chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna arm; rash at the injection stie/covid rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection site/Covid rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VALACYCLOVIR [VALACICLOVIR] and SPIRONOLACTONE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection site/Covid rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE RASH (rash at the injection stie/covid rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-404415, MOD-2021-404423, MOD-2021-404534 (Patient Link).
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K011801 with expiry date 21-AUG-2016 and lot # reported as L005301 with expiry date 17-FEB-2017, dose and route of administration not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
fever started 24 hours after shot and as of now, I am on my 4th day with continuous low grade (100f) fever during the day and at night has been reaching up to 103.6f The 1st day when symptoms started, I have fatigue, headache, nausea, body ached, arm sore - all of these went away within 12 hours but I still have a fever and over the counter medication is not helping
2nd booster dose was given early patient  had 1st booster 5/16/2022 and 2nd was given today 7/12/2022 only about 2 months after.
tinnitus; paraesthesia; pressure; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced TINNITUS (tinnitus), PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache). At the time of the report, TINNITUS (tinnitus) had not resolved and PARAESTHESIA (paraesthesia), HEAD DISCOMFORT (pressure) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal. On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient mentioned all the events occurred on right side  No Treatment information was reported.   This case was linked to MOD-2021-300927, MOD-2021-295926 (Patient Link).
I was vaccinated at 4PM on Thursday and the pain in my left arm was so severe the morning following (around 6AM) that I fainted on my bathroom floor. I was lightheaded and nauseous for the remainder of the day. I know pain is a typical side effect, but this was unusually intense pain and I felt I should report it. I quite literally felt delirious after coming-to on the floor.
Left toes are in pain. Hurt when trying to curl. Hurt when putting any weight on them. Pain started Monday morning in the small toes and moved to the large toe Tuesday morning.   Contacted pharmacy and they had no information about this side effect. Advised to contact my primary.   The patient will contact primary care if the pain doesn't go away in the next few days.
Patient experienced muscle pain on entire left side of body that resided after 3 days.  Patient also experienced vertigo 8 days after vaccination and still persists as of today 8/25/21.
pt received Adacel Tdap + MMR. On 7-25-07. Pt was advised to not get pregnant for 1 month after the vaccine.  Stated she understood, LMP 7-20-07. positive preg test 9-10-07. No problems after vaccines given.
Break through COVID case. Symptoms: sinus congestion, sore throat, cough.  Treatment: decongestant, nasal spray. Secondary sinus infection. Treatment: sought medical advice from PCP; prescriptions for Azithromycin, Prednisone. Total duration: approximately 20 days.
Patient admitted to the hospital on 9/2/21 due to dizziness and cardiac history. COVID 19 was incidental finding - asymptomatic and required no treatment during hospital stay.
4yo female with adverse reaction to vaccines -left thigh is warm and well perfused with swollen area about 7cm in diameter and annular in appearance on anterior L thigh with puncture mark from one shot far from lesion - slightly dusky and tender/warm in center - no fluctuance.  FROM.  unknown if it was Kinrix or Proquad. Likely local reaction or perhaps extravasation of punctured vein. Dexamethasone 10mg given PO as well as 25mg Benadryl. Will have mother apply ice TID and use benadryl and will see back in 3 days or sooner PRN
vaccine placed in refrigerator after the expire date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 27-Nov-2021. Patient did not experience temperature excursion and any adverse event   No treatment medication was provided by reporter.
t103 fever-rectally; wouldn't eat for 24 hrs; very irritable-had to be held all noc-crabby-fussy; lt leg swollen;
This spontaneous report was received from a certified medical assistant referring to 4 unspecified patients. Patient's medical history and concurrent condition were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX that had been improperly stored (strength, dose, frequency, route, expiration date and lot number were not reported). There was no concomitant medication reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sudden High Blood Pressure, Joint pain and Numbness (upper body), reddening rash on both legs very itchy at night with a progressively worsening course
pt recvd 2 doses of vax & on 22JUL92 exp severe vomiting; taken to ER & was treated w/Phenergan or vistaril;
This spontaneous report was received from a certified medical assistant concerning a female patient of unknown age. The medical assistant reported that while the patient was withdrawing a dose of ZOSTAVAX (Lot number J001006, expiration date 24-APR-2014), on 28-MAY-2013, a portion of the vaccine was sprayed in her eye. No adverse effect reported. A Product quality complaint was reported. Additional information has been requested.
