chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 01:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). 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 24Jul2022 at 12:00, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (18Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (19Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (24Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far; (25Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far; (26Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment start date: 14Jul2022, treatment stop date: 18Jul2022, indication: Treatment of COVID-19. No other medication in 2 weeks. No known allergies. Adverse event start time was 12:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age. On an unknown date in October 2013, the patient was vaccinated with first dose of PNEUMOVAX23 (lot#, expiration date, dose, route, indication not reported). On 09-DEC-2013 the patient was vaccinated with second dose of PNEUMOVAX23 (lot#, expiration date, route, indication not reported). No adverse effects reported. Follow up information has been received from the registered nurse refers to the 61 year old patient, (weight 149 unit unknown, height 71 inch). On 09-DEC-2013 (at 09:46 am), the patient was vaccinated with second dose of PNEUMOVAX23 (lot number J010332, expired date 14-JAN-2015) into left deltoid (dosage and route unknown). The patient did not require emergency room/doctor visit. Additional information is not expected.
Within 24hours of vaccine administration had eruption of clear fluid filled vesicles with pruritus over back, chest, face, arms, thighs. worst involvement on back. No treatment administered. vesicles opened and scabbed over and patient is still recovering as of 3/25/2021 without new lesions emerging
25 minutes after receiving vaccine:  flushing, slight throat swelling;Vitals were normal Resolved within 1  hour
Rt arm red & swollen from below deltoid area to elbow, warm to touch & sore, fever 101;
Vaccinated on Tuesday.  Experienced severe symptoms the following Sunday (5 days later).  Symptoms included a sense of impending doom and diarrhea.  Paramedics called.  Upon examination, HR was 50 and SBP less than 100.  Pt taken to ER.  Cardiac tests and labs within normal limits.  Patient does NOT have a history of similar episodes or anxiety attacks.
Patient fainted while attempting to stand shortly after receiving this vaccination. Patient regained consciousness within a few seconds, but fell forward into a shelf partition when he fainted. After he regained consciousness patient stated that he felt ok, except for a mild sore throat. EMS was contacted immediately and responded within minutes. While waiting for EMS patient consumed a small amount of drinking water. Patient remained seated until EMS arrived. EMS took patient vitals and transported to a nearby hospital. EMS did not share findings for vitals.
Patient reported that approximately 5 hours after vaccination, they had uncontrollable hand shaking for approximately two minutes. Felt fine prior. Pt. then had typical flu like symptoms for a full 24 hours before completely returning to normal.
Headache, Fever, NauseaVomiting, fever and body aches Narrative:
Itching/hives, feeling extremely hot but no fever, difficulty breathing, throat feeling tight/difficulty swallowing, shakiness, headache, nausea, confusion. Treatment was epinephrine and Benadryl in the ambulance, saline IV, steroid in the hospital. Prescribed prednisone for 4 days after event.
October I got the flu vaccine in my left arm, I have had pain ever since. I reported this to my employer and my Dr. I then went online and sent to your web site. I have never heard back. I have neuritis now in my arm. Please contact me.
just sick/Just been sick as a dog; tiredness; muscle pain; chills; joint pain; fever; nausea; feeling unwell; headache; I'm not able to get up and get dressed; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, NDC number and Expiry Date: Unknown) via an unspecified route of administration in arm right on 06Feb2021 at 10:30 (Saturday) as dose 2, single for COVID-19 immunisation. The patient's medical history included she has been diagnosed with cancer from an unknown date and unknown if ongoing, chemotherapy from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number EL32 plus 9 (Lot: It was hard to understand their writing, but she thinks it was EL32+9, she specified it looks like a plus sign between the 2 and 9 of Lot number.) via an unspecified route of administration in arm left on 16Jan2021 at 13 as dose 1, single for COVID-19 immunisation. The patient reported that she had experienced multiple adverse reactions since 07Feb2021, a day after her 2nd dose "I have been just sick, she had all of these (Adverse Events, 08Feb2021) tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, her body cannot handle this COVID shot I was not going to radiation because she was just so sick from the shot and was not able to get up and get dressed. The patient had scheduled for radiation starting Monday, 08Feb2021 for 2 weeks, she reported that she had just been sick as a dog since then, clarified onset of event was Sunday, she wanted to know if she should or should not be getting radiation treatments while her body was fighting the Pfizer COVID-19 Vaccine shot right now, because she does not think she should. After yesterday (unspecified date) radiation therapy she said no, she cannot do this, she was just too sick. She asked if it was true that it takes 10-14 days to fight off the vaccine and build up immunity. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
The vaccine that was given was expired past the 30-day recommendation. At this time there have been no s/s of any adverse event.
