chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site reaction with increasing redness and swelling with a large indurated area at the center that developed overnight along with a fever that was treated with tylenol. The hive persisted for 4 days after which topical benadryl was applied and symptoms began to desist. The area is no longer red or swollen but is still hard to the touch.
Itchy and burning eyes. Rash all over. 50 mg BENADRYL.
14:36 C/0 Dizziness , rapid heart beat while sitting in lobby post vaccination. Assisted to exam table to lie down. P 96 RR 18. Denies SOB, chest pain.  14:39 P76. c/o nausea. Assisted to R side. 1447 BP 120/76. P78 O2 sat 97%. Awake and alert, oriented.  SL nausea cont.  1449 p77, Reg , O2 sat. 95%,Breath sounds clear bilateral.  States less dizzy now. Sips of water taken. 1457 BP 110/64. Dizziness resolved.  1458 Assisted to sitting position. P 77, O2 sat 97%. 1505  BP 110/74. States dizziness gone.  1507 Assisted to standing. O2sat 98% p78. Patient feels as she can go back to her dept. now and left vaccine clinic in stable  condition.
Administered expired dose; These vaccines were placed in cooler; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications was reported.  Treatment information was not provided.
Patient presented to ED on 12/8/21 with worsening SOB and increased O2 requirement, found to be covid positive.  Patient is fully vaccinated. Patient received remdesivir and dexamethasone upon admission and continued till discharge on 12/11.
I woke up at approx. 7:30 AM on 7-4-23 with uncontrollable shaking. I called EMS. The ambulance drivers said I needed a Benadryl but wouldn't give me one unless I agreed to be transported. I refused, they left, I got a Benadryl from a neighbor and slept it off. On 7-5-23, I woke up shaking again but it quickly subsided. There were no other issues.
I HAD A METALLIC TASTE IN MY MOUTH SHORTLY AFTER THE VACCINE WAS ADMINISTERED AND IT LASTED FOR APPROXIMATELY 3 DAYS. NO TREATMENT WAS REQUIRED.
33 y/o Hispanic male approach staff member and c/o dizziness and short of breath more than five minutes after receiving  2nd dose of Pfizer vaccine. Staff member notified EMS and NP of the incident   PT was evaluated by on-site by  EMS and NP.  It was found via PT's that he had not eaten or drank anything prior to coming in for vaccine. Patient has a medical Hx of Hypertension. No NKDA reported.   EMS placed patient  on oxygen per Np  orders. Patient was reevaluated by NP and stated he was feeling better and wanted to leave. NP advised patient that since his vitals were still elevated and dizziness was still present that he needed to sign AMA.  Patient agreed to sign AMA and was picked up from the facility (Regency Mall) by family member.
After two days of administered anthrax shot on 09/08/2007 I started to feel some burning sensation in between my legs. On 9/12/2007 I had red spots in between my crotch and buttocks area. I went to the doctor on 09/13/2007 and he told me that I have all the symptons of Herpes.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 07-MAY-2013 the patient was vaccinated with expired COMVAX, 0.5 ml, intramuscular in the left upper thigh (lot # was reported as 1513AA, expiry date in 06-MAY-2013). No adverse effects reported at this time. Additional information is not expected.
My arm is swollen; lymph node swelling; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was swollen and she would like more info on what to do and will it go away. Also stated that she would like to talk to an expert about lymph node swelling. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever, body and joint pain, headache, swollen red raised area at injection site, lymph nodes swollen and painful
the vaccines were mistakenly given to 8 year female patient / no AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA256338.  This case involves a 08 years old female patient who mistakenly received vaccine 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1906 (Expiry date 22-May-2020) via intramuscular route in the left arm on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
She was diagnosed with COVID on November 22nd, she has symptoms on November 21st which included cough and loss of taste and smell.  Patient was doing relatively well after the 22nd and was scheduled for a monoclonal antibodies morning.  When she arrived to the facility they noted she was hypotensive on a wrist cuff blood pressure monitor to the center down to the ER.  Her blood pressure was stable in the ER however they found her to be hypoxic with a saturation in the 70s.  Placed on 2 L of oxygen with the a good response in her saturations.  Workup over there was negative for pneumonia however imaging revealed bilateral patchy infiltrates.  Procal was negative.  Patient was transferred here for further management on 11/26/21 as their hospital did not have any bed availability.  Patient denies any chest pain lightheadedness fevers or chills.  She denies any dyspnea either.  When she arrived to our facility her saturation was 84% on room air so she was placed back on 2 L of oxygen.Treated with dexamethasone, remdesevir, oxygen support. Gradually started to feel well. Weaned off oxygen prior to discharge. Discharged on  11/29/21
fever, body aches, bad cough that lasted for weeks myself ( wife ) still has a lingering cough, not a dry cough as initially experienced
20JUL95 pt rt delotid area red & swollen on 19JUL95 pt told mom it was okay; APAP was given; 20JUL95 pt c/o bad pain in arm-swollen, red, & hot entire deltoid area;T101 & APAP is being given;rash on arm & vomiting;
temp excursion of 9.6 C for 1 hour 12 mins/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  It was a non-valid case since no patient was involved.  It was reported that there was a temp excursion of 9.6 c for 1 hour 12 mins in vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ065AA) due to door to fridge being left opened.  It was of potential medication error case due to incorrect product storage.  Product was unopened hence no use of vaccine was there.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Local reaction (L) del approx 3 mins after admin. Pt monitored x 15 mins. Provider instructed mom to give 25mg BENADRYL at home. ER warnings given.
