chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to get her flu shot.  Asked if she had ever had a reaction to a vaccine before and she stated no.  Said she gets a flu shot every year.  Gave shot and she sat on bench.  Was about to give shot to her friend and he asked her to hold his hand.  She got up and stood next to him and held his hand as I administered the vaccine.  As I was about to put his band aid on she fainted.  I tried to catch her as she fell, but she fell face first on to the ground and bumped her head against the fall.  I immediately kneeled down to her side and called her name.  With the help of friend we rolled her on to her back.  She was breathing normally and not convulsing, but was stiff and her skin felt clammy and her eyes were wide.  She was not bleeding from anywhere I could see.  I again asked her name and she said her name and then asked where she was.  I replied pharmacy and asked if anything hurt.  She said no.  I had her lay down until she felt ok to sit up.  I again asked her if she knew what happened and she said she got a flu shot.  I asked if she felt dizzy or if she felt like she was going to throw up and she said no.  I asked if she felt like her tongue was swelling or if she was having trouble breathing and she said no.  I asked her if she wanted me to call 911 and she said no.  When she felt ok she moved from the floor to the bench in the room and sat with her head between her knees.  I offered water or a cool compress and she declined.  She appeared to have a bright red mark on her right shoulder and another mark on her right cheek from the fall.  She stated that her teeth hurt as she clenched her mouth shut when she fell.  After about 10 minutes she was feeling better and we walked to the pharmacy waiting room.  She was steady and did not want assistance walking.  I had her sit in the waiting room for about 5 more minutes.  She knew the correct answers to her name, dob, what day it was, who our president was.  She could follow my finger with her eyes and had equal strength in both hand when I asked her to squeeze my hands with hers.  I again offered to call EMS and she declined and said she was feeling better.  Her friend who was with her said he'd be with her all night.  I told her if she started to feel like she was going to throw up or had a severe headache she should go to the doctor and also let us know.  I asked her to sit until she felt comfortable to move around and to let me know if she needed anything.  I told patient that I would be calling her the next morning to check in on her. She sat for a few more minutes and then her and her friend decided they were good to go.  9/25/2019 approx. 8-8:30pm
Vaccine 1/7/21. 1/8/21 Body aches, chills. H/A (not unusual as they occur frequently). No fever. 1/9/21 Feeling flushed and the opposite. No fever. S/S mostly resolved on 1/10/21.
Administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that dose administered after 30 day Use By Date or after manufacturer date of expiry. 173 doses were administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contain non significant information include reporter details updated.
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 28-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L001327, expiration date 13-JAN-2017 (dose, route and anatomical location were not reported). There were no adverse effects. This is one of the several reports received from the same reporter. Additional information has been requested.
I had discomfort for 10 days.  I was unable to lift my arm for almost a week.  I am relieved to hear that others experienced the same symptoms.  The arm is still sore.  I would like to know if the shot was administered correctly or if it was the vaccine.
After fever, fatigue, chills, headache, runny nose and nausea for 24+ hours, by Wednesday, March 17, 2021 I had most of the symptoms resurface that I had when diagnosed with Covid in July 2020: Neurological symptoms (buzzing in head, trembling hands, tingly scalp, dysgraphia), Respiratory symptoms (shortness of breath, especially with normal activity, coughing, chest tightness, pain in back/ribs, sore throat) and Cardiovascular symptoms (heart racing, skipping beats). Went to Urgent Care on March 18, 2021 and chest x-ray showed opaqueness in both lungs. Given another dose of steroids for inflammation, most symptoms went away except for SOB, coughing and heart racing and skipping beats. SOB lasted for approximately  1 week, heart racing and skipping beats lasted for 3 weeks. Fasting blood work on 3/29/21 showed significant increase in all cholesterol markers (30-40 points) compared to results from previous tests in 2020-2021. A1C also increased to pre-diabetic levels.
Patient received booster 16 days prior to the 5-month mark. No adverse reaction.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that it was unknown if the vial undergone a previous temperature excursion. The storage condition at the time of the excursion was frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was partially thawed/liquid. The maximum or minimum temperature reached was 8 degrees Celsius. The total duration of the excursion refrigerated temperatures for max of 4 hours. The temperature fluctuations occurred as frozen-refrigerated and refrozen.  And also stated that the vial was moved to the fridge on 06-Oct-2021 and administered post 30 days.  No treatment information was provided.   This case was linked to MOD-2022-496015 (Patient Link).