Given 6/4/14. Seen 6/6/14 - area 7 cm x 7 cm, red, swollen, warm to touch, itching. Per PA - cool compresses and BENADRYL.
Some muscle sorness  and fatigue and mild headche with dizzyness along wit mild diareiah same day. Next day ( 8/7/21)  I started being nuasious when i woke up for work at 4:30 Am.  I took the better safe then sorry route and called out from work. I got home, asked my eldest to watch thier younger sibling so i could grab a nap becuase i was very nasious by about 11 am or so. I was also feeling very hot but with living in a 5th wheel i thought it was just usual too hot even with AC running type hot.  I awoke about 12:27  feeling extremly hot and uncomfratable, so i knew then i had a fever so i grabbed a luke warm shower nad then took my tempture. It was 99.8 so very mild. My diarieah as turned into almost watery poop so i am staying well hydrated as of 8/7/21 1:22 PM
deltoid area became red & swollen w/discomfort & a white pimple @ inj site;
No adverse event; Moderna temp excursion - administered 3 doses past beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna temp excursion - administered 3 doses past beyond use date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Beyond use date was reported as 02-Jul-2023. No other temp excursions experienced by this product. No particulates or discoloration noted. Moderna product was transported and maintained between 36 to 46 Fahrenheit. Treatment information was not provided.  This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732784 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732784:Master case (Patient 2 administered on 7/6/2023  )
RN inadvertently administered DTaP instead of Hep A #1. RN- 1) Notified Medicine Director 2) Client's Physician 3) Parents of child  11/3/08 No adverse events reported by mother.
Patient presented to office on 9/1/09 at about 10:00 am with c/o SA; "shaking", fever. T- 102.6 ear noted., V x 1 in office, injection sites- clear, none redness or induration. 9/2/09, called patient, doing better, no fever, vx1, taking fluids. No "shaking".
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that total of 24 patients including 15 males and 9 females were administered expired vaccine which were mostly for booster shots. No other side effects were reported.  Treatment medications were not provided.
Information has been received from a healthcare professional concerning a 12 year old male who on 01-SEP-2006 was vaccinated subcutaneously with a dose of Vaqta. There was no concomitant medication. It was reported that on 01-SEP-2006 the patient "passed out" within a minute of receiving Vaqta. Patient woke up after a minute and a half. Patient received the vaccination via a subcutaneous injection. An ambulance was called. Unspecified medical attention was sought. It was reported that the adverse event improved, "yes, on therapy". No product quality complaint. Current status was not recovered. Additional information has been requested.
Severe pain in upper left back radiating to the left breast. It felt like I was having a heart attack. Cardiac event was ruled out at the Urgicenter. My Internist believes that I have the symptoms of Shingles without the rash. The symptoms improve with Advil but return daily and continue to today.
12/31/20- fever, headache, arm stiffness 01/06/21-enlarged axillary lymph nodes ipsilateral 01/07/21- rash, itching, swelling of injection site
Pt was taken to ER on 7/2/01 by EMS because of high fever (?) no measured.
"Low grade " temp 2/9/09 in PM. 2/10/09 no temp today but (Rt) leg where PCV given is little swollen. Red hardened area size of dime. No excess crying but baby cries when leg is touched
MALAISE; FATIGUE; LOW-GRADE FEVER; SLIGHT NAUSEA; LACK OF APPETITE; ACHINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced lack of appetite. On APR-2021, the subject experienced achiness. On APR-2021, the subject experienced malaise. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced low-grade fever. On APR-2021, the subject experienced slight nausea. Laboratory data included: Body temperature (NR: not provided) 99-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, malaise, low-grade fever, and slight nausea on 18-APR-2021, was recovering from lack of appetite, and had not recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210440747.
