chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Laryngitis; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 68, Units: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was scheduled to receive her second shot of the Pfizer vaccine on Thursday. She has laryngitis and received prednisone today. She asked if that was ok to take. She stated it had been two weeks since her first dose, so she didn't think it was because of that. The clinical outcome of laryngitis was unknown.  Information on the lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of laryngitis. The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. T his case will be reassessed upon receipt of follow-up information.
Extreme fatigue for about 6 months after vaccination which slowly improved over time. Pins and needles pain. Low stress tolerance. Lightheadedness. Weakness.
Redness, itching, swelling around injection site plus or minus 4 inches around.
10/21/22: The muscles in my left upper arm began to spasm and this continues through 10/25/22. 10/25/22: I experienced numbness and tingling in my left arm, right arm, and left leg.  I was seen in clinic.
Information has been received from a physician concerning a 61 year old female with hypertension, arthritis, imbedded rose thorn removed from left arm in August 2008 and no reported allergies, who on 11-JUL-2008 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX (Merck) (dose and lot number not provided). Concomitant therapy included lisinopril (manufacturer unknown) and CELEBREX. In October 2008, the patient developed bruising at injection site, lymphadenopathy of the left axilla. Subsequently, the patient began to notice paresthesia in the area of the injection site only when the skin of that area was touched. The patient also noticed myalgia of the left arm with use, such as raking leaves. The physician stated that the patient recovered from the bruising, lymphadenopathy, and myalgia on an unspecified date. Skin sensitivity at injection site had persisted. Lab test performed included comprehensive metabolic panel and thyroid function test with normal results. The patient sought unspecified medical attention. Additional information has been requested.
Patient received vaccine and was fine afterwards. Pharmacist had a conversation with the patient for about 5 minutes after the vaccine was administered. Patient was NOT slow to get up after vaccine. About ten minutes later the patient was walking down the aisle of the store, and an employee saw patient stretch his arm completely out. Patient continued walking and about 30 feet later the patient collapsed and Emergency was called. Patient was breathing but not conscience and a faint pulse was observed.
CLIENT INDICATED SHE WAS NOT ABLE TO SEE WITHINS A FEW SECONDS AFTER HER SHOT AND FELT SHE WAS GOING TO FAINT. CLIENT FAINTED AFTER RECEIVING HER 1ST COVID VACCINE. CLIENT LOST CONSCIOUSNESS FOR LESS THAN A MINUTE. AFTER REGAINING CONSCIOUSNESS, CLIENT THOUGHT SHE COULD WALK BUT THEN LOST CONSCIOUSNESS AGAIN. CLIENT WAS ASSISTED TO THE FLOOR AND DID NOT RECEIVE AN INJURY TO THE HEAD OR OTHER BODY PARTS. AFTER A MINUTE, THE CLIENT CAME TO AND REMAINED ON THE FLOOR TO REST. AFTER A FEW MINUTES, SHE QSS ABLE TO SIT AND DRINK WATER, SHORTLY AFTER HE WALKED AND LAID DOWN ON A COT FOR 10 MINUTES UNTIL SHE FELT SHE COULD WALK. PLANS TO VACCINATE LAYING DOWN ON NEXT DOSE. CLIENT SMOTHER REPORTS SHE HAS FAINTED TWICE WITH PREVIOUS VACCINES.
blotchy rash flanks, not itchy. 'Flushed' head to toe. Dry Mouth
w/in 3 days of Td, pt devel swelling, redness, burning, & itching @ inject site; Area felt warm to touch; Pt also had t99; DPH given for itching;
RASH; ITCHING; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) ) 0.5 ml, administered on 02-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced rash. On 09-MAR-2021, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, and itching. This report was non-serious.
