chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very swollen and painful lymph node at right clavicle; Very swollen and painful lymph node at right clavicle; Smaller swelling in lymph node in the right arm pit; Smaller swelling in lymph node in the right arm pit, some arm; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the right arm on 19Apr2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medication included ibuprofen (MOTRIN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of varicella zoster vaccine (MANUFACTURER UNKNOWN) in the right arm on 04Mar2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Apr2021 at 20:00, the patient experienced very swollen and painful lymph node at right clavicle and smaller swelling in lymph node in the right arm pit, some arm, and felt tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very swollen and painful lymph node at right clavicle, smaller swelling in lymph node in the right arm pit, some arm and the event tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
local DTAP rxn swelling, redness, tender;tx motrin, ice compress;
Date of shot: May 18, 2018. May 19, 2018 General Malaise; no strength. High pain at shot location. Unable to function at all.
20JAN91-630AM making funny noises, eyes open & twitching last 30 sec. infant slept p/9A; appeared to be a sz more intense lasted longer; To ER no findings found 1P another sz, seem to be getting more intense & longer med given &transferred.
242 patients were administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (242 patients were administered expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Lot numbers and their following expiration date:   1. 001C21A (12Oct2021)  2. 011A21A (16Aug2021)  3. 011M202A (16July2021)  4. 027C21A (18Sept2021)  5. 031A21A (28Aug2021)  6. 041B21A (4Oct2021)
My tinnitus worsened considerably.   Loud high-pitched ringing in ears which I noticed within a day of receiving vaccine.
I had fever that lasted for 7 days and was the worst of it. I didn't really feel horrible for 2-3 days, I had a sore throat. For the rest of the days I had runny and stuffy nose, slight cough, mild upper respiratory symptoms.
Had tingling in fingers and toes on right side 12 days after first shot.  Tingling & numbness in both sides in all extremities.  Headaches, vision problems, aching and pain in right side, stomach cramps, diarrhea, nausea, fatigue, pain down right arm when vaccine was being administered, sweating & chills, dizziness, tremors
suspected vaccination failure; I've gotten shingles/ in my eye many times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles in eye many times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a nurse refers to a 2 year old  male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Local Skin reaction at injection site. Area of 5 inches by 5 inches red/swollen/ itchy.
Left neck/scalp mm tenderness/pain developed 7-9 days after vaccination. Resolving 6 weeks later.
Arm pain; Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019BZ1A and 026AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included BPH. Concomitant products included TAMSULOSIN for BPH, METOPROLOL and LISINOPRIL (ZESTRIL) for Blood pressure high, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for Cholesterol blood excessive, IBUPROFEN (ADVIL [IBUPROFEN]) and VARENICLINE TARTRATE (CHANTIX) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) and BACK PAIN (Lower back pain) outcome was unknown.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Approximately 5 days after 2/22/07 developed skin soreness progressing to painful movement with abduction of L upper arm and hyper extension. There is a tightness and burning sensation to entire upper L arm. Advil and Heat do not help movement
COVID positive, admitted 9/9 for worsening hypoxia, deceased 9/10 while admitted. Fully vaccinated March 2021.
hives over abd, back & upper extremities next day; recurred-2 wk after
Limited tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Limited tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Limited tiredness). On 11-Feb-2021, FATIGUE (Limited tiredness) had resolved.            No relevant concomitant medications were reported. No treatment information was provided   This case was linked to MOD-2021-314586, MOD-2021-314933.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non-Significant follow up received. Added patient pregnancy status
Patient is fully vaccinated.  ED visit on 12/7/2021.  COVID + test. 88-year-old female presents from nursing facility for cough. The patient denies any chest pain, shortness of breath, nausea, vomiting, diarrhea, fever or chills. She states that she has a nonproductive cough. Staff was concerned that she may have COVID. She states she is otherwise feeling well.BP 173/83  | Pulse 103  | Temp 98.5 °F (36.9 °C) (Oral)  | Resp 17  | Ht 149.9 cm (4' 11")  | Wt 54.9 kg (121 lb)  | SpO2 97%  | BMI 24.44 kg/m² Cx-ray negative for acute process. Patient is not hypoxic. She has no complaints. She will be discharged to the nursing facility. Patient/Guardian told to return to ED for any new, worsening, changing or persistent symptoms.  Patient returned to the hospital on 12/12/2021 and required hospitalization for 8 days.  Assessment:  atrial fibrillation with RVR.  COVID infection, elevated troponins, chronic diastolic heart failure, leukocytosis, COVID infection.  88-year-old female with past medical history of atrial fibrillation, CHF, hyperlipidemia, hypertension, and chronic urinary retention.  The patient was presented to the hospital because of tachycardia. Her heart rate is 126.  The patient seems to have shortness of breath right now.  Her laboratory data and diagnostic showed that potassium is 3, creatinine is 1.13.  BNP is 861.  Troponins are 0.18.  White blood cells elevated at 13. Chest x-ray showed patchy airspace opacities.  The patient was admitted because of atrial fibrillation and COVID-19 infection. Medications:  Eliquis, albuterol, cardizem. Discharged back to Nursing home stable.
