chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noted upper left arm (injection site) was hard 10 PM on 1/16/21.  The next day  I looked.   There was a round circle approx 3" in diameter, reddish, it  was itchy.   Today, 1/19, at 11:15 AM , the red  area has spread and is less itchy.
Arm area  red and hot  near injection site a week after injection. It was gone 4 days after .
12 days post bivalent Moderna booster, full body itchy hives, dermatographia. Currently on high dose prednisone and 5 different antihistamines (Zyrtec, Singulair, Pepcid, Xyzal, Benadryl) every day just to keep it barely manageable. Also had to switch to low histamine diet, foods I?m able to eat now are very limited.
On 10/27/00, the patient received #1 Hep B Vaccine and #1 Hep A vaccine. The next day she had a light rash to her face. The the 2nd day she had a rash all over the entire body, itching, difficulty breathing, and seeing. The patient went to the ER and received a steroid injection. Today 10/30/00 she itching, and bumps on her arms, face, neck, and back.
Left arm became sore at injection site 7 days post injection, today is 9 days post injection and left arm is swollen with a red area the size of 2 golf balls
This report is only in response to the request from the Department of Health to submit all patients into VAERS that received the COVID19 vaccine and subsequently tested positive for COVID19.  No other adverse reactions to the vaccine were reported. This patient received the vaccine on 12/16/20 and tested positive for COVID19 on 12/29/20.
Hives, tachycardia w/laryngeospasm; tx Solumedrol & Benadryl IV;  9 days post vax site redness from shoulder to elbow, tingling in eyes & fingers;
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from 34-year-old female who received a dose of Flumist 08-Jan-2004, and experienced an inability to function, headache front and back of head and on her face, vertigo and ear pain. The patient had a sinus infection concurrent with Flumist administration. Medical History: The patient's concurrent illnesses include hypersensitivity (allergies) and sinusitis with a past history of migraines (15 years ago). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 08-Jan-2004. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant therapy included Flonase (fluticasone propionate) and Zyrtex (cetirizine hydrochloride). Event Details: On 09-Jan-2004, the patient experienced headaches that "exploded" in the front and back of her head, and her face (headache); along with vertigo (vertigo) and she was unable to function (activities of daily living impaired) for two weeks. She was treated with Ceclor for 10 days, Biaxin for 7 days, Levaquin for 3 days along with Sudafed as treatment for her sinus condition that "there was no infection." As of 10-Feb-2004, her headaches persisted along with ear pain. She is currently being treated with Fiorinal. Test Results: Computerized tomogram (results: Negative) was done on an unspecified date. No additional information was available at the time of this report. Follow up: information received on 06APR2004 indicated that the patient had sinusitus at the time of vaccination, provied treatment medication and patient's recovery status. A recent CAT scan was performed with negative results. She indicated taht her physician stated that "there was no infection." As of 10FEB2004, her headaches persisted with pain. She is currently being treated with Fiorinal. The pt had sinusitis at the time of vaccination and was treated with Ceclor. The patient recovered.
confusion; light headed; nausea; body ache; joint pain; headache; fever; radiating pain; vaccination site hardness; tired/feels run down; sore on breasts; sore throat; very forgetful, can't remember 1/2 the time what I'am doing; sore armpit; sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (sore on breasts), OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore injection site), AXILLARY PAIN (sore armpit) and FATIGUE (tired/feels run down) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced BREAST PAIN (sore on breasts), OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore injection site), AXILLARY PAIN (sore armpit), FATIGUE (tired/feels run down), NAUSEA (nausea), MYALGIA (body ache), PAIN (radiating pain), ARTHRALGIA (joint pain), HEADACHE (headache), PYREXIA (fever), VACCINATION SITE INDURATION (vaccination site hardness) and MEMORY IMPAIRMENT (very forgetful, can't remember 1/2 the time what I'am doing). On 21-May-2021, the patient experienced CONFUSIONAL STATE (confusion) and DIZZINESS (light headed). On 24-Apr-2021, PYREXIA (fever) and MEMORY IMPAIRMENT (very forgetful, can't remember 1/2 the time what I'am doing) had resolved. On 25-Apr-2021, PAIN (radiating pain), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. On 24-May-2021, CONFUSIONAL STATE (confusion) had resolved. On 25-May-2021, DIZZINESS (light headed) and VACCINATION SITE INDURATION (vaccination site hardness) had resolved. At the time of the report, BREAST PAIN (sore on breasts), OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (sore injection site), AXILLARY PAIN (sore armpit), FATIGUE (tired/feels run down), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified inhaler for asthma.   No treatment was reported.   This case was linked to MOD-2021-182745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: follow up :new events were added
No adverse event; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-OCT-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot #x019553, expiration date: 19-JAN-2025, administered for prophylaxis (strength, vaccination scheme and route of administration were not provided) following a temperature excursion of -9.2 degrees Celsius (C) for 1 hour 7 minutes and -11.2C for 31 minutes, it was stated that no previous temperature excursions occurred. No additional adverse event was reported.