day 1 of vaccine pain swelling redness at the site chills  1-8-21 day 7 continued swelling of L deltoid size of handball chills  continue  swelling of lymph nodes in L axilla fatigue 1-28-21 developed strong chest pain substernal to L scapula x 7 hours went to er  admitted to hospital elevated d dimer  ct of chest nothing acute ekg nothing acute lab work up for evaluation of heart normal  continued swollen lymph nodes L axilla  swelling of deltoid gone  discharge from Hospital after 1 day  2-5-21  had episodes of chest pain relived by rest 4-5 x a day since 1-28-21 unable to work due to chest pain  swelling of lymph nodes in L axilla continue fatigue   repeated episode of chest pain on 2-5-21 lasting 2 hours went back to hospital monitered for 1 day stress test and echocardiogram normal. 3-2-21 continue to have chest pain with activity ie walk 20-30 ft  taking a shower  have had chest pain 4-5 x daily since 1-28-21
Patient passed out immediately after being given the shot while lying down. Had some seizure-like activity during syncope.
ED to Hosp-Admission  Discharged  10/18/2021 - 10/22/2021 (4 days) Hospital MD  Last attending ? Treatment team Acute on chronic congestive heart failure, unspecified heart failure type  Hospital Problems  POA * (Principal) Acute on chronic congestive heart failure, unspecified heart failure type  Yes  Covid pneumonia, Paroxysmal A. Fib,  Morbid obesity, Nocturnal hypoxia Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9] Acute COVID-19 [U07.1]     Hospital Course   Symptoms started approximately October 15 or 14 with cough with white sputum and exertional shortness of breath as well as shortness of breath lying flat. BNP was a little higher than usual and he was started on IV diuretics but his Covid was also positive. His lungs sounded like Covid in the CT look like Covid. Therefore we diuresed him but on the second day in the hospital I did start him on remdesivir he had been started on steroids upon admission. He certainly improved on a daily basis. On the day of discharge he is feeling well really denying any shortness of breath his edema is better his lungs are clear he is back to his normal diuretic dose and he is not hypoxic with exertion. He got 4 days of remdesivir because he is doing so well we can discharge him before the fifth day but he will complete 10 days of Decadron. LFTs remain normal as always is got a little bit of a hypochloremia with 91 bicarb is mildly elevated at 35 but his BUN and creatinine are stable CBC unremarkable. Rest and exercise oximetry revealed no hypoxia   Operative Procedures Performed   Treatments: IV Decadron IV diuretics remdesivir Procedures: None Consults: PT OT Pertinent Test Results: CTA of chest consistent with Covid pneumonia
PREVNAR given in left thigh and about 5 minutes after inject site became erythematous, warm to touch, and infant screamed with pain on palpation of site. A minute later infant develops facial and abd rash w/ eyelid swelling.
The pt was dx'd today with herpes zoster; dermaline C-3. Some lesions also appear on his right arm. Symptoms present for 1-2 days. Treatment ordered: Zovirax 240mg Q1D X 7 days.
Vomiting, nausea, abdominal cramping, diaphoresis, flushing. IM injection 0.3ml 1:1000 epinephrine immediately, observation for 1 hour with improvement in symptoms.
Two different vaccines give Janssen was give 04/08/21 and Pfizer was given 5/18/21 So far no adverse reaction
Upset stomach; Sweaty; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045V21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa). Concomitant products included DULOXETINE, GABAPENTIN, MELOXICAM, ATORVASTATIN, VITAMIN D NOS and LISINOPRIL for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient treatment medication also includes antacids.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received and vaccination facility information was added.
Headache starting at wake up today, intensified around 5:00pm could be from screen time. I got very tired though more so than usual little energy
This case was reported by a healthcare professional and described the occurrence of swelling arm in a subject of unspecified age and gender who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of Boostrix, subcutaneously. This was an inappropriate route of vaccination. In 2010, at an unspecified time after vaccination with Boostrix, the subject experienced swelling arm. At the time of reporting the outcome of the event was unspecified.
