chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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); "Lone atrial fibrillation" (ongoing), notes: currently managed; "Hypothyroidism" (unspecified if ongoing). Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Mar2003 (ongoing); LEVOTHYROXINE, start date: Jan2017 (ongoing); LISINOPRIL taken for hypertension, start date: Jan2017 (ongoing). The following information was reported: PAIN (non-serious) with onset 2022, outcome "recovering", described as "Body aches"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19"; PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "Fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (06Nov2022) Negative; (09Nov2022) Positive; (10Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of pyrexia, pain. Clinical course: The patient reported that he completed his course of treatment with Paxlovid on 05Nov2022 and tested negative for COVID on 06Nov2022. He did not experience any symptoms of COVID other than fatigue as of 04Nov2022. On the evening of 08Nov2022, the patient began to feel congested and took a COVID test on the morning of 09Nov202, at which time he tested positive. He experienced a modest cough and fairly heavy congestion during this "rebound" phase, although he did not experience any fever or body aches as he had with the first infection during the prior week. The patient did a follow-up test in the morning of 10Nov2022, and the result was again positive for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Slight nausea (approx. 1 day), very dizzy (4-5 days), fatigue.
Arthralgia; Fatigue; left arm is 2 inches bigger than her right; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; experiencing pain and on her left arm where she received the vaccine; soreness and muscle ache; headache; chills; A spontaneous report was received from a nurse concerning a 38-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle ache,headache,chills,injection site pain,swelling,warmth,erythema and peripheral swelling.   The patient's medical history, was not provided.Concomitant medications was not provided by the reporter. On 20 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On  20 Jan  2021, prior to receiving mRNA-1273, the patient felt muscle ache,headache,chills, and on 27 Jan 2021 injection site pain, and on 29 Jan 2021 injection site  swelling,warmth,erythema and 01 Feb 2021  peripheral swelling and she had went to the ER . Lab tests was done included ultrasound ,blood work and covid-19 swab and the results were not provided. Treatment for the events included IV fluid,Tylenol,Bactrim,Keflex,Claritin,Zyrtec,Pepcid,Benadryl and Hydrocortisone cream.Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the events, muscle ache,headache,chills, were considered resolved  and outcome of the events injection site pain,swelling,warmth,erythema and peripheral swelling was unknown.
Reporting this because it happened after the first injection as well.  This is the 3rd day and I am still experiencing headaches and monitoring my blood pressure.  Yes, my blood pressure is elevated.  I?m taking Tylenol around the clock and extra anti hypertension medication for management.  The symptoms started on the first day of each injection.   I?m aware headache is a side effect or  adverse event; however,  were blood pressure?s monitoring done with the occurrence of headaches.
pt recv vax 23JAN96 & on 29APR96 noted a lump on the lt leg up to this date lump still noted
nausea; This is a spontaneous report from a contactable consumer. A 78 years old male consumer (patient) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was first dose of BNT162B2 and experienced sore arm. Patient had a wave of nausea 1 hour after the second shot. Outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Blood Disorder  (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: Patient is a Trans-woman and is currently on HRT. Increased dose since second COVID vaccine administration for HRT is suspected and may contribute to reaction post booster on 12/18/2021. Patient wanted to confirm this detail was included in reporting event.
Saturday 2/27/21: 11:20am onset of chills, sweating and fever, cough and difficulty breathing, fatigue, nausea Sunday 2/28/21: fine Monday 3/1/21: symptoms reappeared  Tuesday 3/2/21: fine
Sore muscles and tiredness for two days.  Sore muscle s for about two weeks.  And lack of stamina.
Sick all night; Stomach cramps; Just all over don't feel good; The shot location is real hot; Shot location is hard; Chills; Headache; Nausea; All over body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot) and VACCINATION SITE INDURATION (Shot location is hard) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ILLNESS (Sick all night), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches). 25-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and VACCINATION SITE INDURATION (Shot location is hard). At the time of the report, ILLNESS (Sick all night), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION COMPLICATION (Just all over don't feel good), VACCINATION SITE WARMTH (The shot location is real hot), VACCINATION SITE INDURATION (Shot location is hard), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (All over body aches) outcome was unknown.     No concomitant medication was reported. The treatment information was unknown.
Patient received high dose influenza vaccine on 9/23/20 in hospital(first time receiving high dose influenza vaccine, previously tolerated regular dose influenza vaccine without issues). During his recent PCP f/u visit on 9/30/20, he reported fever/headache, and weakness in all four extremities that he could not get up from his chair, he did not seek medical attention, but took 2 APAP. The above symptoms then resolved next morning at 5:30. Patient denied taking any medications around that time that could have contributed or related to those symptoms.
p/ pt recv vax approx 14 days later pt devel chickenpox. exp fever lasting 3-4 days, pt had full blown pustule, covered fr head to toe.
