chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(L) anterior thigh 23 cm x 8 cm bright erythematous, blanching, papular rash. No streaking, warmth, TTP, or edema. No treatment.
Came in with a chronic cough (since January 2020), patient states her cough got worse since after getting the covid vaccination. Patient states she sees a pulmonologists on  a regular basis, was diagnosed with asthma.
Two days after receiving the vaccine I got up out of bed and I was very dizzy. I called my doctor and he prescribed me with a medication. He diagnosed me with vertigo. I took the medicine for four days and on the fifth day, I did not feel that dizziness anymore. I have not experienced and dizziness since that day.
Approximately 8 days after receiving the vaccine woke up to a sore arm with red blotches.
in bed for 2 days; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was on a respirator) in 2020. Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Tiredness with Flu vaccine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired). At the time of the report, BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient get tired after any vaccine. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Pain in shoulder, limited mobility, throbbing pain through neck and arm. Sought medical attention after 2 weeks. Also saw an orthopedic who diagnosed pt w/ tendonitis.
Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tired but on day two, felt so much better. Noticed that now her arm w as itchy and had a small round circle. Notice that the red circle was getting bigger and felt hot.
received Pfizer vaccines on 3/25/21, 4/15/21 tested positive for COVID 19 by PCR on 10/18/21 admitted to St Marys Hospital on 10/18/21 w/ pneumonia underlying AML in remission
suffering from a stroke; not being well; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2020 (between his first and second dose of Pfizer BioNtech). The patient went ahead and got his second dose on 21Mar2021. He then went to see his DR in the last week (week of 05Apr2021) because of not being well. The primary care DR thought the patient had perhaps been exposed to COVID between the 1st & 2nd doses (due to symptoms that the DR thought seemed like body's over-reaction to COVID) but a COVID test was done and it was negative. Then the patient has been admitted to the hospital since suffering from a stroke on 08Apr2021. He still has not tested positive for COVID again but he is in ICU with stroke symptoms. The stroke resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was a life threatening illness (immediate risk of death from the event). The patient was in the hospital for four days. The facility where the COVID-19 vaccine was administered was in the Public Health Clinic/facility. It was unknown if the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered. Treatment for the event stroke was given. The patient underwent lab tests and procedures which included COVID test: both negative on 18Mar2021 and 08Apr2021.  Information on the Lot/Batch number has been requested.
Diffuse papulovesicular lesions in varying stages on visit 8/18/15. Patient had fever around 101 on 8/16/15 then rash started. Had 2nd Varicella on 8/6/15.
positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient   A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination.  The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide  The patient experienced  arrhythmia,  valley fever, chills , night sweats, rash looked like confetti,  low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020'   traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved  The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' ,  Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
vaccine given to soon, Mother notified of early administration of vaccine informed of no harm and a third dose would be needed. Mother stated " should I schedule now for third dose" Instructed she will be due on or after 12/23/2022 and I would contact her with clinic dates at that time.
Menstrual changes/menorrhagia after 2nd Moderna dose on 1/26/21.  Started menstruation on 2/17,/21 stopped normally on  2/21/21.  Had a second, heavy bleeding episode that started 2/23/21 and lasted through  2/28/21.  I usually  have a very regular cycle. Saw gynecologist, on 3/12/21 thinking this was perimenopause.  Lab parameters, estrogdial/progesterone, LH, FSH, TSH, CBC all normal.  Menses was delayed the following month, started  3/31/21 but otherwise normal. Then April 2021 was basically normal,  reporting now as I didn?t realize this may be an adverse event.  I saw an article about menstual effects after Covid vaccination and wanted to report
Fever, chills, aches, muscle pain, joint pain, dizziness, headache.
