chrisvoncsefalvay/vaers-outcomes huggingface dataset:
whole face from the nose down was red; lost her voice; extremely exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely exhausted), ERYTHEMA (whole face from the nose down was red) and APHONIA (lost her voice) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL ARTHRITIS PAIN) for Arthritis, LEVOTHYROXINE, FAMOTIDINE, Estrogen ring and METRONIDAZOLE (VANDAZOLE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (extremely exhausted). On 04-Feb-2021, the patient experienced ERYTHEMA (whole face from the nose down was red) and APHONIA (lost her voice). On 05-Feb-2021, APHONIA (lost her voice) had resolved. At the time of the report, FATIGUE (extremely exhausted) outcome was unknown and ERYTHEMA (whole face from the nose down was red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Patient died within 24 hours of receiving Pfizer as a booster.  Received Johnson and Johnson  as primary series.
Information has been received from a physician concerning a patient who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 vaccine live (human-bovine).  The physician reported that the patient subsequently developed moderate diarrhea.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Started on right hand, by morning each arm had one, one on face, small red bumps. As of 08/22/2005 still has bumps. No treatment applied.
SUMMARY OF PATIENT PROGRESS:   STATUS: Pain Primary Problem: Cardiac Discomfort   Key findings related to primary problem: Covid+; decreased EF   Other key findings: Self care ADL w/o CP or SOB         Note Details  Author  (R.N.) File Time 8/10/2023  4:12 PM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct #  Admit Date 8/8/2023  ED to Hosp-Admission (Discharged) on 8/8/2023  ED to Hosp-Admission (Discharged) on 8/8/2023   Detailed Report  Note shared with patient Care Timeline  08/08   Admitted from ED (Observation) 1917 08/11   Discharged 1406
Both vaccines knocked my energy level down for about a week. The first caused chest pains. The second made it clear it was my GI tract with diarhia and reflux.
Headache, temperature, chills, scratch throat, muscle pains in knees artificial joints, tired and fatigue, cold sweats, body aches.
Cough (in the nights) Pressure in the chest Fatigue Muscle or body aches, specially back and chest Sore throat
2/10/21- received second dose of Moderna vaccine. 2/11/21- at 11AM onset of fever/chills, fatigue, body aches. Lasted ~10 hrs. 2/12/21- Positive Lhermitte's sign. After, developed numbness/tingling both hands. 2/23/21- Consult with primary care. She ordered referral to Neurologist and ordered brain/cervical MRI. 3/30/21- MRIs completed (see below). 4/7/21- Met with Doctor. Received diagnosis of Multiple Sclerosis.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Sharp laser like on the upper back shoulder blade.  Feelings of heaviness, magnetic like all over the body. Chest pains, wavelike vibrations at times. Heart palpitations. Numb fingertips and toes. Comes and goes since 5/2021.
Extreme pain in joints, then spreading to muscles from calves up to cranium.  To date, 5 days duration.  I still have not recovered.  I cannot walk without a Walker.
Patient had unexplained asystolic cardiac arrest 3 days after second Pfizer shot was administered.  No recent illnesses or complaints, no fevers.
Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature; Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature; This is a spontaneous report received from a contactable consumer from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as [dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "recovering" and all described as "Lateral flow test was positive/lingering cough, my head/nasal congestion returned with runny nose, worsening cough, and 100.3 temperature". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 2 negative lateral flow tests; Positive, notes: Lateral flow test was positive; Body temperature: 100.3. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication received in 2weeks. Conclusion of previously completed investigation: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 32030BD was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as pre-formulated bulk and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 32030BD. No quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notifications were held as a result of this complaint. The complaint condition of lack of 6706206 6690013 effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.  No follow-up attempts are possible. No further information is expected.
Reported having sinus congestion the day before getting the shot and symptoms continued since then without improvement or resolution.