Pt recvd DTP/HBOC on 17JUL92 @ 48 hrs devel erythema multiforme rash over most of body; dx by MD; UA done neg results;
Exhaustion; brain fog; nausea associated with certain smells; nausea associated with certain smells; swelling at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "Exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "brain fog"; NAUSEA (non-serious), PAROSMIA (non-serious), outcome "recovering" and all described as "nausea associated with certain smells"; VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "swelling at injection site".  Additional information: Exhaustion, brain fog, nausea associated with certain smells, swelling at injection site. Things have normalized since then. She premeditated with Tylenol and Claritin with doctor recommendation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/6: Day of vaccine within a couple of hours I developed rash on both lower legs starting from below the knee to the ankles took a Benadryl because it kept getting worse, I also got a really bad headache and took 2 Tylenols (I have a picture of the rash) 12/7: Rash was still there not as bad, woke up with body aches, neck stiffness couldn't turn my neck to the left, fatigued, malaise, chills, nausea, GI issues, as the night approached I started feeling worse, came down with a fever & cold sweats was like this throughout the whole night, took 5 Tylenols throughout the day 12/8: still having cold sweats, fever was gone, chills, GI issues, body aches not as bad as day before, neck stiffness not as bad, took 1 Tylenol, rash still there not as bad 12/9: still having GI issues, rash still there not as bad but now it looks like tiny blood spots and it's only on the left leg (i have a picture)
woke up next morning after vaccine and have started to develop a rash  and welts over multiple body parts.  c/o itchy and dark in color.  it cleared up in about three days and left little scars.
Information has been received concerning a pt who was vaccinated with varicella vaccine. Subsequently the pt experienced breakthrough disease (varicella). The pt recovered.
Large, hard, red knot under skin at injection site. Very tender to the touch and warm.
DVT and PE Right lower leg pain starting 3 days after vaccine, progressively worsening until time of diagnosis 8 days after dose.  Hospitalized and undergoing IV anti coagulation
Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE ID (batch number: U15904AA, expiry date, dose in series, dose, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe laceration and blistering at and around injection site, which was warm to touch, pain and swelling radiating to left hand. Laboratory data and corrective treatment were not reported. Outcome of all the events were not reported. List of documents held by sender: none.
2 weeks after receiving vaccine. Patient discovered 6 shingles blisters on torso. This was not mentioned in the flyer patient received on adverse reactions. Patient was very concerned as was afraid it would lead to another full episode of shingles.
Slight fever; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Slight fever) and MYALGIA (Body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Slight fever) and MYALGIA (Body aches). In August 2021, PYREXIA (Slight fever) and MYALGIA (Body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2021-315935, MOD-2021-368432 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive, notes: Positive test on 9th day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headache, Myalgia, Fever, chills, light headed, fatigue, confusion Narrative:
High Fever 103.8, Swollen & Lump Bruise Leg at injection site, Lump is still there as of 7/26/2010, Fussiness. Given 2 1/2 tsp of Ibuprofen, every 4 to 6 hrs, had to get child bath in warm water to help bring fever down. Symptoms seems to be getting better, except swollen leg and lump at injection site. As of 7/26/2010.
a temperature excursion for PROQUAD, VARlVAX, and MMR II; products may have been administered; No additional AE's/PQC's noted.; This spontaneous report as received from an other reporter and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of: - Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # U002540, expiration date 24-JUL-2022, - Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # S020161, expiration date 30-JUN-2021, albumin status rHA and lot # T007230, expiration date 27-FEB-2022, albumin status rHA, - varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033953, expiration date 24-OCT-2021 and lot # T027305, expiration date 12-AUG-2022. Doses and routes of administration were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 (13.1) degrees Celsius for 4 hours and 26 minutes. There was no previous excursion of -10 to 8 (8.1) degrees Celsius for 1 hour and 37 minutes reported. Data logger was involved.
Swollen harden area, 7cm x 7cm red, warm to touch, redness has been decreasing.
died; acute immune thrombocytopenia; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2(lot number and expiration date not provided) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died after receiving the covid vaccine on an unknown date. The patient developed acute immune thrombocytopenia on an unknown date. It was unknown if autopsy was performed. The cause of death was unknown. The outcome of the event "died" was fatal and of the event " acute immune thrombocytopenia" was unknown. The reporter wondered if a platelets blood problem may lead to death and if who have a blood platelets condition like essential thrombocytosis should not risk taking the vaccine.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Died
The day after vaccine patient reported she was so sick she couldn't get out of bed. The arm was so sore that she could not lift it initially. 2 days post vaccination she can lift her arm but there are 2 distinct circular red hot areas on the arm. She also reports having an enlarged, sore knot closer to the neck that she said might be a lymph node.