Mild/uncomfortable sore/dry throat; Mild/uncomfortable sore/dry throat; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 24Aug2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune atrophic gastritis and rheumatoid arthritis. The patient had known allergy to pineapple. 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. Concomitant medications included SKIN BRIGHT, two gummies daily, from an unknown date for an unknown indication and unknown if ongoing. On 26Aug2021 at 08:00, the patient experienced mild/uncomfortable sore and dry throat. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events mild/uncomfortable sore and dry throat were resolving at the time of this report.
sz lasting from 6min to 30min;fever, congestion (also runny nose);ear infect;vomiting & diarrhea;
Hospitalization: 1/6/2023 - 1/10/2023 (4 days) Presentation to the ED: intractable emesis x3 days associated with throat and esophageal pain. COVID + date: 1/2/23. Treatment: no treatment. patient stated that he tested positive prior to admission and was asymptomatic.  Discharge to: Home.   044A21A 3/23/2021 039B21A 4/20/2021 037F21A 11/29/2021
Swelling around eyes. Still going on 2 days later. Taking Benadryl.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster),  single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NIKKI taken for contraception. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete: unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course was reported as: 1 week after stopping Paxlovid, patient became symptomatic with milder symptoms and tested positive again for COVID-19 on a home test. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "slightly elevated blood pressure" (unspecified if ongoing), notes: Other medical history: slightly elevated blood pressure; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: AMLODIPINE, start date: 01Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left deltoid area hot, swollen, red. Applied ice pack, ibuprofen given advised parent to continue x 24 hr.
Left arm felt flush, arm turned reddish pink, left hand felt numb, arm became very warm to to the touch, left hand fingers became itchy.  Kept in observation for a couple hours given Benadryl 25mg injection in right arm.  Itching stopped.  Under observation for additional 20 minutes after Benadryl. Arm was still pink and warm. Given instructions if reaction leaves localized area to go to ER and instructed to use ice pack on hand if itching begins again then sent home.  2/18/21 injection site tender to touch and warmer than other arm with no itching.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and patient experienced shingles again. The reporter stated that it was not fun. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a registered nurse refers to her 57 years old husband with no drug reactions or allergies and no pertinent medical history. On 23-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot# and dose not reported). There were not concomitant medications. On 23-OCT-2012 the patient experienced erythema around the injection site almost immediately after vaccination, and that it lasted about 5 days. Patient recovered on approximately 28-OCT-2012. Patient did not seek for medical attention. No treatment was given. No lab diagnostic studies were performed. This is one of several reports received from a same source. Additional information is not expected.
This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Narrative: Admission date: AUG 24,2021 Discharge date: SEP 3,2021. Admission diagnosis: COVID pneumonia 81 y/o M with past medical history of ESRD (hemodialysis 3x per week), CAD (s/p PCI 2011 to RCA), HTN, HLD, presenting to the ED after a fall with back pain. Patient was seen at hemodialysis center yesterday and tested positive for COVID. He is vaccinated with Pfizer vaccine on 3/15/2021 and 4/5/2021 and was not experiencing any symptoms including SOB or diarrhea. He had a mechanical fall yesterday. He was down for about 2-3 hours when a worker found him. Patient states he continued to try and get up, but was too weak. He has been drinking very little as he was told he should no be drinking any more than 32 ounces of liquid per day to decrease swelling. Patient continued to have back pain today, and therefor EMS was called to bring him to the Emergency Dept. Upon admission, COVID therapy was initially held given his asymptomatic state, but he later developed new O2 requirement and fever up to 101.7 on 8/25. Given CXR with R mid/lower lobe opacities consistent with pneumonia, ceftriaxone and azithromycin were started. Dexamethasone was also started 8/25. Due to persistent oxygen requirements, remdesivir was started. Oxygen requirements down to room air on 8/26. Fevers resolved.
PATIENT RECEIVED HIGH DOSE INFLUENZA PRIOR TO AGE 65.  NO ADVERSE HEALTH EFFECTS.
she felt sick for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick for a week) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID) for Hashimoto's disease.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (she felt sick for a week). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram and IBUPROFEN (MOTRIN [IBUPROFEN]) (intravascular) at an unspecified dose and frequency. At the time of the report, ILLNESS (she felt sick for a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 137 (High) BP was usually 105/110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076351:For Second dose
My daughter was fine the first couple of days then began to complain of chest pain and shortness of breath which got worse over the following days so much so it would wake her up in tears and discomfort. I monitored her closely and it resolved after about 5 days from onset.
