chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 041L20A and 041L20A) for COVID-19 vaccination.     Patient had no allergies.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2022-649971 (Patient Link).
fever to 105 w/in 24hrs of vax; septic w/u done & was unremarkable
Inappropriate schedule of vaccine administered; Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise; Sores that have scabbed over and are leaving scars; Leaving scars; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars), SCAR (Leaving scars) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2010, Drug allergy, Fluid retention, GERD and Blood pressure high. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure management, INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) and METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE for Fluid retention, OMEPRAZOLE for GERD.   On 19-Feb-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) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars) and SCAR (Leaving scars). On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, CONTUSION (Bruises on her neck and around her jaw line, one above her temple, sores on face started as bruise), SCAB (Sores that have scabbed over and are leaving scars) and SCAR (Leaving scars) had resolved with sequelae.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Reporter details, patient demographics, medical history, concomitant drugs, product information and event details updated
This spontaneous report as received from a 61 year old female consumer (reporting on herself) with allergy to penicillin and mites allergy, had epipen. The patient's medical history included vein ligation 20 years ago (??-??-1993) and hysterectomy. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (0.5ml dose, route not reported). Concomitant therapy included omega-3 marine triglycerides, unspecified multivitamins and CALCICHEW. On 04-SEP-2013, she broke out in a very itchy red rash on the left side in the middle of her scapula. She stated it has little bumps but has not blistered. The size is about 2x2 and round. She also advised that the injection site was red about the size of a silver dollar and itchy as well. She went back to see her doctor on 07-SEP-2012. Her doctor advised her that about 1 percent of the people injected get shingles after being injected. The patient felt her immune system was not compromised. She advised that she saw what dosage was given to her which was 0.5 and that she had read the normal dosage was 0.675 to 0.7 and wanted to confirm dosage. She did not provide name of nurse that injected her and did not have any further information on address. The patient sought medical attention and she was advised to use over the counter hydrocortisone as well as taking over the counter BENADRYL at night. The patient's outcome was unknown. Additional information has been requested.
2nd Moderna vaccination received severe headache that lasted a couple days. Happened on the 4th week.  Booster Moderna vaccination received migraine side effects which included Severe headache,  Dizziness, Felt like vomiting, Shaking, Hard time walking lasted a couple of days but didn't feel well for a week after that. Happened on the 4th week.
Extreme fatigue; Minor redness at injection site; This is a spontaneous report from a non-contactable pharmacist. A 35-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On an unknown date in 2021, the patient experienced Patient reported extreme fatigue starting around 20 hours post vaccination. No other side effects to vaccine besides minor redness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events The clinical outcome of the event extreme fatigue and minor redness at injection site was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; administration of Fluzone Quadrivalent to a 4 year-old, but now they have realized that it was actually High-Dose/no ae; Initial information received on 20-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 year old patient who was given 0.5mL of dose 1 of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AA, of Expiration date: 09-JUN-2020) via unknown route at left leg for prophylactic vaccination instead of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 31-Jan-2020 (wrong product administered, Product administered to patient of inappropriate age and overdose).  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination, VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination and POLIO VACCINE (POLIO) for prophylactic vaccination.  It was a case of actual medication error case due to wrong product administered, inappropriate age at vaccine administration and overdose.  The patient had no adverse effect at the time of reporting.  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
Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest; Though they have pulled a muscle; Spiting up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in both their lungs), DYSPNOEA (Difficulty breathing), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), CHEST PAIN (Sharp pain in chest) (seriousness criterion hospitalization), MUSCLE STRAIN (Though they have pulled a muscle) (seriousness criterion hospitalization) and HAEMOPTYSIS (Spiting up blood) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced SUSPECTED COVID-19 (though they had covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clots in both their lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Jul-2021 to 05-Jul-2021 due to CHEST PAIN, DYSPNOEA, HAEMOPTYSIS, MUSCLE STRAIN, PULMONARY THROMBOSIS and SUSPECTED COVID-19. At the time of the report, PULMONARY THROMBOSIS (Blood clots in both their lungs), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Oxygen saturation: unknown (abnormal) unable to have a good oxygen level.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included High blood pressure medication and cholesterol medication.  Treatment medications included antibiotics and pain medication.  Reportedly, the patient was scheduled to get the second dose on 20-Jul-2021.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Swollen lymph nodes in groin (1 day)and underarms and under jaw (2 days), headache(2 days), loss of appetite (2 days), muscle aches(1 day), feeling very tired(1.5 days) Treated with acetaminophen and rest.  Symptoms mostly resolved by end of 2nd day
Information has been received from a physician via a company representative referring to a 75 year old female patient. On an unknown date the patient was vaccinated with one dose of ZOSTAVAX (dose, route and lot# unknown) for prevention of shingles. On an unknown date the patient was diagnosed with a mild case of shingles after receiving ZOSTAVAX. The patient made office visit on an unspecified date and received acyclovir (unspecified dose/frequency and manufacturer) as treatment. Outcome of shingles was reported as recovered on an unknown date. This is one of two reports received from the same reporter. Additional information is not expected as the physician refuse to be contacted.
I have the same symptoms that I had with the first shot, only way worse and they have now persisted for over two weeks. Intense headache, body aches, swollen glands and brain fog. I have tried Tylenol, Ibuprofen, Baclofen, topical rub for pain, natural anti-inflammatory remedies like turmeric and CBD, hot bathes, sauna and massage, but nothing has given me any real relief.
