chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain; hives all over the both legs; swelling lymph nodes; going down itchiness all over legs both side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B212A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHEST PAIN (chest pain), URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side). On 29-Mar-2021, URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side) had resolved. At the time of the report, CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On 27 Mar 2021 at 1:00 pm the patient received first dose of Moderna vaccine. On 28 Mar 2021 at 3:00am the patient experienced hives all over the both legs, swelling lymph nodes, going down itchiness all over legs both side and at 10:00 am the patient experienced chest pain and also visited Physician. The Physician asked the patient to monitor this pain for two days because pain did not go away. The patient noticed that it was recently recovered from COVID. On 21 Mar 2021 the patient had already finished the quarantine.  Treatment for the events include Claritin   Reporter did not allow further contact
Hive reaction at site of MMRV-Benadryl 12.5mg tsp
Pt received vaccine on 1/31/00, on 2/1/00 she developed an injection site reaction characterized by redness, swelling.
Severe body aches, high fever upto 103 degree, chills, joint pain, dizziness
Thursday evening started to get nausea, had chills , whole body was shaking for 30 minutes and vomited, 100 degree temp.  Friday morning felt fine and normal body temperature.  Friday evening fever returned and had chills.  Sat morning normal body temperature but still not feeling back to normal.  Saturday evening feeling normal again
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My brother took 3 out of the 6 shots and had to quit. Almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years. Unfortunately, for my mom and me, we lost him in June of 2003, unexpectedly having a grand mal seizure.
some of the vaccine leaked out and syringe part; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (some of the vaccine leaked out and syringe part) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some of the vaccine leaked out and syringe part). At the time of the report, UNDERDOSE (some of the vaccine leaked out and syringe part) had resolved. 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 medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021, contains No New information
ONSET SEVERE MUSCLE STIFFNESS, ACHING, MYALGIAS, LOW GRADE FEVER ON 6/07/08.
Erythema nodosum; 1-2 red spots at his ankle which made it painful to walk/Red bumps on his legs; 1-2 red spots at his ankle which made it painful to walk; Swelling in his foot; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration on 30Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included erythema nodosum from an unknown date and unknown if ongoing Since age 13, recurring every few years he has a occasionally reoccurring autoimmune issue since he was a teenager. The patient's concomitant medications were not reported. On 2021, the patient experienced erythema nodosum, 1-2 red spots at his ankle which made it painful to walk/red bumps on his legs, 1-2 red spots at his ankle which made it painful to walk, swelling in his foot. Therapeutic measures were taken as a result of erythema nodosum (erythema nodosum), 1-2 red spots at his ankle which made it painful to walk/red bumps on his legs (erythema), 1-2 red spots at his ankle which made it painful to walk (gait disturbance), swelling in his foot (peripheral swelling). Description of Product Complaint: Description of complaint: The caller is a consumer that was calling about the Covid-19 vaccine and reported that he had first dose 3 weeks ago on 30Jan2021. He is scheduled for the second shot on 21Feb2021. The patient said that he had occasionally reoccurring autoimmune issue since he was a teenager. The patient is currently 69 and said that it is called Erythema Nodosum and it causes red bumps on his legs. The patient reported that he started getting a occurrence of it and was put on Prednisone tapering dose that was started at 40mg tapering to 10mg. The patient was off of that now for 4-5 days. The patient said that it is unusual, but has happened once before, that when he was started at a lower dose like the 40mg dose, it would not work to get rid of the issue. The patient said that doctors used to start on a high dose like 60mg then taper down over 10 days. The patient said that he finished taking his first tapered regimen and had to be put back on another tapered regimen because the lower tapered dose did not work. The patient said he was put back on a higher dose of 60mg for 3 days, 40mg for 3 days, then 20mg for 3 days then done. He said that he will complete the treatment 3 days after he gets the Covid shot. The patient said that he will had been on Prednisone intermittently for 2 weeks. The patient had a opportunity to reschedule his appointment to Wednesday the 24Feb2021 to get his 2nd injection. The patient said that it would put him at the end of his course of treatment. The patient said that Prednisone not work at the lower dose in the past. It works better with the high dose of treatment over the course of 9-10 days. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
muscle soreness; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle soreness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient c/o fever, chills, hyperventilating within a few hours of injection which lasted a few days.