beginning 20 minutes after the vaccine, patient had near syncope and shortness of breath.  no hives or flushing.  fatigue persisted several days after, along with chest discomfort, worrisome for anaphylaxis reaction.
A pt came in to get a second dose of COVID-19 vaccine.  I usually verify the pt?s DOB and name then ask when and what kind of vaccines he/she received to be sure.  But I got distracted because, when I verified her DOB, she got upset since the tech who helped her didn?t fix her DOB.  I had to fix it myself.  Then when I came back, she told me she had a dental appointment.  I totally forgot to ask her what she had as her first dose and gave her Moderna since I only had the Moderna with me at that time.  When I tried to sign the COVID-19 Vaccination Record Card, I noticed that she received Pfizer-BioNTech.  I explained to her that she received Moderna by mistake.  I also told her that since both mRNA vaccine products are engineered with the same technology, she might not need to repeat the second dose.  And I observed her for about 30 minutes.  I told her that I would find out if she needed to repeat it.  I contacted the Immunization Action Coalition and they told me that as long as the pt had received mRNA COVID-19 vaccine products, pt would not need to repeat a dose.  They also sent me the CDC info on this recommendation.  But the CDC guideline is not clear to me since she received the two doses 21 days apart, not 28 days.  So I emailed a vaccine expert at the CDC, who I usually email whenever I have an immunization question.   I called the pt around 2 pm (two hours after vaccination) and she seemed to be doing fine at that time.   I gave her my cell phone number and told her to call me if she had any concerns.  I talked to her today and she told me that she called out since she was very tired.  I will follow up with her again.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information regarding patient's medical history, concurrent conditions or concomitant therapies were not provided. On unspecified dates, unspecified number of patients were vaccinated with five doses of ROTATEQ were administered lot # L033549 expiry date 05-JUN-2017, lot # L027726 expiry date 10-MAY-2017, lot # L033545 expiry date 30-MAY-2017 (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No symptoms were reported. The reporting nurse was not sure which lot numbers were administered but the lot numbers mentioned were the ones possibly involved. It was reported that the administered vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. This is one of the several reports from the same reporter. Follow up information has been received from Registered Nurse on 09-AUG-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Shot on 7/30/19. By Friday 8/2 - area got swollen and itchy - on 8/5 - area still itchy and little swollen. Went to walk in clinic. Diagnosis - allergic rxn. Prescribed Zyrtec and cortisone cream. 8/9/19 - outline of rash still there but much better. Still a little swollen.
This spontaneous report was received from a pharmacist via company representative concerning a female patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (route, lot #, expiration date, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. On an unspecified date, the patient experienced blistery  rash and it was mentioned that the patient's unspecified physician took a specimen of the patient's blisters and the results were positive for herpes zoster (date unknown). Additionally, the patient sought medical attention by visiting an unspecified physician. The outcome of herpes zoster was reported as recovered, date unspecified. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
5 x 5.5 inch induration which is erythematous, hot to touch, mildly tender on right deltoid area
Chronic Hives-Idiopathic to allergies, joint pain, fatigue chronic, hypothyroid (antibody caused).
On 8/15/2022, I took a COVID-19 home test and the results were positive. The only reason I tested was because my wife tested positive, and we were at a friend's house. My symptoms were very mild. I would not have tested if we were at home. I had a cough. My doctor prescribed cough medicine, promethazine DM and steroids, azithromycin 250 mg.
Patient experienced tightness in chest and phlegm in throat approximately 40 minutes after receiving vaccination.  Went to ER and was treated with Benadryl capsules and Zantac tablets.