02/11/21 fever 100.2 to 101.6, nausea, headache, muscle aches, fatigue, joint pain,  arm pain, lethargy, weakness and continued on 02/12/21 fluids, Tylenol first day and alternated with ibuprofen second day/night febrile until 02/13/21 morning weakness persists all signs and symptoms except weakness resolved by the  morning of 02/13/21
Pt became dizzy and lightheaded. Pt's vitals assessed and found to be stabile and within limits. Pt refused transport to ED
Developed erythema multiforme type rash and itching the evening vaccine was given. Rash continued to spread over next 3 days to present on extremities, face, neck and chest.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength was not provided). 1 min   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009904:
Within 1/2 hour of shots the pt developed a fever of 106 (rectal) with "measles" type rash. The child was fussy the rest of the afternoon. Given Motrin and Tylenol alternately.
Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Received third dose from vial refrigerated for more than 30 days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, PRODUCT STORAGE ERROR (Received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. It was reported that the vaccine was defrosted on 30-Aug-2021. Treatment information was not provided. This case was linked to MOD-2021-358921 (Patient Link).
Area of induration; Area of induration described as large and red; Wrong route of Administration; This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site induration, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site induration, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site induration and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Nurse reported Shingrix was administered subcutaneously, which led to incorrect route of vaccine administration. Nurse reports an area of induration noted following dose two of Shingrix series. Area of induration described as large and red.  HCP declined to provide demographic or contact details. HCP declined to complete full report. This was a medication error with harm.
Received 1st dose Pfizer vaccine on 9/1/2021 at 8:00 PM and woke up next morning 6:00 AM with drooping in right eyebrow and eyelid. Also had mild numbness and weak sensation in cheek area. Seen by primary care provider on 9/2/2021 and diagnosed with Bell's Palsey.  Had same reaction after getting 1st dose Moderna vaccine on 1/21/2021 and was also diagnosed with Bell's Palsey. Primary Care Provider submitted VAERS report on 1/25/2021,  VAERS ID 972455, E- Report 262426.
This spontaneous report as received from a licensed practical nurse via a company representative refers to an unspecified number of patients of unknown age and gender. No information regarding pertinent medical history and concomitant medications was reported. On an unspecified dates in 2015 (reported as "in the past month"), a couple of patients was vaccinated with GARDASIL 9 0.5 ml (also reported as "unspecified dose"), intramuscular (lot numbers and expiration dates were not provided). On an unspecified dates in 2015 (reported as "in the past month"), after receiving GARDASIL 9, these patients fainted. No treatment was given for the event. The patients did not seek medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date in 2015. The relatedness between the event and the vaccination with GARDASIL 9 was not provided. Additional information is not expected as the reporter did not wish to be contacted.
oozing blisters at the injection site, as well as redness and pain; oozing blisters at the injection site, as well as redness and pain; oozing blisters at the injection site, as well as redness and pain; she did not get the dose and maybe the dose came out; she did not get the dose and maybe the dose came out; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she has a patient who had the vaccine on Monday, 07Jun2021. She has oozing blisters at the injection site, as well as redness and pain on an unspecified date in Jun2021. The caller stated that the nurse the patient went to said she did not get the dose and maybe the dose came out on Jun2021, so now the patient wants another dose of the vaccine. The caller stated she does not want to give her another dose until she has more information. The caller wanted to know WHY the patient would be having oozing blisters and pain. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Dizziness, Headache, Rash, NauseaVomiting, left chest cramping, body aches, chills, sweats Narrative:  employee states: 1:40pm left chest cramping x 1-2 minutes 2:30pm rash on arms 6pm pain at injection site 730pm body aches during night: chills, sweats, hot flashes, feverish, bad headache, nausea, dizzy,body aches esp lower back improving but still headache and fatigue
Fever, CoughWheeze, Syncope, lymphadenopathy, chills, fatigue Narrative:  1/19 received the vaccine. 1/20 onset of fever, chills, fatigue and coughing. Temp was up to 101. 1/21 noticed right armpit swelled up to softball size. It's mildly painful. It is not red or hot. 1/22 - The swelling is about the same size but he feels much better. No fever. 1/24 - The swelling completely went away.
pt recvd 4 doses of Engerix-B & failed to convert to HBSAB pos; converted p/5th dose;
Nausea, dull headache, dizziness, fever (101.1), soreness at sight of injection
hearing problems; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious) with onset Mar2022, outcome "unknown", described as "hearing problems".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client received 2nd COVID vaccine of Moderna (Lot# 026C21A expiration date 06/27/2021). Client had completed 30 minutes of observation. Upon leaving, Client reported that she was nauseated 15 minutes ago, but had since resolved on its own to RN and PHN. RN and PHN advise Client to stay for an addition 30 minutes for observation. Client refused and states "I feel better now and it's gone-- I have to go home." PHN educated Client about ED precautions and common adverse effects of COVID vaccines. Client stood up with no complaints. At 1707, Client walked out of facility with a steady gait.
Soreness in the injection site, swollen armpit lymph nodes by the injection site, chills, bodey aches, fatigue.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was dripping sweat, very pale.  blood pressure never dropped below 120/100 per OMRON meter, pulse stayed around 60.  he was given water and recovered in about 5 minutes.  He stayed for 30 minutes further observation, then left feeling very normal
Began having nausea / upset stomach or stomach ache, and often pain behind and/or below sternum .  The symptoms would come and go daily for about 8 weeks and last for about  one to three hours each time, sometimes before mealtimes.  Would often be gone after a meal.  As of today, 5/21 I still have the stomach ache once in a while.      The morning after the first shot, I awoke with a severe stiff neck all the way around.  I've had the stiff neck every day so far.  After 7 weeks I went to a chiropractor for 6 treatments over about 6 weeks with little relief.  As of today the stiff neck is about 60 % better.