chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema, warmth, and swelling of L bicep/deltoid 8.5 inches L arm circumference compared to 6.5 in R arm at site of flu vaccine injection approx. 24 hrs s/p vaccine
experienced swelling in the throat 4 hours after getting the vaccine; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat swelling, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine) 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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up  received: Contain Non significant information
Recurrent headaches since administration of the vaccine. Has been 6 days at the time of visit.
rash down one side of her neck and the upper part of her chest; warm to touch; itchy; A spontaneous report was received from a consumer via voicemail  concerning a 59 years old female  patient who received Moderna's Covid-19 vaccine (mRNA-1273) and  experienced slight rash down one side of her neck and the upper part of her chest . It has gotten slightly worse. It was warm to touch and slightly itchy. Upon callback, patient confirmed information provided.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first dose of mRNA-1273 (Batch number not provided) on 12-JAN-2021 and developed a slight rash down one side of her neck and the upper part of her chest. It has gotten slightly worse. It is warm to the touch and slightly itchy. She stated that the rash has deepened and she assumed it was related to the shot.   Treatment for the event included Prednisolone ( one week course) ,to which the rash has been responding. She also took Benadryl before for the rash. She plans to get the second dose unless told otherwise. Her HCP encouraged her to get the second shot and did not think it was a severe reaction   The outcome of the events were Recovering/Resolving.
No adverse reactions, Patient was vaccinated on 11/29/21 with a vaccine that expired on 11/25/21. Parents will be contacted to bring child back to the office to get revaccinated due to manufacturer could not provide stability data for vaccine administered past expiration date.
Three day later, I started having left leg pain. It is a sharp pain towards the bone. It is my whole leg that feels like that. It is still there today but not as bad. It is a dull pain now.
The day after I received the flu shot about mid afternoon it started w/an earache that increased steadily and then spread to my whole left side head neck. Then several days later subsided. Then paralysis set in, then recovered some after six months. Pain/cramps to my head neck followed yrs. until I became aware of an adverse effect and refused the flu shot. Since then the afflictions subsided. However there is still diffuse pain and loss of dexterity in left hand at times.
Symptoms started on Wed, 9/29 with a stuffy nose. She felt exhausted on Mon and lost sense of taste and smell today.  Has developed cough today, tested positive on 10/1/21
Dose 1:administration date Mar/2021, Dose 2: administration date May/2021; I developed Tinnitus; It is very loud at times and effects my daily life; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date May2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, 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: Unknown. , Does Administration date: Mar2021, Dose Administration time: 12:00 PM, Vaccine location: Left arm), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization.The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset May2021, outcome "unknown", described as "Dose 1:administration date Mar/2021, Dose 2: administration date May/2021"; TINNITUS (non-serious) with onset May2021, outcome "not recovered", described as "I developed Tinnitus"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2021, outcome "not recovered", described as "It is very loud at times and effects my daily life". The events "i developed tinnitus" and "it is very loud at times and effects my daily life" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, loss of personal independence in daily activities.  Additional information: patient did not infected with covid-19 prior and not tested post vaccination. Known allergies: No. it was reported that Within a few days of receiving the second vaccine I developed Tinnitus. It is very loud at times and effects my daily life. No other vaccine in four weeks. No other medications in two weeks: No  It was reported that the Pfizer product had no casual effect to adverse event(s).  Follow-up attempts are completed. No further information is expected.
injection site reactions are worse with this vaccine; This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. The reporter indicated that her practice did not use the Flulaval vaccine because the injection site reactions were worse with this vaccine than with other flu vaccines that they use. The reporter was unable to obtain additional details. The reporter would not provide her any additional information. The reporter consented to follow up.
Hives. Went home and returned to seek medical attention. IV started, given benadryl and transported to hospital. I spoke with her, she states fine and symptoms resolved that night.
Red, itchy, tender upper arm around vaccine site. Tender lymph nodes in armpit closest to vaccination site
Hair loss....my hair has never come out I've had blood work drawn and do not have an auto immune disorder or any previous health conditions. My hair started falling out right after the shot and has progressively gotten worst. I now have 11 bald  spots and am shedding all over as well.
PT USUALLY HAS A SWOLLEN ARM AT THE INJECTION SITE WHEN SHE DOES GET INJECTIONS. AND HER MOM SAID SHE GETS ANXIETY KINDA FEELING WHEN SHE GETS INJECTIONS BC OF THAT.  WAS TOLD AFTER THE SHOT THAT INFO. PT INITIALLY EXPERIENCED , WHILE CRYING VERY LITTLE SHORTNESS OF BREATH. BUT WHEN SHE PUT HER MASKED DOWN, SHE FELT A LOT BETTER. SHE THEN FELT A LITTLE DIZZY THEN AFTER PUTTING HER AGAINST THE WALL AND RAISING HER LEGS ,  FELT BETTER AND DIZZINESS WAS GOING AWAY. AFTER 5 MINUTES, SHE FELT SLIGHT CHEST TIGHTNESS.  KEPT MONITORING HER. CALLED THE AMBULANCE.. THEY CAME AFTER 1O MINUTES..
developed a red area near vaccine site on arm. no other symptoms other than redness. made her aware that if it gets painful, itchy or she experiences any chest pain or trouble breathing, that she needs to seek out immediate medical attention.