Patient was 11 yrs old at the time of visit. Incorrect dose was ordered and given to patient. No symptoms, no signs of adverse reaction.
immediate tingling and fogginess in body then tacycardia lasting about 3-5 minutes no treatment
Child had at least 3 two min tonic clonic sz during the 5 hrs subsequent to the immun; The 1st two were witnessed by the parents & the last by an RN p/admission to the pediatric ward of the hosp.
I got my first jab on 8/9/21.  On 8/14/21, I had a severe hemorrhage on the sclera of my left eye.  I went to Urgent Care, the doctor who attended to me denied it was a side effect of the vaccine.  No treatment.  My second jab was done on 8/31/21 and on 9/5/2021 had a hemorrhage again of the sclera, this time on the right eye.  It is definitely a side effect of the Pfizer vaccine.
Unresponsiveness, possible seizure. Mother is a nurse and noted patient to be rigid and unresponsive. Patient noted she felt nauseous before she became unresponsive.  No loss of bowel or bladder. She now has a headache and is wearing sunglasses which she normally does not have to do.  We will continue to observe and absolutely no driving per seizure procautions.
She had the vaccine, no reaction at all other than soreness, the inside of her elbow was a little achy and a little swollen but nothing major.  Then yesterday  morning was a little achy and by afternoon was miserable the next day she got really tired, joints hurting and had to take a nap.  She cancelled one of her appointments  she's a home health nurse and went to sleep and when she woke up her throat was swollen, hurting, labored swallowing and when she would drink her ears would pop, and her tongue was swollen but could breathe fine, and then it progressed to where she could not swallow at all.  She took two Benadryl's and went to rest, and she was not able to move and had to have help getting dressed.   Her joints are swollen, her hands are swollen, but her throat is not hurting like she was yesterday.
Vaccine administrated via subcutaneously/administration error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) 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)) (Subcutaneous), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error).    No concomitant medications were reported. Patient received a bivalent booster but because of an administration error they missed the deltoid. No treatment details were reported.   Reporter did not allow further contact
Patient received the influenza vaccination (Fluzone) and the COVID vaccination on the same date. Approximately 6 hours after vaccinations patient began having symptoms of throat and tongue swelling and difficulty breathing. Patient took diphenhydramine at home on 10/28/22 and then went to the emergency dept at local hospital on 10/29/22 where she was treated for 3 hours and given diphenhydramine and methylprednisolone.  Pt came to appt at physician clinic office on 12/30 still experiencing symptoms. Patient stated when the dose of the steroid and diphenhydramine wore off her symptoms would resume.  During  visit at physician office she had a worsening of symptoms and increasing difficulty breathing.  Emergency medical service was contacted and patient was transported to the hospital for treatment.
Presented to facility with CDC vaccination card that indicated first dose received 03-25-2021.  After vaccine administered, vaccine monitor attempted to enter 2nd dose documentation when it was discovered patient received first dose 01.23.2021, 03.25.2021 was actually a 2nd dose and we just administered a third dose of vaccine to patient.  RN notified patient & patients MD Dr., FA notified Medical Director Dr.   Vaccine monitor notified -   Patient monitored for any adverse reaction - none noted during remainder of treatment
Approx 9 days after vaccination patient developed a macular-papular rash on posterior aspect of her upper arms and most prominent on her hips and inner thighs.  Rash c/w erythema multiforme.
she had a slight fever; headaches; feeling tired; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program Support.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11May2021 09:35 AM as dose 2, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 on an unspecified date for covid-19 immunization. This morning on 12May2021 she had a slight fever. She also had headaches and feeling tired. At the onset of the call after she reported her experiences after the 2nd dose. Outcome of the events was unknown at the time of reporting.   No follow-up attempts are possible. Information about lot/batch number cannot be required. No further information is expected.
MYALGIA, FEVER, CHILLS, TINNITUS Narrative: Employee missed 2 days of work; he had COVID illness in November 2020 experienced tinnitus at that time-eventually subsided but tinnitus has returned with the vaccination - still present on 8/19/21
Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 30-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Status post vaccine #2  Pfizer covid vaccine.  R arm r preast started itching approx 7:45 .  8:16  Took own allegra, increased pruritis 8:40 called 9111 employee taken to clinic treated with benadryl and zyrtec,   MD next day told to take allegra and Pepcid.  1/14 employee returned to work.  Started Diarrhea on 1/15.  Had intermittent diarrhea since then, still has pruritis. all over.  Taking allegra and pepcid.  benadryl at night.  Employee Advised to  contact allergist for appointment.   Advised to contact MD again because of the persistent itching.