This spontaneous report was received from a pharmacist refers to a 60 year old female patient. On an unknown date approximately in 1986 (also reported as over 30 years ago), the patient was vaccinated with unspecified flu vaccine 'influenza virus vaccine (unspecified)' and an unspecified time after receiving the flu vaccine the patient developed a rash on an unspecified area of the body and experienced unspecified high temperature and nausea and vomiting which lasted for an unspecified amount of time. The patient's other medical history and concurrent conditions were not reported. The pharmacist also reported that the patient has been administered "5 - three dose series" of RECOMBIVAX HB on multiple unspecified dates, lot, dosing details unknown as a part of routine vaccination for employment. The pharmacist reported that the last RECOMBIVAX HB was completed approximately in 2002 (also reported as 14 years ago) and the patient "was not seroconverted". The pharmacist also reported that since unknown date approximately in 2002 (also reported as for the last 14 years), the patient took acyclovir (manufacturer unknown) 400 milligram (mg) twice daily) for the prevention of shingles. The pharmacist stated that patient has developed shingles multiple times on unspecified dates and when the patient has had an exacerbation of shingles, the patient took acyclovir (manufacturer unknown) 800 mg twice daily for 10 days then goes back down to 400 mg twice daily after the shingles resolves. The pharmacist also reported that the patient was also taking TOPAMAX since unspecified start dates for an unspecified reason. The patient sought medical attention to the events by consulting physician. The outcome of event the patient was not seroconverted and shingles was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, route, lot # and expiry date were not reported). The reporter stated that maximum time out of range for the vaccines was minutes only when door was being opened and closed. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day after vaccine, had chills, then sweats, like a flu but no fever. Fatigue, was in bed all say.   Day 2 after shot wasn?t too bad actually, just tired and not 100%.   Day 3 - now. This is what I?m honestly concerned about. Scares the crap out of me honestly!    Since about the beginning of day 3 post shot, I have had a significant cough, I?m fatigued, and feel generally  off. I will call it ?covid brain?. Forget what I?m talking about mid sentence, some shortness of breath, difficulty resolving basic logic problems, and I don?t feel well. The cough is persistent, and has proved some, but still get fits of cough without producing anything from the cough. Prior I was coughing things up.   In addition, on about day 3 from the shot, a painful lump in  the arch of my foot developed, and it?s still there. I need to get that checked soon because it?s been there too long.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 22-Apr-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication was not reported.  It was reported patient had rebound of COVID-19, 4 days later with mild symptoms. Patient had a positive test after negative for 4 days on 03-Jun-2022 and was not recovered. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was treated with Pfizer from  26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency.  Device Date  was reported as 04-Jun-2022.  Company comment-This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Phizer drug from 26th May 2022 to 30th May 2022 for 5 days. COVID-19 test done on an unknown date was negative. Patient reported rebound 4 days later with mild symptoms. Positive test after negative 4 days. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Phizer drug from 26th May 2022 to 30th May 2022 for 5 days. COVID-19 test done on an unknown date was negative. Patient reported rebound 4 days later with mild symptoms. Positive test after negative 4 days. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Headache site pain x days 1-5; flu-like symptoms x day 2-3; sore throat, fatigue and headache x days 4-5 Narrative:
1 week after receiving vaccine,  developed moderate rash, reddened, swollen, itchy and hot to touch at injection site on 1/4/2021. The delayed reaction is my concern.
15 min after vaccine pt developed hives. Swollen lips & tongue, with difficulty swallowing, vomiting, dizziness and headache.  11/03/09 Medical record received for DOS 10/26/09. Office visit. 20 min s/p vaccine developed itchy throat, dizziness, HA, hoarseness, vomiting, hives, swollen lips and tongue. Swallowing diff. Better with tx in ED. Anaphylactic shock. Stable.   ICD9 Code: 999.411/5/2009 ED records from 10/26/2009. Patient with c/o's hives, rash, itching, vomiting, feels "like a lump in my throat". Tx'd with IV Solu-Medrol and Benadryl. DC'd with prednisone Rx DC Dx Allergic reaction 995.0
Small dot like rash all over both arms and 5 minutes later, also noticed signs of rash on legs too.
Right side face swollen, swollen lips and Tong Numb and face can't close right eye all the way and water in right eyes coming out. Hapen in October 26,2021.
Menquadfi were administered to patients after excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old male patient to whom meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] were administered to patients after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (yeast) (Gardasil) for Immunisation.  On an unknown date, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (strength unknown) (lot number, expiry date unknown) via intramuscular route in unknown administration site for Immunization after excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi were administered to patients after excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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:  US-SA-2023SA239679: US-SA-2023SA239548: US-SA-2023SA239960:
Patient has an extreme fear of needles. Patient had mentioned that he might pass out and brought a friend along to help him in case he did. He did not pass out after his first dose 4 weeks prior, but had also mentioned the same thing and brought a friend along then. After about 5 minutes of receiving the vaccine, patient passed out and his friend was able to keep him from falling out of the chair. I came out and helped her lower him to the ground and my technician called 911.