She got her vaccine, and have had issues with shortness of breath when she does anything. Her body temperature has totally changed.  She has gone from being cold all the time to having night sweats.  She has had weakness and some numbness and tingling that she was not able to explain at the time.  Two weeks ago she went to bed and woke up with numbness and tingling in her feet and she then was numb from the waist down.  She went to the ER and has had a lumbar puncture and many other tests.  At the present moment they diagnosed her with transverse myelitis and are checking to see if she has MS as she has lesions on her spine in the thoracic area, and MRI of the brain showed some really small lesions that they could not decifer what it was and did the lumbar puncture to see if she had MS.  She now has a FU appointment on 2/7/23.  They tell her that it is autoimmune response and that her body is attacking itself .  She did not have any of these symptoms or issues prior to starting the vaccines.    The first one was on 1/6/21 and had headaches, slept for 12-14 hours straight, very fatigued.  This lasted for about 16+ hours, but within 24 hours she was back to herself.  She had the same reaction with all of the vaccines.    Starting this year is when all of the other issues have been showing up.  She is not taking any new medications at this time until they come up with a plan after these tests.  She is still numb from  her waist down and increased her blood sugar to 281 and gave her insulin for that.  She was given a high dose of steroids to try and get the inflammation down but so far it is not working.  She was released on no extra medications, still taking her Zoloft and Vitamin D.    She has had COVID twice and the three vaccines and her symptoms have been the same.   She did not have the respiratory symptoms and not hospitalized due to COVID, but now has these symptoms they are trying to find out what they are from.      She is still able to walk but feels like she is on clouds and her legs feel like cement, but they do not work very good.  She has been using a shower chair and not allowed to drive.  Still waiting on home health to come out and assess her at home.
Patient was asymptomatic until afternoon of day 3 post injection. Noticed her arm hurt a little that day but unconcerned. Patient woke at around 1:30am on day 4 in a lot of pain from left shoulder to left elbow. The entire upper arm was bright red and hot to the touch. Patient self treated with ice packs. By afternoon on same day, patient states arm felt as it did on day 3. By day 5, when patient awoke, she was asymptomatic again.
Wrong vaccine administered -- should have been Prevnar 13 - PCV 13 no side effect noted so far by parents on 1-3-2023
fever 5/5/22 x 2 days, chills 5/5/22 x 3 days, headache, sore joints, sore muscles 5/5/22 x4 days, vomiting 5/6/22 x 3 episodes single day,  diarrhea 5/7/22 x 3 episodes single day, loss of taste and loss of smell 5/7/22 - present COVID doctor advised live life and  to take a 2nd COVID test Monday morning, she did not feel I had COVID nor symptoms caused by COVID vaccine Booster since there nothing documented regarding loss of taste or loss of smell from COVID vaccines.
This case was reported by a consumer and described the occurrence of colic in a neonate subject of unspecified gender who was exposed to HAVRIX given to the mother during pregnancy. A physician or other health care professional has not verified this report. In December 2006 the pregnant mother received 1st dose of HAVRIX. She was three months pregnant at the time and the fetus was exposed transplacentary to HAVRIX. At an unknown stage of gestation, mother gave birth to a normal neonate (no congenital defects reported) that was noted sometime later to have second dose of HAVRIX had not been given at the time of report.
Pt c/o itch at injection site; area red, swollen, feverish to touch. MD informed of reaction. Claritin 5mg po, ice pack to arm, pt observed for 40 min for reaction.
Narrative: Patient received COVID -19 vaccine (Moderna) first dose 1/29/2021. Three to four hours after dose, she had tongue and lip swelling and arm swelling. Had fatigue, loss appetite, N/D. Sx improved after Benadryl 25mg PO.
she felt the nurse gave the vaccine via subcutaneous instead of intramuscular; tenderness at the injection site; This is a spontaneous report from a contactable consumer repported for self via from a Pfizer sponsored program. This female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via subcutaneous in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient reported that she felt the nurse gave the vaccine via subcutaneous instead of intramuscular. The nurse squeezed her arm but did not pull the skin taut. The nurse pinched arm and it just didn't feel like it went into muscle. She had no reaction except tenderness at the injection site. The patient asked if she should get another dose. The outcome of event was unknown.   Information about lot/batch number has been requested.
pt recv vax 18MAR99 & devel fever 25MAR, 26MAR, 276MAR, T103 on 28MAR T105;devel rash 27MAR also had OM on 28MAR;
Patient presents clinic with complaints of continued allergic reaction symptoms.  Continues to demonstrate hives.  Has been utilizing 25 mg of Benadryl every 4 hours.  Additionally, has been coating urticarial rash areas with hydrocortisone and Benadryl cream.  Has utilized over-the-counter calamine lotion.  Additionally, has utilized a topical poison IV relief cream.  States this is unbearable.  States the only time she had relief was after the Solu-Medrol shot.  Continues with the Medrol Dosepak.  Would like to discuss an additional steroid injection.
