chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client reports to Rn. Complains of "itching throat" and that it feels swollen. Dr paged to observation center . Vital signs are taken by EMS, client states a few minuets later that he feels improvement in his condition. Client denies SO. Alert and oriented X3 . Vital signs 98%O2 HR- 106  BP 146/100 Client was advise by Dr. To stay at the observation area for an additional 30 min and a second set of vitals go be taken. Client states he no longer have any swollen sensation and he feels safe to leave vaccination site.  No EPI/ Benadryl is needed according to DR.  Second set of VS  taken 11:26 98 O2 75 HR  154/65 BP
Enlarged axillary lymph nodes, widespread hives on lt arm, chest, back and abdomen. OTC Benadryl 25mg po.
patient felt like her throat was closing. a few minutes after dose administered. she was given epi injection, ems was called and she was transferred top the hospital
Severe pain in left arm, shoulder, redness/hot, swelling. Pain in stomach, nausea. Severe rash on face, neck, chest, upper torso, arms, stomach, back, legs. In ER on 6/1/18 given Fentanyl. In Hospital 6/2-6/4/18 given injections of prednisone and benadryl; upon release given a 3 day course of oral prednisone. Rash appeared on 6/2/18 and lasted through 6/8/18.
pt recv vax 18MAR96 & 22MAR96 pt devel pimple-like rash all over face, & a rash on opposite arm that the vax was given in;
scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID; tested/confirmed that patient contracted COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID) and COVID-19 (tested/confirmed that patient contracted COVID) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for Fibromyalgia.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (tested/confirmed that patient contracted COVID). On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID). The patient was treated with VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (scheduled to receive dose 2 on 1Apr2021, but missed it due to COVID) had resolved. At the time of the report, COVID-19 (tested/confirmed that patient contracted COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 26Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: 03May2022; BISOPROLOL; TRUVADA. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12May2022) Negative, notes: Tested negative day 9 and was symptom free; (15May2022) Positive, notes: Tested positive again day 12 and cold symptoms. Therapeutic measures were taken as a result of covid-19.
brain has slowed down; starting to lose his memory/memory loss; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot nubmer: EL1283), via an unspecified route of administration on 29Jan2021 at a single dose on the right arm for COVID-19 immunization.  Medical history included heart valve replacement on an unknown date. The patient stated that he was taking concomitant medications (unspecified) but nothing out of the ordinary. It was reported that on 31Jan2021, Sunday afternoon, he noticed that he was starting to lose his memory. He said he suddenly forgot his age and had to ask his wife about it. He said he has consulted his doctor about this already, but still wants to give Pfizer a call to ask for advice on what to do. He also said he wants to go on record that he's having this kind of experience after receiving the vaccine. He said he has serious memory loss. It was bad Sunday afternoon and Monday morning but Monday afternoon it got better. The day before the report it was better but on the day of the report it is bad again. He went to see doctor regarding this; he hopes he doesn't lose his memory. He stated that on 01Feb2021 his brain has slowed down; his memory is gone. He went to see his primary care doctor, on 02Feb2021 he went to see another doctor, a brain doctor. He did a sleep test on 04Feb2021 with unknown results.  The patient stated that he is still struggling with it. He has seen his doctor and is working on it but wanted to let Pfizer know about this and would like us to know the conditions and if Pfizer would have any information on this happening. The patient had blood tests and an MRI done on an unspecified date in 2021 with unknown results. The patient did not receive treatment for the events. The outcome of the events is not recovered.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 20Apr2021 11:45 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included sertraline; beta carotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL); and ascorbic acid, beta carotene, copper, nicotinamide, selenium, tocopherol, xantofyl, zinc (LUTEIN +). On 22Apr2021, the patient experienced right eye "floater": posterior vitreous detachment. Doctor said probably not due to the vaccination, "just a coincidence". The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.
My friend got the shingles twice after getting the vaccine/ suspected vaccination failure; My friend got the shingles twice after getting the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The reporter stated that the patient got the shingles twice after getting the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
EPILEPSY, UNSPECIFIED 4/20/2022 -- RECURRENCE OF SAME SYMPTOMS
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022).    No concomitant medication was provided.  The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial was initially stored in the refrigerator on 08-Jul-2022 was vaccine was administered since 07-Aug-2022 to 11-Aug-2022.  No treatment medication was reported.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose and route unknown) from lot # M023380 with expiry date of 11-MAY-2018. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
10 hours after vaccine, the mild soreness in my left arm increased in severity to constant pain, like I'd been hit with a baseball bat. Swelling and shooting pains in left armpit made it difficult to sleep. The following day, the pain continued, spread to my left breast, and any amount of pressure made the pain worse. The pain continued the third day, with constant chest pain that felt like bad heartburn. The worst of the pain subsided four days after vaccination.
