chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might have vaccinated with a dose of VARIVAX (Merck) (lot# not reported stored as high as 9F for about 2 months. No adverse effect reported. This is one of several assistant from same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Patient received Dose #1 and Dose #2 with Moderna. Patient mistakenly administered Pfizer for Dose #3 (immunocompromised). Patient reports no adverse effects
Injection given too high on arm. Within 12 hours, patient had significant pain in shoulder, shoulder joint, and through upper back. Inflammation visible within 12 hours and sustained over 2+ weeks. Pain remains 8+ weeks after injection around injection site, with  palpable stiffness compared to right arm. Symptoms remain without clear resolution.
problem with her throat; Ears were ringing; turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her; felt an intense heat in her chest and throat; This is a spontaneous report from a contactable registered nurse (the patient's mother). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 10May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: reflux, "weird allergy" that had popped up before and caused Steven Johnson Syndrome (further clarification unknown). Concomitant medication included an unspecified reflux medicine. The patient daughter received the first dose of the Pfizer BioNtech COVID-19 vaccine yesterday (10May2021), and she had a problem with her throat (May2021). She took diphenhydramine hydrochloride (BENADRYL), and it was resolved after an hour (treatment). The patient's mother also specified that the patient felt an intense heat in her chest and throat, and her ears were ringing (both May2021). The patient turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her (May2021). At the vaccination site, they were able to put an ice bag on her neck and on her chest, and it resolved afterward, after an hour, so ice was applied for an hour as well. The symptoms resolved at the time over there (at the center where the vaccine was given), and they gave her BENADRYL. The patient's weight was maybe in the 150 range. The outcome of the events was resolved in May2021.  Information on Lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received Pfizer COVID Bivalent booster on 11/4/22. On 11/5/22 developed fatigue, body aches. On 11/5/22, also developed rash that started just above injection site at right deltoid. Over the next 48 hours the rash spread to right upper arm,  right side of neck, across upper back, and top portion of chest. The fatigue and body aches resolved within 24 hours. The rash was scattered red papules and was itchy.
Myocarditis; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via unspecified route of administration in right arm on 10Feb2021 02:00 PM (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included atrial fibrillation (AFiB). The patient did not have COVID prior vaccination. The patient's concomitant medications received within two weeks included multiple vitamin (unspecified), vitamin D, escitalopram oxalate (LEXAPRO) and flecainide, all from unspecified date. The patient previously received amoxicillin sodium/clavulanate potassium (AUGMENTIN), sertraline (ZOLOFT), ceftriaxone/beta-lactamase inhibitor (BACTRUM), IVP dye (as reported) and they were reported as known allergies. No other vaccines were administered within four weeks. On 18Feb2021 the patient experienced myocarditis. The event resulted in emergency room/department or urgent care visit and patient was hospitalized for 2 days. Treatment received due to the event included heart catherization, steroids and fluids. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.
Progressive symptoms including muscle weakness, loss of balance, and altered gait, of at least six months duration through the present.  Treatments include physical therapy and hospitalization for IV-IG therapy.
she got a cold; This is a spontaneous report from a non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient informed that she had an appointment to receive her second dose of the vaccine tomorrow, but her HCP advised to wait since she got a cold. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
On September 18, 2021 she noted at the shot location on left upper arm was  swollen red and hot after she scratched her left arm to relieve itching.  She also says she noted a lump under arm pit  on Saturday.  She states the left upper arm is hot and she tried  Aloe Vera with some relief.  Last night fever and sweating. Also since yesterday sore throat and gargled and woke up this morning.  Concerned re:  Reaction from getting shot and she also states concern for possible COVID 19. "Went out to eat on Saturday and waiter had runny nose" and that evening "Everything happened".  Left arm is still sore with adenopathy; she did not seek medical help to date.
