chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 30 Sep 2016. This case involves a 77-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number: UI654AD, expiration date: 07 Apr 2017, dose, dose in series and site of administration were not reported) intramuscularly on 29 Sep 2016. Patient's medical history as Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Patient denied any illness at the time of vaccination. Concomitant medications were not reported. Patient deined any other vaccinations within four weeks of vaccinations. On 30 Sep 2016, one day following the vaccination, the patient developed red, warm to touch, slightly swollen, with 0.5 inch indention on injection site. It was reported that any other symptoms was denied. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient without pertinent medical history. On 06-OCT-2013 the patient was vaccinated with ZOSTAVAX lot # J004267, single dose, subcutaneous. A nurse practitioner mentioned to the reporter that her practice administers ZOSTAVAX in the deltoid muscle. No concomitant medications. Since administration of ZOSTAVAX the patient experienced pain and tenderness at the injections site. The patient visited an unspecified nurse practitioner who evaluated the event. The patient did not receive any treatment. The outcome of pain and tenderness at the injections site was reported as not recovered/not resolved. Reporter causality was not provided. Additional information has been requested
Medical unit: Patient presents for 1st booster dose of  Moderna Covid vaccination. Previous vaccination Jannsen 5/14/2021 When documenting vaccine administration in eCW, the lot # noted expiration date of 07/08/2022.  Vaccine administer to patient on 7/13/2022. No adverse reactions noted during required post vaccination observation period. Scheduled for follow-up.
Pt recvd 3 doses of Engerix-B, 3rd dose recvd DEC90 & it was determined that pt was a non-responder;
two patients were administered "non-viable" FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Media information (under the reference 00872588).  This case is linked to case 2021SA415946(CLUSTER).  This case involves two patients who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (poor quality product administered).  The patients' medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 08-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7376MA and expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong technique in product usage process (latency: same day).  It was reported  pharmacist called to report that two patients were administered "non-viable" FLUZONE QUADRIVALENT today 08Dec2021. Pharmacist reports that they received a shipment of (12) FLUZONE QUADRIVALENT today. Pharmacist reports that two (2) patients received the FLUZONE QUAD vaccine today from that shipment.  Reporter stated that RPh reports that it was discovered later in the day that the packing slip says the package was in transit since September. RPh reports the product was cold upon receipt so no one noticed the packing slip date. RPH spoke with and was advised that vaccines were non viable since the packaging slip reports that it was in transit since Sept 20, 2021. Pharmacy also received (11) boxes of FLUZONE HD in that same package. No patients received the FLUZONE HD vaccine. (12) FLUZONE QUAD with LOT# UT7376MA EXP: 6/30/2022 (11) FLUZONE HD with LOT# UJ7S0AC EXP: 6/30/2022 RPh is inquiring about re-vaccination for these patients  At the time of reporting, no adverse event reported.   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 the 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.
following vaccination patient noticed redness about two inches below the injection site.  She also had some localized itchiness.  She came to the observation area about 1340 HR 75 BP 99/54 oxygen sat 91%.  Which she states are normal vitals for her.  She was observed for 25 minutes with no extension of the redness and itchiness.
Patient presented to the ED and was subsequently hospitalized for syncope and collapse within 6 weeks of receiving COVID vaccination.
Tingling right hand. 148/76 88 16. REFUSED transfer, feeling better.
Nausea/vomiting, chills developed acutely 2 days after vaccine administration
This spontaneous report as received from a physician refers to two patients of unknown age. This field representative noted that this physician stated he "administered ZOSTAVAX (lot/batch  # and dose were not provided) to two unspecified patients with active recurrent herpes simplex virus infections on unspecified dates." No adverse effect reported. Additional information has been requested.
