chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen eyelids; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 17:00 (Lot number: FK5127) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 01Dec2021 07:00, outcome "recovered" (Dec2021), described as "Swollen eyelids". Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. No hospitalization Prolonged. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
On march 4th 1st dose, high fever tfatigue chills 2-3 days, left armpit lymphonode tender pain for about 1 week. on april 1st, 2nd dose,felt worse,but no armpit pain. on the 7th day suddenly ear ringing, noise hearing loss. can hear louder sound with noise can not hear the word. She used to have hearing problem but never has diffeculty for communication ,never use hearing aid. she had hearing test done. The fever and bodyn ache was treated with tylenol. hearing loss treated with methylprednisonlone for 6 days. no obvious effect.
Tremor in (R) arm, weakness in entire body over time. Noticed symptoms of tremor in one week but went away, came back worsened over time, permanent lost 4 mo's. ER visit inconclusive. Seeing neurologist 7/23/15.
Tiny little Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Tiny little Sore throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Tiny little Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Tiny little Sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided. Treatment information was not provided
Patient had 2 Flu shots 8/17/09 and 9/02/2010, only flu shots she has ever had. Narcoleptic events started immediately in November 2010. Narcolepsy with cataplexy. Would wake from sleep not being able to move her limbs, excessive daytime sleeping, cataplexy as well when experiencing laughter (would fall to ground as her legs would give out) Food allergies found as well to egg, dairy, peanut, shellfish. Since the onset is believed to have been caused by the H1N1 flu vaccine, no medication is currently being taken to control the narcolepsy.
Red, swollen, and knots below injection site in right arm - soreness that evening with progression.  The following 2 days - patient advised to take antihistamine and use warm compresses.
Breakthrough case admission after 3 vaccines Pfizer 1/27/21 Lot# El9264;  Pfizer 2/17/21 Lot# N6200;  Pfizer 1/6/22 Lot# 330368D  THIS IS THE INFORMATION AS LISTED IN THE DATABASE
Patient reported that she developed tingling in her face on the same date of her vaccine. Was evaluated by provider on 12/22/2020 and Kenalog 40mg IM given as one time dose. Patient was contacted that same evening and reported that her symptoms had resolved.
Fainted the next morning (9/10/2022) after my 2nd covid booster (9/9/2022.
a patient received MMRII, VARIVAX, and PREVNAR 13 on 3/4/2020 and experienced hives in lower extremities on 3/6/2020.; This spontaneous report was received from a physician referring to a 15-month-old female patient.  The patient's concurrent conditions included a urinary tract infection.  The patient did not have known allergies or concomitant therapies.   On 04-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028919, exp date reported as 16-JUL-2021, but validated as 16-SEP-2021 , subcutaneously as recommended immunization (dose, dose number were not reported), also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA (recombinant human albumin), lot # S007814, exp date: 14-MAR-2021 (dose, route, dose number were not reported), and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dose, route, dose number, lot and exp date were not reported) both as prophylaxis.    On 06-MAR-2020, experienced hives in lower extremities.  The patient received medical attention, and the physician reported the patient received diphenhydramine (BENADRYL) for her hives, laboratory tests were not performed, and she recovered on 07-MAR-2020.   The relatedness of hives in lower extremities and varicella virus vaccine live (oka/merck)(VARIVAX); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), and pneumococcal 13v conj vaccine (crm197)(PREVNAR) was not reported.
After receiving PROQUAD (R) thigh by LPN approx. 2 min, Mom stated that she wanted BENADRYL for patient's leg was red and swollen around PROQUAD site. Local itching present. Dr. assessed patient and then sent home, no distress.
"High fever, muscle ache, neck and jaw froze, shivering, chills, nausea" could not sleep.
Chest pains ever since that has been undiagnosable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Chest pains ever since that has been undiagnosable".  Additional information: Wife of the patient said that he got the Pfizer COVID vaccination and has been having chest pains ever since that has been undiagnosable. We heard that there may be some clinical research into the side effects of the Covid vaccination and didn't know if this was something that was available to him.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Stye developed on 2/1/2021 to left eye, consulted PMD. NO tx  resolved after 4 days later. Then 5 days later developed  rash to bialteral arms and gluteal region, resolved at the end of day.