This spontaneous report was received from the patient's mother an refers to a 4 -year-old male patient with possible asthma and allergy to penicillin. On an unknown date in approximately 2015 (reported as "about 3 years"), the patient was vaccinated with the first dose of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported) and had experienced no adverse events thereafter. On 12-SEP-2018, the patient was vaccinated with the second dose of M-M-R II injection, intramuscularly, lot # N032752 with expiration date on 20-NOV-2019. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On 12-SEP-2018, the patient experienced rash on his arm and and fever. At the time of the report, the patient was recovering form the events. The relatedness between the events and M-M-R II was not reported.
pregnant woman who received INFLUENZA TRIVALENT RECOMBINANT VACCINE/NO AE; Upon internal review information received on 13-Apr-2020, a significant amendment was performed on 15-Apr-2020, to correct report type from " Solicited Non-Sponsored" to " Unsolicited Non Literature".  Upon second medical examination of the case during internal review, a significant amendment was performed on 04 January 2019, to correct study drug from "Quadrivalent Recombinant Influenza Vaccine" to "Trivalent Recombinant Influenza Vaccine".  This is a pregnancy report for a sponsored study.This initial report of a Pregnancy, received on 27Oct2015.  This case involves a 23 year old female patient who received INFLUENZA TRIVALENT RECOMBINANT VACCINE, while he was pregnant.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date is 02-May-2016.  No information on previous pregnancy history was provided.  The patient received first and second dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the arm NOS on 30-Jul-2015 and 20-Aug-2015 for prophylactic vaccination, while she was pregnant.  It was a case of vaccine exposure during pregnancy.  At time of reporting, the outcome of the pregnancy is unknown. Company Assessment: Based on the information received the patient received vaccine Intramuscular on 30Jul2015 and 20Aug2015. The company assessment of causality between the reported event of pregnancy and the vaccine (Flublok Trivalent or Fluarix) is assessed as not related.  Addendum: 04 January 2019, upon second medical examination of case, at time of internal review, a significant amendment was performed to correct study drug from "Quadrivalent Recombinant Influenza Vaccine" to "Trivalent Recombinant Influenza Vaccine".  Addendum: information received on 13-Apr-2020, a significant amendment was performed on 15-Apr-2020, to correct report type from " Solicited Non-Sponsored" to " Unsolicited Non Literature".  Study ID, study type deleted from field and narrative was updated accordingly.
1st Vaccine - uritcaria on hands.  Because I suffer from psoraisis, I didn't realize it was related to the vaccine. Laserr therapy on hands took away the itching, but left dark spots  2nd Vaccine - uritcaria on face, lips and feeling itchy in mouth. severe headache, back and shoulder pain.   Treating all uritcaria with cold compress, topical ointments - cortizone 10, ezcema lotion, lanacaine . I also tried Calritin D  All aches were treated with Advil and hot and cold compressed pads
Right upper arm - reddened, warm to the touch, area swollen - advised, ibuprofen, ice to area and rest arm. Patient stated symptoms started 2 hrs. after vaccination.
This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 7 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were received as follows: The reporter stated that, 2 patients experienced soreness one week out after the vaccination with BEXSERO. The reporter stated that, very little information was known about the event was known and all other information included as batch number of vaccine, age of patient, date of vaccination, initials of patients and expiry date of vaccine were unknown. This case has been linked with the case US2016GSK015440 for the 1st patient reported by the same reporter.
1st dose 30Nov2019. 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26 Jan 2023 Reporters comment: The case was reported by the pharmacist. The pharmacist reported that the patient received the first dose of Shingrix on 30th November 2019 and then patient did not receive the second dose. The reporter asked if they could administer the second dose or if the patient had to start over with the vaccination schedule.  The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of vaccine which led to incomplete course of vaccination.
Pain radiating from top of hand down arm to elbow then up to shoulder and back between shoulder blades.  Consult doctor for results of MRI.  Dr suggested potential onset of Arthritis based on MRI.
Mother reports that child had shots on 1/4/10. She reports that child had 5 raised bumps on rt thigh and 1 raised bump on L thigh that appeared on Saturday 1-9-10. States the next day the bumps looked like carpet burns with a scab on the top of the bumps. The child did not have a fever or any other symptoms.
After vaccine administration, patient became lightheaded, pale and nauseated. Did not want to lie down, felt better sitting with head on exam table. Gave soda to drink. HR=68-B/P 100/62. Stayed in office for 50 minutes. All symptoms resolved patient discharged to home.
Received MMR, VARIVAX, IPV, and Dtap at approximately 10:00am. on 7/18/08. On 7/19/08 "patient" was in our office with both legs swollen at injection sites. Came in again 7/21/08 and still had redness and warmth.
