chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 26 yo M w/ a PMH of COVID 19 infection (resolved), seasonal allergies, and head trauma (2019). He arrived at Facility on 6/15/21. On 7/8/21, pt had his tooth extracted (#30) at 0930 without complication. At 1200 same day, he received the first dose of the COVID-19 Moderna vaccine. At 1323, the pt was found lying on couch in dorm c/o pain in dental area, dizziness, and lightheadedness (BP 150/77, HR 91, RR 18, O2sat 99%). Heart sounds normal, breath sounds absent on auscultation. Pt was confused and in distress. (unable to respond verbally). His eyes were red and tearing. Tongue and lips appeared red and were mildly swollen. RN was unable to visualize throat in dorm. Epipen was administered at 1340 which resulted in an immediate decrease in symptoms. Pt was calmer and in less distress. Normal uvula with some narrowing of airway noted. He was then taken to clinic and was calm but shaking with an open airway and mild swelling noted; VS wnl. He left via EMS in stable condition to ED at 1400 for evaluation.  Pt returned from ED same day in no acute distress but still c/o dental pain (5/10). He was last evaluated by provider on 7/9/21 and is asymptomatic. Denies swelling, SOB, or fatigue. No bleeding or swelling at dental extraction site noted. Pt evaluated by dental on 7/12/21. No swelling, erythema, exposed bone, or signs of infection noted. Area appears to be following normal post-operative course. Pt remains asymptomatic. ED summary- Medical Center (7/8/21): Pt sent to ED for allergic reaction/near-fainting (vagal reaction); Assessment: ?Most likely the syncopal episode was due to vasovagal syncope. Cannot rule out allergic reaction to the COVID 19 vaccination?. Drug screen negative. Discharged on 7/8/21.
Fever, severe muscular and joint pain - lasted 5 days Extreme headache, adrenal exhaustion, and memory loss. Continuing to deal with these adverse symptoms daily.
MUSCLE PAIN, SWELLING AT INJECTION SITE AND RADIATING OUTWARD FROM IT.
One day after vaccination patient experienced diarhea, pain in arm, knee and fingers, fatigue and blurry vision, injection site pain. Two days after vaccination patient experienced vomiting, fatigue, blurry vision, injection site pain. Day 3, symptoms all resolved.
Patient had a syncopal event at night about 2 1/2 weeks after vaccination.  He was found unresponsive the next morning and taken to ER, where he could not be revived.
Patient received a shot from a vial that had been left over in the refrigerator overnight; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a shot from a vial that had been left over in the refrigerator overnight) outcome was unknown. Not Provided      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.   Concomitant medication were not reported  Treatment medication information were not reported
"COVID ARM" according to what I have read.............lump then warm red area two weeks after injection......then next day red area spread to form another circle well away from the injection site but connected...............still has some heat in it today............
Pt called pharmacy on 10/4/18 with complaints of arm swelling, tenderness, redness, and heat at area on right arm below the injection site. I (the pharmacist) instructed pt to take OTC analgesics (APAP, IBU) and Benadryl and call pharmacy tomorrow to update pharmacist on status. On 10/5/18, pt reported to pharmacy so pharmacist could visually inspect arm. The rash appeared to have spread and arm was warm to the touch. Pharmacist instructed pt to go to urgent care facility, but pt declined as pain had decreased. On 10/6/18, pt once again reported to pharmacy and arm appeared worse and rash had spread even further. Pharmacist instructed pt to report to urgent care, which pt did. Pt was prescribed an antibiotic, although NP at urgent care was unsure of what actually was occurring with pt. Pt picked up antibiotic (Keflex) on 10/6/18.
Pt experienced induration at the site of injection after receiving TTA. 25JUN90 pt developed an abscess at the injection site.
pt recv vax 26JUN96 & 5JUL96 pt broke out w/chickenpox w/the rash mainly on face;pt was taken to an acute care ctr & tx w/med;pt recovered;
Adverse event that took place was that the patient received the Moderna bivalent booster before completing the primary 2 dose series. There was no adverse reaction to this, patient's mother was called, and she reported no reactions.
Pt returned for her second dose of Moderna on 5/20.  Pt reports that about ten minutes after the first dose of Moderna on 4/22, she experienced some swelling inside her throat with no trouble breathing and no rash. She drank cold water which gave her temporary relief, but the swelling continued to return repeatedly over the next few hours before resolving completely. She has no other known allergies. She was counseled that she is allergic to the vaccine, and after counseling, elected instead to get the J&J vaccine today (5/20) instead of the second dose of Moderna.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 17 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no severe allergic reactions .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) 0.5 ml, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
fatigue/feels tired; a mild fever (99.7 degrees); he is not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional(Parent) via medical information team. A 12-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180, Expiration date: not reported) via an unspecified route of administration, administered in Arm Right on 09Aug2021 at 16:00 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. Medical history included developmentally delayed and diabetic, her mother she is diabetic. There were no concomitant medications. On 10Aug2021at 08:00, patient experienced fatigue/feels tired, a mild fever (99.7 degrees) and he is not feeling well. On 10Aug2021, patient underwent lab tests and procedures which included body temperature: 99.7. Additional vaccines administered on same date of the Pfizer Suspect was none and no prior vaccinations within 4 weeks. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Per pt -> Travel shots 2/11/13 -> 2/12/13 Pimple eruptions", "looked like chicken pox pimples" over back, left shoulder & abd became scaly & dried up & disappeared left no marks. Pt states she stated oral typhoid 3/1/13 and developed same "pimple eruptions" itchy both times.