about a week after getting my second dose, i broke out in hives, across my abdomen and both thighs, along with my back. they were red swollen and extremely itchy. several of them also joined together to make one huge hive. at first i thought i'd been bitten by something and go freaked about that many bites all at once, but after looking at pictures of bug bites (ugh) i concluded that they were hives and behaved the way mosquito bites do on me. they went away after a shower on the 2nd but reappeared on the 3rd early in the morning, even more widespread and itchy. i took an antihistamine and they went away. i took another dose later in the day when it seemed like it might be starting again. they've been gone since then even without taking more antihisamines.
Tingling in right arm and hand a few minutes after getting the vaccine. Sat and rested for 15 minutes, evaluated by paramedic and RN and then was given a ride home. Patient reported the tingling did not get any worse and stayed about the same.
A physician reported that a child, over the age of one, received Prevnar and developed a fever. The reporter indicated that other children experienced a fever following receipt of Prevnar; however, he did not provide the number of pts. Additional reports will be generated when identifying information is provided.
THE PATIENT RECIEVED AN UNDILTED DOSE OF COVID 19 PFIZER PEDAITRIC AGE5-11 PATIENT GOT A HEADACHE   AND WASN'T FEELING WELL AFTER ADMINISTRATION OF VACCINE. TOLD PATIENT'S MOM THAT SHE COULD GIVE TYLENOL AND TO SEEK FURTHER MEDICAL TREATMENT IF NEEDED.  MOM TOOK PATIENT TO EMERGENCY ROOM  TO BE CHECKED OUT. TREATMENT WAS NOT DISCLOSED. AS FOR OUTCOMES  , MOM ONLY SAID HE'S BEING TAKEN CARE OF  AND IS UNDER OBSERVATION AND WOULD NOT ELABORATE.
After receiving the Moderna covid omicron booster shot, my eyes became irritated and I had trouble reading text or other small things, like my computer screen, and cell phone screen.  My eyes felt very tired (as if attempting to read something that is very small in font size) after receiving the booster shot.  My husband informed me that my eyes were extremely dilated and my pupils were responding poorly to changes in light and dark (staying large, and not shrinking when bright light was shown to my eyes).  My eyes stayed that way for about 12 or so hours after receiving the vaccine booster.  By the next morning (Saturday 10/1/2022) my eyes were responding normally to low and bright lights.
Death due to Complications of Parkinson's disease OSC: COVID-19 (12/21/2020 lab specimen collection date).
Note:  many of these symptoms I had after contracting covid-19 on March 25, 2021, as long haul symptoms.  These started to greatly improve by September-October 2021, so prior to the booster shot I was feeling 85-90% better.   After the booster on 12/17/21, I felt like I was set back by 5-6 months of my recovery with the following symptoms: mild flu-like, achy, sensitive skin, mild headaches, mild feeling of foreign object in eyes, muscle twitching and tingling,  muscle tension, allergy attack on first night with coughing and much mucus,  day 2 intense, intermittent stomach cramps, diarrhea,  eye strain,  some dizziness,  altered sense of smell, burning sensation in lungs while breathing at times,  post concussion like symptoms of temple pressure, ear pressure,  also overall body aches and pins and needles feeling at times.  some of these muscle and nerve, chest pressure, headache symptoms are worse at night, especially while lying down or pressure on my spine.
ED visit for suicidal ideation. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine.
Felt nauseous and dizzy after receiving vaccine (IM) Hx of fainting after immunizations.
24 hours, post vax, pt had a scratch throat, fatigue, aches, uneasy feeling and a cough. Symptoms got worse for 4 days, but then pt began to recover. Pt took Tylenol.