Pt developed right throat tightness 30 minutes after receiving vaccine at 2:40 pm.  Pt was in no acute distress, conversive, and vitals WNL except BP elevated 153/90.  Lung sounds clear throughout.  diphenhydramine administered via IM injection and patient was observed until 3:50pm.
PATIENT SAID HIS ARM HAS BEEN SORE SINCE FOR A COUPLE OF WEEKS SINCE RECEIVING THE INFLUENZA VACCINE. DO NOT KNOW WHEN OR WHAT TIME IT BEGAN HURTING.  HAS NOT SEEN MD YET, BUT IS PLANNING ON MAKING AN APPOINTMENT.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration given as 05/07/2021 No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-364493, MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
Throughout the day my arm had felt a little sore. Within the last two hours I am in serious pain in the area of the injection site. This started out of the clear blue!
Patient tolerated receiving the injection well intermuscular in the left deltoid.  About 5 mins after checking out, the patient then began to complain of throat tightening, shortness of breath, dizziness and a sense of choking while in the lobby.  The patient was then brought back to the exam room via wheelchair were the provider checked 02 STATs and BP which both remained good and stable. EMS called and patient taken to the ER. Remained stable during the entire event.
Pt received Pneumovax 3/10/2014 and returned to pharmacy on 3/12/2014 and reported adverse reactions from the vaccine. Pt was experiencing swelling at the injection site as well as itching around the injection site. She also reported pain to the point she had limited mobility and unable to take care of her child. She was instructed to take ibuprofen for pain and swelling, cold compress on areas of inflammation, and to use Benadryl for the itching. If symptoms have not resolved in 24-48 hours she should make an appointment with her physician.
PATIENT WAS GIVEN MODERNA VACCINE. ABOUT 10 OR 15 MINUTES LATER , PATIENT CAME UP TO COMPLAIN OF NOT FEELING WELL. SHE SAID SHE FELT FLUSHED.  I GAVE HER SOME WATER  AND TOLD HER TO TAKE HER MASK OFF SO SHE COULD BREATH BETTER FOR A FEW MINUTES. SHE CALLED ME OVER AGAIN ABOUT 3 MINUTES LATER AND SAID HER FACE WAS ITCHING. I GAVE 50 MG OF LIQUID BENADRYL AND CALLED HER SISTER TO PICK HER UP. PATIENT HAD NO PROBLEMS BREATHING OR RASH. SHE FELT MUCH BETTER ABOUT 10 MINUTES AFTER THE BENADRYL AND LEFT WITH HER SISTER SHORTLY.
On the day of vaccination approximately 7 hours after, I developed aches all over my body.  The following morning (5-30-21) I got out of bed, sat down to use the bathroom when I experienced an excruciating sharp, sudden pain so powerful it actually threw me back against the toilet tank.  I could not stand up, sit down, or move without the constant, excruciating back pain.  As of this writing I am still experiencing it.
48 hrs after receiving DTP & OPV pt developed a dissimenated erythematous mascular rash over entire body. Pt afebrile active alert w/no respiratory distress.
tachycardia; shortness of breath; chest pressure; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; chest pressure/tightness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP), Program ID:   A female patient received BNT162b2 (BNT162B2), as dose 1, 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: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest pressure/tightness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2013US025054 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly on 27 Nov 2013. No adverse event was reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
approx 24hr post vax pt c/o h/a, body aches (feet hurt), 30-36hr p/vax p/n/v & diarrhea;chills & fever cont today 20JUL98 w/body aches & diarrhea;flu like sx;
Pt recv vax on 3/24/99; on 3/25/99 pt exp fever, swelling/ pain/ red vax site; tx=Ancef, Keflex
A.M. after the vaccine patient noticed excessive tenderness at injection site. At bedtime (day after) pt noticed redness under arm and to the front of arm by pectoral area and soreness under the arm. Symptoms have continued to 2nd day after vaccine.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No relevant medical history information was reported.  Concomitant products included CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for Sleeplessness, PARACETAMOL (TYLENOL 8 HOUR), BIMATOPROST (LUMIGAN), ATORVASTATIN CALCIUM (LIPITOR), MELATONIN and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-377283, MOD-2021-338725 (Patient Link).
Red swollen patch 3-4 inches in diameter of arm at injection site, itching.  Office visit 2 days after date of vaccination, day after reaction started and was starting to improve.