Patient called at 1330 and stated she got the shot earlier today at 1000. The site of injection started twitching around1320 and called to see if it is normal. I spoke to the patient and stated that it is not a common side effect. Patient stated there is no history of this occurring and has ahd flu shots before with no issues. I advised patient to take ibuprofen or tylenol and drink water. If symptoms persist, follow up with MD.
Information has been received from a healthcare worker (office manager) concerning a patient who on an unspecified date was vaccinated with VAQTA. Concomitant suspect vaccination included VARIVAX. Subsequently the patient developed " knots" at the injection site. It was unknown if the patient recovered. No further information was available. Additional information has been requested.
Patient called and said he was feeling sweaty and her stomach hurt and was having abdominal cramping and diarrhea. Said this started today, 3 days after vaccine.
Information has been received from a registered nurse concerning a 52 year old female with no pertinent medical history of allergies, who on 04-APR-2008 was vaccinated subcutaneously in her right upper arm with 0.5 ml dose of VARIVAX (Oka/Merck) (Lot# 658587/1520U). There was no concomitant medication. The nurse reported that on 18-APR-2008, the patient had a rash at the injection site. On 19-APR-2008 the patient had 10 papules (non fluid filled) over her whole body but no pain and no complaints. At the injection site there were papules that were fluid filled. The patient complained on 21-APR-2008 of areas being itchy and the area at the vaccination site was redder, larger and blistering. On 23-APR-2009, the patient had an IgG and IgM done and they were both negative. On 25-APR-2008, the nurse saw the patient and there was not a mark on her. The injection site was a little red but very diminished. At the time of the report the patient had recovered since 24-APR-2008.
incorrectly diluted the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153,) via an unspecified route of administration, in the left arm on 06Apr2021 at 11:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone (MANUFACTURER UNKNOWN), and buspirone (MANUFRATURER UNKNOWN) both were from unknown dates and for unspecified indications.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Apr2021 at 11:15, Walgreen's (the facility name where the vaccine administered) called and said that they incorrectly diluted the vaccine and did not shared any information as what to do. The patient asked for advice on what to do. The event did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event incorrectly diluted the vaccine was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Fever= 104 F, Severe Fatigue, Respiratory congestion and difficulty catching my breath, sever body aches, severe head ache. Debilitating fatigue, I was unable to physically get up off the floor after laying down due to fatigue. symptoms persisted for 30 hours.
Bad headache, arm and neck pain, dizziness, fatigue body aches, chills, nausea, stomachache. Did not sleep well much Friday night due to these symptoms.  Sudden pain in left side of my head about 40 min after the vaccine after I walked to the car and sat down after the 30 min wait. Pain starts as a slow dull ache, increases rather sharply, then goes away quickly. Have this pain several times or so yesterday and today even after taking ibuprofen.   Also pain in my neck with what feels like stress headaches with ibuprofen relieving it.
VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was vaccine injury victim from JNJ covid-19 vaccine (dose number in series 1).  The patient received non-company suspect vaccine included: Pfizer Biontech Covid-19 Vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered on an unspecified date for prophylactic vaccination.  On an unspecified date, the patient was vaccine injury victim from Pfizer covid-19 vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
The Pfizer vaccine was administered and heart problems began shortly after. Hospitalized 3 times since.
Child c/o (R) numbness of leg and foot x 12 hrs 7-17-08 pm then foot leg-but much less today 7-18-08 am total 18 hrs
inadvertently administered 1ml instead of .5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     no medical history was reported.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently administered 1ml instead of .5ml) outcome was unknown. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-092554 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092554:
Roughly 10 hours after injection, moderate muscular pain at injection site, and severe pain in old lower back injury - chronic bulging disc. Back pain onset was severe enough to wake me up from sleep and persisted despite use of OTC pain management. Used 2x extra-strength 500mg acetaminophen, only dulled pain, then 600mg ibuprofen approximately 8 hours later to same result. As of 27 hours post injection, pain is still moderate and disruptive. Lack of sleep and pain make it hard to determine if the fatigue is a unique symptom or purely the result of the pain symptoms. In a non-measurable manner, having had this back injury for over 10 years with multiple reoccurrences, it feels like the joint/disk swelled enough for it to press on the spinal nerves despite attempts to mitigate with ice, elevating feet and head to open intervertebral space.
