chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bone pain thru out the body/pain so bad inability to move without tears; chills; headache; spine pain; nausea; vomiting; diarrhea; bone pain thru out the body/pain so bad inability to move without tears; This is a spontaneous report from a contactable nurse (patient herself). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL3249), via intramuscularly, administered in Arm Left on 26Jan2021 at 08:15 (at the age of 44-years-old) as single dose for covid-19 immunisation at hospital. Medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: 5k9231) via intramuscularly, administered in Arm Left on 04Jan2021 at 08:30 as single dose for covid-19 immunisation. On 26Jan2021 at 07:00 PM, the patient experienced bone pain thru out the body/pain so bad inability to move without tears, chills, headache and spine pain, nausea vomiting and diarrhea. Patient was not received any treatment for the events. At the time of report, patient was recovering from the events.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Beginning the next morning, I had fever, chills, fatigue and muscle aches. These continued for the next 3 days. I was not able to do my normal activities during this time and medicines like ibuprofen did little to ease the pain or reduce my fever. My fever was just about one degree during this time. On the second day, a redness arose around the injection site spreading out and down the size of a tennis ball. The site was also painful. The other symptoms were gone after 3 days though the redness and slight pain at the injection site remains.
Frozen shoulder 12/2015. Bursitis 12/2015. 12/21/15 Adverse effect of vaccines and Biological substances. Physical therapy 1/2016. Adhesive capsulitis 12/21/15.
Pt developed hives the day following vaccines. Benadryl was given and hives resolved.
I?ve been an active runner and swimmer my whole life.  I was  sick for 4-5 days after the second vaccine, and the same after the third, which is referenced above.  However, after third, I experienced significant sharp increases in my heart rate (around 175)  and loss of breath after just a couple of minutes of running.  This has been the case since the vaccine 8 months ago.   Normally I could run 30-40 minutes with no issues.  Swimming, usually an hour with no issues, now my heart rate takes off when I swim.
pt recv vax & 3 days post vax & exp a fever which lasted approx 3wk;pt has been dx w/mononucleosis;sx cont;
Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Doctor diagnosed her with leg clot.
minor fever; aches; breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (minor fever), MYALGIA (aches) and BREAST FEEDING (breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-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 PYREXIA (minor fever), MYALGIA (aches) and BREAST FEEDING (breastfeeding). At the time of the report, PYREXIA (minor fever), MYALGIA (aches) and BREAST FEEDING (breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter    This case was linked to US-MODERNATX, INC.-MOD-2021-089594 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089594:case for daughter
Fever (38.2 C); malaise; lethargy; muscle ache; sore arm; This is a spontaneous report from a contactable physician (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3240) via an unspecified route of administration, administered in right arm on 19Jan2021 10:30 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK5730) via unspecified route of administration, administered in right arm on 29Dec2020 08:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever (38.2 c), malaise, lethargy, muscle ache and sore arm. The patient underwent lab test which included body temperature 38.2c on 20Feb2021. The outcome of the events was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# reported as K010211, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. Lot# K010211 is an invalid lot number for MMR II, however is valid for (Oka-Merck) PROQUAD. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Pt recieved his second dose of Pfizer vaccine at 1120am stated at 1130am that he felt like is throat was feeling itchy and swollen also stated he has a history of severe anxiety then further stated it may not be swollen but i just feel like its very itchy.  Nurse evaluated the patient noted O2 sats of 97% pulse was 80 no visible signs of distress were noted on the patient. nurse was noting signs of anxiety  with figiting and constant movement to the patients limbs. Benadryl 25mg liquid was administered PO patient was able to swallow the medication without any visible difficulties.  Nurse frequently checked on patient with no changes at 1208pm patient stated he was feeling better. Nurse released the patient from high observation area with mother driving and patient in the passenger seat.
Chills, general muscle aches and fatigue. These occurred on the day after the vaccination in the early afternoon and continued through bedtime. The next morning they were generally all gone.
cried for 2 days;t100.2-101- 13MAR96; vomiting-loose stools, tender leg
Tiredness started on 4/8/21 at approximately 2:00 pm.  Chills and body aches started on 4/8/21 at approximately 5:00 pm. Swelling and soreness of the lymph nodes in the right armpit started during the night of 4/8/21.  It is currently 1:55 pm on 4/11/21, at this reporting. The lymph nodes are still swollen and sore.  All other side effects were gone as of 4:00 pm on 4/9/21.  I have been taking Ibuprofen regularly for the pain and swelling.  Swelling has gone down slightly.
Patient inadvertently received his third booster dose earlier than the 6 months recommended interval for booster. He is supposed to be due for his booster on 11/23/2021 but received the booster on 10/29/2021. No adverse reactions were observed since vaccination.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 15-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent temperature excursion of 34-49 degrees Fahrenheit for 302 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA012766.
After the vaccine I had pain in my arm and legs; I had 2 bruises in my leg I was concerned I called my doctor and he said to do ultrasound for a possible blood clot, but I was fine, no clots. A month later, I had a runny nose, coughing and I tested myself at home at I was Positive, and I went to a center and took the test again and it was Positive. The center gave me an antivirus, but I had reaction and stop taking it.
no detectable titer;had series in JUL94;sample done @ KSU on 23NOV94;will take booster dose ID
joint pain travels from foot to knee to shoulder last for a day; inject site swellen , hardend and redness and pain for 8 days
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 95-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  No adverse reactions were reported by patient.