Fever, rigors.Vomiting,1 diarrhea stool,resp distress, <saturations.Shock,lethargic,apneic,cyanotic, w/poor effusion. Chest compression after intubation.Hypothermic svr vomiting, poor perfusion-limbs, head. Autopsy COD-Waterhouse Synd.
RECEIVED ONE DOSE MODERNA COVID VACCINE ON 5/3/2021 AT PHARMACY PRIOR TO JANSSEN DOSE TODAY 6/18/2021.
She started getting symptoms of cough, congestion, sore throat, tiredness, and mild feverish. Most of the symptoms were upper respiratory. We done an at home COVID-19 test that was positive. I called her doctor and due to dwarfism, they did suggest to go to the urgent care. The doctor at the urgent care prescribed PAXLOVID. The PAXLOVID did help her symptoms and within 24 hours she felt better.
Patient mention that the area is red. She does not have any pain but the skin is warm to touch and red
BLOTCHY RED PATCHES SIZE OF A DIME APPEARED ON RIGHT ARM AROUND INJECTION SITE WITHIN HOURS OF INJECTION. PATCHES FILLED OUT INTO AN INFLAMED AREA SIZE OF A PIECE OF BREAD ABOUT 24 HOURS LATER. HAD SLIGHT FEVER, AND FLU-LIKE SYMPTOMS FOR 24 HOURS AFTER INJECTION. SITE STILL INFLAMED, BUT IMPROVING TODAY (DAY 4). NO MEDICAL TREATMENT SOUGHT OR NEEDED.
Pt received IM shot in right upper arm on 10/24/15 by intern. Pt. came to my counter today and showed me the arm. The lower (not upper muscle area) inside of arm was very red and quite swollen. It was even warm to the touch. She said it was not itchy. Recommended pt to see MD to examine arm.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unspecified date in June of 2013, the patient was vaccinated with GARDASIL (lot # 0420AE, expiry date 01-DEC-2014) (dose, frequency and route unspecified). On an unspecified date in January of 2016, the patient was administered a dose of GARDASIL 9 (lot # L014415, expiry date 25-JUL-2017) (dose, frequency and route unspecified) (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Pt had Tdap 10-29-15 states her arm started swelling and had redness the day after.  Stated it continued to swell for the next couple of days but is getting better now.
High grade fever of 104.2; Extreme muscle aches; Migraine for 4 days straight; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 12Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 20:15, the patient experienced high grade fever of 104.2 (unspecified units), extreme muscle aches, migraine for 4 days straight. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events high grade fever of 104.2 and extreme muscle aches was recovering at the time of this report, whereas the outcome of migraine was recovered on 08May2021, after a duration of 4 days.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a n 8-month-old male with a history of gastrooesophageal reflux who was vaccinated PO with a second dose of Rotateq. Subsequently the patient experienced diarrhea with a lot of mucous. The patient tested positive for blood in Stool. The symptoms lasted for a month and the patient was still experiencing mucous. The physician did not give a third dose to the patient. The outcome is recovering. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
FUZONE HD was given to the patient in the left arm first, then PNEUMOVAX was given in the right arm. The patients left arm started to swell around the injection site and to bruise. She said she did not feel pain nor was in distress. An ice pack was applied to the site. She was monitored for 30 minutes and said she was fine to go home. I contacted her in the evening and she stated it had not changed and was just sore. She was advised to seek advice from her PCP if necessary.
PT SAYS SHE HAD THROAT SWELLING, NAUSEA, ITCHY AND COULDN'T BREATHE AFTER PFIZER COVID SHOT, a few hours after receiving the vaccine.
Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason.  (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.
Immediately following injection: rapid heartbeat.; Dizziness/Weakness; Dizziness/Weakness; Flushed feeling; Severe headache that traveled from base of neck to forehead.; Shortness of breath; Difficulty swallowing; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0298) via an unspecified route of administration in the left arm on 05Jul2021(at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 05Jul2021, immediately after vaccination the patient experienced rapid heartbeat, dizziness, weakness, flushed feeling and severe headache that travelled from base of neck to forehead. On 05Jul2021, 10 min after vaccination the patient experienced shortness of breath and difficulty swallowing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events rapid heartbeat, dizziness, weakness, flushed feeling, severe headache that travelled from base of neck to forehead, shortness of breath and difficulty swallowing were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
received 2 doses of FLUZONE-HD QIV with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 72 years old female patient who received 2 doses of fluzone-hd qiv with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 mL of 1 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Injection (lot UJ901AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 14-Oct-2022, she also received 0.7 mL of 2 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Injection (with an unknown batch number) via intramuscular route in the left deltoid for prophylactic vaccination.  On 14-Oct-2022, the patient received 2 doses of fluzone-hd qiv with no reported adverse event (inappropriate schedule of product administration) (latency: same day from dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
pt recvd 2 doses of Engerix-B & immed p/1st dose exp knot on arm @ inject site which reconciled w/no consequences; immed p/2nd dose got knot on arm @ inject site, pain in hand & arm on affected side-pain described as severe aching type pain