Pt experienced local reaction to Diptheria and Tetanus Toxoids and Pertussis vax.  Pt received the pediatric vax instead of the adult vax.
lips are so dry; Red; rash in her face, around their teeth, nose and forehead; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (lips are so dry), ERYTHEMA (Red) and RASH (rash in her face, around their teeth, nose and forehead) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced RASH (rash in her face, around their teeth, nose and forehead). On an unknown date, the patient experienced LIP DRY (lips are so dry) and ERYTHEMA (Red). At the time of the report, LIP DRY (lips are so dry), ERYTHEMA (Red) and RASH (rash in her face, around their teeth, nose and forehead) had not resolved.            Concomitant medication included unspecified high blood pressure medication. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
WOKE UP FEELING FINE, AS TIME WENT ON, BODY ACHES IN JOINTS BEGAN TO HAPPEN
Child recieved vaccinations and approx 5 days later child was in critical condition. Prior to the actual incident my child was extremely cranky the day before it occurred. My Child was found by sitter not breathing and bluish color change to skin and lips. My child was rushed to hospital with seizures and not breathing. Finally after testing they diagnosed encephalitis. When asked if it could be from vaccinations they said "no", he must of caught it from someone in the public? He was on seizure medicine until 1 yrs old and has permanent optic nerve damage from the seizures & from stopping breathing until encephalitis was diagnosed. He is legally blind from the damage received from the encephalitis.
Telephone call from mom on 7/19/02 states swelling from right deltoid to elbow with redness and itchiness ince 7/16/02 evening. PHN recommended Benadryl and to call MD right away.
Right upper arm red/swelling/tenderness. Swelling 4.5x2.5.
A few days after having the shot, I experienced some things at another doctor visit. My blood pressure was high and on the same day, I began to feel tremors and muscle spasm in the arm where this continued for several days. They determined that it was an anomaly as far as the spike. They took it on another area of my arm and the blood pressure was in normal range. I have not had an opportunity to speak with the doctor about the muscle spasms yet. They are not as frequent as before, but they still show up. I'm not sure whether I have completely recovered but I don't recall feeling the spasm in the last 12 hours, but it does come and go. The doctor indicated that they would continue to monitor the blood pressure to see if there are additional issues.
tested covid positive; tested covid positive; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 17May2021 as dose 2, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jul2022, outcome "unknown" and all described as "tested covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive, notes: She also found to have positive COVID-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of vaccine and the information available the Causal relation between the events VACCINATION FAILURE, COVID-19 and suspect drug are assessed as related
THYROID WAS TOTALLY OUT OF RANGE/ IT WAS MESSING UP THE THYROID AND STUFF; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was taking unspecified medication for thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thyroid was totally out of range/ it was messing up the thyroid and stuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thyroid was totally out of range/ it was messing up the thyroid and stuff was not reported. This report was non-serious.
Dislocation of hip and then revision of right hip. ED visit, surgery and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
pt recv vax; stiffness of muscle causing pain radiating in to neck & down lt forearm w/ muscle weakness, n, lasting 5 days; onset approx  10 hr p/ vax;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 208, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
My side hurt from the armpit down, and I also broke out into hives with sweat everywhere. It was very horrible.
Patient possibly inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient notified. State notified.
Positive arm pain worsening x2d after immunization given with appearance of redness/heat on day 2 that spontaneously resolved on day 3 - still some induration day 3.
This spontaneous report was received from an unknown source refers to a patient of unknown age. On 13-JUN-2013, the patient was vaccinated with an expired dose of ZOSTAVAX, (lot number and route was not reported, expiry date 03-APR-2013). Concomitant medications were not reported. No adverse event was reported. Additional information is not expected.
7/19/2022 Felt like an allergy attack.  7/20 this felt like a cold Runny nose, shallow cough, aches and pains.  7/21 slight fever.  7/22 Tested with At home COVID 19 test, negative.  7/24 Tested with At home COVID 19 test, positive.  Called Doctor's office and left a message.  7/25 televisit with doctor, who advised rest and to treat symptoms as needed with tylenol and cough syrup.  Symptoms continued unchanged until time of reporting.  8/3 Tested with At home COVID 19 test, negative.
Epinephrine refill request. This visit was within 6 weeks of receiving the COVID vaccine.
Several  weeks after receiving first dose  of Moderna  Covid  vaccine on January 14,  I  stated having isolated  bullous skin eruptions on my feet. These appear as large tense blisters and last several weeks. These have continued to erupt, independent of trauma or other precipitating factors.  I continued to receive all doses of the vaccine  on 2/11/21 and 9/30/21 and my dermatologist has examined these lesions and can find no other cause and proposed this might be vaccine related
Racing heart rate and chest pain out. My heart rate would not go below 110 for most of the day. I called the nurse line and was told to go to the emergency room, which I did. I had chest x-ray, EKG and blood work done and none of it came back abnormal. I had to be given a beta blocker to be able to bring my heart rate down.