After my first covid vaccine my mild tinnitus doubled.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "After my first covid vaccine my mild tinnitus doubled".  Additional information: After patient's first Covid vaccine mild tinnitus had doubled. This Saturday 2nd shot is due, and patient was scared to take it since the tinnitus had never stopped.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received two doses 6 weeks ago and now she got COVID; received two doses 6 weeks ago and now she got COVID; This is a spontaneous report received from a contactable consumer. A 78-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3246), on 23Jan2021 and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9267) on 13Feb2021 both around 10 AM via an unspecified route of administration at a single dose for covid-19 immunization. Medical history included high blood pressure and over active thyroid. Concomitant medication included metoprolol, hydrochlorothiazide, valsartan (VALSARTAN/ HCTZ) and levothyroxine sodium (SYNTHROID). The patient underwent lab tests and procedures which included covid-19 positive on 26Mar2021. The patient received two doses 6 weeks ago and now she got covid on 26Mar2021. Caller wanted to report quality effectiveness on the COVID vaccine. She received two doses 6 weeks ago and now she got COVID. She is not very happy.  first and second shot of Her whole family had the Pfizer and a member of her immediate family is a cancer patient. Clarified caller is not a cancer patient. She states if anything happens to this person then everyone is going to hear from her. They are now in isolation, in separate rooms in their house. Pfizer needs to go back to the drawing board for research. She still fighting the first battle. She thought Pfizer made made some products but she guesses not. She follows all the rules, she only goes to the store just to get some food. She wears two masks, two gloves, sometimes one pair of gloves and now she wears a face shield and people are laughing at her like hahaha and she doesn't care because she is just there to get her groceries. Pfizer needs some quality control. She states this is a serious matter to her. The nature of her call to let you know what is going on, and if she can do something to improve the quality of the vaccine. Okay at least she is safe for a little while, instead of staying one room each, in her house, instead of all being together, they are stuck in isolation. The outcome of covid was recovering and other was unknown.  Follow up needed, further information has been requested.
-Pt reported itchy welt form at injection site after 4 hrs. RPH advise pt to call MD and to take BENADRYL for the itchiness. - Pt got vaccine 9/29/09 but reported to R ph on 9/30/09 around 3pm.
Pain from left shoulder to elbow - inability to touch or weight bear. Low grade fever. Insomnia. Intractable headache. Sensitivity to light. Shivering for hours at a time. Full body ache. Unable to walk more than a few feet. Nausea. Shortness of breath. Loss of appetite. Felt like 3rd day of original Covid infection June 21 2022. Still recovering since vaccination.
Bad Smell; Bad Smell; Bad Taste; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Bad Taste), the first episode of PAROSMIA (Bad Smell) and the second episode of PAROSMIA (Bad Smell) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history.).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TASTE DISORDER (Bad Taste). On 25-Mar-2021, the patient experienced the first episode of PAROSMIA (Bad Smell). On 30-Mar-2021, the patient experienced the second episode of PAROSMIA (Bad Smell). At the time of the report, TASTE DISORDER (Bad Taste) and the last episode of PAROSMIA (Bad Smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given No treatment information was provided
severe headache on forehead 24/7  continues daily 24/7  sounds like Locusts buzzing around my ears 24/7
3 hours after flu shot symptoms started with low grade fever, eyes burning and red, scratchy sore throat, shaking body aches, headache & fatigue. No rash, no difficulty breathing no swelling at injection site. Plan: BENADRYL, fluids, ibuprofen.
This spontaneous report as received from a consumer refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date, the patient experienced pruritus generalised, secretion discharge (reported as fluid oozing "everywhere") and generalised oedema. The patient stated that the adverse event started at her ankles and then spread. The outcome of pruritus generalised, secretion discharge and generalised oedema was unknown. The causality assesment was not provided.
83-year-old female presented to the emergency department with respiratory distress, chills, body aches and altered mental status 10 days after receiving her third dose of the Pfizer-BioNTech SARS-CoV-2 vaccination on 11/2/2021. Doses from her primary Pfizer series were administered on 2/27/2021 and 3/20/2021. Prior to presenting to the emergency department, on post-vaccine day 4, the patient was seen by her PCP and was diagnosed with pneumonia; oral outpatient antibiotics were initiated empirically. On arrival to the emergency department the patient was found to be in severe respiratory distress with a pulse oximetry of 55% on room air. Supplemental oxygen and ultimately BiPAP were initiated and pulse oximetry increased to the 90s. After admission, supplemental oxygen via high-flow nasal cannula at rates of 40-50 liters per minute was required to maintain oxygen saturations. Chest CT showed severe diffuse ground-glass and interstitial opacities through all lung fields bilaterally. She was swabbed nasopharyngeally for SARS-CoV-2 on admission and the results were negative. White blood cells was 9800 per microliter, D-dimer was 955 ng/mL, C-reactive protein was 4.3 mg/dL, procalcitonin was reported as <0.05 (undetectable). The patient remained afebrile and hemodynamically stable. Corticosteroids were initiated in the form of dexamethasone 6 mg IV q12h for treatment of presumed drug-induced interstitial lung disease caused by the COVID-19 vaccine.