chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was given the shingles shot on Wednesday, October 15.  Noticed on the 16th the site was red and was beginning to itch me.  Tried not to let it bother me, thinking this would only last a few days, but between the 16th and today, the 20th, the redness traveled around my arm, through the arm pit moving closer to my right breast, and up the right side of my neck.  It also appeared at the bend of the elbow.  The area is swollen and itches intensely!  Had no rise in temperature. Went to my doctor who prescribed the following:  Hydroxyz HCL 25 mg tablets Glen, cephalexin 500 mg cap.Ranb,and Prednisone 10 mg tablets West
immediately after, localized arm pain 8 hrs after, flu-like aches pains, fever, chills for 72 hours, fatigue on day 4, nausea and vomiting for 36 hours with bloody diarrhea, fatigue day 6 no more nausea or vomiting, diarrhea and fatigue day 7, body aches all over - skin hurts to touch
child, not previously vaccinated, received a dose of Quadracel, no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 years 8 months 6 days old male patient who was not previously vaccinated, received a first 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number C5635AA, expiration date: 18-June-2021; via intramuscular route in the right deltoid) on 31-May-2019 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination.  It was an actual medication error case due to inappropriate schedule of vaccine administered. Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series.  The patient also received two additional doses of GSKs DTAP VACCINE / IPV (lot numbers and other dosing details not reported) on 10-Mar-2020 and 29-Apr-2020 respectively.  No adverse event reported 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.
I started to feel nausea and arm pain at about 6:30pm. The arm pain progressed over the course of the night until it became untenable the next morning. I had no shoulder mobility and there was a oval red mark (about 2 inches in diameter) that was swollen. My fevers ranged from 98-101.8 degrees F. I had pounding headaches despite taking 800mg Ibuprofen and 1000mg TYLENOL every 6-8 hours. I iced it and heated it alternatively for several days and I experienced nausea and a  loss of appetite. Two days later, my tongue hurt in my throat for a few minutes.  For treatment, the doctor gave me Prednisone (four 10mg tablets per day), ZOFRAN to help with nausea, and ZYRTEC. I started to feel better that night.
Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having tachycardia hr in the 110s, fullness feeling to head, chest irritation. Went to ER, discharged same day. On drive home she started having bilateral lower extremity weakness and felt super sleepy. 01/01/21 symptoms resolved. 01/02/21 woke up with chills at 2am, went back to sleep, woke back up at 5 am same day and symptoms resolved. 01/03/21-mild headache-took Tylenol sinus-headache resolved. Pt. states that she has felt fine ever since.
30APR97 PM felt itchy all over;1MAY97 hands swelled then went down, then lips swelled then went down, then feet swelled & went down;devel rash on arms & chest & hives larger welts on stomach;T/C to ER then to MD ordered DPH;
On 10 Mar 2021 approximately 7 PM  a blotchy, red raised, slightly itchy rash appeared mid right arm  8 days after Moderna Covid 19 vaccine injection  on 02 Mar 2021.  The rash consisted of 4 blotches (3 - 1/2 inch blotches, 1 - 2 inch blotch) .   There was no treatment given for the rash.
June 16 2020: 930 am Spoke with patient, right arm with oval redness about 1 and 1/2 inches. Slightly warm to the touch, painful. No fever. No blister/liquid. Using Neosporin ointment. No other over the counter meds. Started Fri, 6/12/20. Advised to follow up with MD if fever begins, or no improvement, advised not Usual occurrence after varicella immunization. He stated he had similar spot on his back a few years ago, had to be lancedX2. No culture done at that time. Also noticing a few red spots on his back and chest. June 17, 2020: 11 am Follow up phone call. Patient stated he began to have fever,101.4, around 4pm 7/16/20. Went to urgent care. Placed on Bactrim and Clindamycin. Area lanced. Told to go back for follow up 48 hrs. June 18, 2020: 1pm Phone conversation with Patient. Right arm less sore. Still fever 100, fatigue, sometimes headache. More spots all over body and in mouth. Will follow up w/urgent care physician. June 23, 2020 1215 Left message to call us back. June 25, 2020 Phone conversation with Patient. Had visit 6/19/20. Blood culture, Varicella Igg, Covid test done. Blood Culture neg for bacteria, non specific virus, Varicella negative, Covid negative per Patient. Said doctor thought it was Chicken Pox. Arm feeling better, no fever. Spots subsiding. July 9, 2020 2pm Drove wife to our office for immunizations. Spoke with Patient in parking lot as he was waiting in car with their children. Still has some discomfort if presses on site. Otherwise "back to normal." RN.
