chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had two very large blood cloths moved from her leg to her lung; blood clot was pressuring her heart; >42 days received the second vacicne; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (had two very large blood cloths moved from her leg to her lung) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced THROMBOSIS (had two very large blood cloths moved from her leg to her lung) (seriousness criteria hospitalization, medically significant and life threatening) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) (seriousness criteria hospitalization and life threatening). On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days received the second vacicne). The patient was hospitalized from 08-Mar-2021 to 12-Mar-2021 due to CARDIAC DISCOMFORT and THROMBOSIS. On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days received the second vacicne) had resolved. At the time of the report, THROMBOSIS (had two very large blood cloths moved from her leg to her lung) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) outcome was unknown. Not Provided      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.   No concomitant medications were reported. The patient was given Heparin in the hospital for about 2 days and was taking Apixaban at the time of this report.  Very limited information regarding these events has been provided at this time. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information required.
Have been intensely itching all over since later in the evening, the day I was administered the flu shot.  Feel nauseous and have had heartburn. Have had hives, and itchy red skin that seems to swell easily upon itching.  Sinuses feel as if they have swollen shut.  I am worried my throat will close-  I keep having the sensation of fullness in my throat. Very itchy mouth, throat, and deep inside my ears.  Eyes, scalp, and even the bottoms of my feet itch.  These symptoms have persisted over the last 2.5 days, and have been worsening and intensifying.
red circle about 4 inches in diameter at the injection site; A spontaneous report was received from a nurse concerning a 23-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red circle about 4 inches in diameter at the injection site/vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, ten days after receiving the vaccine the patient experienced the event red circle about 4 inches in diameter at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event red circle about 4 inches in diameter at the injection site was unknown.
About 3-5 mins. after DTaP, IVP, MMR & Varivax given, child became pale & fell & hit head on floor.  No LOC but was acting lethargic.  Given Epipen Jr & Decadron 4 mg within 1-2 mins after meds given.  Child more alert, active, color returned.  Monitored about 30 mins in office.
Pt developed a 5" X 4" large, local reaction less than 24 hours, post vax.
suspected vaccination failure; shingles I had; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (3 times).   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 patient had reported for him/herself. The age at vaccination was not reported. Before receiving Shingles vaccine, the patient got shingles 3 times. After receiving Shingles vaccine, the patient again got shingles once. The patient stated that, Shingles vaccine did not stop shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Admitted to the hospital on 4/23/01. Fever 102F-103F; erythema of chest; cellulitis. Spoke to mother on 5/2/01 and she reports that pt still has lesions. His mother reports that lesions were infected. Annual follow up on 11/21/2003: "Vaccine recipient recovered from the adverse events that were reported for this vaccination.  Doctor reported child is fine; no residual symptoms on 07/10/2002."
COAGULATION DEFECT, UNSPECIFIED TYPE, IN PREGNANCY, UNSPECIFIED TRIMESTER
Baby 1 month 23 days old came in to our clinic for well looking check up & exam. Baby has no prior illness, eating well, voids out normal. Baby received the oral RV vac, then the injectable required vaccine, after the PCV vac, baby cried a little then became quiet, sleepy like lethargic. No change in color, normal color. Normal breathing, HR, pulse ox no abn. body movement, cries nl moro reflex but sleepiness lethargic later. Hence we cal the paramedic and brought baby to ER. Observe these for 2 hrs. Then release & sent home. Baby was ok.
2:30PM Chest pains, weakness, dizziness, feeling shaky.  6:20pm Tachycardia, hypertension, fever, fainted, whole body went limp and unable to keep head up.  8:30 able to use arms again and feel them 10:30pm able to use legs and walk again
Pt. tested positive for COVID 5/17/21. Completed COVID vaccine series 1/15/21. Asymptomatic. Positive household member.
Patient received all three hib vaccines (4/18/2017, 6/20/2017, 10/3/2017). Was admitted on 11/4/2017 in respiratory distress. Found to have metapneumoviral pneumonia and Haemophilus influenza type B grew from her aerobic and anaerobic blood culture on 11/4. Repeat Cx after 1 day of ceftriaxone was negative.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified dates in December 2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N021727, expiration date 06-FEB-2019; # M043307, expiration date 24-APR-2018, and VARIVAX lot # N008077, expiration date 09-MAR-2019, # N001528, expiration date 13-JAN-2019; #N012134, expiration date 17-APR-2019, (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccines were exposed to a temperature range of 20.1 °F, during a time frame of 2 hours and 12 minutes. No previous temperature excursions were reported. The call was because of a data logger. No adverse effects were reported.
mom states woke up & vomited x9 since then c/o stomach pain, fever 104.4 given motrin;presented to clinic referred to ER mom states has problems w/gastritis;
FLULAVAL by GSK administered to teenage boy instead of FLUZONE (Sanofi) that is for ages 6 mo and above.