On 2/7/21, felt some neck pain. On 2/8/21 had large raised rash near injection site and large swollen very painful lymph node in neck. Called the clinic first, then made an appt with my doctor's office. On 2/9/21, visited doctor at 12:40pm.
Had CoVid vaccine #1 1/22/21 - felt fine. 2/5/21, eyes became swollen and red - called her eye Dr, who met her after hours at his clinic and diagnosed with shingles. She does not remember ever having chicken pox but states she might have forgotten. She called MC to inform us she could not return 2/11/21 for her second vaccination d/t the shingles. We also had a second person vaccinated the same day that also called with shingles so decision was made to enter this variance report.
Initial misuse report received from a healthcare professional. The patient had received Acthib, FLUZONE, MENACTRA and PENTACEL.  It was reported that on 11 October 2013 temperature was as low as 32F and Acthib and FLUZONE was ok for use. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
-Nausea two days later for one day -Eight days later bright red, itchy circle on injection site.  Lasted for four days.
Hep A given in LD 4-25-07 c/o pain, reddness and swelling at site onset 4-26-07 Sit was warm to toucha nd meassured 50 mm, Instructed mom to apply cool compress and advil as needed
This case was reported by a pharmacist via call center representative and described the occurrence of localized itching in a adult patient who received SHINGRIX. The patient's past medical history included skin lesion. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced localized itching. On an unknown date, the outcome of the localized itching was unknown. The reporter considered the localized itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had itching at the site of a previous shingles lesion. The case has been linked with US2018074652, reported by the same reporter. The pharmacist called with an unrelated question. Whenever they had administered SHINGRIX, they had the recipient call them the next day to let them know if they are experiencing any side effects. The pharmacist was not sure if she should be reporting this events, as they were common and listed in the prescribing information. She had not logged the patient specific information, so unable to provide these details.
NON-CONSOLABLE CRYING WHEN AWAKE, TEMPERATURE OF 101 DEGREES, DECREASED EATING
3/31/05 immunization given, 4/4/05 2am right arm from injection site to elbow (back of arm) red and swollen went to private physician. parents called 4/5/05 3pm referred by physician to call mother stated no antibiotics given doing warm and soaks better 4/5/05 on Zyrtec.
Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder; the pain localization varies in the arm (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain from the shoulder all the way down into the hand (after second dose) mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HCL, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), LISINOPRIL, AMLODIPINE BESYLATE, OMEPRAZOLE, FAMOTIDINE, HYDROXYZINE, METOPROLOL SUCCINATE, GABAPENTIN, MONTELUKAST and ALPRAZOLAM (XANAX) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)). At the time of the report, PAIN (Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Other concomitant medications inluded calcium and vitamin C  No treatment reported.   This case was linked to MOD-2021-314898 (Patient Link).
Patient was hospitalized on 5/13/21 with severe COVID about 6 weeks following her 2nd COVID vaccine dose.  While hospitalized, patient was started on Remdesivir x 5 days in addition to dexamethasone.  Her respiratory status continued to decline so was started on high flow O2 approximately on day 6 which continued x 2 days.  Steroids were continued but patient could not maintain O2 sats with any activity.  Approximately on day 13, the attending physician performed another CT and diagnosed bacterial pneumonia so started  on IV antibiotics.   Patient also received Lovenox bid for VTE prevention.  Dose is unknown.  Tessalon Perles were used PRN for cough.  Patient was discharged on 5/28/21 on oral antibiotics.  At home, O2 sats continued to drop into the 80's during any activity so patient reported to Urgent Care.  Approximately 1 week later, after continued SOB, another visit to PCP on 6/9 prompted home oxygen to be ordered and delivered on 6/15.
Patient comes over our pharmacy today. She got a discharged rx from the emergency room for NORCO 5. She says she may got allergic reaction from the IMZs that she got yesterday on 9/15/17. She reported the following symptoms: Tiredness, muscle ache, joint pain, fever, shakiness. She also shows her injection sites. Her left arm appears to have mild swelling with some redness. Patient has come here every years for her flu-shots and never has any problems. I suspect the reactions come from the PNEUMOVAX-23. Patient also stated that one of the doctors at Hospital ER said she was the 2nd case that have allergic reaction to IMZ. It is unclear if the other patient got IMZ with pharmacy or another location.