After the second vaccine I got very sick for approximately 4 days: fever, chills, excessive sweating, headache, reflux, diarrhea. On 4/5/21 I had heart palpitations from mid day till evening that were not caused by anything. Symptoms kept recurring and I went to Urgent care on 4/16/21.  BP, HR/EKG appeared normal.  General symptoms remained: rapid heart beats/flutter/SVT on occasion, discomfort in left chest/close to throat, heart working harder when going up stairs etc. Symptoms seemed to be more pronounced in the early evening/when lying down and resting. Alongside this, I felt increasingly more fatigue and need to rest.  I did follow up with my PCP, NP, and cardiologist since.
Postural orthostatic tachycardia syndrome; This is a literature report.  A 17-year-old female patient received 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 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: 18; Blood pressure systolic: 30; Blood thyroid stimulating hormone: normal; Echocardiogram: normal; Electrocardiogram: normal; Full blood count: normal; Heart rate: 53; 123; Heart rate variability test: showed an increased sympathetic activity with, notes: occasional spikes of vagal tone after the head-up position; Interleukin level (normal high range 2.8): 5.6 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.3): 10.4 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.1): 9.4 pg/mL, notes: showed increased titer levels; head-up tilt table (HUTT): showed orthostatic, notes: tachycardia without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
12/22 vaccination. Felt fine.  Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER.  Frequent PVCs; occasionally over the years. Discharged home.  Not sure if related to vaccine as under a lot of stress.
received a vaccine past the 30 day storage on the refrigerator; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that patient had no known allergies. Patient was not tested positive for COVID within last month.  Concomitant products included SODIUM FLUORIDE and TRIAMCINOLONE ACETONIDE for an unknown indication.    On 06-Apr-2022 at 3:04 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:04 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in refrigerator 25-Feb-2022. The vial did not undergo any temperature excursions. HCP confirmed that the patients were not experiencing any side effects at the time of this report. Expiry date of vaccine was reported as 25-Mar-2022.  No treatment details were provided.
arm was stiff x 3 days, stomach upset 13OCT93 sick to stomach, h/a; 14OCT93 loose stools, vomiting;
Information has been received from a Medical Technologist concerning pts who on unspecified dates were vaccinated with varicella virus vaccine live. There were no concomitant medications reported. The reporter indicated "over the last year, the clinic had seen about 3-4 cases of break through rash after (varicella virus vaccine live)". It was reported as unknown if the pts sought medical attention. No further details were available. No further information is available.
1/8/2021In the ED, patient was noted to be hypertensive with SBP's ranging  150-172 mmHg and mildly tachycardic.  She was also noted to desaturate to 85 to 86% on room air, and required 2 L of oxygen to maintain her sats.  A chest x-ray revealed "diffuse vascular congestion.  No pleural fluid."  A CT head revealed "no acute cortical infarct, hemorrhage, or mass-effect. " Labs revealed leukocytosis to 14.2, high-sensitivity troponin elevated to 59, and BNP elevated to 349.    On my assessment, the patient notes that she was more lightheaded yesterday than today, but really has not been up much today. She notes that her lightheadedness can occur in any position but seems to be worse with sitting, standing and walking than with lying down. She notes that she did have some nausea yesterday, but none today. She denies any CP, SOB, PND, orthopnea,.or BLE edema. She was not aware of any recent weight gain until informed of her weight on admission. She did have some constipation and underwent digital disimpaction by the ED provider with a moderate amount of soft brown stool. Has chronic rhinorrhea unchanged. No recent cough, fever, rash, HA, or abd pain. Does have a bit of dysuria and is supposed to be taking some antibiotics for this currently.    1/10/2022 PROGRESS NOTE today's chief complaint-  weakness,    She reports she feels much better than yesterday.  The lidocaine cream is helping her perirectal pain.  She has had small BMs but not much since yesterday despite the MiraLAX.  No abdominal pain.  No nausea.   Covid symptoms are similar.  She remains on 3 L O2.  Rare cough, no fevers no chills.  Has no other new symptoms.   Still no leg edema, abdominal girth/swelling seems to be similar.Denies fever, chills, CP, current SOB, abdominal sx including pain, nausea, vomiting, diarrhea, other new symptoms. 1/17/2022 PROGRESS NOTE New to me. C/o dysuria today.   Still feels weaks  Had colonoscopy yesterday No futher episode rectal bleeding
Intense pain in lower back and neck in and around where I have mild disc degeneration.  The pain is right where the affected discs are located and radiates outward.  Symptoms began 18 - 20 hours following the vaccine, and became much worse over the next 24 hours.  I also had suddenly had an elevated body temperature and broke out in a sweat in the middle of the night (about 36 hours following shot).  That lasted only 10-15 minutes and then went away on it's own.   I had the exact same experience following the first shot (2/23/2021, Pfizer Lot #6201).  The symptoms were odd, and I didn't realize at the time that it might have been connected to the vaccine, so I didn't report it.  After receiving the second shot and having the same symptoms with the same timeline, it seems that it is likely a reaction to the vaccine.
