chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not even walk; really sick for about 3 months; Short of breath; both their legs swelled up; really bad cough; extremely weak; getting worse and worse; caused their blood pressure to elevate; elevated ANA; first dose of the Moderna vaccine on 15Feb2021 and no second dose yet; gets tired easy/ can barely walk a mile; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up) and COUGH (really bad cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Seasonal asthma, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile). The patient was treated with AMOXICILLIN at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: elevated (High) elevated. On an unknown date, Blood pressure measurement: high (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product include high blood pressure medication. Pulmonary doctor prescribed an inhaler to use twice a day. Pulmonary doctor referred the patient to a rheumatologist.
Severe left arm pain, swelling. The medical record from MD's office state fatigue, induration at injection site, and hip flexor tendon pull.  60 day follow up on 11/18/2003: "Vaccine recipient did recover from the adverse events that were reported for this vaccination." The discharge summary received on 1/16/04 states diagnoses of adverse tetanus shot reaction and possible overlying cellulitis.
severe abdominal attack w/ "really bad cramping"; severe abdominal attack w/ "really bad cramping"; bottom lip mild to moderate swell; tired; haven't been able to sleep real well; diarrhea; mild nausea; arm soreness; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. (Duplicate number: 2021134867). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: was not reported), via an unspecified route of administration on 25Aug2021 (at the age of 64 years) as dose number unknown, single for COVID-19 immunization and also received complement c1 esterase inhibitor (HAEGARDA, batch/lot number was not reported), subcutaneous from 09Aug2021 and ongoing, at 6000 iU, q 3-4 days for off label indication. The patient's medical history included kidney infections/issues, Diabetes T2DM, HGD. The patient's concomitant medications were not reported. The patient previously took Takzyhro and reports it really helped her kidneys because she had not had an infection since starting. On 25Aug2021 and 26Aug2021 the patient experienced arm soreness. On 26Aug2021 the patient experienced diarrhea and mild nausea. On an unspecified date the patient experienced severe abdominal attack w/ really bad cramping occurs weekly (down from 2x/week prior to HGD therapy); continues to have occasional bottom lip mild to moderate swell; she was real tired today because she had not been able to sleep real well the past 3 days. Firazyr was taken as a therapeutic measure for events abdominal issues and arm soreness. The patient stated that this treatment took longer "than usual" to work. The outcome of all events was unknown.  Follow-up attempts completed. No further information is expected.
No fever, area of vaccine administration with local erythema & warmth, size of cantaloupe, raised and tender, superficial -> developed 2 days after given -> steroids & abx given for reaction & cellulitis.
pt recv vax SEP96 & in APR97 pt exp less than 50 lesions;
Employee called Employee Health office on 1/5/21 with complaint of lymph node pain to Left Arm.  Referred employee to on the Job (Occ Med).
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 08-DEC-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J005011, expiry date: 04-DEC-2014) .5 ml, intramuscular. No concomitant medications were reported. No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Causality was reported as not related to therapy with PNEUMOVAX 23. Additional information has been requested.
I got the shot on Friday evening. Woke up Saturday morning with a fever, slight sore throat and extreme fatigue. Sunday was much the same with the only addition to my symptoms being sore eye's....until I went to bed. Woke up at 1am with sever itching in my left ear. The left side of my face was swollen and my left ear was swollen so badly that the earring I was wearing was stuck in my ear. The ear was very hot to the touch and my eye, face and ear down toward my neck was slightly numb. I also have hematoma's in both eyes.
One hour after vaccine, arm began to hurt then progressed to hurting so much I could not lift it for two days without significant pain. By 7 hours after vaccine, chills and fatigue started and I could not get warm. That same night upset stomach and migraine as well as hot sweats between the chills. No fevers noted. These symptoms worsened on the next day. Very fatigued all day and little to no appetite. Sunday started improving but easily fatigued with walking more than 100 feet. Still little appetite. Able to eat half usual amount at dinner that night. No chills anymore. Still sweats. Monday still easily fatigued but not as bad as sunday. Appetite improving. Still sweats with minimal exertion.
