chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable physician. A 47-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced drug hypersensitivity (allergic reaction to the Pfizer COVID-19 vaccine), and  vaccination site vesicles (developed 4-6 cm blister at injection site), with outcome of unknown. Additional information: Patient experienced an allergic reaction to the Pfizer COVID-19 vaccine. Developed 4-6 cm blister at injection site. No anaphylaxis. No guidance on recommendations for a second vaccination. Non-severe but immediate; needed specific information on reactions to the PEG/distearoyl ingredients. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Swollen Lips per mom. Mom states she gave Benadryl, Tylenol and motrin. Per mom, no hives. Pt not evaluated in clinic.
Skin shows multi red papules, few with vesicles, few with crusting over trunk, scattered on face and upper extremities and legs. Prescribed Acyclovir 2 Tsp x 5 days fluids.
Localized pain/swelling at injection site, fever 103 degrees, severe headache, joint/body aches, generalized weakness
Pt hands cold to touch slightly clammy, experiencing tremors in her hands. Daughter was to take Mom to ER.
Information has been received from a healthcare worker, for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 32 year old female patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 671085/0829AA, expiry date 02-JUN-2013) (dose and route not reported). Secondary suspect therapy included M-M-R II (lot number 670892/0872AA, expiry date 06-JUN-2013) (dose and route not reported) on 02-MAR-2012. It was reported, that the patient came to the immunization clinic (connected to immigration office), received and filled out questionnaire and checked no to being pregnant. Then she received both the VARIVAX (Merck) and M-M-R II that day. Then, the family practice called and reported to the immunization office that the patient was 23-weeks pregnant. The patient's LMP was approximately on 06-OCT-2011. Expected date of delivery was 12-JUL-2012. The patient sought medical attention for pregnancy and her first prenatal visit was scheduled for next week. Follow up information has been received from a Licensed Practice Nurse (LPN), for VARIVAX (Merck), a Pregnancy Registry Product, concerning the 32 year old patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck). Other concomitant therapy included Tdap (manufacturer unknown) vaccinated on the same day. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The patient's Date of last menstrual period was 05-OCT-2011, estimated delivery date was 02-JUL-2012. On 29-MAR-2012, the patient did ultrasound, the result was OK except for hydronephrosis. The patient had 5 previous pregnancies. Full term deliveries was 4 times. There was no  pre-term births. No birth defect occurred in previous pregnancy. The patient had a stillbirth or miscarriage in the previous pregnancy of 4-6 weeks. The patient did not have local reaction at vaccination site and did not have varicella and herpes zoster symptoms post vaccination. Follow up information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry Product concerning a female patient with no infections or illness during pregnancy and no concurrent medical conditions, who on 03-JUL-2012 delivered a live normal male baby at her 40 weeks from LMP. None congenital anomalies and other complications or abnormalities were reported, The infant did not experience adverse event. During pregnancy the patient had gestational diabetes. Concomitant therapy included prenatal vitamins  (name reported as Prenatal), used most of pregnancy, 1 daily, uncertain number of doses taken for nutrition. The patient experienced post partum hemorrhage during labor/delivery. Ultrasound was performed on 29-MAR-2012, 09-MAY-2012 and 26-JUN-2012 and showed hydronephrosis. On 26-JUN-2012 hydronephrosis resolved. On an unknown date, prenatal lab profile was performed with a result of normal. On an unknown date, glucose screening tests were performed with a result of abnormal. Additional information is not expected.
daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022; daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 03Jun2022, outcome "unknown" and all described as "daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19  Clinical course details: It was reported, daughter sick from school on 29May2022, then had symptoms of allergies scratchy throat and stuffy nose 02Jun2022, then Ag Plus test 03Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Leg pain / Diagnosed with polyneuropathy; Paresthesia in the feet likely due to peripheral neuropathy; Pain the right side of her face and sores developed on the right side of her mouth / Herpes zoster; Information has been received regarding a case in litigation, referring to female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 17-JUN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered pain on the right side of her face and sores developed on the right side of her mouth. The patient was diagnosed with herpes zoster and then continued to suffer from leg pain. As a result of leg pain, she was additionally diagnosed with polyneuropathy and paresthesia in the feet likely due to peripheral neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of  zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of defendants' conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the outcome of polyneuropathy, herpes zoster and neuropathy peripheral was reported as not recovered. The reporter considered polyneuropathy, neuropathy peripheral and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, polyneuropathy and neuropathy peripheral were determined to be medically significant.