Patient presented to the ED with severe lower abdominal pain. Patient reports pain as severe, 10/10, in the mid-lower abdomen, constant with radiation to the right LQ. He reports N/V as well. Of note, patient is on chemotherapy (currently FOLFIRI/cetuximab) and follows with an oncologist for his colon cancer. His oncologist believes that the cause of his presentation is due to him taking Imodium for his chemo-induced diarrhea.  Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
High fever 101-103 within 12 hours, lasting for more than 36 hours so far, complete body muscle fatigue and pain, headache, dizziness, hives/swollen rash across chest, nausea
Erythema at site within 24 hrs after injection. Symptoms resolved after 48 hrs.
blood clot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  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.; Sender'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.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus one neonate patient had developed intraventricular hemorrhage grad 3-4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of intraventricular hemorrhage, grade 3-4 and vaccine exposure in utero as serious and important medical event. Documents held by sender: none.
Approximately 18 hours after receiving the second Pfizer COVID-19 injection, I experienced chills, fever, extreme tiredness, and nausea.  Approximately 24 hours after receiving the injection, I experienced swelling, extreme tenderness and slight pain under my left armpit.  After about two days, I didn't experience symptoms any longer.
Rash broke out at injection site 24 hours after administration.  It continued to spread.  48 hours after initial rash, she went to the ER.  She was given prednisone.  Had intermittent hives for 1 month.  She was followed by occupational health services at work.  They felt the symptoms were caused by the flu shot.
How long after testing positive can I receive my second shot?; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?). At the time of the report, SARS-COV-2 TEST POSITIVE (How long after testing positive can I receive my second shot?) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was enquired that how long after testing positive patient can receive second shot.  Company Comment: This case concerns a patient of unknown age and gender, who experienced the non-serious unexpected event of SARS-CoV-2 test positive (AESI). The event occurred unknown number of days after receiving the first dose of mRNA-1273 vaccine. Patient wanted to know how long after testing positive can the second shot be received. There was no available information regarding clinical course or treatment medication. At the time of the report, outcome of event was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the non-serious unexpected event of SARS-CoV-2 test positive (AESI). The event occurred unknown number of days after receiving the first dose of mRNA-1273 vaccine. Patient wanted to know how long after testing positive can the second shot be received. There was no available information regarding clinical course or treatment medication. At the time of the report, outcome of event was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Chest pain with myocarditis (EKG with ST changes, troponin leak) with preserved systolic function
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that an excursion about a month ago and the excursion duration was 7 hours instead 5 min (previously stated) and the patient had been administered from these vaccines. The vaccine was stored in refrigerator at the time of the excursion. Date of temperature excursion was 10-Mar-2022. Lot number was 027L21A and vaccine was administered on 15-Mar-2022. The other lot number and expiration date was reported as 046L21A and 06-Jul-2022. The maximum temperature reached was reported as 64°F. The vials were returned to the refrigerator. No vaccine state change was reported. The vials were unpunctured at the time of excursions. Tran date was reported as 15-Mar-2022. The patient did not experience any adverse events post injection. No treatment medications were reported.
I started sweating profusely within 30 min of the shot. Was light headed and dizzy for approximately 4-5 hrs. Once the sweating stopped I felt severe pain in both knees and ankles. If felt as if you were trying to snap my knees and ankles in half. That lasted 4-5 hrs. After I slept for a few hrs over night I woke up and felt pretty good. Approximately 3-4 hrs after I woke up I felt light headed and nauseated for approximately 3-4 hrs. I felt pretty much back to normal into the third day after the shot. I was slightly light headed and fatigued for approximately 8 days after the shot. After about the 8th day I felt normal again. I said I will never get that shot again. Approximately 25 years ago I had gotten my first flew shot and I was very sick for a week. Never received another flew shot again. Besides the stress and anxiety issues I am a healthy guy. Every 2 years we get full blood work up and my blood levels have always been spot on of where they should be.
Patient ran a fever for >2 days, pain swelling and lump at injection site, and broke out in a pustular rash under breasts that were very itchy.
Became dizzy and felt a hot sensation. adulte emergency called. no injury. pt monitored and transported to ACC. Eval in acc with no meds given. D/C at 1605.
Pt reports phone size and font size on phone appeared smaller after receiving vaccine. Denies blurry vision, dizziness, HA. Declines to have font size checked on settings on phone. All other items: wallet, room, signages, appearing "normal" size to pt. Assessed by EMS. Refuses further eval/transport to ER. Wife will drive him home. Advised to seek further medical eval and report to his PCP.