Skin rashes; Extremely itchy; Difficulty of breathing; This is a spontaneous report from a contactable consumer (patients brother). A male patient of an unspecified age received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCIN, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patients brother reported that, until now, 24Jun2021 his brother he is suffering from severe skin rashes that are extremely itchy along with intermittent difficulty of breathing. He was seen by multiple doctors and was prescribed several antihistamine, steroid medication, anti-itch creams but his condition doesn't seem to improve but instead it is get-ting worse. What would be your best recommendation to ensure his safety from overcoming all the severe side effects of the vaccine. They are extremely worrying for his overall health and condition due to the vaccine. Therapeutic measures were taken as a result of skin rashes, extremely itchy, difficulty of breathing. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Emesis from 8/8/13 1830 - 8/9/13 0600, fever 102.9.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional   This case involves a patient (unknown demographics) who received an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6585AA and expiry date: 11-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.; Sender's Comments:  00561594:
today's date;  6/13/21 hives, extreme fatigue within 24 hrs from vaccine..itchy bumps and when you scratch them, they blister the past 2 weeks, always always tired, bad headaches periodically I maybe 61 but am in great physical condition 5 5 and 125.  Eat healthy, take 1 a day
PATIENT HAD A SEVERE INJECTION SITE REACTION. THE PATIENT COMPAINED OF THE DELTOID REGION WAS RED, WARM AND SWOLLEN AND EXTENDED ABOUT 10 CENTIMETRS GOING UP TO HER SHOULDER, TO THE BEND OF HER ELBOW AND THE BACK OF HER ARM. THIS HAPPENDED THE FIRST DAY OF HER VACCINE AND SHE TOOK BENADRYL WHICH LASTED FOR A COUPLE DAYS. THE SECOND DAY SHE WAS FATIGUED AND NOT EATING. SHE COULD NOT USE HER ARM FOR ABOUT A WEEK.
The pfizer covid 19 vaccine should not be recommended for patient with a history of arrhythmia. Before getting vaccinated I made an appointment with my cardiologist to discuss. I have a history of NSVT which finally resolved 2-3 years ago. Had an ekg before vaccinated and was normal. Cardiologist stated I should no problems with vaccination. Less than 8 hours after receiving my 1st dose of pfizer, dizziness, lighheadedness and rapid NSVTs. dizziness resolved in 4 days. Lightheadedness and NSVT are ongoing. FDA please make our medical professionals clear as to which patients are eligible for each vaccine.
Information has been received from a registered nurse concerning a female patient who was administered her first two doses of GARDASIL (lot # not reported) in the GARDASIL vaccination schedule in 2008 and would be IM administered her third dose of GARDASIL (lot # not reported) in the GARDASIL vaccination schedule on 31-JUL-2012 ("today"). No adverse effect reported. Additional information has been requested.
Patient developed paresthesia in left shoulder and involuntary jerky movements/ muscle spasms in arm, neck, and shoulder x 6 weeks following vaccine. Symptoms subsides then returned after receiving flu vaccine in October.
Respiratory capacity gradually returned to "Long-Haul" condition after each respite.; This is a spontaneous report from a contactable consumer or other non hcp. A adult non pregnant female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on Dec2020 as dose number unknown, single for covid-19 immunisation. Medical history included covid-19 in 2020 if Covid prior vaccination: Yes. The patient's concomitant medications were not reported. In Dec 2020, the patient experienced respiratory capacity gradually returned to long-haul condition after each respite. Reduced respiratory capacity limits and ability to run. Patient received vaccine through workplace program as job requires frequent travel. Patient regained respiratory capacity after each of the two immunizations. Patient was able to run again. The outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.