chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm seeing colors brilliantly/ it has helped my blood pressure; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The Medical history included repaired cones/rods (eye disorder), blood pressure abnormal and cardiac disorder:(Prior to this, I've had very negative side effects from cardiac meds). The patient's concomitant medication included progesterone. On an unspecified date, after the administration of covid shot vaccine, the patient seeing color brilliantly. He or she knew that's not something there concerned with, but he/she wonder if it had somehow repaired my cones/rods. Also wondering if it has helped his/her blood pressure, of it is having started using progesterone. Prior to this, had very negative side effects from cardiac meds, so he/she started progesterone and it seems to be helping. But he/she wonder if the shot was somehow fixing things. The outcome for the event was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
caliber bone swelling; tender arm; swellown arm; redness; headache; some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (cephalosporins).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue). At the time of the report, BONE SWELLING (caliber bone swelling), VACCINATION SITE PAIN (tender arm), VACCINATION SITE SWELLING (swellown arm), VACCINATION SITE ERYTHEMA (redness), HEADACHE (headache) and FATIGUE (some fatigue) outcome was unknown.            no concomitant medications were reported. no treatment medications were reported.
Two days after receiving my 2nd dose of the Pfizer-BioNTech vaccine I experienced large swelling in my right axillary region. The swelling mostly subsided over the next couple of days, but some swelling and mild pressure has yet remained even after 6 months time.  My primary doctor ordered an ultrasound and then a CT-scan of the region to rule out other causes but those procedures found nothing that could be causing this lymphedema and pressure sensation.
felt very weak; bedridden; felt like heck; Fever; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion). At the time of the report, ASTHENIA (felt very weak), BEDRIDDEN (bedridden), FEELING ABNORMAL (felt like heck), PYREXIA (Fever) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  The reporter said that a lady who got Moderna who said that she has the same thing happen to her. No further details provided about the lady who took Moderna.   Treatment medication was unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Significant live follow up was added with new events.
Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC, CMP, and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.
A couple of days after that I started experiencing skipping of heart beat; my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.; I had headache; chills; soreness at the site; after the shot I was fatigued; I could hardly stay awake; first night I had a rapid heart beat; I didn't feel right; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued) and INSOMNIA (I could hardly stay awake) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right). On 24-Apr-2021, the patient experienced EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) and HEART RATE IRREGULAR (my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.). On 24-Apr-2021, HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right) had resolved. On 04-Jun-2021, EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable
C/O headache and rapid heart rate.  Moved to stretcher, gave 25mg PO Benadryl. BP 170/90. Called RRT.  Taken to Emergency Department for further evaluation.
One hour after patient received hi dose flu shot he experienced sore throat, lost voice, earache, headache, runny nose. This symptoms are still persisting after 3 days. Patient had been bed ridden for 3 days.
Pt reported hives and warmth at site of injection and chest tightness. Pt took BENADRYL and will f/u with PCP or go to ER if symptoms worsen.
Areas of blotches and redness on legs and arms, more on legs around knees and calves.  Very uncomfortable and itchy.  Went away within an hour or two.  Has returned most but not all mornings and is now increasing moderately in severity and coverage, but still goes away quickly.
-Inflammation, Redness, Warmth at injection site. MD suggested watch and wait. Muscle pain in arm.
mild reaction, soreness; Fatigue; mild reaction, soreness; This is a spontaneous report from a contactable physician. A 50-years-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Deltoid Right on 14Jan2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included Herniated Disc from 07Dec2017 to 14Mar2018, ongoing pain and inflammation. Concomitant medication included naproxen taken for pain, inflammation, from27Dec2020 to 01Jan2021 at a dose of 500 mg twice a day. The patient previously took first dose of BNT162B2 (Batch/Lot number:EK9231 and expiration date: 30Apr2021) Route of administration: Deltoid on 26Dec2020 at 12:40 for COVID-19 immunization/Front line worker and experienced fatigue, unable to lift arm 27Dec2020 AM. Unable to work and Afterward noticed increasing pain. The patient previously administrated Ibuprofen Motrin 600 mg prior to injection was given in Deltoid. The patient experienced mild reaction, soreness and fatigue on an unspecified date. The patient underwent lab tests and procedures which included x-ray: neg/no fracture on 07Jan2021 at urgent care to rule out. The outcome of the events was reported as unknown. Causality reported as a reasonable possibility that the events is related to suspect product.
