chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leading up to August 7th I had general aches and pains, tiredness, nausea, and right underarm lymph node enlarged.   Later in the morning of the 7th, I had urinary tract pain when urinating.   The urine was a dark yellow and very cloudy with a horrible smell and when I wiped there were a couple of small specks of blood.  I had planned on going to the Emergency Room, however, I was able to control the pain and clear the issue with lots of fluids.  On August 8th I awoke with chills and drenched in sweat.  From that point on all symptoms stopped except for some minor urinary tract pain which subsided on August 10th.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (dose, frequency, route and indication were not provided). No concomitants were reported. No adverse symptoms reported. No further information provided. Outcome of events was unknown. No product quality complaint (PQC) reported. Additional information has been requested.
Information has been received from a nurse concerning a female patient who was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. The patient experienced a rash "a few months after getting the first dose". The patient also developed a rash a few months after second dose of vaccine as well. It is unknown if the patient received her third shot or not. The patient  sought unspecified medical attention. Additional information has been requested.
On 09/09/2015 at 6:00 PM patient arrived home, she felt fatigued, and nauses. On 09/10/15 woke up with congestion, nausea, light headedness, cough. Cough was dry and non productive, sore throat. Treatment rest, fluids 2 tablets of naproxen, tussin DM and musin X D.
First dose in 2018. Late for the 2nd dose.; This case was reported by a other health professional and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient received the first dose but did not receive the second dose till the time of reporting which led to incomplete course of vaccination. The reporter wanted to know if the series needs to be restarted. The reporter consented to follow up. No further information was reported.
31oct89 pt vac hepta B. w/i 12hrs pt ex. fever 101F, malaise& swollen lymph glands in neck and groin.06dec89 pt vax hepta B. w/i 12 hrs ex. fever aches pains, gen malaise & swollen neck glands.flu-like symp resolved.
Information has been received from a physician concerning a 62 year old male patient who on approximately 01-MAY-2011, "beginning of May", was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). On approximately 31-MAY-2011, "Around the end of May", the patient was admitted to the hospital with a rash across his forehead and into both ears and on both hands. Swabs of skin lesions as well as spinal fluid were examined. Lab cultures and PCR were negative for varicella zoster virus (VZV). Acyclovir was given for the treatment of the adverse events. The patient went home at the beginning of June when his lesions crusted over. At the time of the report, the patient was recovering. Follow up information has been received from the physician who reported that the rash was diagnosed as iododerma and not related to ZOSTAVAX (Merck). Additional information has been requested.
3 cm erythema, 4 cm induration on left thigh. Warm to touch. Developed over 2 days.
I did not have an adverse reaction to the vaccine.  I began not feeling well on 12/30/2022 with a tickle in my throat. On 12/31/2022, I tested positive with COVID-19 on 12/31/2022. I saw my doctor, she came out to my car, on 01/02/2023 and I got a prescription for Paxlovid. I tolerated the medication without any complications.  I had spinal surgery 09/2022. After I healed from COVID-19, my spinal pain and my arthritis was very intense for about three months.
began to feel light headed and dizzy during 15 minute wait, after about 15 minutes it did not subside and her hands began shaking uncontrollably, ems was called and they brought her to the tent and checked vitals, b/p and pulse were elevated. after waiting 30 minutes and drinking a little water patient expressed that they felt better and walked out of center on her own accord.
After my first vaccine I noticed a few days I had some menstrual cramps. I didn't give much thought to it. However, after my second dose the cramps were so bad and I felt like my uterus was burning-- it was then I put together the correlation between the first shot and the cramps and the second shot and the terrible pain I felt.
pt recv vax 4DEC95 & 2 days later pt devel fever & fatigue;2 days p/vax pt devel inj site rxn, characterized by a taco shell shaped circular welt, redness, & poss rash;no other details were known as of reporting date;
Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.
