chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His mouth and inside of the mouth was tender; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (His mouth and inside of the mouth was tender) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Periodontitis, High cholesterol and Heart valvular prosthesis user (artificial valve). Concomitant products included AMLODIPINE for Heart valvular prosthesis user, SPECTINOMYCIN HYDROCHLORIDE (TROBICIN [SPECTINOMYCIN HYDROCHLORIDE]) for High cholesterol.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ORAL PAIN (His mouth and inside of the mouth was tender). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Jan-2021 for Mouth pain, at a dose of 1 dosage form. On 25-Jan-2021, ORAL PAIN (His mouth and inside of the mouth was tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported, a month ago he started using a new antiseptic mouth medicine (unspecified) and a nurse said that may be what caused the side effects.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2021: Start date of suspect product was amended.  Patient demographics were updated.
Patient received the Janssen Covid vaccine in July 2021. He started having fever and cough, and he tested the home COVID test kit, resulting in a positive around 12/23/21. His symptoms were progressively worsening, and he came to ED and was admitted to the hospital on 12/26/21. Hospital day 3, he has received azithromycin, ceftriaxone, Remdesivir, and IV steroids. He is not febrile but still requires 3 L supplemental oxygen.
Patient presented to the hospital with nausea and vomiting, tested positive for Covid-19 on 1.31.22. Patient was treated with PPI and sucralfate therapy, anti-emetics as needed.
Moderna 1/29/21, 2/26/21, 9/7/21. Positive on 6/11/22
After the Moderna Bivalent Vaccine with in 4 hours I was showing symptoms of Covid. By 4pm I had the uncontrollable cough, congestion, Headache, Nausea and chills. No fever. This lasted 10 days. Since that time I struggle with fatigue and get ill with headache, body aches, Chills, mental fog, and increase cough. I have seen my PCP APRN-NP x2. Been on a Medrol dose pack x2, which helps but symptoms return after pack is complete. I have missed work and applied for FMLA. On visit to PCP lab and X-ray done, all negative.
This spontaneous report was received from a registered nurse regarding an unspecified 15 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-JUL-2017, 29-DEC-2017 and 21-MAR-2018, the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (dose, frequency, route, lot # and expiration date were not provided) (inappropriate schedule of drug administration). No adverse effect reported.
Information has been received from a pharmacist concerning his 35 month old son, with no known allergies or past medical history, who on 5/24/01, was vaccinated with 1 dose of varicella virus vaccine live. There was no concomitant medication. On 5/28/01, the child was crying and fell "several" times. He was taken to the ER for pain in his left knee and inability to bear weight on his left leg. Diagnostic testing including CBC, sed rate and x-rays were performed (results not provided). Transient synovitis was dx'd. At the time of reporting, the child could not bear weight on his left leg due to the "extreme" pain in his left knee. The child had no hip pain. Additional information has been requested. Upon internal review, transient synovitis was considered to be an "Other Important Medical Event".
Fever started 1/2/2021 and continued for 5 days and then she developed a viral exanthem consistent with post-immunization rash from MMR or Varicella. She also had looser stools during part of the course.Symptoms resolved spontaneously
Difficulty lifting arm; horrible night sweats; This is a spontaneous report from a contactable consumer. An elderly female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced difficulty lifting arm and horrible night sweats the night of injection (27Jan2021) and difficulty lifting arm the following morning. The patient was not tested for covid post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
The patient mistakenly received a second flu shot when he was supposed to receive his second Pfizer dose.
Mild chest pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 308444, expiry date 25th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than a week after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced chest pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain was not recovered/not resolved.   It was unknown if the reporter considered the chest pain to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows; This case was reported by the patient for herself. The age at vaccination was not reported. The provided lot number and expiry date, but SF shows no result for the lot number given.  The patient received FLUARIX QUAD and experienced mild chest pain, for which, she went to emergency room. She had been discharged from the emergency room and had been prescribed steroid medication. The reporter was in rush, therefore, was unable to gather the date of birth, email address, and if the vaccine administered in left/right arm. The patient did not consented to follow-up.  Therefore, Health care professional contact information was not collected.
Reported 4 month after #2 GARDASIL. Temp. 101. Nausea and fainting episode.
Next day after receiving Zostavax vaccine I had swelling and fever in my arm at injection site.  6 days after receiving it my chest broke out in little bumps that did not itch or burn.  8 days after vaccine my right upper arm broke out in same bumps as chest.  Dr. prescribed Nystatin and Triamcinolone Acetonide Cream to be applied 2 times daily.