Severe pain in my arm. Sore throat, sinus headache, severe fatigue, ?COVID Fog?, chest tightness.
Her Behcet's disease was in remission for three years but after 18 hs of the shot it reappeared; tingling; sore arm; A spontaneous case was received from the consumer concerning a 65-years-old female patient who received Moderna's  COVID-19 vaccine and experienced sore arm, tingling and Behcet's disease.  The patient's medical history was not provided. No relevant concomitant medications was reported.  On 29 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number:026L20A) for the prophylaxis of COVID-19 infection.  On 29 Jan 2021 the patient experienced sore arm and tingling. Her Behcet's disease / systemic vasculitis (lupus like element) which was in remission for three years reappeared 18 hours after the shot. Treatment of the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, tingling was not provided. But the outcome of the event for her Behcet's disease was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
At 7pm, we noticed petechiae on his lower legs and feet and heavy bruising on his lower legs. No treatment.
After taking the vaccine, a few days later i begin having hives which went away in about fours days. i had to take over the counter benadryl, pepcid, and zyrtec. When I stopped taking the medications for two days the hives came back. I took the medications for another two and a half weeks. I haven't had any medications for the hives since 2/20/2021.
Within 5 seconds of administering Menactra IM to the R arm, the patient passed out, fell over off the exam table and hit her head on a counter or cabinet. The patient had a short seizure activity after hitting head. Pt then became alert and oriented.
CHILD'S DOB AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER.  CHILD IDENTIFIED in database with a different DOB. THIS IS CHILD'S SECOND DOSE. VAERS FILED FOR FIRST DOSE AS WELL. TOO YOUNG FOR BOTH VACCINES.
A patient was administered an expired Fluzone High Dose vaccine/ No AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical Assistant).  This case is linked to case 2020SA275945 (81 years old patient).  This case involves a 75 years old male patient who received 0.5 mL first dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ306AA, expiry date: 24-JUN-2020) via un unknown route on Deltoid of unknown arm on 30-Sep-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy given.  It was an actual medication error due to the expired vaccine used (latency same day).  No symptoms occurred to the patient.  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.
Customer noticed red rash on left arm (10x7) went to clinic gave shot of DEPO-MEDROL and ZYZAL. Either allergic to flu or Pneumonia shot.
patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; patient had titers drawn on an unspecified date and the results showed "no titers shown to hepatitis b, rubella or varicella."; This spontaneous report was received from a nurse referring to a 21 years old male patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On an unknown date, the patient was administered unspecified varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown), hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown) and rubella vaccine (manufacturer unknown) (strength, dose, route were not reported, batch/lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient had (unspecified) titers drawn and the results showed "no titers shown to hepatitis b, rubella or varicella." The outcome of the events was not provided. The causality assessment was not provided.
This spontaneous report as received from a Licensed Practical Nurse refers to patiens of unknown demographics. On an unknown date, an unspecified number of patients received improperly stored oral, ROTATEQ (dose details, lot number unspecified) (Incorrect storage of drug). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1507USA007760, 1507USA007761 and 1507USA007759 (same reporter link). Additional information has been requested.
pt arrives in observation at 10:45 after experiencing numbness/ tingling in her left side of her throat, left arm, right arm, middle of chest.  BP 134/95 HR 98 oxygen sat 100% room air.  patient rested on stretcher and her symptoms resolved themselves.  pt was escorted to the exit via wheelchair and staff
Body fatigue, headache, nausea all day.  20 second Vertigo , dizziness and weakness spell 04/09/2021 3:00pm. 04/10/2021 nausea and headache all day.
new onset diabetes mellitus hyperglycemia, serum glucose 506 hospitalized for 24 hrs IV fluids, insulin and education
Rash, lips swelling, red eyes treated with Benadryl and hydrocortisone which resolved after several days.  New symptoms-nodules on bilateral lower extremities (calves) extremely tender to palpation for a couple weeks, resolving but palpable, no treatment to these, they are improving, will follow up in a week
Thing that I am serious is an itch; it's not red or nothing from my waist, all the way around except from back and it's very annoying; Last night I could not sleep; When I wear t-shirt it touches, it burns me; It itches but there is no red spots; This is a spontaneous report from a contactable consumer, the patient. This patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. On an unknown date, "thing that I am serious is an itch; it's not red or nothing from my waist, all the way around except from back and it's very annoying,"  "last night I could not sleep" and "w hen I wear t-shirt it touches, it burns me; It itches but there is no red spots." The outcome of itch, burns and could not sleep were unknown.   Information on the Batch/Lot number has been requested.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 012A21A), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer" (unspecified if ongoing), notes: History of cancer with chemotherapy 13 years before this report; "Chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with PF-07321332, ritonavir (PAXLOVID), from 08Feb2023 (Lot number: GF5593) to 12Feb2023. Therapeutic measures were not taken as a result of interchange of vaccine products.