Patient started to experience pain in her shoulder that increased in severity over a few hours to the point she could no longer lift her arm.
since I start using anoro My breathing is worse now when I don't use it; This case was reported by a consumer via call center representative and described the occurrence of dyspnea exacerbated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included umeclidinium bromide, vilanterol trifenatate (Anoro) inhalation powder for difficulty breathing.   Concurrent medical conditions included difficulty breathing.   On an unknown date, the patient received Shingrix and Anoro at an unknown dose and frequency. On an unknown date, immediately after receiving Shingrix and Anoro, the patient experienced dyspnea exacerbated. Anoro was discontinued. On an unknown date, the outcome of the dyspnea exacerbated was unknown.   It was unknown if the reporter considered the dyspnea exacerbated to be related to Shingrix and Anoro.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had breathing problem. The patient notice since start using Anoro the breathing was worse and when did not use it then before started using it was it normal after starting use you cannot go back to not using.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124296:same reporter
Developed redness and itchy spot around the area where she rec'd the vaccination.  She used some anti-itch cream to help.  She felt that it traveled down the arm.
fever of 101-103, strong headache, brain fog, nausea, body aches
Pt recvd vax & exp 1 dose exp nausea which subsided; morning p/dose 2 exp nausea, 5-6 soft stools, weakness both arms, dry mouth, and abdo cramping;
Subpotent dose due to temperature monitoring error offsight.  Patient offered revaccination and came in 10/26/22
Patient started feeling severe fatigue and stomach pain within 4 hours of receiving vaccine, proceeded to vomit 3 times and develop low grade fever (99.6) and body aches/chills. Most of the symptoms resolved within 3 days, however severe fatigue and cold sweats lasted 7 days. After 7 days, all side effects resolved.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 15-OCT-2012 22:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported.  This case contains information for patient 20 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
I lost partial hearing for about a month and when it came back it didn't come back fully.  My eyesite changed for worst within 2 days of shot.   I have a pungent taste and odor I smell all the time.
On 23 Feb 06, pt was screened and received PPD, Typhoid, Hep B #3 in the left arm & Td vaccine in the right arm. He returns today complaining of mild reaction to the Tetanus vaccine. He complains and displays soreness, redness and swelling, complains of chills, sweats, fever. He has takes Tylenol for pain and fever. The Typhoid and PPD vaccines were fine. Pt will see the PCM today.
about 3 hours after vaccination, i experienced palpitations. They continued on and off throughout the evening.
Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A and 066H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy, Chronic pain on 17-Jan-2019, Hypertension on 21-Jan-2021, Type 2 diabetes mellitus on 21-Jan-2021, Hypothyroidism on 18-Oct-2017 and Depression on 08-Dec-2015. Concomitant products included MORPHINE SULFATE from 25-Mar-2022 to an unknown date for Chronic pain, CITALOPRAM from 12-Jan-2022 to an unknown date and BUPROPION HYDROBROMIDE (BUPROPION SANDOZ [BUPROPION HYDROBROMIDE]) from 12-Jan-2022 to an unknown date for Depression, LISINOPRIL from 11-Jan-2022 to an unknown date for Hypertension, LEVOTHYROXINE from 22-Mar-2022 to an unknown date for Hypothyroidism, INFLUENZA VACCINE (INFLUENZA VACCIN).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 millilitre per kilogram. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Jan-2022 at 3:24 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-Jul-2022 at 2:28 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.). On 07-Jul-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster beyond  30-day Use By Date in the refrigerator/15 adult patients (>18-year-old) received expired booster Moderna COVID-19 vaccine on 05JUL2022 through 07JUL2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was given as 67 inches. On 02JUN2022, the vial was initially stored in the refrigerator. No vial doesnot undergo any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2022: Significant follow up appended contains patient details,dose details, medical history and concomitant medication updated
Dizziness; Chills; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043120A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache). At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills) and HEADACHE (a little headache) had resolved.            It was stated that patient had history of bypasses and he was taking medications for that. The concomitant medications were not provided.   This case was linked to MOD-2021-017956 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received and events reported were resolved, and patient declined further follow up.
Severe chest pain for 30-40 seconds. Felt like I was having a heart attack. After pain subsided felt very shakey and light headed. Was hiking at the time. I hike probably over 1,000 miles a year and was on very easy hike.
Increased heart rate from night of shot until today (2/11-2/13). Resting and sleeping heart rate have increased along with intermittent palpitations and feeling like my heart is pounding.