Crushing headache, Major fatigue, Major Body and joint pain head to toe, Fever, Chills, Digestive distress, total loss of appetite, Constant Nausea feeling, continued for 4 days with all symptoms, tapered to Nausea and no appetite through days 5 & 6
74 year old patient was given Fluzone quadrivalent in error instead of Fluzone high-dose with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist on 08-Oct-2020 via Global Medical Information (GMI) (Reference number- 00307175).  This case involved a 74 years old female patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  On 07-Oct-2020, the patient received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Lot number- UT7007KA, Expiration date- 30-Jun-2021) pre-filled syringe via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE for prophylactic vaccination.  It was a case of actual medication error due to Wrong vaccine administered (Latency: same day).  At the time of reporting, patient had no adverse event.  Reporter queried about how soon can it be re-administered with the FLUZONE HIGH DOSE QUADRIVALENT immediately after.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mastitis in right breast. Resulting in a high fever, body aches, headache and chills. Has been consistent since night of vaccination.
Large 8 cm x 7 cm circle of bruising and inflammation around injection site, that became progressively worse 10/3 and 10/4 before improving 10/5 and 10/6. Still visible 10/7.
Vomit 12 hours after the second shot and a rash start after 36 hrs after the second shot, rash still present and increased, coughing also
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of MMR II (lot # K016153 with expiration date 24-SEP-2016 and lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Chest Congestion, Nose congestion, Nose bleeds, Chills, Body aches.
tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID19). At the time of the report, COVID-19 (tested positive for COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot; Headache; got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022; got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Manufacturer unknown), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Oct2022, outcome "unknown" and all described as "got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot"; HEADACHE (non-serious), outcome "unknown". Additional Information: The patient got a Flu shot (Unspecified Flu shot) and the Pfizer, the third booster (Clarified as Pfizer COVID 19 Vaccine) today, 11Oct2022. Arm was just a little sore actually both arms because chose one arm for the Pfizer booster and one arm for the Flu shot and also got little headache.  Stated that his/her arm was sore and it was the same symptoms that he/she had in the past (further clarification unknown). It was reported that patient was told when he/she got the earlier series of vaccine that he/she could take a couple of Tylenol if arm was achy. Reporter was querying if he can take a couple of Tylenol to see if that helps with the achy arm and the slight headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience Right arm pain, numbness/tingling and soreness, note that injection was given in left arm.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of muscle aches (Right arm)         Previous Reactions: No previous reactions to vaccines.     Objective    Vitals Vitals:   01/15/21 1239 01/15/21 1248 BP: 137/89 134/89 Pulse: 99 100 SpO2: 100% 100%     Blood Sugar 66 collected at 1236 * Patient given snack (granola bar) just before blood glucose checked.      Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is not ill-appearing.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Musculoskeletal:     Right shoulder: She exhibits pain. She exhibits normal range of motion and no tenderness.     Right elbow: She exhibits normal range of motion and no swelling. No tenderness found.     Right wrist: She exhibits normal range of motion and no tenderness.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: Ibuprofen/analgesics. Follow up response to treatment: no change. Patient discharge: Stable to go home and follow up with PCP.   Reports that she had work up for Guillain Barre 2.5 years ago but this was ruled out. States that she has had intermittent pain of all extremities since that time and has a handicap parking placard due to this. She denies any pain in right arm prior to the vaccine but states it started just a few minutes after administration. She has full ROM without difficulty and full sensation but reports some numbness and tingling as well as soreness but not necessarily tender to touch. Ibuprofen was administered but shortly after patient requesting to leave and feels this pain is the same as what she's had over the past 2.5 years but wanted to keep us aware. She will be discharging home and states she does not live alone.
Patient passed out in the Lobby approximately 10 minutes after being vaccinated, the patients mother stated earlier during the visit that the patient has never passed out during or after vaccinations when asked by the Medical Assistant.