recurrence of shingles; she was diagnosed with shingles due to back pain and a rash; This spontaneous report was received from a consumer referring to herself, a 70-year-old female patient. The patient's concurrent conditions included depression, hypertension, blood cholesterol increased, lung disorder, arthropathy and drug hypersensitivity (demerol, morphine, versed, penicillin, statins). The patient's concomitant therapies included gabapentin, tramadol hydrochloride, diclofenac, acetaminophen (TYLENOL), duloxetine hydrochloride, hydrochlorothiazide, potassium chloride, montelukast sodium (SINGULAIR), omeprazole and cholecalciferol. Information regarding the patient's medical history and historical drugs was not provided.   The patient reported that on an unknown date in December 2016, she received a dose of zoster vaccine live (ZOSTAVAX) for immunisation (strength, dose, frequency, route of administration, lot number and expiration date were not reported), and on an unknown date in July 2017, she was diagnosed with shingles due to back pain and a rash. Then in July 2020 (reported as "3 years later"), she had a recurrence of shingles. She reported the pain was affecting her every day life. She believed the zoster vaccine live (ZOSTAVAX) had caused her to develop shingles. The patient reported during her first episode of shingles she spoke with a lawyer in regards to a class action suit for zoster vaccine live (ZOSTAVAX), but she was not included in the suit due to the time frame of her diagnosis. She was no longer pursuing legal action. She would like reimbursement for zoster vaccine live (ZOSTAVAX).  At the time of reporting, the outcome of the event shingles was unknown.
Pt had redness, itching, and a hive develop after the vaccine was give. Pt was given (1) 10mg Zyrtec by mouth. Pt's symptoms decreased. No SOB. Airway clear and patent. Dr. d/c patient home.
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
Patient returned to pharmacy after her vaccine stating  that is was laboring to take a full breath in.  She was still getting enough oxygen to stand, walk and talk; however, she felt like it was difficult for her to fully fill her lungs.  Patient denied any mouth/throat swelling, nausea, dizziness, or itching.  Patient presented with out a rash or fever.  Patient sat by the pharmacy for over 20 minutes as we watched her.  Patient's condition was not getting any worse but was not getting any better.  The mother, who was with the patient, took the patient to a clinic setting so that she could get a full exam workup.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-APR-2010, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 21-FEB-2011, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Approximately 22 hours after receiving the injection I had a severe headache, chills, fever of over 101, weakness, sluggishness. It lasted through the day and most of the night but by morning the fever was down and the headache diminished.  The arm was very sore and the gland under my arm still is swollen and sore 4 days later.
surge of high blood pressure; rash on the side of her body/Rash on back, sides, butt, stomach; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (surge of high blood pressure) and RASH (rash on the side of her body/Rash on back, sides, butt, stomach) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (surge of high blood pressure) and RASH (rash on the side of her body/Rash on back, sides, butt, stomach). The patient was treated with STEROIDS at an unspecified dose and frequency. At the time of the report, HYPERTENSION (surge of high blood pressure) had resolved and RASH (rash on the side of her body/Rash on back, sides, butt, stomach) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications reported.
pt recv vax 17SEP97 & the next day pt exp a site reaction consisting of a 3-4inch red welt, irritation & itching @ the site of inj;
Patient was here to get her second Moderna COVID-19 vaccine and was administered a Janssen vaccine instead on 4/8/21.
The adverse event was two months AFTER the 2nd COVID booster so not an adverse reaction to the injection. Instead, COVID symptoms began June 14, and received a positive COVID test on June 15. Symptoms included cough, slight sore throat, mild fever for several days, body aches and headache, fatigue. Received monoclonal antibodies as a COVID treatment on June 16, at the Emergency Department (hospital). Within a few seconds of the beginning of the intravenous infusion I had a negative reaction: Very fast heart rate (more than 130 bpm) and heart "pounding." Was administered benadryl intravenously. Reaction ended after about two minutes.
localized inflammation 3 1/2 x 5 1/2" Keflex x 10 days;
Depression symptoms coming up; Not thinking as well/ Not active/not able to get out of bed; Feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (Depression symptoms coming up), MALAISE (Not thinking as well/ Not active/not able to get out of bed) and FATIGUE (Feeling tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ARIPIPRAZOLE (ABILIFY) and QUETIAPINE FUMARATE (SEROQUEL) for Psychotic disorder.   On 27-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-May-2021, the patient experienced DEPRESSION (Depression symptoms coming up), MALAISE (Not thinking as well/ Not active/not able to get out of bed) and FATIGUE (Feeling tired). At the time of the report, DEPRESSION (Depression symptoms coming up), MALAISE (Not thinking as well/ Not active/not able to get out of bed) and FATIGUE (Feeling tired) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
so sick; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced so sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious so sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
On July 5, 2021 rapid heart rate in the middle of chest, no other symptoms.  This has continued at random times and increased in rate of occurrence.  This happened while resting, working, walking, eating, no trigger or pattern to occurrences.