STOMACH UNCOMFORTABLE; FEELING NOT STRONG; DIARRHEA; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies, there was no drug abuse or illicit drug usage. The patient was previously received with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received booster covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JAN-2022, the patient started having diarrhea. The patient seemed to be better now but mentioned that her stomach was uncomfortable and still not feeling strong (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 17-JAN-2022, and the outcome of stomach uncomfortable and feeling not strong was not reported. This report was non-serious.
First only sore arm, then head and body aches, slight nausea and lightheadedness
3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 12Feb2021 (at the age of 27-year-old), as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. On 13Feb2021 at 12:00, the patient experienced 3 hives on neck and 6 hives on right arm. There was no treatment received for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event  was recovering.  Follow-up (23Feb2021): This follow-up is being submitted to notify that the adverse event occurred date and PRD was 13Feb2021.  Information on the lot/batch number has been requested.
Pt had an injection site reaction. Was red and warm on upper arm and a little hard where IMZ given. Pt applied Benadryl cream, cold compress, and was taking APAP OTC. Suggested seeing MD especially if rash worsened or if fever over 102 degrees F
Pt started feeling ill 5 hours after the vaccination. Symptoms included fatigue, sore throat, cough, sneezing, congestion. Coughing became increasingly worse within the week resulting in chest pain. As of today, 5/16/2022, pt is feeling better but still has mild symptoms.
038K20A 2/3/2021 031M20A 3/3/2021 058H21A 11/29/2021 past medical history significant for hypertension and hyperlipidemia presented to emergency room complain of fever cough associated shortness of breath   3on oxygen support via nasal cannula started on Decadron IV patient offered  remdesivir but she declined the offer she also treated with ceftriaxone IV as well as azithromycin IV
Pt recv 1 dose of vax. Pt devel inject site rash. Capsule shaped & didn't look like chickenpox.
trouble thinking; body is inflamed.; coughing; she feels that her brain is two big for her head; she feels as though her body wants to jump out of her skin; waves of shivers, feeling of chills; This spontaneous case was reported by a non-health professional and describes the occurrence of MENTAL IMPAIRMENT (trouble thinking) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Coeliac disease.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MENTAL IMPAIRMENT (trouble thinking) (seriousness criterion medically significant), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills). At the time of the report, MENTAL IMPAIRMENT (trouble thinking), INFLAMMATION (body is inflamed.), COUGH (coughing), HEAD DISCOMFORT (she feels that her brain is two big for her head), FEELING ABNORMAL (she feels as though her body wants to jump out of her skin) and CHILLS (waves of shivers, feeling of chills) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever of 101, radiating muscle aches, headache, nausea approximately 11 hours after shot
Per mother- Uncontrollable crying, vomiting, low grade fever x several hours, paleness
A few hours after the vaccine, I started to feel pain in my chest and in my left shoulder. The pain was a sharp pain that lasted a few seconds, and it would come and go. As the day progressed, I felt the pain more and more in my lower spine. By mid day/early afternoon, the pain in my lower spine was so sharp and significant, I could not walk or sit. The pain was worst the first two nights. On a pain level of 1 to 10, this was a 10. The pain continued for another 9 days although it started to subside after day four. It felt as though somebody had taken a mallet and smashed my lower back with it. I also felt some numbness in my arms and legs, but the numbness was not persistent. I have felt numbness in my arms about three times a week and still have numbness today.