Receiving the 3rd dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 040A12A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Quintuple coronary bypass (17 year ago had a quintuple bi-pass.). Concurrent medical conditions included Blood pressure abnormal and Heart rate abnormal. Concomitant products included WARFARIN for Anticoagulant therapy, METOPROLOL for Blood pressure management, LOSARTAN for Heart rate abnormal, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster). At the time of the report, INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 4.9 4.9. On an unknown date, Antibody test: 19.9 19.9.         It was reported that patient was not getting the antibody level he was expecting. It was stated that patient did not have any immunocompromise and not taking any immunosuppressive medications. It was reported that patient Initial titer was 4.9 in September which was exponentially lower than anyone after having the first two doses. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow up received and contains No New Information
Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "COVID test (PCR swab): positive" is related to BNT162B2 vaccine.  The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.  The event DVT of legs is not considered related to BNT162B2 vaccine.  The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
immediate symptoms included: cough, dizziness, nausea/vomiting, diaphoresis,  confusion/disorientation,  numbness back of the tongue and itchy/dry throat, blushed face.  while in the ED: continued with acute symptoms plus developed a headache
Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well as muffling in my right ear. My hands and feet became clammy. A small fan helped subside symptoms momentarily. Within minutes my lower extremities became shaky. I developed chills and felt faint. VS were measured. I was hypertensive (BP 134/100, baseline BP usually runs 110/80s). I developed intermittent tachycardic and heart palpitations, with a max HR of 124. Symptoms lasted approximately 1hour post vaccine administration.  I work at a COVID testing site, chances of me being exposed to COVID-19 are high. I was not tested prior to receiving either dose of the vaccine; however, I have remained asymptomatic for the duration of the series.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 06-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
mom reports 48 hrs of temp, ax up to 102 & runny nose w/iritability; did not sleep last 2 nocs; seen by MD 12JUN dx w/rt OM & URI unrelated to vax;
4 days of heavy cough, chills, headache, fatigue, arm site soreness, sore muscles - taking cough syrup, Tylenol
Musle pain is gone after 2days, Nausea :3~4th day after vaccination swelled lymps and thyroid: getting better slowly but still have swelled lymps Fever for first 6 days: 99.8F  after 6th day fever 99.2F~99.5F and start to have dizzyness
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 11-weeks-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 17-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
On 8/17 when pt. got up she had a rash looked like mosquito bites on a patch of her leg & arm. It spread by afternoon. 8/18 AM she was covered with the rash. She complained that her hands & feet hurt & edema hard to close her hand. Mom gave 3 doses of BENADRYL during the day. 8/19 improved but legs swollen - took BENADRYL & went to work.
Felt real bad; Where I got the shot is all red; (Where I got the shot) is hot now; like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu). At the time of the report, FEELING ABNORMAL (Felt real bad), VACCINATION SITE ERYTHEMA (Where I got the shot is all red), FEELING HOT ((Where I got the shot) is hot now) and INFLUENZA LIKE ILLNESS (like I had the flu) outcome was unknown.      No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   Reporter did not allow further contact
From husband phone call 8/5/10. Pain at site, swelling, 2 dots - rash. Dx by MD herpes zoster.
Screaming x 24 hrs, not eating x 24 hrs, rash on face, fever 101, Seen by MD dx as rxn to DTP.
He was awakened at 4 AM with what he described as ?stabbing and burning chest pains.?  They were intermittent.
Received vaccine in (R) deltoid. Began breaking out in a raised itchy rash on his (L) upper arm on 7/28/13. Spread to involve face, neck, arms, legs and back of hands (-spares palms and soles) over the next 5 days. Treated with BENADRYL and hydrocortisone.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 64-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 06-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Felt nauseous with headache Monday morning  05/03/21, third day after vaccine. Noticed in the afternoon that my arm felt very warm to the touch right under where the shot was applied and there was a large red rash. My nausea is better but I still have the rash with the warmth coming from it at 8:00 pm.  My Doctor's office is closed at the time I filled this out and will call tomorrow if my symptoms are not better.
Hives and itchy rash that would come and go and be in different places. Took a Medrol Dose Pack. It is better and calmed down, but still comes and goes a few times a day.
This spontaneous report as received from a physician refers to a 4 year old male patient. On an unknown date that patient was vaccinated with the first dose of VARIVAX (dose, frequency and route were unknown) .  After two weeks, the patient developed a mild case of chickenpox. The outcome of the event was report as recovering. Additional information has been requested.
Information has been received from a registered nurse concerning a 10 year old female with no past medical history and NKDA who on 08/07/98 was vaccinated with a dose of varicella virus vaccine live (site unknown). There was no concomitant medications. On 11/25/01, the pt was seen in the dr's office with 50 to 100 lesions, afebrile and was diagnosed with varicella. The pt was treated with colloidal oatmeal (Aveeno) and diphenhydramine HCL (Benadryl), PRN. It was noted that the pt's sister had a similar experience (WAES01114225). No further information is expected.
The patient received Pfizer as the first dose on  3/23/2022. The patient was given Moderna as a second dose on 4/18/2022. No adverse reactions after Pfizer or Moderna.
This physician received PCV20 and one day later had a splenectomy; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPLENECTOMY (medically significant), outcome "unknown", described as "This physician received PCV20 and one day later had a splenectomy". Clinical course: the patient received PCV20 and one day later had a splenectomy.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Splenectomy performed is not related to PREVNAR 20 use but due to the patient underlying medical condition  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Elevated temperature of 100, chills, joint pain, non productive cough, mild headache, exhaustion.