chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough Covid Infection on July 17.  I had attended my college reunion and was with a classmate who, during n the weekend didn't feel well.  She isolated away from everyone - this was on Friday night/Saturday all day.  We went to visit our son and daughter-in-law on Sunday, July 17.  In the evening I didn't feel right - felt cold and tired, but didn't think much of it.  When I woke up on Monday, July 18, I felt very tire, achy, and had a fever of 102.3 so I took a Covid test and it was positive.  In the afternoon, I contacted an Urgent Care office but I'm not sure of the exact location.  I set up an appointment for a telehealth visit later that afternoon.  I was prescribed Paxlovid, which I started taking on Monday night - one dose.  I followed with the remaining doses and by Wednesday, I felt a lot better.  I continued taking all of the doses and felt really good.  However, after returning to home, I didn't feel well and went to local Urgent Care.  I had developed a bad sinus infection and was given a prescription for Amoxicillin - 850 Mg,   I was instructed to take one pill every 12 hours for ten days.  The doctor at urgent care said that she had recently seen several people who ha been fully vaccinated and boosted who tested positive for Covid and after taking Paxlovid, also came down with a sinus infection.  The friend I was with at the reunion who got infected first and took Paxlovid, also developed a sinus infection.  It took a few weeks before I felt 100%.
BODY ACHES; FLU LIKE SYMPTOMS; SHIVERING; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included received pfizer in past and had no problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) 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 subject experienced body aches, flu like symptoms, shivering, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, shivering, headache and body aches was not reported. This report was non-serious.
Information has been received on 06Oct03 from a 64 year old female with a past medical history of several reactions to other medications who was vaccinated weeks ago with pneumococcal 23v polysaccharide vaccine, IM. There were no concomitant medications. Subsequently, the pt developed redness on her arm accompanied by pain. Additionally she reported feeling dizzy and lightheaded. The pt went to the ER but was not admitted. The pt reported as not recovered. Additional information has been requested.
Flu vax provided by pharmacy to employees at City Hall. A few hours after receiving vax, I noted pain and itching at the vax site. In the evening I could see that the vax site was red and swollen in addition to being painful. No improvement 48 hours later.
Erythromatic Rash 6 x 4 cm on Left arm warm non-tender.
I felt the nausea; everything was so bright you know, I had the same effect but mine went away; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration on 15May2021 at 04:00 PM, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received list of any other medications within 2 weeks of vaccination. She stated that she stayed at hospital like half hours for her daughter because the doctor said to stay there and then she felt the nausea, and everything was so bright on an unspecified date, in May2021 and she had the same effect but went away. She stated that she did not have too many reactions. The patient did not receive any allergy medication Prior to vaccination and was not diagnosed with COVID-19. The patient was not tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient was resolved from the events.  Information on the Lot/Batch number has been requested.
Patient received dose #2 of Pfizer vaccine on 6/6/2021 @ Vaccination site and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 7/4/2021 as recommended. No adverse reactions identified on site.
Two days post vax, pt experienced swelling at the injection site.  Ten days after the onset, the pt recovered.
This spontaneous report was received from a registered nurse and refers to the multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M015926 with expiration date on 28-JUN-2017, dose and route of administration were not reported), for prophylaxis. The vaccines were exposed to temperature excursion of 5.5 degrees Fahrenheit for 4 hours and 45 minutes and 24.8 degrees Fahrenheit for 15 hours and 40 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.  Follow up information has been received on 22-NOV-2016. A message was left requiring a return call from the nurse and a request was made for the patients' identifiers and dates of vaccinations. All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA003925: US-009507513-1610USA004868: MERCK 1610USA004869:Mfr number.
PNEUMOVAX given 12-4-13. Pt called 12-8-13 and stated her arm really hurt and was red and swollen. She also complained of lethargy, chills, and headache on 12-9-13, pt stated it was better - swelling down, but still sore. Swelling a couple of inches in diameter and red around it, but pt does not think it is infected
urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CIPROFLOXACIN for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.        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.   Concomitant medications include Cholesterol and high blood pressure medication
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
upset stomach and headache the evening of injection the next day. 2 days later - rash/bumps on abdomen
No adverse event. Error of giving Pfizer bivalent dose instead of monovalent dose.
Patient experiences a shingles like rash after dose #1 .  STarted 6 days after vaccine.  Provider treated herpes zoster with acyclovir.  Rash - several blisters on left side of lower chest, erythema present.   Did receive 2nd dose on schedule.
