chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palpitations; nausea; pain in the injection arm; lack of air; colics; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), PALPITATIONS (palpitations), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma, Menopause and Diabetic. Concurrent medical conditions included Blood pressure management. Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm). On an unknown date, the patient experienced PALPITATIONS (palpitations). At the time of the report, DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), PALPITATIONS (palpitations), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm) outcome was unknown.            No treatment medications were reported.
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 14-JAN-2022, after a temperature excursion, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX), lot # U022321, expiry date 15-JUL-2023, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of -14.1 degrees Celsius for 12 minutes. There was no previous temperature excursion reported. No additional adverse event was reported.
rash from "head to toe" upon waking up on Wed. Received shot Mon. Patient went to urgent care and was prescribed Benadryl and Zyrtec.
For 2 days patient complained of a headache.  She was found to have had a systolic BP in the low 200s upon admission. Patient was found to have an IPH within the cerebellar vermis with no cause found during cerebral angio procedure.
This spontaneous prospective pregnancy report as received from a female consumer of unknown demographics refers to herself. Patient medical history and current condition was not reported. Patient reported that she was pregnant and on an unknown date during a recent visit to her physician's office, she was vaccinated with GARDASIL (strength, dose and frequency not reported). Due date, pregnancy outcome date and Gestational age at pregnancy outcome were not reported. Other co-suspects and concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from two medical assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted following vaccination. Was unconscious briefly. Upon awakening was pale and nauseous. Was given a chair, water, and juice. EMS arrived to evaluate. Took blood glucose levels which were normal. EMS determined that fainting spell happened too quickly following immunization to be an allergic reaction and that he did not need any further treatment.
01/31/22 presents to Orthopedic Surgery for "Left revision RTSA". PMHx of "Chronic renal failure, Diabetes mellitus, type II, Hypertension, Limitation of joint movement"
Burning pain in mid to upper chest and into throat. Breathing is compromised however, pulse /ox readings are usually upper 90's.  24hr. headaches varying in intensity. Dizziness and fatigue. Unable to drive sometimes.
Redness and induration of right deltoid area and upper arm plus low grade fever. Now with less induration and no fever but slightly increased redness.
I STARTED TO HAVE IRREGULAR HEART BEATS, 4, 5 OR MORE TIMES A DAY.  I HAVE NEVER HAD THAT BEFORE. THE IRREGULAR HEART BEATS COME, STAY FOR A WHILE AND THEY GO UNTIL THEY COME BACK HOURS LATER I EVEN WENT TO MY CARDIOLOGIST TO CHECK FOR THIS 2 OR 3 DAYS AFTER THE VACCINE AND HE TOLD ME AFTER A EKG THAT MY HEART WAS FIND AND PROBABLY WILL BE THE EFFECT OF THE VACCINE
Shortly after receiving 1st of 3 shots, started experiencing sharp pain in right knee. After receiving 2nd shot, joint pain spread rapidly to left knee, feet, hands, left elbow and both hips. I have also experienced a constant burning and tingling sensation in both knees. Symptoms have been worsening over the past year and a half. I have lost considerable time from work and my personal life has been dramatically affected. I had no prior history of arthritis or any joint pain prior to receiving the Lymerix vaccine. Drugs that I have been treated with include Vioxx, indomethacin, Cortizone shot, hydroxychloroquine and prednisone thus far. None of these drugs, with exception of prednisone, have done much for the pain, discomfort and loss of mobility. I am currently seeking treatment for relief from the affects of the vaccine with several doctors. Report 2001005977-1 described arthrilgia in a 37-year-old male who received LYMERIX. Concurrent medical conditions included prostatitis (1995) and gastroesophageal reflux disease. A diagnosis of hypertention was made sometime in the year 2000. The patient did not have gout, psoriasis, Crohn's disease, or Lyme disease. There was no family history of rhematoid arthritis, lupus erythematosus, or other rheumatological disorders. There was no illness at the time of immunization. There were no concurrent medications. The paitent received his first injection of LYMERIX on 10 May 1999 at his place of employment. On 16 June 1999, he experienced arthralgia of the fingers, the toes, and both knees. The paitent received his second injection of LYMERIX on 17 June 1999. The patient was seen by a rheumatologist, an orthodedist, and an infectious disease specialist. No evidence of arthritis was found. He was treated with 10 to 15 mg of PREDNISONE daily, beginning on an uspecified day in June 2000. At the time the reporting physician examined the patient, the patient was taking PREDNISONE. No overt joint swelling, erythema, or warmth was observed by the reporting physician, No joint fluid was obtained. On 20 February 2001, RF, ESR, and CRP were nomral. Rapid plasmin reagin, antistreptolysin O titer, Lyme serlolgy, and Lyme Western blot were negative. Antinuclear antibody titer was positve at 1:80. The LYMERIX administration immunization series was stopped. The most recent information was received from the infectious desease specialist on 16 