COVID+ 12/14/22.  Vaccination Status - Moderna x2 + Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/14/2022 Discharge Date: Dec 16, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? COVID-19 12/15/2022 Unknown ? C. difficile colitis 12/15/2022 Unknown ? Unspecified severe protein-calorie malnutrition  10/03/2022 Yes ? History of deep venous thrombosis (DVT) of distal vein of left lower extremity 09/05/2022 Yes ? Bilateral pulmonary infiltrates on chest imaging 03/29/2021 Yes ? Mild persistent asthma without complication    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Sepsis [A41.9] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present  [A41.9] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Pt. is a 62 y.o. female with a complicated medical history including cirrhosis, hypothyroidism, hypertension, alpha-1 antitrypsin deficiency. She was recently admitted 11/03 to 12/02/2022 during which time she was found to have respiratory failure, hypotension, pneumonia as well as bacteremia with Klebsiella and Morganella.  She completed a course of cefepime and metronidazole during that admission and was discharged on prednisone.  She went to subacute rehab and was recently discharged from SAR. Pt. now presented back to the ED with generalized weakness, SOB, and diarrhea. She was now found to have COVID and readmitted to the hospital. Pulm was consulted and felt her symptoms were likely related her recent bacterial pneumonia and not COVID as she was sating well on her baseline 2L supplemental O2. Recommended continue home prednisone taper. Due to her new onset diarrhea and recent abx use c-diff studies were obtained and found to be positive. She was started on oral vanco and her diarrhea quickly improved. PT/OT recommended to continue with her previously arranged home PT. She will follow up with her PCP and pulm outpatient. Patient is discharging in improved and stable condition.
On March 24, 20211 began to feel a numbness in the right side of my face. The next morning, March  25th, I woke to find that my face had dropped and was completely numb. I immediately went to the  Dr.s office and was only able to see a PA. My Primary Physician ordered a brain CT to rule  out a stroke. The PA prescribed Prednisone and Valacyclovir. It took 3 weeks for my face return to  normal but I can still feel a little bit of numbness in my right cheek.  My brain CT was negative for a stroke so it was determined that the Bell's Palsy was a result of a  negative reaction to the Covid shot.
Case number PHEH2014US010044 is an initial spontaneous report received from a pharmacist on 14 May 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On 12 May 2014, the patient was vaccinated with an expired dose of MENVEO (batch number: M11081, expiry date: 30 Apr 2014) intramuscularly. No adverse event was reported following this administration error.
Patient was administered an expired vaccine.  Vaccine expired on 3/5/2022 after 30 days at refrigerated temperature.  Vaccine was administered on 3/7/2022.  Patient informed of event and need to receive a repeat dose.
1-27-21 pt had a fever and arm was swollen and red. The pain was located right at injection site and it was only present feeling on the muscle. Red oval shape around injection and muscle is about the size of female palm. patient took 2 tylenols on 1-27-21 and helped with fever but pain is still there. recommended ice compress.
I am the epidemiologist reporting on behalf of 77 year-old female patient. Patient was a resident of a facility for approximately two years prior to death.  Patient received three doses of the Pfizer vaccine. The first was on 1/03/2021, the second was on 1/24/21 and the third was on 9/30/2021, according to immunization records.  The patient passed away on 9/30/2021 (the same day the third dose was received) in nursing facility. The death certificate lists ?Cerebral Arteriosclerosis (1 year)? as the immediate cause of death. Prior medical information (obtained from facility) includes: 2019-Time of Death: Hypertension, Wernicke?s encephalopathy 2020- Time of Death: Liver cirrhosis, history of TIAs, unspecified chronic kidney disease (stage 3),  2021- Time of Death: Hyperlipidemia The patient was prescribed amlodipine (heart medicine) and Lipitor.
Patient has severe pain, swelling, redness on left arm from shoulder to elbow. Redness on arm, chest and neck. Patient was given Rx for KEFLEX 500mg TID x 10 days.
Arm hurt; chills; Fatigue; Headache; joint pain; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, CHILLS, FATIGUE, HEADACHE, and ARTHRALGIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST, ALLEGRA, and LABETALOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, CHILLS, FATIGUE, HEADACHE, ARTHRALGIA, and FEELING HOT. At the time of the report, PAIN IN EXTREMITY, CHILLS, FATIGUE, HEADACHE, ARTHRALGIA, and FEELING HOT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included inhaler for asthma. No treatment details reported.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.  Number of doses/vials: 63 doses, 3-4 vials. Date the vial was initially stored in the refrigerator- 01-DEC-2021. No temperature excursions.
About 10 days p/vax arms & legs became sore & felt swollen; limbs were sore to touch & arms were difficult to move; pt said skin felt like it would break it touched; sx caused emotional distress;
Bronchitis; Sinusitis; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In June 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) and SINUSITIS (Sinusitis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BRONCHITIS (Bronchitis) and SINUSITIS (Sinusitis) outcome was unknown.            Company comment: This is a spontaneous case concerning a 54-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the non-serious unexpected AESI Rheumatoid arthritis, that occurred on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623756.; Sender's Comments: Company comment: This is a spontaneous case concerning a 54-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the non-serious unexpected AESI Rheumatoid arthritis, that occurred on the same month after the first dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.