chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presents to Urgent Care on 1/11/2021  at 16:35 for possible allergic reaction to her second dose of covid 19 vaccine. She received the vaccine this morning, went home after being monitored x 30 minutes at the hospital's vaccine clinic. She had prior hx of reaction to vaccines including a severe one in the past to tdap. She noted 1 hour after receiving vaccine that she had a red itchy rash on chest, face, and some swelling of facial area. She drove back to vaccine clinic and was evaluated by vaccine clinic who supplied benadryl oral for her. The rash has dissipated, however, it was recommended to get an oral steroid for rebound reaction. No fever, shortness of breath, difficulty swallowing.  No other attempted treatments. Of note, rash has subsided prior to this immediate care visit.  RX given for prednisone.
Severe headache, body aches, chills, night sweats, burning in left arm, shortness of breath, loss of appetite and fatigue -last approx 36hrs -headache and body aches, burning in arm mostly relieved with ibuprofen and sleep
Patient passed away 20 to 30 minutes after vaccination unsure if related to vaccine or not
At about the same time the standard soreness at the shot site from the shot began to form (in the left arm), soreness also began to form in the left armpit.  Both signs of soreness began around 7pm the evening of the shot. The day after the shot was administered the soreness in the shot site began to lessen but the pain in the armpit persisted. The armpit pain, the day after the shot was administered, felt sore, almost as if I have been holding a golf ball tightly between my arm and torso for hours and a bruise had formed.  That night I checked my armpit to see if there was any swelling or bruising. There was some swelling and a small lump within the tissue of the armpit the night of the day after the shot. The morning of the 23rd , two days after the shot was administered, the armpit pain persisted and the lump was bigger than the night before and the swelling remained.
PETIENT TESTED POSITIVE FOR COVID 19 AFTER BEING FULLY VACCINATED
8 year old patient had been given with Flublok vaccine, no adverse event; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 8 years old female patient who received an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown) via unknown route and site on unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (latency: on the same day)  At the time of reporting, patient did not experience any adverse 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 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.  There will be no information available on the batch number.
After being vaccinated, client stood up walked a few steps withing vaccine room and had an episode of syncope while RN and parent were looking at vaccination sheet.   RN and parent heard thump and looked to see that patient had fallen to the floor and hit her head.  Client came to after a minute and was assisted to sit.  Client was pale but coherent.  Cool compress was applied to client's forehead and back of the neck.  Client stated that she was not in any pain.  Client was given sugary orange drink.  Client's parent stated that client had not eaten anything all morning.  After 10 minutes client stated that she felt better.   Color returned to her face.  When she got up, client felt dizzy again and she started to get pale again.  Paramedics were called to evaluate client.  Client was evaluate by byFire Department.  Client felt better and denied any pain. Fire Department gave okay for client to go home.  Parent also informed of precautions at home for client by Fire Department.
local reaction @ inject site; pain, swelling, warmth radiating under arm to breast up into neck;
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection 25/0.5 Y, lot # K005957; expiry: 08-MAR-2015 in the right arm, subcutaneously (dose unspecified). Other suspect therapies included unspecified influenza virus vaccine (manufacturer unknown) in her left arm (dosing regimen unspecified). Concomitant therapies included oxycodone, AMBIEN, LIDODERM, CELEBREX, clobetasol propionate, dicyclomine hydrochloride, diltiazem hydrochloride, LOMOTIL, CYMBALTA, NEXIUM, estradiol, folic acid, lisinopril (manufacturer unknown), ATIVAN, SKELAXIN, metformin, RESTASIS, SILVADENE, tizanidine hydrochloride and VALTREX. On 26-SEP-2014, the patient returned to pharmacy and contacted pharmacist with redness at injection site and itching at injection site. Treatment given was BENADRYL. No laboratory tests done. The outcome of redness at injection site and itching at injection site was reported as not recovered/not resolved. Causality was not reported. There was no product quality complaint involved. Additional information has been requested.
Rash/hives noted to left upper arm and patient c/o her eyes feeling itchy. Denies shortness of breath.  Given oral Benadryl.