extreme pain in arms & leg muscles appears @ 1 wk p/vax;also devel reddish purple rash on chest, shoulders, nose, cheeks & around eyes;dx w/dermatomyositis & currently being treated w/pred under the care of MD;
This spontaneous report as received from patient's mother refers to an 11 year old male patient with unspecified drug allergies. The patient's pertinent medical history was none. On 16-JUL-2014 the patient was vaccinated with two doses of GARDASIL at once one in each arm inadvertently. Concomitant medications were none. On 17-JUN-2014 (reported as since received) the patient was very tired and usually he was up playing. The patient did not sought medical attention. The outcome of very tired and usually he was up playing was reported as not recovered. The causality of very tired and usually he was up playing was not reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Pt. presented to our office with temp of 101.0 and rash located on head, face and back. H/O fever 3 days prior to visit, 102 but no higher. No ill contacts but received 12 mo vaccine 2 days prior.
Information has been received from a health professional concerning a 4 year old male with no known medical history or allergies who on 3/19/2002 was vaccianted SC with a 0.5 ml dose of varicella virus vaccine live (lot 639127/1237L). Concomitant vaccination that day included as SC first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 640792/1381L). On 6/2/2005 the patient developed a few spots. On 6/3/2005, the patient was seen in the office with 6-8 pox on the abdomen. On 6/10/2005 the patient had a total of 12 pox. No treatment was needed. There were no laboratory diagnostic tests performed. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly.  Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes.  Today I continue to have some tingling. All of this on top of the expected side effects.
Pt exp difficulty breathing, wheezing, red eyes, returned to MD's office 10 min p/immun, MD gave Epi & DPH, pt improved;
Patient is experiences redness at the injection site and also muscle pain. He is convinced it must be infected and probably MRSA. He has not allowed us to view it to confirm.  Patient is a doctor (orthopedic surgeon).
Patient received second dose mRNA vaccine series with incorrect vaccine. First vaccine was Moderna, second dose Pfizer
Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose). At the time of the report, ACCIDENTAL OVERDOSE (Received a full Moderna Covid-19 vaccine Third dose as a Booster Moderna Covid-19 vaccine dose) outcome was unknown.            No concomitant medications was provided.  No treatment medications was provided.  The Patient wanted to know if she can receive a second Moderna covid-19 vaccine Booster dose after receiving a First, Second and Third Moderna Covid-19 vaccine full doses. Patient was not immunocompromised, but stated that patient received a full third dose as a Booster dose because at the time, Moderna's Booster dose was not available and patient needed to get back to work. Patient experienced no symptoms after getting vaccinated.
Within 5-10 min of vaccine, large red (pencil-eraser sized) bumps developed from left wrist to shoulder. Initially were flat, but became raised but did not itch. Vaccine site was red, hot, raised. Took diphenhydramine 25 mg po and ibuprofen 400 mg po. Throughout day, ran temp (100 degrees F) and experienced chills x 4-5 hours. Later in the evening rash changed to fine red rash from left shoulder to elbow and did itch. Resembled beat rash. Repeated diphenhydramine and ibuprofen. Rash improved on 10/4/14 -> BENADRYL gel applied and ibup 400 mg x 2. 10/5/14 pm about resolved.
Immediately following my flu shot, my entire arm hurt from shoulder down to tips of fingers. It was so painful that I had to go back to the nurse that administered it for help. She was already gone but another nurse advised me to put ice on it and take Acetaminophen (Tylenol), but Ibuprofen since Ibuprofen was found to weaken the serum. I took 800 mg. of Tylenol, but it did not help. After an hour, it still hurt so much that I had to go to our EMS office (in my bldg.) and there I found an RN who gave me an ice pack. I held it on the spot where the shot was given until I had to head home. My arm was painful for that entire day. I then decided to take Ibuprofen which I took 800 mg. That finally relieved my arm pain, until it wore off, then I took another 800 mg., which finally stopped it.