Heart felt strained, noticed labored breathing, felt like I was breathing harder. Sour arm, difficulty lifting
Baby had extreme redness and swelling at injection site as well as red pox completely covering his body 10 days after receiving the vaccine.
4/29/2022-Presents to ED, fall 1 week ago leg and shoulder pain.  Has productive cough, ABG 7.419/50.3/67/94 on 2L NC. CXR: perihilar interstitial opacities bilateral. Covid + test.Left R rib fx and occiptal scalp lac. Start decadron, baricitinib, remdesivir, ceftriaxone and azithromycin. Lovenox. Admit acute hypoxemic resp failure s/t Covid.  4/30/2022-Desat to 81% during HS, 02 increased to 4L, sat increased to 93%. 5/2/2022- started Po Doxy. Currently on 3L via NC. 5/5/2022- Completed remdevisir. Continued ceftriazone, doxy and baricitinib. Currently on 2L via NC. Discharged rehab.
The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; no adverse event; Dose administered after manufacturer date of expiry to the patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 5May2022, 6May2022,19May2022, 02Jun2022, 09Jun2022 and 23June2022. vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergo any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:
Right side of body. Severe pain started in back then moved to hip area shooting down right leg into knee and thigh. Still currently having pain.
Patient with tongue tingling 10 minutes after vaccine. No other symptoms, vitals and exam normal.
Vaccine for age 5 -11 years was not diluted as it should have been. No side effects or adverse events reported by caregiver.
received his first dose of the Moderna COVID19 vaccine. 12 days later, he received the Pfizer; received his first dose of the Moderna COVID19 vaccine. 12 days later, he received the Pfizer; A spontaneous report was received from a consumer concerning a 74-year-old male patient who receive his first dose of Moderna Covid-19. 12 days later, he received the Pfizer vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: not provide) intramuscular for prophylaxis of COVID-19 infection. Twelve days later the patient was given the Pfizer vaccine. The pharmacist on the phone did not want to provide any further information.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The events were considered resolved.; Reporter's Comments: This case concerns a 74 year old male patient who received their first of two planned doses of mRNA-1273 (batch number not provide) intramuscularly for prophylaxis of COVID-19 infection. Twelve days later the patient was given the Pfizer vaccine. There were no reported adverse events in this case of product substitution issue and Inappropriate schedule of product administration.
Vaccination out of manufacturers specifications.  Pt stated 2nd dose was within 4 day grace period when in fact after checking the patient was 7 days early.  Discovery was after injection was given.  Per CDC guidelines series not needed to restart.
Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Medium, Additional Details: Patient said she got hot and then threw up. She said she was fine after throwing up.
Lost all my vision; A spontaneous report was received from a consumer who was an 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost all my vision (blindness).   The patient's medical history, as provided by the reporter, included an eye transplant 9 or 10 years ago. Concomitant medication included acetylsalicylic acid, metformin, tamsulosin, ropinirole, Ramipril, and gabapentin.  On 09 Feb 2021 at 10:00 AM, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 FEB 2021, at exactly 10:00 PM,  the patient "lost all my vision."  He stated he had an adverse reaction to his first injection and said "my first shot messed up my vision."  By 5 am, his vision was perfect.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The event of lost all my vision was considered resolved on 10 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe headache, chills, fever, nausea each beginning the day after the vaccination and lasting 2 days. Extreme fatigue beginning the day after the vaccination and still ongoing (8 days since the vaccination).
experienced reoccurring shingles infections after receiving an older shingles vaccine/ suspected vaccination failure; experienced reoccurring shingles infections after receiving an older shingles vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced reoccurring shingles infections after receiving an older shingles vaccine. No additional information provided. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
No adverse event; Given a little lower on the arm than typical; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical) 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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical).    The concomitant medication was not reported by reporter. The caller was the store manager of the pharmacy. He stated that a patient got her booster, and it was given a little lower on the arm than typical. Patient enquired was that going to cause any issues with the vaccine being less effective. The lot number was not available.  The treatment medication was not reported by reporter.
