 at 15:00 for COVID-19 immunization and there is no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received OTC women's gummy vitamins received within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 since the vaccination. On 17May2021 at 5:00 Am, the patient had a 101.4f temperature that gradually lowered to 98.6f on 18may2021 at 6:45am after taking otc acetaminophen, resting at home and drinking a lot of water. The patient also had chills, headache and sore throat starting on 17May2021 at 5 Am that also gradually went away by taking OTC medicine, sore throat medicine, resting at home and drinking a lot of water. The outcome of event body temperature increased was recovered on 18May2021 while all other events recovered on an unknown date in May2021.   Device Date : 30May2021  Follow-up attempts are completed. No further information is expected.
On 17 May patient states he awoke with stiffness, decrease back to left hip & left side. As the day progressed pt stated sharp pain noted Sat. Pt unable to stand Monday PM & Tuesday (17/18) Tuesday PM pt saw private med doctor. Physician treating accordingly with x-rays and medication therapy. Duration for 4 days.
Narrative:  COVID infection after completion of COVID vaccine series: 03/17/2021 COVID vaccine dose #1 04/09/2021 COVID vaccine dose #2 07/12/2021 Pt reported onset of cough and rhinorrhea 07/17/2021 COVID positive per facility nasopharyngeal swab 07/18/2021 Pt reported onset of chills, fever, and myalgia. Stated did have close contact with COVID positive case. 07/19/2021 Pt reported improvement of chills and fever. Still experienced "slight, dry cough." 07/20/2021 Pt reported onset of loss of taste/smell and continued body aches. Stated improvement of other sx. 07/21/2021 Pt reported renewed sweating and chills, congestion. Cough resolved. 07/22/2021 Pt reported continued loss of sense of taste/smell and rhinorrhea 07/23/2021 Clinical resolution of COVID infection per CDC guidelines
Initial report received on 02/22/2006, from the patient who is a health care professional. A 55 year old male patient with no reported significant medical history, had received a second administration (route not reported of Adacel, lot number C2454AA), in the left deltoid on 02/10/2006. The next day he experienced entire upper arm swelling, redness, warmth,pain and the area was the size of a baseball. He also had nausea and headache resulting from the intensity of the pain. The duration of the symptoms lasted approximately ten days then the area measured 1 x 1/2 in size. The patient was seen by a physician. He had not recovered from these events at the time of this report. Follow up information received on 03/29/2006 from the patient. The patient was treated with Tylenol and heat. The patient recovered from the event.
Large red area, painful. Took to ER given steroid and Benadryl.
Case number PHEH2015US026963 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 29-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Patient fainted 5 minutes after vaccine administration. Pharmacist got him on the floor, gave him water, and elevated his feet. 911 was called and paramedics checked vitals. After patient was stabilized, parents took him home
I have had pain in my right arm at injection site (tender, nothing serious). Recently I noticed a lump the size of a grape in my right arm at the injection site.
Information has been received from a health professional concerning a female who on approximately 02-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On approximately 30-MAY-2008 (3-4 weeks after receiving the vaccine) the patient experienced pain in her right temporal lobe. The patient sought unspecified medical attention on an unspecified date by calling the office and the pain in her right temporal lobe persisted. Additional information has been requested.
Thirty six hours after vaccine I developed the most excruciating myalgias that continued for about a week. This was followed by 4 days of severe malaise, mild chest pain and generalized weakness requiring me to go to the ER for labs and fluid resuscitation. ER docs as well as my partners were unable to find any specific abnormality on exam. Had no muscle weakness. Test for orthtostasis did show mild orthostatsis
Psyncopy 2; Myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Psyncopy 2) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient experienced myocarditis and psyncopy 2 days after vaccine.  Company comment: This case concerns a  patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
periods of hot flushing; arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site). On 24-Feb-2021, HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved.            Action taken with mRNA-1273 was not applicable. No concomitant medications reported by reporter. No Treatment medication was taken.   This case was linked to MOD-2021-021554 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: TCR received on 25-FEB-2021. Updated patient identifiers. Added new events. Information about dose 1 and dose 2
On the morning following the vaccination, fever 102.1. Extreme generalized body aches, difficult to move in bed, lethargic, weak, severe headache. No appetite, slept off and on and stayed in bed ti? 6 p.m. that day. Only up for a couple hours at most. Still slow today.