Could not breath well when lay down; Started wheeze; Felt Lethargic; Coughing/Cough; Feels ache/pain; Feels sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Could not breath well when lay down), WHEEZING (Started wheeze), LETHARGY (Felt Lethargic), COUGH (Coughing/Cough) and PAIN (Feels ache/pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DYSPNOEA (Could not breath well when lay down), WHEEZING (Started wheeze), LETHARGY (Felt Lethargic), COUGH (Coughing/Cough), PAIN (Feels ache/pain) and MALAISE (Feels sick). At the time of the report, DYSPNOEA (Could not breath well when lay down), WHEEZING (Started wheeze), LETHARGY (Felt Lethargic), COUGH (Coughing/Cough), PAIN (Feels ache/pain) and MALAISE (Feels sick) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient feels little better and then worst. Patient is not on concomitant medication. Treatment information includes Antibiotics and steroids.
Pt began experiencing redness and swelling at injection site within hours of receiving vaccination. Redness spread to cover entire deltoid region (appox 3-4 inches in width) by evening. Redness persisted through the next day and swelling increased. Treated with Benadryl and symptoms are now resolving on day 3.
Child came home 1 hour after vaccine running temp of 102.5 vomited x2 and sore throat. Temp stays down with TYLENOL and MOTRING alternated every 4 hours. Still running temp this am at 102.0. Mom States she thought child wouldn't get mist because of asthma. Mom's form checked asthma - no. Child not having symptoms of respiratory distress.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Lot # K011802, expiry date 21-AUG-2016). At the time of this report, no adverse reactions were reported. This is one of several reports from the same source.
Information has been received from a physician concerning a 8 week old male infant who on 11-JUL-2008 was vaccinated with a first dose of ROTATEQ and immediately vomited the dose and milk. Medical attention was sought in the office. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the reporting physician indicated that the 9 week old (previously reported as 8 weeks old) male with a history of immunization (hepatitis B virus vaccine unspecified) at birth) who on 11-JUL-2008 at 17:00 was vaccinated with his first dose of ROTATEQ. Concomitant vaccination administered on that same day at 15:00 included the first IM dose of DAPTACEL (lot# C2952BA) in the right thigh, the first IM dose of ACTHIB (lot# UF342AB) in the right thigh, the first SC dose of IPOL (lot# A0491) in the left thigh and the first IM dose of PREVNAR (lot# C65045) in the right thigh. At the time of this report, the outcome was unknown. Additional information has been requested.
Stomach and legs worse; Broke out with a red rash over most of my body.; Stomach and legs worse; Broke out with a red rash over most of my body.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 15:45 (Batch/Lot number: unknown) at the age of 68 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Not known , Location of injection: Arm Left), for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), for Covid-19 Immunisation. The following information was reported: LIMB DISCOMFORT (medically significant), ABDOMINAL DISCOMFORT (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "Stomach and legs worse"; RASH ERYTHEMATOUS (medically significant), RASH (medically significant) all with onset 06Dec2021, outcome "recovering" and all described as "Broke out with a red rash over most of my body."; IMMUNISATION (medically significant) with onset 03Dec2021 15:45, outcome "unknown", described as "booster". The events "stomach and legs worse", "broke out with a red rash over most of my body.", "stomach and legs worse" and "broke out with a red rash over most of my body." were evaluated at the physician office visit. Therapeutic measures were taken as a result of limb discomfort, rash erythematous, abdominal discomfort, rash.  Clinical Course: Lot and batch was unknown as patient was unable to locate or read the details. Prior vaccinations within 4 weeks was unknown. Steroid and Benadryl was received for adverse event treatment. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. other medical history: Non major, Events started about 2 days after the booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given PNEUMOVAX 23 vaccine IM (Deltoid (0.5 mL). The next day patient arm was sore and red. Patient went to urgent care. Patient was told that she had cellulitis. Patient was put on clindamycin 300mg.
The day after her vaccinations (3) she developed a sore, red, warm lump on her left deltoid and upper arm. Clinic started KEFLEX for cellulitis. It worsened over night. She was admitted to the hospital for IV antibiotics.
Pt. describes swelling near collar bone on same side as the arm where shot was administered, with headache. Denies shortness of breath, denies egg allergies, denies trouble breathing, or swelling of facial area.
Pt felt dizzy, lost her balance, then fell, within 5 mins of receiving vaccine.
arm soreness; could not sleep; stomach pain; itchy palm; bumps on left side of scalp; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, insomnia, stomach pain, itching both hands and scalp swelling. On an unknown date, the outcome of the pain in arm, insomnia, stomach pain, itching both hands and scalp swelling were unknown.   It was unknown if the reporter considered the pain in arm, insomnia, stomach pain, itching both hands and scalp swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had arm soreness, could not sleep, stomach pain, itchy palm and bumps on the left side of her scalp.