chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and general body pain. On an unknown date, the outcome of the shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: Within 24 hours of vaccination, the patient experienced shivering, fever (body temperature of 102 degree F), and generalized body aches. The patient reported that, she took something for the fever. She said these symptoms lasted for 24 hours and then resolved. The reporter did not consent to follow-up.
I administered the vaccine to the patient with no issues what-so-ever.  The patient's mother indicated that she was very nervous, and the patient did as well.  After administering the vaccine I instructed the patient to sit in the waiting (visible from pharmacy) for 15 minutes.  After several minutes I noticed the patient didn't seem to be feeling well, and I responded.  She was slumping in her chair and beginning to pass out.  I helped her to the floor and told an associate to call 911.  She fainted on the floor and I checked for pulse, which was normal.  Within seconds she regained consciousness, though she looked pale.  I sat with her until the EMS arrived, just a couple minutes later.
Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This report to VAERS provides the following narrative: A report had been received from VAERS (Health Authority) concerning a 45 year old, female patient. Patient's relevant history and concomitant disease were not reported. Patient received FLUMIST (intranasal) on 24-Sep-2009. Patient became symptomatic mid-November with head pain and extremity weakness. Patient was admitted on 20-Nov-2009 and discharged 23-Nov-2009 with a diagnosis of extremity paresthesias and weakness. Patient readmitted on 02-Dec-2009 to 10-Dec-2009 because of persistent lower extremity weakness, numbness, tingling and upper extremity weakness. Patient was diagnosed with Guillain-Barre syndrome. Patient's labs included: CSF: WBC=1, Protein=99, Glucose=64, Culture negative, Thyroid studies high, CSF cell CT and culture normal, CRP and ESR normal, CBC, WBC and platelet high, Hgb and Hct low, CMP, AST and ALT high, Na low, CPK, Troponin and Lipase normal, Hepatitis panel, alpha-1 antitrypsin, ANA negative, Iron studies, TIBC and serum iron low. Action taken with FLUMIST was unknown. The outcome of the event of Guillain Barre syndrome was unknown. The reporter considered the event Guillain Barre syndrome to be serious with seriousness criteria of hospitalization and patient also required emergency room.
rash on hands and some spots above knees no rash at injection site given benadryl 25mg by mouth once monitored and discharged in stable condition
Constant pain in shoulder lingered 4 months. (ranging from the upper arm towards shoulder)  ADMINISTRATION ERROR : Shoulder injury related to vaccine injection. (SIRVA)
7/31--8/3 48-year-old male with past medical history significant for COPD and newly diagnosed right sided adenocarcinoma of the lung.  He presented on 7/31/2022 for complaint of chest pain.  He initially presented to Facility on 7/30 for the same complaint and his EKG revealed ST elevation in leads II, III and aVF as well as V4 through V6.  He was transferred here to Facility for higher level of care.  He was taken to the Cath Lab emergently, but the angiogram revealed normal coronaries.  He was also found to be COVID-positive. This is a new infection as he had a recent negative COVID test on 7/2/2022.  Of note he was recently discharged from Facility after a long hospital stay from 7/6 until 7/19 for an acute SVC syndrome secondary to his lung carcinoma.  At that time he was treated with chemotherapy and a few bouts of radiation with resolution of his symptoms.  Given his COVID-positive status and the recent radiation, his chest pain was considered to be an acute pericarditis.  He was requiring 2 L nasal cannula of oxygen during his stay, thus he was started on Decadron 6 mg daily to treat his COVID as well as treating his pericarditis until discharge. He was also started on Remdesivir 100mg IV once daily on 7/31 and Robitussin by ID for COVID. 7/31 he was no longer needing supplemental oxygen, saturating well on room air. Troponin wnl. CTA PE on 7/31 was negative for PE and 2D echo on 8/1 had no pericardial effusion visualized but was limited as patient could not turn; L ventricle normal size with EF 55% and R ventricle moderately decreased. During admission, WBC was up-trending, and he continued to have unchanged R back and R shoulder pain, some relief with leaning forward. IV morphine for breakthrough pain started on 8/1 was switched to Percocet on 8/2 every 6 hours for longer pain relief. Chest pain improved over the 3 day stay and he regained his appetite and was able to eat full meals starting 8/2. His constipation improved as well and he did not need bowel regiment on 8/2. He continued to have sputum production once a day with relief of SOB after coughing out sputum. He was continued on abluterol and breo during his stay. Hemeonc withheld chemo and radiation in the context of his current COVID + status.  Prior to discharge, cardiology recommended discontinuing Decadron and beginning colchicine 0.6mg daily (weight adjusted) until followup with them in outpatient clinic.  Patient has been saturating well on room air for over 3 days and he is stable for discharge home.