7/8/19 12pm MMR injection  5:30pm headache 6:40pm worsening headache, dizziness, nausea, extreme fatigue 8:45pm vomited (As headache became severe I tried to reach his healthcare provider to no avail.)  7/9/19-7/11/19 Malaise, lethargy, runny nose  I was unable to reach his healthcare provider that evening. No treatment was given. Energy returned within a few days. Runny nose persisted for months. I did report to healthcare provider.
Pain, sore at the injection site after getting Trumenba; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced pain, sore at the injection site after getting meningococcal group b rlp2086. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information on the batch number cannot be obtained.
Child was 11 yo at the time when they signed up for the vaccine appt - software does not allow 12 yo to make appt.  By the time the child presented for vaccination he was 12 yo and 17 days.  This error was recognized minutes after the first Pfizer Covid vaccine was administered - this was a 10mcg dose.  So my profession judgement concluded that the vaccine would be invalid so I administered  2 more dose of the Pfizer Covid vaccine  which gave the patient a total of 30 mcg which is equivalent to the 12 and over Pfizer Covid Vaccine dose.  I followed up with the system to document all 3 doses in the system then was referred to Pfizer Medical for how to proceed with second dose.  Pfizer medical recommended if this were to happen again not to repeat the dose.  And to follow up in 21 days with 12 and over dose of pfizer covid vaccine.  Father was made aware last night and I will follow up with him with these instruction from Pfizer Medical for dose 2.
Administration error: During the vaccination the needle came loose from the syringe and approximately 50% of the vaccine was spilled.  When removing from arm the needle on attached syringe and the needle was separately removed from the arm.
3 times the size; arm started itching; red; swollen, 3 times the size; little circle at the injection site; arm hurt for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for 2-3 days), VACCINATION SITE SWELLING (3 times the size), VACCINATION SITE PRURITUS (arm started itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen, 3 times the size) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stenosis (neck stenosis) and Thalassemia minor. Concurrent medical conditions included Penicillin allergy, Contrast media allergy, Drug allergy and Latex allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and DIAZEPAM (VALIUM) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt for 2-3 days) and VACCINATION SITE RASH (little circle at the injection site). On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (3 times the size), VACCINATION SITE PRURITUS (arm started itching), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen, 3 times the size). At the time of the report, PAIN IN EXTREMITY (arm hurt for 2-3 days), VACCINATION SITE SWELLING (3 times the size), VACCINATION SITE PRURITUS (arm started itching), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen, 3 times the size) and VACCINATION SITE RASH (little circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
pt recv vax 10JUN98 & 11JUN98 pt devel h/a & dizziness;adm to hosp 11JUN98;a spinal tap was negative for bacteria & WBC count was extremely high;dx w/asymptomatic meningitis;
she has had her menstrual cycle come back; This spontaneous case was reported by a patient and describes the occurrence of MENOPAUSE DELAYED (she has had her menstrual cycle come back) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENOPAUSE DELAYED (she has had her menstrual cycle come back). At the time of the report, MENOPAUSE DELAYED (she has had her menstrual cycle come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications was not provided.
Pain in right shoulder. Pain in right base of neck. Pain in area behind right ear. Pain in right temple (to the right of forehead). Localized headache in right side of back of head. Shooting pain down right arm. Pain in elbow and wrist in right are. Tension in right hand. Tingling sensation in right hand during typing (computer use). Pain at injection site. Mild fever.
Epigastric Pain and Diarrhea. She could not work for 2 weeks; Epigastric Pain and Diarrhea. She could not work for 2 weeks; This is a spontaneous report received from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date in Apr2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that patient received the first dose of the Pfizer COVID vaccine 3 weeks before the present report (Apr2021) and 36 hours later she had epigastric pain and diarrhea. She could not work for 2 weeks and reporter wanted to know data on risk of having it again for the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a other health professional refers to a 12 years old female patient with no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (670048/0963AA) dose 3 GARDASIL, right deltoid on 04-JAN-2012 at 03:39 PM. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.