APPROXIMATELY 5 MINUTES FOLLOWING ADMINISTRATION, PATIENT FAINTED WHILE SITTING IN THE OBSERVATION AREA POST-VACCINATION. PATIENT WITHIN A FEW SECONDS OF FAINTING. WAS HELPED BACK UP TO CHAIR AND GIVEN WATER. MONITORED CLOSELY FOR AN ADDITIONAL 30 MINUTES. PATIENT WAS FULLY AWAKE AND ALERT WITHIN A FEW MINUTES WITH NO OTHER REPORTED EFFECTS. FOLLOWED UP WITH PATIENT VIA THE PHONE A COUPLE HOURS LATER AND PATIENT STATED THEY HAD EXPERIENCED NO OTHER EPISODES OR SIDEEFFECTS UP TO THAT POINT.
Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 012A21A) for COVID-19 vaccination.     No specified medical history has been reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MYALGIA (Achy) and FATIGUE (Tired). At the time of the report, MYALGIA (Achy) and FATIGUE (Tired) had resolved.            Treatment information was not provided. Concomitant medications were not provided. on 19-JUL-2021 AE contact information was updated Call was transferred from Moderna Customer Care, case # 00181349 They are inquiring about the potential of needing a booster shot.   This case was linked to MOD-2021-052885 (Patient Link).
Patient received her first Shingrix vaccination 8/1/19. Reported fatigue same day. Next day patient reported her lymph nodes in the left arm pit were noticeably swollen. As of 08/5/09 the swelling had diminished. The patient contacted her doctor who referred her to the pharmacy.
Woke up very light headed, difficultly standing/walking without loosing my balance.  Lasted during the night, woke up next morning without further symptoms
Moderna covid-19 monovalent booster administered after 9/2/22.  On 9/23/22 monovalent booster administered, no adverse reaction noted.
Painful arm from injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6198) via an unspecified route of administration in the right arm on 03Mar2021 at 13:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to codeine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced painful arm from injection. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with Advil for the event painful arm from injection. The clinical outcome of the event painful arm from injection was resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
p/vax pt devel h/a & diarrhea w/in 2hr;h/a subsided by noon, diarrhea subsided by 10/4/99;notice a rash in groin area 10/5/99;
Patient felt tingling sensation all throughout her arm, starting at her shoulder, no sensation in her hand.  After about 30 mins waiting in the pharmacy, she got her hand sensation back, but tingling was still there.  Patient didn't want to go to hospital for further check-out.  She decided she would go home, monitor herself, if things get worse, she would see a doctor.
CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and fatigue was not reported. This report was non-serious.
A report has been received from a Physician concerning 11 patients. This case belongs to one of them. The patient of unknown gender, had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST during 2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/16/2021. The patient experienced the following reaction(s) during the immediate   of observation: 11:42am Patient c/o "dizziness and mumbling noise." Patient alert, oriented, and verbal. Patient assessed in treatment area. Patient was treated/managed as follows:  11:44am VS BP 118/64, HR 67, RR 18, O2 sat 98% on room air. Patient denies shortness of breath or difficulty breathing. No swelling noted to face, mouth, or tongue. 11:59am VS BP 134/80, HR 70, RR 18, 97% on room air. Patient reports feeling better and symptoms have subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:08pm Escorted to car by sister and RN.
Later after shot (approx. 2 hrs) patient began diarrhea, then SOB, coughing, and finally vomiting. Temp up to 103 degrees. About 3 hrs after shot called 9-1-1; went to hospital. Was found to also have kidney infection; Discharged next day.
Breakthrough COVID infection. Symptoms of malaise, congestion, and shortness of breath. Unsure symptom onset. Positive test collected 12/08/2022
C/O fussy about 6pm, Rt thigh red, swollen and warm to touch, called Dr on call was instructed to give TYLENOL and warm compress. Redness, swollen, warm decreased then red pinpoint red rash on Rt leg on 5/6/14, then 5/6/14 left leg pinpoint red rash.
Within 12 days or so of the first injection, patient began having severe nerve pain radiating from his spine. His body would involuntary jerk and twitch. He also  had pins and needle sensations in his back. About 6 weeks passed and his symptoms reduced by 80%. So then he received his second Pfizer shot thinking it might be okay. Within 12 days all symptoms were back but worse. He also had a new symptom of sensations of heat on his back and head.  He is about 2 months out from his second shot and the symptoms are still present.