Pt received Hep A #1 left deltoid. 5cc IM. ON 9/3/04 mom contacted our office on 9/7/04 with c/o swollen, redness, warm to touch, blistered around left deltoid, noticed this on 9/4/04.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-237447 (Patient Link).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2104 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 11, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
PT HAS LINGERING HEADACHE SINCE 5/14, RISING HEART BEAT AND SWELLING JOINT
Patient experienced fever/chills, migraine headache, fatigue, decreased appetite, and swelling in right side neck lymph nodes. No reaction at injection site. These symptoms lasted 2-3 days and then went away, pt still feels a little fatigue. she stated she felt like she had the flu. Patient did not seek medical attention.
Within 2 hours of the vaccination, patient became unusually lethargic with low grade fever but recovered 4 hours later. 8 days later continuing on to present time (1/19/08), patient develops fever whenever he sleeps. Fever has been up to 101.3 but has been controlled with infant Tylenol. Patient has also lost appetite, exhibited rash at hairline on 10th day after vaccine and exhibits itching during fever episodes.
This spontaneous report was received from a public health nurse and refers to a 23-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 24-MAY-2017, the patient was vaccinated with an expired dose of VARIVAX injection (lot # L012038, expiration date: 07-APR-2017; dose and route of administration were not reported). Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient received byvalent booster as a second dose by errorinstead of the monovalent vaccine, Pt felt tired, no other efects noted.
arms now magnetic where I received the vaccine/shot;; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 an unknown date, the patient experienced VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;). At the time of the report, VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;) outcome was unknown.            NO CONCOMITENT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED. Patient wants to know why are  arms magnetic where received the shot and had both shots .
patient started feeling light headed in the chair after the vaccination, then he started to faint and fall out of the chair. our cashier caught him, we then got him onto the ground. he was very pale, sweaty, nauseous, and dizzy. he fainted a second time while sitting on the floor. we got him a garbage can in case he got sick, and an ice pack and bottle of water to help cool him down. after 10 minutes he stated he felt much better, and he went back into the chair. we asked him to wait another 15 minutes to make sure he was okay because he had to drive himself home. after that period of time i took his blood pressure and it was normal. he said he was going to go get something to eat here in the store before driving and he would come back to let us know if he started feeling sick again.
Information has been received from a pharmacist referring to a 63 year old female patient who was not pregnant. The patient had unspecified thyroid function and unspecified allergic reactions to amlodipine, amoxicillin, codeine, lisinopril (manufacturer unspecified), penicillin, sulfa and iodides. On 16-NOV-2017 the patient was vaccinated with ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, subcutaneous; dosage and frequency unspecified). Concomitant therapies included unspecified thyroid medication and calcium supplement with Vitamin D. On 17-NOV-2016 the patient called the pharmacy to report that she was experiencing an injection site reaction. On 18-NOV-2016, the patient came to the pharmacy and the pharmacist examined the patient's injection site. The pharmacist stated that the injection site area was "really red with a huge welt around the injection site". The pharmacist described an area of "less redness" in a perimeter surrounding the injection site. The patient also reported that the welt and redness had worsened since she first noticed it "yesterday (17-NOV-2016)" and the area was "hot to touch". The patient also reported muscle pain, joint pain, severe headache, congestion, fever, and chills. The patient reported waking up from sleep "in pool of sweat." The patient reported that she was being "shaking and itchy," especially in her ears and neck area. The pharmacist stated, "It looked like an allergic reaction, so the pharmacist instructed her to take BENADRYL." The pharmacist did not know if the patient had taken any BENADRYL, and she didn't know if the BENADRYL was helpful to the patient's adverse symptoms. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Per patient's wife: arm sore 9/3. 9/4 pt was no feeling well with symptoms of fever, chills, vomiting, and arm swollen and warm when touched. 9/5 pt went to ER and was hospitalized for cellulitis. Pt is taking antibiotics.
SOB, CP, Fever, Nausea, Body aches.  Seen in ER for cardiac work up.  Labs normal and CT chest normal
On 10/10/01, the pt received his 2nd 10mcg, IM dose of Engerix-B. Ten minutes later, the pt experienced "agitation, severe headache, heat sensations, flushing" and 1 episode of "passing out". The pt received Benadryl immediately and ER observation later for a brief period. As of 10/10/01, the adverse events had resolved.
