chrisvoncsefalvay/vaers-outcomes huggingface dataset:
outbreak of shingles from the vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 reported as follows: The age at vaccination was not reported. The reporter said that well after reading his/her neighborhood paper. The patient's here were had an outbreak of shingles from the Shingles vaccine. This was in patient's from 13 on up. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patient with sustained seizure about 72 hours post vaccination. Follow up 01/25/05: Patient on phenobarbital to control seizures. Discharge summary states viral encephalitis. msv Medical records state Fever, cyanosis. msv
Breakthrough case admission after 5 vaccines Pfizer 2/26/21 Lot# EN6200;  Pfizer 3/19/21  Lot# EN6205;  Pfizer 9/30/21 Lot# FF8839;  Pfizer 4/7/2 Lot# FK9894;  Pfizer 9/28/22 Lot# FH9702
client reported that she feels like she has a lump in her throat. She is hoarse, States she feels sleepy, has difficulty swallowing, and feels swelling in her larynx. Is short of breath. Had pt. remove mask, lips pale, tongue not swollen. No stridor per auscultation. Lungs clear bilaterally. BP 150/90; HR 70: O2 98% on room air.  1231: Emergency services called. Patient had her own liquid benadryl and self medicated with 50 mg of benadryl by mouth.  1241: Emergency services arrived.  1244: BP 154/95; HR 69: sat 100% on room air. Lips pink now.  Still SOB especially when speaking.  1250: HR 64: sat i 98% on room air 1300: Declined transport per recommendation of emergency services paramedics.  BP 155/97; HR 57: Sats 100% on room air. Speaking with less dyspnea. Emergency services left  1305: patient left facility with friend via personal vehicle. Stable, gait steady. Respirations mild labored with exertion.
Since receiving the 2nd vaccine, I have had constant mouth ulcers/canker sores.  As one heals another one starts.  They never go away.
skin irritation; palm of her hands and bottom of feet feels like its burning; patches of itchy spots; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin irritation), BURNING SENSATION (palm of her hands and bottom of feet feels like its burning) and PRURITUS (patches of itchy spots) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F1A, 042B21-2A and 022C1A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SKIN IRRITATION (skin irritation), BURNING SENSATION (palm of her hands and bottom of feet feels like its burning) and PRURITUS (patches of itchy spots). At the time of the report, SKIN IRRITATION (skin irritation), BURNING SENSATION (palm of her hands and bottom of feet feels like its burning) and PRURITUS (patches of itchy spots) outcome was unknown.            No concomitant medication details was reported. The patient states a week or two after the booster she had skin irritation. The palm of her hands and bottom of feet feels like its burning. She had patches of itchy spots. No treatment medication details was reported.   This case was linked to MOD-2021-417848 (Patient Link).
12:20 pm  face felt "hot"/burning.  Face turned very red.  symptoms were on the face, top of ears and  under chin.  No other symptoms 12:25 pm took 25 mg Benedryl 12:50 pm - burning started to subside.  Redness subsided by about 3pm Notified Primary Care MD a few days later - stated ok to get second shot
Day after receiving shots (HPV and Meningococcal) pt could not think straight. Could not finish sentences. Patient was very fatigued. Cound not remember what she was doing, went to bathroom to brush teeth and forgot what she was doing. Patient complained to Mom that she could not think straight. Patient acted loopy. C/O sore Rt. arm, no temp.
Baby received vaccines around noon time and was fine, after few hours woke up at home, was crying and mother held her she seemed in pain she was straining then has some discoloration on face followed by frothing from mouth and became unconscious for 5-10 min, 911 called taken to nearest Emergency department.
Hard nodule left upper arm injection site red and hot to touch. Metallic taste in mouth dizziness stiff all over and hard to move tired achy
Patient woke up with slightly itchy face.  Face became red and slightly raised on cheeks, forehead, chin. No difficulty breathing, wheezing, or swelling of mouth, lips, eyes, or tongue.