Patient reported pain at injection site that started at around 9 PM (approximately 8 hours after immunization occurred) with heat radiating down the length of the arm. She woke up at around 12 midnight with restless sleep throughout the night and into the morning. She did not take any pain medication. Upon reporting this to the pharmacy she was advised to inform her primary care physician to determine course of action including any pain medication she can take.
Fever, Chills, Full Body Aches, Injection Site Soreness, Fatigue
Flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported Got the flu shot in Sept. and had the flu after November.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
She woke up feeling fine and her period symptoms also stopped out of nowhere; Her period just stopped out of nowhere; Had common side effects of chills; Second shot within 5 hours she started to feel achy,she was hurting all over; Patient got her first shot on 20Sept2021 and second shot 1Nov2021; It was a rough night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It was a rough night), THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere), AMENORRHOEA (Her period just stopped out of nowhere), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced MALAISE (It was a rough night), CHILLS (Had common side effects of chills), MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021). On 02-Nov-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) and AMENORRHOEA (Her period just stopped out of nowhere). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her first shot on 20Sept2021 and second shot 1Nov2021) had resolved. On 02-Nov-2021, MALAISE (It was a rough night), CHILLS (Had common side effects of chills) and MYALGIA (Second shot within 5 hours she started to feel achy,she was hurting all over) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She woke up feeling fine and her period symptoms also stopped out of nowhere) had resolved and AMENORRHOEA (Her period just stopped out of nowhere) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Some areas on my skin that are quite a little large that I have that I would like to report; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report) in a female patient of an unknown age 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. On an unknown date, the patient experienced SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report). At the time of the report, SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up information received on 05-JUN-2021 contains significant information- event outcome added. Patient stated her events resolved in 3days and she did not took any medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
lower back pain; muscle tight; muscle pain; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain), MUSCLE TIGHTNESS (muscle tight), MYALGIA (muscle pain) and ARTHRALGIA (shoulder pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided.  Patient took every day 2-3 Advil and Tylenol to ease   This case was linked to MOD-2021-095167 (Patient Link).
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Chills, vomiting, muscle soreness, shakes, clamy skin, pain, redness, swelling, headaches, fatigue, seeing colors and sparks, etc.
Developed a cold sore within 5 hours of receiving shot. No tingle or itch to warn of impending cold sore which is unheard of with cold sores. Right arm extremely sore with large warm red lump extending beyond the site of the shot which lasted for four days.
ONE MONTH AFTER VACCINE, DEVELOPED SEVERE ALLERGY TO ORANGES. VOMITING, HIVES, SEVERE ITCHING. SYMPTOMS ;ASTED 2 HOURS. OCCURED AGAIN AFTER EATING ORANGE 2 WEEKS AFTER 1ST REACTION.
Patient received vaccine that was involved with a Temperature excursion and was not deemed viable by manufacturer to use.
Droopy Eyelid, Lymph Node Inflamation, Swelling near Lymphnode (armpit, pectoral muscle)
about 12 hours after the shot, I woke up with excruciating headache, body aches, compromised ability to walk to bathroom, dizzy, nauseous,to times I took my temperature it was 101.4 and 101.9, normally it i s low 95s.. also got chills, felt very ill, abdominal pain along with bad back ache. also very fatigued.  Felt worse than I did when I had covid in Nov. Spent 3 days in bed as every time I got up I felt like i was going to pass out.  On 3rd day got chest pain/tightness  and at times it felt like bad heartburn.  I am better today  with only slight chest discomfort.  No appetitite - lost 7 pounds Wed - Friday
At the onset was extreme lower right leg pain, pain was so bad walking wasn?t possible! The pain proceeded to shoot up the leg and nothing would help, heat, ice, chiro, stem all tried. One week later with pain the whole week the right foot broke out in blister like rash and went to the hospital and was diagnosed with shingles.