Patient is a 88 y.o. female admitted with acute cholecystitis. Initially treated with abx and surgery consulted. However, upon discussion with family, true goal is comfort measures. Dc all meds with family permission and will return to facility with palliative care intentions.
aches -- start 9:00PM chills, fatigue, headache -- start 10:00PM fever (102.8) -- measured at 10:00PM Low grade fever, fatigue, headache and body aches persisted for at least next twelve hours.
Within about 5 minutes of receiving my 1st shot of the Moderna COVID vaccine,  I felt like my tongue, lips, and throat were itchy.
metallic taste in mouth and nausea. Was asked to wait an extra 15 minutes and give pretzels and water. Felt a little better and wnt home. Nausea continued for 5days u with discomfort at the pit of my stomach, then I started with multiple bowel movements for the past 3 days.
pt started with soreness, then developed a rash that was itchy and then a large knot underneath the skin that is lasting up to a week after vaccination
Pt. presents to clinic reporting that she received at total of 3 shot in both of her arms on Friday of last week. That evening her tongue began to feel numb. Sat- R side of lipSun- whole lip and R side of face starting below her eye. Also in Sunday she experienced a shooting pain in her neck and radiated down her R arm. She couldn't feel her R arm. Immediately her head started tingling in the back of her head.  She called a friend whom told her that she did not have enough symptoms to be  seen at the hospital and they probably wouldn?t do anything for her anyways. So  she turned round and went home. Pt. came into the clinic today because she feels like ? there is definitely  something wrong? Pt. is unable to control spit from R corner mouth. Cannot close eyes with arms straight without veering to the R and becoming dizzy. Pt. was directed to go to the ER for eval. Pt. drove herself in today and refuses ambulance ride.  Patient came back to clinic May 3rd to report to vaccine clinic that the ER diagnosed her with bells palsy.
Joint stiffness; Muscle stiffness; Sinus headache; This spontaneous case was reported by a non-health professional and describes the occurrence of JOINT STIFFNESS (Joint stiffness), MUSCULOSKELETAL STIFFNESS (Muscle stiffness) and SINUS HEADACHE (Sinus headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (Joint stiffness), MUSCULOSKELETAL STIFFNESS (Muscle stiffness) and SINUS HEADACHE (Sinus headache). At the time of the report, JOINT STIFFNESS (Joint stiffness), MUSCULOSKELETAL STIFFNESS (Muscle stiffness) and SINUS HEADACHE (Sinus headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-396161, MOD-2021-396164, MOD-2021-395909 (Patient Link).
the gap between dose 1 and dose 2 would be > 18 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the pharmacist on behalf of patient's wife via web. The age at vaccination was not applicable for this report. The reporter had a patient that was requesting that they complete her Shingrix series however, gap between dose 1 and dose 2 would be more than 18 months. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter was looking for safety and efficacy data and to determine if this dose would be appropriate. The pharmacist explained that patient's wife told him that they both received the 1st dose on the same day. The consent to follow-up was granted. This case had been linked with US2021094169, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094169:same reporter