April 2001. This physician considered the arthralgia to be moderate in intesity and possibly related to LYMERIX administration. The arthralgia presisted as of 13 March 2001. As of 28 March 2001, the patient's serlogies have continued to remain negative. The adverse event of arthralgia does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Pt began feeling BLE heaviness. Pt reports similar symptoms after first vaccine, which did not improve before d/c to home, so EMS was called to transport pt to ER for further evaluation. Pt brought to med obs #1 via personal wheelchair with spouse and staff. Pt ambulated with staff and reports symptoms aren't as bas as with first dose. Pt monitored and ambulated multiple times prior to d/c to home. Pt reports no worsening symptoms. Gait is slow and steady with SBA, which is baseline per pt and pt spouse report. Pt states she would like to go home and will seek further treatment should symptoms worsen. No s/s of distress noted at time of d/c to home. VSS. Escorted to exit via wheelchair by staff with spouse. VS are as follows: 1605: BP 145/75, HR 88, RR 17, O2 sat 98% on RA 1620: BP 134/75, HR 86, RR 17, O2 sat 97% on RA
Vision issue returned after getting 1st vaccine; Rash all over; Flu-like symptoms; Flushed, cold flushes; Red hot rash developed on upper body and up; Husband is bald and the veins on his head were popping up; Had hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up) and VEIN DISORDER (Husband is bald and the veins on his head were popping up) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Temporary vision loss and Eye disorder (History of an eye issue where the fluid builds up in back of retina and results in vision loss).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up) and HOT FLUSH (Had hot flashes). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine) and RASH (Rash all over). At the time of the report, VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up), HOT FLUSH (Had hot flashes) and RASH (Rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. It was reported that vision issue returned after getting 1st vaccine. As per reporter, the vision issue is caused by blood pressure spikes but the patient's blood pressure was never checked. Side effects are ongoing. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021 , contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for Covid-19 immunisation. The patient's family history included: "Rheumatoid arthritis", start date: 10Oct1998 (ongoing), notes: Mother had RA. The patient's concomitant medications were not reported. The following information was reported: HERNIA (medically significant), outcome "unknown"; PANCREATIC CYST (non-serious), outcome "unknown", described as "cyst in pancreatic duct"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "little tiredness". The patient underwent the following laboratory tests and procedures: Diagnostic aspiration: (13Sep2021) for cyst in pancreatic duct; SARS-CoV-2 test: (10Sep2021) negative; (22Oct2021) negative; (06Feb2022) negative. Therapeutic measures were taken as a result of hernia. Clinical course: Vaccination facility type was other and did not administer at Military Facility. The patient did not receive prior vaccinations (within 4 weeks) and did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient had Laparoscopic hernia surgery on 25Oct2021. After speaking with patient's rheumatologist, patient stopped taking methotrexate the week of his Covid booster shot and the week after. The patient has not had an adverse reaction to any Covid-19 shot other than a sore arm and a little tiredness after the 2nd shot. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Began to experience wheezing and coughing and nasal drainage with clear phlegm. Necessitated me to use Proventil rescue inhaler 2-3 times a day whereas previously had used inhaler 2-3 times a year. Also on Day 10 post had 6 inch long red rash on right thigh site of injection.
Mother reported that on the following day, child was unable to walk, left leg was swollen and had a slight bruise. No fever. Instead of walking, he refused to stand and cried when leg was touched by mother. Mother reports that pt was seen in ER. Child was walking, running and completely recovered. MD at the hospital informed mother that it was a vaccine reaction.
About 10 minutes after receiving the vaccine, I felt dizzy.  Four hours later, I started having a dry cough and my throat was itching.  When I woke up on the morning of 1/26/10, my face was swollen including my eyes, which were swollen half shut and red.  My chest was hurting and I had a terrible headache.
Initial report received from a health care professional on 22 September 2014. A 78-years-old female patient had received a yearly intramuscular injection of FLUZONE HD (batch number U5003AA) in the left deltoid on 02 September 2014. She had previously received yearly flu shots. She had a history of long term health issues. She denied any specific illness at the time of vaccination. She was allergic to iodine, and she was taking PLAVIX as concomitant medication. On 03 September 2014, about 24 hours after she received the FLUZONE HD vaccination, she developed severe left shoulder pain, numbness in the right arm radiating to her jaw, generalized weakness and profuse sweating. She was evaluated by her cardiologist who had her admitted to the hospital based on her symptoms to rule out heart attack and stroke. She was hospitalized for 1 week. Date of admission and of discharge were unknown. Official diagnosis was unknown from reporter. The symptoms resolved on an unspecified date and patient had no lingering effects. Patient's outcome was recovered. Documents held by sender: none.