Initial and follow-up information has been received through the Merck Pregnancy Registry from a licensed practical nurse concerning a 16 year old white female with no previous pregnancies, with asthma who on 02-FEB-2007 (previously reported as 09-APR-2007) was vaccinated with a first dose of GARDASIL (lot # 655205/1426F). Concomitant vaccination on 09-APR-2007 included MMR II. Concomitant therapy included albuterol and "quar". The patient was in her first trimester at the time of the vaccination. Unspecified medical attention was sought. No adverse event was reported. It was reported that the patient delivered a healthy and normal baby girl on 13-DEC-2007 at 38 weeks gestation. No further information is available.
itchy area at the injection site; 3-inch red, itchy area at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itchy area at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "3-inch red, itchy area at the injection site".  Additional Information: The adverse events occurred about 9 days after her first dose. She is due for her 2nd dose of Pfizer-Biontech Covid19 vaccine, tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate swelling around injection site. Soreness at site and radiating around upper arm. Overnight, rash and soreness in upper arm, armpit and onto chest. Day two, soreness migrating to shoulder (less in arm and chest). Day three soreness and stiffness to base of head, soreness in arm and chest is gone.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2011, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. In May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 27-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L001327, expiration date 13-JAN-2017 (dose, route and anatomical location were not reported). There were no adverse effects. This is one of the several reports received from the same reporter. Additional information has been requested.
After 5 minutes of receiving the vaccine, felt numbness of tongue & also metal taste & smell.   At 9:05 am Benadryl 50 mg PO given.  Patient was monitored until 9:36 am. Tongue remained numb, not worse, went back to work, continued to self monitor. Repeat own dose Benadryl 50 mg  at 4:45 PM. Metal taste resolved in 24 hour post vaccine. Tongue numbness resolved in 48 hours post vaccine.
SM was initially treated on scene by medical specialist and physician assistant. Protocol was followed to prevent shock. SM was initially turned onto side to prevent aspiration if said patient were to vomit. Patient had syncopal episode which resulted in him landing in the prone position on a cement floor. Initial assessment discovered frontal head laceration approx. 2" along the medial sagittal line. Hemostasis was achieved and a non-adhesive bandage was secured to laceration. There was also left nare epistaxis noted. Direct pressure was applied until bleed was stopped. Pulse and B/p were low upon initial assessment but returned to normal after approx. 20 minutes. SM was provided with hydration as well a recumbent chair while vital signs were monitored every 5 minutes by medical personnel.
Patient reports dry mouth and thirst beginning a few hours after vaccination and still currently present. I advised patient to check blood glucose, which was normal. Patient says if symptom doesn't resolve by tomorrow, she will call her primary care provider.
PATIENT RECEIVED A  EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25/MAY/2021) dose was not reported, administered on 26-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced subject received a expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of patient received a expired vaccine was not reported. This report was non-serious.
I had a extremely rapid heart beat a few days after taking the vaccine. Walking, standing up made me feel weak and extremely tired. I got an EKG. Laying completely still wasn't an issue.
Evening pt received vaccine, she experienced swelling, redness, pain at injection site. Pt seen in office 72 hrs later without improvement. Pt treated for local RXN with Ibuprofen and ice and antibiotic Rx'ed for possible cellulitis.
Fever to 103 degrees F x 3 days swelling, redness, pain over injection site (of TDAP). Tx: ice, BENADRYL.
Patient currently hospitalized. Patient is a 86 y.o. male with PMH p a fib on xarelto, HTN, HLD, OSA w. CPAP, who presents today due to hypoxia. Pt was found to be COVID-19 positive on 12/28/21 and was admitted 12/28-12/31 due to hypoxia. Pt was weaned off O2 and was discharged home with home PT. Today when OT arrived to the pt's house, pt was found to be hypoxic with spO2 79%.    Pt reports that he was feeling ok when he was discharged on 12/31, but states started to not feel well. Pt does not elaborate on why he was not feeling well, states his appetite has been normal and he has been eating and drinking a normal amount. He checks his blood pressures at home, is not sure what they normally run, but his son can bring in his log from home tonight. Pt's son at bedside states pt has been using his walker at home and has been slightly weaker than normal and has not been able to get to the bathroom at times. Pt denies any shortness of breath, chest pain, headache, dizziness, diarrhea, constipation, LE edema, falls. Pt reports sore throat. Pt states he has been compliant with home CPAP.    Upon arrival to the ED, pt saturating 88-89% on room air and was placed on 2L NC. CXR performed revealed bibasilar airspace disease. Pt also noted to be hypotensive with BP 66/39. Pt was administered total 3L IV fluid bolus with improvement BP. Labs significant for PLT 102. Pt admitted to the hospital for observation.    Pt reports has 1-2 alcoholic drinks/week. Reports former cigarette smoking, about 3 cigarettes/daily for 15-20 years. Pt denies recreational drug use.  Acute hypoxic respiratory insufficiency COVID-19 PNA - pt admitted 12/28-12/31/2021 due to weakness/hypotensive episode and noted hypoxia during sleeping - currently requiring 2L NC with spO2 96% - temp 37.9 on arrival - CXR shows bibasilar airspace disease     - proBNP 528, no evidence of acute HF     - PCT 0.10, WBC 3.52, 5 bands, doubt bacterial PNA     - monitor off abx - continue decadron 6 mg daily - continuous pulse oximetry - check CRP/Ddimer - out of window for Remdesivir (based on previous documentation, symptoms started 12/23) - monitor VS/labs - encourage IS
It was sore throat and cough but not a cough that went into the lungs. More like sinus drainage cough. It was pretty mild but lasted a week. I was on a cruise and out of the area.