Chills, fever, night sweats, insomnia, nausea, muscle weakness, and muscle pain from 10:00 pm (10/21/2019) until 9:00 am (10/23/2019).
STARTED ITCHING NOT LONG AFTER VACCINE GIVEN.  HIVES  NOTICED ABOUT 4 DAYS AFTER (POSSIBLY SOONER).  RASH MOVED TO BACK, CHEST, SHOULDERS, BOTH ARMS, AND LEGS.  CONTINUES TO HAVE ITCHING AND HIVES.   RECOMMENDED SEEING PCP.
A report was received from a 67 year old female vaccinee on 6/9/04. The vaccinee's past medical history includes atrial fibrillation, for which she is taking Coumadin 5mg alternating with 7.5mg (start date May 2003) and Calan 240mg (start date unknown). On 12/17/03, the vaccinee received one dose of Fluvirin into the left upper arm. About two days later, she developed cold symptoms with fever and sweating that lasted approximately two weeks. Within four to five days of the cold symptoms developing, she also experienced joint pain with inflammation and warmth on her hand. As the pain gradually subsided, soreness appeared at the same site. The vaccinee stated that the cycle of pain and soreness occurred at one particular part of the body at a time (i.e. one arm then the other arm, but not together) and rotated around different parts of the body. The vaccinee took Tylenol for the pain attacks, but this did not have any effect. The attacks stopped at the end of May 2004. The vaccinee stated that recent laboratory test results of an unknown blood test specific for arthritis showed high levels. She will consult a rheumatologist in the near future. The vaccinee stated that she had previously received influenza vaccines for many years without any problem. The vaccinee consulted a physician regarding the events. The physician did not think the events were related to the Fluvirin injection. Follow up received 7/13/04: Report received from a health care professional stating that this 67 year old female received an influenza vaccination (brand not specified) on 12/17/03 into the left deltoid. The vaccinee developed arthritis pain and soreness in the muscles starting on 1/5/04. The event has not resolved. The vaccinee's history includes allergies to Antivert, Zocor, and Baycol. The vaccinee has not been seen by the reporter in the past 3 months. No further information is expected.
Very high blood pressure followed by somewhat lower within same day, continuously going up & down, Dr has doubled the dose on Losarten 2 times. Started with 25 mg now, 100 mg, added Bystolic on 7/28/21, 2 Dr visits so far, another scheduled for 8/31/21 after heart echo test on 8/26/21
started with cold chills and muscle  weakness, chills got very bad by 0230 the next morning (12/16/21) some tightness of chest by 0500 (12/16/21) chills continue to now as does muscle weakness, especially in the thighs. tightness of chest worse too.
p/ pt recv vax 12/96 & in 7/98 pt exp pain in her arm. & when pt cast was remove shingles were found from back of shoulder to tip of lt thumb. she had numerous vesicular type lesions
Redness and swelling over area of shot and 10 days later has 1 cm knot.