Client was given 3rd dose of Hep B vaccine, Heplisav-b, too early. First dose given 5/3/2023 (EngerixB), second dose given 6/7/2023 (Engerix B), and 3rd dose (Heplisav-b) given 7/5/2023. Third dose showing not valid as given too early, and needs to be repeated on 10/18/2023 or later. Client notified and scheduled final dose.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient seen his/her ex mother-in-law suffer bad with shingles.  The patient went and got a shingles shot, it made his/her arm sore for a week, so patient did not get any more shots. Additional supportive information: The follow up would not possible as no contact details were available.
Patient is on our inpatient service, currently on hospital day 13, admitted with 7 week history of limbic encephalopathy of unknown etiology.  Symptoms inlcude 7 week history of episodes of palpitations and an olfactory aura, often followed by headache.  Clinically, she demonstrates severe impairment in ability to form new long-term memories. 8/21/08-records received for DOS 6/19-7/2/08-DC DX: Limbic encephalopathy of unknown etiology. Presented with tachycardia and or pallor in setting of memory dysfunction. C/O episodes of fatigue, tachycardia associated with intermittent and occasional shortness of breath, pallor and dazed expression, nausea. Memory changes. On 5/12 presented to ED and diagnosed with questionable supraventricular tachycardia.  Seen by neurologist for headaches. Personality changes increased laughter and hyperphasia and weight gain. Treated with IVIG. 1/25/2010 Persisted, severe cognitive impairments particulary memory. Unable to return to regular school.  Personality change as well. Follow-up Information 15-OCT-2008: 1st doses HPV 1-28-08. 2nd doses HPV 3-25-08. 3rd doses Pt was hospitalized was not administered.
Numbness in left cheek, jaw and neck (described feeling similar to having novocaine for a dental procedure)  Monitored for any changes in condition or if swelling or difficulty breathing developed
Feeling tired; t's hard to breath; Get's agitated a lot; Back pain when she lays down; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included PREGABALIN, LEVOTHYROXINE SODIUM (EUTHYROX), ASCORBIC ACID (VIT C), ZINC and FISH OIL for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down). At the time of the report, FATIGUE (Feeling tired), DYSPNOEA (t's hard to breath), AGITATION (Get's agitated a lot) and BACK PAIN (Back pain when she lays down) outcome was unknown.        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.
This spontaneous report was received from a physician referring to a 1 year old patient of unknown gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 10-JAN-2019, the  patient was inadvertently administered a dose of PROQUAD, subcutaneous, lot # R011802 and expiration date 21-OCT-2019 (dosage schedule, and anatomical location were not reported) instead of an intended dose of M-M-R II (wrong vaccine administered), which was administered concomitantly with a dose of VARIVAX subcutaneous, lot # R009411 and expiration date 29-MAR-2019 (dosage schedule, and anatomical location were not reported). Both PROQUAD, and VARIVAX doses were reconstituted with the same lot of sterile diluent lot R001088, expiration date 16-SEP-2020 (dosage schedule, and anatomical location were not reported). The physician reported the error occurred because the nurse mistook PROQUAD for M-M-R II, because the vials are similar in color (product appearance confusion) and she did not notice that the PROQUAD label said "varicella" in addition to "measles/mumps/rubella (product label confusion)." No adverse effect reported.
At about 9 AM on 12/30/2022, I started feeling strange. I felt sort of lightheaded and dizzy. I could hear my heartbeat in my ears and feel it a little bit. I called my doctor's office and spoke to the triage nurse. I used my pulse oximeter, which gave strange readings. The nurse tried give me instructions on how to check my heartrate, but I couldn't find my pulse. She then told me to go to the ER, which I promptly did. At the ER, the nurse measured my heartrate at 176 BPM. I then underwent an EKG. The ER doctor then instructed me to do the Valsalva maneuver, which I did. The first time brought my heartrate down. I then did it a second time, and it brought my heart back into rhythm. I stayed at the ER for about six hours, during which I was monitored. When they did my bloodwork, they found something concerning, so they did a CT scan of my lungs to check for blood clots. When the CT scan was performed, the results were normal. I was referred to a cardiologist, whom I am scheduled to see for the first time in the near future. On 1/12/2023, I saw a PA at a cardiology institute, and he scheduled an echocardiogram and a stress test. After I underwent the echocardiogram on 1/19/2023 and an aortic aneurysm was discovered, the stress test was cancelled. On 1/25/2023, I underwent a simple prostatectomy to treat an enlarged prostate issue I had been dealing with for at least 20 years. After my surgery, I was in the hospital for two days. I stayed at home and recovered for six weeks, and I was instructed to not do any heavy lifting. Ever since then, I have been doing fine and feel well enough to play golf and work out at the gym.