Extensive maculopapular rash on trunk/extremities/head and diaper area.  Rash started 10/28/07.
Shingle developed on patient back approximately 3 weeks after 1st vaccination.  Has not seen a provider for this
Immediate injection in left arm at site was burning , which continued for 5 minutes.  24 hours after shot in left arm, sore and sensitive in area of shot.  48 hours after shot in left arm, sensitivity and soreness spread to muscle of left arm.  Five days later of shot in left arm extreme pain developed in shoulder.  in the five days after shot in left arm, painful movement and weakness in left arm.  to date it has been two months and  sensitive in shoulder still present, movement of arm still limited without pain, weakness in certain positions still present.
This spontaneous report was received from a certified medical assistant, concerning 2 patients of an unknown age and gender. Medical history and current conditions were not reported. On 27-JAN-2015, the patients were vaccinated with a dose of VARIVAX (Merck) (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that had been improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
FEELING OF FATGUE, HEADACHES, BODYACHES, CHILLS, CELLULITIS TO AREA VACCINE WAS GIVEN IN.
Extreme itching around shot site; swelling, moderate-not huge around shot site; Redness around the shot site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site). In January 2021, PAIN IN EXTREMITY (Sore arm) was resolving. At the time of the report, VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No new information was updated.
Pt got redness and hardening areas around the injection site for 2 weeks. (It was about 2 inches radius).
Information has been received concerning a 3 year-old female patient who was vaccinated with a dose of varicella virus vaccine live (it was noted that there was no immunization record however, the patient's mother stated the child was immunized). The patient developed a moderate case of chickenpox. It was also noted that there was an outbreak of chickenpox at a local elementary school. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. It was also reported that three other patients experienced similar reactions (WAES #0305USA00312), (WAES #0304USA00534) and (WAES# 0305USA00535). Additional information has been requested.
pt recv vax & started crying @ 12:#0, mom gave pt APAP -advised mom to come to see MD-tx motrin;
On 11/18/02 patient was administered .5cc DTAP right thigh. Presented in our office on 11/21/02 stating child was seen at urgent care on 11/19/02 for redness, warm to touch, swollen and hard to touch at right thigh were shot was given.
couldn't move; Covid-19(Fatigue and bad headache); This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fall. Concurrent medical conditions included MS, Asthma, Seasonal allergy and Allergy to animal (Pet Allergy). Concomitant products included DULOXETINE, GABAPENTIN, BACLOFEN, MULTIVITAMINS [VITAMINS NOS], VITAMIN D NOS, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)). At the time of the report, MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)) outcome was unknown.            Treatment information was not provided.  Company comment: This is a spontaneous case reported by a patient. A 43-year-old male patient received two doses of mRNA-1273 vaccine with an interval of 35 days between doses and, on an unknown date, experienced non serious events of COVID-19 (AESI) and mobility decreased. Relevant concurrent medical conditions included multiple sclerosis which could be a contributory factor for mobility decreased. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient. A 43-year-old male patient received two doses of mRNA-1273 vaccine with an interval of 35 days between doses and, on an unknown date, experienced non serious events of COVID-19 (AESI) and mobility decreased. Relevant concurrent medical conditions included multiple sclerosis which could be a contributory factor for mobility decreased. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
lightheaded and intermittent dizziness since being vaccinated. worse when bending over or lying down, o changing positions when lying down, ie rolling over
Pain in left arm still persist. Pain is unexplained. It seems like mud is applied and it has dried out. it is kind of annoying pain. Pain keeps moving from lower part of arm (wrist) to shoulder. sometime it hurts then it goes down.
Within minutes, heart pounding, dizzy, metallic taste in mouth. This is same reaction she gets to IV iron.