pain on  vaccination site , unable to move arm, body aches, fever, weakness for 48 hours
slight ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (slight ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (slight ache). At the time of the report, MYALGIA (slight ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
I got covid ~3 weeks after the vaccine (25Sep2022); I got covid ~3 weeks after the vaccine (25Sep2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021), on 14Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2016 (unspecified if ongoing), notes: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "I got covid ~3 weeks after the vaccine (25Sep2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Negative, notes: symptoms on the 13th and that was negative; (15Oct2022) Positive, notes: tested again and was positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient received the Pfizer bivalent Covid 19 vaccine on 25Sep2022 and got covid 3 weeks after that because she went to a wedding. About 4-5 days after the wedding, she started getting some mild symptoms. Her home test showed negative at first, then had sore throat and then tested again and was positive for Covid on 15Oct2022. Patient was a light case with very mild symptoms. The date she felt better and stated she started with symptoms on the 13th and that was negative but retested on the 15Oct2022 and was going to see her family and then by the 17Oct2022 or 18Oct2022 she was fine. In total it was about 5-6 days from the beginning of her symptoms and not necessarily from when she tested positive for how long this lasted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271821 Same patient/same product, different dose/event;US-PFIZER INC-202300271839 Same patient/same product, different dose/event;US-PFIZER INC-202300271841 Same patient/same product, different dose/event;US-PFIZER INC-202300271840 Same patient/same product, different dose/event;US-PFIZER INC-202300271999 Same patient/same product, different dose/event;
Pt stated (L) arm swollen, red, warm to touch, painful, fever 102 degrees - called on-call MD was advised to take Ibuprofen to bring fever down. Fever came down that night & was sx free at time of phone call at 0930.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Spicy foods" (unspecified if ongoing), notes: Spicy foods; "sulfa meds" (unspecified if ongoing), notes: sulfa meds. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: Negative 4 days; Negative; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29th and still sick. throwing up every 15 to 20 mins.  Called Dr. on Sunday and was told to take aspirin and Tylenol
Large bruise at site by 07/24/04. Redness, swelling, soreness, warmth in band around arm between vaccine site and elbow; saw doctor in Urgent Care on 7/28/04: infection in arm, prescribed Cephalexin 500mg/3x day for 10 days. Still sore around band but much improved.
Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional. Follow-up received on 18Mar2021, was processed together with initial information.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient experienced sore arm. Patient mentioned that their grandson hadn't had the vaccine yet and his mother was exposed to a COVID- 19 patient. Patient wanted to know if it was okay to bring their grandson into their home. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
After given patient ADACEL, pt started to have allergic reaction (rash localize where inject medication). Pt seem alright in term of breathing and alert. Advise Mom to give patient ice-pack around rash area.
About 20-30 minutes after the vaccine, I began to feel dizzy. I was no longer comfortable driving. I did not pass out, but felt dizzy for about 4 hours after the vaccine. I had a minor sore arm from hour 2-24 after the vaccine. I had a headache (rated 4 out of 10) for hours 4-27. I had a fever of 102 which I woke up with (hour 14) which lasted until hour 22.
Fever chills headache nauseous joint pain started 12 hrs after shot and lasted 24 hrs felt tired and weak on day 2
Within 3 hours of vaccination, headache, nausea, dizziness, extreme fatigue, felt like I was freezing - fever of 100.8 (normal for me is 97.4).    I couldn't stay awake for more than about 15 minutes at a time.   Medication taken was 400mg Aleve (Naproxen Sodium). Fever lasted through the night.  As of today (3/16/21) all other symptoms except nausea persist.  Headache comes and goes.  I can stay awake for longer periods of time, but if I get up for anything for any more than a few minutes, I feel weak and dizzy again.
Information has been received from a registered nurse (RN) concerning an elementary aged child who was vaccinated with a dose of Varivax. The RN reported that in February 2006 the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
After the first injection, my migraines went from approximately 1-2 a month to 15--18 a month.  Subsequently, I have been unable to hold down a job, participate in life, attend church or spend quality time with my family.  I spend half of a month in a dark room, in bed, alone and away from my entire family.  Sometimes I get an aura as a warning that my migraines are about to come on, sometimes I just get intense pressure immediately.  My general practitioner and neurologist have tried to help me with multiple medications, but nothing seems to work. My chronic migraines typically last 1--2 days.
A report has been received from a physician concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), started on an unknown date. The patient experienced  PATIENTS DEVELOPING CONGESTION AFTER FLUSMIT QUADRIVALENT ADMINISTRATION. The outcome of event of PATIENTS DEVELOPING CONGESTION AFTER FLUMIST QUADRIVALENT ADMINISTRATION is unknown. The report was considered to be non-serious.
Approximately 12 hours post-vaccination a fever began and reached 100.2F, chills and body aches also occurred and lasted for another 24 hours despite taking OTC Aleve throughout the time.  Headache though not to migraine level also onset.  About 24 hours post vaccination I noted my left axillary lymph node was swollen to about the size of a quarter, this happened with the prior two doses as well.  However, an additional 12hours later (~36hrs post vaccine), the same lymph node had swollen to the size of a lime/plum, and was very painful to the touch and had some radiating pain distally, and difficult to perform the full range of motion. The following day (~72hrs post-vaccine) the lymph node had decreased to a large strawberry and radiating pain was relieved. At time of reporting this is the case.
Product exposed between 0.64 degree Celsius and 2 degree Celsius for 4.5 hours/ no AE; Stability data of vaccine was not provided and vaccine was not administered hence non case.
