chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Known allergies: Anti-inflammatories" (unspecified if ongoing), notes: Known allergies: Anti-inflammatories. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 06Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: The patient received Paxlovid (anti-viral) for COVID-19 Treatment, started from 08Dec2022 to 13Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediate headache when administering shot dizziness  next day fever sore throat blisters at injection site swollen lymph nodes in back of arm severe pain with numbness and extreme  heat  sensation in arm and 3 fingers loss of strength in left arm headaches every day pain in ears that don?t stop unless I take ibuprofen.  May 2021 headaches seem to be subsiding other symptoms also still sensitivity in left near shoulder.
Swelling, redness, pain to touch that involved entire anterior thigh of leg that received Dtap. Required abx for possible cellulitis.
A lot of pain on left elbow then numbness seconds after shot on lwft forearm and top of hand, then 3am next day numbness on  left leg.  This triggered my Dystonia.  Treatment IV and valium.  Outcome got released from hospital with left arm and left leg still numb  and 21 days latter my left arm and left leg  still numb, maybe only 25% better.
little bumps on back/ little bumps on across shoulder; rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizures.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash). At the time of the report, SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant included medications for seizures. No treatment was reported.   This case was linked to MOD-2021-044944 (Patient Link).
Left ear hissing, crackling ringing sounds like shortage of an electric currency dysfunctioning, sounds like a bunch of cricket or night lit up insects sounds  or fireworks crackling sounds or someone constantly crumbling or crackling which  happens on a daily basis since 3/24/2021
He?s freshly 12 and has started in December to hear voices especially at night while falling asleep or middle of night or waking up. He came into our room in morning saying he heard dad call for him. Then a few days later he said he heard my voice calling for him. This has continued on and off throughout December. Where he comes into our room saying innocently that he heard us calling out for him to come to our room.
Area around injection site became red, hot, swollen, extremely itchy all overnight the first night. Continued to enlarge, skin dimpled like an orange peel. Redder and harder, with one pustule at needlepoint site. Injection was Saturday. The Tuesday after, it  began to improve: redness receding, itching less.
Information has been received from a registered nurse concerning a 9 year old white female who on 12-FEB-1998 was vaccinated with a dose of Varivax. On 06-APR-2006 the patient developed chickenpox. She was diagnosed on 07-APR-2006. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
patient states vaccine cause her to " clear " her psych meds at an unusually high rate and now she is having withdrawing symptoms
This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (reported as hepatitis vaccine) (dose, lot#, expiry date were not reported) one shot in an unknown location. The patient could not recall what "hepatitis" vaccine this was or who manufactured the vaccine. The patient reported that after receiving the vaccine she could not go out into the sunlight. If she went into the sunlight, she would have a "bad reaction". The outcome of the event was recovered. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Mist - Lightheaded, Dizziness, ears ringing, nausea headache.
This case was reported by a consumer (subject and GSK employee) and described the occurrence of itching of arm area in an adult female subject who was vaccinated with influenza vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to molds. The subject stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. On 7 November 2012 the subject received a dose of influenza vaccine (unknown details). On 8 November 2012, 1 day after vaccination with influenza vaccine, the subject experienced itching of arm area ("small, itchy" "area of skin under my left armpit"), and red areas on skin. The subject stated that, on 8 November 2012, she noticed "a small, itchy, red area of skin under my left armpit, about the size of a silver dollar." On 13 November 2012, the subject experienced rash all over body, red welts, and skin irritation. The subject stated that "the rash spread all over my body, with red welts, and severe itching and irritation." The "symptoms were minimally controlled with antihistamines." On 15 November 2012, the subject sought medical attention from a physician at an urgent care facility who determined that she experienced "an allergic reaction to the flu shot." The subject was treated "with a shot of prednisone and began an oral prednisone taper." On an unknown date in 2012, the subject "subsequently saw an allergist who performed allergy skin testing." The results of the allergy skin testing were negative for everything but positive for mold. The subject stated that the allergist told the subject she had suffered "an eczema flare." The subject, however, stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. In November 2012, the subject stated the itching resolved "shortly after beginning prednisone." In 2012, the rash resolved. "The rash was visible for about 14 to 21 days" after 15 November 2012. The outcome of the red areas on skin, red welts, skin irritation, allergic reaction, and eczema flare was not reported.
soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not provided. The patient received a dose of Shingrix approximately 2 months before the date of reporting. The patient developed pain and soreness at the injection site. The reporter did not consent to follow-up. The reporter did not wish to provide any additional details or contact information
Initial report received from a health care professional on 06 August 2008.  A male infant born, 151 days after receiving a transplacental dose of FLUZONE (lot number U2507AA) on 18 October 2007, was diagnosed with a congenital anomaly, bilateral hydronephrosis.  The baby was born at 35 weeks gestation by Cesarean section.  Bilateral hydronephrosis was detected in a level 2 ultrasound performed at 28 weeks gestation.  The baby's birth weight was 3.8 kg.  Apgar scores were not reported.  Concomitant medication reported for the mother during pregnancy was prenatal vitamins.  During pregnancy, the baby's mother had experienced polyhydramnios in addition to premature labor at 32 weeks gestation.  The reporter indicated that the mother's health had been unremarkable except for the polyhydramnios.  It was reported that the baby's bilateral hydronephrosis resolved at six weeks of age.  No additional details were provided.  The reporter of this case is the same as case 2007-03576.
I was having palpitations and sometimes tachycardia. I've had a history that started a few months before. I had difficulties and didn't feel well after the vaccine. I had heart palpitation. Shortly afterwards I was complaining about chest pain that turned out to be muscular. I was getting testing in June and it was detected that I had a single blockage in my LAD that was 99% blocked. I was rushed into open heart surgery and had a bypass done. I've also had electrolyte imbalance and was placed on a whole new set of medications.  All the tests before the 2nd dose vaccination never showed a blockage. The blockage occurred around the vaccination time. What I was told that it unique about this is that only 1 artery was blocked with the other arteries being fine.
I had my first Moderna shot on 8/7/2021.  On 9/7/2021, I experienced chest pains.  I originally thought it was heartburn and took several antacid tablets.  But felt no relief.  I started to feel numbness in my arm.  So, I became concerned.  I walked into the other room to tell my husband.  I said ?I think I?m having a heart attack? and then I fainted.  I awoke a few minutes later and felt OK.  I went to the E.R. to get checked out.  And they found no heart problems.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medication was reported.  Patient was over the age of 65 years.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was unknown.  The vaccine was administered in the deltoid site.  On 10-May-2023, 27 patients received 0.25ml of the Moderna bivalent vaccine instead of the 0.5ml booster dose.  On 11-May-2023, 26 patients were contacted.  On 12-May-2023, 18 patients received additional 0.25ml.  No treatment medication was reported.  This case contains information for the patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
7:30 pm Patient with dizziness and presyncopal episode after vaccination. Per mother pt did not eat well and last ate over 7 hours ago. No prior hx of vaccine reaction.  No hx of syncope.    RNP walked in to pt laying on exam bed with post syncopal drowsiness.  She was responsive to provider questions and able to follow commands.  Vitals were stable. 102/68 , HR 86 laying down   Pt observed office under RN care.  Pt was given water and electrolyte drink without emesis.   Repeat vitals 112/83 HR 83 sitting. Pt alert and orient x 3 Informed mother if pt unable to walk out independently recommend further observation and evaluation at downstairs ED.    8:05 pm Pt was able to stand and walk out of clinic with mother.
Swollen, hot to touch, red in color, hard lump. Temperature 99.8 - tympanic.
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then  motrin 2-3hrs later given,  then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and   popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
Redness and swelling at site of injection; Ring-shaped perimeter swelling around injection site; Bumpy, red, itchy rash on arms, legs and torso; on 10/02/2013 ring-shaped perimeter swelling became VERY ITCHY; on 10/03/2013 bumpy, red rash on extremities and torso became more inflamed and ITCHIER!