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
Arm pain: about 3 on a scale of 1-10, 10 being the worst. 2+ hours after the injection Low fever: about 4 hours after the injection Arm pain: at about level 5, 6 hours after injection Tiredness: 3+ hours after injection Body aches: 4+ hours after injection (level 3)
positive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive COVID-19 test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (positive COVID-19 test). At the time of the report, COVID-19 (positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant drug information was provided.  Patient had recieved booster dose of Moderna COVID-19 Vaccine on 22-Dec-2021.  No treatment drug information was reported.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 5 months and 23 days after receiving booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. Patient received a 2 dose-primary series of mRNA-1273 vaccine given 27 days apart,  the last dose administered approximately 10 months and 17 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 5 months and 23 days after receiving booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. Patient received a 2 dose-primary series of mRNA-1273 vaccine given 27 days apart,  the last dose administered approximately 10 months and 17 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I have constant vertigo of varying degrees of intensity.  It is worst when I try to be active and gets even worse when I try to focus on something while in motion.
pt recvd vax AM 5JAN94 by 1230PM devel rash, (red blotches w/white center) on hand; In evening mom didn't notice; Next day, mom saw hands, arms, legs (many areas); few on trunk; face had a few; behavior nl, happy; no fever eating well; itch
Five days after the third dose of the Pfizer COVID shot I had an episode of my heart skipping several beats in a row for about 5 seconds total, making me short of breath and light-headed. All I was doing was sitting down.  After that I had continual skipping (or premature) heart beats, pounding, etc.  Not rapid, not slow, but almost continual skipped/premature/pounding beats.  Some days were better, some days were worse.  My doctor prescribed a 48 hour heart monitor that showed the premature/skipping beats but nothing serious.  I also had an echocardiogram which showed mild to moderate mitral valve prolapse. I then came down with COVID two months later.  When I was sick my heart pounded a lot, was very uncomfortable, sometimes making me short of breath.  The only other COVID symptoms I had was a headache. My doctor prescribed a 14 day heart monitor, which showed the activity of skipped and premature heart beats, but did not show my heart going into afib.  I have not taken my doctor's offer to take medication to control the heart irregularities because he said it would only be for my own comfort and wasn't medically necessary, and I feel I'm on enough meds already.  I didn't report right away because I figured that it would go away eventually, but it still bothers me almost every day and I just think it should be reported.  I didn't notice any side effects from the 1st and 2nd doses of the Pfizer vaccine.
Received Pfizer Bivalent Booster dose at 1:18pm and at 1:27pm she complained of feeling hot and sweaty, had her sit in front of fan with ice pack on back of neck, laid down for 15 minutes and observed with RN , gave bottled water also complained of nausea and shakiness. Sat up for 10 minutes had 2 candies stated she felt much better, stood up and talked with us for another 5 minutes before leavening the office.
Facial pain, swelling, and inflammation; swollen glands under chin,  no treatment,
VERY AFFECTED BY JANSSEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very affected by Janssen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very affected by Janssen was not reported. This report was non-serious.
Tingling in feet, (L) arm pinching/twitching difficulty in walking/standing dizziness - demyelinating polyneuropathy, AIDP Tx steroids & IVIG
Rhinorrhea, cough and fever starting on 5/29; 6 days of high fevers including Tmax > 42 degrees Celsius on 6/3, seen in ED on that date, no evidence of other infectious source other than possible viral URI; self-resolved after this time and returning to normal self at time of reporting today ~1 week; parental concern for loss of some verbal expression/single words; regaining general verbal skills with resolution but not some specific words; also previously waving spontaneously to people and not now, but otherwise social engaged and will wave on command.