Colitis ulcerative aggravated; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ulcerative colitis.    The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) had not resolved.        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 concerns a 62-year-old female with a serious unexpected event of ulcerative colitis flare. Event onset the same day as first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of ulcerative colitis flare. Event onset the same day as first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022; Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 11-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Vial initially stored in refrigerator on 04 Apr 2022. Vaccine did not undergone any temperature excursion issue.  No treatment medication reported by reporter.
Syncope occurred 10-15 seconds after getting COVID vaccine.  Was sitting  in the car with mother at a drive-through clinic and no injury was noted.   He was not driving vehicle.  He was immediately aroused and was oriented to person, place and time.  He did not seek medical help after leaving clinic due to feeling well.  Symptoms resolved immediately.  Upon speaking to patient(Mother with him), he continues to have no symptoms and advice was given about future vaccines and hydration.   Patient stated that he will seek medical help if having any new/worsening symptoms.
Vaccine given 10/12/2016 after about 2 weeks, decreased arm strength. No other symptoms. Progressive decline in ability to do push-up (no pain, no joint sx, no injuries) normally I was doing 15-17 push-up at times, regular exercise could not do more than 2-3 push-up. Lasted about 8 weeks, normal strength regained after 3-4 months. Did not do any investigations as there was no associated leg weakness. Weakness of both arms equal. Only decline in capacity to do lifting, push-up. Did not drop any objects. Minor activity no difference. No neck issues at this time. No tingling or numbness pure muscle strength decline.
Body aches, chills, low grade fever, and small amount of chest congestion with cough.  Seem to have lost taste and smell
dizziness that at times felt like she was going to faint; cannot use her left arm to do certain things; pain in her arm goes all the way down to her hand; itch at injection site; arm is still hurting, arm hurts more while she drives, pain in her arm goes all the way down to her hand; fever; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness that at times felt like she was going to faint), JOINT RANGE OF MOTION DECREASED (cannot use her left arm to do certain things), PAIN IN EXTREMITY (pain in her arm goes all the way down to her hand), VACCINATION SITE PRURITUS (itch at injection site) and MYALGIA (arm is still hurting, arm hurts more while she drives, pain in her arm goes all the way down to her hand) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced DIZZINESS (dizziness that at times felt like she was going to faint), JOINT RANGE OF MOTION DECREASED (cannot use her left arm to do certain things), PAIN IN EXTREMITY (pain in her arm goes all the way down to her hand), VACCINATION SITE PRURITUS (itch at injection site), MYALGIA (arm is still hurting, arm hurts more while she drives, pain in her arm goes all the way down to her hand), PYREXIA (fever), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness that at times felt like she was going to faint), JOINT RANGE OF MOTION DECREASED (cannot use her left arm to do certain things), PAIN IN EXTREMITY (pain in her arm goes all the way down to her hand), VACCINATION SITE PRURITUS (itch at injection site), MYALGIA (arm is still hurting, arm hurts more while she drives, pain in her arm goes all the way down to her hand), PYREXIA (fever), VOMITING (throwing up) and HEADACHE (headache) outcome was unknown.            No concomitant medication was provided.
UrticariaPruritus Narrative: Patient with mild rash to his tors/BUE after receiving his first dose of COVID-19 Pfizer vaccine. Patient has anseredno know allergies to any medications. Patient alert and oriented x 4, denies shortness of breath, chest pain or palpitation. Denies dizziness, nausea, or vomiting.
Information has been received from a registered nurse concerning unspecified number of patients of unknown gender in greater than 18 years old. The patients' relevant medical history was not reported. On unknown dates, the patients were vaccinated with M-M-R II (lot# K005109, expiration date 04-APR-2016) (dose, dose number and route not reported) which were improperly stored. Information about concomitant medication was not reported. The temperature excursion for M-M-R II was not supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. The registered nurse provided that there had been no adverse events reported following the administration of the vaccinations and on need for revaccination. PQC (product quality complaint) was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no medical history and drug allergies who on 25-AUG-2008 was vaccinated with her second dose of GARDASIL.  There  was no concomitant medication.  Subsequently the patient was pregnant and her LMP was 18-AUG-2008.  She had a fetal ultrasound showing possible unspecified fetal abnormalities.  Lab diagnostics studies included unspecified blood test and fetal ultrasound.  The patient had an office visit for medical attention.  Additional information has been requested.