Rash never left back area it spread to arms, legs and became more irritated and itchy.  Feels warm as though there is inner fever.  It was determined that an allergic reaction had occured.
Pt states feels unwell red rash spread from injection site to upper arm - very painful - Had RN look at & mark developed next day & progressed looks to be bruised as well. Going to family dr next day as advised by Rph.
The pt developed swelling 6-8 hrs post DT vaccination on the right thigh and with erythema and pain. ER evaluated and prescribed antibiotics and good resolution in 48 hrs.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (terrible pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included mRNA-1273 (batch no. Unknown) for COVID-19 vaccine.    No Medical History information was reported.   [an_susp_product_dose_history_s] On an unknown date, the patient experienced PAIN (terrible pain).   At the time of the report, PAIN (terrible pain) outcome was unknown. Not Provided    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes:  On 25-May-2021: non-significant follow up
This report was received from a pharmacist and described an adult of unspecified gender over the age of 50 years who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. Medical history, concurrent conditions, and concurrent meditations were not provided. On unspecified dates, the subject received three injections of Engerix-B. Sometime after the injections, the reporter indicated that the subject had "not converted". Comment: The reporter indicated that another adult experienced this event, but was unable to identify the subject.
Developed COVID symptoms 7/6/22. Positive home and clinical PCR test 7/7/22. Admitted to hospital 7/7/22 due to syncope and COVID19. Remains hospitalized as of time of this report.
Patient's mother requested and consented to Moderna vaccine booster dose for her children as she was receiving her own Moderna Booster.  An incorrect booster dose of 0.25 ml of Moderna was administered to her teenage children. A separate VAERs form has been filed for the other teenage recipient. The booster dose was administered outside of dosage guidance for the discussed age group.
One to two minutes after immunization being given, pt's body stiffened, eyes got glassy and rolled back in head and she was incontinent of urine (lasted 20 seconds). Body relaxed, alert and oriented x 3, red rash appeared lasting 2-3 minutes, EMS was called and transported to ER.
headache, body aches, chills, nausea, feeling so sick that I had to go to bed last night and still not feeling right this morning
9/29/17- I began noticing pain in my left shoulder. Later that afternoon, the pain became worse radiating to my hand, arm, and left collarbone. I have had a terrible time sleeping since 9/29/17 with constant pain in my left arm, especially the collarbone. I have been brought to tears several times. I visited a Urgent Clinic due to the pain. I have been using ICYHOT, Ibuprofen, ice packs, and pharmacy brand pain relieving patches. I am still having trouble with range of motion and putting my clothes on without pain. I am unable to lift my child at this time.
swelling of lymph nodes on same arm of injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 20Jan2021 14:30, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history and concomitant medications were none. Family Medical History Relevant to the adverse event: Patient's mother has bad allergies and knows she is contraindicated to this vaccine, but patient has never experienced any allergic reaction to anything. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: not reported), via an unspecified route of administration, on 30Dec2020 1:30 pm, at a single dose on the left arm for COVID-19 immunization (age at vaccination: 41-year-old). The patient was administered her first dose the vaccine on 30Dec2020. She was administered her second dose of Pfizer COVID-19 Vaccine 20Jan2021, completing treatment. On 23Jan2021 08:00, three days after receiving the second dose of the vaccine she experienced swelling of lymph nodes on same arm of injection site. She reported onset of swollen lymph nodes in left arm 23Jan2021 which is ongoing. The swollen lymph nodes are present in the same arm that she was administered both first and second doses. She looked on the CDC website and did not know that this was a reported a side effect of the vaccine. She assumes it will go away. She called to clarify if she should tell her healthcare provider about this or if there are any recommendations regarding this event. She has taken some Motrin to help with the swelling. The event did not require a visit to the emergency room of physician's office.  Therapeutic measures taken as a result of the adverse event included Motrin. Outcome of the event was not recovered. The patient assessed the event as non-serious. She does believe the event was potentially caused by the vaccine.
Rash on torso starting 04/24/2005. No other signs or symptoms. No TX reassured , rash macular.