Pt started with rash on back which increased overnight, presented in office on next day with 2 circular areas around size of silver dollar. Vesicular lesions which were painful and itchy. No history of varicella. no specific treatment required.
18 days after receiving MMR and VARIVAX, presented to ER with erythema multiforme rash of face, trunk and 4 extremities.
20 hours after injection, I started having progressively worsening severe back pain, neck pain, headache, chills (no fever), skin sensitivity, noise sensitivity, fatigue, and brain fog. 2 days after the vaccine, I had abdominal pain, and cough. All of that is now better except for the cough. It is now 4 days after the vaccine, and it seems the vaccine has triggered an asthma attack requiring inhaled albuterol. My asthma attacks typically linger for a couple weeks after upper respiratory infections, and this feels exactly like that, I wouldn?t be surprised if this asthma attack persists for a couple of weeks.
I Initially just had a sore left arm which felt better the next day.  I  woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
Patient developed a rash at injection site, throat closed up and got swollen lips. She stated she took BENADRYL and got better.
Blister formed on bottom lip the day after vaccine was giving. No history of cold sores or fever blisters
1. Severe chills on first night 2. Body pain and ffatigue 2nd snd 3rd day 3. Severe Radiating pain in arm of injection from day 4th and 5th continue
On 11/19/99, the pt experienced muscle rigidity and a red round ring that traveled down the elbow. The pt's elbow was tender. The pt felt that the symptoms were related to therapy with vax.
Patient reports facial drooping and watering of eye on right side of face.   Patient was taken to ER on 10/11 for suspected stroke and was diagnosed Bell's palsy.  Patient is unable to drink from cup (must use straw), has visible drooping, and is experiencing watery eye due to inability to blink or fully close eye.  Patient is patching eye at night and will see and eye doctor today (10/13/22).  Patient was prescribed prednisone dose pack and valacyclovir, and has slight improvement today.
Patient noticed some warmth at 1530 and took of jacket to see arm.Patient noticed that there was a red area about the size of a half dollar. In the morning of 09/10/2017 patient noticed area had increased by .5 cm so came to clinic. Patient was assessed by Nurse and PA.  Lungs, clear, VS Stable. Patient going on a 45 min flight home. Patient given an epi pen and 50 mg of Benadryl as a precaution.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 07-FEB-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Patient was sitting in the post-vaccination waiting area and fainted.  I am unsure of the exact timing of how long he was unconscious, but was told it didn't last very long and he was able to cooperate with store management to file an accident report with them.
WITHIN ABOUT 16 HOURS I WOKE UP WITH A HEART RATE OF 122 BPM (I WEAR A FITBIT WATCH TO SLEEP).  OVER THE COURSE OF THE NEXT 24 HOURS MY HEART RATE RANGED BETWEEN 99-125 BMP AND MY BLOOD PRESSURE READING WAS 140/95.  I WENT TO THE DOCTOR THE FOLLOWING DAY (DEC. 9) AND WAS SEEN, RECEIVED AN ECG WHICH WAS NORMAL AND WAS TOLD TO MONITOR THE HEART RATE.  BY THE MORNING OF DEC. 10 (APPROX 48 HOURS AFTER 2ND DOSE) MY BPM WERE AVERAGING 85-90 AND 70'S DURING RESTING.  IT IS NOW 5 DAYS POST VACCINE AND HEART RATE APPEARS TO BE MORE OF MY NORMAL RANGE WITH AN OCCASIONAL INCREASE, HOWEVER, I AM NOW EXPERIENCING A BURNING SENSATION IN THE BACK OF MY THROAT ALONG WITH A DRY PAINFUL COUGH.
Allergies; left arm was sore; Stuffy nose; loss of smell/ smell not working; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, lot number: either EH9899 or CH9899), via an unspecified route of administration at the left arm on an unspecified date at a single dose for an COVID-19 immunization. The patient has no medical history. There were no concomitant medications. On 22Dec2020, the patient experienced loss of smell. The patient reported having like what appears to be allergies, stuffy nose and her smell not working. The left arm was sore until the 19th and four days after the injection and just soon after getting it she had stuffy nose. The arm was not really sore, but the patient was still having stuffy nose and the loss of smell. The outcome of the events loss of smell/ smell not working and stuffy nose was not recovered; allergies was unknown; left arm was sore was recovering.  Information on the lot/batch number has been requested.