Mild waves of dizziness/vertigo which is not constant.; Mild waves of dizziness/vertigo which is not constant.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 11:00, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 08May2021 at 11:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced mild waves of dizziness/vertigo which was not constant. The patient experienced this with the first dose as well, but not as strong as second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild waves of dizziness/vertigo which was not constant was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Dose was given after 12 hours in the syringe. Asseptic technique was used.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 28-MAR-2005, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
ON 1/14/2021 TYPICAL UTI SYMPTOMS FOR RESIDENT DEVELOPED INCLUDING FEVER AND RIGIDITY. RESIDENT IS NON-VERBAL. IV ANTIBIOTICS WERE STARTED. FREQUENT UTI'S ARE COMMON FOR THIS RESIDENT.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unspecified dates since 16-JAN-2015, the patients were vaccinated with doses of ZOSTAVAX (dose, dose number, lot/batch# and expiration dates were not reported) that were improperly stored. Information about concomitant medications was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. The nurse called back for temperature stability information. Additional information has been requested.
I had the expected fever and headache the day after the vaccine. I woke up vomiting during the night. I had ongoing GI  problems. One week after the vaccine I fainted one day during a walk with my husband. I woke up and I had lost control of my bladder but I was unaware of the fact that I was unresponsive. I lost consciousness for 2-3 minutes. I had Gastrointestinal problems for one month after the second dose of the vaccine. My stomach was upset and I had Diarrhea as well as a raw feeling in my stomach. I have never had those problems before.  I recovered after one month approximately .
Narrative: 67yo male pt died at outside agency hospital from sepsis. Pt was admitted to hospital on 9/29/21 for weakness, bilateral edema. COVID (-) 9/29/21, & was on on 5L O2, & morbidly obese. Pt had received covid vaccine on 3/14/2021 (j&J). Likely vaccine is not related to pt's death given pt's medical record of death (septic - covid negative) and length of time between date of death and date of covid vaccine administration.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with expired dose of PNEUMOVAX 23 (strength and route unspecified) lot # J010396, expiration date 16-FEB-2016. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Red, tender, painful at injection site. Patient was evaluated 09/29/2021 in clinic day after the vaccine was administered.
pt recv vax 17MAY96 & 6JUN96 pt devel breakthrough chickenpox w/lesions all over body;
2 days after injection arm red and swollen.  Resolved to days later.  The following Saturday 1/30 the same area turned red again but this time very itchy and again swollen and soar.  Went to  but nurse practitioner was confused because  said injection is given higher on the arm in the muscle area.  Not sure if this is a reaction to the vaccine.  The confusions is because it?s the same arm after the vaccine was administered, so what else could it be from.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1284), in right arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: 003K21A) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RAD" (unspecified if ongoing); "OSA" (unspecified if ongoing); "CPAP" (unspecified if ongoing); "HTN" (unspecified if ongoing); "BPH" (unspecified if ongoing); "TURP" (unspecified if ongoing); "Hayfever" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure and covid 19 cannot be ruled out.
LOCAL SWELLING AT SITE AND TENDERNESS WITHIN 8 HOURS.  4-5 CM.
She cam in on Thursday Nov 18 2004 for CPE. Doctor gave her at Td injection in left deltoid. In today with left arm red and swollen site 305 x 305 cm was worse yesterday.
Droopy right eye, pain and pressure behind right eyeball, drooling out right side of mouth, slight head head ,  droopy right eyelid, thought I was having a stroke. After 2 visits to the E.R. , multiple test,  diagnosed as having bell-palsy.
BLOOD CLOT; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211156823-COVID-19 VACCINE AD26.COV2.S-Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
October 5 is when I received my first Moderna shot. October 15 is when I clearly felt COVID like symptoms. October 16 I was disgnosed with COVID. October 19 a red ring appeared around my injection spot. October 20 my face completely swelled up and rings around my eyes appeared.
Pt recv vax on 2/24/99; on 3/1/99 pt exp splotchy rash on neck, raised, bumpy rash on legs on 3/2/99
Dose administered more than12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient had taken booster dose(12 hours post punctured) and the information related to the first vaccine is unknown  No Treatment medication was  provided by the reporter.   Reporter did not allow further contact