She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; Ear feels plugged up; This is a spontaneous initial report from a Pfizer sponsored program . This consumer (patient) reported for herself that. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 1 via an unspecified route of administration on 13Apr2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (She was probably diagnosed 40 years ago with high blood pressure), ongoing thyroid disorder (She was probably diagnosed 45 years ago or longer with her thyroid issue), ongoing hip surgery (She had hip surgery two months ago). There were no concomitant medications. No Investigation Assessment. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No Patients Medical History including any illness at time of vaccination. Family Medical History Relevant to AE(s): NO whole family has allergies. No Relevant Tests. The patient experienced she thinks she has a sinus or allergy related ear infection, and ear feels plugged up on 03May2021. It was reported that the caller is scheduled to get the second dose of the vaccine on 07May2021. She thinks she has a sinus or allergy related ear infection, but she is not sure. She was taking Coricidin, a cough and cold medication with high blood pressure. She stated she has high blood pressure. She took this yesterday morning at 9:30 AM and she did not take any more because she thought it might affect the shot. She stated she won't restart it until after the shot. She stated she is feeling better but does not know if this medication will affect the vaccine. It was reported that She was calling to see if she needed to stop this medication before getting her second dose. Confirmed caller has already stopped the medication. It was reported that she has had the ear infection for last four or 5 days, and she did not get it right after she had the shot. It was reported that she guesses it won't bother her, but it might bother him regarding contacting her physician. She never went to the doctor, or that she doesn't know if it is an ear infection or sinus drainage. She states her ear just feel plugged up. It was reported that it is not as bad as it was. She states she took 4 of those pills (Coricidine) and she got better but she still has the ear infection. She had to stop the pills because they could interfere with, COVID vaccine, and could not read the information on the box without glasses nor could she locate the NDC number on the box. Reporter seriousness for events: Unspecified. Patient was not visited Emergency Room or Physician Office for events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of administration of H1N1 vaccine into one nostril and tiredness was received from a patient parent concerning a 3.5 year old male subsequent to the administration of H1N1. Relevant medical history and concomitant medications were not reported. On 14-Oct-2009, the patient received H1N1. During administration of H1N1, the whole dose was administered into one nostril. According to the reporter, the patient seemed fine; however he was a bit tired at the time of reporting. The outcome of the event was not reported. Rechallenge is not applicable because re-administration of this product was not reported.
Rapid development of cough, "throat closing" and shortness of breath. Epinephrine 0.3 mg SQ, 50 mg diphenhydramine IM, DUONEB nebulizer and 60 mg prednisone PO given shortly after reaction began. Transferred to ED via ambulance and observed over 2 hrs with resolution of symptoms.
Hair is falling out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ALOPECIA (non-serious), outcome "unknown", described as "Hair is falling out". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed injection site swelling extending to her forearm. Pt was treated with Benadryl.
The first shot I had a period starting one week after and lasted almost 3 weeks total. I have IUD for two years and I?ve never had a full period  with IUD.  Prior to IUD I was normal cycle 28 days period for 6 days for 25+ years.  Second dose/2nd shot in right arm I have swelling  in my armpit lymph nodes from 2nd day until 4th day and I?m reporting on my fourth day after my 2nd shot.  I?m breastfeeding my 2 year old child.  I have not gone into the doctor yet.
Patient experienced right eyelid and cheekbone numbness following the first dose. She received her second dose 11 days after the first in error. Following the second dose, she reported cheek numbness and nausea, which had resolved when I spoke with her on 1/11/21.
Pain for 48 hours after injection, red swollen bump appeared at injection site 7 days after injection (covid arm?).  Chills for 2 hours 57 hours after injection.
Itching; muscle swelling; Hot; Pain at injection (L); Red Circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection (L)), INJECTION SITE ERYTHEMA (Red Circle), PRURITUS (Itching), MUSCLE SWELLING (muscle swelling) and FEELING HOT (Hot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection (L)) and INJECTION SITE ERYTHEMA (Red Circle). On 30-Jan-2021, the patient experienced PRURITUS (Itching), MUSCLE SWELLING (muscle swelling) and FEELING HOT (Hot). On 24-Jan-2021, VACCINATION SITE PAIN (Pain at injection (L)) and INJECTION SITE ERYTHEMA (Red Circle) had resolved. At the time of the report, PRURITUS (Itching), MUSCLE SWELLING (muscle swelling) and FEELING HOT (Hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . This was followed by dizziness, high BP, SOB, and nausea. The 2nd shot triggered post itching my neurocardiogenic syncope.
A 34 year old male reported that he received a booster dose of Typhoid Vaccine, USP, Acetone Inactivated, Dried in 1996 and subsequently developed fever and weakness. He was seen in the ER, but was not treated. He also developed a skin disorder characterized by thinning, cracked and bleeding skin of the axilla and genital areas. A dermatologist prescribed a "steroid and moisturizing cream which has helped". However, the skin disorder returns whenever he stops using the creams.