This spontaneous report as received from a medical assistant and refers to unspecified 24 patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II which had a lot # of M027637 and an expiration date of 02-JUN-2018; however, dosage number and route of administration were not reported, for prophylaxis. Nevertheless, no adverse effects were reported. The vaccine experienced the following temperature excursions during 5 minutes: 9 grades centigrades. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014268: US-009507513-1701USA014269:
Patient is fully vaccinated. Chief complaint COVID and dizziness. 23 y/o with a Med Hx of anxiety and recent COVID-19 diagnosis presenting to the ED today with the concern of dizziness. She reports she tested positive for COVID-19 last Friday and has been taking steroids that she was prescribed for her shortness of breathe. She no longer endorses SOB but is concerned about intense fatigue. She states that earlier today she went to rise from her chair to use the bathroom when she felt dizzy and saw stars. She denies any shortness of breath, chest pain or palpations. She denies any previous syncopal history. Positive for congestion and sinus pain. Discharged from ED.
Sweating, headache, blurry vision, hot flash. Checked blood pressure and sugar all normal.
Small quarter sized rash around injection site left upper thigh. No irritation noted. Both Hep A and MMR given in this area.
After administering both vaccines and going to enter lot number into EMR, writer realized that monovalent was administered to patient instead of the appropriate bivalent booster. Writer went to waiting room to discuss with patient, but he had left prior to the 15 minutes recommended.  Clinic manager and vaccine coordinator were notified immediately.
Immediately after vaccine: chills and body aches, etc. and that was for about a day. Then I noticed after working out, and towards the end of the working out I felt a little lightheaded, kind of faint and wobbly. I tried to sit down for a bit and didn't feel good. I laid down for an hour and that didn't work, and I drank some water. It has happened four times total in the past six months at random times. The first time it happened was definitely the worst. I tried to drink water. I am not sure if it's rest time that helps me feel better or if water helps. The last time it occurred, I had a chest strap monitor. If I was seated, it was high if I stood up it calmed it spiked up to 110/120 something. Normally it is around 60-70. It calmed down in an hour or so still a little shaky but later that day it felt fine. I'm a physical therapist and I will be seeing a cardiologist. It is weirdly recurrent sometimes and other times it doesn't occur.
Pt had tingling feeling in her right arm after vaccination, complaining about paralysis in her right arm and neck. Warm compressed applied to affected arm, later pt stated that her symptoms improved, good range of motion in both arm and neck.
No additional AE. No PQC.; Nurse reporting an expired VAQTA was administered to a patient.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 16-MAR-2023 the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)) (lot # U021561had been verified to be a valid number; expiration date 14-JAN-2023, and upon internal validation established as the same date) for prophylaxis (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). No additional adverse event was reported.
During administration of the vaccine, most if not all of the dose leaked out of the side of the syringe instead of actually going into the patient's arm.
Sudden onset of stomach pains and extreme nausea with vomiting.  Duration  about  two hours.
FLU LIKE SYMTOMS, EXTREME PAIN IN NECK, EAR AND FACE
Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient). At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient was under any concomitant or regular medication.  It was unknown if pharmacist experienced additional symptoms after occupational exposure. It was unknown if any treatment was given besides Moderna Safety Data Sheet recommendations.   Reporter did not allow further contact
Covid 19 vaccination was improperly diluted and the manufacture recommends getting revaccinated patient was contacted and informed.
chills to the bone; couldn't crawl herself to bed; slept for 18 hours; headache was worst than a migraine; vomiting; passed out; arm sun brunt; swollen; arm red; she wish she was dead,brutal; four good days of life, not a happy camper, lost three days of existing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SUICIDAL IDEATION (she wish she was dead,brutal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) (seriousness criterion medically significant) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing). At the time of the report, CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing) outcome was unknown.            No concomitant medication were not provided patient underwent treatment medication of Tylenol  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Pt w/ hx of allergy to Penicillin, Reglan, Zofran (rash).  Pt w/ a PMH Bowel obstruction and Anxiety.  Pt c/o flushing/sweating, dizziness, heavy/red eyes 3mins after vaccination.  BP 86/51, HR 68, RR 18, Temp 97.8 -- > 123/74 -- > 103/82. Had pt lean back and elevate feet.  Blanket given to the pt as they felt cold.  Benadryl 50mg IM given 12min after vaccination.  Pt also given water.  Pt states that they feel better; just got scared.  Pt stable and released from the vaccination site.  Recommended that pt f/u with healthcare provider, instructions provided.
Within 15 minutes of vax, the pt developed red hives and wheezing. The pt sought unspecified medical attention and was given Benadryl and a nebulizer treatment. The pt was sent home with a referral to an allergist. Additional information has been requested.