Pt. states that after receiving the 1st dose of Moderna 09/03/2021, started experiencing symptoms 09/07/2021 of fatigue, off-balance, and loss of motor skills (through the right arm/hand). Right leg weakness (unnatural feeling to move). VA Primary visit 09/13/2021 no recommendations, just told to call in a report. No exam.
10:45 a.m. Fatigue 12::00 pm headache 2:00 pm achy joints 5:00 p.m. took one Tylenol Rapid Release 500mg 9:00 p.m. low grade fever 99.8 10:00 p.m. took two Tylenol Rapid Release 500mg 3:00 a.m. awoke, joint pain all joints, low grade fever and headache took two Tylenol Rapid Release 500mg 9:00 a.m. awoke, fever gone temperature normal, headache, achy joints continued throughout the day 7:00 p.m. headache subsided 10:00 p.m. less fatigue but still achy joints  Took two Tylenol Rapid Release 500mg  1/18/2021 9:00 a.m. awoke feeling normal
Got vaccinated and still got shingles/ Suspected vaccination failure; Shingles but not as bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 patient was the reporter's sister in law. The age at vaccination was not reported. The reporter stated that, the patient got vaccinated and still got the shingles but not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR001918:Same reporter.
About 9:30 started getting right facial numbness and right arm numbness.  Resolved within a couple of hours.
During the injection she experienced severe pain like the injection entered the shoulder joint. She had significant difficulty moving her arm since the injection despite ibuprofen and ice. She has pain and trouble performing any movement - getting dressed, driving, lifting, pushing and sleeping.
Vaccine leaked from injection site; A spontaneous report was received from a nurse concerning a patient who received COVID-19 vaccine and experienced the event, vaccine leaked from the injection site. The patient's medical history was not provided. Concomitant product use was not reported.   On an unknown date, the patient received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the  vaccine leaked from the injection site. No treatment information was provided.   Action taken with in response to the event was not provided.   The event, vaccine leaked from the injection site, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection and vaccine leaked from the injection site. There were no reported adverse events after the vaccine was administered in this case of vaccine leaked from the injection site.
Vaccine administered BUD (on day 32); This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided.  Patient has experienced no side effects with no unusual symptoms was reported.  The 8 patients received a dose from a vial that was stored refrigerated for more than 30 days which was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit, was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Significant follow-up received on 04-OCT-2021 and included first dose information.
Headaches, body aches, fever, facial numbness, blisters in my nose, fatigue.
Tingling and swelling to face and hands. Facial flushing to bilateral cheeks. Difficulty swallowing. Patient received Benadryl PO, Pepcid PO, and Decadron Injection for reaction.
small fever; aching; high chest congestion; sore throat; getting sick; sore throat feels like there is ground up glass in there, and is red; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 76-year-old female patient received bnt162b2 (BNT162B2, formulation; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:30 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE (at the age of 76-year-old) for COVID-19 immunisation. Medical history included mitral valve prolapse from 1980 to an unknown date, hypertension from an unknown date and unknown if ongoing (Caller says this was diagnosed 13 years ago). There were no concomitant medications. The patient did not receive any other product. The patient experienced small fever, aching, draining, high chest congestion and sore throat on 10Feb2021. It was reported that the patient started getting sick on 10Feb2021. Patient stated doesn't know if it was correlated to the vaccine, she has some symptoms and has been to the doctor twice, the worst thing was a terrible sore throat. Patient says that she has been taking a Z-Pak and was on day 5 of 6 days of that, but it doesn't seem to be helping. She says that they swabbed her throat for strep test, which was negative and had underwent a COVID test, waiting for results. Patient stated that her next dose was due 23Feb2021 for the vaccine and she has been terribly sick for 6 days. Patient wonders if 11-12 days afterwards would be too long for getting side effects of vaccine or if it was still within that time. The patient received Z-Pak sixth dose today (NDC 59762-2198-1, LOT ER7479, EXP 31Oct2024 manufactured by Greenstone) which was prescribed by the urgent care. The patient felt sore throat feels like there is ground up glass in there, and is red. The patient received gargle with salt, honey, lemon and used Chloraseptic spray. No details provided about Chloraseptic spray. It reported that patient wanted to know was sore throat a side effect of the Covid-19 vaccine. The patient took Z-pack but it was not helping. Therapeutic measures were taken as a result of sore throat and sore throat feels like there is ground up glass in there, and is red. The outcome of events small fever, aching and high chest congestion reported as unknown. The outcome of events sore throat feels like there is ground up glass in there, and is red, sore throat was not recovered and outcome of the other events was unknown.  the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fever, body pain, excessive headache, lung pain, burning skin, joint pain, chest pain and earache.