Had very many apnea spells directly after shot all day at least 1 sometimes 2 per hour, she had not had any in weeks. (Attending Physician had already spoke to us about going home within in the week, before vaccines. Delayed 2 mths. Of EXTRA time in NICU stay) The night of the shots at  approximately 2:03 am she flat lined and was perceived dead on monitor, complete flat-line. The hospital alarms went off about 20 doctors and nurses rushed into the room and had to give her oxygen and  recessitate her. The following week she could not eat or do anything on her own, she regressed back to tube feeds,  also effected her Digestive tract & doesn't go to the bathroom for days at a time when normally she went 5-6 times a day. The right leg she got the shot in shakes uncontrollably a lot too when it never once did that before.
COVID arm (red, itchy rash on arm near injection site starting 6 days after 2nd dose)
On the morning of the 10th, patient complained that there was something on his arm that itched. Directly beneath the injection site, a bulls eye rash had developed, the central portion of which was approximately 2" in diameter. The outer portion was spreading. He was taken to the doctor and, by 9:30 AM, the rash had clearly spread. By evening, it covered most of his arm from the shoulder to the elbow. He did not complain of intense itching, pain, or stiffness. Administration of Benadryl reduced redness. He was given Benadryl every 4-6 hours. By the next evening, Oct 11, the rash had nearly disappeared. The rash may have appeared before the 10th, but the injection site was not observed prior to the 10th. Pictures of the rash are available if needed.
Pt received  her 2nd Moderna vaccine and 2 minutes later  started experiencing  very hot flashes and face turned completely red. She begin to cry due to pain and anxiety. I quickly gave her one dose of EpiPen 0.3mg and Diphenhydramine 50mg/ml. EMT were called and came to assist. She was taken to hospital.
Patient received PEDIARIX, PEDVAXHIB, PCV-13, ROTARIX ON 12/10/2014 - 1 hour after vaccine had marked irritability and way not consolable over 5-6 hours. Fever noted. ER visit. Swelling around mouth and eyes developed at 1 hour after vaccines and was still present in ER at 5-6 hrs. Fussiness x 48h with fever. Fully recovered.
One minute after getting his vaccination, he felt lightheadedness, and had blurry vision. He was taken to a private section of the arena and monitored.
I have been very sick for 7 days; I have been so dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 4 (booster), single (Batch/Lot number: unknown) for immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Previous immunization series complete, MANUFACTURER UNKNOWN); Covid-19 vaccine (DOSE 3 , MANUFACTURER UNKNOWN); Prevnar 13 (DOSE 1). The following information was reported: MALAISE (non-serious), outcome "recovering", described as "I have been very sick for 7 days"; DIZZINESS (non-serious), outcome "unknown", described as "I have been so dizzy". Additional information- It was reported that A week ago yesterday patient  went to the withheld pharmacist to receive my 4th shot, my second booster and the pharmacist said you can also get your second Prevnar, your pneumonia shot toady. I said really, she said yeah so I said okay and than about a minute later I said I dont think that's a really good idea today I'm just going to get one. He said why wouldn't you get it you haven't had a reaction have you? It wont hurt you. I have ben very sick for 7 days. I am feeling better today. I have been so dizzy because I did get the shot. I got two vaccines in both of my arms last week on Sunday I got my 4th covid shot and that Prevnar, my second." Note: The reporters/patients name was not provided on the phone call The following information was not provided during the call  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Period comes every 23-25 days; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3246) via an unspecified route of administration in the left arm on 21Jan2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 29Jan2021 (after two doses of vaccine), the patient's period was coming every 23 to 25 days, prior to the vaccine the patient had a very regular period that came every 30 days on the dot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19. On an unknown date in 2021, the patient underwent Id now COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event period comes every 23 to 25 days was not resolved at the time of this report.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
pt recv vax & devel swelling @ the site of inj;also exp shakes & shivering;pt self-medicated w/advil & recovered w/in a few hr;this is 1 of 6 reports from this site of inj site rxn p/vax;
Patient was given 4 vaccines. Went to go get up to go to waiting room to wait 20 minutes ->patient fell back up against wall while sitting on exam table and fainted. Patient stayed in room, cool compress on head, blood pressure taken x2, pulsox x2, sent home.