25 minutes into a 30 minute observation following 1st dose Pfizer client reported feeling a progressive hoarseness in her throat and tingling in her fingers, she stated she had a transient bout of dizziness that lasted less than a minute.  Vitals were taken and client denied any other symptoms. Her symptoms improved and she stated after an additional 30 minute observation that her hoarseness in throat was resolved and fingertip numbness/tingling was resolving. Client left facility on her own accord with a steady gait.
Difficulty injecting vaccine into muscle (person giving shot seemed to be having some issues). 16 hours after - moderate headache, pulsing and especially painful when bending over or moving quickly 24 hoyrs after- tightness, muscle spasms spreading from left lower back to right diaphragm. 40 hours after- fever (at first 99.8; 100.6 at 10:00 PM on 5/19, 101.7 at 10:00 PM on 5/20, 102.4 at 10:00 PM on 5/21, 103.2 at 10:00 PM on 5/22. 60 hours after - slight (mostly unproductive) cough with occasional faint bubbling/buzzing when laying down and breathing.  From 30 hours later to 60 hours later- Ibuprofen 400 mg 5 times daily - some relief in fever, but very temporary  After appointment with clinic: Acetaminophen 1 mg 3 times daily. Just started on 5/22- has not helped yet.
Patient's parents who are both physicians noted 10 vesicular appearing lesions in different spots on her body. Father called our office and spoke with Dr. directly in r/t sx on 2/11/2019. She advised to treat symptomatically and that patient could return to daycare/sitter once fever free and after lesions are scabbed over for at least 24 hours.
Presented to ER w/ rash and hives to both thighs at injection sites. Fever on 12/08/12. Pt given Prelone 30mg and Benadryl 25mg PO.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 9/9/2021-9/12/2021. Death 9/12/2021. Death certificate not yet available
Area where vax was given sore, could raise arm. Left arm swollen & sore to below L wrist. Referred pt for MD eval.
After the vaccine my IBS flared (I have not had any major symptoms for many months). I have been nauseated every day since. Three or four days after the vaccine I had a burning sensation in the skin above my eyebrows and then severe headaches every day across my forehead. After that the skin under my eyes started to burn too. So I am currently experiencing daily nausea, burning sensation in my skin above and below my eyes and headaches. The IBS symptoms have slowed down in the last three days. None of the symptoms have sent me to the doctor but I will be trying to see them before my second dose on April 28th.
Sudden onset Optic Neuritis, going blind. Extreme headache, Nausea. Loss of Color Vision. Gray Vision, Spots. Vision Loss. Extreme eye pain around eyes. continued extreme headache.
Information has been received from a consumer concerning her 62 day old son who on 085-MAR-2009 was vaccinated with ROTATEQ vaccine (therapy dose, route, site unknown). Concomitant therapy included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and Hib conj vaccine (unspecified carrier). The mother reported that her son on 05-MAR-2009 received ROTATEQ vaccine that expired on 01-FEB-2009. Her son was "a little hot and sleep a lot". They did not seek medical attention. As of 05-MAR-2009, the patient had not recovered. Additional information has been requested.
Primary series Pfizer vaccine administered mistakenly instead of the bivalent booster as intended.
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient was asked to them to return for redosing with unexpired vial lot 037C21A noted.
Mild eczema around eyes. Mild rash. Children's Benadryl given po. Orapred po also given. edema and rash resolved in MD's office.
She died at 4 days old. Enlarged liver. Enlarged spleen. Labeled it sudden unexplained death.
ActHIB was administered to a patient 1 day after the expiration date/ NO AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involves a 16-months-old male patient who administered a vaccine HIB (PRP/T) VACCINE [ACT-HIB] 1 day after the expiration date (batch number: UJ147AAC and expiry date: 17-Feb-2021 via an unknown route in right vastus lateralis) (expired product administered) on 18-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and booster INFLUENZA VACCINE (FLU) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter would like to know if the patient must be revaccinated. vaccine was accidently used the expiration date on the diluent initially which was 22-Apr-2021.   At the time of reporting, no adverse event was reported.  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.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J008652, exp. date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
COVID breakthrough. Patient came to the emergency department on 8/30/22 for a fall after testing positive for COVID and starting on paxlovid on 8/29/22.
TO ER ON 7/21/21 WITH SHORTNESS OF BREATH AND DYSPHAGIA.   POSITIVE PCR TEST FOR COVID-19.  HAD MONOCLONAL INFUSION IN THE ER AND WAS HOSPITALIZED INTO THE ICU.  DIED ON 8/1/21.   WAS FULLY VACCINATED WITH THE MODERNA VACCINE.  DOSE 1-2/22/21 AND DOSE 2-3/23/21.