This spontaneous report as received form a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 18-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient came in for her first dose of Moderna vaccine today.   I was called by MA to see Patient as Patient was having symptom(s) 15 minutes after the vaccine was given.     I saw Patient at 0935.  Patient stated that she feels pressure in her anterior throat, that it was hard for her to swallow saliva, and that her tongue felt big.     I performed physical examination: Cardiovascular:  RRR S1 S2 Pulmonary:  Lungs clear to auscultation Mouth/Throat:  Posterior pharynx doesn't look swollen, tongue doesn't look swollen  MA and myself continued to monitor Patient.     I asked Patient to call her mother who Patient stated was waiting downstairs.     I asked MA to obtain vitals: BP:  128/79 HR:  102 bpm   I explained to Patient and mother that I think Patient should be given the Epi-pen in order to prevent any of the symptom(s) from worsening.   Patient and mother agreed to have the Epi-pen administered.     At 0950, Patient stated that her tongue doesn't feel big anymore, but that she still feels pressure in her anterior throat.  Patient asked for water, she was given a water bottle by MA.  After drinking water, Patient stated it was hard to swallow the water.     At 0955, I administered the Epi-pen in Patient's right thigh.  Patient felt okay with the administration of the Epi-pen.   I asked  MA to observe Patient for 15 minutes, Mom was in the room with the Patient as well.   At 1015, I went in to see Patient, and per MA and Patient, Patient was feeling much better.  Patient stated that her symptom(s) had resolved, she was not feeling pressure in her anterior throat any longer, she was able to drink water normally, and she didn't feel that her tongue felt big any longer.     I performed repeat physical examination: Cardiovascular:  RRR S1 S2 Pulmonary:  Lungs clear to auscultation Mouth/Throat:  Posterior pharynx didn't look swollen, tongue didn't look swollen   I asked  MA to obtain repeat vitals: BP:  116/73 HR 94 bpm   I have advised Patient to talk to her PCP about whether she should get the second dose of Moderna, or perhaps get another vaccine such as Pfizer in place of the second dose of Moderna.     I have let Patient know that I will CC her chart to her PCP and will try to get a Telemedicine visit with the doctor for Patient during the next week.     I have let Patient know that I will e-prescribe Epi-pen for her.     I have advised Patient and Mom that if symptom(s) worsen or if new symptom(s) start (such as chest pain, SOB, hives, throat/mouth/face/tongue swelling or any other concerning symptoms) to take Patient to the ED.    Mom and Patient understood and agreed.
Flu vaccine administered in pm of 1/9/07. In am of 1/10/07 patient was noted to have a 4x4.5 cm swelling on her left arm at the site of injection.  No redness, fever, or other symptoms were noted.  She received a flu vaccine last year with no problems.
The patient had what were described as low-grade fevers (up to 101) the night after receiving her immunizations.  The parent witnessed a generalized seizure lasting approximately 40 seconds.  She did not know if the patient had another event prior to this.  The patient was taken to the emergency room--she was afebrile at the time, and had no focal neurological deficits, signs of localizing infection, or lethargy/toxicity.
This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing). At the time of the report, EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing) outcome was unknown. Not Provided. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Consumer states she was scheduled to receive the second dose of Moderna vaccine on Wednesday. She has an ear problem, unsure if it is an infection or wax build-up. She does have dizziness when standing.
HCP Calling to report PROQUAD administration to 13 Y/O.  No additional AE.  No PQC.; HCP Calling to report PROQUAD administration to 13 Y/O.  No additional AE.  No PQC.; This spontaneous report was received from Other Health Professional and refers to a 13-year-old. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot number X018570, expiration date: 05-JAN-2025), administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse events were reported.
headache, abdominal pain, severely swollen right ankle and severe lower right leg pain, swollen left ankle and left lower leg pain, eyesight also was affected
Tested positive for COVID after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination). On 28-Dec-2021, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID after vaccination. On 28-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative with a home test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  Reporter stated that the son needs a booster to return to college. Does he have to wait 90 days before receiving the booster or can he get.  Company Comment - This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected event of SARS-CoV-2 test positive. The event occurred on a unknown date after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected event of SARS-CoV-2 test positive. The event occurred on a unknown date after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Fever, Chills, Muscle Aches, Fatigue, Soreness at injection site - 15-36 hours following injection Redness, Swelling, Fever at injection site 36+ hours following the injection.  This disappeared on day 7.