About 36-40 hours after getting the shot I could feel it breakup and go through my arm. I never experienced any symptoms @ the injection site but  for about 10 days I felt  miserable. I had high fevers severe flu like symptoms  including body aches headaches muscle spasms and occasionally vomiting.
menopausal, started spotting and cramping, now have a mild period or heavy spotting
got the shot and then I got shingles; got shingles; it hurts; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received the Shingles shot and then experienced shingles and stated shingles hurts. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a medical assistant concerning her daughter an 18 year old female with no medical history who received 2 doses of GARDASIL last summer in April 2009 and June 2009. In April 2009, after her initial dose of GARDASIL the patient experienced fainted. The patient was treated in office. The same day of vaccination (in April 2009), the patient recovered from faint. The patient was fine with her second dose. The patient's mother was considering not getting the third dose scheduled on 11-JAN-2010. This is one of several reports received from the same source. No further information is available.
PT HAD APPOINTMENT FOR 1ST DOSE VACCINE AND HAD FILLED OUT THE SCREENING QUESTIONAIRE AND CONSENT FORM FOR PFIZER COVID-19 DOSE #1 INDICATING THAT THEY HAD NOT RECIEVED ANY OTHER VACCINES IN THE LAST 4 WEEKS AND DID NOT INDICATE THAT SHE HAD ALREADY RECIEVED A DOSE OF J & J JANSSEN COVID-19 ON OR ABOUT 04/08/2021 AT PHARMACY.  VACCINE WAS ADMINISTERED AND WHEN BILLED IT WAS NOTICED THAT SHE HAD POTENTIALLY RECIEVED A DIFFERENT COVID-19 VACCINE.  UPON CALLING THE PATIENT SHE ADMITTED SHE HAD PREVIOUSLY BEEN GIVEN J&J AT PHARMACY AND HAD "INDEPENDENTLY AND KNOWINGLY DECIDED UPON HER OWN TO GET THE PFIZER VACCINE ALSO WITH FULL KNOWLEDGE THAT THE J&J VACCINE WAS A ONE TIME DOSE.  PT STATED SHE IS A BIOSTATISTICIAN HANDLING CLINICAL TRIALS AND CLAIMED TO HAVE KNOWLEDGE ABOUT THESE VACCINES.  NO REACTION OR ADVERSE EVENTS TO REPORT AT THIS TIME.  PATIENT ADVISED TO REPORT THIS INCIDENT TO VAERS ALSO AND TO REPORT ANY ADVERSE EVENTS TO US OR PRIMARY DOCTOR.
Chest pain/possible MI Thrombocytopenia GI bleed COVID 19 PNA
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 3:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 3:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was minus 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. Total 280 patients received Moderna COVID 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This Nurse reported for a 74-year-old African American female patient that received PREVNAR 13, via an unspecified route of administration in arm on 17Nov2017 to at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced severe local reaction and a lot of swelling initially on an unknown date. 48 hours later, she had severe muscle pain. Over time, the pain travelled to the shoulder and up to her jaw. Even today (on 06Apr2018) she had limited movement in the arm that the shot was given in. The outcome of the events was unknown. Information about lot/ batch number has been request in follow-up.
Sore and swollen  lymph node in left armpit. Took 10 days to return to normal.
Patient received Tdap on 9/21/07 at approximately 2:40 PM. At approximately 2:50 PM, child complained of dizziness, decrease of vision, nausea, and vomiting. Child appeared very pale and had a B/P of 82/58, P 60, R 18. After five minutes, B/P was 90/60. EMT was called. Child stated he did feel better. Mother took child to E.R. Was told by E.R. doctor child may have had reaction.
headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 (at the age of 59-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of the Pfizer Covid-19 vaccine on 11Aug2021 (reported as yesterday) and within 2 hours developed a headache on 11Aug2021 (reported as within 2 hours). Outcome of the event was unknown.  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-202101042163 same reporter and drug, similar event, different patient
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site inflammation and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site inflammation and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site inflammation and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced extensive swelling of vaccinated limb, inflammation, swelling and redness at the injection site, and these symptoms were large and almost down to her elbow. No further information was provided.