Patient experienced HA on way home from receiviong vaccine.  HA persisted on 4-23-21 throughout morning and into early afternoon.  Patient became catatonic at home, family called 911 and pateint was rushed to hospital via ambulance in hypertensive crisis and seizure activity.   Patient diagnosed with brain bleeds in two sepearte areas of brain.  Original commentary by neurosurgeon was this was unrelated to Moderna vaccine, current neurologist thinks it could have been related.  Patient was in hospital for several days then released on 4-28-21.  Patient is healing, going to therapy and compliant with all neurology follow ups.  Patient still not released to return to work or to driving as of 5-26-21.
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ,patient received 2nd vaccine today, during observation patient complained of feeling light-headed, sweaty , and hot, his skin felt cool to touch and he was pale in color, patient transferred to wheelchair onto stretcher, Vitals taken at 445p, BP-98/58 ,P-54, O2- 98. T- 98.6, R- 16, patient given water and he is drinking currently, at 449p VS rechecked, BP - 131/96, P- 82, O2- 94, R- 20, T- 97.7, 5pm BP- 133/94, P- 81, R- 20, O2- 97%, T- 97.8, 515p, BP- 128/ 94, P- 77, R- 19, T- 98.2, O2- 98% patient reports feeling better and continues in observation. He was discharged   without incident. He was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
sore, stiff injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore, stiff injection arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore, stiff injection arm). On 10-Mar-2021, PAIN IN EXTREMITY (sore, stiff injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Had redness around site the day after injection. Started fever also. Next day it got really red with edema going down arm. Fever continued. He was sent into ER on 3/21/15 and started on Keflex 500mg.
Macular rash on 18th with papules on top of macules (macular-papular). Rash on chest, back, neck, spreading to vaginal area. Parent not certain if pruritic rash.
I have an IUD for birth control.  I do not get my period anymore and have not since 10/2020.  A week after the vaccine I got my period but it was a change in the normal bleeding I am use to and has continued  longer.  I still have mild bleeding and cramping started today.
CHILD BROUGHT TO OFFICE AM ON 3/12/07 HARD STOOLS,FUSSY & CRYING DIAPER WITH BLOOD IN STOOL BROUGHT BACK TO OFFICE IN PM 2 DIAPERS BLOOD STAINED DIAPER TESTED POSITIVE FOR BLOOD INTUSSUSUPTION-COULD NOT BE REDUCED BY ENEMA WAS SURGICALLY REDUCED BOWEL VIABLE  4/13/07 Received medical records from hospital which reveal patient experienced bloody stools, vomiting, lethargy & fever.  Transferred from outlying hospital for higher level of care 3/12/07-3/17/07. Given IVF & antibiotics & taken to OR for exp lap & reduction of IS & appendectomy.  Progressed well & d/c to home on 3/17/07. No D/C summary available. FINAL DX: Ileocecal intussusception, surgically reduced.
I received the shot the Friday afternoon.  On that Monday (the 3rd day after the 2nd shot) I noticed small bumps on my right forearm.  By Wednesday the 2nd of June the bumps presented as Shingles.  It is now June 8th and I have Five Small clusters of Shingles on my right forearm, and they are now at the oozing fluid stage.  Previously I have had 3 Shingles outbreaks on the chest and abdominal area since age 32.  There are no clusters on the chest or abdominal area this time.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 11:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: turned positive again 4 days after negative Covid test; (2022) Positive, notes: turned positive again 4 days after negative Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had taken Paxlovid from 12Jul2022 to 16Jul2022 for Treatment of COVID-19. The patient did not receive any other medications in 2 weeks. There were no known allergies.
Rash covering all of back Arm pain severe  Fever of 100.8 for 24 hours Body pain severe
After receiving the vaccine I had some left arm soreness. The pain increased throughout the day. About 12 hours after receiving the vaccine the pain in my left arm became severe. I experienced nausea, fever of 100, body aches, chills, headache, diarrhea, chest pain, and left hand numbness throughout the night and into the day following
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms  On 1/6 eve, approximately 10 pm,  noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
Vaccine stored in refrigerator on 10/26/2021, expired product 10/13/2021, administered date on 10/28/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/2021, expired product 10/13/2021, administered date on 10/28/2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/2021, expired product 10/13/2021, administered date on 10/28/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/2021, expired product 10/13/2021, administered date on 10/28/2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 26-Oct-2021. There was no temperature excursion. No other events were reported for patient. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. No Treatment information was reported.
Thyroid issue; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation; Bnt162b2 (dose 2, single), for COVID-19 immunisation. The following information was reported: THYROID DISORDER (non-serious), outcome "unknown", described as "Thyroid issue". Additional information: The patient reported that she got Pfizer COVID vaccines including the booster but not the 4th one. She didn't get the 4th because of a thyroid issue. She has not had COVID. All the COVID she's had are all Pfizer and she didn't have bad reactions to them.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.