Vaccination site urticaria; Vaccination site hypersensitivity; Joint pain; Welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest; This is a spontaneous report from a contactable consumer. This is a spontaneous report based on information received by Pfizer.  A 45-years-old male patient received second dose of bnt162b2 (TOZINAMERAN, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscularly on 2021 as a single dose for COVID-19 immunization. alimumab (HUMIRA, Formulation: Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to May2021, at unspecified dose for colitis ulcerative. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (TOZINAMERAN, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscularly on 2021 as a single dose for COVID-19 immunisation with no reaction on previous exposure to drug. On an unspecified date in 2021, the patient experienced vaccination site urticaria, vaccination site hypersensitivity, joint pain, welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest. The consumer reported that "Allergic reaction / patient stopped Humira after second Covid vaccine. Due to bad reaction/ next morning had Welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest and joint pain. The outcome of event welts/ where arms touch the desk got hives, that moves up arms/ worse at night/ hives on chest was unknown and rest all events were not recovered.  The reporter's causality for the events of Allergic reaction / patient stopped Humira after second Covid vaccine. Due to bad reaction/ next morning had Welts/ where arms touch the desk got hives. That moves up arms/ worse at night/ hives on chest  onset in 2021, Joint pain was not reported.
For past day - mild rash on lower back. Pt. reports itching and painful with pressure. No blister seen at pharmacy.
Moderna vaccine vials (Lot#:002C21A, expiration 10/14/21) were removed from freezer and delivered from larger healthcare facility within enterprise to our facility with a fridge expiration date of 6/24/21. The fridge expiration date was written on the bag that the vials came in, but not directly on the vials. The nurse administering vaccines on 6/30/21, grabbed a vial from the pharmacy fridge without knowing about or looking at the expiration date on the bag. The nurse then administered 8 doses of the expired vaccine that day.  Pharmacy caught adverse event on 7/9/21 when reporting doses given. Notified Moderna safety team on 7/12/21 who recommended to report to report to VAERS but not to administer additional dose as no studies done on patients receiving more than 2 doses. No further follow-up recommended. No adverse reactions noted.
FLU-LIKE SYMPTOMS; DIZZINESS; ACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms, dizziness, ache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, ache, dizziness and low grade fever was not reported. This report was non-serious.
This case was received from a healthcare professional on 30.Jan.2011 and forwarded by Crucell: This spontaneous report concerns a patient of unspecified age and sex who received VIVOTIF (batch number not reported). The patient took the 4 doses of VIVOTIF on consecutive days, with the last one taken on 29- or 30.Jan.2012. The patient subsequently developed sore throat and stomach cramps. At the time of this report, she  had not yet recovered. The case was considered non-serious. Follow-up information was received from the pharmacist on 14.Feb.2012: The patient was a 20-year-old male with no medical conditions and no known drug allergies. The patient failed to read the product leaflet and took VIVOTIF daily for four days consecutively from 26- to 29.Jan.2012 as typhoid prevention for travel in March 2012. On 30.Jan.2012, the patient complained of sore throat, stomach cramps, fever and "felt immune system weakened". The symptoms resolved on 08.Feb.2012.
This spontaneous report as received from a licensed practical nurse refers to a 11 months old patient. The patient was vaccinated with the first dose of VARIVAX (lot# and route not reported) on 17-NOV-2000 when the patient was 11 months old. On 14-SEP-2006 the patient received a second dose of VARIVAX (lot# and route not reported). No adverse effect reported. Additional information has been requested.