In about six hours after receiving the vaccine, I felt achy all over for about a day. On 01/17/2023, I was working out with a training doing core muscle exercises and I felt very lightheaded. I sat down and got very nauseated, and my blood pressure was 60/42 and going down. I asked to lay down with my legs propped up and I felt better.  I went to my doctor on 01/20/2023 and it was determined that I did not drink enough water during the workout. I am wearing a heart monitor for 30 days as of 03/28/2023.  In 04/2022, I tested positive for COVID-19. I got a prescription for Paxlovid and tolerated the medication without any issues.
Pt presented with lower addominal Pain and Covid. Treated with remdesivir and dexamethasone. Antibiotics given for uti. Pt discharged to hospital.
This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX (lot # L010146 with an expiration date of 24-MAR-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was reported that the VARIVAX was reconstituted with sterile diluent (manufacturer unknown) (lot number M031575 with expiration date of 26-MAR-2019). No adverse effects were reported. Additional information has been requested.
Redness,warmth,swelling painful, treatment was steroids 20 mg 2x daily x 5 days, ceflex 500 mg x7 days was resolved in 3 days.
migraine headache, severe neck pain, nausea, sinus issues, ear pain, joint pain, chills, sweating . symptoms started on 9/14/2021 and are still ongoing with just sinus issues and chest congestion that just started. Worst of symptoms occurred for 5 days.
On that Saturday night, I noticed that there was a bruise on my left breast. Next to it there was a red mark. That's not normal for me. On Monday morning, I called my doctor and told her about it. She said she had a patient who had the same exact symptoms. She wanted me to get a mammogram and ultrasound and my gynecologist said she wanted to see me before the tests. I went and saw her the next day and she examined me. She said she didn't feel like it was anything serious and let me go ahead with the tests. 11/26, I went in for the ultrasound and mammogram, reports on the same day and they showed nothing. By 11/27 the bruise healed and got better throughout all of this. That Saturday the marks were gone, and I just never noticed them because there were no symptoms. They were visual but I never noticed them until that point. Unable to provide Lot number currently.
This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 26-SEP-2018, the patient was vaccinated with an unsupported and improperly stored dose of M-M-R II lot # N027780 with expiration date on 08-AUG-2019 (strength, dose and anatomical location were not provided), administered subcutaneously for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (MERCK). The storage temperature of the vaccine was reported as 9 to 25 degrees Celsius (°C) (13.5°C) for a time frame of 3 hours and 4 minutes. There was a previous temperature excursion from 9 to 25°C (14.1°C) for 2 hours 13 minutes; therefore, the cumulative time for the temperature excursions at the same temperature was 5 hours 17 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
administered expired vaccine to 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 (administered expired vaccine to patients, after the manufacture date of expiration) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion and it was unknown when the vial was initially stored in the refrigerator Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
Based on additional information received on 11 January 2016, this case become medically confirmed. Initial unsolicited report received from a consumer on 15 October 2015. This case involves a 46-years-old male patient who was vaccinated with a dose of YF-VAX (batch number: unknown, dose, dose in series, route of administration were not reported) in left arm on 27 September 2015. The patient illness at time of vaccination was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as allergies to bee stings. Concomitant medications were not reported. On an unknown date, fifteen days following the vaccination, the patient had developed intermittent, rash, over chest, arms, and stomach that was sometimes itchy and continues to have "bruise" at injection site. It was reported that rash developed at times of increased body heat such as after a workout or after morning shower which lasts for about twenty minutes and goes away and had intermittent rash over the past 3 days. Laboratory data and corrective treatment was not reported. The patient was not recovered from all the events. Follow up information received from physician on 11 January 2016. The patient was vaccinated with YF-VAX (batch number: UI094AA, expiry date: 30 October 2016) via subcutaneous route in left arm on 27 September 2015. List of documents held by sender: none.
Case number PHEH2014US007744 is an initial spontaneous report received from a pharmacist on 15 Apr 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of FLUVIRIN (batch number: not reported) in the mid of Nov 2013. It was reported that after vaccination, on an unknown date in the mid of Nov 2013, she experienced vaccination site reaction which was further described as red lump about the size of a pea at the site. She saw a physician on an unknown date in Jan 2014 or Feb 2014. The event outcome was unknown. The seriousness and causality were not reported.