chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported that the patient have booster scheduled for 14 Jan 2022.  Company comment: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred  on 03-Jan-2022, after the administration of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred  on 03-Jan-2022, after the administration of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
He complained of dizziness the evening of the shot.  He went to bed and when he woke up the next morning he was having double vision.  Is eye drifted off to the side and he was too dizzy to get up.  He was taken to the hospital.  They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason,  so they could not determine for sure if he had a stroke.  They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side.  The nurse practitioner saw him today and she reports he is doing very well now.  He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow.
6 inch red raised red patch that itched and pained so far for 5 days. It is not at site of injection but in the inner crease of my elbow. I used ice and benydrel.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017640, expiration date 20-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009255: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009261: US-009507513-1811USA009254: US-009507513-1811USA009142.
Patient was hospitalized at an outside hospital and treated for cellulitis. Rash & ErythemaMultiform
woke fr nap cried; 3MAR-5MAR listless, lethargic, no appetite, shallow breathing, swallowing seemed to be a problem, slept continuously (10-12 hrs); unable to stand, sit up or hold head up in crib; cranky, lost prev acquired language,t104.2
20 y/o female, s/p 1st vaccine. C/o blurred vision,  pale, diaphoretic. Code green called by clinic staff, med consult, and medic with patient, laid down onto cot. Cold water bottle applied to neck, ice to head by staff. Speech clear, he of allergies to MMR per mother. Symptoms resolving, pt signed out AMA with medic. Cleared by med consult Dr to go home. Requested pt to remain on site for additional 15 minutes. Head of cot raised, eating Cliff Bar and drinking Gatorade. C/o feeling tired. Escorted to car via wheelchair with mother. Denies any symptoms.
Swollen neck, Achy neck, stiff neck and Left arm. Headache, teeth hurting.  Swelling started in my lymph glands esp. left arm,  Lower calves hurting and bottom of my feet.  Second day left lymph glands swelling more,  I didn't do anything. Body hurting like the flu.  Third day, headache continues, swollen neck,, glands, calves & feet.
Heart attack June 5, 2021.  No prior symptoms of heart disease.  Per cardiologist he saw no other evidence of significant plaque buildup in other heart arteries, just in hte one that caused the heart attack.
nausea; dizziness; no appetite; This is a spontaneous report from a contactable consumer (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 at 10:00 (at the age of 86 years-of-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included atenolol, pravastatin and Aspirin. On 07Feb2021 at 07:00, patient experienced nausea, dizziness and no appetite. The patient had no other vaccinations within 4 weeks prior COVID-19 vaccination and was not tested for COVID-19 since vaccination. The outcome of all the events was recovered on an unspecified date Feb2021.
Patient presented in the clinic complaining of fever and chills. Temperature reading was 100.8. Patient's right arm was swollen and hot, ANP ordered patient to have ibuprofen 800mg now and to go to ER if symptoms get worse. Pt also given Rx for Amoxicillin and ibuprofen.
The first symptom was a sore throat, followed by nasal congestion, irritated eyes, sneezing, runny nose and cough.  I am still sick on 10/13/2013.  I am using Flunisolide nasal spray which isn't helping much.
No side effects reported; improperly stored PEDVAXHIB administered to a patient; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history, concurrent conditions were not reported, allergies, drug reactions and concomitant therapies were not reported.  On 11-OCT-2023, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (lot #W032687 has been confirmed as valid, and expiration date was reported and validated on 13-JUN-2025, dose, vaccination scheme, strength, and route of administration were not provided). The vaccine underwent temperature excursion, with a maximum temperature of 8.7 degree Celsius in a time frame of 18 minutes (Product storage error). No previous temperature excursion and additional side effects were reported.
Patient stated he felt really dizzy and that it would happen in "spells" also stated that he vomited on the day he received the vaccines. He states he still feels dizzy today. (02-24-14).
Caller states that she had vaccine 2 weeks ago , now with fever of 100.4, red rash at injection site.  Denies cold or other URI.  Instructed to apply warm compresses to arm and continue to take  OTC pain med of choice for muscle pain and notify PCP if sx persist. Staff , RN
severe pain in upper arm & numbness w/profound weakness & loss of use 5 mins p/inject; tx Motrin; referred to neurologist 30NOV03 brachial plexopathy brought on by post-vaccinal synd; poss demyelinating disease; poss of MS;
weakness, site reactions Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient received his first covid vaccine on 3/8/2021, "and the following day I started having alot of dizziness, it just hasn't let up." Pt is c/o dizziness x 6 days, no improvement. States dizziness is random, not limited to movement or standing up too fast. No headache, slurred speech, unilateral weakness or other s/s CVA. Patient states prior h/o CVA with residual L sided weakness. He is unsure of what his symptoms were during his last CVA. "I don't remember, it's been several years." This nurse did recommend local ER, cannot rule out CVA based on symptoms (dizzy all the time, not necessarily only with movement). Patient states he will have family drive him to ER now.