Fever, headache, exceptionally sore arm, rash from shoulder to elbow, and development of shingles rash within 72 hours of administration of the Covid19 vaccine
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 3rd February 2023, the patient received Havrix. On 3rd February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up via postal mail. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
patieht came in 10/9/2021  said that he had gotten 3 vaccines on 10/5/2021 as listed above and the next day 10/6 started developing signs of cellulitis,  Patient went to his primary on 10/8/2021 and she sent him directly to the ER.  HE was admitted overnight with IV antibiotics and released today 10/09/2021 on oral antibiotics
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of ROTATEQ (lot # K023157, expiration date 23-JUL-2016) (orally, dosage and frequency were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient came into the pharmacy for a scheduled flu shot. He had been in earlier that day and had talked to me about both the Covid vaccine and the flu shot. When they came in, the pharmacy was very busy and I recalled our conversation about the Covid vaccine booster. Therefore, I pushed the paperwork through for the Moderna booster instead of the flu shot. The shot was given and when the patients were asked for their Covid cards, the pharmacist then discovered that they were here for flu vaccines. I, the pharmacist, then came over and talked with pt about the mix-up. I confirmed that he was due for the booster vaccine, but was wanting to wait a couple weeks for it. I tried answering all of their questions that I could at the time and then made sure to document it after. Their provider was contacted that day to communicate the mistake.
The vaccine was given fairly high up on my right deltoid on Thurs pm 3/11/21. The next day the shoulder itself (not just the injection site) was very swollen and  painful  and I had very little range of motion (on a scale of 1-10 it was worse than having a dislocated shoulder, which I have experienced) . The swelling abated in my shoulder by Friday pm but then moved up (??) my neck to the triangular place between the neck, collar bone, and trapezeid muscle and was large enough to cup my palm over. It is now 3/16/21 pm and the majority of the swelling is gone, no more pain, some residual stiffness in my neck and shoulder. I had the "normal" COVID response to the vaccine of a fever and fatigue.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the heath dept. on a compliance improvement plan and has been reinstated vaccination privileges.
DEATH CERTIFICATE LISTS "COVID-19, OLD CVA, AND DEMENTIA" AS THE CAUSE OF DEATH.  PATIENT WAS A RESIDENT AT LTCF WHEN DEATH OCCURRED.
C/O extreme fatigue, nausea, decreased appetite. Hot/call "thrashing around in bed" x 3 days.
This spontaneous report as received from a other health professional refers to an adult patient of unknown exact age. On 01-AUG-2017, the patient was vaccinated with PROQUAD lot # M022402 for prophylaxis. Concomitant therapies included STERILE DILUENT. No adverse events were reported. Additional information has been requested.
The day after I received the vaccine I noticed some redness and swelling at the injection site.  Over the next 2 day the swelling increased to about 2-2.5 inches in diameter and became itchy.  At the time this form was filled out, the swelling had decreased to about 1.5 inches in diameter but the redness had not decreased and there was still mild itching at times.
Large red area on left arm (two shots given in this arm) and warmth. Patient was told to monitor and if redness worsened, spread or fever developed to be seen immediately by physician.
Pain at site, hot to touch, redness and swelling to site.  Taking Advil and ice to site.
7:35 AM RECEIVED VACCINE 8:15AM NOT GIVING EYE CONTACT, NECK TURNED TOWARDS HER LEFT SHOULDER WITH HER LEFT EYE CLOSING & LEFT SIDE OF MOUTH DROOPING. EYE TURNED OUTWARD.  LEFT SIDE FACIAL TWITCHING. BP 220/110. POX 79-80% RA. PLACED ON OXYGEN & TRANSPORTED TO MEDICAL CENTER ER FOR EVALUATION.  9:19AM PCP NOTIFIED 9:23 AM FAMILY NOTIFIED BY PCP CLIENT WAS  ADMITTED TO THE HOSPITAL
A report has been received from a non-medically confirmed source concerning a 3 year old female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 17-Dec-2014 the patient was received nasal FLUMIST QUADRIVALENT but the vaccine was expired (Preferred Term: expired drug administered) on 02-Dec-2013. At the time of reporting, the outcome of the event of gave expired FLUMIST QUADRIVALENT was unknown. The report was considered to be non-serious by the reporter.
severe muscle pain, hallucinations, chills, severe shacking, headache, fever. Long term on going side effect bouts of Vertigo 1-3 times a week.
About 2 minutes I received the vaccine I felt my right upper lip swelling and tingling, then left start and migrated to my ear and down to my jawline. Difficult to swallow.