Within 5 minutes of receiving both vaccines I had indigestion and gas in my chest requiring me to burp frequently to expel the pressure.  This sensation lasted about an hour.  Sore arm and difficult to lift arm higher than shoulder- lasted 2 days
pt devel fever; c/o sore throat, hands & feet ached & felt yukey; refused to take more APAP; fell asleep till 230-3AM-woke crying & blabbering & making no sense-couldn't see;
The patient complained of swelling at injection site with no redness, she could not move her arm in any direction. She complained of chest pain, cramps and coughing. The patients arm was hurting. The Emergency room physician prescribed KEFLEX.500mg capsule and PERCOCET. All test came negative. The patient was asked to follow up.
There were no additional AE's; the vaccine was expired when administered; This spontaneous report was received from a pharmacist, referring to an approximately 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 21-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter (injection site, route of administration, lot number and expiration date were not provided) for prophylaxis. There were no additional adverse events reported. The reporter was seeking to determine if the vaccine is effective if administered after the expiration date. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Case number PHEH2015US024868 is an initial spontaneous report received from a physician assistant on 25 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that FLUVIRIN prefilled syringe was kept at 47 F for 10 min. No adverse event was reported following this maladministration. No further information was provided.
Hot, itchy arm at injection site a week after injection. Reporting date is one day after start if reaction, effects still active.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JUN-2009, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-OCT-2015 the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "Insomnia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI ACUTE ST ELEVATION MI, LEFT CORONARY ARTERY
Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 24-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
pt recv vax & 24 hr later exp palpitations, tachycardia, chills, aches, vertigo & tingling hands; had no hx of adverse rxn to prev meds; No further details were provided;
So at approx. 18 hrs after my 2nd dose, I felt lethargic with some body aches and about 24hrs after my 2nd dose I felt chills in addition to those symptoms. I checked my temp. and it was 102.0. I continued to feel poorly that evening but was able to fall asleep. Other than being dehydrated the next morning, I felt fine the next morning. I took Tylenol and ibuprofen.
Suspected vestibular neuritis unconfirmed; Brain fog; Head pressure; Ear fullness; Vertigo; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0167) via an unspecified route of administration in the left arm on 18May2021 at 14:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. 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 18May2021 the patient experienced brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events and included treatment with NSAID (MANUFACTURER UNKNOWN) from unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event brain fog, fatigue, head pressure, ear fullness, vertigo, dizziness and suspected vestibular neuritis unconfirmed was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The morning after receiving vaccine my right eye was swollen, making it hard to see out of my right eye. This lasted for four days.
clearing his throat constantly; pressure in the bridge of his nose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose). At the time of the report, THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Pt has large knot at the injection site, rest of arm is warm to the touch and red. Pt is having pain throughout upper arm. Will have pt take MOTRIN at home for pain and swelling. Pt will follow-up if symptoms worsen or if he starts having discharge from injection site or fevers.
got covid; got covid; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid". Caller (patient) called to ask about the booster of the Pfizer COVID-19 vaccine. She stated that she received 2 doses of the vaccine last Jan2021 and Feb2021 but got COVID-19. She was advised to wait for 90 days before taking the booster shot but before the 90 days were up, she took a flu shot and got Guillain-Barre and at the time of this report she was walking in a cane. She said she wanted to travel and based on her research, the booster of the Pfizer COVID-19 vaccine had less incidence than any other boosters. She wanted to know if there was any information or reports regarding Guillain-Barre after receiving the booster shot. She stated that she wanted a document about the reports of Guillain-Barre syndrome (GBS), if there was any, to show to her doctor so she might get the booster as her doctor did not want her to receive it because she already had a history of GBS due to the flu vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
COVID shot 4/30. Then the day after getting back pain mid back- constant in pain and headaches. Headaches are in the AM and sometimes at night. She takes Ibuprofen and it doesn't really help. Been nausea after she eats or before she eats. Started 2 weeks ago. With each meal. Not improving and not worsening. Has IUD.  No sexual activity.