myocarditis with elevated troponins and mildly decreased cardiac function on echocardiogram. He was treated with steroids, IVIG, lisinopril
I noticed on about 3/30 at about 5 PM, I started itching in the upper right chest area where I had had a mastectomy of the right breast. I scratched and thought it would relieve the itch, but it didn't. I looked and noticed there was a welt there. I put on a little cortisone cream, which helped for only about 10 minutes. Afterwards, the itching became more pronounced, so I took 1 Benadryl tablet. It eased the itch a little, so I put on a little more cortisone cream. It got rid of the itch for a little longer. About 2 hours later, the rash became hot to the touch. I took another Benadryl tablet and went to sleep. I woke up at about 4 AM on 3/31, and my legs, left arm, and ankle were itching. It had spread. I took off my bracelets, because they aggravated the itch. I contacted medical center and had an e-visit with on-duty ER doctor about midnight on 4/1. She wasn't sure if my symptoms were caused by the seafood I had eaten earlier or by the COVID vaccination. She recommended i stop eating seafood and that I follow up with my PCP and to make sure I answered every V-safe text I received. She prescribed a steroid cream and oral steroids. She prescribed a 6-day regimen of steroids. After that, my situation improved. The steroids worked and the itching stopped. She urged me to keep my appointment for the second COVID vaccination. Everything cleared up, but then a week later (before the second vaccination), the itching returned on my neck and left arm. Welts and pimples reappeared. The skin was hot to the touch in the affected area. Intermittently, the welts would go down, but the pimples would appear and that was when the itching was especially bad. After that happened, I contacted my PCP by email to update her and assure her I had followed all her recommendations. She had recommended that I see a dermatologist. I had an e-visit with a dermatologist named Dr./MD. I don't remember the exact date, but it was before I received the second COVID vaccination. Dr. wasn't sure if the situation was caused by the seafood or by the vaccination, though he leaned towards the condition being possibly caused by the vaccine. He told me to continue with the Benadryl and he made an appointment for me to see him in person on June 8. He examined me in person that day and said that it looked like it had a bite pattern. He said it wasn't bed bugs, but it was possibly caused by a spider bite. I spend a lot of time outside, and he told me that I could have once been bitten in the past and that the venom could have lain dormant before it manifested its symptoms. He prescribed me clobetascol topic cream and put me on a 12-day regimen of prednisone. This regimen relieved my symptoms within hours. The cream works well on contact. On April 18, I received the second COVID shot. After the second shot, I didn't have any major side effects other than fatigue and sore muscles around the injection site.
After injection, patient was lightheaded for a brief period of time; This is a spontaneous report from a contactable consumer reporting for a patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included covid-19 (had COVID prior vaccination) from an unknown date. The patient's concomitant medications were not reported. After injection, patient was lightheaded for a brief period of time on 21Jan2021 12:00. Feeling went away fairly quickly. The patient was not pregnant at the time of vaccination. It was unknown if COVID was tested post vaccination. There was no treatment for the event. The event outcome was recovered.  Information on Lot/Batch number has been requested.
doctor wants a 32 year old patient to get Shingrix / doctor sent the prescription / to a pharmacy / pharmacy declined it. (No mention of patient being administered); This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were reported as follows: This case was reported by a pharmacist. Age at vaccination was not applicable. Pharmacist called in to inquire on information on Shingrix and under 50 years of age. Pharmacist reported a doctor wants a 32 year old patient to get Shingrix and also mentioned the doctor sent the prescription for Shingrix to a pharmacy and the pharmacy declined it. (No mention of patient being administered), which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Initial misuse report received from a healthcare professional on 12 June 2013. A 05-month-old patient (No information was provided regarding the patient) had received ACTHIB reconstituted with Merck sterile water. No adverse event was reported. Documents held by sender: none.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 31-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Rash Narrative: 17x20 delayed 3d after site rxn flat tender erythema with inf LUE 3cm echcymosis , sig PMH - lymphoma
Right after vaccine as walking from one room in the facility to other eyes felt flurry confusion. When arrive to other room doctor took vitals and were ok. Felt lightheaded, kept blinking because couldn't see at distance. 3 hours later at home headache started for 36 hours. Took TYLENOL, helped a little. Stayed in bed because had upset stomach. 3 days later still had little headache. Injection site was aching, itchy, hot, hard. Today had sore throat.
2:21 pm. patient noted onset of chest  tightness, diffuse in nature. Patient's face was flushed.  Chest tightness resolved after a few minutes as well as facial flushing.  Evaluated by onsite EMS and NP. 2:30:  176/75; 87; finger stick glucose 89.  O2 Sat 100% RA 2:45:  136/95; HR 88 1455  136/77; HR 78.  EKG done.  NSR.