I began to have noticeable pain in my shoulder, particularly in the joint. The pain got increasingly severe over time and has continued through today. It has led to restricted range of motion I called the nurses line and they recommended that I take ibuprofen. I took ibuprofen for 3 days but it had no impact on the pain. I scheduled a doctor's appointment on 07/30/2020 where they indicated I likely had an inflamed bursa and recommended prednisone. The only possible initiating event we were able to identify was the administration of the vaccine. I decided not to take it due to the significant side effect possibilities. Instead, I went to the chiropractor on 08/03/2020 and 08/07/2020. Since receiving that treatment, the pain has begun to fade, though it is still present.
Patient received second dose at clinic (signed up himself) when it was too early.  First dose was administered on 3/16/2021 which would make it 23 days as opposed to 26 days required by manufacturer.
Vomiting and headache ->redness, enduration, warmth. Tenderness at injection site.
Vaginal bleeding at 21 weeks, due 1/7/2022. I had a normal anatomy ultrasound the day before on 8/26/2021. The placenta was low lying but unremarkable otherwise, baby looked healthy. Dose 1 administered the next day8/27/21 noticed spotting 2 days later and increased  over the next 3days later, started  bleeding vaginally. OBGYN  did an ultrasound to check on baby and found 4 large veinous lakes(pockets of blood) in the placenta. Was put on bedrest for 6 weeks. Bleeding stopped after 5 days and baby was delivered healthy at 37 weeks, 4 days.
Overall skin is now darker; Arm pain in other arm after pain in injection arm subsided; Bruise at injection site; Arm of injection pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Overall skin is now darker), PAIN IN EXTREMITY (Arm pain in other arm after pain in injection arm subsided), VACCINATION SITE BRUISING (Bruise at injection site), VACCINATION SITE PAIN (Arm of injection pain) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) for an unknown indication.    Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (0.5 ml, first dose) in April 2021, Pfizer (0.5ml and second dose) in May 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.   On 17-Dec-2021, the patient started INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced SKIN DISCOLOURATION (Overall skin is now darker), PAIN IN EXTREMITY (Arm pain in other arm after pain in injection arm subsided), VACCINATION SITE BRUISING (Bruise at injection site), VACCINATION SITE PAIN (Arm of injection pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, SKIN DISCOLOURATION (Overall skin is now darker), PAIN IN EXTREMITY (Arm pain in other arm after pain in injection arm subsided) and VACCINATION SITE BRUISING (Bruise at injection site) had not resolved, VACCINATION SITE PAIN (Arm of injection pain) and FATIGUE (Fatigue) was resolving and PYREXIA (Fever) had resolved.      No concomitant medications and no treatment medications were reported.  Alcohol was applied to the skin before injection but not after and bandage was applied.   This case was linked to MOD-2021-423597 (Patient Link).
This spontaneous report was received from a licensed practical nurse refers to a 18 year old patient (gender unknown). On 30-JAN-2013, the patient was vaccinated with dose 1 and on 14-MAY-2013, patient received dose 2 of GARDASIL (lot#, expiry not reported) 0.5 milliliter (ml), intramuscularly. On 01-AUG-2013, the patient received dose 3 GARDASIL (lot#, expiry not reported), 0.5 ml, intramuscularly. No adverse effects reported. Additional information has been requested.
received 2 doses of fluzone qiv started having hives; Initial information was received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old and unknown gender patient who  received 2 doses of influenza quadrival A-B vaccine [Fluzone QIV] and started having hives.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknow dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and and received 2 doses of fluzone qiv started having hives (urticaria) (latency: 3 days).  The information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
On April 6th  I  awoke with fever, aches, weakness and a headache.  The headache persisted all day.    On April 7th  beginning at 6:20 pm had chest pain  radiating under my arms which prompted me to go to the ER.  At the ER  I had elevated cardiac enzymes which prompted  admission to the hospital.
This case is a part of 2 cluster cases (same reporter, same product: ADACEL, lot number C4344AB) and is linked to case number 2013-04003. Initial report received from a healthcare professional on 11 March 2013. A male patient (date of birth: not available and age at the time of vaccination not reported), had received first dose of ADACEL vaccine (batch number: C4344AB, expiry date: 06/04/2015, site of administration was not reported) intramuscularly on 07 March 2013. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were unknown. The patient's concomitant medications were not reported. On 08 March 2013 (next day after vaccination), the patient felt a knot which was painful at the injection site and had a red rash around the lump with pain in arms in both direction. Corrective treatment and laboratory details were not reported. The patient's outcome was recovered. List of documents held by sender was none.
One year after administration of ZOSTAVAX, I developed burning sensations in skin on left side of back extending into left breast, including sharp burning needle-like pain. My doctor prescribed NEURONTIN which helped relieve the discomfort.