Starting at 9:00pm, I woke to excruciating pain in every joint,  dizziness, felt like my heart was racing, my body felt like it was on fire. I couldn?t breath, when I stood up I thought I was going to pass out and my chest was heavy. Elevated temperature for 4 days, three days of joint pain and headache. Lost taste and smell three weeks after injection, still can?t smell 4 1/2 months later.
Headache soreness at vaccination site Left arm on inside of elbow a sore that developed 2 days after vaccination in that  arm which was very red, angry, sore, itchy, painful. It had bubbles that eventually turned to scab.  It still exists & will probably scar.
pt developed symptoms on 4/19/2021 after receiving shot on 4/7/2021.  Patient was admitted to hospital and discovered to have a clot in left leg.  Patient is receiving Lovenox.
two painful events in foot; second painful event in foot was not as severe as the first episode; hand pain with a clot on the inside of wrist with spontaneous bruising; one painful event in hand; spontaneous pain and bruising on the left foot above the heal which prevented the patient from; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events two painful in foot, one painful event in hand, spontaneous pain and bruising on the left foot above the heal which prevented the patient from, second painful event in foot was not as severe as the first episode, hand pain with a clot on the inside of wrist with spontaneous bruising.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) two painful in foot. On 16 Mar 2021, the patient experienced the event(s) one painful event in hand. On 10 Mar 2021, the patient experienced the event(s) spontaneous pain and bruising on the left foot above the heal which prevented the patient from, second painful event in foot was not as severe as the first episode, hand pain with a clot on the inside of wrist with spontaneous bruising.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), two painful in foot, one painful event in hand, spontaneous pain and bruising on the left foot above the heal which prevented the patient from, second painful event in foot was not as severe as the first episode, hand pain with a clot on the inside of wrist with spontaneous bruising was unknown.
Swollen lymph node 1/13/2021 Red swollen skin area at vaccination site ~ 2.5" X 3.5"
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 13-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 912 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient begin treated for CoVID 19 with Paxlovid  ,  on day 5. suffered cardiac arrest  at home
Doesn't know if it was like a bells palsy reaction; mild numbness and tingling sensation in left side of face; mild numbness and tingling sensation in left side of face; Like there was novocaine on/in it; This is a spontaneous report from a contactable other health care professional, the patient. A 25-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration in the deltoid left on 22Mar2021 11:00 as dose 1, single (at the age of 25-years-old) for covid-19 immunization. Medical history included medication allergy. There were no concomitant medications. Vaccination Facility Type Hospital. The patient previously took flu vaccine for immunization. The patient received the first dose of this vaccine in Mar. Shortly after, clarified on her drive home from receiving the dose, the left side of face just face felt numb and tingly, like there was novocaine on/in it. The patient stated that her PCP assessed and did a neurological check. Again, stated that the numbness and tingly sensation was very mild, it was not a strong and it lasted 3-4 months after her first dose. She stated it was very weird and she was a healthy individual and not on any medications, she gets the flu vaccine every year, so this was scary and concerning. The patient discussed with her PCP and went by what the CDC said in regard to being 80 percent effective after one dose, versus 90 to whatever after the second dose. Both her and her doctor came to an agreement that they did not know what the reaction was. Patient did not know if it was like a bell's palsy reaction, so she delayed getting her second dose. The patient did not receive any other vaccine within four weeks prior to vaccination. The patient went to emergency room and physician office for the events. It was reported that doctor poked the patient face with a pen. The clinical outcome of the events mild numbness and tingling sensation in left side of face was recovered on an unknown date in 2021 while outcome of the other events was unknown.; Sender's Comments: Based on the information available the causal association between the events bell's palsy and the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient did not experience adverse events from vaccine. When given second dose on 9/19/2021 she was administered Pfizer instead of Moderna
two other people in family had the Pfizer vaccine and only had minor aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome unknown, described as two other people in family had the Pfizer vaccine and only had minor aches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264596 same reporter, product and event; different patient
pt reported achiness, fatigue AND A RUNNY NOSE and redness in the armpit area and back of neck
Patient felt nauseated and lightheaded. Patient lied down, slowly drank some orange juice and within 10 minutes felt fine.
Constant moderate buzzing in both ears (Tinnitus); generally consistant 24/7 since May 2021