5 days after the shot the left arm was hot and swollen and had a red ring about 5 inches around Saw my PCP-thought it was infected-gave me antibiotic and steroid cream
Pt rcvd ADACEL, FLUZONE, and PNEUMOVAX on 9/30/2009, seen 10/2/09 for localized erythema/induration (6.5 x 8.0 cm L deltoid and 3.0 x 3.0 cm R), body aches, chills. Treated with TYLENOL, warm/cold compresses for comfort. Pt has follow up appt 10/5/09 to recheck.
Fever; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PYREXIA (non-serious), outcome "unknown", described as "Fever".  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.
02/20/22 presents to Birth Center Triage for "contractions" "38w4d" "No pertinent past medical history"
This spontaneous case, initially received on 20-Sep-2018, reported by a pharmacist and concerns a 50-year-old, adult, male patient. The patient had no medical history and did not receive any concomitant medications. On 20-Sep-2018, the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the case as non-serious. Non-significant follow-up received from the reporter on 09-Nov-2018: It was confirmed that the patient did not experience any adverse event.
Day following inj headache, nausea, runs, dizziness, joint pain all over and extreme fatigue. Followed that pm by high fever 104.8, symptoms treated pushed fluids x 3 days slowly recovering. Missed work on 10/19/06.
Actually, mild left thumb joint pain several days before this; however, severe left foot big toe joint pain all of a sudden and lasting approximately 12 hours on 11/12.
Received pneumonia shot. On 1/21/02, I was home for about 2 weeks sick. On 2/6/02, was in the hospital so sick that I was all swollen and could not walk and filled with fluids. I thought I was going to die and could not hardly breathe. My brother took me to another doctor. 6 pills I was on and so sick and couldn't barely eat. I still only weight 120 lbs. The doctor said I got the 1 in a thousand that was infected in pneumonia site. The discharge summary states serum sickness, hypotension, and elevated lab values. The annual follow up states "I went to doctor one year and in 6 months I see him again that pneumonia shot poisoned your whole system I was never sick in my life and this poison's your system, not much of a apposite I weigh 117 pounds my face sure got the wrinkles. I felt better before this shot I had never again will I have it. I am thinning and my arms have the veins showing. Large veins on my legs and my hands the veins get red at times.
Significant and painful right axillary lymphedema that began 6 hours after injection with worsening in severity over the next 48 hours. Treated with warm compress and acetaminophen for the pain. Currently swelling continues, but pain is a little improved.  Associated chills, body aches and diaphoresis  onset 6 hours after injection that resolved in 48 hours.
Headache, muscular aches, low-grade fever, chills, diarrhea, fatigue, light-headedness. Treated with bedrest.
Extreme body aches, joint paints, fever, fatigue, headache, chills, and nausea. Test positive for COVID 01/09/2021
he started having pain in his right arm, from elbow to shoulder. He still has it on and off; This is a spontaneous report from a contactable consumer reporting for himself. A 77-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 15Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Apr2021, he started having pain in his arm, from elbow to shoulder. He still has it on and off. When it goes away it's only for a little bit. He received the shot in his left arm and the pain is in his right arm. The event had not resolved yet at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
itchy; swollen; red; lump in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (swollen), ERYTHEMA (red) and VACCINATION SITE MASS (lump in arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (swollen), ERYTHEMA (red) and VACCINATION SITE MASS (lump in arm). At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (swollen), ERYTHEMA (red) and VACCINATION SITE MASS (lump in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included rubbing alcohol.
2nd dose given subcutaneous.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (2nd dose given subcutaneous.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Vaccine administration error, gave bivalent covid vaccine when patient had already received 1 dose of bivalent covid vaccine on 10/07/2022. Patient claims he did not realize the October dose was the "newest bivalent" one.  No side effects reported at this time.
Reports that 3 days after she was immunized, her (R) deltoid was very sore & it has gotten worse each day. No redness, no swelling no nodule felt. Enc. to use warm compress - TYLENOL for discomfort.