Extreme pain, arm could not be lifted, Nausea and feeling of fainting. Followed by chills and fever. Lasted 17 plus hours.
This case was reported by a physician via patient support programs and described the occurrence of allergic reaction in a adult female patient who received Seasonal Influenza vaccine. The patient's past medical history included alcohol use (4 beers consumed daily). Concurrent medical conditions included ex-smoker, caffeine consumption (coffee 1 cup a day), arthritis, chronic obstructive pulmonary disease and penicillin allergy. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced allergic reaction. On unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Seasonal Influenza vaccine.
Severe stomach cramps; Bad lower back pain; it felt like I was trying to pass a brick through my bowels; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EN6202), dose 1 via an unspecified route of administration in arm left on 03Mar2021 at 16:00 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. Patient medical history included known allergies from penicillin and had COPD, asthma, chronic pain, GERD, all from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. Patient denied for any other vaccine taken in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 18:00, the patient experienced severe stomach cramps, bad lower back pain and patient felt like he was trying to pass a brick through his bowels. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Nausea, fatigue, muscle aches, fever, chills, headache, joint pain
Headache, Myalgia, Arthralgia, redness/numbness in injection arm the day of vaccine Narrative:
I have symptoms of paresthesia. first dose was very mild (only pricking sensations for a few hours the first day and limited to my extremities). Second dose the symptoms are pricking and burning sensations that are more intense and are quite frequent. They also happen almost everywhere on my body and are random in nature. Pfizer 2nd dose is lot # ER8729 given to me on April 15.
Approximately 15 minutes after vaccine administration pt. reported tingling of her lips and mouth. She was placed on a cot and tingling continued. 911 was called and evaluated pt. She refused additional medical attention.  She continued to rest on the cot and  stated that the tingling had resolved when she left the building.
Symptom: 2:00am Extra in radiating arm pain from neck down to fingers with particular pain in elbow and forearm, woke me up in the night; pain so great could not sleep.   Treated with Tylenol and ice packs.  7:45 am Lips going numb intermittently
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single at the age of 40 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 18Jul2023 to 22Jul2023 for the COVID-19 treatment.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5], has been requested and will be submitted if and when received.
PULMONARY FIBROSIS (IPF); This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 4 weeks after the vaccination, the patient experienced pulmonary fibrosis (IPF). It was reported that, "I had the J and J and 4 weeks later diagnosed with Pulmonary Fibrosis (IPF). It's been down hill since then I will not get another vaccine".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary fibrosis (IPF). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221229098-pulmonary fibrosis (IPF). The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Systemic: Heart Attack-Medium, Systemic: Hypertension-Medium, Additional Details: per patient she experienced chest pain and high blood pressure and went to urgent care & emergency room. She was admitted to the hospital and MD reported she had A.fib, pericarditis, heart attack, and high blood pressure. she got discharged with losartan, asa, pepcid, metoprolol, plavix, lipitor and nitroglycerin SL
Wenesday Night at 11"00 I got out of bed, to use the bathroom, then when I got back in bed, my head was a little dizzy, then it became worse as I lay there.  I got up and went to the living room and sat down on the end of the couch, and my head was just spinning. So I was sitting up straight, and I put my chin down toward my chest, and it slowed it down. I leaned back on the couch and I stayed there all night and I didnt sleep very well. When I awoke, I was still dizzy, I couldnt really get up, and when I could get up I had to hold on to things so I wouldnt fall. I had to lean against the wall and all. It was like that all thursday and all Friday. Friday night it felt like it was easing up. Saturday I was able to go outside. It just about ended yesterday, Sunday. Thursday and Friday I had dysentery.