Moderate aches, fatigue and headache for 24 hours followed by lymph node inflammation in left armpit which is ongoing, though improving slightly every day.
I started to feel like I had a fever and I was exhausted. I couldn't do yoga, I started to lose my voice I was also coughing. I went to an urgent care facility. They took all my vitals and gave me a COVID-19 test and received a positive result 2 days later. The urgent care PA walked me through the next steps and advised me to contact my doctor to get a referral for a monoclonal antibody infusion. I then had a telenet appointment with my doctor, she provided me with the referral for  monoclonal  and I received the infusion on 8/12/2021. I also lost taste and smell I had a horrible headache. I had nausea vomiting and dry heaving. blood sugar dips, congestion, random sneezing. stomach cramps and diarrhea accompanied by constipation. I also had loss of appetite  I did not experience body aches or trouble breathing.
Leg weakness on left side that resulted in a fall.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Feb2021 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer and hypertension (reported as HTN). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and lovastatin (MANUFACTURER UNKNOWN); both for unspecified indications from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified vaccine on 10Mar2021. On 28Mar2021 at 09:00, the patient experienced leg weakness on left side that resulted in a fall. The patient was taken to emergency room for workup - no indication of stroke or spine injury and was released that evening. The patient was advised to follow up with cardiologist and possibly neurology. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event weakness of limbs was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Migraines, dizziness, Tinnitus, Vertigo. Fatigue, Difficulty concentrating, difficulty sleeping
Information has been received from a 70 year old male consumer with "thyroid problems" and a VICODIN allergy who on 12-JUL-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included levothyroxine Na.  On approximately 19-JUL-2007, within a week after receiving vaccination, the patient experienced numbness on his feet.  Medical attention was sought, the patient saw the physician.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Follow-up information from the patient indicated that his feet are still numb and cold, and he desperately needed some relief.  Additional information has been requested.
This spontaneous report as received from a registered nurse via company representative refers to a 60 year old female patient immunosuppressed. The patient's medical history included two cases of shingles. On 22-MAY-2015 the patient was vaccinated with ZOSTAVAX lot # L003217, expiration date 30-APR-2015, subcutaneous. Concomitant therapies included methotrexate. The nurse reported that the patient had many red spots with blisters (that were about 1.25 by 2 centimeters) after receiving ZOSTAVAX (on 22-MAY-2015). It was also reported that the patient had two cases of shingles prior to get the ZOSTAVAX, which is other-than-indicated in the Prescribing Information. No treatment was given for adverse events. No lab diagnostic studies were performed. The patient seek medical attention, visited the pharmacy. The outcome of rash macular and blister was reported as not recovered. The causality was not reported. Additional information has been requested.
Thurs, 04/01/2021, She exhibited excitability episodes (no triggers) multiple times after vaccine, starting within 45 minutes. Fri, 05/02/2021, when she woke, she had first grand mal seizure in 4-5 years; called 911 EMS to ck her before driving her to urgent care.  She was cked by Dr & no severe tongue injury  noticed. He sent referral for neurologist to followup.  Called her primary Dr. & was told Dr out for several days. Call back from another Dr who refilled ATAVAN script in case further seizures.  Apt set w/neurologist, for Wed. 04/14/2021.
fluttering of the heart; shortness of breath while laying down; Pulse was taken at rest as 58 bpm; Chest pain; fever; chills; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2021 12:00 (Lot number: FJ8757) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma (non-chronic)" (unspecified if ongoing), notes: Asthma (non-chronic); "Junior Rheumatoid Arthritis (non-chronic)" (unspecified if ongoing), notes: Junior Rheumatoid Arthritis (non-chronic); "Known allergies: Walnuts, Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM Intramuscular), administration date: 20Mar2021, when the patient was 20 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Intramuscular), administration date: 27Feb2021, when the patient was 20 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 12:00, outcome "unknown", described as "booster dose"; CARDIAC FLUTTER (medically significant) with onset 21Dec2021 22:00, outcome "unknown", described as "fluttering of the heart"; DYSPNOEA (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "shortness of breath while laying down"; HEART RATE DECREASED (non-serious) with onset 21Dec2021 22:00, outcome "unknown", described as "Pulse was taken at rest as 58 bpm"; CHEST PAIN (non-serious) with onset 21Dec2021 22:00, outcome "not recovered", described as "Chest pain"; PYREXIA (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "fever"; CHILLS (non-serious) with onset 21Dec2021 22:00, outcome "recovered" (22Dec2021 02:00), described as "chills". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) 58 bpm, notes: Pulse was taken at rest as 58 bpm; sars-cov-2 test: (23Dec2021) pending, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac flutter, dyspnoea, heart rate decreased, chest pain, pyrexia, chills and included treatment with 1 table of 200 mg of Advil (Ibuprofen). Clinical course: Patient did not have covid prior vaccination. No follow-up attempts are possible. No further information is expected.