This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (She passed away) and THROMBOSIS (Clots in her leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (She passed away) (seriousness criteria death, hospitalization and medically significant) and THROMBOSIS (Clots in her leg) (seriousness criteria hospitalization and medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, THROMBOSIS (Clots in her leg) outcome was unknown.            No concomitant medications reported.  Description: The patient had clots in her leg and was hospitalized. There was talk of amputation, but she passed away before that occurred.  No treatment information provided.  Company Comment:  Very limited information regarding these events have been provided at this time.  Further information cannot be requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death
around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body aches all over, and severe headache, around 3am had nausea to the point of needing zofran, chills continued until around 5am, body aches continued and was yelling, crying and tossing and turning, woke up at around 8am with 9/10 headache, light and sound sensitivity, alleviated some with coffee, extremely fatigued and weak (had trouble walking half a block), headache mostly gone by. 10am, fatigue continued throughout the day, NO appetite, intermittent chills. At bedtime ~9pm day 2 temperature 99.8. Slept through night. Sunday fatigue and excercise intolerance (typically exercise daily and am in good physical shape), had to sit down during walks with dog, Monday fatigue continued as did difficulty exercising long periods of time until afternoon, continued difficulty monitoring body temperature, getting cold really easily. Tuesday (today) continued weakness and exhausted but can't nap, no appetite. Never took anything except zofran 2x for nausea
Sore throat, night sweats, malaise, severe headaches with no relief of any OTC or prescription medication, dizziness, numbness in extremities, numbness to touch head, bumps in mouth, weakened immune system, chest pain, jaw pain, eye pain, blurred vision, extreme fatigue, brain fog.  Symptoms ongoing 14 months post-vaccine.
Fever up to 102.5 F; pulse up to 136; BP 154/97; PO2 lowest 87%,; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 09Sep2021 13:00 (Lot number: FC3183) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Seizure Disorder", start date: 02Dec2020 (ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE] taken for seizure; XANAX; TORSEMIDE. The following information was reported: BODY TEMPERATURE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "Fever up to 102.5 F"; HEART RATE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "pulse up to 136"; BLOOD PRESSURE MEASUREMENT (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "BP 154/97"; PO2 DECREASED (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "PO2 lowest 87%,"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch)"; HEADACHE (non-serious) with onset 10Sep2021 03:00, outcome "recovered" (2021), described as "headache"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 10Sep2021 03:00, outcome "recovered" (2021) and all described as "pain and mild swelling at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature, heart rate, blood pressure measurement, po2 decreased, pain, arthralgia, headache, vaccination site swelling, vaccination site pain.  Additional information: Patient had no other vaccine in four weeks. Patient had no Covid prior vaccination. Patient had not tested for COVID post vaccination. Patient had no vaccinations within 4 weeks prior to vaccinations. The facility type vaccine was pharmacy or drug store. Patient had no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
Redness, soreness, warmth at injection site, soreness and pain in lower back and leg
It severe pain from my right hand to my elbow for about a week. I had to be prescribed Gabapentin for pain. The pain lasted for 3-4 weeks before it went away.
Information has been received from an office manager concerning a 5-month-old female with a history of vaccination with a dose of MMRV with no reaction and no other pertinent medical history or known allergies who on 02-APR-2007 was vaccinated SC in the right anterior thigh with a dose of MMRV (Lot # 656160/1396F). Concomitant vaccines administered on that same day included a dose of DTaP (+) tetanus toxoid, a dose of poliovirus vaccine inactive (unspecified and a IM dose in the right thigh of Vaqta. The office manager reported that on 04-APR-2007 the patient presented to the office with large swelling, redness, heat and bruising at the injection site (exact date of onset not provided). No laboratory/diagnostic test were performed. The patient was treated with cold compress as needed. At the time of this report, the patient's event persisted. Additional information has been requested.
A few minutes after receiving the vaccine, the pharmacist was informed that the patient was falling over in our waiting area. The pharmacist got to the patient and caught him before he hit the floor. He lost consciousness for less than a minute and EMS were contacted. The patient was helped into a sitting position, given water and monitored.  The patient was alert and by the time the paramedics arrived. He was assessed by them and the patient did not go to the hospital.
Very sore arm, painful to lift above my head. Headache and general body muscle aches. Feeling a little nauseous, but not to terribly nauseous. Currently resting, icing the sore arm and taking tylenol.
Pt reported feeling SOB during post vaccination waiting period.  Pt declined epi pen and believed it was her asthma flaring up, and wanted to use her inhaler instead.  Pt felt fine after 5 minutes, then left.  She came back after 10 minutes again complaining of tightness in the chest.  Pt still declined epi-pen but agreed to benadryl.  Pt did not report any AE with first two doses of moderna.